The BioMaP-Consortium’s Executive Steering Committee is made up of member-elected representatives, serving in a volunteer capacity to advise and represent the biopharmaceutical industry in peer-level engagements with the BioMaP-Consortium and our partners in the US Government.
Chair for Enabling Platforms
Flavia-D'Souza - Enabling Platforms
Flavia D’Souza is the Co-Founder of Sentio BioSciences, a FDA registered development and cGMP manufacturing small business, where she has served as Head of Quality for over 10 years. While leading Sentio’s quality and regulatory affairs, Flavia has developed a deep understanding of the regulatory environment and taken two drug products from development to FDA approval and commercial manufacturing. As new platforms and technologies for Manufacturing Drug Substance and Drug Product develop, Flavia intends to help guide the ESC and BioMaP-Consortium by bringing together industry experts and FDA to provide insight on topics and assist in defining the regulatory pathways for generic and new products and novel technologies.
Flavia-D'Souza - Enabling Platforms
Chair for Drug Substance Manufacturing
Melissa Berquist - Drug Substance Manufacturing
Melissa Berquist currently serves as the Senior Director of Strategy & Execution, and Chief of Staff, for FUJIFILM Diosynth Biotechnologies Texas (FDB Texas), an industry leading CDMO. Prior to joining FDB Texas, Melissa served in senior leadership roles at a number of biotechnology firms and has nearly 20 years of experience in the Biodefense sector, leading organizations monitoring and researching public health threats, then identifying and manufacturing countermeasures.
Melissa has well developed skills in data interpretation and measuring the progress, and success of business and development activities via quantitative and qualitative metrics. She has a keen ability to analyze organizational structures, business processes, performance measures, and evaluate criteria, which she has used to transform operations, increase efficiency, and align internal strategies with crucial policy changes. She is passionate and excited about new innovations in the biopharmaceutical industry, and the impact they will have as they are integrated into the existing health security manufacturing base and supply chain.
Melissa Berquist - Drug Substance Manufacturing
Chair for Logistics & Supply Chain
Helen Bush - Logistics & Supply Chain
Helen Bush is a seasoned Supply Chain and Logistics Director with over twenty years of experience driving operational excellence and strategic innovation in global supply chain management. During her tenure at UPS and Evonik Corp, Helen has developed proven expertise in data analytics, enhancing efficiencies and reducing costs in competitive environments. She is skilled at ensuring seamless coordination across procurement, production, and distribution channels, with a strong focus on problem-solving and leading cross-functional teams to achieve organizational goals. After the COVID-19 pandemic severely stressed and changed the global supply chain and logistics industry, Helen wishes to use her experience and skills to advise the ESC and BioMaP-Consortium to help support supply chain resilience using new and developing technologies across the biopharmaceutical manufacturing space.
Helen Bush - Logistics & Supply Chain
Chair for Commercial Scale Manufacturing
Sean Kirk - Commercial Scale Manufacturing
Sean Kirk is a Global Strategic Healthcare Operations Executive with significant multi-disciplinary experience, diverse financial and business acumen, corporate governance experience, and a track record of increasing responsibility. Currently he serves as the Principal for Arena BioPharma Consulting, LLC, an executive consultant services provider in the life science industry.
Previously, Sean dedicated 18+ years of focused effort, and played a key role in driving the expansion of Emergent BioSolutions (NYSE: EBS) from a one site, one product, ~$50M annual revenue company to a global life science organization with 20+ locations, 11 commercial products, 15 product candidates, and ~$2B in annual revenue. As the internal and external face of the company through employee, investor, Board of Directors, government, and media relations, worked diligently to optimize the business, enhance value, and ensure a strong link between corporate strategy, operational capability, and an engaged and motivated workforce.
