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
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.
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.
Figure 1. Biotech Products Entering Late-Stage Trials