GAINing Ground in Antibiotics: New Incentives for Biopharma

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2:00 p.m. - 2:55 p.m., Tuesday, October 8, 2013, Twin Peaks North/ South

Antibiotic resistance is one of the largest threats to global health. A recent report released by the CDC estimates that every year in the US, 2 million people acquire an antibiotic-resistant infection. But with only 9 new antibiotics approved in the last 15 years, it is apparent biopharma companies have not had much incentive to develop any new and novel antibiotics. However, last year Congress passed, and the President signed into law, the FDA Safety and Innovation Act (FDASIA) which included provisions specifically designed to increase investment in the research and development of antibiotics (GAIN -Generating Antibiotic Incentives Now).

This panel will explore how those incentives work and discuss how and if they will spur development of antibiotics. Additionally, the panel will discuss new approval pathways being proposed by FDA, Congress and other stakeholders, and how they could jump-start development of new antibiotics and address the rising threat of antibiotic-resistance.

Moderator

  • Dr. E. Cartier Esham, Acting Executive Vice President Emerging Companies, Health and Regulatory Affairs, Biotechnology Industry Organization

Panelists

  • Steve Conafay, JD, Principal, The Conafay Group
  • Michael J. Eichberg, PhD, Senior Director, Alliance Management, Achaogen
  • Thomas Kapsner, CEO, Morphochem AG
  • Brad Spellberg, MD, Investigator, LA BioMed
  • Eugene Sun, MD, Executive Vice President, Research & Development, Rib-X Pharmaceuticals

Who's Who

Dr. E. Cartier Esham
Acting Executive Vice President Emerging Companies, Health and Regulatory Affairs, Biotechnology Industry Organization

Dr. Cartier Esham is currently the Acting Executive Vice President Emerging Companies, Health and Regulatory Affairs for the Biotechnology Industry Organization (BIO). She is responsible for working on health and regulatory issues important to BIO's small biotechnology companies, the majority of which do not yet have a product in the market place. Issues of particular importance to emerging companies include intellectual property, technology transfer, clinical trials, investor relations, and funding. The emerging companies section also works on a wide range of FDA regulatory issues and is a strong advocate for NIH's biomedical research programs.

Prior to joining BIO, Dr. Esham was a Vice President and Director of Research at Dutko Worldwide, a private consulting firm in Washington, D.C. There she worked on a variety of environmental, education, science, technology and health care related issues both on the federal and state/local levels.

Steve Conafay, JD
Principal, The Conafay Group

Steve Conafay has 35 years of leadership and management experience in government relations, public policy and communications. As the sole principal at The Conafay Group, he oversees all client servicing. While leader of the Bio-Life Science Practice at Fabiani & Company, he oversaw over $400M in non-dilutive financing being awarded to the team’s clients. For 12 years, Mr. Conafay was Vice President of Government Relations for Pfizer, where he was elected a corporate officer in 1984.

He served as Senior Vice President of Corporate Affairs for Glaxo Inc., where he was a member of the Board of Directors. After heading the legislative practices for Jones, Day, Reavis and Pogue, the world’s second largest law firm, he was tapped by the Pharmaceutical Research and Manufacturers of America (PhRMA) to assume the number two position of Executive Vice President of Strategic and Legislative Affairs. He also served as an Executive Fellow at the American Enterprise Institute, the leading free market think-tank in the U.S. After moving to the New York area, Mr. Conafay joined Shandwick, where he assumed positions of increasing responsibility culminating with his appointment as CEO-America’s East in 2000. Mr. Conafay is a lawyer and a decorated Vietnam veteran. He served as an infantry platoon leader and was awarded the Silver Star, Bronze Star with Oak Leaf Cluster, the Air Medal and the Army Commendation Medal, among others. Steve is an avid golfer and has been a member of Congressional Country Club for over 30 years. 

Thomas Kapsner
CEO, Morphochem AG

Thomas Kapsner has been serving as CEO of Morphochem AG in Munich, Germany since 2008. Morphochem is a 100% subsidiary of Biovertis AG in Vienna, Austria. Thomas Kapsner is also CEO of Biovertis which he joined in May 2006. Previously, he served as managing director of Kapsner & Schmid GmbH, a European corporate finance counsel focusing on the healthcare and life sciences industry. He held several management and executive positions in client companies ranging from start-up to turn-around situations. From 2002 to 2006, he was managing the European operations for Argos Therapeutics, Inc. (Durham, NC). Thomas Kapsner was investment manager with GE Capital before founding Kapsner & Schmid in 1999. At GE, he concentrated on M&A of healthcare companies. Prior to joining GE, he worked as a consultant with McKinsey & Company focusing on healthcare and pharma clients. Before joining McKinsey, he was co-founder and managing director of the Bavarian Public Health Research Center in Munich. Thomas Kapsner holds a medical degree from the University of Munich, and was research fellow at the University of Munich in the Department of Internal Medicine and the Department of Medical Informatics, Biometry and Epidemiology.

Brad Spellberg, MD
Investigator, LA BioMed

Dr. Brad Spellberg is an infectious disease specialist who works as an academic hospitalist, attending on the inpatient medicine wards. He also works closely with the Infectious Diseases Society of America (IDSA) to bring attention to problems stemming from an increase in drug resistance and a dip in new antibiotic development. His research has become a cornerstone of the IDSA’s white paper, Bad Bugs, No Drugs, and has been cited extensively in medical literature and on Capitol Hill. A Fellow in the IDSA, Dr. Spellberg joined the IDSA’s Antimicrobial Availability Task Force (AATF) and has first-authored numerous IDSA position papers and review articles relating to public policy toward antibiotic resistance and development. Dr. Spellberg has appeared on numerous television programs, including The CBS Evening News with Katie Couric, the Dr. Oz show, and The Doctors, and has been interviewed for dozens of radio and newspaper stories regarding the antibiotic resistance crisis. He wrote the book, Rising Plague, to inform and educate the public about the crisis in antibiotic-resistant infections and the lack of antibiotic development.

Eugene Sun, MD
Executive Vice President, Research & Development, Rib-X Pharmaceuticals

Eugene Sun, M.D. has been our Executive Vice President, Research and Development since April 2013. Prior to joining us, Dr. Sun held multiple positions over a 17-year career at Abbott Laboratories (now Abbvie) where he most recently served as Corporate Vice President, Global Pharmaceutical Clinical Development. Dr. Sun was responsible for global clinical development, medical affairs, and clinical operations for all therapeutic areas of the pharmaceutical portfolio. Prior to 2005, he held various leadership positions in the R&D organization. During his tenure at Abbott, Dr. Sun oversaw the development and approval of multiple indications for Humira, and also led the development and worldwide regulatory approval of the landmark HIV protease inhibitor Kaletra. Dr. Sun earned his Bachelor of Arts degree from Harvard University, his M.D. from the New York University School of Medicine, and completed his residency in Internal Medicine and fellowship in Infectious Diseases at the University of California, San Francisco.