A custom collaboration with: Quintiles
While ongoing R&D in pharmaceutical company laboratories and basic research from academic researchers reveal new ways to improve the science of drugs and medical devices, a changing world also provides new challenges for medicine to conquer. What is more, specific regions can face very specific health problems.
“The key health challenges in Africa arise largely from the burden of three diseases: HIV/AIDS; tuberculosis, or TB; and malaria,” says Vaila Clements, vice president for public health and government services at Quintiles. “To give an idea of the impact those diseases are having, the average life expectancy fell by half in Swaziland between 1990 and 2007 to 37 years. That’s predominantly because of HIV, or a combination of HIV and TB.”
Clements continues, “The key to battling these diseases is the successful development and approval of efficacious treatment and preventative technologies—most importantly, vaccines. This could come from efforts like the Critical Path Institute, which was pioneered by the Global Alliance for TB Drug Development. The institute harnesses several pharmaceutical companies, the Bill & Melinda Gates Foundation and the U.S. Food and Drug Administration with the aim of reducing the development time frame from 24 to 6 years. Moreover, this will avoid the repetitive efforts and multiple independent journeys to a dead end.”
To take on such regional challenges, however, more funds must be made available. “Despite the efforts of the Critical Path Institute,” says Clements, “Africa still requires more resources. For example, the Aeras Global TB Vaccine Foundation only gets 8 percent of its funding from governments. Furthermore, we have—as a global health community—allowed TB to evolve from multidrug-resistant to now extremely drug-resistant TB. We need strong global political will to solve these burdens, and we don’t have that now.”
These emerging markets—places with new diseases or evolving health challenges—attract attention from many segments of the pharmaceutical industry. To some extent, changing approaches to investment reflect such interest. For example, the April 29, 2010, Dow Jones VentureSource reported that first-quarter venture financing in China increased by 35 percent in comparison with the first quarter in 2009. By the same comparison, venture capital financing in India more than doubled.
Other events illustrate the specific emergence of pharmaceutical opportunities in Asia. In the April 2010 Nature Biotechnology, for instance, Bea Perks wrote: “Three big pharmas—Pfizer, Merck, and Eli Lilly—are pooling their resources to set up an independent nonprofit company to spur research into innovative treatments for cancers common in Asian populations.” This Asian Cancer Research Group (ACRG) will start by collecting data on lung and gastric cancers. “The pharma giants are searching for ways to capture the emerging Asian markets,” wrote Perks. In particular, this collaboration will provide the big-pharma trio with the information needed to develop drugs specifically aimed at Asian populations.
As Western pharmaceutical companies move east, harmonization of regulatory requirements could simplify the development of drugs for use around the world. According to “HealthCast: The Customization of Diagnosis, Care and Cure,” a 2010 report from PricewaterhouseCoopers, “Globally, more health leaders are talking about a common regulatory regime for all healthcare products and services, rather than separate regimes for pharmaceuticals, medical devices, diagnostics and the like (as is presently the case in most countries). The next step would be a single global system, administered by national or federal agencies responsible for ensuring that new treatments meet the needs of patients within their respective domains.” While such a global regulatory approach would benefit multi-national pharmas, many experts see such a system as unlikely, at least for now.
When speaking about regulatory harmonization, Sir Andrew Dillon, chief executive of the UK’s National Institute for Health and Clinical Excellence (NICE) says, “It’s pretty unlikely that we’d get some Europe-wide or world-wide assessment of products. What could be harmonized, though, are the methods. Some standard techniques for bringing evidence together and interpreting it could be unified around the world.”
But the development of emerging markets should not just be about identifying new populations to treat or smoothing the pathway to drug approval; it should also represent an opportunity to build innovation resources in new places. For example, Merck runs facilities in Hong Kong and Shanghai, and Pfizer, which built its first plant in China in 1989, now employs nearly 4,000 people in four plants operating there.
So as pharmaceutical companies continue to expand across the globe and into new markets, they must find faster pathways to more effective and safer medications. Tomorrow’s compounds must also provide personal treatments, based on an individual patient’s condition and genotype, as well as other physiological indicators, cultural background and behavioral experience. In many cases, reaching these objectives demands remodeling steps from drug discovery and development to clinical trials and post-market surveillance. The economic environment created by the need for more personalized medicine—as well as the end of the era of blockbusters— impedes the success of vertically integrated pharmaceutical giants that do not reach out for productive collaborations. Consequently, tomorrow’s successful companies will work with academics, reach out to CROs, spawn innovation around the globe and build strong networks of capable and creative teammates.
The process of developing therapeutics has multiple expense points, which will undoubtedly change as new business models replace old ones. Here is a snapshot of the current major expenditures related to the bench-to-bedside enterprise.
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