Pharmaceutical Pricing Consultant and Pharmaceutical Business Development

Technical Consultant #1497


Expertise

  • Pharmaceutical pricing.
  • Pharmaceutical business development and sales.
  • Pharmaceutical business strategy and decision making: Economic data analysis, tree analysis, probability of success calculations, resource and capacity requirements, drug pricing strategies, scenario presentations and critical path analysis.
  • Pharmaceutical chemistry.
  • Analytical method development and validation for drug stability, impurities, assay, release, content, uniformity, cleaning validation and identification.

Experience

Independent Consultant, 2003 - Present

  • Business and pharmaceutical consulting.

Quintiles, Kansas City, MO, Director, Business Development 1999 - 2003

  • Established pricing system for all Pharmaceutical Sciences products in the U.S.
  • Implementation of sales plan with new sales growth of $36 million per year.
  • Development of long term service agreements.
  • Negotiation of proprietary technologies agreements.
  • Process knowledge of multiple business lines and best practices for project and drug development.
  • Expansion of business into areas and new clients.
  • Worked with over 40 different companies selling pharmaceutical sciences, preclinical and Phase 1 services.
  • Negotiated two new technologies for Quintiles.

Associate Director, Business Development, 1999 - 2001

  • Development of pricing system for pharmaceutical sciences. This includes analytical chemistry services, pharmaceutical development and formulation services.
  • Established and managed proposal group.
  • Managed accounts and developed relationships with clients.

Global Project Manager, 1999

  • Managed new drug development from discovery to post market.
  • Similar duties, Project Manager and Research Chemist employed with Hoechst Marion Roussel.

Hoechst Marion Roussel Inc., Kansas City, MO, 1996 - 1999

Project Manager

  • Managed new drug development.
  • Implemented business case and project development plan.
  • Coordinating activities with licensing and co-development partners.
  • Optimizing the long-term and short-term tactical plans.
  • Tracking and financial aspects of projects.
  • Coordinating operational project team, including investigator drug brochure.
  • Filing activities globally, including new drug applications, MAAs, INDs, CTAs.
  • Presentation to senior management for viability of projects.
  • Decision making using availabe of scientific and economic data: Decision tree analysis, probability of success calculations, target product profiles, plant capacity requirements and pharmaceutical.

Research Chemist

  • Responsible for project development and writing of methods for drug substance and drug product from pre-clinical to NDA filing, (GLP/GMP/cGMP).
  • Chemistry section in IND applications, (including amendments) to regulatory agencies.
  • Analytical method development and validation in: Drug substance, drug formulations, stability, impurities, assay, release, content uniformity, cleaning validation, identification.
  • Setting specifications for drug substances and drug products according to USP/JP/EP/ EPA/FDA/ICH guidelines.
  • Performing GLP and GMP audits.
  • Responsible for answering questions from governmental agencies.

Bayer, Inc., Chemist, Stilwell, KS, 1989 - 1993

  • Method development.
  • Writing methods and Standard Operating Procedures (GLP).
  • Study support and special projects.
  • Instrument maintenance and troubleshooting.

University of Missouri, Visiting Instructor, Kansas City, MO, 1991 - 1992

  • General analytical and instrumental chemistry laboratories.

Honors & Publications

Academic and Professional Affiliations

  • American Association of Pharmaceutical Scientists
  • American Chemical Society
  • National Institute of Chemists

Education

  • MBA Finance, University of Missouri, Kansas City, MO
  • M.S. Analytical Chemistry, University of Missouri, Kansas City, MO
  • B.S. Biology, University of Missouri, Kansas City, MO
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