Science Advisory Board
Kevin B. Clark, PhD, Co-Chair
NSF XSEDE Domain Champion in Biomedicine, NASA ARC Affiliate, IEEE Nanotechnology and Biometrics Councils Member
Kevin B. Clark earned his Ph.D. from the Brain and Cognitive Sciences Program at Southern Illinois University in 1999. His academic lineage includes seven Nobel laureates. Dr. Clark uses his broad professional expertise to advance smart quantum biomolecular logic and memory systems in cell biology and for theragnostic medicine and other purposes. He helped pioneer neurocybernetic prosthetic-driven targeted neuroplasticity training for human cognitive-emotional restructuring and disease/injury treatment, natural and technology-based classical/quantum (anti)Hebbian learning in neurocognition and problem solving, and exotic information processing in spatial cognition and communication. Dr. Clark serves or has served as Founding Member of Max Planck Alumni Entrepreneurs, Founding Organizer of MPAA shared interest group for Natural and Artificial Intelligence; Consultant/Collaborator/PI at VAGLAHS; Member of BioCoRE at NIH Center of Macromolecular Modeling and Bioinformatics; Senior Scientist/VP of Finance and Partnership Development at CBSA (an Ivy League/Oxbridge consortium); Subject Matter Expert, Entrepreneur, and Mentor at UPenn’s Penn Center for Innovation; Computational Neurolinguist/Ethnobiologist for Alliance for Linguistic Diversity and Google’s The Endangered Languages Project; Affiliate at NAI Virus Focus Group, NASA NfoLD, and SETI Institute; Guest Expert of NASEM Projects/Workshops on astrobiology strategies, public health emergencies and biodefense, emerging health technologies, student success and health, and digital clinical trials; Entrepreneurship Incubation Finalist at Stanford University’s Brainstorm Innovation Lab; Molecular Foundry User Community Member at Berkeley Lab; Founding Member of Peace Innovation Institute at Stanford University and The Hague; Member of IEEE Brain, Life Sciences, and Quantum Initiatives; Mentor at NeuroLaunch, CyberLaunch, NeuroLex Laboratories, OTRADI/OBI, OSU Advantage Accelerator, OHSU-MIT Hacking Medicine Invent-a-thon, and MIT COVID19 Challenge; Postdoctoral Fellow at MPI for Biological Cybernetics; Editor for professional journals and technical books; and Manager/Technical Advisor/Mentor for STEAM scholastic, entrepreneurial, and/or community outreach programs sponsored by SfN, HHMI, NSF, NASA, Conrad Challenge, Portland Public Schools, UN, and The Franklin Foundation for Innovation, where he was CPO and acting Chairperson, Board of Directors. He also has (co)authored over 70 peer-review scientific journal articles and book chapters, generated millions of US dollars in research funding, licensed patents, and received over 50 news releases from notable multimedia sources for his collaborative science, business, and charitable activities.
Jeff Sherman, MD, FACP, Co-Chair
Chief Medical Officer & Executive VP, Horizon Therapeutics
Jeffrey (Jeff) W. Sherman, MD, FACP, is Chief Medical Officer and Executive Vice President at Horizon Therapeutics based in Deerfield, Illinois. Jeff has more than 25 years of experience in the pharmaceutical industry. Before joining Horizon Therapeutics, Jeff was Chief Medical Officer and Senior Vice President of Research and Development at IDM Pharma. He also served previously as Vice President of Clinical Science at Takeda Global Research and Development, and Chief Medical Officer and Executive Vice President at NeoPharm. In addition, Jeff held various positions at Searle/Pharmacia, including Director, Senior Director, and Executive Director of Clinical Research, for a variety of therapeutic areas, including infectious diseases, women’s health, sleep, central nervous system, and oncology. He also served as Head of Oncology Global Medical Operations. Prior to Searle/Pharmacia, Jeff worked at Bristol-Myers Squibb in Clinical Pharmacology and Clinical Research.
