Steffen Lang

As President, Operations, Steffen Lang leads a team of 35,000 associates dedicated to manufacturing and supplying high-quality medicines to patients, and providing operational support to the entire Novartis enterprise. Novartis Operations incorporates the company’s manufacturing, quality, and supply organization, as well as information technology, data and digital, procurement, environmental sustainability, facility services, and other global services.

Prior to taking on this role, Steffen was Global Head of Novartis Technical Operations (NTO). Under his leadership, NTO underwent a transformation to become one of the leading manufacturing and supply organizations in the industry, providing agile, efficient support to the business, and reliably delivering life-changing medicines to patients around the world. During this time, the unit adapted its manufacturing capacity and capabilities to the changing needs of the Novartis strategy and product portfolio, maximizing the potential of its assets and expertise. As well as delivering technological innovation to enable the production of advanced therapeutic platforms, the unit collaborated with industry partners to support global demand for COVID-19 vaccines and therapies.

“I’m inspired by our patients, steered by our people, and passionate about data science and technologies. I am proud that through the diversity and unique expertise of our organization, our collaborative approach, and our strong focus on operational excellence, we are enabling Novartis to deliver transformational solutions that are helping us to expand the positive impact we have for our patients, our associates, the business, and society.”

Steffen draws on a wealth of experience in the pharmaceutical industry, with a career that ranges from research through development to manufacturing and supply. He joined Novartis in 1994 as Head of Laboratory in Research, and held positions of increasing responsibility before taking on his present role in 2022.

In his spare time, Steffen enjoys indoor and outdoor sports, and spending time with his family and friends.

Karin Shanahan

Karin Shanahan oversees worldwide product development, manufacturing and supply for Bristol Myers Squibb as executive vice president, Global Product Development & Supply (GPS). GPS develops and produces active ingredients and drug products and delivers the company’s medicines throughout the world. The GPS team achieves this mission through a relentless focus on innovation, quality, safety and agility.

“I’m excited to return to Bristol Myers Squibb, where I began my career in the pharmaceutical industry. Though I’ve worn many hats in the industry since then, I was drawn back to Bristol Myers Squibb because of its unwavering dedication to quality and delivering innovative medicines to patients in need,” says Karin. “I am honored to help lead the integral GPS team as we navigate an everchanging landscape.”

Karin began her career in the pharmaceutical industry at Bristol Myers Squibb in corporate procurement, global supply chain, and global quality. Karin moved into manufacturing operations, leading two manufacturing sites in Billerica, MA, and Latina, Italy. After almost 14 years with Bristol Myers Squibb, Karin joined Becton-Dickenson as a leader of global operations, followed by Catalent Pharmaceuticals where she led global Biologics operations. In 2013, Karin joined Teva Pharmaceuticals as senior vice president and chief operating officer of global operations, where she led global Manufacturing Science & Technology (MS&T) and Network Strategy and a network of 25 sites across Europe and the Americas. Most recently, Karin served as senior vice president of Global Biologics & Sterile Operations at Merck.

Karin earned a bachelor’s degree in political science and international relations from Rutgers University and a master’s degree in jurisprudence (MSJ), pharmaceutical and device law, from Seton Hall Law School.

Peter Marks

Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.

Jim Cafone

Jim Cafone has been with Pifzer since 2010.  In his current role as Senior Vice President, Global Supply Chain, Jim oversees global demand forecasting, demand and supply planning, worldwide logistics, and inventory management for Pfizer.

In his previous role, as Vice President, Network Design & Performance, Jim was responsible for business development, supply chain network design, Pfizer’s lean production system, all performance reporting and analytics, innovation, and recognition programs.

Prior to joining Pfizer Jim spent almost two decades with Wyeth Pharmaceuticals as part of the manufacturing and operations analysis team. He held numerous positions within manufacturing, materials management, customer order management, physical distribution, and information technology functions. This included Vice President, EMEA Manufacturing and Supply (2003-2007) and Vice President, Worldwide Logistics (2008-2009).

Jim holds a Bachelor of Science degree in Industrial Engineering, and a Master of Science degree in Mechanical Engineering, both from the University of Rhode Island. In addition, Jim holds a Master of Science in Technology Management from the University of Pennsylvania, College of Engineering, and the Wharton Business School.

Jim resides in Collegeville, Pennsylvania with his wife and two sons. When the weather permits, you’ll find him deep sea fishing in the ocean somewhere off the East Coast.

Charles L. Cooney

Charles L. Cooney is the Robert T. Haslam (1911) Professor of Chemical and Biochemical Engineering, Emeritus in the Department of Chemical Engineering at MIT and founding Faculty Director, Emeritus of the Deshpande Center for Technological Innovation. He has been involved as founder, advisor or board member of over 25 companies and currently sits on the Boards of Directors of Codiak Bioscience, Innovent Biologics (1801.HK), Levitronix Technologies, and is chairman of GreenLight Bioscience and Mitra RxDx. In addition, he is Trustee Emeritus of Boston Ballet, Advisor Emeritus of the Boston Symphony Orchestra and Trustee of the Leventhal Map Center. Other interests include: high altitude mountaineering (assents of Denali, Ama Dablam, Mont Blanc, Kilimanjaro, Huascaran). and antique map collecting.

Pat Yang

Dr. Pat Yang is one of the most accomplished biotech manufacturing executives and technical operations leaders in the industry.

From 2017 to 2019, Pat was executive vice president at Juno Therapeutics, a leading CAR-T biotech company (now part of BMS) based in Seattle.

Previously, from 2009 to 2013, Pat was Executive Vice President and Global Head of Technical Operations at F. Hoffman-La Roche based in Basel, Switzerland. In this role, he was responsible for Roche’s biopharma process research and development, analytical sciences, engineering, quality, technical regulatory, supply chain and all manufacturing plants with approximately 15,000 employees around the world. From 2003 to 2009, Pat was Executive Vice President of Product Operations at Genentech. He assumed his role as Global Head of the combined technical operations of Roche and Genentech upon the acquisition of Genentech by Roche in 2009.

Before Genentech, Pat worked for 11 years at Merck & Company from 1992 to 2003, based in New Jersey, in various leadership positions including vice president of Asia Pacific Operations and vice president of Global Supply Chain Management. Prior to joining Merck in 1992, Pat spent 12 years at General Electric, serving in research, engineering, technology, and manufacturing leadership roles with increasing scope of responsibilities.

Pat holds a Bachelor of Science from the National Chiaotung University in Taiwan, a Master of Science from the University of Cincinnati, and a Ph.D. in engineering from Ohio State University.

Pat is a member of the Board of Directors of three public companies, Amyris, Codexis and PharmaEssentia. In addition, he is on the board of several private companies, including Acepodia, AltruBio, Antheia and Sana Biotechnology.

Carlo de Notaristefani

An international operations executive with global technical, operational, and P&L experience, Carlo has deep expertise in designing and operating global supply chains in complex regulatory environments, leading accretive M&A activity and devising and executing value-creating strategies in global markets.

Since May 2020, Carlo has been the lead advisor for Manufacturing and Supply Chain to Operation Warp Speed/Federal Covid Response, the US government initiative to support the acceleration of development and supply of Covid-19 vaccines and therapeutics. He has collaborated with the sponsors, suppliers and CDMOs to ensure the fast scale-up of manufacturing and distribution for the entire US.

In Carlo’s most recent corporate position, he was Executive Vice President of Operations at Teva Pharmaceuticals Inc.  In this role he was responsible for all Manufacturing, Technology and Capital Investments, Supply Chain, Quality and Compliance and Procurement operations, as well as the global API and CMO business. Carlo retired from this position in October 2019

Before joining Teva Pharmaceuticals in 2012, Carlo was the President, Technical Operations and Global Support Functions for Bristol Myers Squibb from 2004 to 2011. At BMS he significantly contributed to their successful transformation to a focused biopharma company.

Carlo received his Doctorate in Chemical Engineering and graduated Summa Cum Laude from the University of Naples in Naples, Italy.

Michael Kamarck

Michael Kamarck was the Chief Technology Officer at Vir. Previously, he was senior vice president of Global Vaccines and Biologics Manufacturing and president of Merck BioVentures where he was responsible for the establishment of Merck’s global biosimilars business.

Prior to joining Merck BioVentures, Dr. Kamarck held positions of increasing responsibility in Biotechnology and Vaccines Operations at Wyeth, including leading the development of the global biotechnology network with $3.5 billion of capital investment. While at Wyeth, he also was responsible for global technical operations for all of the Company’s businesses. Dr. Kamarck began his career in biotechnology and pharmaceutical research at Bayer AG.

Dr. Kamarck graduated from Oberlin College where he currently serves as a Trustee. He received his Ph.D. in biochemistry from the Massachusetts Institute of Technology and is the author of more than 50 peer-reviewed publications and 20 issued patents. He also holds an Honorary Doctorate of Science from University College Dublin.

Andy Wirths

Andrew (Andy) Wirths is a senior pharmaceutical operations leader with over 30 years’ experience in the industry spanning small and large molecule manufacturing.

Andy joined AstraZeneca in 2015 and is currently Senior Vice President, Americas Supply, where he is responsible for overseeing the manufacturing operations of 8 sites in North and South America.

Previously Andy held various senior positions at Merck where he was fundamental to the development of their manufacturing strategy and its execution at multiple sites.

Andy holds an MSc in Engineering Technology from the University of Pennsylvania and an MBA and Bachelor of Science from Lehigh University in Pennsylvania.

Tim Moore

Tim Moore is Executive Vice President, Chief Technical Officer for Allogene, overseeing product sciences, supply chain, manufacturing, quality and technical operations. Tim has more than three decades of leadership experience in biopharmaceutical manufacturing and operations and was responsible for the global development of two of the most successful autologous CAR T manufacturing processes in the industry. Prior to roles as Chief Operating Officer of Instil Bio, and President and Chief Operating Officer of PACT Pharma, Tim was Executive Vice President, Technical Operations at Kite Pharma (now a Gilead company) from 2016 to 2019, where he was responsible for the process development, manufacturing, quality and supply chain for Yescarta®, the first FDA approved CAR T therapy for the treatment of non-Hodgkin lymphoma. He and his team also developed the manufacturing process for Kite’s second FDA approved autologous CAR T therapy, Tecartus®. Tim previously served as Senior Vice President, Head of Global Technical Operations – Biologics of Genentech, Inc. and as a member of the Genentech Executive Committee where he oversaw global leadership for more than 7,500 professionals across 10 internal sites and over 37 contract manufacturing organizations, as well as global manufacturing and end-to-end quality supply performance of more than 20 biological product families. Tim serves as a Board member for Cerus and BioLife Solutions. He received a B.S. in Chemical Engineering from Tulsa University and a M.S. in Engineering Management from Northwestern University.

Joanne Beck

Dr. Joanne Beck is currently Chief Technology Officer at Aerium Therapeutics, a startup dedicated to the discovery & development of antibodies and small molecule antivirals against SARS-CoV-2 and other epidemic & pandemic threats.  Prior to this, she served as COO at Boston Pharmaceuticals, a private company developing candidates across multiple indications in cardiometabolic, oncology, and immune/inflammatory diseases.  Prior to joining Boston Pharmaceuticals, she was Executive Vice President of Global Pharmaceutical Development and Operations at Celgene where she oversaw the company’s Product Development, Global Manufacturing Operations, Supply Chain, Engineering and Quality.  Prior to Celgene, she was SVP of Pharmaceutical Development at Shire.  Prior to Shire she held roles of increasing responsibility in Process Development at Genentech and Amgen and in Operations at Abbott’s Pharmaceutical and Vascular Divisions.  Beck holds a BA in Chemistry from Lewis and Clark College, a Ph.D. in Biochemistry and Molecular Biology from University of Oregon Medical School and completed a postdoctoral fellowship in the department of Pharmaceutical Chemistry at the University of California, San Francisco.  Dr. Beck serves on the board of directors for Orchard Therapeutics and Astria Therapeutics.

Craig Beasley

Craig Beasley is the Chief Technical Officer at BlueRock Therapeutics. Prior to joining BlueRock, Craig was the Vice President, Cell Therapy Supply Chain at BMS, where he oversaw supply chain for BMS’s clinical and commercial stage cell therapy assets. Previously, Craig was Head of Manufacturing and Supply Chain at Juno Therapeutics and Vice President of Next Generation Manufacturing at Biogen. Prior to working in biotechnology, Craig worked for Union Carbide in process development. Craig holds a B.S. in Chemical Engineering from Purdue University.

Morrey Atkinson

As SVP and Head of Commercial Manufacturing & Supply Chain, Morrey’s current responsibilities include defining the commercial manufacturing and supply chain strategy needs, as well as, designing and building a global organization and supply network. In addition, Morrey is responsible for assuring reliable supply of Vertex’s transformative medicines.

Morrey is a trained laboratory scientist who brings more than 25 years of experience leading the development and commercial manufacturing of multiple products at organizations like Eli Lilly and Bristol Myers Squibb. An accomplished leader and builder of strong scientific, engineering, and operations teams, Morrey also has prior experience in process development for cell and gene therapies, including the development and manufacturing of one of the first gene therapy candidates for cystic fibrosis.

Jens Vogel

Dr. Jens Vogel rejoined Bayer in March of 2020 as Global Head of Biotech for the Bayer Pharmaceuticals Product Supply organization. He has more than 20 years of professional and leadership experience in the area of biologics operations, development and technology management. From 2012 until 2020, he held positions of increasing responsibility at Boehringer Ingelheim (BI), including as President and CEO of BI Fremont Inc and member of BI’s Biopharma Executive Committee. Prior to his years at BI, Dr. Vogel was a member of the Biologics Development Leadership team at Bayer in Berkeley. Jens holds a PhD in Biotechnology from University of Braunschweig, Institute of Technology, Germany.

Luis Roman

Currently, Luis is responsible for management of Janssen Supply Chain’s global Small Molecule Platform. This includes oversight of the global internal and external network, management of critical strategic partnerships, reliability, and continuous improvement. His main focus is on orchestrating the end-to-end supply chain to drive business results and enhance the customer experience.

