Reid Adler, JD, has been involved with intellectual property and technology transactions in the life sciences field for more than 30 years. His legal career includes experience as a senior partner of two international law firms, Morrison & Foerster and Morgan Lewis, and as general counsel of the J. Craig Venter Institute for genomics research. He continues to advise clients on life science matters in his current law practice. Most recently, he founded Practical Innovation Strategy, consulting on innovation management and translational research for nonprofit organizations and on intellectual property (IP) strategy for a major multinational pharmaceutical company. He also publishes the “Practically Strategic” blog. Mr. Adler was the founding director of the National Institutes of Health (NIH) Office of Technology Transfer, and played a key role in developing policies and model agreements, research integrity guidelines and the Uniform Biological Material Transfer Agreement. He holds a law degree from the George Washington University. After law school, he clerked for Judge Giles Rich at the U.S. Court of Appeals for the Federal Circuit and after that was a fellow at the Max Planck Institute for Foreign and International Patent, Copyright and Competition Law in Germany. Mr. Adler has testified before Congress on technology transfer, has published numerous articles, and has taught courses in innovation management, strategic planning, technology transfer, and legal aspects of biotechnology for Johns Hopkins University and DePaul University Law School. He has also chaired the boards of several community nonprofit organizations involved with education and the fine arts.
Joan Awunyo-Akaba, PhD, MCommH, is Executive Director, Future Generations International (FUGI) and a member of the Ghana Coalition of Nongovernmental Organizations (NGOs) in Health. She has a PhD in medical sociology, University of Ghana Legon (2007). She is a Community Health Development Consultant, and the Founder and Executive Director of FUGI, a Ghana-based NGO. A registered nurse, she has penetrated the development sector by her dedication and sensitization of child rights and maternal and child health, including childhood immunization advocacy, behavior change communication, youth development and empowerment, school sanitation and hygiene, and promotion of income generation activities for women. She is involved in civil society organizational activities, has served as National Vice Chairperson of the Ghana Coalition of NGOs in Health (2010-2012), and has also served as a board member and former Vice Chair of ActionAid International Ghana, a nonprofit NGO that targets poor and marginalized people to eradicate poverty (2005-2010). She recently served as the civil society organizations representative on the Board of Gavi, the Vaccine Alliance, Geneva, Switzerland (2012-2015).
Beth P. Bell, MD, MPH, is the director of the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID). She provides leadership for the prevention and control of a broad spectrum of infectious diseases, including rare but deadly diseases like Ebola and anthrax, and more common conditions like foodborne diseases and health care–associated and antibiotic-resistant infections. In addition, Dr. Bell provides oversight for a diverse portfolio of science-based programs that promote water safety, global health and the health of migrating populations, and the identification and control of diseases transmitted by animals and insects. She is responsible for providing leadership and direction for NCEZID’s world-class laboratories, which are developing new tests, vaccines, and, since the 2014 launch of advanced molecular detection, next-generation sequencing to enable faster diagnosis and more effective prevention and control of infectious diseases. Since Dr. Bell assumed the position in 2010, she has led NCEZID’s response to several major infectious disease threats, including the largest Ebola epidemic in history affecting multiple countries in West Africa, chikungunya spreading throughout the Americas, a multistate outbreak of fungal meningitis that exposed thousands of patients who had received contaminated steroid injections, the second-largest outbreak of West Nile virus disease in the United States, the worst cholera outbreak in recent history that caused more than 8,000 deaths in Haiti, and dozens of outbreaks of foodborne disease that occur each year.
Graeme Bilbe, PhD, is the Research & Development Director, Drugs for Neglected Diseases initiative (DNDi). Dr. Bilbe has the overall responsi-
bility for advancing the discovery and development of new treatments for neglected diseases and building DNDi’s project portfolio. Prior to joining DNDi in 2012, Dr. Bilbe was Global Head of Neuroscience Discovery at Novartis, tasked with discovery and early development to proof-of-concept testing of novel treatments for brain diseases. During his scientific leadership of Novartis Neuroscience Discovery, he and scientific teams participated in development and registration of new therapies for Alzheimer’s and Parkinson’s disease and multiple sclerosis. Under Dr. Bilbe’s leadership, the Neuroscience Discovery group built and developed a portfolio of novel therapies up to clinical efficacy testing for Parkinson’s disease, fragile X mental retardation, cognitive disorders, gastroesophageal reflux disease, epilepsy, and chronic pain states. Dr. Bilbe held executive leadership positions within both the Novartis Institutes for Biomedical Research as well as the Novartis Franchise Board for Neuroscience and was a visiting professor at the University of Liverpool. He currently is a member of Scientific Advisory Boards for Biotech Companies, Public Institutions and the Special Program for Research and Training in Tropical Diseases (TDR). Dr. Bilbe completed post-doctoral fellowships at the Zentrum for Molecular Biology in Heidelberg and Imperial College, University of London. He received his PhD in biochemistry from the University of London, Imperial College, and his BSc in zoology and biochemistry from the University of Nottingham.
Fred Binka, PhD, MBChB, MPH, is Vice-Chancellor, University of Health Allied Sciences, Ho, Ghana and Professor of Clinical Epidemiology. He holds an MBChB (Ghana, medical degree), MPH (Jerusalem), and PhD in epidemiology (Basel). Before joining the University of Health and Allied Sciences, he had held the position of Dean, School of Public Health, University of Ghana, and worked with the Ghana Ministry of Health for more than 20 years in several capacities, including Director of the Navrongo Health Research Centre. He was a member of the initial team that developed the Roll Back Malaria Initiative at the World Health Organization (WHO) in Geneva. He established the Indepth Network, an international health research NGO. His research interests are in malaria (epidemiology, control), intervention studies (drugs and vaccines of tropical diseases), and Ebola vaccines. Dr. Binka is a recent recipient of the Ronald Ross Medal (2010) from the London School of Hygiene & Tropical Medicine, and was the first recipient of the Rudolf Geigy Medal (2000) by the Swiss Tropical Institute. Dr. Binka is a strong advocate for research capacity strengthening in Africa, through support from African governments and their partners.
Robert M. Califf, MD, MACC, is Deputy Commissioner for Medical Products and Tobacco for the U.S. Food and Drug Administration (FDA).
Appointed in February 2015, Dr. Califf provides executive leadership to the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, and Center for Tobacco Products. He also oversees the Office of Special Medical Programs and provides direction for crosscutting clinical, scientific, and regulatory initiatives, including personalized medicine, orphan drugs, pediatric science, and the advisory committee system. He attended Duke University both as an undergraduate and for medical school, completing his residency at the University of California, San Francisco, before returning to Duke for a cardiology fellowship. Dr. Califf served as the Donald F. Fortin, M.D., Professor of Cardiology at Duke and, most recently, Vice Chancellor for Clinical and Translational Research. An international leader in cardiovascular medicine, health outcomes, health care quality, and medical economics, he is recognized by the Institute for Scientific Information as 1 of the top 10 most cited medical authors, with more than 1,200 peer-reviewed publications. Dr. Califf co-chaired the Clinical Trials Transformation Initiative, a public–private partnership co-founded by Duke and FDA to identify and promote practices that will increase the quality and efficiency of clinical trials. He also served as co–principal investigator (PI) of Duke’s Clinical and Translational Science Award, funded by the National Center for Advancing Translational Sciences; PI for the coordinating center of the NIH Health Care Systems Research Collaboratory, a Common Fund program that develops, tests, and disseminates innovative methodologies for pragmatic clinical research; and co-PI for the Baseline Study, a collaboration among Duke University, Stanford University, and Google that seeks new understandings of states of health and disease in humans.
