Consultant in Biotechnology and Pharmaceutical Research and Development: New Drug Discovery, F.D.A. Filings, Patent Evaluation and Litigation

Technical Consultant #1484

Biotechnology and pharmaceutical research and development:

Pharmaceutical process research and process development.
Multi step organic drug synthesis: Route and reagent selections; literature and patent survey of synthetic routes; synthesis of API or API intermediate to ensure non infringing routes.
Skilled at the use of Boron reagents.

Drug discovery:

Strategies for discovery of new Inotropic agents (synthesis of modified Adenosine Monophosphate) for heart failure.
Discovery for synthesis of novel prodrug oligonucleotide for Cytarabine release.
Anti cancer compounds - Aryl Styryl sulfone.

Other:

Skilled with analysis methods: NMR, UV-Visible spectrophotometer, HPLC, FT-IR, GC, GCMS. IT/MS, EDXA,ICP and chemical kinetics.
FDA cGMP Compliance: Provided technical support to production group/analytical QC group; technical support to DMF (drug master file) filing of API, and ANDA (abbreviated new drug applications) filing of various drugs.
Patent evaluation and litigation: Patents for drug discovery and generic pharmaceuticals.

Independent Consultant, 2007 - Present

Zydus Pharmaceuticals/Healthcare USA Inc., Director, Princeton, NJ, 2003 - 2007

Synthesis of API or API intermediate and ensure non infringing route, evaluate route of synthesis (ROS) against all relevant patents.
In house patent draft examination, review and application filing.
For the FDA, fiiled more than 45 ANDA and more than 30 DMF in less than 4 years.

Chemir, Senior Scientist, Maryland Heights, MO, 2002 - 2003

Reliable Biopharmaceutical, Senior Scientist, St. Louis, MO, 2000 - 2002

Developed a new ten-step synthesis of fludarabine monophosphate (anti cancer drug) and launched in a pilot plant leading to production.
Synthesized many modified nucleosides.
Carried out drug discovery projects based on modified nucleoside synthesis.

Borregaard Synthesis Inc., Senior R&D Chemist, Newburyport, MA, 1996 - 2000

Involved in the synthesis, development and scale up, to more than 1000 gallon reactor production scale, the following projects: Abacavir intermediate, FADCP (for anti viral drug for Glaxo SK); Sidenafil citrate intermediate, PSEBA (for male erectile dysfunction, Viagra) for Pfizer; Tasosartan Intermediate, (for Verdia, anti hypertension drug) for American Home Products; and many synthetic intermediates (mostly 3-6-step synthesis) of phase-1 and Phase-2 drugs.

Aldrich Chemical Company, Research Scientist, Sheboygan Falls, WI, 1992 - 1995

Synthesized and developed library of new compounds.
Process research and improvement on the synthesis of optically active amino alcohols, n-boc protected amino alcohols and asymmetric reduction of pro chiral ketones by DIP-chloride.
Developed many new aryl triflates for cross coupling reactions.
Developed and improved methods for making (s)-1, 2, 4-butantriol and (s)-3-hydroxy tetrahydrofuran.
Developed many new boron reagents and carried out many boron based synthetic transformations, asymmetric synthesis.

Published 20 papers, including papers in these professional journals.

Ph.D., Indian Institute of Technology, New Delhi, India

M.S., Jammu University, Jammu, India

B.S., Jammu University, Jammu, India