Throughout his career at J&J of over 20 years, Luis has held positions of increasing responsibility within Supply Chain across various functions in Manufacturing, Engineering, New Product Introduction and Strategy Development/Deployment and Distribution/Logistics. Prior to his current role, Luis was Vice President of Janssen’s Partnership and External Supply with supply chain responsibility for Janssen’s external network of ~160 Contract Manufacturers across Small Molecules, Large Molecules, and New Modalities. Additionally, he has held multiple roles as Vice President of Supply Chain within MedTech leading Cardiovascular Care and Specialty Solutions (CSS) and Ethicon with supply chain end-to-end responsibility of finished goods and services for the franchises.

In all prior roles, organizations delivered a strong track record of improving key operational performance and stabilizing product supply while delivering enhancements in all phases of the business that have been recognized both internally and externally.

Luis is a strong developer of talent, an advocate for Diversity & Inclusion while also being a strong supporter of social justice. He is also a member of the Seton Hall University Transformative Leadership in Disruptive Times Program Advisory Board. In this role, Luis also shapes the Seton Hall Supply Chain graduate curriculum and provides mentorship to graduate students regarding the changing landscape of pharmaceutical supply chain external manufacturing. Throughout his tenure, he has been known for his active participation and sponsorship of Employee Relationship Groups (HOLA/Open & Out). Additionally, he is a Board Member for the Pace Center for Girls which is an innovative prevention and intervention program focused on providing an opportunity for a better future through education, counseling, training, and advocacy.

Luis earned his Bachelor of Science degree in Industrial Engineering from Purdue University and a M.B.A degree from the University of Texas. He is certified as a Six-Sigma Black Belt, Lean Green Belt and in FPX (Flawless Project Execution). Additionally, he is an active member of the Institute of Industrial Engineers (IIE), Society of Manufacturing Engineers (SME), and American Society of Quality (ASQ).

Jennifer Baxter

Jennifer Baxter has over 20 years of experience in pharmaceutical development and manufacturing activities. During her tenure at Merck, Jennifer has worked in research & development, technical support, and strategic planning of small molecules in roles across the human health, animal health, research and manufacturing divisions. Jennifer is currently the Vice President of Small Molecule Science and Technology, leading a group of approx. 800 scientists and engineers located worldwide. The group is responsible for the late-stage development of Merck’s small molecule pipeline across drug substance, drug product and packaging for both worldwide and regional products as well as all technical support for in-line small molecule products and lifecycle management activities. The group also manages manufacture and supply of late-stage clinical materials, technology development of new and innovative manufacturing technologies and provides site based technical support to all of Merck’s small molecule sites. Jennifer holds BS, MS and PhD degrees in Chemical Engineering from Rutgers University.

Chris Horan

Christopher Horan spent nearly 14 years at Genentech, a member of the Roche Group, where he held several leadership positions across technical operations, including as Senior Vice President, Global Product and Supply Chain Management for Roche in Basel, Switzerland. In that role, he led a 480-person team supplying all of Roche biopharma products worldwide. Mr. Horan joins Artiva from SanBio, where, as Chief Technical Officer (CTO), he led the process development, manufacturing, supply, and quality systems for their mesenchymal stem cell regenerative medicine approach to brain injury in support of a near-term registration in Japan. Previous to SanBio, he was Chief Technical Operations Officer at Dermira, where he led all aspects of pharmaceutical sciences, manufacturing, quality, supply chain, and procurement to launch the company’s first commercial product. He led the effort to prepare Dermira’s IL-13 monoclonal antibody program for Phase 3 trials and commercial filing and had a key role in supporting the company’s successful acquisition by Eli Lilly and Company. Mr. Horan started his career with over a decade of increasing responsibility in technical operations at Merck & Co. He earned a B.E. in engineering from the Stevens Institute of Technology in New Jersey.

Spencer Fisk

Spencer has more than 30 years of experience in Manufacturing and CMC product development. While at Rubius, Spencer built the technical functions to design and deliver the RED™M manufacturing platform, including clearance of 4 IND’s over 4 years.

He also led the acquisition and re-fit of their Red Cell Therapeutics manufacturing site in Smithfield Rhode Island, where the team transferred and delivered clinical supplies for their 3 oncology programs. Prior to joining Rubius, Spencer served as VP & Global Head of Cell & Gene Technical Development and Manufacturing at Novartis where he led the CMC development and manufacturing organization to deliver the CAR-T portfolio. Under his leadership, the team successfully registered and launched the first CAR-T cellular therapy product, Kymriah, which has demonstrated transformative efficacy in patients with acute lymphoblastic leukemia. While at Novartis, Spencer also led technical development teams across the Novartis Biologics portfolio in support of the commercialization of Cosentyx® and the registration and approval of Erelzi™M? and Rixathon®.

Prior to Novartis, he led manufacturing and CMC functions in support of Somavert®, Elonva®, Retavase® and Puregon® while at Merck, formerly Schering Plough, Organon and Covance. Prior to Merck, Spencer held various process and technical development and manufacturing roles at Genentech, Genencor and Novo Nordisk.

Kathy Azuara

Kathy Azuara is the Senior Vice President of Quality Assurance for Ultragenyx Gene Therapy. She has been with Ultragenyx since 2019.

In this role she is responsible for leading quality strategy for the company’s clinical stage gene therapy portfolio and Europe. She focuses on deploying phase appropriate quality systems that support rapid development and licensure of ultra-rare disease products, driving the Ultragenyx “Responsible Quality Mindset” into every aspect of the business, and building a team that can deliver clinical supply and evolve to manage the companies first gene therapy regulatory approvals in the next two years. Kathy was responsible for the design and startup of the company’s first QC laboratories in Woburn, Massachusetts. She has also managed the early regulatory discussions, design, and quality aspects of the company’s first GMP manufacturing facility in Bedford, Massachusetts.

Prior to Ultragenyx, Kathy held roles in Marketing, Manufacturing Strategy, Quality Control, and Quality Assurance at Baxter, Baxalta, Shire, and Alexion. She holds a Bachelor of Science degree from the University of Wisconsin – Madison.

Tim Elliott

During a 25 year tenure in the Merck Manufacturing Division (MMD), Tim Elliott has held positions of increasing responsibility in Technology, Operations, and Supply Chain Management. In his current role, Tim oversees all aspects of supply chain for North America including supply chain planning, new product introductions, warehousing, and logistics. In addition to his operational responsibilities, Tim is tasked with leading and enabling transformational strategic initiatives for MMD.  These include running the business more efficiently, adoption of new technologies, mitigation of supply risk, reducing Merck’s carbon footprint through sustainability initiatives, and enabling of innovative ways of serving Merck’s customers. Tim holds a BS and PhD in Chemical Engineering from Lehigh University and an MBA from New York University.

Rich Kilmer

Has been at CargoSense for over 10 years. He is the Co-Founder of CargoSense and is currently President and CEO. Previously was the President and CEO of InfoEther until its acquisition by LivingSocial in March 2011. Rich started his career in the U.S. Air Force working on computer encryption programming at the Pentagon.

Anders Vinther

Anders joined Kronos Bio in June 2021 as Vice President of Quality. Currently he is the SVP of pharmaceutical development and manufacturing. He brings more than 30 years of experience in the biopharmaceutical industry, from small startups of which he co-founded one to large, global companies. Anders has worked in senior positions in several companies prior to joining Kronos Bio including Novo Nordisk, AGC Biologics, Genentech, Roche, Sanofi, Intarcia. His achievements include quality and cGMP compliance improvements, development and deployment of quality systems, culture change and employee career development. Throughout his career, Anders has led various industry-wide initiatives related to quality, compliance and sustainable drug product supply to patients. Anders received his M.Sc. and Ph.D. in chemical engineering from The Technical University of Denmark.

Babita Parekh

Currently, Babita Parekh is the Vice President of Analytical Sciences and Global Bioassay Steward at Eli Lilly & company. She has obtained an M.S and a Ph.D. in Microbiology/Biochemistry from the M. S. University of Baroda, India. Babita began her post-doctoral career at United States Department of Agriculture, Maryland and postdoctoral fellowship at NYU medical Center.

Babita joined Lilly NJ in 1996 and started her career in Quality Control. She has provided leadership to the BioAnalytical Sciences and is responsible for the strategic direction and organizational capability. She was involved throughout the development and regulatory submission/commercialization for four monoclonal antibodies. Her group is responsible for managing analytical methods through all phases of product development, for studying correlation between structure/function, bioassay stewardship and regulatory filing support.

Rick Panicucci

Rick has been at BridgeBio for over one year. He currently responsible for the role of Senior VP of CMC. Prior to BridgeBio he worked at QED Therapeutics, Origin Biosciences , Novartis, Vertex and Biogen. He earned his PhD, Chemistry at the University of Toronto.

Tori Arens

Tori leads the Resilience RTP gene-therapy manufacturing facility. Tori joined Resilience from Aerie Pharmaceuticals, where she was VP of Drug Product Manufacturing, providing end-to-end leadership for the manufacturing and supply of both commercial and clinical drug products. Previously, Tori also held leadership roles at Biogen and Eisai.

Laquisha E. Crawford

Laquisha E. Crawford is a leader that centers her leadership philosophy around vision engagement, effective change management, and accountability. Deeply rooted in her faith, colleagues appreciate her transparent and pragmatic approach towards problem solving.

Laquisha earned her BS and an MS degree in chemistry from Lincoln University, PA, and Drexel University, respectively. She is currently completing a doctoral degree in the University of Southern California’s Organizational Change and Leadership program, where her doctoral dissertation probes into the lack of leadership diversity in Europe. Laquisha is a results-driven and award-winning quality management professional with over 20 years of progressive management experience in quality assurance and compliance operations within the pharmaceutical industry. She currently serves as the Executive Director of Development and Commercial Biologics Quality at Gilead Sciences, Inc. where she is responsible for the quality and compliance oversight of both Gilead internal site manufacturing and contract manufacturers producing biological products for global development and commercial markets. Prior to joining Gilead Sciences, Inc, she lived and worked in Basel, Switzerland for ~ 8 years where she was most recently responsible for external manufacturing quality and compliance of pharmaceutical products as well as the Swissmedic responsible person for Bayer Pharmaceuticals AG.

Kaoru Nishino

Kaoru has been with BMS for almost 2 years. He is responsible for the role of Executive Director, Global QMS Operational Controls. Prior to BMS he worked at MyoKardia, Dermira Inc, Ultragenyx Pharmaceutical Inc & Roche among others. He earned his Biochemistry & Molecular Biology degree at University of California, Berkeley

Murali Muralidhara

Murali Muralidhara (Murali), PhD, as the CTMO at RVAC Medicines oversees CMC, Development, Manufacturing , Supply Chain  of mRNA based vaccines & therapeutics products and Global IT function.

He has over 22 years of technical and leadership experience in Product Development, Manufacturing, and Commercialization Protein Biologics, Vaccines  & Gene Therapy products in large & mid-size pharma set-up.  Murali has contributed to product development/module-3 preparation/investigations/manufacturing and approval of nine biologic & vaccine products ( Flumist®, Elelyso®, Xiapex®, Trumenba®, Imfinzi®,  Crysvita®, Reblozyl® , and  Imdojo^®  ) and  over 30 INDs/IMPDs for clinical development as an  individual contributor, team leader and executive manager with his careers at Pfizer Biotherapeutics, AstraZeneca, Ultragenyx, Acceleron (now Merck)  and GSK Vaccines.

He has deep leadership expertise in organizational design, leading multi-site/multi-country operations, CDMO operations, Manufacturing foot-print build-up, talent development & retention, and divestment and value creation.  He has published 50 research papers & reviews, made over 40 industry podium presentations and serves on journal editorial boards of Drug Discovery Today, PDA, mAbs , & Vaccines & Vaccination.

Richard D. Braatz

Dr. Richard D. Braatz is the Edwin R. Gilliland Professor of Chemical Engineering at MIT, where he conducts research into advanced biopharmaceutical manufacturing systems. In this role, he leads process data analytics, mechanistic modeling, and control systems for several projects on campus, including those focused on monoclonal antibody, viral vaccine, and gene therapy manufacturing. Dr. Braatz received an M.S. and Ph.D. from the California Institute of Technology and was the Millennium Chair and Professor at the University of Illinois at Urbana-Champaign and a Visiting Scholar at Harvard University before moving to MIT.

Dr. Braatz has collaborated with more than 20 companies including Novartis, Pfizer, Merck, Bristol-Myers Squibb, Biogen, Amgen, Takeda, and Abbott Labs. Honors include the AIChE PD2M Award for Outstanding Contribution to QbD for Drug Substance, the AIChE Excellence in Process Development Research Award, the Technical Innovation Award from the International Society of Automation, and the IEEE Control Systems Society Transition to Practice Award. He has published over 200 papers and three books, including Fault Detection and Diagnosis in Industrial Systems. Dr. Braatz is a Fellow of IEEE, IFAC, AIChE, and AAAS and a member of the U.S. National Academy of Engineering.

Pascal Bécotte

Pascal leads Canadian operations for Russell Reynolds Associates and is also a member of the firm’s global Executive Committee. He is a key member of the Healthcare Sector where he advises clients across the globe on their overall talent strategy, particularly with respect to leadership assessment, succession planning and the recruitment of directors, CEOs and other senior executives. More specifically Pascal specializes in Biotech and Pharma Technical Operations including Process Development, Manufacturing, Quality, Engineering and Supply Chain leadership across modalities.

José Manuel Otero

Jose Manuel recently joined Auregen and is responsible for the role of Chief Technical Officer. Prior to Auregen he worked at Turnstone Biologics as CTO, Seres Therapeutics as VP, Bioprocesses Developments & Merck as Director, Engineering. He is currently is still and advisor for Turnstone Biologics and a principal consultant for the University of Chicago

Sarah Miksinski

Respected and trusted visionary leader with more than 20 years of experience in regulatory affairs, quality and biopharmaceutical policy.  Highly experienced in strategic organizational transformation, executive leadership and business planning.  Mentorship, research and publications support CMC benefit risk, accelerated assessments, patient centricity/CMC, and advanced manufacturing technologies. Recognized thought leader in global regulatory affairs, and extensively and visibly networked across biopharmaceutical industry and global health authorities.

Carl Finamore

Carl is the head of the Manufacturing PMO and Operational Excellence at Ultragenyx and the Program Director for Ultragenyx’s largest capital project, the construction and startup of a large-scale Gene Therapy Manufacturing Facility.  The greenfield facility brings internal manufacturing capabilities on-line to support Ultragenyx’s growing pipeline of gene therapies for rare diseases.  Carl has over 25 year of experience in the pharma, biotech, and med device industries with previous roles in industry and as a management consultant at PRTM / PwC where his focus has been on Operational Strategy, Program Management, Product Development, Continuous Improvement and Lean, Regulatory and Quality Systems, Manufacturing / CMC, Post-merger Integration, and Operating Model design.

