Speakers
The PBOA Meeting & Conference features speakers and panelists who represent decades of expertise in pharma and biopharma outsourcing fields. More speaker bios will be posted as they come in!
Eugene Bae, Ph.D.
Director of Biotechnology Policy
Bureau of Cyberspace and Digital Policy (CDP/ECTP)
U.S. Department of State
Dr. Eugene Bae is part of the leadership team in the Office of Emerging and Critical Technology Policy in the Bureau of Cyberspace and Digital Policy at the U.S. Department of State. As the Director of Technology Policy, Dr. Bae leads the emerging technology team overseeing biotechnology, quantum, and other emerging tech issues.
Dr. Bae has served multiple overseas tours in New Delhi, India; Seoul, Korea; and Beijing, China. Across these diplomatic assignments, he focused on the intersection of science, technology, and foreign policy, with the mission of leveraging America’s S&T strengths to advance U.S. economic and national security interests. He served as a member of the Executive Secretariat staff for Secretaries of State Clinton and Rice, and prior to joining the State Department, was a Program Manager in the Office of the Secretary of Defense.
An engineer by training, Dr. Bae has a doctorate in nuclear engineering from the Massachusetts Institute of Technology (MIT); a master’s degree in technology and policy from MIT; and a bachelor’s degree in electrical engineering from Missouri S&T University. He hails from Kansas City, Missouri and is married with two children.
Kevin Baughman
VP of AI Consulting Services
Aizon
Kevin Baughman is responsible for the delivery of value-based solutions that transform customers’ operations by merging technology with strategic vision. He has held multiple customer-facing roles, ultimately landing in consulting specializing in Artificial Intelligence and cloud-based solution integration. As a consultant, he has led projects in both the private and public sector for clients in many industries, including finance, insurance, transportation, healthcare, and pharmaceuticals.
Kevin attended N.C. State University for both undergraduate and graduate school where he received B.S. degrees in Applied Mathematics and Economics as well as an M.S. degree in Advanced Analytics from the Institute for Advanced Analytics.
Now at Aizon, Kevin continues to deliver value by working hand-in-hand with customers to co-create, develop, and implement strategic, AI-focused solutions.
Daniel Cohen
Managing Director
Morgan Stanley | Investment Banking Division
Mr. Cohen is a Managing Director at Morgan Stanley. He is an accomplished M&A practitioner, having worked with and advised companies over more than 20 years on the execution of M&A transactions valued at over $75 billion. He advised TH Lee and Frazier Healthcare on their acquisition of Adare Pharma, Permira on its acquisition of Cambrex and financing transactions on behalf of clients including Cambrex, AMRI, Danaher, Catalent, IQVIA and Huntsworth.
Alonza Cruse
RETIRED Director • Office of Pharmaceutical Quality Operations
FDA, Office of Regulatory Affairs
Alonza Cruse recently retired from his role as director of the Office of Pharmaceutical Quality Operations within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA). His office was responsible for all pharmaceutical quality inspections and investigations, working in conjunction with FDA’s Center for Drug Evaluation & Research and the Center for Veterinary Medicine.
From 2013 to 2015, Mr. Cruse served as the acting director of the Office of Medical Products & Tobacco Operations within ORA, overseeing activities such as implementation of the Generic Drug User Fee Amendments, pharmacy compounding, and the development of a new inspection protocols program.
Prior to that, Mr. Cruse was the director of the Los Angeles District Office, where his responsibilities included providing executive leadership to implement, manage and evaluate FDA’s regulatory operations. Mr. Cruse first joined ORA in 1983 as a microbiologist. He received his Bachelor of Science degree in medical technology from York College (City University of New York).
Patrick Day, M.S.
Principal Consultant
Lachman Consultants
Patrick is an established pharmaceutical executive and practitioner with proven leadership in proactive risk identification, deployment of strategies to enhance compliance controls, and implementation of detection systems to eliminate blind spots. He is skilled in policy deployment, Computer System Validation, Data Integrity/Governance, Risk Management, Supply Chain Logistics and application of AI for the next generation of quality professionals. He has trained FDA field inspectors for facility inspection techniques and has delivered talks on deployment of risk strategies and modern signal detection. His expertise also includes outsourcing and integrating efficient governance of Facilities Management and laboratory services across US/UK and Asia-Pacific. Pat’s frequent blogs and articles help educate the industry become aware of emerging global risks, technologies, and their effect on the global supply chain.
Brent Del Monte
Principal • Head of the Health and Life Sciences Practice
BGR Group
Brent Del Monte, Head of the Health and Life Sciences Practice and firm Principal, joined BGR in July, 2015. He helps clients formulate policies, and then works with them to achieve these policy priorities by developing strategies to best engage with Congress and the Administration, and then executing upon these strategies with, and on behalf of, clients.