Sean Kirk - Commercial Scale Manufacturing
Chair for Delivery Devices
David Powell - Delivery Devices
Dave has worked in the pharmaceutical industry for over 30 years, mostly in roles and companies in the CDMO industry. The majority of his experience is in the fill-and-finish segment of the industry, from early days as an engineer in operations to an executive role in a leading CDMO. He has been a member of the industry trade organization Pharma & Biopharma Outsourcing Association (PBOA) since its inception in 2014, and has gained considerable experience in the past four years working directly with BARDA leadership on the COVID-19 PHE response, the Mpox PHE response, and the Industrial Base Expansion program. Being the lead Government Affairs contact for Grand River Aseptic Manufacturing during this time, he gained knowledge of the BARDA organization and Government contracting.
David Powell - Delivery Devices
Chair for Critical Infrastructure
Peter Stolba - Critical Infrastructure
Peter Stolba is the Chief Business Officer (CBO) at Artis Biosolutions, bringing extensive experience in business operations and development across the pharmaceutical industry. Before joining Artis Biosolutions, Peter was Vice President of Business Development at Halozyme and previously served as Vice President of Business Operations at TriLink Biotechnologies / Maravai LifeSciences, where he played a key role during a transformative growth phase that included advancing nucleic acid technologies and contributing to pandemic response efforts.
Prior to that, he worked within the Clinical Strategy and Supply Management organization at Pfizer and at Halo Pharmaceutical, where he led operations serving pharmaceutical companies ranging from large multinationals to emerging biotechs in API and drug product manufacturing.
Peter holds an MBA from National University and a Master of Science in Biology from Liberty University.
Peter Stolba - Critical Infrastructure
Chair for Sterilization
Whitney Tull - Sterilization
Whitney Tull joined STERIS in April 2019 to lead Government Affairs for the Company. In this role, she coordinates external engagement with a broad set of stakeholders comprising of associations, government officials, policy makers, and Customers for STERIS. Additionally, Whitney serves on STERIS’s Senior Management Team (SMT) and sits on the Ohio Life Sciences Board of Directors. Prior to joining STERIS, she managed U.S. Government Affairs for 11 years at Zimmer Biomet, another medical technology company. She started her career representing patient advocacy organizations and scientific societies. Whitney has a proven record of developing strategic plans to address critical corporate challenges, focused on healthcare policy.
Whitney Tull - Sterilization
Chair for Drug Product & Fill/Finish
John Clapham - Drug Product & Fill/Finish
John Clapham is CEO of PSC Biotech Corporation, PSC Software, BioTechnique, and Future Cures. He is the Founder of PSC Biotech Corporation and has been with the Company since founding the Company in 1996.
John is a graduate of the University of Rhode Island, with a bachelor’s degree in chemical engineering in 1989. He has done graduate studies at the University of New Haven. He has worked for the United States Department of Defense (Naval Ordnance Station), CPI Plants Inc., Lockwood Greene Engineers, Johnson and Johnson, and Fluor Daniel prior to founding PSC Biotech Corporation.
He is certified Computerized System Auditor from the Parenteral Drug Association (PDA). He is also a certified Regulatory Affair Certified professional with the Regulatory Affairs Professional Society (PDA). He is the Past President of the ISPE Greater Los Angeles Chapter, for two consecutive terms. John is also an active member of American Society of Quality (ASQ), as well as the Building Commissioning Association (BCxA).
John is the CEO of BioTechnique. BioTechnique is in York, Pennsylvania. BioTechnique provides contract development, manufacturing of sterile injectables and cGMP storage solutions for life sciences customers globally.
John is the Chairman of the Board, and the current CEO, of PSC Biotech Corporation “PSC”. PSC is an international, multidisciplinary technology firm with offices located in North America, Europe, Asia, and the Middle East. PSC specializes in life sciences consulting services, enterprise software applications and solutions and sterile injectable manufacturing.
John is the CEO of PSC Software, which is a wholly owned division of PSC Biotech Corporation and provides software as a service (SaaS) application using its flagship products: Adaptive Compliance Engine™ aka “ACE” and regulatory inspection management software AuditUtopia™. ACE and/or AuditUtopia are currently being used by 15 of 20 the largest life sciences companies in the world by revenue.ohn is the CEO of Future Cures, a registered 501(c)(3) non-profit agency that is dedicated to finding cures for diseases that are currently incurable. Future Cures distributes grants to academic institutions and sponsors research with a variety of academic researchers.
