Speakers
The PBOA Meeting & Conference features speakers and panelists who represent decades of expertise in pharma and biopharma outsourcing fields. We will add more 2024 speakers as they’re confirmed:
Jason Brown
Senior Manager, Analytical Sciences, R&D
Adare Pharma Solutions
Jason Brown brings a wealth of knowledge and practical experience to his role as Senior Analytical Sciences Manager at Adare Pharma Solutions, where he serves the role of global nitrosamine subject matter expert. He has led Adare’s innovative approaches to understanding nitrosamine formation, measurement, and mitigation to ensure regulatory compliance internally and for our customers. With a deep-rooted understanding of cGMP, ISO17025, and ISO9001 standards, Jason has skillfully managed numerous investigations, including Out of Specification (OOS), Out of Control (OOC), Corrective and Preventive Actions (CAPA), and Root Cause Analyses. Before joining Adare, he served organizations including Q Laboratories, Fujimi Corporation, Hydration Technology Innovations, and W. R. Grace & Co. Jason has a BS in Chemistry from George Fox University.
John Chiminski
Fmr. Chairman and Chief Executive Officer
Catalent Pharma Solutions
John Chiminski was named Chief Executive Officer of Catalent, Inc. in March 2009 and appointed Chair of the Catalent Board in October 2016. He then served as Catalent’s Executive Chair from June 2022 to June 2023, as part of a planned succession of a new CEO and transition to an independent Chair of the Catalent BoD. Mr. Chiminski partnered with the PE firm Blackstone to complete a carve-out of the Catalent business from Cardinal Health and transform it to its current position as a market leader in biopharma services. Included in that transformation was a successful IPO in 2014 and the transition to a fully independent public company in October 2016. Under a decade of his leadership, Catalent’s revenue grew 8% CAGR at constant currency and its enterprise value more than quintupled to $18.5 billion.
Mr. Chiminski has a diversified medical diagnostics and pharmaceutical background that includes operations leadership, product development and services, with a track record of growing global businesses.
He joined Catalent after more than 20 years at GE Healthcare. From 2007 until 2009, Mr. Chiminski served as President and CEO of GE Medical Diagnostics, a global business with sales of $1.9 billion. From 2005 to 2007, he served as Vice President and General Manager of GE Healthcare’s global magnetic resonance business, and, from 2001 to 2005, Mr. Chiminski served as Vice President and General Manager of Global Healthcare Services. Earlier in his career, Mr. Chiminski held a series of cross-functional leadership positions in both operations and engineering, including GE Medical Systems assignments in France.
Mr. Chiminski holds a bachelor’s degree from Michigan State University and a master’s degree from Purdue University, both in electrical engineering, as well as a master’s degree in management from the Kellogg School of Management at Northwestern University. In 2012, he received a Distinguished Engineering Alumni award from Purdue for his record of accomplishments. In 2019, Mr. Chiminski was the first recipient of the CPhI Lifetime Achievement Award for a distinguished career in the biotech or pharmaceutical arena. He is a Senior Advisor at Abingworth, a bioscience investment firm, and previously served as a director of PhenomeX, DJO Global as well as Graham Packaging. Married with three children, Mr. Chiminski lives in Southeastern Florida.
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.
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.
Jacqueline Corrigan-Curay J.D., M.D.
Principal Deputy Center Director
FDA/CDER
Jacqueline Corrigan-Curay, J.D., M.D., is the Principal Deputy Center Director in FDA’s Center for Drug Evaluation and Research (CDER). Most recently, she served as the Acting Center Deputy Director for Operations, directing center and agency-level priority and initiative programs and leading GDUFA III reauthorization negotiations.
Previously, Dr. Corrigan-Curay was director of CDER’s Office of Medical Policy (OMP). In that role, she led the development, coordination, and implementation of medical policy programs and strategic initiatives. She worked collaboratively with other CDER program areas, FDA centers, and stakeholders on enhancing policies to improve drug development and regulatory review processes.