Immediately prior to joining BGR, Brent served as the Vice President for Federal Government Relations at the Biotechnology Innovation Organization (BIO) for ten years. In this role, he was responsible for leading the efforts to accomplish BIO’s priorities on the Hill and within the Administration. Before accomplishing these objectives, Brent first had to achieve consensus on policy among BIO’s more than 1,000 member companies. During his time at BIO he helped the organization successfully engage with the Congress in the enactment of legislation creating a FDA biosimilars approval pathway and legislation allowing refundable tax credits for pre-profit biotechnology companies working on certain priority treatments.
Before joining BIO, Brent served as FDA Counsel at the Committee on Energy and Commerce under Rep. Tom Bliley (R-VA) and then Rep. Billy Tauzin (R-LA). During his time at the Committee, he successfully negotiated the reauthorization of the Prescription Drug User Fee Act, as well as the creation of Emergency Use Authorization authority and the Medical Device User Fee Act. Before that, Brent worked in the personal office of Rep. Bliley, where he served as his Legislative Director while attending Georgetown Law in the evening.
Prior to joining RBC in 2015, Mr. Cohen was a member of the Executive Leadership Team and head of Global Corporate Development at Catalent. He joined Catalent in 2010 and was responsible for developing and executing on Catalent’s inorganic growth strategy. Mr. Cohen’s transaction experience at Catalent included acquisitions, divestitures, structured transactions and emerging markets, completing 14 transactions valued at approximately $1 billion. Prior to Catalent, Mr. Cohen spent 13 years on Wall Street where he focused on healthcare M&A, particularly within the drug delivery, specialty pharma and generic pharma industries, including at JP Morgan and Bear Stearns.
Rhys Dubin
Policy Advisor, Office of the Special Envoy for Critical and Emerging Technology (S/TECH)
US Department of State
Rhys Dubin is a policy advisor and biotechnology policy coordinator in the Office of the Special Envoy for Critical and Emerging Technology at the U.S. Department of State. Previously, Mr. Dubin was a fellow at the Council on Strategic Risks, where his research focused on the intersection of emerging technology and arms control, and served in editorial roles at Foreign Affairs magazine and Foreign Policy. He has a master’s degree in international relations from the University of Oxford and a bachelor’s degree from Yale University.
Alec Gaffney
Executive Director, Regulatory Policy And Intelligence
AgencyIQ
Alexander Gaffney is the Executive Director of Regulatory Policy and Intelligence for POLITICO’s AgencyIQ, where he leads a team of more than a dozen regulatory intelligence professionals. Alexander has worked in regulatory for more than a decade, including at the Regulatory Affairs Professionals Society (RAPS) and PricewaterhouseCoopers (PwC). At AgencyIQ, his research, insights and analysis is relied upon by the regulatory teams of many of the world’s leading companies. He is also the author of AgencyIQ’s flagship daily newsletter, “FDA Today.”
Neil Kelly
Founder, CEO
Vector Talent
Neil Kelly is a global talent acquisition leader turned entrepreneur. Neil has a blend of consulting and industry experience, leading talent teams with some of the most recognised brands in the world. Working alongside CEOs and their leadership teams, Neil will find the right talent solution to meet the business objectives.
Eric Langer
Managing Partner
BioPlan Associates
Eric Langer, President and Managing Partner, has over 20 years experience in biotechnology and life sciences international marketing, management, market assessment, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He is an experienced biotechnology strategist, marketing practitioner, publisher, and researcher. He has published, edited and authored numerous books, reports, and major studies on topics including: Advances in Biopharmaceutical Technology in China, Advances in Large-scale Biopharmaceutical Manufacturing, Biopharmaceuticals in the US Market, cell culture reports, media, sera, tissue engineering, stem cells, diagnostic products, blood products, genetics, DNA/PCR purification, blood components, and many others. He lectures extensively on marketing, pricing and channel management topics, and teaches at Johns Hopkins University and American University: Biotechnology Marketing, Marketing Management, Services Marketing, Advertising Strategy, and Bioscience Communication. In 1989 he co-founded BioPlan Associates, Inc. He has launched and managed marketing programs for product lines ranging from $500k to $500 million.
Renaud Jacquemart, Ph.D., M.B.A.
Senior Advisor
BioPlan Associates
Renaud is a strategic commercial leader and biopharmaceutical product development expert with 25 years of international experience. His expertise spans the full lifecycle of biologics, from early-stage development to commercialization, with a focus on cost-effective, scalable solutions. Renaud delivers strategic solutions for go-to-market strategies and M&A, driving growth, operational excellence, and competitive advantage in a complex, regulated landscape. He has played pivotal roles in driving strategic growth, fundraising, and market expansion for biopharmaceutical companies, contributing to successful acquisitions by major industry players. His leadership has advanced cutting-edge bioprocessing technologies, resulting in impactful partnerships and commercial success. Renaud has contributed to globally impactful projects with leading pharmaceutical companies and international organizations, as well as large NGOs to support the development and distribution of life-saving vaccines and biologics, helping to address critical health challenges worldwide. His dual expertise in technical innovation and commercial strategy ensures that bioprocess solutions are aligned with market needs and positioned for success.