Jeff received his medical degree from the Rosalind Franklin University/Chicago Medical School. He completed an internship and residency in internal medicine at Northwestern University, where he also served as chief medical resident. Additionally, he completed fellowship training at the University of California-San Francisco (UCSF) and was a research associate at the Howard Hughes Medical Institute at UCSF. Jeff is an Adjunct Assistant Professor of Medicine at the Northwestern University Feinberg School of Medicine and a member of a number of professional societies as well as a Diplomat of the National Board of Medical Examiners and the American Board of Internal Medicine.
Jeff is a Past President of the Drug Information Association (DIA) and a former member of the Board of Directors. He also was chairperson of the DIA Annual Meeting, received an Outstanding Service Award, is an inaugural fellow, and serves as the DIA liaison to the FDA Clinical Trial Transformation Initiative (CTTI) Steering Committee. Jeff in addition serves on the Board of Advisors of the Center for Information and Study on Clinical Research Participation (CISCRP).
Russ B. Altman, MD, PhD
Kenneth Fong Professor of Bioengineering, Genetics, Medicine, Biomedical Data Science and (by courtesy) Computer Science, Stanford University
Russ Biagio Altman is a professor of bioengineering, genetics, medicine, and biomedical data science (and of computer science, by courtesy) and past chairman of the Bioengineering Department at Stanford University. His primary research interests are in the application of computing and informatics technologies to problems relevant to medicine. He is particularly interested in methods for understanding drug action at molecular, cellular, organism and population levels. His lab studies how human genetic variation impacts drug response (e.g., http://www.pharmgkb.org/). Other work focuses on the analysis of biological molecules to understand the actions, interactions and adverse events of drugs (e.g., http://feature.stanford.edu/). He helps lead an FDA-supported Center of Excellence in Regulatory Science & Innovation.
Dr. Altman holds an AB from Harvard College, and an MD from Stanford Medical School, and a PhD in Medical Information Sciences from Stanford. He received the U.S. Presidential Early Career Award for Scientists and Engineers and a National Science Foundation CAREER Award. He is a fellow of the American College of Physicians (ACP), the American College of Medical Informatics (ACMI), the American Institute of Medical and Biological Engineering (AIMBE), and the American Association for the Advancement of Science (AAAS). He is a member of the National Academy of Medicine (formerly the Institute of Medicine, IOM). He is a past-president, founding board member, and a fellow of the International Society for Computational Biology (ISCB), and a past-president of the American Society for Clinical Pharmacology & Therapeutics (ASCPT). He has chaired the Science Board advising the FDA commissioner, currently serves on the NIH Director’s Advisory Committee, and is cochair of the IOM Drug Forum. He is an organizer of the annual Pacific Symposium on Biocomputing, and a founder of Personalis, Inc. Dr. Altman is board certified in Internal Medicine and in Clinical Informatics. He received the Stanford Medical School graduate teaching award in 2000 and mentorship award in 2014.
Tim Cunniff, PharmD
Executive VP, Development, Paragon Pharmaceuticals
Dr. Cunniff is responsible for all scientific and regulatory matters associated with new product development, approval and maintenance on a global basis.
He joined Paragon from the multinational biopharmaceutical company Lundbeck, Inc. (formerly Ovation Pharmaceuticals) where he served as interim President and Vice President for Global Regulatory Affairs, Pharmacovigilance and Clinical Quality Assurance. Under his leadership, Lundbeck/Ovation developed and obtained approval for several products to treat CNS disorders and rare diseases. The company also became an industry leader in the creation and implementation of Risk Evaluation and Mitigation Strategies (REMS). Dr. Cunniff also served as the company’s initial Corporate Compliance Officer and led the company’s expansion from North American to global markets.
Dr. Cunniff also worked for Abbott Laboratories, Pfizer/Agouron and Warner-Lambert /Parke Davis where he began his career in 1989. He participated on several successful development and registration programs for anti-infectives, anti-virals, and cardiovascular agents.
