Mr Cerrone has a successful track record and extensive experience in the financing and restructuring of micro-cap biotechnology companies. He has founded nine biotechnology companies in oncology, infectious diseases and molecular diagnostics, and has taken six of these companies to the NASDAQ Market and one to the AIM Market in London. Mr Cerrone co-founded Trovagene, Inc. (NASDAQ: TROV), a molecular diagnostic company and served as its Co-Chairman; he was a co-founder and served as Chairman of both Synergy Pharmaceuticals, Inc. (NASDAQ: SGYP) and Callisto Pharmaceuticals, Inc. (OTCMKTS: CLSP), and was a Director of and led the restructuring of Siga Technologies, Inc. (NASDAQ: SIGA). Mr Cerrone also co-founded FermaVir Pharmaceuticals, Inc. and served as Chairman of the Board until its merger in September 2007 with Inhibitex, Inc. Mr Cerrone served as a director of Inhibitex, Inc. until its US$2.5bn sale to Bristol Myers Squibb Co in 2012.
Mr Cerrone is the Executive Chairman and Co-Founder of Gensignia Life Sciences, Inc., a molecular diagnostics company focused on oncology using microRNA technology; Chairman and Founder of Tiziana Life Sciences plc (AIM: TILS) an oncology focused therapeutics company; Chairman and Co-Founder of Rasna Therapeutics Limited, a company focused on the development of therapeutics for leukaemias; Co-Founder of ContraVir Pharmaceuticals, Inc. (Nasdaq: CTRV); and founder of BioVitas Capital Ltd.
Willy Jules Simon is a banker and worked at Kredietbank N.V. and Citibank London before serving as an executive member of the Board of Generale Bank NL from 1997 to 1999 and as the chief executive of Fortis Investment Management from 1999 to 2002. He acted as chairman of Bank Oyens & van Eeghen from 2002 to 2004. Willy Simon has been the chairman of Bever Holdings, a company listed in Amsterdam, since 2006 and Chairman of Ducat Maritime since 2015. He also serves as the Executive Chairman of OKYO Pharma Ltd.
Mr. Brancaccio, retired CPA, is a financial executive with extensive international and domestic experience in pharmaceutical and biotechnology for privately and publicly held companies. From 2000 to 2002, Mr. Brancaccio was the Chief Financial Officer/Chief Operating Officer of Eline Group, an entertainment and media company. From May 2002 until March 2004, Mr. Brancaccio was the Chief Financial Officer of Memory Pharmaceuticals Corp., a biotechnology company. From April 2004 until May 2017, Mr. Brancaccio was the Chief Financial Officer of Accelerated Technologies, Inc., an incubator for medical device companies.
Mr. Brancaccio is currently a director of Cardiff Oncology, Inc., Hepion Pharmaceuticals, Inc., OKYO Pharma Ltd., and Rasna Therapeutics, Inc.
Matthew W Davis, MD, RPh
Chief Operating Officer and Chief Medical Officer
Dr. Davis has extensive experience in new drug application, or NDA, and biologic license application, or BLA, FDA approvals and device clearances. Notable approved brands that Dr. Davis has worked on include Lidoderm®, Sculptra®, Colcrys® and most recently QWO®.
Dr. Davis previously served as Chief Scientific Officer and Chief Medical Officer at Endo Pharmaceuticals where he restructured the R&D department and collaborated to obtain BLA approval for QWO®. Additionally, Dr. Davis was Chief Medical Officer for Lupin Inc. and URL Pharma, Inc. where he spearheaded three NDA approvals and was the inventor on all 17 Orange Book listed patents for Colcrys®. He also was on the executive team that sold URL Pharma to Takeda Pharmaceutical Company for approximately $800M combined with over $1B in performance-based contingent earn out payments.
Dr. Davis matriculated to the University of Pennsylvania as an undergraduate. He received his Pharmacy Degree from Temple University and his Medical Degree from the Medical College of Pennsylvania. Dr. Davis undertook his surgical training at Brown University and his Urology training at Washington Hospital Center
Chief Financial Officer
Keeren Shah serves as our Chief Financial Officer. Ms. Shah currently also serves as the Chief Financial Officer of OKYO Pharma Ltd, Accustem Sciences Limited and Rasna Therapeutics Inc., having previously served as the Group Financial Controller for all businesses from June 2016 to July 2020. Prior to joining the Company, Ms. Shah spent 10 years at Visa, Inc. as a Senior Leader in its finance team where she was responsible for key financial controller activities, financial planning and analysis, and core processes as well as leading and participating in key transformation programmes and Visa Inc.’s initial public offering. Before joining Visa, Ms. Shah also held a variety of finance positions at other leading companies including Arthur Andersen and BBC Worldwide. She holds a Bachelor of arts with honours in Economics and is a member of the Chartered Institute of Management Accountants.
William Clementi, PhD
Chief Development Officer
Dr. Clementi has followed a science-driven career path since completing his NIH Training Fellowship (under John L. McNay M.D. and Thomas M. Ludden Ph.D.) Upon completing his Fellowship research in drug metabolism and vascular smooth muscle relaxation, Dr. Clementi joined the University of Texas Graduate School of Biomedical Sciences (UTGBS) faculty and the College of Pharmacy faculty in Austin, Tx, in the Departments of Medicine and Pharmacology at the Health Sciences Center in San Antonio. His primary responsibilities were interdisciplinary, and he led innovative programs in the Colleges with teaching, research, and clinical commitments. Dr. Clementi directed the Clinical Pharmacokinetic Consultation Service, providing novel computer-based drug dosing to the acute care settings at two major teaching hospitals.