Margaret Chan, OBE MD, DSc, MScPH, FFPHM, JP, from the People’s Republic of China, obtained her medical degree from the University of Western Ontario in Canada. She joined the Hong Kong Department of Health in 1978, where her career in public health began. In 1994, Dr. Chan was appointed Director of Health of Hong Kong. In her 9-year tenure as director, she launched new services to prevent the spread of disease and promote better health. She also introduced new initiatives to improve communicable disease surveillance and response, enhance training for public health professionals, and establish better local and international collaboration. She effectively managed outbreaks of avian influenza and of severe acute respiratory syndrome. In 2003, Dr. Chan joined WHO as Director of the Department for Protection of the Human Environment. In June 2005, she was appointed Director, Communicable Diseases Surveillance and Response, as well as Representative of the Director-General for Pandemic Influenza. In September 2005, she was named Assistant Director-General for Communicable Diseases. Dr. Chan was elected to the post of Director-
General on November 9, 2006. The Assembly appointed Dr. Chan for a second 5-year term at its 65th session in May 2012. Dr. Chan’s new term began on July 1, 2012, and continues until June 30, 2017.
Craig E. Colton, CIH, MA, is a certified industrial hygienist in the Regulatory Affairs and Technical Service group of the 3M Personal Safety Division with experience specializing in respiratory protection. Currently a Division Scientist, he has conducted workplace protection factor studies on 3M respirators, monitored and responded to regulatory affairs issues related to respiratory protection, and provided technical assistance to respirator users. Previous to working for 3M, he was an instructor at the Occupational Safety and Health Administration (OSHA) Training Institute, where he was course chair for the respiratory protection course covering OSHA, the National Institute for Occupational Safety and Health, the National Research Council, the American National Standards Institute (ANSI), the Compressed Gas Association, the Canadian Standards Association, and the National Fire Protection Agency standards, as well as the complete range of respiratory protective devices. While at OSHA he was a member of the four-person team that first implemented quantitative fit testing for OSHA personnel. Mr. Colton has also taught continuing education courses for several universities and associations. He is a past chair of the American Industrial Hygiene Association Respiratory Protection Committee and Americas’ Section of the International Society for Respiratory Protection (ISRP) (1998-2000). Presently he is serving as the vice chair of the Americas’ Section of ISRP. He has authored several articles and book chapters on respiratory protection. He is currently a member of the ANSI Z88 Committee on respiratory protection and a member of the Z88.2 subcommittee. Mr. Colton was a member of the last ANSI Z88.10 (2010) subcommittee on fit testing. He is also a member of the International Standards Organization (ISO) committee developing respiratory protection standards (TC94 SC15). This work included serving as convener for the working group that produced ISO 16972 on respiratory terminology.
Peter Dull, MD, MS, is Deputy Director for Integrated Clinical Vaccine Development within the Global Health Division at The Bill & Melinda Gates Foundation. In this role he provides technical and strategic guidance to the foundation’s program strategy teams and external partners. During the Ebola response, he was seconded to WHO to support in facilitating clinical trial coordination in West Africa. He joined the foundation after 10 years at Novartis Vaccines and Diagnostics, where he was the Clinical Franchise Head for Meningitis and Sepsis Vaccines. At Novartis, he led the clinical development and global licensure for infants, adolescents, and adults of a quadrivalent meningococcal glycoconjugate vaccine (Menveo®; Men-
ACWY-CRM) as well as a protein-based serogroup B vaccine (Bexsero®; 4CMenB). In addition, he led the clinical development for the Group B strep glycoconjugate vaccine, which is targeted to pregnant women to prevent neonatal disease. Prior to joining Novartis, he was an Epidemic Intelligence Service officer in the Meningitis and Special Pathogens Branch at the U.S. Centers for Disease Control and Prevention (CDC), where he was responsible for conducting ongoing surveillance and investigating outbreaks of pathogens such as meningococcus and Bacillus anthracis. Dr. Dull holds a BS in physics and an MS in neuroscience. He attended medical school at the University of Wisconsin–Madison and completed his internal medicine training at Oregon Health & Science University in Portland, Oregon. After his service as an Epidemic Intelligence Officer, he completed subspecialty training in infectious diseases at Emory University.
Victor J. Dzau, MD, is the President of the National Academy of Medicine (NAM), formerly the Institute of Medicine (IOM). In addition, he serves as Chair of the IOM Division Committee of the National Academies of Sciences, Engineering, and Medicine. Dr. Dzau is Chancellor Emeritus and James B. Duke Professor of Medicine at Duke University and the past President and CEO of the Duke University Health System. Previously, Dr. Dzau was the Hersey Professor of Theory and Practice of Medicine and Chairman of Medicine at Harvard Medical School’s Brigham and Women’s Hospital, as well as Chairman of the Department of Medicine at Stanford University. Dr. Dzau has made a significant impact on medicine through his seminal research in cardiovascular medicine and genetics and his leadership in health care innovation. His important work on the renin angiotensin system (RAS) paved the way for the contemporary understanding of RAS in cardiovascular disease and the development of RAS inhibitors as widely used, lifesaving drugs. In his role as a leader in health care, Dr. Dzau has led efforts in innovation to improve health, including the development of the Duke Translational Medicine Institute, the Duke Global Health Institute, the Duke–National University of Singapore Graduate Medical School, and the Duke Institute for Health Innovation. As one of the world’s preeminent health leaders, Dr. Dzau advises governments, corporations, and universities worldwide. He has served as a member of the Advisory Committee to the Director of the NIH and as Chair of the NIH Cardiovascular Disease Advisory Committee. Currently he is a member of the Board of the Singapore Health System and Hamad Medical Corporation, Qatar. He was on the Board of Health Governors of the World Economic Forum and chaired its Global Agenda Council on Personalized and Precision Medicine. Among his many honors and recognitions are the Gustav Nylin Medal from the Swedish Royal College of Medicine, the Distinguished Scientist Award from the American Heart Association, Ellis Island Medal of Honor, and the
Henry Freisen International Prize. In 2014, he received the Public Service Medal from the President of Singapore. He is a member of the NAM, the American Academy of Arts and Sciences, and the European Academy of Sciences and Arts. He has received eight honorary doctorates.
