1. How do you see clinical trials changing in the next 3-5 years?
My view on clinical trial conduct reflects the view of a biotechnology company whose future depends on partnering to big pharma/biotech. Although big pharma/biotech are big due to successful drugs earning substantial profits, many of these drugs are coming off patent and there does not appear to be suitable replacements. Generic competition will have the result of eroding big pharma/biotech’s monetary war chest. This being said, big pharma/biotech will need to support its current operating expenses with significant drug replacements to earn them sufficient money to keep operations going at is current pace. For this reason one might think that big pharma/biotech will want to partner early with biotechnology companies to fortify their pipelines. However this does not appear to be the case as risk appears to trump innovation. Hence, big pharma/biotech want to de-risk their partnering events with statistical proof of concept in the clinic. Under such a circumstance, typical Phase I studies, essentially showing safety and identifying a Phase II dosing regimen is often insufficient to entice big pharma/biotech to partner. For this reason early clinical trials, notably Phase I, needs to pack more power to their punch. This means not just safety data but a greater deal of efficacy. Including surrogate markers has become a must and utilizing clinical trial protocols which result in a better view of efficacy is becoming necessary. I will not go into specific clinical trial protocols here as each disease indication type merits its own approach. However I will say that clinical trial protocols are evolving into more of a Phase II design than its simple predecessor Phase I study in the past.
2. What are the top 3 challenges facing small and virtual companies in today’s outsourcing environment?
It is vitally important to know your potential CRO’s capabilities prior to signing the deal. One can’t simply going by their marketing group verbiage. Getting opinions by companies that have used CROs is helpful but even then not necessarily useful due to variability in their personnel assigned to your study. Secondly, one must read the fine print in the agreement with a CRO. Be sure that if things go south, you will be in a position to right the wrongs in a way that does not hurt the company but forces the CRO to make appropriate amends. Lastly, working close with the CRO is a necessity. Do not expect everything will work as planned and as one needs to ensure the trial is not only done well but in a timely manner, ensure that deadlines are met.
3. How can virtual/small companies demand the level of attention from their CRO partners?
It is imperative that agreements are put in place with deadlines. If the CRO has to meet certain deadlines in their agreements, and if they do not meet such deadlines they are penalized, this will work to ensure a proper level of attention. Also, it is helpful to determine whether your CRO, prior to choosing the CRO, has little competition within the company for resources for your indication area. This will help in your getting your work done well and in a timely manner.
4. What are the key innovation lessons that midsized and large pharmaceutical companies can learn from virtual/small companies?
Innovation depends on using the right people for the right work without a hierarchical trickle down mentality.
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