Science Advisory and Grant Review Board
Dr. Stephen Kron, MD, PhD
Chair, University of Chicago
Stephen J. Kron is a Professor of Molecular Genetics and Cell Biology and an Investigator in the Ludwig Center for Metastasis Research at the University of Chicago. Trained in bioengineering, medicine and cell and molecular biology, Dr. Kron directs an interdisciplinary research group using diverse approaches to dissect signaling pathways for cell proliferation and DNA damage response.
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.
Russell B. Altman, MD, PhD
Russ Biagio Altman is a professor of bioengineering, genetics, & medicine (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 basic biological 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. Other work focuses on the analysis of biological molecules to understand the action, interaction and adverse events of drugs. He leads one of seven NIH-supported National Centers for Biomedical Computation, focusing on physics-based simulation of biological structures. Dr. Altman holds an A.B. from Harvard College, and M.D. from Stanford Medical School, and a Ph.D. 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, the American College of Medical Informatics, and the American Institute of Medical and Biological Engineering. He is a member of the Institute of Medicine of the National Academies. He is a past-president, founding board member, and a Fellow of the International Society for Computational Biology, and the President-Elect of the American Society for Clinical Pharmacology & Therapeutics. He currently chairs the Science Board advising the FDA Commissioner. He is an organizer of the annual Pacific Symposium on Biocomputing, and a founder of Personalis, Inc. He won the Stanford Medical School graduate teaching award in 2000.
Kevin B. Clark, PhD
Faculty, University of California Los Angeles; Principal Investigator/Consultant, Veterans Affairs Greater Los Angeles Healthcare System
Kevin B. Clark, Ph.D. is Affiliate Faculty at the California NanoSystems Institute at the University of California Los Angeles and Principal Investigator/Consultant with the Research and Development Service at the Veterans Affairs Greater Los Angeles Healthcare System. His academic lineage includes six Nobel laureates and additional distinguished scientists. Among other professional activities, Dr. Clark serves or has served as Member of many professional societies: Editor for professional journals and technical books: Member of proprietary and independent nonprofit science advisory boards for new and rediscovery medical science and clinical practice: Senior Scientist and Vice President of Finance and Partnership Development at the Complex Biological Systems Alliance (a nonprofit consortium of scientists and technologists from Ivy League, Oxbridge, and other highly ranked institutions): Consultant/Collaborator with the Extreme Science and Engineering Discovery Environment at the University of Illinois’ National Center for Supercomputing Applications and the Biological Collaborative Research Environment at the University of Illinois’ NIH Center of Macromolecular Modeling and Bioinformatics: and Technical Advisor for STEM scholastic and community out-reach programs sponsored by the Society for Neuroscience, the Howard Hughes Medical Institute, FIRST, and The Franklin Foundation, where he sits on the Board of Directors.
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
CEO, Caveda Consulting
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 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 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).
Telethon Institute of Genetics and Medicine
Dr. Andrés Klein’s research interests include uncovering the genetic and cellular basis of phenotypic variability as a way for identifying novel therapeutic targets for genetic diseases. His work has led to the discovery of potential treatments for two of them, using FDA-approved drugs. Recently he has been modeling diseases in many mouse strains for precision medicine studies.
Andrés Klein received his B.Sc in Biochemistry and his PhD in Cellular and Molecular Biology at the Pontificia Universidad Católica de Chile where he studied the cell death mechanisms involved in Niemann-Pick type C (NPC) brain degeneration. Dr. Klein did a postdoc at Stanford University (2009-2011) where he developed novel mouse models for studying the relevance of different cell types for NPC disease pathology and a second postdoc (2011-2015) at the Weizmann Institute of Science uncovering modifier genes of Gaucher disease progression. Currently he is working at the Telethon Institute of Genetics and Medicine where he is applying cutting edge technologies, such as exome sequencing plus multi-omics, for the identification of modifier genes of disease progression and biomarkers.
Shuli Kulak, MD
Director of New Business Development, Fortress Biotech
Shuli Kulak, MD obtained a medical degree, with a distinction in research, from Albert Einstein College of Medicine, and went on to complete a residency in pediatrics at The Children's Hospital at Montefiore. She recently obtained an MBA and is working as a Director of New Business Development at Fortress Biotech, focusing on bringing new treatments to children with rare pediatric diseases.
Chief Medical Officer & Executive VP, Horizon
Jeffrey (Jeff) W. Sherman, MD, FACP, is Chief Medical Officer and Executive Vice President at Horizon Pharma based in Deerfield, Illinois. Jeff has more than 25 years of experience in the pharmaceutical industry. Before joining Horizon Pharma, 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.
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.