The PBOA Meeting & Conference features speakers and panelists who represent decades of expertise in pharma and biopharma outsourcing fields. We’ll post their bios as they’re confirmed!
Remy Brim, Ph.D.
Health and Life Sciences Practice Co-Head
BGR Government Affairs
Remy L. Brim, Ph.D. is a scientist and health care policy expert focused on strategic policy and advocacy support for clients with FDA-regulated products and activities. She is a Principal at BGR and on the firm’s Executive Board. As co-head of BGRs Health Care Practice, she helps clients effectively navigate the complex regulatory and political landscapes required to advance the discovery, development, and delivery of innovative products to patients and consumers. Her success for clients is rooted in her deep technical understanding, thoughtfulness, and commitment to sound public health policy.
Prior to joining BGR Group, Remy served as Senior FDA Policy Advisor to the Senate HELP Committee’s Ranking Member, Patty Murray (D-Wash.). In this role, she was lead negotiator and advisor for U.S. Senate Democrats on FDA medical device, prescription drug, biologic, food safety and cosmetic policy initiatives, including the 21st Century Cures Act and the FDA Reauthorization Act of 2017. She managed FDA-related policy development and relationships for the Ranking Member, both internally with Senate leadership, other Senate offices, and their House counterparts, and externally with the FDA and other governmental organizations, regulated industry companies and trade associations, patient advocacy organizations and other key stakeholders.
Previously, Remy served under Sen. Elizabeth Warren (D-Mass.), including as the Senator’s Senior Health Policy Advisor from 2015 to 2016. She managed a comprehensive health care portfolio, with emphasis on policies relevant to the biotech, medical device, and health care industries rooted in Massachusetts.
Remy earned her B.S. in Microbiology and Molecular Genetics from Michigan State University and her Ph.D. in Pharmacology from the University of Michigan Medical School, where she advanced pre-clinical research to support an investigational new drug application at the FDA for a Breakthrough-designated biologic currently under clinical investigation. Remy served as a Bioethics Post-Doctoral Fellow at the National Institutes of Health from 2011 to 2013, where she analyzed ethical issues in clinical research, public health and health care, applying frameworks from philosophy, ethics and law.
RBC Capital Markets LLC
Mr. Cohen is a Managing Director at RBC Capital Markets, where he is responsible for the firm’s relationships with pharmaceutical and medical device outsourcing companies including CMOs and CROs. He is an accomplished M&A practitioner, having worked with and advised companies over the past 20 years on the execution of M&A transactions valued at over $75 billion. Recently 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.
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. Additionally, Mr. Cruse is leading ORA’s pharmaceutical collaboration efforts under our Program Alignment initiative.
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.
Kelly DiBattista, Esq. is the Research Manager at Pharma Solutions and leads the research efforts in assessing and determining state licensing and compliance requirements for Pharma Solutions clientele. She brings over 5 years of experience in conducting research for the pharmaceutical supply chain. Kelly is an attorney admitted to the New York State Bar.
President, Managing Partner
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.
Jim Miller, MBA
Founder and President
PharmSource Information Services, Inc. (ret’d.)
A preeminent expert in bio/pharmaceutical outsourcing, Jim Miller established and presided over the industry’s principal resource for serious consumers of information on contract drug development and manufacturing, PharmSource Strategic Advantage. He was editor and publisher of Bio/Pharmaceutical Outsourcing Report and Emerging Markets Outsourcing Report, before his retirement last year.
Jim served as an Editorial Advisory Board member for Advanstar Communication’s Pharmaceutical Technology and BioPharm magazines, and wrote regular columns on outsourcing for Pharmaceutical Technology, Contract Services Europe and BioPharm magazines. He served on the board of directors of the American Type Culture Collection (ATCC) from 2007 until 2016. Jim chairs the advisory committee of the PBOA.
Jim formerly was Vice President of Sales and Marketing at Circa Pharmaceuticals, Inc., a solid dose manufacturer. Prior to that, he was President of St. Anthony Publishing, a provider of database information services for the health care industry. He also was a consultant in corporate strategy with the Boston Consulting Group. Jim holds an MBA degree from the Stanford University Graduate School of Business.
Piramal Enterprises Limited
Nandini Piramal is the Executive Director at Piramal Enterprises and Chairperson at Piramal Pharma Ltd. She is responsible for setting strategy and driving results at Piramal Pharma. Additionally she heads the Human Resources function and the Information Technology function at Piramal Group and Quality at Piramal Pharma. She is leading a five-year transformation agenda across the Piramal Group for top talent identification and development process across levels. Piramal Enterprises is also the only Indian company to be part of Willis Towers Watson Global High Performing Norm. In 2020, Ms. Piramal was recognized amongst ‘India’s Most Powerful Women’ by Business Today and in 2014, the World Economic Forum recognised her as a `Young Global Leader’. Ms. Piramal also advises Piramal Foundation and Piramal Sarvajal, which serves clean water daily to approximately 7,50,000 people across 20 Indian States. She graduated with BA (Hons) Politics, Philosophy and Economics from Oxford University, followed by an MBA from Stanford Graduate School of Business.
Sumeet is the Founder and CEO of Pharma Solutions, leading the development and implementation of strategy and vision for the company. As a thought leader in the space, he has been invited to educate state regulatory agencies, has been published in trade publications including Pharmaceutical Commerce, and has spoken at events including ACI Controlled Substances Summit, IQPC Pharmaceutical Traceability Forum, the Annual PBOA Meeting & Conference and Chain76.
Managing Director and Partner
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.
FDA/CDER/OPQ/Office of Quality Surveillance
Obinna is currently a Division Director in CDER OPQ Office of surveillance, where he oversees the catalog of CDER regulated manufacturing sites and products and provides oversight to the CDER ORA Site Selection Model (SSM) that is used to prioritize sites for risk-based surveillance inspection. He leads the Integrated Project Team that is tasked with building the CARES Act Drug and Biological Products Amounts Reporting Portal.
Before joining FDA, Obinna worked with Macfadden Associates (now part of PAE) as an enterprise search architect. Obinna earned his B.S. in Electrical Engineering from University of Nigeria, and his M.S. in Telecommunication and Computers from The George Washington University, Washington DC.
Sue Winter, CQA
Quality & Regulatory Compliance Manager
Sue leads the Quality and Regulatory Compliance initiatives for Pharma Solutions clientele. She brings over 12 years of experience in the drug supply chain industry. She has previously participated as an active member on two Washington D.C. based pharmaceutical and medical device coalitions where she acted as an SME on DSCSA regulatory licensing areas working with FDA and Capitol Hill. She is also an ASQ Certified Quality Auditor.