Hans-Georg Eichler, MD, MSc, is the Senior Medical Officer at the European Medicines Agency in London, United Kingdom, where he is responsible for coordinating activities between the Agency’s scientific committees and giving advice on scientific and public health issues. Prior to joining the European Medicines Agency, Dr. Eichler was at the Medical University of Vienna in Austria for 15 years. He was vice-rector for Research and International Relations since 2003, and professor and chair of the Department of Clinical Pharmacology since 1992. His other previous positions include president of the Vienna School of Clinical Research and co-chair of the Committee on Reimbursement of Drugs of the Austrian Social Security Association. His industry experience includes time spent at Ciba-Geigy Research Labs, United Kingdom, and Outcomes Research at Merck & Co., in New Jersey. In 2011, Dr. Eichler was the Robert E. Wilhelm fellow at the Massachusetts Institute of Technology’s (MIT’s) Center for International Studies, participating in a joint research project under MIT’s NEWDIGS initiative. Dr. Eichler graduated with an MD from Vienna University Medical School and a master of science degree in toxicology from the University of Surrey in Guildford, United Kingdom. He trained in internal medicine and clinical pharmacology at the Vienna University Hospital as well as at Stanford University.
Krishna M. Ella, PhD, MS, is the Chairman and Managing Director of Bharat Biotech International Ltd. He received his PhD from the University of Wisconsin–Madison. Bharat Biotech has invested more than $138 million toward facilities and projects, and sold more than three billion doses in 65 countries. Under the Social Innovation concept, Dr. Ella developed the ROTAVAC vaccine in collaboration with the government of India’s Department of Biotechnology, The Bill & Melinda Gates Foundation, PATH, CDC-Atlanta, and NIH-USA, and the first novel vaccine was launched by the Honorable Prime Minister of India. Bharat Biotech entered into a partnership with the University of Maryland to work on nontyphoid Salmonella vaccines for Africa with a grant of $4 million from Wellcome Trust. Bharat Biotech obtained more than 65 global patents with 8 new molecules. Dr. Ella has been awarded more than 100 national and international awards, which include Bio Spectrum Person of the Year in 2013, University of Wisconsin Distinguished Alumni Award (2011), Business Leader of the Year 2011, and Best Technology and Innovation Award from the Prime Minister of India in 2008. He has served on numerous committees, including as
member of the Scientific Advisory Committee to the Government of India (SAC-C); member of the Governing Body of the Council of Scientific & Industrial Research; Chairperson of the Board of Governors of the National Institute of Technology, Warangal; and Co-Chairman of Indo-USA High Technology Cooperation Group for 5 years on behalf of the government of India; he also facilitated the knowledge initiative bill signed by the United States.
Maria Freire, PhD, is the President and Executive Director and Member of the Board of Directors of the Foundation for the National Institutes of Health (FNIH). Prior to this appointment, Dr. Freire was the President of the Albert and Mary Lasker Foundation, from 2008 to 2012, where she established novel programmatic initiatives that expanded the brand and reach of the foundation. From 2001 to 2008, she served as President and Chief Executive Officer of the Global Alliance for TB Drug Development (TB Alliance), a not-for-profit organization that develops drugs to fight tuberculosis (TB), and directed the Office of Technology Transfer at NIH from 1995 to 2001. Dr. Freire obtained her BS degree at the Universidad Peruana Cayetano Heredia in Lima, Peru, received her PhD in biophysics from the University of Virginia, and completed post-graduate work in immunology and virology at the University of Virginia and the University of Tennessee, respectively. She is active on national and international boards and committees, including the Board of the Global Alliance for Vaccines and Immunization (GAVI) Alliance and Alexandria Real Estate Equities, Inc. She is Chair of the Science Board of FDA, which advises the Commissioner. Dr. Freire was selected as 1 of 10 Commissioners of WHO’s Commission on Intellectual Property Rights, Innovation and Public Health, and is a member of the Executive Committee of the United Nations’ Sustainable Development Solutions Network. She is the recipient of numerous awards, including the U.S. Department of Health and Human Services (HHS) Secretary’s Award for Distinguished Service, The Arthur S. Flemming Award, and The Bayh-Dole Award. Dr. Freire is a member of the NAM and of the Council on Foreign Relations.
Charles Goldstein, PhD, MA, MSE, is Chief Scientific Officer, Greater Asia, Becton Dickinson (BD) Technologies, a position he assumed in October 2013. Dr. Goldstein is responsible for the strategy and global performance of BD’s regional research and development (R&D) operations in Asia. The strategic goal of the role Dr. Goldstein fills is to enhance the company’s growth in emerging countries via market-appropriate solutions. In 1997 Dr. Goldstein was appointed BD’s Vice President, Research, responsible for BD Technologies. Some of BD’s accomplishments include commercialized microneedle-based drug delivery devices, nanotechnology-based point-of-
care diagnostics, and novel products for stem cell growth. From 1988 to 1998 Dr. Goldstein was Vice President of R&D for BD’s Hypodermic and Injection Systems business. During this period the major product development work was done for BD’s highly successful health care worker needle stick prevention safety products. Prior to joining BD, Dr. Goldstein led the product development efforts for Millipore Corp in Bedford, Massachusetts. Dr. Goldstein has received numerous high-level awards at BD recognizing his leadership and innovation contributions. Dr. Goldstein served on the Board of North Carolina Biotechnology Industry Organization (BIO), the local affiliate of national BIO. Dr. Goldstein was Chairman of the Board of Ibiliti, a nonprofit focused on supporting and growing the Med Tech industry in North Carolina. Dr. Goldstein served as Chairman of the Board of the Singapore Bio Venture Center, an incubator that was a joint venture between BD and Johns Hopkins Medical. Dr. Goldstein served on the Board of Synecor. He is a member of numerous professional organizations and engages in outside charitable and philanthropic efforts on behalf of the Juvenile Diabetes Research Foundation (JDRF) and Princeton University. He served 6 years as a board member of the Eastern North Carolina chapter of the JDRF. Dr. Goldstein serves on advisory committees for the Chemical and Biological Engineering Department at Princeton, the Whiting School of Engineering at Johns Hopkins, and the Chemical and the Biomolecular Engineering Departments at Johns Hopkins. He recently received an award from Johns Hopkins University for distinguished alumni service. He received several awards from JDRF for service to that organization as well. Dr. Goldstein has a PhD and an MA from Princeton University, an MSE degree from Johns Hopkins University, and a BChE degree from the City College of New York.
