Our multidisciplinary consortia management team has over 15 years of experience in the formation of focused industry consortia that address common scientific, regulatory, legislative or policy goals of clients. Given the highly regulated nature of U.S., European and international pharmaceutical markets, it is often critical for companies to respond jointly to governmental proposals or emergent regulatory regimes that affect the core interests of the industry. Through the management of industry consortia, we facilitate a consensus-building process and assist companies in efficiently devising and executing their common initiatives in the United States, the European Union and elsewhere.

Representative Engagements:

  • International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), an association of more than a dozen research-based pharmaceutical companies, seeks to advance the science of orally-inhaled and nasal drug products by collecting and analyzing data and conducting joint research and development projects.
  • International Pharmaceutical Privacy Consortium (IPPC), an association of more than a dozen multinational pharmaceutical companies, provides a forum for industry dialogue and consensus-building on privacy and data security issues related to the research, marketing, adverse event reporting, and other activities of member companies.
  • International Pharmaceutical Aerosol Consortium (IPAC), an association of leading manufacturers of metered-dose inhalers that contain chlorofluorocarbons and hydrofluorocarbons, represents members on issues related to the Montreal Protocol on Substances that Deplete the Ozone Layer and the Kyoto Protocol to the UN Framework Convention on Climate Change.
  • Alliance for Biosecurity, a collaboration among 13 pharmaceutical and biotechnology companies, works in the public interest to promote sound biosecurity policy and more effective partnerships between government and companies investing in research and development of vaccines and therapeutics effective against bioterror agents and emerging infectious diseases.
  • IRB Sponsor Roundtable, facilitates communications between sponsors of clinical research and Institutional Review Boards on significant clinical research issues and proposes strategies for improving clinical trial processes and human subject protections. 
  • A number of pharmaceutical consortia organized to address specific technical and regulatory issues, e.g., to establish common test methods and acceptance criteria, to manage joint quality testing, or to conduct safety testing for specific ingredients in pharmaceutical products.