Christopher Temple

Christopher Temple serves as Vice President, Operations for Athersys, an allogeneic cell therapy company for acute indications. Christopher’s current responsibilities include leading clinical operations for Athersys’ global Phase 3 pivotal study in Ischemic Stroke as well as process optimization activities across all of Athersys’ operations.

During his career, Christopher has held operational leadership roles of increasing scope and responsibilities. He has excelled in leading domestic and international lean transformations for manufacturing companies across various industries; focused on improving culture, enhancing efficiency, driving quality, and bringing value to the customer. Christopher holds a BS in Manufacturing Engineering from Brigham Young University.

Ndidi Rickert

Ndidi Rickert is an experienced Quality Assurance leader with over 20 years of experience in the Pharmaceutical/Biotechnology Industry. Presently, Ndidi currently leads Quality Culture Excellence Program at Ultragenyx where she has worked for over 8 years. Her overall responsibilities focus on the development and execution of the Quality Culture Excellence Program, where she is acknowledged for her passion for nurturing a responsible quality mindset across the organization. She has been recognized as a thought leader in driving strategy and continuous improvement.

After completing her education in the United Kingdom, Ndidi began her career working for Parexel followed by Merck Sharp & Dohme. She then ventured across the pond to the United States, spent several years working for Novartis and Gilead Sciences, and is now settled in the San Francisco Bay Area with her husband. Her background in Biotechnology and proficiency in Data Management solidified her proven ability to identify data integrity risks, Quality Risk Management, Vendor Management, and innovative solutions-driven capabilities.

Ndidi is the former leader and steering committee member of the X2 Women in Biotech and was one of the founding members of the UltraMosaic Employee Resource Group. In her spare time, Ndidi enjoys creative writing. She intentionally injects laughter and authenticity into everything she does. She is an advocate for kindness, and issues impacting women and children.

Aaron Allen

Aaron Allen is an experienced Manufacturing Sciences and Technology professional with more than 25 years of process engineering, manufacturing and MS&T experience. Mr. Allen has transferred and executed process validation for multiple vaccines within Novartis and Moderna. He has recently transitioned to a new role as Global Quality External Engagement.

Mr. Allen’s previous experience includes positions with Diosynth, Biogen, Jacobs Engineering and Novartis Vaccines. Mr. Allen holds a bachelor’s degree in Chemical Engineering from the University of California at Santa Barbara.

Julie Go

Julie Go has been with Seagen since 2020.  In her current role as Executive Director, Technical Operations – Strategy and Business Ops, Julie oversees the Strategic Initiatives, Operational Excellence, Portfolio Management, Communications and Outreach functions for Seagen’s Technical Operations Division which encompasses Technical Development, Global Commercial Product Supply & Manufacturing, and Global Quality.

Prior to joining Seagen, Julie was at Gilead Sciences leading the Pharmaceutical Development and Global Manufacturing Portfolio, Program Management and Systems function. She oversaw the portfolio program management for 50+ development pipeline products, 25 commercial products, 30+ Outsourced Manufacturing teams and the Operational Excellence Initiatives for the CMC area.  During her time at Gilead, she was part of the successful approval and launch of the HCV Cure Franchise and 2^nd generation HIV products encompassing 14 product approvals in 10 years.   She also supported multiple integrations of acquired companies into Gilead.

Julie holds a B.S. in Physiology from UCLA and an MBA from the University of California, Davis.

Marty Smyth

As the senior vice president of go-to-market strategy, Marty Smyth is responsible market intelligence, product strategy, and bringing MasterControl quality and manufacturing products to market globally. He brings 20 years of technology strategy, marketing, sales, and support experience across high-growth private SaaS companies as well as Fortune 500 companies.

In previous roles, Marty has driven strategic planning, customer experience, and go-to-market for technology leaders like Cisco, Panasonic, Verizon, and AT&T. He is a University of Notre Dame alumnus.

Teresa Gorecki

Teresa Gorecki comes to Compliance Architects^® from Johnson & Johnson, Janssen Pharmaceuticals, where she was most recently Vice President, Market Quality.   At Johnson & Johnson, Teresa was one of J&J’s top Quality professionals, known for her ability to manage inspections and remediate and improve deficient operations.  Teresa had senior level roles across all three sectors within Johnson & Johnson:  Pharmaceuticals, Consumer Products and Medical Devices.

Teresa is one of Compliance Architects’^® lead subject matter experts, and has primary responsibility for strategic client engagements.

At Johnson & Johnson, Teresa’s key accomplishments included:

• Chair of Johnson & Johnson Cross Sector Business Quality Governance Team responsible for developing a Governance Model and Organizational Structure to develop and oversee an aligned Quality Management System, Processes and Procedures across the J&J Enterprise Business/Marketing Company Quality Units.
• Member of J&J Company Leadership Teams/Boards including Regional Management  Board for North America; J&J Consumer Healthcare Company (CHC) Board; and Neutrogena Management Board.
• Management of all aspects of Quality Systems, Quality Assurance, and Regulatory Compliance with Worldwide Regulatory Authorities including FDA (CBER, CDER and CDRH), MHRA,EMA, ANVISA, CFDA, Health Canada, etc.  Extensive experience in combination products, pharmaceutical dosage forms for both OTC and Rx products; biological (r­ DNA and monoclonal antibody) products and a wide range of consumer products (class I and II medical devices, OTC drugs, cosmetics and consumer products) in the US and Puerto Rico.
• Over 20 years’ experience and lead J&J subject matter expert in handling FDA inspections (routine, special cause, and PAI) for Cosmetic and Consumer, Combination Drug/Device, Pharmaceutical, and Biological products.
• Extensive experience with new product introduction; product and technology transfer, and commissioning of new/re-constructed facilities.
• Leadership of ERP System (SAP) implementation for Pharmaceutical Sourcing Group of the Americas Sites in New Jersey and Puerto Rico. Management of large-scale Supply Chain projects for “Demand Pull,” or LEAN Manufacturing.  Sponsorship of Six Sigma initiatives in Manufacturing and QA, which increased quality and compliance and yielded business benefits.

Teresa received her B.S. in Microbiology, with a minor in Chemistry from South Dakota State University.

Judith Koliwer, PhD

After her PhD on the genetic background of autism spectrum disorders, Judith was leading an academic research group, which analyzed the physiological role of proteins associated with cancer and epilepsy by using lenti and retroviral transduction for genetic modification of cell cultures. As the leading scientist for BSL2, she supported the development of all virus-based projects of the university. In 2019, Judith joined the MES Company Werum IT Solutions GmbH, now Körber Pharma Software GmbH, where she works as principal consultant for cell and gene therapy projects. She works closely with cell and gene therapy / ATMP manufacturers, supporting them in transitioning their manufacturing process from paper to a digital solution.

Andy Alasso

Andy Alasso is the Chief Product and Customer Success Officer at Aizon. At Aizon Andy is responsible for leading product delivery of the Aizon AI Cloud GxP platform designed to optimize manufacturing in Life Sciences. Prior to Aizon, Andy was Global Vice President of Product Management within the Oracle Health Sciences Business Unit. Andy and his team were responsible for defining, specifying, and facilitating the delivery of 20+ products within Oracle’s Clinical Research, Pharmacovigilance, and Healthcare portfolios. Prior to his role at Oracle, Andy led product management for several product portfolios within Healthcare services company Optum. Prior to Optum, Andy was Director of Clinical and Regulatory IT at Astra USA (now part of AstraZeneca). Overall Andy has over 25 years of experience in providing software solutions to the Life Sciences and Healthcare industries.

Kim Forte

Kim is a partner with Deloitte’s Life Sciences Supply Chain and Network Operations practice. Based in New York, she has over 20 years of consulting operations experience across the pharmaceutical, biologics and medical device sectors. Having held leadership positions at Amazon and SAP, she brings smart / digital manufacturing and plant floor operations, plant engineering, facilities management, material sourcing, distribution, performance improvement, operational excellence and market entry operations strategy expertise. Her current focus at Deloitte is enabling advanced analytics across the end-to-end global supply chain.

Iknam Gill

Iknam is a trusted advisor for Life Science clients ~20 years of deep expertise in Technical Operations, enabling reliable supply and accessible treatments.

As a leader in Technical Operations, Iknam delivers End-to-end Digital Transformations involving innovative solutions in manufacturing, quality, product/process development and lifecycle management. In addition, her focus includes large Operating and Business Model Transformations that ensure fit-for-purpose organizations that are transformed to deliver on the execution of growth-enabling strategies.

Areas of expertise include the following in pharmaceutical and medical device companies: manufacturing and distribution strategies, operations due diligence,  competitive intelligence, benchmarking,  process design and continuous improvements, organizational transformations, quality systems and validation, product lifecycle management and eQMS software implementation.

Aishwarya Mantha

Aish is a Technology Lead at Deloitte Consulting with over 12 years of experience leading global, cross-functional  teams in design, development and delivery of technology-powered solutions in Life Sciences, Healthcare, and Oil & Gas industries. In her current role, Aish leads the development and implementation of AI/ML-based solutions to provide proactive insights to Biopharma and MedTech manufacturers to help optimize manufacturing processes and product quality.

Aish has a strong track record of successfully leading and delivering impactful AI/ML solutions on time and budget in both corporate and startup environments. In addition to strong technical skills, Aish is adept at business strategy, project execution and stakeholder management. Aish is proactive, anticipates challenges, and strives to deliver the best solutions to enable organizations gain/extend their competitive edge.

Amy Lovasco

As a highly accomplished pharmaceutical manufacturing professional with over 22 years of experience in the biopharma industry, Amy currently manages the successful integration of new products into Pfizer’s external supply chain. As a leader at one of the three sites in the United States responsible for manufacturing the Pfizer-BioNTech COVID-19 vaccine, Amy led the operational overhaul at the Andover, Massachusetts facility to rapidly scale up production during the coronavirus pandemic. With a strong background in project management, process engineering and optimization, and cross-functional collaboration, Amy has consistently demonstrated her ability to drive results and deliver exceptional value to her stakeholders. She holds a Bachelor’s in Engineering and a Master’s in Biotechnology Engineering from Tufts University.

Omar Kassim

Kassim is a highly accomplished pharmaceutical professional with extensive global experience in pharmaceuticals, devices, biologics, and oncology. He currently manages a global team of CDMO relationship managers at Takeda Pharmaceuticals, collaborating with internal and external teams to execute critical global programs. Omar also oversees supply chain needs, finance impact, and combination device development strategies at Takeda to meet current and future needs for Takeda’s development and commercial needs.

Previously, he held management roles across category management, external network strategy, sales, finance, accounting, and global supply chain strategy at Astra Zeneca and other life sciences companies bringing several therapies from development to commercialization. Before migrating to the pharmaceutical industry, Omar worked in corporate banking with BMO Harris Bank and RBC.

Omar has a bachelor’s in biochemistry and biotechnology from the University of Waterloo, an MBA from Wilfrid Laurier University, and is a CPA and CMA from the Chartered Professional Accountants of Canada.

Ravi Samavedam

Ravi Samavedam is a Biochemical Engineer with more than 20 years of experience in the pharmaceutical and biotechnology industries. Before he was appointed Chief Innovation Officer at Azzur Group, he was President and Chief Operating Officer of Azzur Cleanrooms on Demand™. In 2019, Ravi was the General Manager of Azzur Boston and has been with the company since 2012. Prior to Azzur, Ravi has been part of the technical operations and quality/validation departments at Baxter, Amgen, and Shire. Ravi is an expert in phase-appropriate cGMP implementation, process validation, supplier management, and technology transfer.

Chris Mansur

Chris Mansur serves as Azzur Group’s Executive Vice President of Corporate Development and specializes in providing innovative quality and compliant solutions to the life sciences industry. Throughout his career, Chris has specialized in the startup of new and renovated facilities, project management, commissioning and qualification, computer validation, quality management systems, and application of QRM principles. He is passionate about the use of phase appropriate GMPs to help companies solve problems that accelerate their product’s lifecycle or project timeline. Chris holds a Bachelor of Science degree in Mechanical Engineering from Worcester Polytechnic Institute.

Joe Goodman

Joe Goodman is the Global Vice President of Solutions Engineering and Customer Engagement at Honeywell/Sparta Systems where he leads the efforts to strategically partner with their global clients and prospects to find the quality system solution that best fits their need.  Joe is recognized as a thought leader in the fields of quality systems, regulatory compliance, and the implementation of enterprise software across manufacturing.  Prior to joining Sparta Systems Joe spent more than 7 years at Merrill Lynch as a Six Sigma Black Belt.  He owes much of his penchant for process and solution design to his time spent in that role.  Joe also speaks internationally at Compliance and Manufacturing events.

Adam Pfeiffer

Adam Pfeiffer is the Vice President of Strategy at Project Farma. In his role, Adam drives overall business strategy, aligning with operations, marketing, and business development groups in growing the firm’s global life sciences partnerships.

With 16+ years of life sciences consulting experience, Adam has supported countless drug manufacturers in bringing life-saving therapies to the market, with an emphasis on engineering and qualification in the advanced therapy and large-molecule biologics space. He has a degree in Chemical Engineering from Colorado State University.

Charlie Harper

Charlie is a Vice President at Project Farma and the regional lead for the Boston and East Coast Region.  He has over 25 years of experience encompassing gene therapy, microbiome, vaccines, and sterile injectables including four facility startups and the completion of a consent decree workplan.  Charlie has held positions of increasing management responsibility across technical operations and CMC including roles in manufacturing, quality, supply chain and program management.

Prior to Project Farma, Charlie was the VP, Manufacturing and Supply Chain at Intergalactic Therapeutics, a company focused developing a best-in-class non-viral gene therapy to overcome the limitations of viral-based gene therapy.  Prior to Intergalactic, Charlie held progressive roles at Voyager Therapeutics, Seres Therapeutics, Sanofi/Genzyme, GlobeImmune and Amgen.

Charlie holds an MBA from the University of Denver and a B.S. in Biology from Baylor University.