Dr. Corrigan-Curay brings to the position a unique legal, scientific policy, and clinical background with expertise in risk and scientific assessment, and clinical trial design and oversight. Before joining FDA, she served as supervisory medical officer with the Immediate Office of the Director, National Heart, Lung and Blood Institute (NHLBI) at the National Institutes of Health (NIH). She also served in director and acting director roles with the Office of Biotechnology Activities (OBA), Office of Science Policy at NIH, where she was executive secretary of the NIH Recombinant DNA Advisory Committee. She has held positions as an attending physician with the VA Medical Center, a policy analyst with the Congressional Office of Technology Assessment, and as a practicing attorney in Washington, D.C.
Dr. Corrigan-Curay earned her law degree from Harvard Law School, her medical degree from University of Maryland School of Medicine, and a bachelor’s degree in history of science from Harvard/Radcliffe College in Cambridge, MA. She completed her training in internal medicine at Georgetown University Medical Center, where she also served as a clinical assistant professor of medicine. She has continued to practice internal medicine part-time at the Veterans Affairs Medical Center in Washington, D.C.
Alonza Cruse
Director • Office of Pharmaceutical Quality Operations
FDA, Office of Regulatory Affairs
Alonza Cruse is director of the Office of Pharmaceutical Quality Operations within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA). His office is 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).
Brent Del Monte
Senior Vice President
BGR Government Affairs
Brent Del Monte currently serves as Senior Vice President at the BGR Group. In this role he represents clients, particularly life sciences companies, to help them achieve their objectives with the Federal government.
A native of Northern Virginia, after graduating from the College of William & Mary in Williamsburg, Virginia, Brent embarked on a career in public policy by joining the staff of Senator John Warner (R-VA). Brent later served on the staff of Representative Tom Bliley (R-VA), where he held various positions, all with responsibility over health care issues. While serving for Representative Bliley, Brent attended Georgetown University Law Center in the evening, graduating with high honors.
After graduating law school and clerking for United States District Judge Claude Hilton, Brent returned to the Hill where he served as a Counsel for the House Committee on Energy and Commerce, with primary responsibility over food and drug issues. In this position, he successfully saw enactment of the Medical Device User Fee Act, the Project BioShield Act, and the reauthorization of the Best Pharmaceuticals for Children Act and the Prescription Drug User Fee Act (PDUFA).
Brent then served as the Senior Vice President for Federal Government Relations at the Biotechnology Industry Organization (BIO), where he successfully worked for the successful enactment of priority legislation, such as: a pathway for the approval of biosimilars at the FDA; the Therapeutic Project Discovery Tax Credit; liability protections for bioterrorist and pandemic countermeasures; two reauthorizations of PDUFA, including important reforms to the Accelerated Approval pathway at FDA; patent reform; and the 21st Century Cures Initiative.
Robert P. Kadlec, M.D.
former Assistant Secretary of Preparedness and Response
HHS
Robert P. Kadlec, M.D. is the former HHS Assistant Secretary of Preparedness and Response, and a former U.S. Air Force Colonel (ret.) who brings 35 years of public service.
Dr. Kadlec has built a distinguished record of service at the highest levels of U.S. biodefense, both in civilian and military roles. From 2017 to 2021 he served as Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services. In this capacity, he played a central role creating and executing Operation Warp Speed which developed COVID-19 vaccines and therapeutics in record time.
From 1993 through 2023, his key national leadership roles in the public sector included Special Assistant to the President & Senior Director for Biodefense Policy in the Homeland Security Council; Director for Biodefense Preparedness & Response, Homeland Security Council; Special Advisor and Senior Assistant roles to the Secretary and Assistant Secretary of Defense for International Security Policy; Majority Deputy Staff Director for the U.S. Senate Select Intelligence Committee; Staff Director for the U.S. Senate Subcommittee on Bioterrorism & Public Health Preparedness; and most recently Senior Pandemic Policy Minority Advisor to the U.S. Senate Health, Education & Labor Committee. In the private sector he has undertaken ongoing advisory roles to the Secretary of Defense as well as the National Academy of Sciences and the Intelligence Community.
