Setting new standards in information exchange for the pharmaceutical and biotech industry
Craig Lipset, Head of Clinical Innovation at Pfizer, asks, Can We Bring Disruptive Innovation to Clinical Trials?
September 12, 2012
Later this week I am co-chairing a conference on this topic along with colleagues from Janssen and Novartis. The program will include presentations from pharmaceutical companies, technology companies and others looking to impact this space.
Holding a conference on innovation in the conduct clinical trials makes an assumption — that we are actually able to innovate in this space. The notion that pharma can innovate, however, is often a topic of debate.
Some claim that pharmaceutical companies innovate everyday – researchers are aggressively exploring new disease pathways and developing new technologies to impact disease.
Others suggest that pharma has grown too large to innovate – that innovation can only come from small and nimble companies.
I worked at a very small and very successful biotechnology company before joining Pfizer. We were roughly 30 people, and I was responsible for our regulatory application to FDA and clinical plans to start our Phase I clinical trial. Like most companies this size, we were nimble and entrepreneurial; attributes most large companies envy. Our science was cutting edge – truly innovative.
That clever young company, however, was not going to innovate and transform the field of clinical trials. Because it barely had any activity or presence in clinical trials.
While some suggest we must rely on the small and nimble company to drive innovation for pharma, that model does not extend past research and into clinical development. Rarely is a venture-backed biotech company running clinical trials; for the few in the clinic they often have very few studies, are limited to early phase, are heavily outsourced, and with extremely limited financial resources. That is hardly the presence needed to bring transformation to a field.
If there will be innovation in this space, it must come from those with the most at stake – pharmaceutical companies with extensive pipelines in the clinic running hundreds of concurrent clinical trials.
Fortunately disruptive innovation in this field does not have to be born and nurtured exclusively within pharma companies. Today more than ever, drug development includes unprecedented partnerships – with academia, with contract research organizations, with non-profits and with patients. Innovation in the conduct of clinical trials will come from this intersection. And when it comes, we must be willing to listen.
We must appreciate that we have the ability to innovate in the conduct of clinical trials. We are able to maintain our regulatory and legal obligations, our commitments to patient safety and quality and still embrace disruptive change.
We must appreciate that we have also have an obligation to innovate in this space. The increasing cost and complexity of clinical trials jeopardizes the ability to develop new medicines for patients in need. We must innovate in this field to ensure a sustainable pipeline of medical product development for patients and healthcare providers.