Kara Price

Dr. Kara Renai Price is the Site Leader of PGS Rocky Mount, North Carolina facility. Kara joined Pfizer in May 2021 as Rocky Mount’s Integrated Manufacturing Operations Lead, with responsibility across Filling, Finishing, R3, Engineering, and Transformation (including IMEx and Operational Excellence).
Prior to Pfizer, Kara served as site leader for Minaris Regenerative Medicine, a contract manufacturer, where she was responsible for the research and development, clinical and commercial manufacturing operations for cell and gene therapy.

Kara has over 24 years of progressive experience in the pharmaceutical industry, particularly in aseptic/sterile manufacturing for small and large molecules, including senior leadership roles within Merck across manufacturing, quality, engineering, technical services, and strategy, as well as demonstrated transformational leadership in these organizations. Kara sits on the board of Eastern University and the International Leadership Association (ILA). She holds a Bachelors degree in Biology from Hampton University, a Masters degree in Cell Biology & Biotechnology from University of the Sciences, and a Doctorate in Organizational Leadership from Eastern University.

David Ege

David Ege is the Executive Vice President and Chief Technology Officer of Seres. He has 20 years of experience in the pharmaceutical industry, with a focus on vaccine and biologics manufacturing, facility development and process optimization. Prior to joining Seres, Dr. Ege had been at Merck since 2003, in a variety of technical and leadership roles in R&D and manufacturing, in the U.S. and Switzerland. His most recent role was global lead for digital strategy in Merck’s Manufacturing Division. From 2015-2019, Dr. Ege served as Executive Director of Vaccines & Biologics Manufacturing at Merck’s plant in Elkton, VA where he led bulk manufacturing operations for the Gardasil® and Gardasil9® cervical cancer vaccines, as well as adjuvants and Cancidas® – a broad-based anti-fungal medicine made by fermentation. He has contributed to the successful first-in-class licensure and launch of cervical cancer vaccines, Gardasil® (2006) and Gardasil9® (2014), and a breakthrough cancer immunotherapy, Keytruda® (2014). He graduated summa cum laude from Princeton with a BSE in chemical engineering and earned his Ph.D. in chemical engineering from the University of Pennsylvania.

Amy Doucette

Amy leads the Pharma Automation Product Group Business Operations team (Business Development, Sales, Pre-Sales, Marketing, Operations and Client Success) that’s providing SmartFactory Rx® automation solutions.  SmartFactory Rx® is developed for process manufacturing to harness the power of data, reduce development time, and improve productivity to optimize high value manufacturing, while increasing throughput, decreasing risk, and accelerating time to market for new products.  Amy earned a Master’s Degree in Biotechnology Engineering from Northeastern University.

Rick Johnston PhD

Rick is a senior technical leader within Applied Materials’ pharmaceutical business unit. He has more than 15 years of experience in building software that solves big data, machine learning, scheduling, forecasting and advanced analytics problems in pharma. Software built by Dr Johnston is used by more than 90% of the world’s largest pharmaceutical companies. He has a Ph.D. in operations research and bioinformatics from UC Berkeley.

Craig Kennedy

Brad Wynja

Brendan Walker

Carlo de Notaristefani

An international operations executive with global technical, operational, and P&L experience, Carlo has deep expertise in designing and operating global supply chains in complex regulatory environments, leading accretive M&A activity and devising and executing value-creating strategies in global markets.

Since May 2020, Carlo has been the lead advisor for Manufacturing and Supply Chain to Operation Warp Speed/Federal Covid Response, the US government initiative to support the acceleration of development and supply of Covid-19 vaccines and therapeutics. He has collaborated with the sponsors, suppliers and CDMOs to ensure the fast scale-up of manufacturing and distribution for the entire US.

In Carlo’s most recent corporate position, he was Executive Vice President of Operations at Teva Pharmaceuticals Inc.  In this role he was responsible for all Manufacturing, Technology and Capital Investments, Supply Chain, Quality and Compliance and Procurement operations, as well as the global API and CMO business. Carlo retired from this position in October 2019

Before joining Teva Pharmaceuticals in 2012, Carlo was the President, Technical Operations and Global Support Functions for Bristol Myers Squibb from 2004 to 2011. At BMS he significantly contributed to their successful transformation to a focused biopharma company.

Carlo received his Doctorate in Chemical Engineering and graduated Summa Cum Laude from the University of Naples in Naples, Italy.

Michael Kopcha

Michael Kopcha, Ph.D., R.Ph., Director, Office of Pharmaceutical Quality (OPQ), is a leader in the development of innovative solutions to resolve scientific, manufacturing, and commercialization issues worldwide – and in standardizing and harmonizing global processes. With more than 25 years of pharmaceutical industry experience, his areas of expertise include formulation and process development, process validation, technology transfer, off-shoring/outsourcing, and change management. Dr. Kopcha recently served as vice president, and global research and development franchise head, for cough, cold, and respiratory products at Novartis Consumer Health, Inc. in New Jersey. He joined Novartis in 2008 as the global head for pharmaceutical and analytical development, later serving as global head for new technologies and product innovation, and vice president and global head for global product development. At Novartis, Dr. Kopcha led the creation of a global R&D vision and strategies to drive innovation for the cough, cold, and respiratory franchise – through development, sourcing, manufacturing, and supply. He restructured and reorganized global product development to provide for a category-focused, globalized organization, and is credited for the creation of a successful strategic off-shoring/outsourcing program to increase project capacity and efficiency. Before joining Novartis, Dr. Kopcha served as vice president for pharmaceutical development at KV Pharmaceutical, Inc. in St. Louis, where he directed and managed analytical research and development, product development, process development and technology transfer, stability, drug delivery, project management, and external alliance. His experience also includes related roles with Schering-Plough, J&J, and Ivax. Dr. Kopcha earned his doctorate and master’s degrees in pharmaceutical science, and a bachelor’s degree in pharmacy, from Rutgers University in New Brunswick, New Jersey. He served as an adjunct assistant professor in the Department of Pharmaceutics, Ernest Mario School of Pharmacy at Rutgers.

Joanne T. Beck

Joanne Beck joined Boston Pharmaceuticals in 2019 from Celgene, where she was Executive Vice President of Global Pharmaceutical Development and Operations, and oversaw Product Development, Global Manufacturing Operations, Supply Chain, Engineering and Quality. Prior to Celgene, she was SVP of Pharmaceutical Development at Shire. Prior to Shire she held roles of increasing responsibility in Process Development at Genentech and Amgen and in Operations at Abbott’s Pharmaceutical and Vascular Divisions. Beck holds a BA in Chemistry from Lewis and Clark College, a Ph.D. in Biochemistry and Molecular Biology from University of Oregon Medical School, and completed a postdoctoral fellowship in the department of Pharmaceutical Chemistry at the University of California, San Francisco. Dr. Beck serves on the board of directors for Orchard Therapeutics and Catabasis Pharmaceuticals.

Wolfram Carius

Prof. Wolfram Carius is the EVP Pharmaceuticals at Bayer AG and is a member of the Executive Committee for Bayer Pharmaceuticals. He is based in Berlin, Germany. Prior to joining Bayer, Wolfram was a corporate senior vice president and member of the global leadership team at Sanofi Genzyme for nearly three years. Before that, he worked for Boehringer Ingelheim from 1987 to the end of 2013, eventually becoming responsible for that company’s worldwide chemical, pharmaceutical, and biopharma production network. In his over 30 years in the pharmaceutical industry he has worked in Asia, South America and Europe. In 2009, the Biberach University of Applied Sciences awarded him the title of honorary professor in recognition for his long and exceptional service. He also holds a PhD in pharmaceutical biology and analytical phytochemistry from the University of Saarland, Germany.

Arleen Paulino

Arleen Paulino, Senior Vice President, Manufacturing, leads Amgen’s commercial manufacturing organization. Prior to this role, Paulino served as vice president, Site Operations at Amgen Singapore Manufacturing from 2016 to 2018, where she led the team to the successful licensure of Amgen’s first Next-Generation Biomanufacturing plant.

Paulino joined Amgen in 2002 and over the years has held various positions with increasing responsibility in Process Engineering and Process Development. She was also the head of Clinical Operations and Development Supply Chain, where she was responsible for the end-to-end supply chain for the manufacture and delivery of clinical product to support Amgen’s global clinical trials.

She began her career in Operations at Genentech and later joined Immunex, where she held a variety of roles overseeing development and scale-up operations, contract manufacturing and technology transfer, as well as plant manager for the cell culture facility.

Paulino holds a Bachelor of Science degree in Biochemistry from Marquette University.

Linzell Harris

Linzell Harris is senior vice president of Global Supply Chain and Strategy for AstraZeneca, with overall responsibility for the development and execution of the end to end supply chain platform and product supply strategies. In addition, he is responsible for ensuring the strategic development of network designs and supply chain capabilities supporting the global AZ operational network.

Reporting into the EVP of Operations and Information Technology, Linzell is a member of the Global Operations Senior Leadership Team.

Linzell has more than 30 years of diverse general management and global operations experience in the consumer product goods, pharmaceutical and luxury goods industries.

Prior to joining AstraZeneca, Linzell held the role of Senior Vice President, Global Supply Chain for TEVA Pharmaceuticals – supporting the company’s comprehensive global supply network for generic and specialty pharmaceuticals.  Before TEVA, he served as Head of Global Operations for Godiva Chocolatier and as a member of Godiva’s Executive Leadership team reporting to the CEO and President.

Additionally, Linzell has worked in Senior Management roles at Johnson and Johnson, Pfizer, Warner Lambert and Baxter Healthcare. He began his working career as a Supply Corp officer in the US Navy.

Linzell earned a BS in Mathematics from the US Naval Academy in Annapolis, MD with graduate studies at Villanova University. He has completed executive studies at Michigan State, Columbia and Harvard Universities.

Brendan O’Callaghan

Brendan O’Callaghan leads an international network of manufacturing and distribution sites. His ambition is to enable successful commercialization of Sanofi’s diverse pipeline, to build world-class standards of manufacturing and supply chain excellence and to future proof Sanofi’s manufacturing network, leveraging the latest digital, process and technology solutions, to ensure the continued reliable supply of essential, high-quality medicines to patients worldwide.

Brendan joined Sanofi in 2015 and was previously our Global Head of Biologics and Industrial Affairs head of the Specialty Care portfolio. He has played a key role in supporting our transformation to a fully integrated BioPharma company and advancing the digital transformation of our manufacturing network, notably the Framingham site in the US, which was awarded the prestigious International Society for Pharmaceutical Engineering Factory of the Future and Facility of the Year Awards in 2020.

Prior to Sanofi, Brendan worked at Schering-Plough before moving to Merck / MSD as Head of Biologics and later Vice President of its Europe, Middle East and Africa Operations.

Brendan graduated in chemical engineering from the University College of Dublin, where he currently serves as an honorary adjunct Professor of Chemical and Biochemical Engineering.

Ger Carmody

Ger Carmody is responsible for global pharmaceutical and packaging operations comprising approximately 4000 colleagues and internal 9 manufacturing sites.  His organization supplies drug substance and drug product for Merck’s small molecule portfolio, leads the late stage development and commercialization of the small molecule pipeline as well as packages the entire human health portfolio. Ger has worked with Merck for almost 30 years, working in Europe, Asia and the US primarily in operations, technical and operational excellence roles. As well as ensuring safe, compliant supply of high quality products, current focus areas include increasing productivity through operational excellence and digital, positioning for an evolving pipeline and environmental sustainability. Ger is from Ireland, is currently based in Pennsylvania and graduated as a chemical engineer from University College Dublin.

Derek Adams

Derek Adams is PlateletBio’s Chief Operating Officer. Derek has spent the past four years as Chief Technology and Manufacturing Officer at bluebird bio, a leading lentiviral gene therapy company, overseeing pharmaceutical sciences and quality functions: process and analytical development, vector manufacturing, patient operations, global supply chain, quality assurance and quality control. Prior to that, Derek was Senior Vice President of Chemistry, Manufacturing and Controls at Evelo Biosciences, establishing the process development function and supply chain for clinical studies. For over a decade prior to Evelo, he held senior leadership roles of increasing responsibility in process development and manufacturing at Alexion Pharmaceuticals, where he led process development, analytical sciences, global technical services and clinical supply within global operations and helped to more than double the size of the clinical manufacturing network. Derek started his manufacturing career with Merck & Co, Inc. as a Process Engineer for vaccine production technologies. He earned a Ph.D. in Chemical Engineering from the University of Minnesota and a B.S. in Chemical Engineering with High Distinction from Worcester Polytechnic Institute (WPI).

Brendan Hughes

Brendan is responsible for all of BMS Pharma and Biologics manufacturing from internal and external sources. He is based in Devens MA.

Brendan joined BMS as Head of CMC Strategy for Biologics in 2012. From 2015-2020 Brendan led MS&T for the company with responsibility for all technologies used in manufacturing including biologics, pharma products, parenterals and devices.

Before joining BMS, he led MS&T and Technical Services teams in Wyeth and Pfizer.

Brendan has worked in the US, Ireland and the UK. He started his career in the UK working for Wellcome which then became Glaxo-Wellcome and then GSK; roles included leadership positions in Quality, analytical sciences as well as project leadership. Brendan came to US in 2001 joining the Biotech Development team in Wyeth. He later joined the leadership team for the Wyeth Grange Castle biotech start-up in Ireland from 2003-2010 and returned to US in 2010 to work in Pfizer Global Manufacturing.

Brendan received his B.Sc and Ph.D in Biochemistry in Ireland and carried out post-doctoral studies in Oxford UK. He was a member of the ICH Expert Working Group which drafted the initial Quality Guidelines for biotech products in the 1990s and later for ICH Q11.

John Kelly

John F. Kelly is Vice President, Quality Operations and Environment, Health & Safety, responsible for leading the overall Quality function for Pfizer and for leading global EHS across the Company.  John is a member of the PGS Leadership Team.  John is a member of the Pfizer PAC Board of Directors and past member of the Pfizer PAC Steering Committee and is Chairman of the Board of Directors of Zydus Hospira Oncology Private Limited, a joint venture between Pfizer and Zydus Cadila.  He is also a member of the Board of Directors of The Patterson Club, Fairfield, CT, a member of the Board of Trustees of Wakeman Boys & Girls Club, a member of the Worcester Polytechnic Institute Engineering Dean’s Advisory Board, and past co-President of the Fairfield College Preparatory School Fathers’ Club.

