Pharmaceutical Pricing Consultant and Pharmaceutical Business Development

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.