PLENARY SESSION:
MONEY, COLLABORATION, POLICY
11:00 Chairperson’s Remarks
Melissa Stundick, Ph.D., Head of Strategic Alliances, Spero Therapeutics
11:15 Series of Brief Presentations
Driving Re-Investment in Antibiotics: Update from Europe’s DRIVE-AB
Kevin Outterson, Professor of Law, Boston University & Executive Director, CARB-X
DRIVE-AB has spent three years evaluating economic incentives to rekindle antibiotic R&D (www.drive-ab.eu), funded by the European Union with matching contributions from EFPIA companies. Final results and recommendations from DRIVE-AB will be presented.
Venture Capitalists: What Are Investors Looking For?
Vikas Goyal, Associate, SR One
CARB-X: What Does It Mean to be Powered by CARB-X?
Tyler Merkeley, CARB-X Co-Founder, BARDA’s CARB-X Program Manager, U.S. Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA)
CARB-X is a global innovation fund to support antibacterial product development supported by the Biomedical Advanced Research and Development Authority (BARDA), National Institute of Allergy and Infectious Diseases and Wellcome Trust, the UK-based global charitable foundation dedicated to improving health. Co-founder, Tyler Merkeley, will share BARDA’s continued vision for CARB-X as the “Global Innovation Fund” to address antibiotic resistant infections, highlight the Powered by CARB-X portfolio, and discuss future partnerships and funding opportunities.
Update on Pathways & Policies to Facilitate Antibiotic Development
Nicole Mahoney, Director, Global Policy, Merck
Antibiotic resistance continues to be a focus for policy makers determined to ensure the continued availability of effective treatments for patients with serious infections. This talk will provide an update on recent discussions with an emphasis on regulatory developments.
12:15 pm PANEL DISCUSSION:Non-Scientific Solutions to Advance Antimicrobial Pipeline
Moderator:
Melissa Stundick, Ph.D., Head of Strategic Alliances, Spero Therapeutics
Panelists: Speakers of the Session
Keynote Biographies
Nicole Mahoney, Director, Global Policy, Merck
Nicole Mahoney is the Director Global Regulatory Policy at Merck, where she focuses on U.S. and international regulatory policy, with a particular emphasis on infectious disease products. She works with a variety of stakeholders to spur antibiotic development, serving on the Innovative Medicine’s Driving Re-investment in R&D and responsible use of antibiotics (DRIVE AB) Project, a joint undertaking by the EU and European Pharmaceutical Industry Association. Prior to joining Merck from Cubist, Nicole served as the senior officer for the Pew Charitable Trusts' antibiotics and innovation project. She also served as a U.S. Food and Drug Administration Commissioner’s Fellow in the FDA’s Office of Antimicrobial Products, analyzing trends in the regulatory process for all new antibiotics reviewed by the agency over three decades. Nicole earned her PhD in biochemistry from the Albert Einstein College of Medicine and completed postdoctoral training at the University of California, San Francisco.
Vikas Goyal, Associate, SR One
Mr. Vikas Goyal is a Principal at SR One. Mr. Goyal served as Senior Associate at SR One. He joined SR One in 2011, after interning with SR One since 2009. Prior to this, Mr. Goyal served as a Consultant at McKinsey & Co, a Co-Founder of Extera Partners, and a Business Development Manager at Infinity Pharmaceuticals. Over his career, he has supported business and corporate development activities for nearly 50 large and small public, venture-backed, and angel funded life science companies. He serves as a Director of Morphic Rock Therapeutic, Inc., Macrolide Pharmaceuticals, CalciMedica, Inc and Spero Therapeutics, LLC. He is a member of Class 17 of the Kauffman Fellows Society. Mr. Goyal earned an M.B.A. in Wharton's Health Care Management program from the Wharton School of the University of Pennsylvania and B.A. in Neurobiology from Harvard University.
