STRATEGY, EVALUATION & TROUBLESHOOTING

Analyzed the R&D portfolio (success probability and design of NDA/BLA
programs--clinical, regulatory, & market prospects) for a medium-sized
Pharma company.

Evaluated Product Development Plan and Clinical Study Protocols for a
multicenter clinical program on a cardiovascular stent for a large Device
company.analyzed.

Analyzed & resolved dispute between two large Pharma companies
(originator and licensee) on a large, stalled NDA; advised on overall
International strategy.

Evaluated Psoriasis Development Program for a large biotech company.

Analyzed and interpreted aberrant early Phase 2 results in a leukemia
project for a medium-sized Biotech company.

Evaluated potential commercial opportunities in Genomics for a large
University's Cardiac-risk Epidemiology Database; introduced the University
to the most suitable Genomic/Pharmacogenomic partner.

  BUSINESS DEVELOPMENT, EVALUATION, & SUPPORT

Evaluated small-company opportunities, specific compounds, and product
portfolios for an Investment Firm.

Evaluated commercial prospects and positioning of a new product for
Adverse-Event Analysis on marketed products for a startup
Pharmacovigilance company.

Assisted an Internet-based Clinical-Trial Patient-Recruitment company with
business-development opportunities and pharma corporate financing
contacts.

Evaluated and assisted in defining the applications of a Managed-Care
Claims Database for a Health Information company.

Provided extensive Business Development, Marketing, and Consulting
support for pharmaceutical clients of a large CRO.

Provided Business Development Support for small- and medium-sized
Pharma companies and CROs.

  OPERATIONS

Wrote the European Device safety submission for a small US Drug/Device
company.

Wrote the initial Product Development Plans - with time and costing -- for a
portfolio of 12 drugs for the Virtual Division of a medium-sized Pharma
company.

Wrote program for QT evaluation of a drug in Phase 3 for a medium-sized
Pharma company.

Wrote Product Development Plan for an Analgesic Drug/Device for a
medium-sized Device company.

  SMALL COMPANY SUPPORT

Approximately half of WAI's projects
have been performed for small
companies, including startups.

Identified issues in the Development of
Botanical Products as US NDAs for
a small Drug Development
company and for a Government Agency.

Helped several small companies in
areas ranging from hypolipidemics,
pharmacogenomics, and oncology, to
pharmacoeconomics.

  SPEAKER / LECTURES

Most of Dr. Wardell's numerous lectures
and presentations have been
sponsored by Covance or other
companies or by the conference organizers,
and include the following topics:

Drug Development (General), including Outsourcing

Regulation and Regulatory Reform

Specialized Drug Development Areas, including Biotechnology,
PharmacoGenomics, and Botanicals

Medical Device Development and Regulation

Avoiding Late-Stage Failures and Increasing Overall Success in Product
Development

Strategic Errors That Small Companies Must Avoid

  CORPORATE BOARD AND SCIENTIFIC ADVISORY BOARD SERVICE

Current Board Memberships:  OrthoLogic, Inc.,
PhytoCeutica, Inc.

Scientific Advisory Board:  Eleos, Inc.