John joined Pfizer in 1982 as Plant Services Engineer at the Brooklyn, New York site.  Prior to his current position, he held assignments in New York, (Technical Services, Plant Network Strategy, Strategy, Transitioning Sites), Brooklyn, New York (Engineering, Manufacturing), Barceloneta, Puerto Rico (Manufacturing, Quality Operations) and Vega Baja, Puerto Rico (Site Leader).  He assumed his current position in 2017.

John holds a B.S. in Chemical Engineering from Worcester Polytechnic Institute and an M.B.A. in Operations Management from Pace University.

He and his wife, Beth, have three sons: Christopher, Thomas and Andrew.

Charles L. Cooney

Charles L. Cooney is the Robert T. Haslam (1911) Professor of Chemical and Biochemical Engineering, Emeritus in the Department of Chemical Engineering at MIT and founding Faculty Director, Emeritus of the Deshpande Center for Technological Innovation. He has been involved as founder, advisor or board member of over 25 companies and currently sits on the Boards of Directors of Codiak Bioscience, Innovent Biologics (1801.HK), Elektofi, Hovione, LayerBio, Boyd Technologies, Levitronix Technologies, and is chairman of GreenLight Bioscience. In addition, he is Trustee Emeritus of Boston Ballet, Advisor Emeritus of the Boston Symphony Orchestra and Trustee and Treasurer of the Leventhal Map and Education Center. Other interests include: high altitude mountaineering (assents of Denali, Ama Dablam, Mont Blanc, Kilimanjaro, Huascaran). and antique map collecting.

Aine Hanly

Aine Hanly, Ph.D., serves as Chief Technology Officer at Vir Biotechnology, where she is responsible for overseeing the Company’s technical operations. Her purview includes product and process development, supply chain, manufacturing, quality and CMC strategy. Her career in the biomanufacturing industry, which has spanned roles in the UK, Ireland and the US, has been dedicated to advancing innovative solutions to accelerate the delivery of medicines to patients.

Prior to joining Vir, Dr. Hanly served as the Vice President of Process Development for Amgen, accountable for clinical manufacturing and global supply of clinical trial materials. During her nearly decade-long tenure, she led teams enabling the commercialization of Amgen’s pipeline products as well as providing technical support for ongoing commercial manufacturing operations. Additionally, as site head at Amgen’s Cambridge facility, Dr. Hanly led the site’s transformation and staff growth, and together with the research and development team, greatly increased Amgen’s partnerships and presence within the local Cambridge ecosystem. She also worked for more than 10 years at Pfizer (formerly, Wyeth), where she held roles of increasing responsibility in analytical R&D, process development, quality and product supply strategy.

Dr. Hanly received her bachelor’s degree in biological chemistry and a Ph.D. in physical organic chemistry, from the University of Ulster, Northern Ireland. She completed her post-doctoral fellowship at Creighton University School of Medicine before joining the collaborative research wing at Yale University and CuraGen Corporation as lead scientist studying gene isolation and subsequent confirmation using a variety of molecular biology techniques.

Greg Troiano

Greg serves as Chief Manufacturing Officer at Translate Bio, a Sanofi Company, where he is responsible for cGMP Strategic Supply and Operations at Sanofi’s mRNA Center of Excellence.  Over his 20+ year career in the drug delivery field, Greg had various roles leading the pharmaceutical development of complex formulations, including numerous nano- and microparticle based systems.  This includes leading groups for Formulation Development, Process Development, Analytical Development, Supply Chain Management, Manufacturing and Facilities at companies including Pfizer, Seer, BIND Therapeutics, Alkermes, and Guilford Pharmaceuticals.  He’s brought myriad novel products into the clinic and helped commercialize five.  Greg received his MSE and BS in Biomedical Engineering from The Johns Hopkins University and was elected and inducted into the American Institute for Medical and Biological Engineering (AIMBE) College of Fellows in 2020 for recognition of his accomplishments in drug delivery.

Elaine Shannon

Elaine currently holds the role of Global Head of Quality Oncology and External Supple Small Molecules. Prior to this she was the Global Head of Quality Audits and Supplier Management. Elaine joined Takeda Pharmaceuticals Global Quality Compliance and Systems group in June 2016 to develop the companies Knowledge Management processes.

Prior to this, Elaine worked with Teva Pharmaceuticals, responsible for Quality Compliance with European and Israeli operations.

Elaine has 25 years of experience in the Pharmaceutical Industry. She holds an MSc in Pharmaceutical Manufacturing Technology.  Elaine has held positions in Quality Assurance, Compliance, Quality Control and Research and Development.

In her spare time, Elaine enjoys spending time with her husband, 2 kids and 2 dogs especially outdoors. She likes to shop and relaxes with a good book and a nice glass of wine.

Cedric Dubois

Mr. Dubois has 20 years of experience in the biopharmaceutical industry. He holds a MSc in Industrial Engineering from a French “grande ecole” (ENSAM), a MSc in Pharmaceutical Engineering from The University of Manchester (UK) and an MBA from Hong Kong University of Sciences and Technology.

During his career, Mr Dubois has worked in the United States, in China and Algeria, leading strategic investments and building manufacturing facilities in these countries during the 1st part of his career, and has now been leading manufacturing operations for close to 10 years.

Through his professional career, Mr. Dubois has designed, built and managed vaccines and traditional pharmaceuticals plants. Over the last 3 years, he has been providing oversight to external partners producing biologics products for Sanofi.

Daniel Couto

Daniel Couto is the Chief Operating Officer of Vedanta Biosciences, a leading Microbiome company. Mr. Couto is an Operations Management Executive with almost 30 years of experience starting and advancing Biopharmaceutical Development and Manufacturing organizations to higher levels of capability, growth and productivity. Mr. Couto has a comprehensive knowledge and hands-on experience leading organizations through improvement initiatives and developing new therapeutic modalities. Mr. Couto is the former SVP of Manufacturing and Operations of ContraFect Corporation, a public company developing new Lysin enzymes for MRSA infections. His previous employment was with Merck Sharp Dohme Biologics UK Ltd. (former Avecia Biologics) where he served as Vice President of Commercial Manufacturing Operations responsible for all late stage and commercial product. Prior to this he was responsible for 7 World Wide Contract Manufacturing sites including API/BDS and Final Fill Finish as he served as Director of Manufacturing for Nuvelo Inc. (San Francisco Bay area). He has been instrumental in 2 BLA submissions for drug approvals, 2 major Pre-Approval Inspection (PAI), and several IND submissions. Mr. Couto holds patents for several novel separation technologies such as Bulk Protein Crystallization, HPTFF, SMB, and Bacterial formulation and Lyophilization. Prior to this he served in a number of Sr. Management positions for companies including Genzyme Transgenics Corp. (GTC Biotherapeutics), Advanced Biosystems Corp., ImmuCell Corp., and Sepracor Corp. Mr. Couto received his B.S. Degree in Chemical Engineering with a minor in Economics from Rensselaer Polytechnic Institute.

Kerry Hawitt

Dr Kerry Hawitt is the SVP Quality & Compliance at Boston Pharmaceuticals, a company that focuses on the transformation of innovative molecules into differentiated medicines. Kerry leads all aspects of Quality strategy and execution to applicable global regulations, and is responsible for Compliance and Risk across the BP enterprise. Over the last 10 years, Kerry has served as SVP Alexion West Site head and Global Transformation lead, SVP Quality & Compliance at Portola Pharmaceuticals, and has held several roles at Shire Pharmaceuticals including Head of Business Operations and VP Global Quality Systems and Product Quality. Kerry holds two degrees from University of Manchester, UK, a PhD in Pharmaceutical Microbiology and BSc. Hons., in Microbiology. Kerry is also a fellow of the International Women Forum Leadership Program.

Kathleen Munster

Kathleen Munster is SVP, Enabling Functions (Quality, Facilities, and IT) at 2seventy bio.  2seventy bio is a cell and gene therapy company focused on the research, development, and commercialization of transformative treatments for cancer.  Kathleen joined bluebird bio in October 2020 and transitioned to oncology spin-off 2seventy bio in November 2021.  She has over 20 years of experience in clinical and commercial manufacturing in site-based and global roles spanning multiple product types and biopharma companies.  She has expertise in Health Authority inspection management and has supported numerous product approvals/launches.  Prior to bluebird/2seventy, Kathleen was responsible for a global network of sites as VP, Biologics, Cell & Gene Therapy Quality at Catalent Pharma Solutions. Before this, she led Quality at the Devens, MA site for Bristol-Myers Squibb after holding a number of leadership roles in Quality, IT, and Supply Chain during her tenure at BMS.  Kathleen started her career at Merck & Co., Inc. and holds degrees in Chemistry and German from Lafayette College and an MBA from Rutgers University.

Ken Kent

Ken is the Senior Vice President of Chemical Development and Manufacturing Operations. He is responsible for Gilead’s entire drug substance supply and oversees process R&D functions in Foster City and Edmonton, as well as internal and outsourced manufacturing.

He played a critical role leading CDMO in sourcing ingredients and scaling up production of remdesivir drug substance, to speed up and increase production. Ken has contributed to the development and commercialization of more than 25 approved products while growing his career from developing new synthetic routes as a process chemist to increasing leadership responsibilities in cross-functional roles. He has built and led teams with a reputation for innovation, quality and safety while also fostering inclusion and career development. He joined Gilead in 1988, he is a member of the American Chemical Society and has published over 10 papers and patents on the research he has conducted at Gilead.

Kim Burson

Kim K. Burson, Ph.D. is the Head of Quality Assurance and Quality Control at Denali Therapeutics located in South San Francisco, CA.  Kim received her Ph.D. in Chemistry at Stanford University.  She has over 25 years of experience in the pharmaceutical, biotechnology and medical device industries with in-house and virtual manufacturing and testing.  Kim’s global background includes both clinical and commercial products and tenure at Genentech, Roche in Switzerland, Millennium Pharmaceuticals and two medical device companies.  Kim’s areas of expertise include Quality Control and Quality Assurance, global inspection management (FDA, EMA, ISO and ROW), internal and external auditing and development and implementation of global Pharmaceutical Quality Systems.

Dannielle Appelhans

Dannielle Appelhans is the Chief Operating Officer at Rubius Therapeutics, joining in August 2021. She brings experience in gene therapy, strategy, manufacturing, supply chain and operations. As COO, she oversees corporate strategy, technical development, and operations for Rubius.

Dannielle joined from Novartis Gene Therapies, where she served as Senior Vice President of Technical Operations and Chief Technical Officer, and oversaw late-stage development, clinical and commercial manufacturing, supply chain and all supporting operational functions for the gene therapy unit and AAV portfolio. Before that role, she served as Senior Vice President, Global Head of Supply Chain Management for Novartis and was responsible for end-to-end supply chain of all Novartis divisions worldwide, across 60-plus plants in more than 120 countries to ensure $50 billion in sales. Since 2014, Dannielle held positions of increasing responsibility in global supply chain, strategy and operational excellence across several divisions within Novartis. Before joining Novartis, Dannielle was a senior engagement manager at McKinsey & Company, working in the pharmaceutical operations practice. Earlier in her career she held roles of increasing responsibility at Eli Lilly and Company.

Dannielle has an MBA from MIT Sloan School of Management, a Master of Science from Massachusetts Institute of Technology and a Bachelor of Science from the University of Michigan in mechanical engineering.

Laurent Boer

Laurent Boer is vice-president and general manager of the Allston Landing and interim Chief Manufacturing Officer for Resilience. He has been on the site since 2017 and led the divestment of the site from Sanofi-Genzyme to Resilience. Prior to the role in Allston, he led the Northborough Operations Center of Sanofi from a brown field site to a world class center for Raw Materials Management as well as Label & Packaging hub for rare diseases with global distribution responsibilities. Before his arrival in Genzyme in 2011, Laurent was VP Global Supply Chain for UCB in Brussels, Belgium. From 2002 to 2007 he had roles in the global Supply Chain of Biogen (-Idec). And surprise, surprise- Laurent worked 10 years at United Parcel Service in sortation automation and industrial engineering (still having brown blood). He started his career in The Netherlands as Operations Research Consultant in Quantitative Modeling.

His Alma Mater is the Erasmus University in Rotterdam where he obtained a Masters of Science in Econometrics.

Laurent and his family moved 3 times to the USA and moved back 2 times to Europe but after the 3^rd relocation to the USA became US Citizen (‘one of my better decisions”).

My motto: Do you dare looking in the mirror every night and ask yourself, “What did I do for a patient today?”

Michele C. D’Alessandro

An Information Technology professional for more than 28 years, Michele C. D’Alessandro is most recently Vice President and CIO of Manufacturing IT at Merck. In this role, she provided strategic leadership, oversight and delivery of information technology and digital solutions for the Merck Manufacturing Division. A change agent with proven track-record of delivering high-impact projects producing outstanding business results broadly across Pharmaceutical Supply Chain and Manufacturing, Michele and her team were nationally recognized in the areas of technical innovation, including next generation data and analytics platforms; supply chain transformation; and resiliency /modernization/digitization in manufacturing plants. In Nov 2017, Michele was awarded a Gold Stevie® Award for Women in Business in the Life Sciences and Healthcare Transformation category. She was named to Bold’s Business Top 20 of Chief Information Officers in 2019. She currently runs her own consultancy business, providing advisory services with an emphasis on IT Transformation and Women in STEM.

Greg Sukay

Greg Sukay serves as Arcutis Vice President of Manufacturing and Process Technologies where he leads a group of engineers and scientists in developing and manufacturing their pipeline of novel human therapeutics.  Mr. Sukay has worked in the biopharmaceutical industry for over twenty-five years in drug development and technical operations.  Prior to joining Arcutis, Mr. Sukay was at Amgen where he held various positions in the US and Asia within Process Development, Clinical and Commercial Manufacturing, as well as Contract Manufacturing.  Prior to joining Arcutis, Mr. Sukay led Amgen’s Contract Development and Manufacturing Organization, responsible for the development and manufacture of multiple clinical and commercial synthetic and biologic drug products across a global CDMO landscape.  Mr. Sukay started his pharmaceutical career at Roche as a Process Engineer supporting a pipeline of synthetic molecules.  Greg earned his BS, Chemical Engineering from Purdue University.

Celia Xue

Celia Xue is currently the Executive Director of Integrated Product Strategy for Cell Therapy Supply Chain at BMS. She leads a team of strategic product leaders and product launch leaders, responsible for maximizing the value of Cell Therapy commercial portfolio. Within her tenure with BMS, she also led a team to champion the BMS clinical supply chain digitization strategy and transformation.

