Science Advisory Board

Kevin B. Clark, PhD, Co-Chair

Kevin B. Clark, PhD, Co-Chair

CPO and Director of The Franklin Foundation for Innovation, Mentor at NeuroLaunch and NeuroLex; Consultant/Collaborator, Veterans Affairs Greater Los Angeles Healthcare System

Biography

Kevin B. Clark, Ph.D. is CPO and Director of The Franklin Foundation for Innovation, and Mentor at NeuroLaunch and NeuroLex, as well as Consultant/Collaborator with the Research and Development Service at the Veterans Affairs Greater Los Angeles Healthcare System. His academic lineage includes seven 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): 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 Manager/Mentor/Technical Advisor for STEAM entrepreneurial, scholastic, and community out-reach programs sponsored by the Society for Neuroscience, the Howard Hughes Medical Institute, NSF, FIRST, and The Franklin Foundation, where he is Chief Programs Officer and sits on the Board of Directors.

Dr. Clark’s award-winning research and patented inventions improving learning, memory, and recovery from traumatic brain injury through peripheral neuromodulation gained recognition from MacArthur fellow Dr. James McGaugh and other members of the National Academy of Sciences, USA. This work was instrumental in the US Food and Drug Administration’s decision to approve Vagus Nerve Stimulation (VNS) for complex-partial seizures – the only medical device currently marketed for treatment of convulsive epilepsy – and has encouraged potential derivative medical indications for VNS, including treatments for Alzheimer’s disease, traumatic brain injury, post-traumatic stress disorder, and tinnitus, among other pathologies. Complementing this area of endeavor, Dr. Clark’s more recent work concentrates on rational design and application of smart pharmaceuticals, such as drugs and nano-/microscale devices important for next-generation smart theragnostic and regenerative medical technologies.

Jeff Sherman, MD, FACP, Co-Chair

Jeff Sherman, MD, FACP, Co-Chair

Chief Medical Officer & Executive VP, Horizon Therapeutics

Biography

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

Russ B. Altman, MD, PhD

Kenneth Fong Professor of Bioengineering, Genetics, Medicine, Biomedical Data Science and (by courtesy) Computer Science, Stanford University

Biography

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

Tim Cunniff, PharmD

Executive VP, Development, Paragon Pharmaceuticals

Biography

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

Luis Caveda, PhD

Director Regulatory - Biologics, Axogenic

Biography

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

Douglas Feinstein, PhD

Research Professor, University of Illinois at Chicago

Biography

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

Andrés Klein, PhD

Universidad del Desarrollo (Chile)

Biography

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

Shuli Kulak, MD

Head of Strategy, Lonza Biotech and Pharma

Biography

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.

E. Mitchell Seymour, PhD RAC

E. Mitchell Seymour, PhD RAC

Research Faculty, University of Michigan Medical School; Founder and Principal, R&D Advisors, LLC; Founder and Principal, SciMedLit, LLC

Biography

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

Larry A. Sklar, PhD

Department of Pathology, University of New Mexico

Biography

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.