The CRO Advantage: Outsource Clinical Trials to Launch Biotech Development Success

Jun 01, 2005
Volume 18, Issue 6

Wendy Porter
With the exponential growth in biotechnology product development, there is a corresponding increase in the demand for experience and expertise in the implementation and conduct of biotechnology clinical trials. Small- and medium-sized biotechnology companies continue to look for ways to increase return on investment and potential earnings. Many of these companies have products in their pipelines that are indicated for rare and orphan diseases, prompting the need to reduce their clinical development time and employ aggressive strategic planning. This in turn will fulfill their promise of being independent, lean, and more efficient in drug development.1

Biotech companies have proven they can deliver innovative drugs. Several commercially successful biotech drugs have reached the market in the past three years. Of the 21 new molecular entities approved by FDA in 2003, six were developed through biotechnology techniques, more than any previous year.2 There are currently 370 drugs in clinical trials from biotechnology companies.3 Despite these figures, the drug development process is exceptionally risky for biotech companies. Less than 35 percent of all biotech companies have sufficient finances to survive beyond one year. Those who do face even more daunting statistics — only one out of five drugs entering Phase I trials gains market approval. Of the approved, only 30 percent recoup development costs.4

Biotech companies face big risks in getting their products to market. And with such limited resources, mistakes become costly. At all stages of growth, biotech companies need three things to succeed: a robust technology platform, capital, and a successful clinical development program. With the first and second in place, the final success of a drug lies in developing a safe and efficacious biological product for human use as demonstrated through clinical trials, which test the safety and efficacy of that drug in a clinical setting. Hitting a home run with successful clinical trials is key. Planning the optimum clinical development strategy and implementing that strategy correctly can make all the difference. That's where contract research organizations (CROs) can become valuable partners for biotech companies.

Partnering with or outsourcing to a qualified CRO experienced in biotech drug development can provide a strategic benefit — realized as a time and cost savings in the development and approval process of a new therapeutic agent or device. The process of conducting clinical trials with biological products is essentially similar to that for any pharmaceutical product. However, trials with these products present different challenges in terms of trial design, patient recruitment, and supplies. Limited resources and a science-versus-management focus present additional challenges. This article addresses issues that should be considered when outsourcing biotech drug development to a CRO.

WHY OUTSOURCE?The current regulatory environment is becoming stricter, making it more difficult and requiring more resources to develop new drugs, biologics, and devices. Drug development, for example, requires expertise in broad scientific disciplines: preclinical, clinical, ancillary clinical (chemistry, packaging, manufacturing, etc.), project management, and regulatory affairs. All of the required functions must be coordinated to minimize start-up time, effectively utilize time of operations, maximize efficiency, and support the filing of an appropriate regulatory submission. The end result: to produce a high-quality product in record time and within budget.

Figure 1. Biotech Products Entering Late-Stage Trials
The primary reason biotech companies outsource clinical trials to CROs is that they have limited internal resources to manage these functions. Often, small- to medium-sized biotech companies are unable to employ experts in all the required clinical development areas. Experience earned by veteran drug developers is a valuable asset to any new program or biotech company. In the end, the clinical development team for a biotech company will require the efforts of a biostatistician, data managers, a scientific writer, a medical affairs expert, and a project manager. This team comprises senior members from various departments. An expedient route to developing this resource is to outsource to a CRO partner with biotech drug development expertise.

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