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Drug Combinations: New Rules, New Opportunities
FirstWord Publishing, May 2011, Pages: 48
For years, drug therapy has been built on that basic equation. Yet as genomic biology sheds light on the astonishing intricacy of disease pathology, it is clear that drugs that combine several compounds must be developed in response.
According to Biovista president Dr Aris Persidis, the possibility of such combination drugs “opens up this wonderful world of re-exploration of shelved, ineffective compounds in the pipelines of pharma companies that can be investigated for additive effects.”
This “wonderful world”, however, has its hurdles. While recent US Food and Drug Administration (FDA) guidance offers much-welcomed room for establishing codevelopment strategies, it also opens the door to wider questions regarding pharmacovigilance requirements, additional trials and more complex risk-benefit calculations. What’s more, the FDA strictly limits the scope—for now—of scenarios for codeveloped drugs, indicating approval will not be easy.
In this latest report, Drug Combinations: New Rules, New Opportunities, the authors unravel some of these issues by drawing on the insight of 18 experts working in cutting-edge biological research and regulatory affairs. The tightly-written report outlines the guidance offered by the FDA, and explains how it can be deployed to develop effective new treatments. The report also addresses the remaining barriers to development and provides insight into co-development trials as well as discussing commercial factors such as anti-trust, intellectual property and working across different corporate cultures.
The report includes:
- A concise overview of where codevelopment currently sits and what lies ahead
- Insight into the FDA guidance and how it can be applied
Key features
- Explanation of the FDA's regulatory approach
- Examination of legal challenges presented by working collaboratively across companies
- Four cases studies of companies actively codeveloping or have the potential to do so
- Overview of non-regulatory issues, such as antitrust, financials, intellectual property and corporate culture
Key quotes from the report
“We are learning more and more that nature, when it needs to control something complex, both inside and outside the cells, uses a combinatorial approach. Some of the combinations nature uses are larger than the drug combinations we use now.”
– Dr Giovanni Paternostro, adjunct assistant professor at the Sanford-Burnham Medical Research Institute
“Diseases are proving themselves to be more complicated than we thought. The idea that we can have a consistent outcome by modulating a single target at one position of a pathway is no longer accurate and no longer valid.”
– Dr Aris Persidis, president of Biovista
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