As a 26-year military veteran, Kadlec served in operational roles with the 1st Special Operations Wing, Hurlburt Field, the 24th Special Tactics Squadron at Fort Bragg and as an US Special Operations Command detailee to the Counterproliferation Division, Directorate of Operations, Central Intelligence Agency. He has had combat deployments in support of counterproliferation operations during DESERT STORM and IRAQI FREEDOM.
Kadlec was a Distinguished Graduate from the U.S. Air Force Academy. He earned his M.D. and a masters in tropical medicine & hygiene at the Uniformed Services University of the Health Sciences. He received his masters in national security studies from Georgetown University, and he is a member of the Council on Foreign Relations.
Peter Marks, M.D., Ph.D.
Director
FDA/CBER
Peter Marks, M.D., Ph.D. is the director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. The center is responsible for assuring the safety and effectiveness of biological products, including vaccines, allergenic products, blood and blood products, and cellular, tissue, and gene therapies. Dr. Marks and center staff are committed to facilitating the development of biological products and providing oversight throughout the product life cycle. Examples of these activities include:
- reviewing and providing advice during product development
- evaluating applications and making approval decisions based on safety and effectiveness data
- monitoring the safety of biological products
- conducting research that supports product development and characterization
Dr. Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University. Following this, he completed an Internal Medicine residency and Hematology/Medical Oncology fellowship at Brigham and Women’s Hospital in Boston, where he subsequently joined the attending staff as a clinician-scientist and eventually served as Clinical Director of Hematology.
He then moved on to work for several years in the pharmaceutical industry on the clinical development of hematology and oncology products prior to returning to academic medicine at Yale University where he led the Adult Leukemia Service and served as Chief Clinical Officer of Smilow Cancer Hospital. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in 2016. Dr. Marks is board certified in internal medicine, hematology and medical oncology, and is a Fellow of the American College of Physicians. In 2022, he became a Member of the National Academy of Medicine, one of the highest honors in the fields of health, science and medicine.
Raman Sehgal
Founder & Global President
ramarketing
Having founded several niche companies, Raman has grown ramarketing (headquartered in the UK’s North East with a presence in Boston, MA and an office hub in Toronto, Canada) beyond what he ever could have imagined. A $multi-million, PE-backed, specialist marketing agency, with over 75 employees and growing, supporting clients in the life science space across the world to raise their profile and grow.
Today, alongside being an entrepreneur and ramarketing’s Founder and North American President, Raman’s role is more dynamic than ever. Working out of the agency’s Toronto office, he is focused on expanding the North American presence and operates as the guardian of ramarketing’s culture, ensuring it continues to be a beacon of excellence in the pharma and biotech sector.
Raman is the co-founder of Lead Candidate, a specialist talent acquisition partner for the pharma and biotech outsourcing space, and the host of industry-leading pharmaceutical podcast – Molecule to Market where he takes listeners inside the outsourcing space of the drug development and manufacturing ecosystem.
An active investor in several start-ups and early-stage businesses. Raman’s role with these companies is to advise CEOs and founders acting like a sounding board he listens, reflects, and guides. Gravitating towards opportunities that excite or interest him Raman has pursued investments in growth markets, and with companies that offer scale-up potential. His investment portfolio includes: a B2B SaaS marketing education platform, a 0% non-alcoholic beer brand, a regional editorial business, a global podcast platform, and an alternative beverage brand focused on improving gut health.
Outside work, Raman is family-oriented. He is a happily married father of three boisterous boys. An active and sociable guy, Raman is a keen runner and a die-hard Newcastle United football fan.
Keen to share his knowledge, mistakes, and learnings in an honest manner, Raman is focused on helping others and is an active member of the business community. One of his favorite mottos is “sharing is caring, right?”, which is reflected in the impact that his work has on other businesses and individuals alike.
Bharath Sundararaman
General Manager, Supply Network Orchestration
TraceLink, Inc.