Tyler Merkeley, CARB-X Co-Founder, BARDA’s CARB-X Program Manager, U.S. Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA)
Tyler Merkeley, MS, MBA, PMP is currently the Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority’s (BARDA) Acting Chief of Staff and Head of Special Projects & Portfolio Management. Mr. Merkeley joined BARDA in 2009 as a Health Scientist in an effort to accelerate the advanced research and development, procurement, stockpile and sustainment of medical countermeasures (MCM) against biological, chemical, radiological, and nuclear (CBRN) agents under Project BioShield . During his tenure at BARDA he has supported various initiatives including BARDA’s Total Life Cycle Costs containment initiative, designing and launching HHS’s Combating Antibiotic Resistant Bacteria (CARB) Biopharmaceutical Accelerator and managing HHS’s 1st agreement using Other Transaction Authority (OTA).Prior to his transition to the BARDA Office of the Director in 2016, he worked within the BARDA Antibacterial (AB) Program. In 2010, Mr. Merkeley assisted in the strategic planning and launch of BARDA’s AB Program with the goal to revitalize the antibiotic development pipeline so that critically needed novel antibiotics are developed to treat an increasing number of antibiotic resistant infections. Over the last 6 years, Mr. Merkeley assisted in the strategic direction and growth of the AB portfolio from an initial vision in 2010 to a $1.4 billion portfolio with 7 public private partnership(s). While a member of the AB Program, Mr. Merkeley also led two integrated matrix teams overseeing a portfolio in excess of $700 Million for novel antibacterial and antiviral candidates. Mr. Merkeley was responsible for leading and assembling public private partnerships with SIGA Technologies Inc. and GlaxoSmithKline (GSK) including the interagency effort that successfully delivered a smallpox antiviral drug to the Strategic National Stockpile (SNS).Prior to BARDA, Mr. Merkeley was an international team member with the U.S. Department of Defense’s Biological Threat Reduction Program (BTRP) in Kazakhstan. The BTRP program supports the planning, design, implementation, and maintenance of Kazakhstan’s public health infrastructure. Mr. Merkeley was responsible for providing scientific subject matter expertise and program management support. Mr. Merkeley received his Masters of Science in Biohazard Threat Agents and Emerging Infectious Diseases from Georgetown University and his Masters of Business Administration (MBA) in Finance and International Business from Iona College in New York.
Kevin Outterson, Professor of Law, Boston University & Executive Director, CARB-X
Professor Kevin Outterson teaches health law and corporate law at Boston University, where he co-directs the Health Law Program, currently ranked #3 in the country by US News and World Report. He is the executive director of Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a global partnership hosted at BU Law that is focused on supporting developers of promising new antibiotics, diagnostics, and vaccines that tackle the threat of untreatable bacterial infections. He serves as the editor-in-chief of the Journal of Law, Medicine & Ethics; faculty co-advisor to the American Journal of Law & Medicine; past chair of the Section on Law, Medicine & Health Care of the AALS; and a member of the Board of the American Society of Law, Medicine & Ethics. Professor Outterson was recently named to the Advisory Panel for the Longitude Prize, which awards £10 million to address antibiotic resistance. Before teaching, Outterson was a partner at two major US law firms.His research focuses on the organization and finance of the health sector. Areas of specialization include global pharmaceutical markets, particularly antibiotics and other antimicrobials that can degrade in usefulness over time through resistance. He received a grant from the European Union’s Innovative Medicines Initiative to study business models and incentives for antibiotic development, and he leads an interdisciplinary project on the legal ecology of antimicrobial resistance, funded in part by the Robert Wood Johnson Foundation program on public health law. He is an associate fellow at the Royal Institute of International Affairs at Chatham House, London, where he works on global solutions to antibiotic resistance, and an appointed member of the Antimicrobial Resistance Working Group at the Centers for Disease Control.Professor Outterson has testified before President Obama’s Advisory Council on Combating Antibiotic Resistance, where he presented the results of a two-year study sponsored by the European Union on designing economic incentives for antibiotic development.
Professor Outterson publishes in both legal journals (Yale Journal of Health Policy, Law & Ethics; Cardozo Law Review; University of Pittsburgh Law Review; Kansas Law Review; American Journal of Law & Medicine) and peer-reviewed medical and health policy journals (New England Journal of Medicine; Health Affairs; Lancet Infectious Diseases; Environmental Philosophy; Medical Journal of Australia; Journal of Generic Medicines; Clinical Infectious Diseases; Journal of Law, Medicine & Ethics). He blogs on health policy issues at The Incidental Economist, one of the leading health economics blogs in the US.On behalf of The New England Journal of Medicine and other clients, Outterson filed an amicus brief in the US Supreme Court, supporting Vermont’s prescription privacy law. His work was cited by Justice Breyer in Sorrell v. IMS Health. A team led by Professors Outterson and Moncrieff at Boston University filed four amicus briefs supporting the Affordable Care Act, which was heard by the Court in the spring of 2012.
Melissa Stundick, Ph.D., Head of Strategic Alliances, Spero Therapeutics
Melissa Stundick, Ph.D., is the Head of Strategic Alliances for Spero Therapeutics in Cambridge, MA. Previously, she was the Anti-infectives Program Chief within the Biomedical Advanced Research and Development Authority (BARDA) at the Department of Health and Human Services (DHHS) for over 5 years. During that time, she oversaw a portfolio of contracts that supported the procurement or research and development novel antibacterials, smallpox antivirals, antitoxins and ebola therapeutics. Prior to HHS, she was a consultant at Booz Allen Hamilton where she provided scientific consultation to the Department of Defense, the Bill and Melinda Gates Foundation and other organizations.
Dr. Stundick received a B.S. in Chemistry from Bates College and a Ph.D. in Biochemistry, Cellular and Molecular Biology from the Johns Hopkins University School of Medicine. She also holds a Certificate of Intelligence Analysis from the University of Maryland.