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

Technical Consultant #1484


Expertise

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.

Experience

Independent Consultant, 2007 - Present

  • Anti cancer drug research program for API development.
  • Patent protection for new drugs.

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

  • Established a new division, Chemir Synthesis.

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.

Honors & Publications

Published 20 papers, including papers in these professional journals.


Education

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

M.S., Jammu University, Jammu, India

B.S., Jammu University, Jammu, India

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