Expert Profile
I have more than 25 years of ***** experience. Most recently I was the senior VP and head of discovery and development of small molecules and biologics at a multinational company, coordinating the efforts of 60+ scientists across three international sites. A majority of my drug discovery experience is in the area of inflammatory and immunological diseases (RA, atherosclerosis, IBD, T2D & MS) and cancer involving various targets: receptors (TLRs/ IL-1, GPCRs and nuclear), enzymes (MMPs), cytokines (IL-1, TNF-, and IL-6) and signal pathways (TLR/IL-1, MAPKs, RANK/RANKL and NF-kB). I have a proven track record of drug development - managed a pipeline of 13 compounds (4 discovery, 2 lead optimization, 4 phase I and 3 phase II) and filed regulatory documents (INDs & IMPDs). In terms of business development, I have made scientific presentations to various ***** companies in the US and Europe. I have led due diligence and licensing efforts that led to out-licensing of 3 NCEs and contributed to partnering development/commercialization and M&A deals. My career interests are to apply my background and experience towards developing novel therapies for chronic/lethal diseases. I can leverage my toxicology, PK and pharmacology skills to advance compounds rapidly through the discovery pipeline. My experience with the early clinical management teams and translational pharmacology and biomarkers teams would be valuable in rapidly driving quality candidates from preclinical research to clinical proof of principal. Furthermore, through my many years of senior management experience at both small and large ***** companies, I can help establish strategic directions and priorities. In addition to my scientific and management experience, I can also contribute through my business development experience associated with licensing and partnering activities. With these abilities and strengths, I feel that I will be a strong asset to your institution.
03/2010-Present:Consultant, ***** ***** Consultants, Ypsilanti, MI Preclinical drug discovery and development (pharmacology, PK and toxicology) of small molecules and biologics. Clinical Monitoring
04/*****/2009:Senior Vice President, Biology Glenmark *****s -a multinational company with R& D sites at Navi Mumbai, India, La Chaux‐de‐Fonds, Switzerland and Oxford, UK, and regulatory/licensing group at NJ, USA - managing a pipeline of 13 small molecule and monoclonal antibody programs (3 in phase II, 4 in phase I, 2 in preclinical development and 4 in discovery) in the areas of inflammation/autoimmune diseases, cancer (pancreatic), pain (neuropathic, cancer and OA), metabolic diseases, asthma/COPD, obesity/dyslipidemia/ NAFLD and CV indications. I was responsible for 60 scientists across departments (toxicology, preclinical & clinical DMPK and pharmacology) and sites (UK, Switzerland and India)
*****: Director of Preclinical Research, Alantos Pharm. Cambridge, MA- My responsibilities included all the in-house activities from target identification to phase II at our Cambridge (US) and Heidelberg (Germany) sites. I also designed and outsourced studies in OA, cancer (HNSCC), multiple sclerosis, RA, CV and liver fibrosis areas
*****: Various positions from Scientist to Senior Research Fellow / Director In inflammation therapeutic area , Pfzer Global Research & Development (previously Parke-Davis /Warner-Lambert Company ) Ann Arbor, MI. I was involved in the management, operations, and technical aspects of drug discovery research and development of biologics (monoclonal antibodies, cell and gene therapy and ribozymes) and small molecules. The following are some of the projects/ therapeutic areas that I contributed to: inflammation and autoimmnune diseases, Cancer, wound healing (diabetic ulcers), osteoporosis, OA & sports injury and pain.
BS (1975), MS (1978), University of Agriculture Sciences Bangalore
Ph.D. (Nutrition & Biochem.), Auburn University, Auburn, AL (1984)
Postdoctoral (Arthritis) Tufts Medical School, Boston, MA (*****)
*****:Assistant Professor of Medicine, Washington University School of Medicine, St. Louis, MO.
1997: Professor, Ferris State University, Big Rapids, MI
1997: Visiting Scientist, University of Iowa, Iowa City, Iowa
PROFESSIONAL SOCIETIES: Inflammation Research;Orthopaedic Research Society; American Society for Cell Biology, American for Bone and Mineral Research
EDITORIAL BOARD: Current Opinion in Anti-inflammatory & Immunomodulatory Drugs;
OARSI Corporate Council Member
I have been working as a consultant providing drug discovery and development support to various academic groups and ***** companies including Amgen, Glenmark *****s, and more recently to Nycomed GmbH, Germany, the Campbell Family Institute for Breast Cancer Research, Toronto Canada and Cerenis Therapeutics, Ann Arbor, Michigan. I am consulting with Nycomed mainly in the inflammatory and autoimmune diseases (IBD/IBS, MS, RA, SLE, T2D). My research efforts at the Campbell Family Breast Cancer Research involved providing strategic direction, and designing and reviewing data for both in-house and outsourced studies that spanned from target identification / validation through discovery and development of a first-in-class lead and a backup compound for breast cancer. Several other analogs potential of utility for treatment of colon, ovary and lung cancers were identified and evaluated. I consulted with Cerenis Therapeutics on developing a strategy and doing all the necessary enabling studies for repositioning of their antiatherogenic compounds as potential symptom and disease-modifying agents for treatment of rheumatoid arthritis.
I have reviewed data for all the in-house IND-enabling pharmacological, toxicology and PK to ensure that all the studies were done and report completed to meet the time lines for filing of US, European and Indian regulatory documents, and participated in FDA pre-IND meetings and provided timely response to regulatory queries.
In terms of clinical studies, I contributed to the preparation of clinical plan and investigators brochure; evaluated PK data obtained from Phase I (SAD & MAD, food effect), Phase II POC and bridging studies, and made recommendation for starting dose and dose-escalations based on PK and safety data.
In terms of business development activities associated with licensing and partnering activities, I made scientific presentations to several US & European ***** companies and led technical due diligence on three out-licensing opportunities. I have successfully outlicensed 3 small molecules and one monoclonal antibody. I have also been involved with one M& A deal.