Pharmaceutical, biotech, medical device, and diagnostic companies operate in a demanding, constantly-shifting market environment. Navigating these shifts requires continual evaluation and analysis of options and competitive responses.
For more than 30 years, CRA has consulted directly with major life science corporations, the governmental agencies that regulate them, and legal counsel to these firms. Our involvement has helped them address their most difficult strategic issues and take the strongest positions in the most contentious disputes. We believe the critical issues faced by life sciences companies will continue to be shaped by these fundamental challenges:
- Tension between the need to improve access to high-quality health care and the need to contain its costs
- The need to clinically differentiate new products to justify the pricing required to support necessary investments
- Frequent, high-stakes commercial negotiations necessitated by the consolidation of payers, particularly government payers
- The need to adapt to evolving regulatory environments, including changes in the statutes and implementation of the Hatch-Waxman Act
- The need to adjust fundamental business models in response to the shifting roles of stakeholders, including patients, physicians, and payers
CRA’s Life Sciences team combines deep industry focus with superior analytical tools to help our clients address critical business, competitive, and litigation issues. We have advised life science clients on global product strategy and a range of other issues, including pricing, contracting, and opportunity assessment; and we’ve enhanced our clients’ competitive strength by using our expertise in economics, finance, management, intellectual property valuation, game theory, and statistics.
Like our clients, we have a global presence in the life sciences industry. Worldwide, trends toward coordinated, multi-country diagnostic and therapeutic launches increase the potential gains available to manufacturers, while also increasing the number of economic, regulatory, and policy constraints on success.
CRA’s international expertise helps our clients develop marketing and reimbursement strategies specifically adapted to the countries of interest, within a unified global framework. Our team also has significant experience in high-stakes international arbitration hearings involving life sciences companies.