THE GLOBAL GUIDE
TO COMPASSIONATE
USE PROGRAMS

Sean Turbeville, PhD, is a versatile biotech enthusiast, executive, and strategic advisor with over 20 years of experience in the life sciences industry. He specializes in global medical affairs, orphan drug strategy, digital health solutions, global operations, and government relations. Throughout his career, Sean has partnered with more than 40 companies across diverse therapeutic areas—including rare diseases, oncology, genetics, metabolic, and neuromuscular indications—in both small molecules and cellular and gene therapies. Recognized for spearheading and leading global teams in biotech and digital healthcare, he provides strategic guidance on building robust medical affairs organizations, developing and aligning international commercial strategies and market access plans, and navigating complex regulatory and compassionate use initiatives to advance early-stage assets through commercialization and beyond.

Karen Frascello has over 26 years of experience in the biopharma industry in a variety of commercial and strategic consulting roles. She started her career as a pharmaceutical sales representative with increasing levels of managerial responsibility, eventually having oversight for large sales teams across the US for Pfizer and AstraZeneca. Karen moved into the Compassionate Use arena in 2010 when she joined Clinigen (formerly Idis, Inc.). In 2015, she was recruited by Caligor Coghlan to build a new compassionate use business unit, responsible for new business development and oversight of global operations and regulatory affairs. In 2019, Karen joined Alnylam Pharmaceuticals as Director, Global Medical Affairs, Early Access.

Silvia Vaisbich Fridman, MSc is the Executive Director and Senior Regulatory Affairs Consultant of Silvia V. Fridman e Associados, a pharmaceutical regulation consulting firm she founded in 1998 to support companies operating under the Brazilian Sanitary Surveillance System. She earned a Master of Science in Fermentation Technology and a Pharmacist degree from the University of São Paulo, São Paulo, Brazil. Mrs. Fridman brings over 35 years of experience in the pharma industry, including serving as Manager of the Regulatory Affairs Department and Marketing Manager of the Vaccines Division at Merck & Co (MSD) in Brazil. As Regulatory Affairs Manager, she led the approval of Merck’s first AIDS product in Brazil, making the country the first globally to register the product following U.S. approval. As Marketing Manager of the Vaccines Division at Merck & Co she helped the reestablishment of the Vaccines Business Unit in Brazil. Still with MSD and as a Consultant, she actively contributed to shaping new regulations issued by the Brazilian Sanitary Surveillance Agency (ANVISA) through her participation in the former Brazilian Pharmaceutical Industry Association (ABIFARMA) and was involved in the early stages of MERCOSUL’s regulatory harmonization efforts. At Silvia V. Fridman e Associados, Mrs. Fridman provides strategic and operational regulatory consulting, helping multinational and national pharmaceutical laboratories, biotech companies, and manufacturers of active pharmaceutical ingredients meet Brazil’s regulatory requirements. In addition, Silvia has been deeply involved in the advancement of orphan drug regulations and quality practices.

Carl S. Hornfeldt, PhD, RPh provides medical information and medical writing expertise with an emphasis on specialty diseases to numerous pharmaceutical, biotechnology and medical device companies. He has written or assisted with the publication of over 200 peer-reviewed manuscripts and hundreds of abstracts and standard response letters for client use in the fields of oncology, dermatology, toxicology and numerous rare diseases such as narcolepsy and liposomal storage disorders.

Richard Klein is an internationally recognized expert in pre-approval or expanded access to unapproved therapeutic agents. He currently serves as Director, Expanded Access Programs & Policy for the GE2P2 Global Foundation after more than a 41-year career with the Food and Drug Administration (FDA). During that time, he worked in various capacities at FDA, providing him with a well-rounded understanding of the regulatory issues that affect patients. He helped develop the revised expanded access regulations and guidelines, led the creation of the FDA expanded access website, and played an active role in developing the streamlined application for individual patient access and the Reagan-Udall Foundation.

Georges van Baelen, MScPh studied Medical and Pharmaceutical Sciences at the Katholieke Universiteit Leuven and the Université Catholique de Louvain, Belgium, followed by doctoral work in Toxicology and Advanced Pharmacology at the Joint Graduate Program at Rutgers University / Robert Wood Johnson Medical School in New Jersey, USA. He started career in Medical Information and Drug Safety in the pharmaceutical industry. He obtained certification in Pharmacovigilance Practices from the University of Antioquia in Medellin, Colombia. He became a Director of Cardiology at United Health, and later Global Director of Pharmacovigilance at AXA USA, where he instituted and built comprehensive pharmacovigilance systems and global Medical Information Services for various biotechnology and pharmaceutical companies. His pharmacovigilance activities led to a position as Head of Pharmacovigilance for Latin America/Caribbean for Baxalta, a spin-off of Baxter. He is currently head of his own Chicago-based consultancy firm for regulatory and pharmacovigilance for several US and EU-based corporations. Mr. van Baelen spends his time between Chicago, Lisbon (Portugal) and Sao Paulo, Brazil.

Joanne Sparkes, MSc is the operational lead for this resource. Like all the team she has a scientific background having trained and worked in the UK National Health Service as a Medical Physicist. She now runs a data-driven digital marketing agency, Expedio.

Joanne is an expert in Excel, Power BI and data-driven decision-making, dedicated to helping small businesses unlock the full potential of their data. A semi-finalist in the 2017 Microsoft Excel Champ International competition, winner of Best Business Enabler at the National Entrepreneur Awards 2021 and a certified Microsoft Office Specialist, she brings both technical mastery and practical insights to every project.

In addition to data consulting, Joanne empowers small business owners and their teams to build in-house technical expertise. She integrates data-driven strategies with practical digital solutions—whether designing dashboards, automating complex reporting or enhancing digital operations. Her work spans developing websites, creating online courses, managing self-publishing projects and automating marketing workflows through social media campaigns and email marketing. By combining data insights with hands-on digital tools, Joanne helps businesses streamline operations, strengthen their online presence and make smarter, data-informed decisions.