He serves as Clinical Instructor of Pharmacy for the University of Michigan College of Pharmacy, where he received his Doctor of Pharmacy degree in 1989.
Luis Caveda, PhD
Director Regulatory - Biologics, Axogenic
Luis Caveda has a Pharmacy Degree from the Medical University of Szeged in Hungary and a Doctorate (PhD.) Degree in Biology from the University of Havana.
In 2019, Luis joined the Axogenic team after serving as Senior Director of Regulatory Affairs of Rockwell Medical Inc. Previously he was the Regulatory Head of Pharma Bio-Serv a Consulting Company with a global presence.
In 2011 he founded the company Caveda Consulting, specializing in consulting programs in human and animal health in Latin America and Europe. He is considered a world expert in development of new drugs to treat vascular diseases and cancer. Previously he served as Executive Vice President of Thrombotargets Group in Spain and North Carolina, USA and Vice President of Pharmaceutical Development and Regulatory Affairs in ViviaBiotech SL in Madrid, specializing in the preclinical and clinical development of new molecules (chemical and biological) and in regulatory affairs in connection with medicine agencies (FDA and EMA).
Luis has brought several compounds into market and into clinical phase in Europe and obtained several orphan drugs designations. He has authored over 30 scientific articles and book chapters and 4 patents.
Douglas Feinstein, PhD
Research Professor, University of Illinois at Chicago
Doug is a Research Professor in the Department of Anesthesiology at University of Illinois at Chicago (UIC). Doug earned his Bachelor’s degree from MIT, his PhD from Johns Hopkins University, and then carried out post-doctoral training at the Scripps Clinic in San Diego.
He gained further experience in laboratories in Sweden, Switzerland, and France before moving back to the US to become an Assistant Professor in the Department of Neurology at Cornell University Medical College in New York. In 1999, he moved to UIC in Chicago where he is now Full Professor. His work has centered around novel approaches to reduce damage and inflammation in neurodegenerative diseases, working primarily in animal models of Alzheimer’s disease (AD) and Multiple Sclerosis (MS).
His work has been funded by the NIH, the VA, the National Multiple Sclerosis Society, the Alzheimer’s Assocation, as well as by several pharmaceutical companies including GlaxoSmithKline, Takeda, Boehringer Ingelheim, and Sanofi Aventis. He became involved with Cures Within Reach almost 10 years ago (as Partnership for Cures), at which time he received two grants to carry out repurposing studies of a drug to treat AD, and one to treat MS. The latter provided data that enabled him to obtain a large research grant from the NMSS. He also initiated repurposing of Actos, a drug used to treat type 2 diabetes, for protection in MS, which led to a clinical trial.
Andrés Klein, PhD
Universidad del Desarrollo (Chile)
Prof. Andrés Klein’s research interests include uncovering the genetic and cellular basis of phenotypic variability as a way for identifying novel therapeutic targets for diseases with lysosomal dysfunction including Parkinson’s disease. To this end he uses population based approached in yeast, flies, mice and humans. His work has led to the discovery of potential treatments for two genetic diseases (Niemann-Pick C and neuropathic Gaucher disease), using FDA-approved drugs.
Andrés Klein received his B.Sc in Biochemistry and his PhD in Cellular and Molecular Biology at the Pontificia Universidad Católica de Chile. Dr. Klein did a postdoc at Stanford University (2009-2011) and a second postdoc (2011-2015) at the Weizmann Institute of Science in Israel. Currently he is the Director (Head) of the Center for Genetics and Genomics at the Universidad del Desarrollo (UDD) in Chile, where he is applying system biology approaches for the identification of modifier genes of disease progression and biomarkers (precision medicine).
