Jess Rabourn, CFA
Founder/CEO, WideTrial, Inc.
Jess Rabourn has concentrated exclusively on expanded access policy and practice since 2011. Rabourn is the co-founder of the National Board of Early Access Medicine, the longest-standing organization that is focused on pre-first-approval access programs in the United States. He also is the producer of the Expanded Access Summit, which establishes best industry practices for integrating EAPs into the drug development process. Rabourn is founder of WideTrial, a specialty platform for third-party sponsorship of EAPs, an industry consultant, and frequent speaker at medical conferences.
Senior Partner, King & Spalding
David Farber is a partner in the FDA and Life Sciences practice at King & Spalding, resident in the firm’s Washington, D.C. office, where he maintains a health care practice focused on government advocacy and regulatory counseling. A leading national expert on Medicare matters, he works regularly on Capitol Hill and with key regulatory agencies, particularly the Centers for Medicare & Medicaid Services and U.S. Food and Drug Administration, on legislative and regulatory advocacy and counseling matters. His regulatory experience complements and augments the firm’s FDA regulatory, life sciences and healthcare teams, all of which are recognized as leading practices by Chambers USA. David regularly speaks before national audiences on expanded access, health care reimbursement, secondary payer, and CMS and FDA regulatory matters.
Vice President of Business Development, Caligor
Karen has over 24 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 and was promoted into increasing levels of responsibility eventually having managerial oversight for primary care and specialty sales teams across the US. Karen moved into the Global Expanded Access arena in 2010 and has been responsible for leading the business discussions with pharma and biotechs clients as they explore and plan for early access to their innovative and life saving medicines. She has had extensive involvement in leading the strategic program initiatives for global early access programs in therapeutic areas of oncology, CNS, auto-immune and rare disease. Karen graduated with honors and holds a BS in Biology from the University of Akron. She has been a contributor to several patient facing publications which center around obtaining early access to medicines in the US and Canada, as well as a contributor to rare disease publications on this unique topic.
Carrie-Lynn Langlais Furr, PhD, RAC
Vice President of Regulatory Affairs and Program Management, AmpliPhi Biosciences
Carrie-Lynn Langlais Furr, PhD, RAC, is Vice President of Regulatory Affairs and Program Management at AmpliPhi Biosciences, a clinical-stage biotechnology company focused on the development of bacteriophage-based therapies for the treatment of antibiotic-resistant bacterial infections. Dr. Furr has over a decade of integrated product development and regulatory affairs experience. Prior to joining AmpliPhi, Dr. Furr served as Senior Director of Operations at Rho, Inc., a clinical research organization, where she also held leadership roles in regulatory affairs, integrated development, program management, and medical writing, which stemmed from her early years in regulatory operations at PPD. Dr. Furr’s experience includes providing strategic and operational support through all phases of clinical development, including formal interactions and negotiations with regulatory authorities as well significant contributions to FDA market approval of 5 drugs and a biologic-device combination product. She received a PhD from Texas A&M University in biochemistry and biophysics and studied the antibiotic mechanism of bacteriophages. With AmpliPhi, Dr. Furr is applying her bacteriophage basic research knowledge to treat patients with serious or life-threatening bacterial infections under Expanded Access regulations, as well as under traditional development pathways.
Hank Mansbach, MD
VP Clinical Development, Ultragenyx
Hank Mansbach is a neurologist who, over his 19 years in the pharma/biotech industry, has served in leadership roles in the development and commercialization of numerous novel therapeutic agents. He is currently VP, Clinical Development and Ultra Programs for Ultragenyx, a clinical-stage biopharmaceutical company focused on novel treatments for rare and ultra-rare genetic diseases. One of the Ultra Programs he oversees at Ultragenyx is the individual and cohort expanded access program.
Consultant, Pre-Approval Access, TW Consulting
For the last five years, Tom has partnered with pharmaceutical and biotech companies to design their strategy for expanded access and develop global programs, allowing patients to gain access to treatments that would otherwise be unavailable to them within their respective countries. His role as head of U.S. business development for Idis, part of the Clinigen Group, has provided a platform to help patients around the world while developing strategy for many of the top 20 pharmaceutical companies in this important area. In his new role, Tom is looking to make a broader and more significant positive impact on the early access landscape. Previously, he spent 14 years within the pharmaceutical industry fulfilling a range of leadership roles including head of marketing for a multinational pharmaceutical company. Within this time, he has led a wide range of global pre-launch and launch activities for treatments addressing areas of high unmet medical need. Tom is a member of the NYU School of Medicine Working Group on Compassionate Use and Pre-Approval Access.
Adjunct Associate Clinical Professor, Co-Chair, Expanded Access Oversight Committee, University of Michigan Medical System
Kevin Weatherwax directs the staff of the MICHR IND/IDE Assistance Program (MIAP) at the University of Michigan Health System (UMHS). He also Co-Chair’s the UMHS Expanded Access Oversight Committee to develop/enhance internal process and infrastructure to support treating physicians interested in providing access to investigational products to patients with no alternatives. Kevin has been instrumental in the development of institutional policy and processes as it relates to FDA regulated research at the University of Michigan. Under his direction, the MIAP team has consulted with over 500 investigators, including device, drug and biologics development along with regulatory support for IND/IDE clinical studies. With a multidisciplinary support focus, MIAP has interfaced with hundreds of faculty and staff across many Schools, Departments and Divisions at the University of Michigan.