Encouraging Faster and Agile Drug Development Paradigms in Dealing with Aggressive Global Pandemics
In light of the current circumstances of a global pandemic, it’s time to reconsider the current paradigm of drug development, clinical trials and regulatory approvals.
The medical community, life-sciences industry, health institutions, government, and regulatory bodies must act with a sense of urgency to examine any and all recommendations that bear a promise to delay or stop the spread of global pandemics.
Experts believe it’s time to ask some probing questions:
- Are prevailing industry norms, processes, and regulations — largely unchanged for decades— adept and agile enough to deal with accelerating global pandemics such as COVID-19?
- What aspects of drug development and regulatory approval need to be nuanced or shouldbe fundamentally revisited in the face of increasing pandemics to ensure critically neededtherapies?
- How can we leverage modern digital sciences and technologies to accelerate developmentof new therapies in epidemics and pandemics, while also enabling the earliest possibleaccess of promising, potentially live saving, new treatments to those afflicted?
- Are there best practices of providing rapid access to novel treatments to patients in needduring epidemics in other countries we can learn from?
Three industry leaders, representing life sciences and technology, attempt to answer these questions and explore thoughtful and perhaps even provocative approaches to drug development:
Srinivas (Srini) Shankar, Senior VP, Global Head – Life Sciences Cognizant
Ulo Palm, M.D., Ph.D., Senior VP – Digital Sciences, Allergan
Corporate Secretary, TransCelerate BioPharma Inc.
Thomas A. Bock, M.D., MBA, Founder, HeritX;
Chairman, Healthcare Advisory Board, Columbia Business School;
former Senior VP, Global Head – Medical Affairs, Alexion Pharmaceuticals
AGILE DRUG DEVELOPMENT