Dr. Klein has been endorsed by several institutions including Pew Charitable Trust (2009-2011), the UK Gaucher Association (2011-2013), and others. Prof. Klein was awarded with the young Chilean innovator prize by MIT technology reviews (2013) and he was selected as one of the top 100 young Chilean leaders of 2013. He has received grants from several organizations including the Rosetrees of Trust (UK), Cure & Action for Tay-Sachs disease (UK), Horizon 2020 (EU), FONDECYT (from the Chilean Government), and recently from the Pew Innovation Fund.
Shuli Kulak, MD
Head of Strategy, Lonza Biotech and Pharma
Shuli Kulak, MD, MBA obtained a medical degree, with a distinction in research, after which she went on to complete a residency in pediatrics and obtain an MBA. Her passion rests in drug development for rare diseases. Past professional experience includes starting portfolio companies in the venture space and leading the gene therapy business development efforts at BioMarin Pharmaceuticals. She now serves as Lonza’s Head of Strategy.
Murray M. Lumpkin, M.D., M.Sc.
Deputy Director – Regulatory Affairs and Lead for Global Regulatory Systems Initiatives, Bill and Melinda Gates Foundation
Dr. Lumpkin became Deputy Director – Regulatory Affairs and Lead for Global Regulatory Systems Initiatives at the Bill and Melinda Gates Foundation in January 2014. In this capacity, he leads the Foundation’s strategic initiatives around global regulatory systems. These initiatives currently include the Foundation’s regulatory systems optimization work with partners such as: (1) the World Health Organization and other multinational organizations, (2) regional and other regulatory harmonization/alignment initiatives, and (3) national and regional medical products regulatory authorities. These initiatives are focused on working with these and other partners to make more efficient and effective (without sacrificing product quality or safety) the regulatory processes through which products must pass in order to be developed, legally marketed, and overseen appropriately after marketing authorization in low- and middle-income countries.
He retired from the US Food and Drug Administration in January 2014 after just over 24 years as a part of that organization. He was most recently (2011 to 2014) the Commissioner’s Senior Advisor and Representative for Global Issues. Prior to 2011, Dr. Lumpkin was responsible for the policy development and operational aspects of the FDA’s international activities, served as the Deputy Center Director (Review Management) of FDA’s Center for Drug Evaluation and Research (CDER) and was the Director – Division of CDER’s Anti-infective Drug Products.
He is an M.D. with post-graduate training in pediatrics and pediatric infectious diseases at the Mayo Clinic in Rochester, Minnesota. As a Fulbright Scholar, he completed an M.Sc. in medical parasitology at the London School of Hygiene and Tropical Medicine. He is certified in both pediatrics (U.S.) and tropical medicine and hygiene (U.K.) Prior to his work with the US FDA, he was head of pediatric infectious diseases at East Tennessee Children’s Hospital in Knoxville, and he worked at a refugee camp in Bangladesh.
His undergraduate work was at Davidson College, from which is graduated with a BA in German. The third year of his undergraduate work was spent at the Philips University in Marburg, Germany.
Wilfred Ngwa, PhD, MSc
Associate Professor, Johns Hopkins University
Dr. Wil Ngwa is an associate professor of Radiation Oncology at Johns Hopkins University, and Distinguished Professor of Public Health at ICT University. He is founding Director of the Global Health Catalyst, dedicated to catalyzing high impact collaborations to reduce global cancer health disparities. Dr. Ngwa also recently held guest professorships at the University of Pennsylvania USA, and University of Heidelberg Germany. He has won numerous awards with 17 prestigious awards/honors over the past 5 years alone, including 2 awards on global radiation oncology, 2 awards for Research Excellence from the United States National Institutes of Health, the 2019 BWH Physician Organization Award, and the 2015 BWH BrIght Futures Prize at Harvard Medical School. Dr. Ngwa is also founding director of the award-winning Global Oncology University education platform focused on training oncology health professionals at Low and Middle Income Countries. Dr. Ngwa is currently a chair of the Lancet Oncology Commission for Sub-Saharan Africa. He also serves on the editorial boards of the Journal of Global Oncology, Frontiers in Oncology, and is the Series Editor for the IOP Science Publishing series on Global Health and Radiation Oncology. He has published over 200 peer-reviewed journal and conference papers including in journals like Nature and the Proceedings of the National Academy of Sciences.
