THE GLOBAL GUIDE
TO COMPASSIONATE
USE PROGRAMS

Sean Turbeville, PhD, has 18 years of biotechnology experience and has worked extensively in Global Medical Affairs. His expertise is in orphan products (Oncology, Genetics, Metabolic, and Neuromuscular) with small biopharmaceutical companies and creating international programs to support clinical and commercial therapies in the United States, Latin America, European Union, Asia Pacific, and the Middle East.

Sean has held a variety of roles in Medical Affairs from building medical affairs organizations, overseeing strategy and operations, creating medical information, and scientific communications to launching compassionate use/expanded access programs and medical research initiatives.

Connie Coulomb, MBA., has more than 20 years of experience in biopharma. Mrs. Coulomb has held a variety of roles in the areas of strategy, business development, marketing, sales, market research, and market access in large, medium, and small biopharma companies, including Merck, Amgen, Biogen, Gilead, and Onyx. In her most recent corporate role, Connie Coulomb served as Divisional Vice-President and General Manager for Biogen, where she managed a $1.5B Multiple Sclerosis Business in the United States.

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.

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, Belgium, and did doctoral work in Toxicology and Advanced Pharmacology at the Joint Graduate Program at Rutgers University / Robert Wood Johnson Medical School in New Jersey, USA, before starting a career in Medical Information and Drug Safety in the pharmaceutical industry. He also obtained certification in Pharmacovigilance Practices from the University of Antioquia in Medellin, Colombia. He became a Director of Cardiology at United Health, participating in publication planning and authoring several articles on heart disease and its therapies. As Global Director of Pharmacovigilance at AXA, Mr. van Baelen instituted and built comprehensive pharmacovigilance systems while overseeing global Medical Information Services for various biotechnology and pharmaceutical companies.

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 excels at designing bespoke spreadsheets for the analysis and presentation of data. She also helps businesses use their data to make decisions and to connect the technical pieces of working online – from developing websites, online courses and self-publishing to social media campaigns and email marketing automation.