Prior to joining BMS, Celia was with Kite, a Gilead Company. During her time there, she led a large operational readiness team to successfully launch one of the first automated greenfield Cell Therapy manufacturing site. Celia spent more than 10 years with Deloitte Consulting, Biogen, and Novartis. She specialized in life sciences M&A strategy, operations strategy, portfolio management, and technology transfers.

Celia holds an MBA degree from UCLA Anderson School of Management, a MS degree in Chemical Engineering from the University of Colorado, Boulder, and a BS degree in Chemical Engineering from the University of Nevada, Reno.

Mark Butchko

Mark A. Butchko, Ph.D. is currently Associate Vice President for Eli Lilly and Company in Indianapolis, IN. He is responsible for leading Lilly’s Global Quality Laboratories organization to provide analytical method stewardship, specialized analytical services, and laboratory informatics support.  Mark has 22 years of experience in the pharmaceutical industry, joining Lilly in 2000 as a Senior Organic Chemist to develop and optimize manufacturing routes for Lilly’s Active Pharmaceutical Ingredients (API’s).  He subsequently served as Manager of Lilly’s Technical Services organization (supporting day-to-day cGMP commercial manufacturing activities), and then as Director/Senior Director of Lilly’s Product Research and Development Quality Assurance organization (providing Quality oversight for internal and external cGMP activities associated with Lilly’s clinical development pipeline).  He received his Ph.D. in Chemistry from the University of Notre Dame (Notre Dame, IN), and his B.S. Degree in Chemistry from King’s College (Wilkes-Barre, PA).

Rajiv Panwar

Dr. Panwar holds MS and PhD degrees in interdisciplinary pharmaceutical sciences from Northeastern University, Boston, where his work was focused on use of antibodies and antibody drug conjugates (ADCs) for molecular imaging and cancer therapy. After graduation, he spent his career at Akrivis Technologies, Eleven Biotherapeutics, Magenta Therapeutics and more recently Disc Medicine, where he is the head of CMC and Supply Chain Operations.

George Skillin

George currently has responsibility for all Spark Therapeutics Engineering, EHS, and Facility Management areas where he manages a group of roughly 60+ professionals driving our Engineering and Capital Management efforts, EHS Programs and Compliance,   George has been in the Life Sciences Industry for over 30 years, working for Merck, Wyeth, Pfizer, WuXi Biologics and Spark Therapeutics after starting his career with Eastman Kodak.  George has deep technical experience in all areas of Life Sciences Manufacturing and Supply Chain, and deep integrated systems experience as well.

George received his BS in Chemical Engineering at the University of Maine and his MBA in Finance from the William E. Simon School of Management at the University of Rochester.  George also serves as a Board Member for the ISPE Boston Chapter and is a Member of the PDA.

Joseph O’Brien

Joe is currently the Head of Spark Engineering Operations, and has responsibility for Facilities Engineering, Maintenance, Equipment Validation and Computer System Validation in the Scientific and Manufacturing Facilities. Joe has over 20 years’ experience in the Life Science Industry with Wyeth, Pfizer, and Spark Therapeutics. Joe started his career in the maintenance and facilities field in high-speed manufacturing with Hewlett Packard, before focusing on process automation, working on projects in the brewery, dairy, and life science industries.

Joe received his BE in Electrical/Electronic Engineering and his Masters in Engineering Management (MIE) from University College Dublin (Ireland).

David Bottari

Director of External Quality Assurance with over 17 years of quality related experience in commercial/clinical manufacturing and packaging of pharmaceutical and biotech products. Extensive knowledge and experience in the development and implementation of quality systems as well as multi-phase clinical and commercial product disposition. Subject Matter Expert for the management and oversight of contract manufacturing facilities, laboratories, vendors, and suppliers. As QA Contract Manufacturing Lead at Spark Therapeutics I provided quality oversight of the launch and continuous commercial production of the first in vivo gene therapy approved in the US, now approved and distributed in over 40 countries worldwide.

Jennifer McGee

Jennifer is a Specialty Medicine Supply Chain and Strategy Senior Director at GlaxoSmithKline (GSK).  Her scope of responsibility includes biopharmaceutical, small molecule and oligonucleotide products from early development through commercial supply.  Her primary focus is ensuring robust supply chain strategies are in place to deliver new product launches and continued commercial growth for established products.  Her personal passion is ensuring people at the end of the GSK supply chain have the medicine they need to live their best life.  Over Jennifer’s 20+ year career in the pharmaceutical industry, she has held operational roles in manufacturing and quality of increasing responsibility across GSK’s internal and external network.  She consistently delivers business results through her collaborative, energizing leadership style and is always ready for new career challenges.  Jennifer received her BS at Ursinus College and MS at Temple University.  She is based in the Philadelphia area.

Manel Luis

Manel Luis leads Strategy and Business Operations for Global Manufacturing Operations at BMS since 2020. This includes Network Strategies, Governance and Forums, and facilitation and representation of GMO in strategic and Enterprise level initiatives. Since June 2021, Manel is the Interim Lead for the Pharma Network Operations including Oral Solid Dose 4 sites in Switzerland, China and Japan managing their General Managers with P&L and Talent development accountability as well as overall site performance and daily issue resolution. He’s currently based in Princeton, NJ.

Prior to his experience in Manufacturing, Manel took a number of roles in Global Supply Chain, including the BMS Supply Chain Lead role for the company in the Integration with Celgene; Strategic Product Leader for E2E Technical Operations responsibility for 2 biologics products (one commercial and one to be launched) and Global Logistics Strategy Lead for BMS.

Before moving to the US, Manel lead the BMS Market Logistics Organization for Europe, Middle East, Africa and India from Paris, France including the management of internal warehouses and external partners in the region. In addition to his experience at BMS, Manel worked at Pfizer for 9 years in different roles in Global Logistics and Supply in Belgium and Italy and for Kearny as a consultant for the Pharmaceutical industry from his native Spain.

He holds an Industrial Engineer degree from Universitat Jaume I in Castellon and an MBA from ESADE Business School Barcelona.

Heather Nunn

Heather Nunn, Process Development Principal Scientist, oversees pivotal biologics drug substance development at Amgen where she is responsible for the commercialization of late-stage molecules. Additionally, Heather leads regulatory strategy, data integrity and compliance, lab operations and high-throughput strategy for the organization.

Over her 20-year career at Amgen Heather held various positions with increasing responsibilities in Process Development. She led a drug substance program from design to commercial launch, designed and managed the next generation labs in Cambridge, performed and led bioprocessing and cell line development activities in Seattle, and supported the start-up of two commercial manufacturing facilities in Rhode Island.

Heather holds a Bachelor of Science in Biology from Willamette University and a Masters of Pharmaceutical Bioengineering from the University of Washington.

Jack Garvey

Jack Garvey is the Founder and Chief Executive Officer of Compliance Architects, a leading consulting and advisory firm specializing in innovative quality and compliance solutions for FDA-regulated manufacturers. Jack possesses over 30 years of hands-on technical, operational, quality, regulatory and legal experience at top-performing life science companies including Johnson & Johnson, C.R. Bard, Ciba-Geigy, BASF Corporation and Ayerst Laboratories. As both a chemical engineer and practicing attorney, Jack possesses the legal, regulatory, quality and compliance expertise that allows him to excel at the complex interplay of science, law and business.

Michael Weisenbeck

Mike Weisenbeck is the VP of Sales at Körber, for the Pharma Business Area. For over fifteen years, Mike has been helping companies improve their operational efficiency by utilizing technology’s such as ERP, PLM, IoT and MES.

At Körber, software solutions deliver the difference that add value in the pharmaceutical, biotech, and cell & gene industries. Mike and his team are working with drug manufacturers to digitize their pharmaceutical, biotech, and cell & gene therapy companies to control and monitor their production digitally. This allows companies to boost their efficiency, lower the fault rate, and reduce production costs. Körber‘s Werum PAS-X MES Suite is recognized as the world’s leading Manufacturing Execution System for pharma, biotech and cell & gene.

Jaime Velez

Jaime is the co-founder of Operations & Quality Systems Improvement Experts (OQSIE), a management and technical consulting company focused on supporting manufacturing, supply chain, and quality systems improvement initiatives at Life Science companies.

Over the last 20 years he has supported more than one hundred consulting engagements with Life Science companies delivering significant productivity improvements.  Started his consulting career at McKinsey & Company’s Pharma Operations practice, has led major improvement initiatives with J&J, Teva, Novartis, Abbott, and Pfizer among others.  He co-founded OQSIE in 2013.

He holds a bachelor’s degree in Industrial Engineering from Stanford University, where he was a three-time NCCA All-American water polo player.

Steve McCarthy

Steve McCarthy serves as an industry evangelist and customer advocate for Sparta, working closely with customers to help them define and execute their quality management transformations. He leads Sparta’s strategic thought-leadership and customer coalition programs, partnering with industry, regulators and analysts to shape the future of quality management in life-sciences. Steve has nearly three decades of experience as a quality and supply chain leader within the healthcare industry. Prior to joining Sparta, he held several high-profile positions within Johnson & Johnson, the most recent of which was as VP of Quality Systems Shared Services for their Pharmaceuticals, Medical Devices and Consumer sectors. There he implemented several complex quality system and process transformations across the enterprise. His earlier career was spent in virology research at the University Hospital St. Thomas’ in London. Steve holds a BSc in Medical & Industrial Biology from Cardiff University in Wales, UK.

Michalle Adkins

Michalle Adkins, Director Life Sciences Consulting, has been with Emerson for 16 years. Prior to Emerson, she worked for Merck & Co., Inc for 13 years in instrumentation, automation, manufacturing automation support, computer validation, manufacturing, and scheduling and planning.

Ms. Adkins has a B.S. in Chemical Engineering and an M.E. in Industrial Engineering from The Pennsylvania State University as well as a Six Sigma Black Belt Master’s Certificate from Villanova University. She has been a speaker at several conferences including Interphex, IFPAC, CBI MES, FDA Quality Systems and Six Sigma, ISPE Puerto Rico, and Emerson Exchange.

Ernesto Gemoets

Ernesto Gemoets brings over twenty years of manufacturing facilities management experience in the areas of strategic planning, operational excellence, quality assurance, supply chain management, problem solving/analysis and engineering of process improvements with companies like Treehouse Foods and Kraft. As Executive Director at JLL, Ernesto focuses on helping scaling and mid-tier bio pharma companies grow and achieve their purpose. Ernesto received his Bachelor of Science in Chemical Engineering from The University of Texas in Austin. He lives in Chicago with his wife and two children. His hobbies include classic cars and attending car shows with his family.

Brian Curran

Brian Curran joined MasterControl in 2002 to direct and expand MasterControl’s product development efforts. He has more than 25 years of experience leading the direction for enterprise and entrepreneurial software development companies.

Curran began his career with IBM, where he spent five years leading consulting engagements with Fortune 500 companies such as MCI, BellSouth, and many others. After this, he held several director and vice president level product management and marketing positions for entrepreneurial software development companies in the telecommunications and web analytics sector.

Curran has an MBA with an emphasis in information systems.

Simona Mills

Simona Mills, PMP is the Director of Product Lifecycle Management at ProPharma Group. Simona has a broad range of biotech experience, with over 20 years in Quality, Compliance, Validation, Engineering, Regulatory, and Program Management. She is a proven leader who has helped influence and mentor both colleagues and clients to recognize and adhere to compliant strategies, effective project management, and techniques leading to improved knowledge and understanding. Customer-focused and results-driven, Simona has additional experience in facility construction/start-up, Inspection Readiness and Technical Transfers. She studied Chemical Engineering at The Ohio State University and is an avid football fan.

Shawn Cain

Shawn has over thirty years of experience in combining process engineering with project management to direct the development and manufacture of sterile pharmaceuticals, cell-based biologics, and medical devices. Most recently he was at Organogenesis, Inc., specializing in bio-active wound healing. Mr. Cain was also the Director of Operations for another pharmaceutical CDMO, Formatech, Inc. Prior to that, he was Interim President and Chief Executive Officer of Arbios Systems, Inc. Mr. Cain was also the Vice President of Operations for Circe Biomedical, Inc., where he led the development of the bioartificial liver technology.

Andy Alasso

Andy Alasso is the SVP of Product Management at Aizon. At Aizon, Andy is responsible for leading product delivery of the Aizon AI Cloud GxP platform designed to optimize manufacturing in Life Sciences. Prior to Aizon, Andy was Global Vice President of Product Management within the Oracle Health Sciences Business Unit. Andy and his team were responsible for defining, specifying, and facilitating the delivery of 20+ products within Oracle’s Clinical Research, Pharmacovigilance, and Healthcare portfolios. Overall, Andy has over 25 years of experience in providing software solutions to the Life Sciences and Healthcare industries.

Chris Mansur

Chris Mansur currently serves as the President of Azzur Group’s Consulting division, which specializes in providing innovative quality and compliance solutions to the life sciences industry. Throughout his career, Chris has specialized in new and renovated facility startups, project management, commissioning and qualification, computer validation, implementation of quality systems, and application of quality risk management principles. He is passionate about use of phase-appropriate GMPs to help companies solve problems that accelerate their product’s lifecycle or project timeline. Chris holds a bachelor of science degree in Mechanical Engineering from Worcester Polytechnic Institute.

Sara Sheriff

Sara is a dynamic leader and change agent of Operations/Supply Chain Excellence and Business Process/Digital Transformation. Sara joined Thermo Fisher in 2019 as VP of Integration and has led various initiatives, most recently Engineering Operation Services optimization. In her previous roles, Sara developed and implemented key strategies driving operational success, strategic alignment, and integration across all major organizational functions. She brings hands-on experience in direct industry and management consulting to lead to lead rapid post-merger integration and delivery of scalable solutions to facilitate complex transformation and optimize next-generation digital operations platforms. Sara’s global manufacturing and service experience extends across industries, including energy, aviation/aerospace, building automation controls, consumer goods, communication, and information technology, which enables her to providing unique insights to pharma manufacturing and services.

Pascal Bécotte

Pascal leads Canadian operations for Russell Reynolds Associates and is also a member of the firm’s global Executive Committee. He is a key member of the Healthcare Sector where he advises clients across the globe on their overall talent strategy, particularly with respect to leadership assessment, succession planning and the recruitment of directors, CEOs and other senior executives. More specifically Pascal specializes in Biotech and Pharma Technical Operations including Process Development, Manufacturing, Quality, Engineering and Supply Chain leadership across modalities.