Glenda Gray, MBBCH, FCPAED (SA), is the President of the Medical Research Council in South Africa, a non-Executive Director at the Perinatal HIV Research Unit, in Soweto, South Africa, and a Professor of Pediatrics in the Faculty of Health Sciences at the University of Witwatersrand. Dr. Gray’s prior research has focused on studies of prevention of mother-to-child transmission, pediatric treatment trials, large-scale HIV clinical trials (including HIV vaccine trials), tuberculosis, influenza, and human papillomavirus (HPV) vaccine studies in infants, children, adolescents, and adults. Dr. Gray has been the recipient of multiple grants from NIH, including an R21 and a U01. In 2009, she received the N’Galy Mann Lectureship award at the Conference on Retroviruses and Opportunistic Infections. She has been the Soweto Clinical Trials Unit PI since 2010. In addition, Dr. Gray is the HIV Vaccine Trials Network co-PI, and Director of International/Africa Programs. She has been involved in HIV research in South Africa for more than a decade. She is currently leading the clinical development of South
Africa’s first two HIV vaccines. Dr. Gray has expertise in HIV prevention in adolescents, and is the co-chair for a pivotal study investigating the efficacy of coitally dependent tenofovir gel, called FACTS 001. This multicentered study involves nine clinical trial sites and is a purely South African–run consortium, giving Dr. Gray the necessary experience and expertise in leading multicentered studies. She is on the WHO/Joint United Nations Programme on HIV/AIDS (UNAIDS) Vaccine Advisory Board, and on the data and safety monitoring board for two vaccine studies in Africa. Dr. Gray chairs the standing committee on health for the Academy of Science, and represents the academy in the South African National Research Committee. As a recently inducted member of the NAM, she serves on the Global Health Committee and the Vaccine Committee.
Shanelle Hall is the Director of the United Nations Children’s Fund’s (UNICEF’s) Supply Division and oversees UNICEF’s global logistics and procurement function. In this capacity she is responsible for the effective, efficient, and ethical provision of essential and emergency supplies to children in need, through direct UNICEF programs and cooperation with governments and partners. UNICEF’s global annual expenditures in these areas approach $3.382 billion. Prior, she was the Chief, Immunization, where she is credited with introducing the concept of “vaccine security” as a means of ensuring a sustainable, uninterrupted supply of affordable, quality vaccines to the world’s poorest countries. Ms. Hall has traveled extensively in Africa and Asia in addition to working out of Europe. Prior to joining UNICEF, Ms. Hall worked for 9 years in the private sector where she was involved in energy sector infrastructure development in various countries.
Margaret A. Hamburg, MD, is the former Commissioner of FDA, having stepped down from that role in April 2015 after almost 6 years of service. As the top official at FDA, Dr. Hamburg emphasized the critical role of innovation in meeting the nation’s rapidly growing public health needs and set the agency’s course for fulfilling two central public health tasks. She launched a nationwide public–private effort to strengthen regulatory science as a means for advancing the development and evaluation of innovative, breakthrough medical products, and led FDA’s transformation into a global regulatory agency capable of ensuring the safety and quality of imported food, drugs, and medical devices. Before taking on the post of FDA Commissioner, Dr. Hamburg was founding Vice President for Biological Programs at the Nuclear Threat Initiative, a foundation dedicated to reducing the threat to public safety from nuclear, chemical, and biological weapons. Prior to that she served as Assistant Secretary for Planning and Evaluation in HHS. Dr. Hamburg’s other public health responsibilities also included Assistant Director of the National Institute of Allergy and Infec-
tious Diseases, as well as Commissioner of the New York City Department of Health. Dr. Hamburg earned her BA from Harvard College and her MD from Harvard Medical School and completed her residency at Weill Cornell Medical Center and currently is a member of the NAM where she now serves as Foreign Secretary.
Andre Kalil, MD, MPH, FACP, FIDSA, FCCM, is currently a Professor of Medicine at the University of Nebraska Medical Center, Omaha, Nebraska. He is a faculty member of the division of Infectious Diseases, Department of Internal Medicine, Department of Pathology and Microbiology, and Department of Anesthesiology and Critical Care. Dr. Kalil received his training in infectious diseases at the Massachusetts General Hospital–Harvard University (Boston, Massachusetts), Critical Care Medicine at NIH (Bethesda, Maryland), and Internal Medicine at the Jackson Memorial Hospital, University of Miami (Miami, Florida). Dr. Kalil’s primary research is focused on viral and bacterial infections in critically ill and immunosuppressed patients, as well as on clinical research methodology. He is a referee for 30 scientific journals and has more than 140 peer-reviewed publications in scholarly journals such as the New England Journal of Medicine, JAMA, Annals of Internal Medicine, Lancet, and the British Medical Journal.
Peter H. Kilmarx, MD, FACP, FIDSA, is the Deputy Director of the John E. Fogarty International Center (FIC) of NIH, a preeminent center for global health research and capacity building. The FIC achieves its mission through supporting and facilitating global health research conducted by U.S. and international investigators, building partnerships between health research institutions in the United States and abroad. After graduating from Dartmouth College in 1983, Dr. Kilmarx served in the Peace Corps in Zaire (Democratic Republic of Congo [DRC]) as a fisheries volunteer. Dr. Kilmarx earned his MD degree in the Dartmouth–Brown combined program in medicine, graduating in 1990. He completed his internship and residency in internal medicine and initiated a fellowship in infectious diseases at Johns Hopkins. In 1994, Dr. Kilmarx joined the Epidemic Intelligence Service at CDC in Atlanta. He directed CDC’s northern Thailand HIV and sexually transmitted disease prevention research field station from 1996 to 2002 and CDC’s Botswana office from 2002 to 2005, implementing the President’s Emergency Plan for AIDS Relief and conducting HIV and TB prevention research. He served in the CDC Division of HIV/AIDS Prevention as the Chief of the Epidemiology Branch from 2006 to 2010 and as the Senior Advisor to the Director for Health Reform from 2010 to 2011. Dr. Kilmarx directed CDC’s Zimbabwe office from 2011 to 2015. He is a Captain in the U.S. Public Health Service and is board certified in internal medicine and infectious diseases. Dr. Kilmarx led household surveillance in the Ebola
outbreak in Kikwit, DRC, in 1995, and initiated the CDC response to the Ebola outbreak in Kasai Occidental, DRC, in 2007. He served as the CDC Ebola response team leader in Sierra Leone in September and October 2014 and principal deputy team leader in Guinea in January and February 2015. He is the recipient of numerous awards and the author or co-author of more than 100 scientific research articles and book chapters.
Myron M. (Mike) Levine, MD, DTPH, is the Bessie & Simon Grollman Distinguished Professor at the University of Maryland School of Medicine, Associate Dean for Global Health, Vaccinology and Infectious Diseases, and the Founder and Former Director of the Center for Vaccine Development (1974-2014). He has extensive experience in design and evaluation of vaccines to prevent bacterial enteric infections, particularly Salmonella and Shigella. Dr. Levine is a vocal advocate for mucosal immunization, i.e., the administration of vaccines by oral and intranasal routes. He has made substantial contributions in basic vaccinology, bacterial pathogenesis, clinical research, field epidemiology, and public health. He sits on editorial boards of several journals, consults for many organizations (e.g., WHO, NIH, NAM, U.S. Department of Defense) and serves on Scientific Advisory Boards of multiple vaccine companies. He has authored 581 scientific articles, 115 book chapters, and is Senior Editor of New Generation Vaccines. A few of his achievement awards include the Albert B. Sabin Gold Medal Award for lifetime achievement in vaccine development and implementation; the American Society for Microbiology’s 2012 Maurice Hilleman/Merck Award for contributions to pathogenesis, vaccine discovery and development, and control of vaccine preventable diseases; the Donald Mackay Medal of the American Society of Tropical Medicine and Hygiene; and the American College of Physicians Award for Outstanding Work in Science as Related to Medicine. He is a member of the NAM.
