Pharmaceutical Consultant Specializing In Marketing Research, Drug Development, Clinical Trials and FDA Issues

Technical Consultant #1704


Expertise

  • Senior consultant with 15 years of research experience in academic and industrial settings with a Ph.D. in Immunology.
  • Marketing research of competitive assessment of pharmaceutical market segments and geographical regions.
  • Pharmaceutical and biotechnology drug development, drug company portfolio analysis, strengths, weaknesses and opportunity assessment.
  • Pharmaceutical and biotechnology drug and intellectual property valuation.
  • Clinical trials, FDA filings, product lifecycle management and project management.
  • Experience in collaborating with customers, at different levels of the organization, to understand research objectives and to apply biological approaches and technologies to provide scientific insight.

Experience

Undisclosed Company, Senior Scientific Consultant, 2006 - Present

  • Development of pre-clinical project outlines, experimental planning, data analysis, budgets, business plans, technical report and SOP writing and review.
  • Use of "Guidelines for the Conduct of Research Involving Human Subjects," (ICH/GCP) and compliance with detailed clinical protocol development and clinical report writing.
  • Completive pharmaceutical market studies by geography and therapeutic type.
  • Experience with project management activities including planning, initiation, execution, financial reporting and project coordination.
  • Currently providing project management services to University of Western Ontario, Canada for a Genome Canada funded project.
  • Managing large or complex projects, (schedules development and management.)
  • Financial planning, forecasting, resource allocation and financial reporting.
  • Provide comprehensive project audits and reports to determine the true progress, status, forecast and risks.
  • Provide scientific due diligence, competitive assessments, and strategies for product development, evaluation and validation of scientific data, product feasibility and other business development related issues.
  • Provide CRO support and management for preclinical and clinical studies.

Fanshawe College, London, ON, Canada, Professor, 2007 - 2009

  • Responsibilities include teaching Manufacturing Process engineering, Project Management and business plan development, Bioprocessing, Biochemistry, Pharmacology/ Toxicology, and Microbiology courses to undergraduate students in the Biotechnology degree program.
  • Curriculum and course information sheets development, and methods of evaluation.

KGK Synergize Inc., London, ON, Canada, Scientific Director, 2004 - 2006

  • Managed the contract research services division of the company, lead and managed various pre-clinical and clinical research projects.
  • Prepared and reviewed protocols and reports for pre-clinical and clinical studies.
  • Analyzed and interpreted study data.
  • Managed research contracts with academic and corporate collaborators. Supervised lab personnel.
  • Facilitated ISO9001 and GLP certification of the laboratory.
  • Designed proof-of-principal animal models, pharmacokinetic, bioavailability and toxicity studies.
  • Worked in defining toxicology studies for FDA approval of therapeutics.
  • Responsible for preparing project outlines, budget forecasting, development and control, develop and adhere to timelines and milestones, detailed protocols, planning and completion of projects on time and budget.

Diabetogen Biosciences Inc., London, ON, Canada, Senior Scientist, 2000 - 2004

  • Responsibilities included setting up of the research lab including hiring of technical staff, purchase of equipment, and arrangements for animal studies.
  • Developed fully human monoclonal antibodies and peptide/small molecule based therapies for the treatment of autoimmune diseases.
  • Supported drug discovery and development efforts by designing and implementing numerous functional assays.
  • Designed and executed assays for screening, purification and detection of antibodies.
  • Identified and implemented new methods for projects. Supervised technical staff.
  • Prepared scientific reports, coordinated collaborations and made presentations to investors.

University of Western Ontario, London, ON, Canada, Post Doctoral Fellow, 1994 - 2000

  • Identified a peptide from self-MHC molecule that prevents the development of diabetes.
  • Determined that class II associated invariant chain peptide (CLIP) modulates the antigen specific immune responses.
  • Proposed that the affinity of antigens for MHC determines the generation of TH1/TH2 responses.
  • Investigated the maturation and differentiation of dendritic cells in response to a naturally occurring peptide and their role in type 1 diabetes (T1D).

Lucknow University, Lucknow, India, Post Doctoral Fellow, 1992 - 1994

  • Purified and characterized dengue virus induced helper cytokine.
  • Determined the structure of helper cytokine by protein fragmentation.
  • Involved in identification and characterization of receptors for dengue virus induced suppressor cytokine.

Honors & Publications

Academic and Professional Affiliations

  • Serve as reviewer for The Journal of Immunology, Bethesda, MD.

Credentials and Honors

  • Young Scientist Award- Indian Council of Medical Research, India.
  • Juvenile Diabetes Foundation International Post Doctoral Fellowship.

Publications

  • Published twenty one papers in peer-reviewed journals.
  • Publisher of several presentations.

Education

  • Ph.D. Immunology, Lucknow University, Lucknow, India
  • M.S. Zoology, Lucknow University, Lucknow, India
  • B.S. Chemistry and Biology, Lucknow University, Lucknow, India
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