Science Advisory Board

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).

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.

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.

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 also previously served as Lonza’s Head of Strategy.

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.

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 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.