Sanat Chattopadhyay

Sanat Chattopadhyay is responsible for Merck’s worldwide manufacturing and supply operations supporting annual global sales revenues exceeding $47 billion. Merck is known as MSD outside of the U.S. and Canada.

Sanat oversees a network of 50 pharmaceuticals, vaccines, biologics/therapeutic proteins and animal health manufacturing, commercialization and distribution sites with approximately 20,000 staff in over 20 countries around the world producing annually 17.5 billion tablets, 700M injectables, 1 billion packs, and 90 billion animal health vaccines doses in 22,000 product finishes. He also serves on Merck’s Executive Committee.

In his current role, he has successfully launched a new strategy for the manufacturing and supply organization, restructured the organization into four independent, interconnected business units, and further integrated supply planning and operations across the company.

He has a 30-year track record of success in commercialization, manufacturing and supply chain excellence in therapeutic proteins, vaccines and pharmaceuticals for Hoechst, Aventis, Wyeth and Merck.

Before joining Merck in November 2009, Sanat worked for Wyeth Pharmaceuticals as Senior Vice President, New Products & Process Development. A graduate Chemical Engineer and a post-graduate Industrial Engineer from India, Sanat started his career with Hoechst Pharmaceuticals in 1983 and worked in many senior leadership assignments in 5 countries across 3 continents, rising to the level of Senior Vice President, Product Development & Supply at Aventis where he led global supply chain, including new product commercialization, technology and engineering.

Outside Merck, Sanat serves on the Board of Directors of Hilleman Laboratories, an equal joint-venture partnership formed between Merck and the Wellcome Trust, a global charitable foundation dedicated to human and animal health.  He is also a member of the Advisory Board of the USA-India Chamber of Commerce.

Azita Saleki-Gerhardt

Dr. Azita Saleki-Gerhardt is Executive Vice President, Operations, at AbbVie, leading a team of scientific, engineering, business, quality, supply chain, security, purchasing and manufacturing professionals responsible for supply and distribution of all AbbVie products, as well as a number of corporate services.

Dr. Saleki-Gerhardt joined Abbott in 1993 as a research scientist. She has worked in key leadership positions of increasing responsibility across a broad range of areas, including science and technology, manufacturing and quality assurance. Following AbbVie’s separation from Abbott, Dr. Saleki-Gerhardt was appointed head of AbbVie Operations.

She has been published in a number of scientific publications and has been awarded several patents related to pharmaceutical sciences.

Dr. Saleki-Gerhardt is a member of the board of directors for Entegris and also serves on the board of directors at the United Way of Lake County. She is a member of the Dean’s Advisory Boards for the School of International Studies and School of Pharmacy at UW-Madison. At AbbVie, she is the executive chair of the Asian Leadership Employee Resource Group.

Dr. Saleki-Gerhardt earned her bachelor’s, master’s and doctorate degrees in pharmaceutics from the University of Wisconsin at Madison.

Jens Vogel

Dr. Jens Vogel rejoined Bayer in March of 2020 as Global Head of Biotech for the Bayer Pharmaceuticals Product Supply organization. He has more than 20 years of professional and leadership experience in the area of biologics operations, development and technology management. From 2012 until 2020, he held positions of increasing responsibility at Boehringer Ingelheim (BI), including as President and CEO of BI Fremont Inc and member of BI’s Biopharma Executive Committee. Prior to his years at BI, Dr. Vogel was a member of the Biologics Development Leadership team at Bayer in Berkeley. Jens holds a PhD in Biotechnology from University of Braunschweig, Institute of Technology, Germany.

Charles L. Cooney (Chairperson)

Charles L. Cooney is the Robert T. Haslam (1911) Professor of Chemical and Biochemical Engineering, Emeritus in the Department of Chemical Engineering at MIT and founding Faculty Director, Emeritus of the Deshpande Center for Technological Innovation. He has been involved as founder, advisor or board member of over 25 companies and currently sits on the Boards of Directors of Codiak Bioscience, Innovent Biologics (1801.HK), Levitronix Technologies, and is chairman of GreenLight Bioscience and Mitra RxDx. In addition, he is Trustee Emeritus of Boston Ballet, Advisor Emeritus of the Boston Symphony Orchestra and Trustee of the Leventhal Map Center. Other interests include: high altitude mountaineering (assents of Denali, Ama Dablam, Mont Blanc, Kilimanjaro, Huascaran). and antique map collecting.

Donna Gulbinski

Donna’s expertise spans worldwide operations, quality, and regulatory experience across vaccine, biological, pharmaceutical and device technologies where she was an operational leader with a history of delivering exceptional quality, compliance and business performance. Donna has a 30-year plus career where she held positions of significant responsibility for Quality and GxP Compliance, including various roles in drug discovery, operations, quality and regulatory affairs. Donna is currently the Chief Quality & Regulatory Affairs Officer at Civica, Inc., a new independent not-for-profit company founded by health care systems to address critical generic drug shortages caused by market failures.

Donna was previously at Lachman Consultant Services, LLC where she was Vice President of the Compliance Practice. Prior to that Donna was the Head of Quality for Bristol-Myers Squibb where she led Quality through 13 NME approvals with flawless pre-approval inspections, built, qualified and approved several biologics facilities and led transformational activities in moving from 34 sites to 12 both from a quality perspective and as the CMC regulatory leader.

Donna’s expertise spans a strong foundation in technical and quality & compliance including basic research at Merck & Co., Inc. across cardiovascular, bone biology, HIV, anti-coagulants and multiple drug resistance.

Derek Adams

Derek Adams joined bluebird bio in March 2017 as Chief Technology and Manufacturing Officer leading all pharmaceutical sciences that includes process and analytical development, manufacturing, technical operations, and supply chain. Prior to joining bluebird, Derek was the Senior Vice President of CMC at Evelo Biosciences. At Evelo, Derek established the initial process development function and supply chain for clinical studies and drove strategy for product development. Prior to his time at Evelo, he served as Vice President of Technical and Strategic Product Development at Alexion Pharmaceuticals, where his responsibilities included developing and supporting all manufacturing processes globally as well as global clinical supply chain.  His Alexion career also included roles as Plant Manager for Alexion’s Rhode Island Manufacturing facility and head of upstream process development.  Derek began his career in process technical support for live virus vaccine production at Merck & Co, Inc.

Derek holds a Ph.D. in Chemical Engineering from the University of Minnesota and a B.S. in Chemical Engineering with High Distinction from Worcester Polytechnic Institute (WPI).

Kimberly Lounds Foster

Kimberly Lounds Foster is Senior Vice President, Global Supply Chain at Bristol-Myers Squibb, where she oversees the clinical and commercial supply chain. Bristol develops and manufactures products on multiple technology platforms, including small molecules, biologics and cell therapies. Kimberly joined Bristol through the Celgene acquisition in 2019 after leading Celgene’s Global Technical Operations organization. Prior to Celgene, Ms. Foster was Head of Global Supply Chain at Novartis’ Cell & Gene Therapy unit, where she was responsible for building out the commercial and clinical autologous supply chain for KYMRIAHTM (tisagenlecleucel), the first FDA approved CAR T cell therapy. Ms. Foster held various positions at Sandoz a Novartis company where she built the External Supply Operations functions for the Americas and managed Sandoz US supply chain for in-line products, new products launches and managed the warehouse and distributions network. Prior to Sandoz, Ms. Foster held various roles of increasing responsibilities at Catalent Pharma Solutions, Baxter Healthcare, Accenture and Merck. Ms. Foster’s diverse experience includes business development, mergers & acquisitions, management consulting, strategic planning, process engineering and operational excellence. Ms. Foster holds an M.B.A from The Wharton School, University of Pennsylvania and a B.S. in Chemical Engineering from Northwestern University.

Patrick Yang

Dr. Pat Yang is one of the most accomplished biotech manufacturing executives and technical operations leaders in the industry.

From 2017 to 2019, Pat was executive vice president at Juno Therapeutics, a leading CAR-T biotech company (now part of BMS) based in Seattle.

Previously, from 2009 to 2013, Pat was Executive Vice President and Global Head of Technical Operations at F. Hoffman-La Roche based in Basel, Switzerland. In this role, he was responsible for Roche’s biopharma process research and development, analytical sciences, engineering, quality, technical regulatory, supply chain and all manufacturing plants with approximately 15,000 employees around the world. From 2003 to 2009, Pat was Executive Vice President of Product Operations at Genentech. He assumed his role as Global Head of the combined technical operations of Roche and Genentech upon the acquisition of Genentech by Roche in 2009.

Before Genentech, Pat worked for 11 years at Merck & Company from 1992 to 2003, based in New Jersey, in various leadership positions including vice president of Asia Pacific Operations and vice president of Global Supply Chain Management. Prior to joining Merck in 1992, Pat spent 12 years at General Electric, serving in research, engineering, technology, and manufacturing leadership roles with increasing scope of responsibilities.

Pat holds a Bachelor of Science from the National Chiaotung University in Taiwan, a Master of Science from the University of Cincinnati, and a Ph.D. in engineering from Ohio State University.

Pat is a member of the Board of Directors of three public companies, Amyris, Codexis and PharmaEssentia. In addition, he is on the board of several private companies, including Acepodia, AltruBio, Antheia and Sana Biotechnology.

Al Boyle

Al is Chief Technical Operations and Quality Officer for Alnylam Pharmaceuticals. He leads a global organization responsible for all aspects of siRNA process and analytical development, clinical and commercial manufacturing, supply chain operations, engineering, facilities and real estate operations, and quality assurance and quality control oversight for all GxP activities. Prior to joining Alnylam in 2015, Al worked for a number of global biotechnology, chemical and pharmaceutical companies including Alexion, Bristol-Myers Squibb, Hercules, Akzo-Nobel and Celgene. Al holds a PhD in Microbiology from Rutgers University and BS and MS degrees in Environmental and Forest Biology from The State University of New York College of Environmental Science and Forestry.

E. Morrey Atkinson

As SVP and Head of Commercial Manufacturing & Supply Chain, Morrey’s current responsibilities include defining the commercial manufacturing and supply chain strategy needs, as well as, designing and building a global organization and supply network. In addition, Morrey is responsible for assuring reliable supply of Vertex’s transformative medicines.

Morrey is a trained laboratory scientist who brings more than 25 years of experience leading the development and commercial manufacturing of multiple products at organizations like Eli Lilly and Bristol Myers Squibb. An accomplished leader and builder of strong scientific, engineering, and operations teams, Morrey also has prior experience in process development for cell and gene therapies, including the development and manufacturing of one of the first gene therapy candidates for cystic fibrosis.

Uwe Buecheler

Uwe Buecheler, Ph. D. joint Boehringer Ingelheim (formerly Dr. Karl Thomae GmbH) in 1991. During his time at Boehringer Ingelheim he held different positions in Biopharmaceuticals in regulatory affairs, Validation, CMC/GMP documentation and biological safety. For several years he was leading the Quality Unit as well as Process Science for Biopharmaceuticals. Starting 2006 he was appointed site head for the Boehringer Ingelheim site in Biberach, Germany, got member of the board of the German subsidiary being responsible for the mammalian cell culture business at the Biberach site Boehringer Ingelheim. Starting October 2010, he was responsible for global Biopharmaceuticals Operations including sites in Germany, Austria and US. Since May 2014 he is SVP Biopharmaceuticals responsible for the entire Biopharma Business Unit at Boehringer Ingelheim including the new site in Shanghai.

Uwe Buecheler has conducted his Ph. D. in Molecular Biology at the University of Heidelberg and the Cancer research Center in Heidelberg. Prior joining Boehringer Ingelheim he worked at Roche (former Boehringer Mannheim site in Penzberg). He has been awarded Professor h.c. at the University of Ulm and is member of Advisory boards of University´s and the Society for Biochemistry and Molecular Biology (GBM). He is Chairman of the Biopharma Cluster South Germany and is Member of several (Bio-) Pharmaceutical Industry Associations e.g. the international leadership forum of ISPE.

Jon Cammack

Jon Cammack is the Chief Quality and Compliance Officer at Nevakar, Inc. He provides strategic direction and oversight of activities that align with business objectives, and ensures compliance with overall biopharma regulations and standards. Jon has over 25 years of commercial and development experience with medical products, including leadership roles in large and small pharma/biotech companies, and as a co-founder of a risk management consulting company. He has a Ph.D. in Pharmacology, holds advisory board positions, and also co-chairs the AAMI/ISO Working Group on Combination Products with John (Barr) Weiner of FDA’s Office of Combination Products.

Anders Vinther

Anders Vinther serves as Site Head (Hayward) and VP Global Quality at Intarcia Therapeutics. He joined Intarcia in 2018 as VP Global Quality and Engagement, previous to this Anders was the Chief Quality Officer at Sanofi Pasteur accountable for cGMP compliance, quality leadership, and the quality of the company’s vaccines worldwide.

Prior to that he worked for Roche and Genentech most recently as the VP of Biologics Quality which included operational quality leadership for 10 Biologics Roche and Genentech manufacturing sites and all outsourced manufacturing for biologics products. Previous to that role he led the Global Quality System and Processes organization in Genentech & Roche. In that role areas of responsibility included developing and overseeing implementation of the Pharmaceutical Quality System (PQS), Quality Risk Management, Operational Excellence, Portfolio Management, Computer Systems and Inspection Management.

Previously he was the co-founder and Chief Quality Officer of the contract manufacturing organization CMC Biologics, where his responsibilities on the Board of Management included QA, QC, IT, Human Resources and Strategic Planning.

Anders holds a PhD in Chemical Engineering from the Technical University of Denmark and has 20+ years of business and biopharmaceutical experience, including research and development, quality assurance and control, compliance, regulatory affairs and senior management.

In PDA, Anders is currently the Immediate Past Chair of the Board of Directors. Additionally over the past 20 years in PDA he has been Chairman of the Board of Directors, Treasurer, Board of Directors member, task force and conference planning committee leader and member, and author of numerous articles.

Michele D’Alessandro

Michele is Vice President and CIO for the Manufacturing Division with Merck.  In this role, she provides strategic leadership, oversight and delivery of information technology and digital solutions for the Merck Manufacturing Division.   A change agent with proven track-record of delivering high-impact projects producing outstanding business results broadly across Pharmaceutical Supply Chain and Manufacturing.

