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Contract Sourcing failure rate in Phase 3. You would expect and even prefer Phase 2 rates to outweigh the Phase 3s, but it remains a challenge — and, yes, an opportunity — that both rates have been rising. Regulators offer more than rhetorical support for clinical trial effectiveness — partly in improving consultation of the type just described but also where it counts most for industry, helping more trials succeed. The most outstanding current example in my mind is in oncology. Richard Pazdur, director of the FDA's Office of Oncology and Hematology Products, has cited poor endpoint selection and insufficient patient populations as common problems with trials for drugs his office has famously rejected. He credits better practices in part for the new crop of cancer drugs the FDA has been rapidly approving. Lesson: Interact with regulators early and often, specifically with your clinical trial and generally with guidances, workshops, and consortia dedicated to GCP (good clinical practice). A LEAP OF VISION You may notice I've said nothing so far about personalized medicine (PM). To be honest, I accept that PM and Dx/Tx combinations may help patients with true rare diseases in ideal settings, but I fear the PM approach is becoming a closed and tightening circle that may condemn the industry to marketing mostly tiny-niche products with infinitely bloated price tags. I see no mere coincidence in the three out of four top areas (besides cancer) where clinical trial failures prevail: metabolic/diabetes, neurology, and cardiovascular. All of those are historical territories for primary care medicines. You, the industry, say medical need is always the guiding light for R&D;? Or have expensive clinical implosions and "niche mania" caused you to look away from the largest needs of all? Consider this. What if improved models, operations, and basic practices could put a dent in the late-stage failure rate for primary care drugs? The same question might apply to broadly applicable oncology drugs such as immunotherapies. Would that make the medical need there more visible? Failure is inevitable, and maybe even necessary overall. The fact is, science depends on failures to advance in knowledge and understanding. But to fail in an experiment is one thing; in a clinical trial, quite another. One teaches, the other also teaches, but in a costly and often destructive way. No matter how reformed or unreformed your system, what matters most in producing real innovations is the quality of planning and decision making at every stage leading up to and extending through clinical trials. Clean Utilities made simple. Not only clean, but pure. When producing pharmaceuticals, hygiene must take top priority. The ELEMENT diaphragm valves from Bürkert make your life simpler: featuring a hygienic design, easy cleaning and minimum space requirements, they can be used flexibly with optimal flow for maximum process safety. Perfect for high process yields and your peace of mind. ELEMENT diaphragm valves: A highlight in our system and more than just a hygienic solution. We make ideas flow. www.burkert.com October 2013 LifeScienceLeader.com 49