Adel A. F. Mahmoud, MD, PhD, is a professor at Princeton University. He recently retired as President of Merck Vaccines. Prior to that, he served at Case Western Reserve University and University Hospitals of Cleveland as Chairman of Medicine and Physician-in-Chief. Dr. Mahmoud’s academic pursuits focused on investigations of host resistance to infections. At Merck, Dr. Mahmoud led the effort to develop four new vaccines, including a combination of measles, mumps, rubella, and Varicella; rotavirus; shingles, and human papillomavirus. He is a member of the NAM. He received the Bailey K. Ashford Award of the American Society of Tropical Medicine and Hygiene, and the Squibb Award of the Infectious Diseases Society of America. He is a past president of the International Society for Infectious Diseases.
Lynn Marks, MD, is Senior Vice President, Projects, Clinical Platforms & Sciences, GlaxoSmithKline (GSK). He currently has operational accountability for clinical trials over a broad range of disease and therapeutic areas on a global scale ranging across the phase I to IV development landscape. Additionally, he has responsibility for business support functions such as performance metrics, clinical systems support, clinical trial contracting, outsourcing strategy and implementation and good clinical practice, as well as core training across R&D. Further, his remit includes key capabilities such as project planning and management, study and data management, clinical trial monitoring, programming, and statistics (nonclinical and clinical). Areas of analytical science and modeling are included through the Global Health Outcomes, Genetics, Computational Biology, pharmacokinetic/pharmacodynamic modeling and Epidemiology teams. He is the Corporate Secretary and chaired the initial Operations Committee for Transcelerate Biopharma, which is a not-for-profit collaborative effort across approximately 20 pharmaceutical companies. He joined the company in 1993 working in the Infectious Diseases Clinical organization with increasing levels of accountability. He then was appointed head of the Infectious Diseases Therapy area. Over the next 10 years, he had the opportunity to grow and learn from varying organizational changes with resultant shifts in accountability as head of the Infectious Diseases Development group. Dr. Marks is board certified in internal medicine and infectious diseases. Before joining GSK, he was on faculty at the University of South Alabama Medical Center with joint appointments in infectious diseases, microbiology, and pharmacology. In addition to teaching and patient care responsibilities, he led an NIH grant-funded research effort focused on the molecular genetics of bacterial pathogenicity.
Michelle Mulder, PhD, has a dual role with the Strategic Health Innovation Partnerships unit of the South African Medical Research Council (SAMRC), where she manages the Technology Transfer Office and the HIV Programme. She also oversees the Grants Management Division of the SAMRC. Her responsibilities include IP management and commercialization, coordinating and managing funding for HIV product development, and oversight of the external grant mechanisms of the organization. Dr. Mulder has a doctorate in medical microbiology from the University of Cape Town and has post-doctoral experience in a startup biotechnology company emanating from the University of Cambridge (UK). She spent 10 years consulting on technology innovation through her company Idea to Industry cc (I2I), including 5 years driving business development for two plant-based medicine companies. She has also been involved for the past 10 years in the strategic management and commercialization of the MRC’s IP and in extensive capacity building in these areas in Southern and East
Africa. Dr. Mulder has served as a member of the Executive Committee of the Southern African Research & Innovation Management Association (SARIMA) since 2005, including 3 years as Vice President: Innovation and Technology Transfer, and 2 years as President. She served previously as Chair of the Board of Acorn Technologies, a life sciences incubator, a director of the Licensing Executive’s Society South Africa, the South Africa Liaison for the Life Sciences Committee of LESI, and a member of the Higher Education South Africa Strategy Group for Innovation and Technology Transfer. She recently received the South African Department of Science and Technology/SARIMA award for Excellence in the Leadership of Innovation Management.
Ceci Mundaca-Shah, MD, DrPH, is a senior program officer with the National Academies of Sciences, Engineering, and Medicine Board on Global Health. She is currently directing the Multi-Stakeholder Initiative for Creating a Global Health Risk Framework for the Future. Prior to directing this study, she was the study director for the Academies Board on the Health of Select Populations report Beyond Myalgic Encelphalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness. She also served as a postdoctoral fellow with the Academies Board on Global Health on the Outcome and Impact Evaluation of Global HIV/AIDS Programs Implemented Under the Lantos-Hyde Act of 2008. Prior to joining the Academies, Dr. Mundaca-Shah was employed as head of the Surveillance Center of the Emerging Infections Program in the U.S. Naval Medical Research Unit 6 in Lima, Peru. In that role, she led the successful implementation of a technology-based disease surveillance system (Alerta) at sites across the nation and the initial phase of a project sponsored by the U.S. Southern Command to expand Alerta to five other countries in South America. Alerta is a partnership involving the Peruvian Navy and the U.S. Navy. Dr. Mundaca-Shah also led the collaborative syndromic surveillance pilot implementation in the Peruvian Ministry of Health. She was part of the Early Warning Outbreak Recognition System Working Group and participated in several studies, including a field visit to evaluate the performance of the system in Lao People’s Democratic Republic. She obtained her MD from San Marcos University, Lima, Peru, and her MPH and DrPH degrees from the Uniformed Services University of the Health Sciences, Bethesda, Maryland. Her dissertation work focused on developing a framework to guide the implementation of disease surveillance systems in developing countries. Dr. Mundaca-Shah completed a certificate in emerging infectious disease epidemiology at the University of Iowa.
Trevor Mundel, PhD, MSc, MBBCh, is president of the Global Health Division, The Bill & Melinda Gates Foundation. Dr. Mundel leads the foun-
dation’s efforts in research and development of vaccines, drugs, and diagnostics to address major global health challenges in the developing world. He oversees the foundation’s strategies in HIV, TB, malaria, pneumonia, diarrheal disease, enteric and diarrheal diseases, and neglected infectious diseases. Under Dr. Mundel’s leadership, the Global Health Division also works on platform technologies to accelerate development of global health solutions. All of this work occurs in collaboration with an international network of grantees and partners. Prior to joining the foundation in 2011, he was global head of development with Novartis, and previously was involved in clinical research at Pfizer and Parke-Davis. A native of South Africa, Dr. Mundel earned his bachelor’s and medical degrees from the University of the Witwatersrand in Johannesburg. Dr. Mundel also studied mathematics, logic, and philosophy as a Rhodes Scholar at the University of Oxford, and he earned a PhD in mathematics at the University of Chicago.
