31 July 2020 | Opinion
The NIH recognized the incredible value of collaboration in this pandemic by establishing the ACTIV public-private partnership
Image credit- shutterstock.com
Could COVID-19 collaborations change the future of the pharma industry?
Even prior to COVID-19, collaboration in the pharmaceutical industry with other companies and academic institutions were already on the rise. What this pandemic has reinforced, however, is how large scale collaboration and the unifying of strengths and assets among different companies/organizations can help meet the urgent, massive global demand for therapeutic, diagnostic and prevention solutions for COVID-19.
The NIH recognized the incredible value of collaboration in this pandemic by establishing the ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines) public-private partnership between the government, non-profit, and industry organizations. By helping to prioritize therapeutic and vaccine candidates, streamline the process of clinical validation, as well as coordinate regulatory processes and company assets, ACTIV strives to accelerate the response to this pandemic as well as future pandemics.
Additionally, with the production of therapeutic molecules like monoclonal antibodies being a complex and highly customized process, companies like Genentech, Amgen, Eli Lilly, Glaxo Smith Kline and Abcellera have started sharing knowledge of available manufacturing facilities, capacity, and raw materials for COVID-19-related biologics production. With this knowledge, companies can reduce inefficiencies and better anticipate and plan around what is available in the supply chain, significantly reducing lead time to producing therapeutic molecules, especially given the extremely customized and complex nature of biologics production.
Given the beneficial nature of these collaborations for companies, particularly in the accelerating of timelines from the research lab to the clinic, and the reduction in process inefficiencies, if the outcome of these large COVID-19 collaborations are beneficial, it is likely that multi-industry collaborations are likely to persist into the future.
How can firms protect IP and navigate antitrust implications of partnerships?
As collaborative research agreements continue to rapidly increase, for a productive partnership, it is often inevitable that companies will need to share proprietary intellectual property (IP) in order to advance research projects. It is important that these companies have both legal and non-legal strategies in place to protect their IP.
Legal non-disclosure and joint development agreements outlining the activities of the collaboration in detail should be signed after careful negotiation between partners. In addition, partners should discuss the risks and technical intents of their partnership, and consider training their employees in terms of information that can and cannot be shared with a partner.
While the details of regulatory, insurance, and agency relationships may differ slightly between different global regions and countries, it also goes without saying that all companies must abide by antitrust and competition policies in their respective markets and should expect rigorous monitoring by governmental agencies (such as the Federal Trade Commission and the Department of Justice in the United States). With partnerships adding another layer of regulatory complexity to the already complex pharmaceutical industry, companies should always seek legal counsel and consult with relevant regulatory authorities when navigating antitrust issues.
Dr. Marinella Sandros, Ph.D. Sr. Global Product Manager, GenScript Biotech Corporation, US