Raymond P. Warrell, M.D.

Founder, Chief Executive Officer, and Member of the Board

Inventor of the Acquist drug prototype, Ray has more than 25 years of achievement in scientific research, clinical development, finance, operations, regulatory and legal affairs, and senior executive business management in the pharmaceutical, diagnostic, and biotechnology sectors.

Ray was the lead inventor of two earlier drugs, drafted their INDs, secured their designations as “Orphan Drugs”, and designed and led the Phase 1-3 clinical trials that were pivotal for FDA approval. These drugs were acquired by Fujisawa (Astellas) and Cell Therapeutics Inc. For this work, he received FDA’s Public Health Service Award for “Exceptional Achievement in Orphan Drug Development”.

Ray was Chief Executive Officer and Chairman of Genta Incorporated (Nasdaq: GNTA), a biotechnology company focused on mRNA regulation of cancer cell apoptosis. Previously, he was an Associate Physician-in-Chief and Member at Memorial Sloan-Kettering Cancer Center in New York, and Professor of Medicine at the Weill Cornell University Medical College. He received a B.S (Chemistry) from Emory University, a M.D. from the Medical College of Georgia, and a M.B.A. from Columbia University.

Selected publications

John J. Piwinski, PhD

Drug Discovery and Nonclinical Research

As a senior medicinal chemist, John has over 30 years of experience in running drug discovery programs from project initiation to delivery of clinical candidates.

At Schering-Plough and Merck, John was most recently Site Head and Group Vice-President of Merck’s Cambridge, MA site, which focused on medicinal chemistry (lead identification and optimization), affinity-based screening, bio-nuclear magnetic resonance (screening and structure-based drug design), protein science, and biologics. Previously, as Group Vice President, he oversaw Chemical Research at Schering’s Kenilworth, NJ facility with broad experience in immunology, cardiovascular, CNS, oncology and infectious disease. Prior to joining Schering Plough, he was a Senior Scientist at Revlon Health Care in cardiovascular diseases. He is a Principal of JJPiwinski Pharma Consulting, LLC, Lebanon, NJ – a firm that specializes in medicinal chemistry and drug discovery.

John received a B.S. (Chemistry/Biochemistry) from SUNY-Stony Brook and a Ph.D. in Organic Chemistry from Yale University. He currently serves on an NIH Drug Development Program Review Panel and is a member of the Advisory Board for the Institute of Chemical Biology & Drug Discovery at Stony Brook.

Selected publications

John Thottathil, PhD

Chemical Process Research, Outsourcing, and Scale-Up

Dr. Thottathil is a senior scientist with a long career in the pharmaceutical industry and extensive experience in drug development. Most recently, he was Chief Scientific Officer (CSO) of New River Pharmaceuticals (now part of Shire Pharmaceuticals), where he was responsible for nonclinical development of small molecule drugs. Previously, he worked at Abbot Laboratories, serving as Director of Core R&D Chemistry and Director of Outsourcing. Earlier, he was with Bristol Myers Squibb as Director of Chemical Process Research and Development and later, Director of Outsourcing. John is a mentor in the Chicago Innovation Mentor Program, which is dedicated to increasing success rates of early-stage life science companies. He also participates in the drug discovery course within the Pharmacology Department, Loyola University of Chicago.

John received a Ph.D. (organic chemistry) from the Indian Institute of Science, Bangalore, and a M.S. and B.S. from Calicut University, Kerala. He has published more than 40 scientific papers and is an inventor/co-inventor on more than 80 patents or patent applications, including several with Acquist scientists.

Edward Spindler, MBA

Operation and Clinical Development

Edward Spindler was most recently Vice President and Head of Research and Development Operations at The Medicines Company, Inc. (MDCO). In this role, he led all phases of development for both approved and investigational products, including anticoagulants, antihypertensives, anti-infectives, anaesthetic injectables, opioid pain management devices, and a cholesterol management NCE. This work led to recent regulatory approvals for Kengreal® (cangrelor, a P2Y12 inhibitor), IONSYS® (fentanyl iontophoretic transdermal), and Vabomere® (meropenem/vaborbactam).

Previously, he was Vice President and Head of Pharmaceutical Development at Genta, Inc. (GNTA), which focused on clinical development of novel anticancer agents. In this role, he led the clinical, non-clinical, and pharmacology groups for Phase 2-3 clinical trials for an antisense oligonucleotide and an oral taxane. Ed was a founding partner in Rosemont Research, Inc., a CRO providing pharmacology and regulatory consulting services small to mid-sized pharmaceutical companies. Over his career, he has led programs in toxicology, pharmacology, formulation, clinical development, biostatistics, and IT. He has served on product development committees that review, approve, and monitor all clinical and non-clinical programs.

Ed received an MBA from the University of Pennsylvania–Wharton Business School and a B.S. in computer science, Rutgers University. He holds multiple pharmaceutical patents and has authored numerous articles related to scientific, medical and pediatric drug development.

John Carbine, MBA

Financial Strategy and Analysis

John has 20 years of pharmaceutical industry experience. Most recently, he was Director of Financial Strategy at The Medicines Company, Inc. (MDCO), where he provided financial analyses and recommendations for investment or divestment of core assets. He co-led the company’s strategic planning process based on modelling, scenario projections, and long-term financial analyses. These data were adapted for investor and other external communications.

Previously, John was Executive Director, Corporate Operations at Genta, Inc. (GNTA), where he was responsible for financial strategy and analysis related to commercial operations and manufacturing. At Genta, he led an integrated team of scientists, consultants and contract API manufacturers, which successfully developed new synthetic routes for the company’s lead Phase 3 drug, tesetaxel.

Prior to Genta, John held various positions in finance reporting to the Chief Financial Officer at Ortho Biotech (Johnson & Johnson). John received an MBA from Columbia University – Business School and a B.S. in accounting from Rutgers.

Brad Zerler, PhD

Dr. Zerler has extensive experience in discovery research and development of new chemical entities and biologicals that encompass a broad range of therapeutic areas. As Vice President, Nonclinical Development at The Medicines Company, Brad is responsible for nonclinical compound development across the entire portfolio, including the approved drugs Kengreal® (cangrelor) and Orbactiv® (oritavancin), and the novel siRNA PCSK9 inhibitor (inclisiran). Previously, Brad was Vice President of Research at CollaGenex Pharmaceuticals and Global Head of Pharmacology and Toxicology at Barrier Therapeutics, each of which was acquired following regulatory approvals of three therapeutic agents. Brad started his career at Bayer Pharmaceuticals where he was Head of the Bone and Joint Research Group, which focused on osteoarthritis. He is currently an advisor to the i3 Asset Accelerator program at Mt. Sinai Innovation Partners.

Brad received his PhD in Microbiology from New York Medical College and did his Postdoctoral Research at Cold Spring Harbor Laboratories in the lab of Nobel Laureate, Richard Roberts.