Kevin Outterson, JD, LLM, is a Professor and N. Neal Pike Scholar in Health and Disability Law, Boston University. Mr. Outterson teaches health law and corporate law at Boston University, where he co-directs the Health Law Program. His research work 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 leads an interdisciplinary project on the legal ecology of antimicrobial resistance. He is an Associate Fellow at the Royal Institute of International Affairs (Chatham House) and a founding member of the Antimicrobial Resistance Working Group at CDC. He was a senior consultant on the Eastern Research Group study on antibiotic markets for FDA/HHS. Starting in October 2014, he joined DRIVE-AB, a 3-year, €9 million project on antibiotic business models sponsored by the European Union’s Innovative Medicines Initiative. Mr. Outterson also serves on the Advisory Panel for the Longitude Prize for an inexpensive rapid point-of-care antibiotic diagnostic. 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 Association of American Law Schools; and a member of the Board of the American Society of Law, Medicine & Ethics. Mr. Outterson is an occasional author for the New England Journal of Medicine on health law topics.
Rudi Pauwels, PhD, co-founded Biocartis SA and Biocartis Group NV in 2007 and serves as its Chief Executive Officer. He is a scientist-entrepreneur. Following a 3-year sabbatical at the Swiss Federal Institute of TechnologyÉcole Polytechnique Fédérale de Lausanne (Lausanne, Switzerland) where he became more familiar with the advances in micro- and nanotechnologies,
he took the initiative to create Biocartis to address new needs in the field of diagnostics. He was a Venture Partner of Advent Venture Partners. He co-founded Tibotec-Virco Virology BVBA in 2001 and served as its Managing Director. He was Laboratory Head at the Rega Institute. Dr. Pauwels is a pharmacist who started as a researcher at the Rega Institute for Medical Research in Leuven, Belgium, an academic research center that is internationally known for its pioneering work in the field of antiviral chemotherapy. For more than two decades Dr. Pauwels mainly focused on the search and development of anti-HIV drugs, a number of which have been approved and introduced on the market, and the development of diagnostic tools to allow personalized HIV treatment. His research as well as his entrepreneurial career is driven by medical needs and the passion to advance and significantly impact medicine. In 1994, he co-founded Janssen Infectious Diseases-Diagnostics BVBA. As Chief Executive Officer and Chief Scientific Officer, he recruited and guided a passionate team of co-workers and collaborators who made Tibotec one of the most productive companies in the field of anti-HIV drug discovery. In 1995, he co-founded Virco. In 1999, he co-founded Galapagos Genomics, a joint venture between Tibotec and Crucell. Dr. Pauwels serves as Executive Chairman of Biocartis Group NV. He served as Chairman of Galapagos Genomics from 1999 to 2002. He serves as a Member of the Scientific Advisory Board at Interuniversity Micro-Electronics Center. He has been an Independent Director of MDxHealth SA since 2013. He served as an Independent and Non-Executive Director of Galapagos NV from January 2007 to April 27, 2010. Dr. Pauwels is a co-author of more than 150 publications in peer-reviewed journals. He received several awards for his scientific and entrepreneurial initiatives and serves on the boards of several companies and research institutes. His credentials are in the discovery of several new antivirals such as d4T and TIBO. He played a key role in the scientific development of phenotypic resistance testing. Besides his scientific background, he has a strong track record in automation and informatics. He is (co-)author of more than 150 publications in peer-reviewed journals. He has received several awards for his scientific and entrepreneurial initiatives. Dr. Pauwels completed his PhD in pharmaceutical sciences and virology (1990) at the Rega Institute for Medical Research (University of Leuven) in Belgium.
Michael Pfleiderer, PhD, is a biologist holding a PhD in molecular virology. After his university career, he worked on various aspects related to the production of recombinant medicinal products, including vaccines in the molecular biology laboratories of IMMUNO AG, Vienna, Austria (now BAXTER). Since 1998 he has worked at the Paul-Ehrlich-Institut (PEI), German Federal Institute for Vaccines and Biomedicines. In his current position he is the Head of the Human Viral Vaccines Section and respon-
sible for all issues related to vaccine licensing and regulation, as well as for batch testing and release. On a national level, Dr. Pfleiderer is a member of a number of advisory boards, in particular with regard to issues related to pandemic influenza vaccines and pandemic preparedness planning. On the European level, Dr. Pfleiderer is a member nominated by Germany for the Biologics Working Party (BWP) of the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) in London, as well as for the BWP Influenza ad hoc Working Group which he is chairing. For the CHMP Vaccine Working Party (VWP), Dr. Pfleiderer is acting as Chairman. In this position he also is a member of the CHMP Coordination Group. For EMA, Dr. Pfleiderer was chairing the Pandemic Task Force (ETF) coordinating regulatory and scientific issues related to the latest influenza pandemic. Under the new mandate, Dr. Pfleiderer is acting as the vice chair of the ETF. Dr. Pfleiderer has significantly contributed to EMA and WHO guidance on scientific and regulatory issues related to vaccines. For WHO Dr. Pfleiderer frequently acts as a temporary advisor. He is a member of various SAGE subgroups. The European Centre for Disease Prevention and Control nominated Dr. Pfleiderer as an expert for the Scientific Expert Panel on Vaccines and Immunisation. The Viral Vaccine Section that Dr. Pfleiderer heads at PEI has a leading function for many of the Marketing Authorization Applications for vaccines submitted so far to EMA, either as a rapporteur, co-rapporteur or peer reviewer. Moreover, many pieces of scientific advice submitted to EMA for vaccines have been assessed by the Viral Vaccine Section. Finally, this section acts on behalf of Germany as the Reference Member State (RMS) for the European Union for a broad range of vaccines, in particular seasonal influenza vaccines.
David Reddy, PhD, has been CEO of Medicines for Malaria Venture (MMV) since January 2011. Under his leadership, this not-for-profit research foundation has brought forward five new antimalarial drugs, and broadened its malaria-drug pipeline to include nine novel drugs in clinical development. In addition, MMV has received board and donor endorsement of a 5-year strategy focused on developing new medicines to address the unmet needs of vulnerable populations most affected by malaria. Prior to joining MMV, Dr. Reddy was a Vice President in the Global Product Strategy unit at F. Hoffman-La Roche Ltd., Basel, Switzerland, where he served as Pandemic Taskforce Leader. Prior to that he was the Global Franchise Leader for HIV/AIDS at Roche, where he oversaw the successful development and introduction of enfuvirtide, the first HIV fusion inhibitor. He was also responsible for developing Roche’s HIV drug access policies and initiatives. His resume includes more than 20 years of “Pharma” experience, including successful leadership of drug development teams, licensing and alliance management, product and disease area management, market analytics, and
business planning. His roles also included interfacing with governments, NGOs, and patient advocacy groups around access to medicines for priority diseases. Dr. Reddy holds a PhD in cellular and molecular biology from the University of Auckland, New Zealand. His PhD thesis involved cloning the serotypic antigen for rotavirus and development of a recombinant rotavirus vaccine. He completed a post-doctoral fellowship at the Freidrich Miescher Institute in Basel, where he cloned and expressed developmentally regulated brain-derived microtubule-associated proteins.
