Mr. Pines serves as Senior Director and a member of the International Advisory Council at APCO in Washington, D.C. Mr. Pines is an international consultant on issues related to the Food and Drug Administration (FDA), including media, legislative, regulatory and marketing challenges, and other government agencies. He advises clients on government policies, navigating products through the FDA approval process, and promotional issues. 

Additional career highlights include:

• Served for ten years in senior positions at the FDA, including as Chief of Consumer Education and Information, Chief of Press Relations and Associate Commissioner for Public Affairs.  
• In 2020, he served as a Senior Advisor on COVID-19 to the FDA commissioner.  
• Authored or edited 16 books about the FDA, including about the product approval process, FDA’s regulation of medical communications, crisis management, and the history of the FDA. His latest book, published in 2022, is “How FDA Really Works: Insights from the Experts.”  
• Widely published and quoted in the media about the FDA and health care issues and policies. He also is co-host of the podcast FDAWatch (www.fdawatch.net).  
• Was a Director and former Chairman of the Board of the MedStar Health Research Institute, which oversees research at ten hospitals in the Washington-Baltimore area. 
• A Founder, Director and former President of the Alliance for a Stronger FDA, a coalition seeking more appropriated funding for FDA.  
• A Co-Founder of the FDA Alumni Association; a member of the Public Health Service’s first Task Force on AIDS Education; Executive Vice President of an international public relations agency; and Chairman of a health care market research firm. He also serves as a member of the Executive Committee of the Regional Board of the Anti-Defamation League. 

Dr. Hirani is a board-certified executive with over 21 years of experience in investigational drugs/biologics from bench to clinic with a strong scientific background. The highlights of his career include building an operational and regulatory infrastructure for clinical trials that enables optimal product development in several therapeutic areas. His expertise includes oversight of operational units in industry and academia; regulatory and quality management leadership in drugs, biologics, and combination products; increasing efficiencies, improving quality control, and optimal outcomes.

As a principal strategic and regulatory consultant for small and medium-sized companies, Dr. Hirani has supported Signos Inc, Rancho Santa Fe Bio Inc, Ambulero Inc., Eyepharma Inc., Betalin Therapeutics Inc., and others. In addition, he is a scientific co-founder of the University of Miami spin-off clinical stage (Phase 3) biotech company, PriZm Therapeutics.

Throughout his career, he has played vital roles as a drug safety investigator in over 25 clinical trials. These include sponsors such as Johnson & Johnson, Genentech, Millennium, Merck, Tibotec, Pfizer, Bayer, BMS, Gilead, and the National Institutes of Health.

Dr. Hirani has served as member of the data safety monitoring boards, human ethics boards, feasibility expert, and review editor for over 20 peer-reviewed journals. He has taught Fundamentals and Advanced Regulatory Affairs, Quality Assurance, and Ethics in product development to MVSIO (MD/MS Vision Science and Investigative Ophthalmology) course at the Bascom Palmer Eye Institute. Dr. Hirani obtained his Bachelor’s degree in Pharmaceutical Sciences from the College of Pharmaceutical Sciences, Manipal, India, his MBA/PGDBA from the Indian Institute of Modern Management, and his M. Pharm-Ph.D. in Pharmacology from the Department of Pharmaceutical Sciences, Nagpur, India. He completed his postdoctoral fellowship at the College of Medicine, University of South Florida, and a summer research internship at RIKEN Brain Science Institute, Wako-shi, Japan. Currently he serves as the Deputy Director of the Diabetes Research Institute and Associate Vice Chair of Regulatory and Research Compliance for the Department of Medicine, University of Miami Miller School of Medicine.

Sandra Cohen Kalter is an influential legal & regulatory executive with extensive expertise in FDA law and regulatory leadership for one of the world’s leading medical device companies. She is a seasoned senior legal executive most recently serving as Vice President & Chief Regulatory Counsel at Medtronic, overseeing global strategies in regulatory compliance, quality, clinical affairs, and medical safety for a medical-device leader with over $34 billion in revenue and 90,000 employees. She has led transformative enterprise-wide initiatives, including a patient safety and quality program that delivered major reductions in FDA findings and field corrective actions.  

 Additional career highlights include:  

• Built and managed an in-house FDA legal team that navigated 17 regulatory inspections in a single year, ensuring product continuity.  
• Guided due diligence and integration efforts for more than 27 acquisitions, led regulatory responses to FDA violations and high-profile media scrutiny, and steered approval strategies for groundbreaking devices like the Evolut TAVR system and Micra leadless pacemaker. Her leadership in integrating the Covidien acquisition into Medtronic earned her the company’s prestigious Wallin Award.  
• Previously served as FDA/Health Care Counsel at King & Spalding, advised on complex regulatory filings and FDA panel proceedings, and began her career as a journalist. 
• Received several awards including: Service to FDLI Award, Food and Drug Law Institute, 2023; Rapport Lifetime Achievement Award, Juvenile Diabetes Research Foundation, 2019; Medtronic Wallin Leadership Award, June 2010; Marketing Campaign Team Award, Spinal & Biologics “Just the Facts,” 2010; Medtronic Star of Excellence Award, 2009 
• Member of AdvaMed (Advanced Medical Technology Association) Legal Committee 
• Co-Chair of AdvaMed Advertising and Promotion Working Group  
• Board of Directors of Food and Drug Law Institute (FDLI)  
• Board of Directors of Juvenile Diabetes Research Foundation (JDRF)  
• Member of AdvaMed Business Case for Quality Working Group  
• Co-Chair of AdvaMed Off-Label Working Group  
• Member of Food and Drug Law Institute Medical Devices Advisory Committee  
• Corporate Recruitment Chair of JDRF One Walk  
• Founding Board Member of Our Place DC (non-profit to help resettle women coming of out prison) 

Sandra Kalter attended George Washington University, The National Law Center and received a Juris Doctor Degree.  

Marc Schneebaum is a highly experienced life sciences finance executive with more than 25 years of experience leading corporate finance, capital markets strategy and financial operations across public and private biopharmaceutical, medical device and diagnostics companies. He is a proven advisor to executive teams and boards, with deep expertise in capital formation, M&A, financial planning and analysis, investor relations and value creation across all stages of company growth, from venture-backed startups to large-cap public companies. He has conducted successful financings exceeding $1 billion, public offerings, strategic transactions and guiding companies through periods of transformation, commercialization and exit.

Additional career highlights include:

• Raised over $1 billion in equity and venture capital, including public offerings, PIPEs, ATM facilities, and late-stage private financings
• Served as Chief Financial Officer for multiple public and private life sciences companies, overseeing financial strategy, reporting, controls and investor communications
• Led and advised on mergers, acquisitions, divestitures and strategic restructurings, including transactions valued at $300+ million
• Played a central role in building a public biopharmaceutical company that achieved FDA approval and commercialization, now with a market capitalization of approximately $12 billion
• Extensive experience working with boards of directors, audit committees and institutional investors, including more than 10 years as a public company board member and audit committee chair
• Guided companies through complex capital markets environments, balancing capital efficiency, shareholder value and long-term strategic objectives

Marc received his Bachelor of Science in Business Administration with a concentration in Accounting from the University of Maryland, College Park.