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Article | March 12, 2014
The changing face of clinical trial services
A contract packager examines trends affecting the pharmaceutical industry.
The competitive landscape for pharmaceutical and biotech companies is different today than in years past. We operate in a truly global market and thus healthcare pressures are felt not only from the markets of traditional developed countries, but across the globe. Every day we read about a new development, including ongoing M&A activity creating industry consolidation, challenges, and opportunities created by drugs going off patent, the rise in affluence of developing countries, the potential for growth in emerging markets, and healthcare reform efforts in the U.S. and abroad.
The economic pressures on the industry have had dramatic effects on the pipeline development of major drug companies. With the extraordinary costs associated with bringing a compound from discovery to commercialization, a tremendous amount of scrutiny is placed on drug candidates at each phase of clinical development. The result is that companies have significantly narrowed their pipelines.
This has given rise to startup companies, often funded by venture capital, that give their undivided attention to developing only a handful of molecules or sometimes even a single product. If they succeed, they can be assured that the major pharmaceutical companies will either partner or acquire their company to help shore up their own pipelines. We see firms both large and small also focusing on narrow therapeutic indices or developing orphan products to assure timely approval for commercialization. The U.S. Food and Drug Assn. has set precedent that expedited review will be granted for companies developing products for unmet need. While the patient populations for these products may be relatively small compared to the blockbusters of years prior, the value of the products are significant and competition from products is limited.
The changing face of the pharmaceutical industry has created an evolution in the clinical services industry. Because of the time it takes to develop drug products, there is tremendous pressure to expedite products through the clinical phases and bring them to commercialization. This is a balancing act, as firms need to ensure they have data to demonstrate robust safety and efficacy, while at the same time maximizing speed-to-market and return on the investment for each study, at each phase of clinical development.
Impact to the clinical supply chain
The effect of these timing pressures can be felt across the clinical services segment. Firms are coming to providers like PCI looking for creative solutions to execute activities faster, provide increased flexibility, and identify ways to reduce cost. These pressures are felt across the spectrum of clinical trial services, including analytical services and drug development, clinical packaging services, as well as storage and distribution of investigational materials.
Adding to the complexity is the trend by companies looking to execute studies in a multitude of international countries, increasingly in emerging markets. While the U.S. and the various European member states have traditionally been and continue to be the strongholds for study execution, companies are now looking at places like Russia, Ukraine, and eastern bloc countries, Latin American developing countries such as Brazil and Argentina, as well as the Central America region. There is also a rise in the execution of studies the Asia Pacific region, with significant population growth and rapidly developing healthcare infrastructure in dense urban areas attractive for executing studies.
Responding to challenges and opportunities
With studies now being executed in faraway places, requiring supplies to be labeled in multiple languages and needing to support patients in vastly different cultures and healthcare environments, coupled with the mounting cost pressures, pharmaceutical and biotech firms come to service providers looking for added value and solutions. Companies need flexibility in their supply. For example, how can service providers enable them to potentially redirect study materials from one country to another, even when that requires completely different labeling or potentially different packaging? How do you ensure that the material is not compromised in the long journey to these remote study destinations? Firms need assurance from their partners that these invaluable study materials are of the highest quality and integrity, while balancing the need for flexibility and responsiveness.
Effective vendors need to be focused on evolving services to meet the current needs of the industry, but at the same time look to anticipate future needs as we see changes in global healthcare. Methodologies like Rapid Response teams help challenge the status quo by providing custom solutions to clients based on their unique study needs. Solutions that can help creative supply chain strategy are methodologies such as late-stage customization of investigational materials or just-in-time packaging to help firms pool their drug supply, enabling them to be ultra-responsive to their investigational sites.
High performing and trusted vendors can work to partner with clients and understand their challenges and pressures, which in turn allows a service provider to tailor our services to help them succeed in bringing life-saving medicines to patients around the globe. Overcoming these challenges gives each party pride in knowing they were able to help save lives. For more information about emerging global trends in the clinical trial services market, please visit pciservices.com.
Bob Misher is Senior Vice President and General Manager of PCI’s Clinical Services. He has been with PCI since 2009 and heads PCI’s Global Clinical Services group. Misher has over 28 years of experience in the pharmaceutical industry, both with research and development companies and outsource providers.
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