Patient Engagement in Drug Development: DIA 2016

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Phase 3 study of Ocrevus (ocrelizumab) in PPMS

When I see a new drug for MS come to market, I only think of the company behind that product – it could be one of the big names such as Genentech, Genzyme, EMD Serono, Biogen, or one of the many other players in the field.  I never stopped to think about what their drug development process really entails, other than acknowledging it is a lengthy and costly process.

I had the opportunity to attend the recent DIA 2016, in Philadelphia, as a Patient Fellow and I learned so much more about how these companies get their product to market.

DIA is promoted as Design, Innovate and Advance but it also the initials for the Drug Industry Association, a non-profit organization that supports and promotes drug development in all aspects.

The four-day convention featured presentations from panels on a wide variety of topics. Most infused the concept of patient engagement into their talks and even in their titles, but only a limited number of them actually had a patient on their expert panels. The exhibit area was massive, with the big and little companies all jockeying for position in the drug development process. The inside view busted my concept of how the big name pharmaceutical company drugs come to the market.

It seems most of the activities associated with the ultimate goal of approval from the Food and Drug Administration (FDA) are outsourced to other companies.  Sampling the various companies, there were those that handle patient recruitment for trials, securely storing trial data, filing the requests for approval with the FDA, shipping ancillary supplies, and translation services.  I found many pieces to the process and it was like putting a puzzle together to see the final product. My preconceived idea that drug companies do their own development from start to finish was apparently wrong – I had a lot to learn.

I did my best to cover the entire exhibit area and talk to company representatives manning the booths. I explained my presence, patient advocacy, and how iConquerMS is a research model that puts patients at the center of everything we do.

My message seemed better received by the smaller companies than the large ones, who have already grabbed their part of the drug development market and have their own ideas of what patient engagement might look like for their company. But maybe my perception is wrong. Maybe they were just trapped at their booth and they had to listen to my pitch.

I did my best to spread the word about my organization and how iConquerMS has almost 3,000 people interested in engaging in research, and who should be viewed as a valuable resource for their companies.

I had the opportunity to talk with Donald Deieso, Chairman and CEO of the WIRB Copernicus Group, one of the largest IRB firms in the country.  IRBs are Institutional Review Boards that provide oversight to ensure clinical trials follow ethical and legal requirements, and protect the rights and health of human subjects in biomedical and behavioral research. Copernicus is the IRB used by my research  iConquerMS; they oversee our studies. We talked about their review process.

Dr. Deieso said they involve members of the community such as pastors in their IRB review panels, but when I asked if patients are included in their IRB review process, he said no and that they had not even considered patient inclusion. I was encouraged when he listened to my ideas, and he agreed that patients should be included – and he would look into that idea further. I plan to follow-up with him to see where the idea goes.

There were 20 of us; all representatives from various non-profit organizations selected to attend DIA2016 as Patient Fellows. Our participation was meant to help DIA increase interest and visibility in patient engagement. In talking with these other Fellows, the consensus was that companies want to say they are talking about the idea of patient engagement, but most have no clue about what that might look like in their business model.

I will be writing more about the presentations I heard from industry and regulatory leaders at DIA 2016 and sharing them here.  Getting a true patient voice in all phases of drug development is an uphill battle but it is a need the leadership at DIA acknowledge and appear to embrace.

Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this blog article are not those of Multiple Sclerosis News Today, or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to Multiple Sclerosis.

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Laura Kolaczkowski comes from Beavercreek, Ohio, and worked at the University of Dayton for over 25 years until MS challenged her enough to go onto full-time disability. She is active in the MS community on multiple levels, and writes for her own personal blog, InsideMyStory and as a patient expert for Laura is the Lead Patient Representative and co-principal investigator for iConquerMS™, a patient powered MS research network. Laura freely admits her Liberal Arts background fuels her interest in patient engagement and empowerment and she struggles with the science of MS.
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