In the development of biopharmaceuticals and pharmaceuticals, the line is blurring.
Like any other discipline, the pharmaceutical science industry is not immune to change. In recent years it has seen company consolidations, expansions, and mergers; limited/declining research funding; and a decreasing pool of workforce talent. The nature of our industry has shifted, and the growing interest in biotechnology has led to a metamorphosis. Pharmaceutical companies continue to diversify into biologics through acquisitions of biotechnology companies, in-licensing of products, academic-industry partnerships, and R&D alliances.
A decade ago, a clear distinction was made between biopharmaceuticals and pharmaceuticals based on their origin and method of manufacture. Since then, however, various industry business reports, including those supported by the Pharmaceutical Research and Manufacturers Association (PhRMA), have asserted that with the metamorphosis of the industry noted above, driven in part by the adoption of significant technological advances, “pharmaceutical” and “biopharmaceutical” are essentially synonymous, signaling that the lines between large and small molecules, chemical entities and biologically derived therapeutic drug products, and also between large and small companies are rapidly disappearing, which is—in fact—reflected in and across the PhRMA and the Biotechnology Industry Organization memberships.
As of 2011, consistent with these industry trends, nearly 50% of American Association of Pharmaceutical Scientists (AAPS) members are now affiliated with small biopharmaceutical/pharmaceutical companies, contract research organizations, or consultancies, with many of these pharmaceutical scientists having, or expected to have in the future, overlapping responsibilities for the discovery, development, and manufacturing of both small and large chemical and biologically derived molecules, as do those members affiliated with large biopharmaceutical/pharmaceutical companies, regulatory agencies, and universities. With the acceptance of biosimilars, pharmaceutical scientists affiliated with both brand and generic-drug companies, large and small, are likely to have overlapping responsibilities for large and small molecules. Though details may differ, the overarching principles, processes, and challenges of academic pharmaceutical research, industrial drug development and manufacturing, and regulatory review, approval, and oversight of new therapeutic products are not significantly different for large and small molecules.
AAPS is working to merge its National Biotechnology Conference and its Annual Meeting beginning in 2018 to provide a forum for all pharmaceutical scientists to work together to advance the field and facilitate the discovery, development, and approval of new medicines. The programming for this single meeting will be designed to leverage the diverse expertise of its members to provide opportunities for sharing of cutting-edge science, building on the commonalities between large and small molecules, as well as for furthering the understanding of unique differences.
As the pharmaceutical industry changes, the association must change as well if it is to remain relevant. The new combined meeting is a response to one key aspect of the evolving industry and consequently the professional needs of our members; other changing needs have been and will continue to be identified and addressed through the dynamic strategic planning and management processes initiated this past year. AAPS is playing an important part in advancing the capacity of pharmaceutical scientists to develop products and therapies that improve global health.
By Alice Till