Dr. Clementi continued his career in the pharmaceutical industry, joining Synthelabo and the U.S. affiliate Lorex Pharmaceuticals, where he held the Worldwide Director of Market Development position. Lorex and Synthelabo launched three EMA and FDA-approved products (betaxolol, zolpidem, and alfuzosin).
In 1991 Dr. Clementi established a regulatory consulting company, Clementi & Associates, Ltd. (dba as Clementi Ltd). Clementi Ltd. provides regulatory and clinical consultation to small companies developing drugs, biologics, cell-based therapies, organ sustainability products and contrast media for medical imaging. Clementi Ltd. has experience with required regulatory submission standards and processes, including orphan designation, exploratory INDs, expanded access INDs, and combination drug-drug and device-drug products. Clementi Ltd also provides high-level cGMP and GCP oversight.
Dr. Clementi is a graduate of Boston University and the University of Texas and the College of Pharmacy.
Executive Director of Chemistry, Manufacturing, Controls & Non-Clinical Development
Jules Jacob has 30 years of drug development experience and was previously Senior Director, Product Development at Aprecia Pharmaceuticals where he headed development of Spritam®, the first FDA-approved dosage form manufactured using 3-Dimensional Printing and other 505(b)(2) pipeline products. Prior to that Mr. Jacob was Director of Formulation Development at Panacos Pharmaceuticals, developing first-in-class maturation inhibitors for treatment of HIV and Director of Research and Development and Director of Technology Development at Spherics Pharmaceuticals developing bioadhesive dosage forms for treatment of CNS disorders, following the 505 (b)(2) regulatory pathway.
Mr. Jacob holds over 30 issued patents (US and international) and 38 US patent applications in the fields of drug delivery (proteins, peptides, DNA), nanoencapsulation, microencapsulation, solid oral dosage formulation, polymer compositions, gene therapy, tumor immunotherapy, protein micronization and formulation, imaging and bioadhesion. He has authored more than 30 scientific articles and book chapters and was Grand Award winner of the 2005 Eurand-CRS sponsored “Novel Approaches in Industrial Oral Drug Delivery Award”. Mr. Jacob completed his undergraduate degree and graduate education in biological and medical sciences at Brown University and has an active visiting faculty appointment in the Department of Molecular Pharmacolgy, Physiology and Biotechnology at Brown.
Vaseem A Palejwala PhD
Senior Director, Clinical Operations
Dr. Palejwala has 18 years of experience in drug discovery and development. Since 2012, Dr. Palejwala served as Director of Discovery and Preclinical Research at Synergy Pharmaceuticals Inc. where he actively contributed to establishing preclinical animal models for testing therapeutic efficacy and mechanism of action of plecanatide (Trulance™) and dolcanatide in the gastrointestinal tract. He also prepared the preclinical pharmacology section of NDA for Trulance™.
From 2001 - 2012, Dr. Palejwala served as Discovery Scientist/Manager at Sanofi Pharmaceuticals contributing to advancing small molecule and biologic programs in immunology, inflammation, oncology, CNS and metabolic disorders. He contributed to establishing and managing high throughput gene expression profiling platform capabilities at Sanofi and collaborated/contributed in cross-cultural/cross-functional team settings.
Dr. Palejwala received his Ph.D. degree in Microbiology from the M. S. University of Baroda in India and post-doctoral training in Molecular Genetics at the University of Medicine and Dentistry in New Jersey.
Howard Weiner MD
Harvard Medical School
Dr. Howard Weiner is the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis (MS) Center and Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham & Women's Hospital in Boston. The Partners MS Center is the first integrated MS Center that combines clinical care, MRI imaging and immune monitoring to the MS patient as part of the 2000 patient CLIMB cohort study. He has pioneered immunotherapy in MS and has investigated immune mechanisms in nervous system diseases including MS, Alzheimer's disease, amyotrophic lateral sclerosis, stroke and brain tumours. He has also pioneered the investigation of the mucosal immune system for the treatment of autoimmune and other diseases and the use of anti-CD3 to induce regulatory T cells for the treatment of these diseases.
Kevan Herold MD
Dr. Kevan Herold is Professor of Immunobiology and of Medicine (Endocrinology) as well as Deputy Director, Yale Center for Clinical Investigation, Director of the Yale Diabetes Center and Director of the TrialNet Center at Yale. His investigative work has focused on developing new ways to prevent and treat autoimmune diseases, using novel translational immunologic and metabolic approaches to prevent progression, in particular anti-CD3 monoclonal antibody therapy. His clinical interests are in the management of endocrine diseases, and he is involved in a number of national and international clinical studies of new treatments.
Arun Sanyal MD
Virginia Commonwealth University
Charles Caravati Distinguished Professor and Chair, Division of Gastroenterology, Hepatology and Nutrition at Virginia Commonwealth University School of Medicine.
Dr Sanyal is a world leader in the field of liver disease.
Professor Napoleone Ferrara, MD
University of California's Moores Cancer Center in San Diego
Dr Ferrara is Senior Deputy Director for Basic Sciences at University of California's Moores Cancer Center in San Diego; and Distinguished Professor of Pathology at the University of California's School of Medicine, also in San Diego. Dr Ferrara's research led to the development of the anti-VEGF monoclonal antibody bevacizumab (Avastin®) which was initially approved for the treatment of colorectal cancers, now one of the top ten selling global pharmaceutical products and won the 2010 Lasker Award for his work on VEGF.