Speakers
The PBOA Meeting & Conference features speakers and panelists who represent decades of expertise in pharma and biopharma outsourcing fields.
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
(invited)
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).
Patrick Day, M.S.
Principal Consultant
Lachman Consultants
Pat has over 25 years experience in pharmaceutical manufacturing and services with two major pharma operating companies. He obtained his BS in Engineering from Drexel and his Masters in Industrial Engineering from Penn State University. He is currently employed at Lachman Consultants focusing on data integrity helping companies in the pursuit of great data governance using Lean Compliance tools, a risk mindset and leadership principles to not only be compliant, but deploy practical strategies for maximum value. He is also a founding member in the Duke-Margolis Drug Supply Chain Resilience and Advanced Manufacturing Consortium actively working to bring solutions to the drug shortage global problem.
Michael de la Torre
CEO
Redica Systems
Michael is the founder and CEO of Redica Systems, a data and analytics platform, which helps life sciences companies stay compliant with changing regulations and enforcement. A data analyst at heart, Michael seeks to combine the best of industry expertise with technology to produce extraordinary insights and actionable intelligence to create new ways of decision-making, powered by highly domain-specific and complex data.
Michael previously served as the CRO for LeisureLink, a VP/GM at Sungard Availability Services, and started his career at McKinsey. Michael holds his MBA from the University of Chicago, where he received the Outstanding Academic Award for the highest GPA in his graduating class. Michael is also a graduate of Texas A&M University, receiving his BA in International Finance and Spanish, and was a full scholarship member of the football team.
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.
Bryant Headley
CEO
Pacific Force Consulting Group
Bryant is a life sciences industry professional with over 20 years’ of experience in regulated and regulatory government organizations, including the U.S. Food and Drug Administration (FDA). He has held several high-level positions with various government offices including the FDA, the U.S. Department of Veterans Affairs (VA), the Department of Defense and the Department of the Treasury. With the FDA, he served as a business program manager tasked with reframing the agency’s QMS. Bryant was also a program manager and certified ISO 9001 trainer with the U.S. Department of Veterans Affairs (VA).
Laura Jacoby
Application Specialist
Apprentice.io
Laura Jacoby has dedicated her career to streamlining biologic processes. In her current role, she specializes in digitization and automation of batch records and general methods for execution with real time data. She almost 30 years’ experience in pharmaceutical process development. Laura has a Bachelor Degree in Biology from Rutgers and an MBA from Oxford Brookes.
Elizabeth M. Kelley, M.P.H., J.D.
Regulatory Counsel
FDA / CDER / Office of Compliance / OMQ Policy
Elizabeth Kelley, M.P.H., J.D., is a Regulatory Counsel with the Policy Staff in the FDA’s Center for Drug Evaluation and Research, Office of Compliance, Office of Manufacturing Quality (OMQ). She has served as a lead counsel within OMQ since 2014 and is frequently consulted to advise OMQ management and staff on drug statutes and regulations and develop and revise policies, programs, guidance, and regulations involving complex and high priority matters affecting drug quality.
Prior to joining FDA, she worked as a public health analyst with the Health Resources and Services Administration (HRSA) for 12 years. During her HRSA career, she worked in various program areas, including in the Division of Vaccine Injury Compensation where she assisted DOJ attorneys with injury claim depositions, and in the Division of Practitioner Data Banks, where she was responsible for rulemaking activities.
She earned her law degree from the University of Maryland Francis King Carey School of Law in Baltimore, MD, and a master’s degree in public health and bachelor’s degree in microbiology from the University of South Florida in Tampa, FL.
Eric Langer
President, Managing Partner
BioPlan Associates
Eric Langer 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.
Jack Shute
Managing Director
Vector Partners
As Managing Director of Vector Partners, Jack leads the global leadership hiring and overall business operations. He is fortunate to have partnered with a variety of start-ups, scale ups and enterprise organisations across life sciences, with a primary focus on CDMO, CRO and Biotech organisations. As a trusted partner for over a decade, Jack has a track-record of enabling and driving business change as well as creating and rejuvenating global leadership teams. Additionally, he has led projects for embedding recruitment teams on an outsourced basis to support companies in the areas where talent is most difficult to source and most important for business success.
Sumeet Singh
CEO, Founder
LightouseAI
Sumeet Singh is the CEO of LighthouseAI, a leading innovator in developing AI solutions to automate compliance in the life sciences and pharmacy sectors. Under his astute leadership, LighthouseAI has rolled out pioneering AI solutions that excel not just in regulatory compliance but also in honing operational efficiency, making a marked difference in the pharmaceutical landscape. Boasting a rich career that spans over a decade, Sumeet has journeyed from hands-on roles to leading a compliance service provider, proudly serving over 700 clients across diverse business models.
Sumeet has enjoyed strategic and successful exits for two pharmaceutical services startups. As a recognized thought leader in pharmaceutical supply chain compliance, Sumeet remains an active voice in the industry, having shared his expertise at premier conferences, including PBOA, ACI, and NASCA. His insights also find their way into prestigious industry publications, with features in Pharmaceutical Commerce and Pharmacy Times.
Guided by a mission to seamlessly meld technology with healthcare, Sumeet ardently pursues the goal of aligning AI potential with regulatory imperatives, ensuring the industry stays both cutting-edge and compliant.
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.
Speakers & topics subject to change