E. Mitchell Seymour, PhD RAC
Research Faculty, University of Michigan Medical School; Founder and Principal, R&D Advisors, LLC; Founder and Principal, SciMedLit, LLC
Dr. Seymour is research faculty at the University of Michigan Medical School and also serves in Michigan Institute for Clinical and Health Research. In this unit, he assists faculty with their Investigational New Drug (IND) and Investigational New Device (IDE) submissions to FDA. He also serves on their Institutional Review Board. As a freelance consultant, he provides regulatory affairs services for industry and academia. Regulatory experience includes US FDA regulatory writing and submissions, FDA meeting preparation and engagement, regulatory strategy, regulatory intelligence, and regulatory due diligence. As a life scientist, he has over 20 years of experience in basic science and clinical research in industrial and academic settings. He earned his BS in Biology from the University of Notre Dame and his PhD in Biochemical and Molecular Nutrition from Michigan State University. Dr. Seymour is active in the Drug Information Association, the Regulatory Affairs Professional Society, and the American Medical Writers Association. He has also earned the US Regulatory Affairs Certified (RAC) credential from the Regulatory Affairs Professional Society.
Larry A. Sklar, PhD
Department of Pathology, University of New Mexico
Larry (Ph.D., Physical Chemistry, Stanford U.) is PI and Director of both the University of New Mexico Center for Molecular Discovery (CMD) and the Chemical Biology Consortium Center for the NCI Experimental Therapeutics Program, as well as Co-PI of the NIH Illuminating the Druggable Genome Initiative. He is Regents Professor of Pathology, Distinguished University Professor, Maralyn S. Budke and Robert E. Anderson Endowed Chair in Cancer Drug Discovery in the NCI Designated University of New Mexico Cancer Center, and leader of a national drug repurposing network for the Clinical and Translational Science Center (CTSC) Consortium.
He has >400 publications and patents in leukocyte biology, molecular assembly in signal transduction and cell adhesion, as well as high throughput flow cytometry for drug discovery and repurposing leading to clinical trials. He is co-inventor of the HyperCyt high throughput flow cytometry platform and co-founder of the Albuquerque startup Intellicyt which licensed the technology and was recently acquired by Sartorius. He has made intellectual property contributions to several biotech and startup companies.
Sklar has experience in leukocyte biology (36 years), small molecule discovery and drug repurposing (12 years primarily in the NIH Molecular Libraries Program), high throughput flow cytometry (18 years as inventor including 36 patents and company founder), and management of technology (34 years in shared resources, as well as program management, translational technology, and related leadership positions in support of the UNM CTSC, UNM Environmental Health Center, UNM Comprehensive Cancer Center and the program in Cancer Therapeutics. CMD has completed large screens on more than 60 targets and uploaded more than 13 million data points to PubChem. The unique suspension cell and molecular target technology has enabled multiplex and multi-parameter target analysis that includes integrins, efflux transporters, GPCR, and protein assemblies, and leukemia/cancer stem cell microenvironment. Sklar has mentored more than 50 trainees at all levels including faculty and students.
Vidula Sukhatme, MS
Co-Founder and CEO of GlobalCures; Co-Founder of the Morningside Center for Innovative and Affordable Medicine, Emory University
Vidula Sukhatme is the co-founder and CEO of GlobalCures, Inc. GlobalCures is a non-profit medical research organization dedicated to curing patients with cancer and other diseases by rapidly promoting clinical research on scientifically promising, readily available and cost-effective treatments. She is also the co-founder of the Morningside Center for Innovative and Affordable Medicine at Emory University. She has 20 years of experience in information systems in health care environments. She holds two master of science degrees: one in mathematics from Northeastern University and a second in epidemiology from Harvard T.H. Chan School of Public Health.