Bharath Sundararaman joined TraceLink in 2019 after ten years at Merck KGaA, where heled the digital transformation of the company’s global manufacturing and supply function into a machine-driven, “self-driving” supply chain. His work has been covered by the Wall Street Journal, CIO Online, Forbes, and other popular media channels. Bharath joined TraceLink to bring his passion and experience in digital transformation of supply chains to TraceLink’s network of customers in the life sciences industry. Bharath and his team are now on a mission to digitize the pharmaceutical supply chain to improve patient experience.
Ian Tzeng
Managing Director and Partner
L.E.K. Consulting
Ian Tzeng, a Managing Director and Partner in L.E.K.’s Boston office, joined the company in 1998 with experience in growth strategy, regulated markets, innovation, pricing, and mergers and acquisitions. He focuses on healthcare and life sciences, including pharmaceuticals, vaccines and medical devices. He leads L.E.K.’s Pharmaceutical Contract Services practice, including CROs, CDMOs, supply chain and distribution, commercial, medical, and market access services. Other areas of deep experience include rare diseases, biodefense, biosimilars and generics, and consumer-directed healthcare. Additionally, Ian has extensive consulting and board experience with nonprofit organizations in education, arts, LGBT advocacy and public service. He received a Bachelor of Arts degree, magna cum laude, in chemistry from Harvard College and is a George F. Baker Scholar, Master of Business Administration with high distinction from Harvard Business School.
Jennifer Vavala
Senior Director, Quality Assurance
Ajinomoto Bio-Pharma Services
As the Senior Director of Quality Assurance at Ajinomoto Bio-Pharma Services, Jennifer oversees all QA operations for aseptic fill/finish contract development and manufacturing organization across multiple buildings. She has more than 27 years of experience in the global pharmaceutical and medical device industries, with expertise in operational QA, QC, and strategic product lifecycle oversight.
Jennifer leads a team of approximately 85 Quality professionals at a global CMDO with over 30 commercially approved products performing QA on the floor, batch review, document control, QA investigation oversight, data governance, risk management, training, compliance and regulatory affairs. She has successfully restructured the department, and led multiple PAI and surveillance inspections for new and existing facilities and filling lines. By implementing process improvements, reduced number of deviation investigations by 65%.
She holds an MBA from Waynesburg University. Recently, she spearheaded Aji Bio’s participation in FDA’s Quality Management Maturity (QMM) prototype assessment program in a commitment to continuous improvement and transparency with the agency. Her core mission is to drive business solutions, operational efficiencies, talent retention, and increased revenue through world-class quality leadership and value creation.
Christopher Williams
Senior Director, Analytical Development ILM
Alcami
Chris Williams is Director of Laboratory Operations at Alcami. Chris is a technical leader with 13 years of laboratory experience in pharmaceutical product development and small molecule testing. He is focused on capability expansion and process improvements that drive growth and efficiencies. He is an accomplished leader that has held roles overseeing QC, analytical development, and specialty analytical services. Chris holds a Master’s degree in Chemistry from East Carolina University in Greenville, NC.
David Windley
Managing Director
Jefferies LLC
Dave Windley is a managing director and founding member of Jefferies’ Healthcare Equity Research team. Over a 26-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 deeply involved in the pharma services industry, as a regular speaker and industry expert to company boards, industry conferences, and biopharma buyers of outsourced services. Dave also is involved in his local Nashville financial and healthcare community, serving on boards of the CFA Society of Nashville and Owen Graduate School of Management. Dave also enjoys mentoring start-up companies and young finance professionals.
Mr. Windley 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 (inactive).
Marta Wosińska, Ph.D.
Senior Fellow – Economic Studies, Center on Health Policy
Brookings Institute
Marta E. Wosińska, Ph.D., is a senior fellow at the Center on Health Policy. She is a healthcare economist with a particular expertise in prescription drugs and experience spanning academia and federal government. Dr. Wosińska’s government experience includes serving as director of the Bureau of Economics at the Federal Trade Commission, chief healthcare 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.
Speakers & topics subject to change