Michele and her team have been nationally recognized for the past 7 years in the areas of technical innovation, including next generation data and analytics platforms; supply chain transformation; and resiliency /modernization/digitization in manufacturing plants.  In Nov 2017, Michele was awarded a Gold Stevie® Award for Women in Business in the Life Sciences and Healthcare Transformation category.

Michele holds a Bachelors’ double major degree in Math and Computer Science from Rutgers University and an M.B.A. in Information Sciences from Rutgers Graduate School of Management.

Michele serves on the National Association of Manufacturer’s Manufacturing Leadership Council Board of Governors, and the Big Data Advisory Board for Rutgers University.

Dennis Nsenkyire

Dennis is responsible for leading a high performing team responsible for designing, developing, and executing Janssen’s integrated end-to-end supply chain strategic roadmap in partnership with R&D, Commercial and global cross-functional teams.

Success in his current role is working with Commercial, R&D, and end-to-end Supply Chain leaders to translate customer/patient value proposition into an operational strategy and ensure the continual evolution of supply chain capability through innovation, agility, end-to-end value and people/leadership development.

Most recently, Dennis served as Vice President, Supply Chain Culture & Capability Development, where he led the development and implementation of innovative capabilities to further advance Supply Chain talent, skills, competencies, and development programs. Prior to that, Dennis held critical leadership roles responsible for J&J Supply Chain Insights, Strategy and Business Excellence where he led and shaped the development, deployment and execution of J&J Supply Chain strategy and strategic innovation programs.

Prior to joining the Supply Chain organization, Dennis led the Commercial Operations team at Ethicon (J&J Medical Device Sector), responsible for go-to-market models, sales force design and deployment, commercial analytics, planning, and operations.

Dennis joined Johnson and Johnson in 2002 at McNeil Consumer and Specialty Pharmaceuticals, where he held several leadership positions in Process Excellence and Business Strategy and Insights. Dennis also worked at J&J Vision Care, where he was responsible for market insights, sales force deployment, sales force compensation, CRM, territory management, and business analytics. Prior to Johnson and Johnson, Dennis held various leadership roles in Marketing,

Process Excellence and Engineering at Honeywell International and Therma Tru Corporation.

Dennis holds a master’s degree in Electrical Engineering from Arizona State University, an Executive MBA from Drexel University (Lebow College of Business) and is a Certified Process Excellence Master Blackbelt.

Daniel Couto

Daniel Couto is the Chief Operating Officer of Vedanta Biosciences, a leading Microbiome company. Mr. Couto is an Operations Management Executive with over 25 years of experience starting and advancing Biopharmaceutical Development and Manufacturing organizations to higher levels of capability, growth and productivity. Mr. Couto has a comprehensive knowledge and hands-on experience leading organizations through improvement initiatives and developing new therapeutic modalities. Mr. Couto is the former SVP of Manufacturing and Operations of ContraFect Corporation, a public company developing new Lysin enzymes for MRSA infections. His previous employment was with Merck Sharp Dohme Biologics UK Ltd. (former Avecia Biologics) where he served as Vice President of Commercial Manufacturing Operations responsible for all late stage and commercial product. Prior to this he was responsible for 7 World Wide Contract Manufacturing sites including API/BDS and Final Fill Finish as he served as Director of Manufacturing for Nuvelo Inc. (San Francisco Bay area). He has been instrumental in 2 BLA submissions for drug approvals, 2 major Pre-Approval Inspection (PAI), and several IND submissions. Mr. Couto holds patents for several novel separation technologies such as Bulk Protein Crystallization, HPTFF, SMB, and Bacterial formulation and Lyophilization. Prior to this he served in a number of Sr. Management positions for companies including Genzyme Transgenics Corp. (GTC Biotherapeutics), Advanced Biosystems Corp., ImmuCell Corp., and Sepracor Corp. Mr. Couto received his B.S. Degree in Chemical Engineering with a minor in Economics from Rensselaer Polytechnic Institute.

Stephen Scypinski

Dr. Stephen Scypinski received his B.S., M.S. and Ph.D. degrees in Chemistry from Seton Hall University, South Orange, NJ USA. Involved in pharmaceutical research and development for over 30 years, Dr. Scypinski has held positions at Berlex Laboratories, Hoffmann-La Roche, the R.W. Johnson Pharmaceutical Research Institute, Eyetech Pharmaceuticals, and Bristol-Myers Squibb Company. He is presently Vice President, Pharmaceutical Technology for Daiichi Sankyo Inc. His professional interests encompass the development of pharmaceutical processes and methods for drug substances and dosage forms, technical transfer, stability, bioanalytical methodologies, and new technology as applied to the reduction of cycle time and enhancement of productivity in preclinical and pharmaceutical development. Dr. Scypinski has extensive experience in both line and matrix management. He has played a key role in the filing of over fifty global regulatory submissions for both synthetic small molecule and biologic products. Dr. Scypinski is also active in the scientific community, having served as General Chairman of the Eastern Analytical Symposium and Chairman of the Laboratory Robotics Interest Group of New Jersey. He serves on the President’s Advisory Councils of Duquesne University College of Pharmacy and the Stevens Institute of Technology Pharmaceutical Manufacturing & Engineering Program. Dr. Scypinski is also an adjunct professor at Duquesne University School of Pharmacy. He is the recipient of many awards, including the New Jersey Institute of Chemists Honor Scroll Award and the Distinguished Alumnus Award from Seton Hall University. Dr. Scypinski is the Editor-in-Chief for The Journal of Pharmaceutical Innovation and is co-editor of the textbook “Handbook of Modern Pharmaceutical Analysis”, currently in its second edition.

Traci Seaman

Traci ran her own consulting company for nearly 15 years, focusing on issues management. She primarily worked with pharma companies with warning letter and consent decrees. She holds a bachelor’s degree in journalism and an MBA with an emphasis on Human Resource Management. She is a six sigma green belt and a certified professional coach. Traci is a believer in servant-based leadership, and a strong proponent of accountability. She studies the impact of accountability on company culture.

Traci is married to her husband Jim and they have two (grown now) sons. She enjoys traveling, sports, reading, DIY and spending time with family.

Shannon Holmes

Shannon is the Director of Product Development Quality at Biogen, based in Research Triangle Park, NC. She leads a global team responsible for quality oversight and strategy of all products and devices in clinical development as well as lifecycle management of commercial programs. Prior to this role, Shannon was a member of the Regulatory Affairs CMC team at Biogen and led a global team responsible for early phase and commercial biological products as well as change management/compliance activities. While at Biogen, Shannon has led successful submissions for clinical, licensed, and post-marketing regulatory applications for biological and combination products. Shannon is an active member of the PhRMA Global Quality and Manufacturing Work Group. Prior to Biogen, Shannon worked in regulatory roles at Synthon Pharmaceuticals and Merz Pharma supporting small molecules, biosimilars, and medical devices. Shannon received her PhD in Chemistry from the University of North Carolina and a BS degree in Chemistry from Davidson College.

Michael Boyson

Mike is responsible for global operations strategy, including life-cycle planning and overall operations value management for Takeda’s oncology portfolio and select small molecule therapies. Mike joined Takeda Oncology in 2002. Since that time, he has held various positions in External Manufacturing, Supply, Quality Operations, and GMP Training. Prior to joining Takeda, Mike was with Biogen’s Bioassay Development Group. He holds a B.S. in Microbiology from the University of Massachusetts, Amherst and is a graduate of the General Management Program at Harvard Business School. In his spare time, Mike enjoys snowboarding, running, hiking, improving his private pilot skills, and spending time with his wife and dog.

“The working lesson most important to me is that the power of ethnic, cultural, racial and gender diversity, plus a diversity of perspective is a critical success factor for teams.”

Saul Fink

Saul is Vice President, Pharmaceutical Development at Goldfinch Bio where he leads teams for small molecule and biological assets to provide CMC strategic guidance, budgets and all operational activities to establish a supply chain for clinical supplies.

Saul is a biotech and pharmaceutical R&D leader. He has led CMC teams across many therapeutic areas for both small molecule and biologic assets. He also led large, complex strategy & business operations units with emphasis on financial & resource management, project management, capital facilities & equipment, tracking/reporting business performance and metrics.

Saul has held key strategy and business operations leadership roles in pharmaceutical development, translational medicine, discovery, regulatory, pharmacovigilance, biostats, manufacturing and supply chain. He was a key leader in R&D and manufacturing M&A transactions and strategic planning.

Saul spent a good part of his career in the pharmaceutical industry with Bristol-Myers Squibb (BMS). In these roles he worked closely with C-suite and other senior executives to accelerate strategy execution, business transformations and operational performance. Saul led a multi-disciplinary, global integration manufacturing team following the acquisition of Amylin Pharmaceuticals by BMS and AstraZeneca (AZ). He then participated in the $7B divestiture of the BMS diabetes portfolio to AZ including the negotiations for deal close and led the BMS manufacturing transition team. He also drove the recent R&D transformation across 7 sites.

Saul received his B.S. in Chemistry from Millersville University and Ph.D. in Chemistry from the University of Houston

Saul has substantial not-for-profit board and local government experience. He is currently a member and President for the Millersville University Foundation Board. He formerly served as a councilman for East Brunswick (NJ) township. Saul is a licensed recreational pilot.

Jean Bender

Brendan Hughes

Brendan is responsible for all of BMS Pharma and Biologics manufacturing from internal and external sources. He is based in Devens MA.

Brendan joined BMS as Head of CMC Strategy for Biologics in 2012. From 2015-2020 Brendan led MS&T for the company with responsibility for all technologies used in manufacturing including biologics, pharma products, parenterals and devices.

Before joining BMS, he led MS&T and Technical Services teams in Wyeth and Pfizer.

Brendan has worked in the US, Ireland and the UK. He started his career in the UK working for Wellcome which then became Glaxo-Wellcome and then GSK; roles included leadership positions in Quality, analytical sciences as well as project leadership. Brendan came to US in 2001 joining the Biotech Development team in Wyeth. He later joined the leadership team for the Wyeth Grange Castle biotech start-up in Ireland from 2003-2010 and returned to US in 2010 to work in Pfizer Global Manufacturing.

Brendan received his B.Sc and Ph.D in Biochemistry in Ireland and carried out post-doctoral studies in Oxford UK. He was a member of the ICH Expert Working Group which drafted the initial Quality Guidelines for biotech products in the 1990s and later for ICH Q11

Thomas Seewoester

Thomas Seewoester is the Vice President External Supply, an organization that orchestrates a global operations network of external partners for contract development and manufacturing, materials, components and devices to extend Amgen’s capacity and capabilities.

Prior to this role he served as Vice President Site Operations Rhode Island, Amgen’s largest commercial drug substance manufacturing operation where he also oversaw the construction of a second next-generation plant.

He joined Amgen in 2001 and has held various positions in Process Development before gaining further operational experience through leading drug substance plants, a drug product plant, a device assembly and packaging plant and a small molecule API plant at Amgen’s California and Rhode Island locations.

Mr Seewoester worked at BASF and Abbott before. He was a postdoctoral fellow and holds a M.S. and a Ph.D. in Biotechnology from the Institute for Cell Culture Technology, Germany.

Andrey J. Zarur

Andrey co-founded GreenLight Biosciences in 2008 to develop advanced biological solutions to overcome some of the biggest challenges faced by the human race, including sustainable food production, response and preparedness for pandemics, and global access to effective human health.

He is a co-founder and was Chairman of the Board of Solid Biosciences, Inc. (NASDAQ: SLDB), a gene-therapy company targeting Duchenne Muscular Dystrophy. He is also co-founder and Chairman of the Board at Lumicell Surgical, an oncology company delivering advanced imaging solutions to cancer surgery. He has been a co-founder and senior executive in more than a dozen companies in the healthcare and clean energy sectors. Prior to starting GreenLight, Andrey was Managing Partner at Kodiak Venture Partners, an early-stage, technology-driven venture fund based in Boston.

Dr. Zarur carried out graduate doctoral studies in Chemical and Biomedical Engineering at the Massachusetts Institute of Technology, and Immunology at Harvard-MIT. Andrey is a frequent invited speaker at scientific and trade conferences, has authored a number of landmark peer-reviewed articles in prestigious scientific journals, holds over 100 provisional and issued patents and has been regularly quoted in international media on the pandemic and RNA vaccines, including recent opinion pieces in Fortune and Stat as well as quotes in the Financial Times, Investors Business Daily, Wired, Business Insider and CNBC.

Pascal Bécotte

Dr. Pascal Bécotte leads the firm’s Canadian operations and leads the firm’s global Corporate Officers practice which includes the Finance, Human Resources, Operations & Supply Chain, Legal, Regulatory & Compliance and Corporate Affairs practices. Pascal is also a member of the firm’s Global Executive Committee as well as a member of the Healthcare and Industrial teams, where he advises clients across the globe on their overall talent strategy, particularly with respect to leadership assessment, succession planning and the recruitment of directors, CEOs and other senior executives. He splits his time between the Toronto and New York offices.

Pascal has more than 18 years of executive search experience, most recently with a leading global executive search firm where he was Managing Partner for the Montreal office. Immediately prior to joining Russell Reynolds Associates, Pascal worked for Target, where he was Group Vice President for Stores and Officers in Canada. Earlier in his career, he was President of a boutique recruiting and consulting firm specialized in sales and marketing. Pascal began his career as National Sales Manager for a sportswear manufacturing company.

Pascal received his Bachelor of Engineering Physics degree from the Royal Military College of Canada and was trained as an aerospace engineer with the Royal Canadian Air Force. He also earned Master’s and Doctorate degrees in business administration from Athabasca University in Canada, where he focused his research and dissertation on CEO succession. Pascal speaks fluent French and English.

Franck Chassant

Since he completed his PharmD degree, Franck has been working in the industry for 20 years, with roles of growing responsibilities in pharmaceutical, vaccines and biologic manufacturing operations (drug substance and drug product) as well as industrial strategy, in France, Canada and the USA.

After leading large industrial and R&D campuses as site head in Swiftwater, PA and then at Marcy-L’Etoile, France, Franck is now in charge of Rare Disease, Oncology and Immunology Industrial cluster (5 sites), at Sanofi Speciality Care.

He is based in Boston with his wife and 2 kids.