PK/PD Drug Discovery and IP Strategies Expert

Expertise

• Hit generation, lead identification, and lead optimization. Strategies, implementation plans and problem solving.
• Drug Discovery - "Concept to Clinic" - Road map and expectations. Goal setting, testing schemes, progression path tracking.
• Intellectual Property - Assessment, strategies and management. Due diligence on prior art, patentability. Expert witness
• Drug discovery across therapeutic areas - Pain, inflammation, cardiovascular, metabolic, oncology and antimicrobial therapeutics.
• PK/PD (Pharmacokinetic and Pharmacodynamic) correlations of drug molecules - Evaluation of ADME profile and recommendations to address gaps.
• Strategies to build risk balanced portfolio. Mentoring and leading discovery teams to success.
• Project Management - Experience leading teams in preclinical, IND enabling and phase-I studies. Strong connectivity with quality, specialty pharma CROs (preclinical and clinical).
• Documents and Reports - Preparation and review.
• Due Diligence - In-licensing and out-licensing assets or projects.
• Good knowledge of pharma industry trends - Experience working in large, mid-size and small biotech companies across the globe.

Experience

Undisclosed Company, Chief Executive Officer, 2015 - Present

• Biopharmaceutical company focusing on the discovery and development of innovative small molecule products for treatment of unmet needs in painful peripheral neuropathy and Parkinson's disease.
• Leading discovery efforts to identify lead candidates for clinical validation.

Kareus Therapeutics SA/Kareus Therapeutics LLC., Atlanta GA and Switzerland, 2010 - 2015

Chief Advisor and Head, Pre-Clinical and Medicinal Chemistry

• Provided strategic and technical leadership in the drug discovery projects in diabetes and chronic pain.
• Led diabetes project from "concept to clinic". Lead molecule from diabetes completed Phase-I successfully.

Reddy US Therapeutics, Atlanta, GA, Vice President, 2003 - 2009

• Provided overall strategy and leadership for global drug discovery projects in cardiometabolic disorders, inflammation, and anti-microbial therapeutics.
• Led First in Class, Best in Class and Drug Repositioning discovery projects yielding two molecules in clinic; one is active in P-II.
• Promoted to Site Head for Reddy US Therapeutics.
• Member of Discovery Management Council and Executive Leadership Team.

Pfizer/Pharmacia/Searle, Skokie, IL, Senior Research Advisor and Fellow, 1986 - 2003

• Joined Searle filling the position as Principal Investigator and rose through discovery ranks to Senior Research Advisor and Fellow with increasing technical and management responsibilities.
• Designed and discovered novel therapeutics in inflammation and pain, cardiovascular, anti-infective and oncology therapeutics.
• Co-inventor of First in Class celecoxib, with Celebrex being commercialized.
• Participated as an internal reviewer and consultant for discovery projects.
• Member of the steering committees to evaluate and implement new technologies with drug discovery.
• Member Fellow Program and Discovery Research Leadership Team.

Searle, Skokie, IL, Research Collaborator, 1984 - 1986

• Development of novel methodologies of broad synthetic utility. The research led to multiple publications in international science journals.

University of Kansas, Lawrence, KS, Department of Medicinal Chemistry, 1981 - 1984

Postdoctoral Fellow

• Designed and synthesized novel anthracylcine antitumor agents to reduce cardiotoxicity associated with daunorubicin.
• Studied the structural activity relationships and mechanism of action on the class of Quinolone class of antibiotics. The research led to multiple publications in international science journals.

Honors & Publications

License

• Professional Engineer-P.E

Languages

• Hindi

Academic and Professional Affiliations

• Reviewer for Journal of Medicinal Chemistry, Bioorganic and Medicinal Chemistry, European
• Journal of Medicinal Chemistry, Drug Discovery Today, Expert Opinion on Therapeutic Patents,
• Journal of Organic Chemistry, Journal of Carbohydrate Chemistry, Tetrahedron Letters, Organic
• Letters, CNS & Neurological Disorders - Drug Targets, Evidence-Based Medicine,
• Pharmacological Research, Mini Reviews in Medicinal Chemistry, Letters in Drug Design and Discovery, Future Medicinal Chemistry
• Reviewer for GRA Ventures Grant Proposals
• Mentor - TI:GER Program, Georgia Institute of Technology, Emory University
• American Chemical Society - ACS
• Pfizer Research Fellow
• Pharmacia Fellow
• Searle Fellow

Publications and Patents

• Lead author or co-author of 35 peer reviewed publications in international journals.
• Invited speaker or presenter at international conferences or institutes.
• Co-inventor of 85 issued or published U.S. patents.

Education

• Ph.D. Synthetic Chemistry, National Chemical Laboratory, University of Bombay, Bombay, India
• B.Sc. Chemical Technology, (Dept. of Chem.Tech, UDCT), University of Bombay, Bombay India