David Ripin, PhD, is the Executive Vice President of Access and Malaria, and the Chief Science Officer at the Clinton Health Access Initiative (CHAI). In these roles, he oversees CHAI’s work on increasing access to medicines and diagnostics for HIV, malaria, TB, and other disease areas through the use of sustainable market interventions. CHAI’s Access program has successfully implemented agreements with pharmaceutical companies and diagnostic manufacturers to lower the price of key drugs and diagnostics by up to 80 percent, among other achievements. He also oversees the strategy and work of CHAI’s Malaria program. Dr. Ripin joined CHAI in 2007. Prior to assuming his current role, he led CHAI’s Pharmaceutical Sciences Team, which conducts research and development work. These efforts focus on reducing the cost of key drugs through recommending formulation, manufacturing process, and sourcing improvements, as well as conducting the transfer of these processes to manufacturing partners. Dr. Ripin is actively involved in setting international priorities for HIV drug optimization work, including organizing the Conference on Antiretroviral Drug Optimization in 2009. Before joining CHAI, he worked at Pfizer Inc. for 10 years as part of the research and development group, focusing on the commercialization and manufacturing of drug candidates.
Robin Robinson, PhD, was appointed in April 2008 as the first director of the newly, created federal agency, Biomedical Advanced Research and Development Authority (BARDA), and Deputy Assistant Secretary in the Office of the Assistant Secretary for Preparedness and Response within HHS by the Pandemic and All-Hazards Preparedness Act of 2006. BARDA develops and provides medical countermeasures to man-made and natural threats, including chemical, biological, radiological, and nuclear threats, pandemic influenza, and emerging infectious diseases. BARDA meets this mission by supporting product innovation, advanced development, acquisition and stockpiling, and building manufacturing infrastructure. Dr. Robinson led the nation’s effort to develop and manufacture the largest amount of vaccine in U.S. history in response to the 2009 H1N1 pandemic. Dr. Robinson previously served from 2004 to 2008 as the Director for the Influenza & Emerging Disease Program within BARDA and its predecessor agency
at HHS. Dr. Robinson was recruited by HHS from the vaccine industry in May 2004 to establish a Manhattan-like program with scientific and technical experts to implement the strategic plans and policies for medical countermeasures outlined in the National Strategy for Pandemic Influenza (November 2005). These tactical measures included development, acquisition and establishment of national medical countermeasure stockpiles, and expansion of domestic manufacturing surge capacities for influenza vaccines, antiviral drugs, rapid diagnostics, and nonpharmaceutical countermeasures including respiratory devices. For his leadership in this role, Dr. Robinson was the recipient of the Department of Defense’s Clay Dalrymple Award in 2008 and a finalist for the Service to America Medal in 2009. Dr. Robinson received a bachelor’s degree in biology from Millsaps College in 1976, a doctoral degree from the University of Mississippi Medical School in medical microbiology under the mentoring of Dr. Dennis O’Callaghan in 1981 with a dissertation on herpesvirus oncogenesis, and completed in 1983 an NIH postdoctoral fellowship with the State University of New York at Stony Brook in molecular oncology under the mentoring of Dr. Arnold Levine on p53 tumor suppressor gene and tumor virus activation of cellular genes. While on faculty in the Department of Microbiology and Immunology at the University of Texas Southwestern Medical School from 1983 to 1990, his laboratory investigated the molecular pathogenesis of herpesviruses and HIV gene expression. Later at the NIH National Cancer Institute (1990-1992), he studied the regulation of negative repressor factors on HIV replication. Subsequently for 12 years in the pharmaceutical industry as Director of Vaccines at Novavax, Inc., he developed patented platform vaccine technologies including virus-like particles and subunit protein vaccines for human pathogens including malaria, human papilloma, hepatitis, and influenza and for prostate, melanoma, and cervical cancers. Dr. Robinson also serves on WHO international expert teams on pandemic influenza vaccines. Additionally, he continues to serve as an editorial board member and reviewer for several professional scientific and technical journals on virology, vaccines, public health, and biotechnology.
BT Slingsby, MD, PhD, MPH, is CEO and Executive Director of the Global Health Innovative Technology (GHIT) Fund. Previously, he was the global head for access strategies at Eisai Co., Ltd., where he developed new business models for R&D and overlooked market access in the developing world. Dr. Slingsby has helped launch numerous startups in Japan and the United States, and currently advises at the Graduate School of Medicine at the University of Tokyo and Kyoto University. He sits on the Forum on Public–Private Partnerships for Global Health and Safety at the National Academies of Sciences, Engineering, and Medicine in the United States, and has published more than 50 peer-reviewed articles on
medicine and public health in both Japanese and American literature. Dr. Slingsby graduated with honors from Brown University, earned master’s and doctorate degrees from Kyoto University and the University of Tokyo, and received his medical doctorate from the George Washington University.
Anthony So, MD, MPA, is Professor of the Practice of Public Policy and Global Health and Director of the Program on Global Health and Technology Access at Duke University’s Sanford School of Public Policy and the Duke Global Health Institute. He also oversees the Strategic Policy Program of ReAct—Action on Antibiotic Resistance; served on the Lancet Infectious Disease Commission on Antibiotic Resistance; served on the Institute of Medicine’s Committee on Accelerating Rare Disease Research and Orphan Product Development; chaired a WHO expert working group on fostering innovation to combat antimicrobial resistance; and was part of the Antibiotic Resistance Working Group of the U.S. President’s Council of Advisors in Science and Technology. In a 6-year, combined program at the University of Michigan, he received his BA in philosophy and biomedical sciences and his MD. He earned his MPA as a Woodrow Wilson Scholar at Princeton University and subsequently trained in internal medicine at the Hospital of the University of Pennsylvania. He completed his fellowship as a Robert Wood Johnson Clinical Scholar at the University of California, San Francisco/Stanford and studies antibiotic innovation as a current recipient of the Robert Wood Johnson Investigator Award in Health Policy Research.
Samba Sow, MD, MS, is Director General of the Center for Vaccine Development–Mali and a Professor of Medicine at the University of Maryland School of Medicine. At the Center for Vaccine Development, Dr. Sow heads the implementation of field and hospital-based epidemiologic studies and clinical trials in the study of vaccine-preventable diseases. Previously, Dr. Sow has served as the coordinator for WHO Multi-Center Field Trial on Leprosy Chemotherapy. He received his MD in medicine from the National School of Medicine and Pharmacy of Mali and his MSc in epidemiology from the London School of Hygiene & Tropical Medicine. Dr. Sow’s honors include the 2000 Paul Laviron Prize in Tropical Medicine from the University of Marseille, France. He was also named the Commemorative Fund Lecturer of the American Society of Tropical Medicine & Hygiene in 2006.
