Botanical drugs and disruptive innovation
The high cost and high failure rate of drug discovery are well documented (see this from Tufts Centre for the Study of Drug Development). Nearly 43% of drug candidates fail due to efficacy problems, 33% due to safety concerns and 11% due to pharmacokinetic issues during development. Further, approved and marketed drugs are being withdrawn due to concerns regarding long-term safety, with 94% of such withdrawals due to toxicity. Seems like a losing proposition. But there are a lot of smart people working in the global pharmaceutical market, which is valued at US$880 billion and is expected to grow five to seven percent in 2011.
An array of disruptive innovations is required to change the existing drug discovery paradigm. One of the approaches is selecting drug candidates whose efficacy and safety have already been established by traditional use. As such, a developer who looks to traditional herbal sources starts with a built-in “safety” advantage. Regulatory agencies recognized that a botanical drug’s special features require consideration and adjustment during the FDA review process. The FDA issued a Guidance for Industry-Botanical Drug Products (PDF – 437KB) to take into consideration these features and to facilitate development of new therapies from botanical sources.
Another important feature of botanical drugs is their polymolecular composition, which, in turn, promotes a multifunctional mode of action. Modern medicine may be at a crossroads, where single-molecule drugs evolve to multiple components as our understanding of disease and health becomes more sophisticated. Some of the most promising therapies come from our evolving understanding of the diverse roles of natural compounds both in normal and pathological states. Botanical drugs work fundamentally the same way cocktail drugs for HIV patients work, by hitting multiple disease targets simultaneously. If only one component is removed, the synergistic dynamics involved in multi-compound drug fail, and a treatment is no longer effective.
Polymolecular drugs can exhibit clinical efficacy comparable to their monomolecular counterparts, yet are generally safer and more tolerable, suggesting that this novel class of therapeutics may be a promising alternative to conventional therapeutic agents. The challenge is incumbent on researchers and botanical drug companies to expand the body of scientific evidence that show botanical products do work.
There is a strong optimism around the world, and especially in developing countries, that botanical drugs will not only open up avenues for new therapies for indications, but also will perhaps reduce the cost of therapies.
Canada has made significant strides in the field of polymolecular drug development, and is well-positioned to be a world leader in this innovative and emerging area of health and therapeutics. MaRS is one of the co-creators of the Botanical Drug Discovery Forum. As is often the case at MaRS, a convergent innovation centre, the goal is to bring together professionals from various disciplines. This event will feature experts in the field that will discuss their original research and policy perspectives with an audience of professionals and key opinion leaders with diverse backgrounds and roles. Come to MaRS on Nov 15th (for free) and see for yourself!
Veronika Litinski provides advisory services to entrepreneurs and high growth companies, with a special focus on life sciences markets, specializing in corporate finance and business development. See more…