Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology & Hematology

Posts tagged ‘Clinical Research’

I was supposed to be at the Innovation in Healthcare Symposium today at MIT in Cambridge, MA, but the winter ice storm that’s set to hit the North East has forced me to change my plans and return early from Boston to New Jersey. I am hoping to outrun the storm this morning (unlikely I know).

Hopefully, the presentations will be videoed and uploaded to You Tube or Webcast. Having traveled to Boston specially, I’m disappointed not to be able to write about the Symposium as planned.

A hot topic that came to my attention courtesy of an article in the Irish Medical Times, is how companies are handling incidental findings in the medical images they obtain during clinical trials.  To me, this is the flipside of innovation in that it often yields both positive and negative consequences.

Innovative medical imaging such as positron emission tomography (PET), Optical Coherance Tomography (OCT) and Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) are now widely used in clinical trials, and have opened the door to new ways to visualize joints, blood vessels, organs and tumors.  This innovation is leading to the development of imaging biomarkers such as reduction in joint space or reduction in tumor size that became surrogates for drug efficacy.

However, in the process, these clinical trial medical images are generating “incidental findings” (IF).  An incidental finding is something that shows up in a medical image obtained during a clinical trial, but is not related to the clinical trial protocol or study objectives.  The challenges is that what the reviewing radiologist sees may impact the health of the subject, making it an ethical issue not only for the reviewer, but for investigators and sponsors such as biotechnology companies.  How companies handle incidental findings in clinical trial imaging is a hot topic at the moment.

Part of the debate is to whether this is something that companies should worry about, given that we are talking about may be a relatively low incidence.  A September 2010 paper from Fletcher et al, “Incidental Findings in Imaging Research,” published in the Archives of Internal Medicine, reported that 39.8% (n=567) of 1426 research medical images showed an incidental finding. Of these, in only 6.2% was clinical action taken upon the IF and in only 1.1% (n=6) was there resulting clinical benefit to the patient.  This raises the questions of to what extent there is an obligation to report findings, who pays for this, and whether it is ethically necessary?

The National Institute of Biomedical Imaging and Bioengineering (NBIB) has published recommendations, that states researchers should anticipate incidental findings and have a policy to deal with them.

If I were a biotechnology company looking to hire a Contract Research Organization (CRO) or other outsourcing company for central review of clinical trial images, one of the questions that I would ask is what is their policy for handling incidental findings?

While innovation in medical imaging provides new ways of measuring and detecting disease, this innovation also generates unanticipated data that has to be addressed.

As reported today by BBC News,  a NJ based specialist pharmaceutical company, Antares Pharma has developed a gel based contraceptive, Nesterone® that is as effective as taking a pill, acccording to phase 2 clinical trial data presented at the annual meeting of the American Society of Reproductive Medicine (ASRM) in Denver.

According to researchers, the contraceptive delivered by the gel is as effective as that delivered by a traditional pill, but doesn’t show many of the adverse events and side effects such as weight gain & acne.  As always with promising phase 2 data, there is no guarantee that the phase 3 trial will show the same results, but this is definitely an innovative product to watch.

Nesterone® is being jointly developed with the Population Council (a non-profit organization). According to the lastest Antares Pharma investor presentation, they are looking for partnership opportunities for this product.  Based on the positive phase 2 data and a market worth $1B,  I am sure they will now have some business development interest.

Also, the company has a number of other injectable and transdermal gel products in development and collaborations with Teva, Uman Pharma and BioSante Pharmaceuticals. It will be interesting to watch how this small, emerging company and its products develop. A company to watch.

Welcome to the biotech strategy blog which provides commentary and insight on current news and emerging trends in biotechnology.

As a strategy and marketing consultant with a background in clinical development I am interested in how biotechnology companies grow, manage alliances, partner with CROs and bring new products to market. I hope that you will find posts on this blog to be informative and interesting.

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