Mel Spigelman, MD, is the President and Chief Executive Officer of the Global Alliance for TB Drug Development (TB Alliance). Prior to being appointed President and CEO in 2009, Dr. Spigelman served for more than 5 years as the Director of Research and Development at the TB Alliance. Dr. Spigelman previously spent a decade as Vice President of R&D oversee-
ing all research and development at Knoll Pharmaceuticals (a division of BASF Pharma). Dr. Spigelman holds board certifications from the American Board of Internal Medicine, the American Board’s Subspecialty Board of Medical Oncology, and the American Board of Preventive Medicine, and was the recipient of the American Cancer Society Clinical Oncology Career Development Award (1985-1988). He served on the full-time faculty at the Mount Sinai Medical Center in New York City upon completing his subspecialty fellowships. Presently, Dr. Spigelman serves on the Coordinating Board of the Stop TB Partnership, is co-chair of the Working Group on New Drugs of the Stop TB Partnership, and is a member of the Governing Board of the Tres Cantos Open Lab, GSK. He also serves on the boards of The Medicines Company and Synergy Pharmaceuticals.
Paul Stoffels, MD, is Chief Scientific Officer and Worldwide Chairman, Pharmaceuticals, at Johnson & Johnson. In his role as Chief Scientific Officer, he works with R&D leaders across Johnson & Johnson to set the enterprise-wide innovation agenda and is a member of the Johnson & Johnson Executive Committee. Dr. Stoffels chairs the Johnson & Johnson R&D Management Committee and provides oversight to the Johnson & Johnson Development Corporation and the Johnson & Johnson innovation centers, with the goal of catalyzing innovative science and technology. Additionally, Dr. Stoffels has oversight for product safety of all products of the Johnson & Johnson Family of Companies worldwide. Dr. Stoffels is also Worldwide Chairman of Janssen Pharmaceutical Companies of Johnson & Johnson, with responsibility for expansion of the company’s therapeutic pipeline through global R&D and strategic partnerships, licensing, and acquisitions. He leads teams across Janssen to discover and develop treatments for unmet medical needs in the therapeutic areas of cardiovascular and metabolism, immunology, infectious disease and vaccines, neuroscience, and oncology. Prior to his role as Worldwide Chairman, he served as Global Head, Johnson & Johnson Pharmaceutical R&D from 2009 to 2011, as Company Group Chairman, Central Nervous System & Internal Medicine, from 2006 to 2009, and as Company Group Chairman, Global Virology, from 2005 to 2006. Dr. Stoffels joined Johnson & Johnson in 2002 with the acquisition of Virco and Tibotec, where he was Chief Executive Officer of Virco and Chairman of Tibotec, and he led the development of a number of leading products for the treatment of HIV. Dr. Stoffels studied medicine at the University of Diepenbeek and the University of Antwerp in Belgium, as well as infectious diseases and tropical medicine at the Institute of Tropical Medicine in Antwerp, Belgium. He began his career as a physician in Africa, focusing on HIV and tropical diseases research.
Rajeev Venkayya, MD, is the President of the Global Vaccine Business Unit of Takeda Vaccines. He is responsible for Takeda’s global vaccine business, including a long-standing business in Japan and a global development pipeline that includes vaccine candidates for norovirus and dengue, gained through the acquisitions of LigoCyte Pharmaceuticals and Inviragen Inc. Dr. Venkayya was previously the Director of Vaccine Delivery at The Bill & Melinda Gates Foundation, where he was responsible for the foundation’s top two priorities of polio eradication and new vaccine introduction. This included the foundation’s engagement and investments in the Global Polio Eradication Initiative and GAVI, and an investment portfolio of approximately $500 million per year. He also served as a member of the GAVI Board. Prior to the Gates Foundation, Dr. Venkayya was Special Assistant to the President and Senior Director for Biodefense at the White House, where he directed the development of policies to prevent, protect, and respond to bioterrorism and naturally occurring biological threats. He led the development and implementation of the National Strategy for Pandemic Influenza, as well as Presidential directives on medical countermeasures and public health preparedness. Prior to his positions at the White House, he was 1 of 13 individuals appointed by President Bush to the nonpartisan White House Fellowship program. Dr. Venkayya was previously an Assistant Professor of Medicine in the Division of Pulmonary and Critical Care Medicine at the University of California, San Francisco (UCSF). He was Co-Director of the Medical Intensive Care Unit and Director of the High-Risk Asthma Clinic at San Francisco General Hospital, and the principal investigator for a 5-year research grant from the National Institutes of Health to study the immunologic mechanisms leading to asthma. Dr. Venkayya completed his fellowship training in Pulmonary and Critical Care Medicine at UCSF. Prior to this, he was a Resident and Chief Medical Resident in Internal Medicine at the University of Michigan Medical Center. He completed his undergraduate and medical school education in the 6-year BS/MD program at the Northeastern Ohio Universities College of Medicine, where he was inducted into the Alpha Omega Alpha honorary medical society. He is a lifetime member of the Council on Foreign Relations.
Mike Ward, BSc, recently assumed the position of Coordinator, Regulatory System Strengthening, Essential Medicines and Health Technologies, Health Systems and Innovation Cluster, WHO Headquarters. Mr. Ward joined WHO in 2015 as the Coordinator, Prequalification Team in the same department. Mr. Ward previously worked within Health Canada for close to 30 years as a good manufacturing practice specialist, drug evaluator and manager, international policy analyst, and for the past 15 years as Manager of the International Programs Division of the Therapeutic Products Directorate. Mr. Ward has extensive experience in the area of international
regulatory cooperation, having served on numerous international harmonization steering committees. He was also responsible for helping launch the Asia-Pacific Economic Cooperation Regulatory Harmonization Steering Committee, the International Generic Drug Regulators Pilot, and the International Medical Device Regulators Forum. Mr. Ward started his professional career working in the areas of quality assurance and production for Burroughs Wellcome, a former multinational pharmaceutical firm based in the United Kingdom. Mr. Ward won the Regulatory Affairs Professional Society Global Leadership Award in 2012. Mr. Ward has a BSc in physiology from McGill University.
Tadataka (Tachi) Yamada, MD, is a Venture Partner with Frazier Life Sciences. Prior to joining Frazier he was Executive Vice President, Chief Medical & Scientific Officer and a Board Member of Takeda Pharmaceuticals. Dr. Yamada has served as President of The Bill & Melinda Gates Foundation Global Health Program. In this position, he oversaw grants totaling more than $9 billion in programs directed at applying technologies to address major health challenges of the developing world including TB, HIV, malaria and other infectious diseases, malnutrition, and maternal and child health. He was formerly Chairman, Research and Development, and a Member of the Board of Directors of GSK and before that he was Chair of the Department of Internal Medicine and Physician-in-Chief at the University of Michigan Medical Center. Dr. Yamada holds a bachelor’s degree in history from Stanford University and obtained his MD from New York University School of Medicine. In recognition of his contributions to medicine and science he has been elected to membership in the NAM, the Academy of Medical Sciences (UK), and the National Academy of Medicine (Mexico) and he has received an honorary appointment as Knight Commander of the Most Excellent Order of the British Empire (KBE). He is a past president of the Association of American Physicians and of the American Gastroenterological Association and he has served as a member of the President’s Council of Advisors on Science and Technology and the Advisory Committee to the Director of NIH. He is currently Vice Chair of the Council of the NAM and serves on the Board of Directors of the Clinton Health Access Initiative.
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