Retina 2016 Workshops – Thursday, November 10

Fighting Blindness held two topic-specific workshops as part of Retina 2016. These events were attended on an invite-only basis.

Stem Cell Workshop

The first of these focussed on stem cells as a potential treatment for degenerative retinal conditions. This meeting included scientists, clinicians and industry representatives with expertise in the area. The goal of the session was to assess the global progress of ocular stem cell research and to identify the current issues and challenges, with a view to assisting Fighting Blindness in determining where we can have the greatest impact. One of the key points discussed was that while stem cell clinical trials have demonstrated good safety, there has so far been a lack of evidence for the benefit of these therapies in preventing vision loss or ultimately restoring vision. As such substantial further research is required in the area. It was also noted that it is key for Fighting Blindness to bring the patient perspective to the research, in terms of design of clinical trials and endpoints and also advocacy and informing patients.

Clinical Trials Roundtable

The second workshop brought together researchers, clinicians, regulators, policy makers, representatives of the pharmaceutical and biotechnology industry and people affected by vision loss. This was the fourth year of holding such a roundtable discussion at Retina, with the goal of helping to clear the path in bringing treatments to patients. The topic of this year’s discussion was regulations and how researchers could expedite the process of meeting regulatory requirements.

It was agreed that researchers often perceive that the regulatory requirements for getting a potential treatment to clinical trial are insurmountable and that this can lead to delays in moving therapies along the path to patients. A representative from the Irish Health Products Regulatory Authority (HPRA) discussed new measures being taken by the agency to engage with researchers at a much earlier stage in the development process in order to ensure that they are on the right track.

The attendees also heard testimony from patients who shed light on the realities of living with vision impairment. The necessity for patients to become informed partners in the research and development process and be consulted at all stages of research in a meaningful way was discussed.

The take home message was that in many cases research in the lab may be closer to becoming a therapy in humans than the researchers think. It was clarified that while the role of regulators is to protect the public and society, they are the ally of both patients and researchers and are much more flexible than people may think. Their role is to help and advice, and input from patients is invaluable.

You can download a full report from the Clinical Trials Roundtable meeting below;

Click here to download as a PDF document.

Click here to download as a Microsoft  Word document.

 

 

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