Complex pharmaceutical litigation requires true industry expertise.
The pharmaceutical industry is characterized by interdependent relationships between clinical, regulatory, and commercial factors. To position your client for success and to avoid mistakes that can sink a case, you need support from experts who know how these systems work and how all the pieces fit together.
Drawing on decades of high-level experience across the range of pharmaceutical industry activities, Value of Insight Consulting’s expert witness services provide intense focus on the specifics of your case that are informed by the broader dynamics of this complicated and highly regulated global business.
As in our consulting practice, we take an empirical approach, relying on diligent research and proven analytical tools to arrive at thoroughly grounded positions that are then communicated clearly to audiences at all phases of litigation.
Where existing information is insufficient to establish the facts of a case, we are also adept at developing custom approaches: for example, conducting tailored research to determine norms for supply relationships, regulatory practices, commercially reasonable marketing behavior, and other industry activities.
All expert witness engagements are headed by the company’s president, Todd Clark, who has advised clients on strategic issues spanning the pharmaceutical product lifecycle for more than 25 years. Mr. Clark has testified as an expert witness in federal and state courts, in international arbitration settings, and before the USPTO Trademark Trial and Appeal Board.
Areas of prior expert witness work include:
- Authorized generics.
- Brand and generic drug marketing.
- Commercially reasonable behavior in joint ventures, licensing and co-marketing agreements.
- cGMP regulations.
- Clinical-research standards.
- Contract manufacturing and supply agreements.
- Distribution and wholesaling practices.
- Drug development and clinical trials.
- FDA approval standards for innovative and generic drugs: BLA, NDA, ANDA, 505(b)(2).
- Economic modeling.
- Generic substitution practices.
- Paragraph IV and other aspects of the Hatch-Waxman Act.
- Brand and generic drug approval standards in Europe, Asia, and Latin America.
- License and royalty disputes.
- Lost profits (but-for damages) modeling.
- Patent and trademark disputes.
- Pricing, reimbursement, and formulary access.
- Regulatory compliance.
- Securities fraud.
- Valuation of assets and intellectual property.