Adam Siebert Ph.D.
Managing Director
L.E.K.
Adam Siebert is a Managing Director in L.E.K.’s New York office and joined L.E.K. in 2013. He specializes in biopharma manufacturing, advanced diagnostics, and life science research tools, with a specific focus in biopharma manufacturing and supply chain across therapeutic modalities and parts of the value chain. He has advised biopharma, equipment, critical reagent providers, and service providers within this market. He received his Ph.D. in Cell and Molecular Biology from the University of Pennsylvania and a B.S. in Chemistry from Boston College.
John Stone
Principal
BGR Group
John Stone leads the FDA and Public Health Working Group within BGR’s Health and Life Sciences Practice. John helps FDA-regulated clients navigate congressional and administration policy development processes that impact their products and commercial activities.
John joined the firm after spending nearly seven years with the House Energy and Commerce Committee (E&C), first as a Counsel on the Oversight and Investigations Subcommittee and then as a Senior Counsel on the Health Subcommittee primarily handling issues under the jurisdiction of the FDA.
Working for Chairman Fred Upton (R-Mich.) he played a leading role in developing, negotiating and ultimately passing numerous bipartisan bills, including the Drug Quality and Security Act (DQSA), the Safe and Accurate Food Labeling Act and the landmark 21st Century Cures Act (Cures)—widely considered one of the most comprehensive biomedical research and FDA reform bills ever signed into law. Under subsequent Chairman Greg Walden (R-Ore.), John facilitated timely passage of the Food and Drug Administration Reauthorization Act (FDARA) in the midst of a very challenging political environment.
Upon John’s departure from the Committee, Rep. Upton noted that “John’s knowledge and expertise in the health care field is second to none. His contributions to our team over the years to improve public health, particularly our 21st Century Cures effort, were immeasurable. We will miss his good nature and wise counsel.”
Rep. Walden added that “John has been a valuable asset at Energy and Commerce and I’m particularly glad we had him by our side leading up to and during the critical passage of the FDA Reauthorization Act earlier this year. He brings with him a tremendous wealth of knowledge and the skills to push big tasks across the finish line. Our loss is BGR’s gain.”
Prior to joining the Committee in February 2011, John spent two years in the Washington office of Sanofi. He received his undergraduate degree from Miami University in Oxford, Ohio, and his law degree from American University in Washington, D.C.
Ian Tzeng
Managing Director
L.E.K.
Ian founded and leads L.E.K.’s pharma services practice globally. He has served hundreds of clients across life science enablement and pharma services since joining the company in 1998. His expertise spans products, technologies, and services purchased by pharma in the R&D, manufacturing, and commercial ecosystems across product modalities and therapeutic areas. Ian holds an A.B., magna cum laude, in Chemistry from Harvard College and is a George F. Baker Scholar, M.B.A. with high distinction from Harvard Business School. With over 60 years of cumulative non-profit board service, Ian also brings expertise in governance, fundraising, and non-profit operations.
Dave Windley
Managing Director
Jefferies
Dave Windley is a managing director and founding member of Jefferies’ Healthcare Equity Research team. Over a 25-year career in investment research, Mr. Windley has covered a broad range of healthcare product and service sectors, including managed care, healthcare information technology, pharmaceutical services, and specialty pharmaceuticals. Dave is a five-time Wall Street Journal Best on the Street honoree and a 6-time Starmine award recipient. Dave is involved in the Nashville financial and healthcare community, having served on boards of the CFA Society Nashville and Owen Graduate School of Management. Dave also enjoys mentoring start-up companies. Dave earned his Masters of Business Administration from the Owen School at Vanderbilt University and his BA from Transylvania University. Dave is a CFA charter holder and certified public accountant.
Marta E. Wosińska, Ph.D.
Senior Fellow
Brookings Institution • Center on Health Policy
Marta E. Wosińska, Ph.D., is a senior fellow at the Center on Health Policy. She is a health care economist with a particular expertise in prescription drugs and pharmaceutical supply chains. Her experience spans academia and federal government. Dr. Wosińska’s government experience includes serving as director of the Bureau of Economics at the Federal Trade Commission, chief health care economist in the Office of Inspector General (OIG) at the U.S. Department of Health and Human Services, and director of economics staff at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation & Research. Dr. Wosińska also served as economic advisor to the U.S. Senate Finance Committee, providing drug market analysis and expert guidance for the Committee’s bipartisan investigative and legislative work on drug pricing. Among academic institutions, she was consulting professor and deputy director for policy at the Duke-Margolis Center for Health Policy at Duke University and an assistant professor of marketing at the Harvard Business School. Dr. Wosińska serves as an expert witness in pharmaceutical antitrust cases.