Who Is Advising Regulatory Authorities and Why You Should Know

Scientific and medical experts who serve in an advisory capacity can bring highly relevant insights and expertise in partnership with life science organizations.

Advisory positions come in a number of different guises: corporate advisory boards, whose members provide informed guidance on scientific, medical and business aspects, journal editorial boards whose members are highly qualified and recognized for their contributions to their field of work or medical society board or committee members who are on the forefront of medical, policy and advocacy issues.

For input on regulatory issues and developments there is a small, highly relevant and qualified group of professionals: medical and scientific experts who advise regulatory authorities, e.g. who serve of the FDA Advisory Committees or are designated “European experts” by the European Medicines Agency (EMA).

A quick overview of FDA advisory committees …

The FDA has established advisory committees as a way of obtaining independent expert input and advice on scientific, technical, and policy matters related to drugs, biologics, medical devices, and food.

Individuals who serve on these committees need to meet stringent requirements, specifically they must be “technically qualified experts in their field (e.g. clinical medicine, engineering, biological and physical sciences, biostatistics, and food sciences) and have experience interpreting complex data.” (1)

  • Academician/Practitioner - use their expert knowledge to advise the FDA on issue currently being deliberate, e.g. in their role as a scientific or technical member.
  • Consumer Representative - represent the consumer perspective and to serve as liaison between the committee and interested consumers, associations, coalitions or consumer organizations and facilitate the dialogue on scientific issues that affect consumers.
  • Industry Representative - represent the perspective of the regulated industries as a whole rather than that of a specific company. To avoid conflicts of interest industry representatives are non-voting members.
  • Patient Representatives - share insights and input from the patients’ perspective to inform product development and decision making. They have to have personal experience with the disease as patient or caregiver and fullfil additional criteria (2).

FDA advisory committees have significant impact on the FDA’s decisions. Although the advisory committees’ recommendations are not binding, the agency typically follows their endorsement. A 2019 study (3) shows that in 78% of the cases the FDA’s final actions were in line with the advisory committee recommendations and in cases where there was disagreement the agency tended to follow the consensus of the advisory committee.

… and EMA European Experts

The EMA has a pool of European experts that “serve as members of the Agency’s scientific committees, working parties and other groups, and provide scientific expertise to the Agency’s activities (…).” (4) Nominated either by the EMA directly or by one of the member states (EU, Iceland, Liechtenstein and Norway) these European experts are involved in aspects of authorization, supervision and maintenance of medicinal products, e.g. the Committee for Medicinal Products for Human Use (CHMP) can request the support of its working parties, scientific advisory groups or ad-hoc expert groups to answer specific questions.

European experts are required to declare conflicts of interest (DoI) yearly or as they arise and are required to work independently of their nominating authority.

The EMA consults external experts in about 25% of the assessments of new medicines (5).

Regulatory authority experts as source of information for life science companies

Experts tasked with advising regulatory authorities play a crucial and prominent role in shaping the decisions of these authorities and their behavior provides distinct and valuable input for life science companies:

  • Experts activity focused on safety, biological activity, and efficacy may provide valuable input concerning trial design.
  • Experts opinion linked to the approval process for biologic products may be helpful in shaping clinical development plans.
  • Experts who focus on the rationale, safety, and adequacy of study design and interpretation of results could be excellent advisors on important topics like protocol design or review.

For life science companies engaging these experts is highly challenging. Of the EMA European experts, for example, the majority currently declares no direct (e.g. employment by or consultancy for a pharmaceutical company) or indirect (e.g. research work for a pharmaceutical company) interests and these experts might therefore be reluctant to engage with a company. However, it is nevertheless important to know who they are and understand their scientific behavior and opinions and then apply that knowledge to decision making.

How to identify regulatory authority experts using Monocl Professional

Both the FDA and EMA publish information about the experts who advise them. The FDA publishes the rosters, current and previous meeting materials and the charter of different advisor committees on their website (6). The EMA publishes the list of European experts on their website (7) along with downloadable DoIs and CVs; additional information about an expert’s specific areas of expertise and prior DoIs are made available on request.

While this high-level information is accessible, it provides little information about an expert’s scientific point of view and behavior. To develop in-depth profiles of experts, additional information, such as their publication history, clinical trials, speaking engagements or committee memberships, is necessary.

Collecting that information about a number of experts is an extremely time-consuming task that can be made more manageable by applying a data-driven approach utilizing an expert database.

Monocl Professional provides a straight-forward filtering function to identify experts associated with the FDA or the EMA. Based on that initial search you can narrow down the list by applying additional criteria and filter options and then develop a comprehensive overview of each of the short-listed experts by looking at their publication history, research focus, meeting presentations, and other activities.

This data-driven approach offers another advantage: while experts engaged with regulatory authorities might not be available for engagement with a life science company, the collaborator information provided in Monocl Professional can help you identify colleagues within their network who have similar qualifications who might be available for engagement.

In summary, comprehensive profile and network information enable you to develop a better understanding of the experts advising regulatory authorities and that knowledge can inform internal decision making.

If this blog piqued your interest in Monocl Professional, please do not hesitate to book some time with one of our team members who will be happy to give you a personalized tour. You can do so by clicking here.

Related Reading

Editorial Boards – Experts Selected by Experts

Advisory Boards – The Challenge of Selecting Advisory Board Members

Medical Societies - Five Ways Medical Society Board Membership Can Inform Selection of External Experts

References

(1) www.fda.gov/advisory-committees/advisory-committee-membership/advisory-committee-membership-types
(2) www.fda.gov/patients/learn-about-fda-patient-engagement/about-fda-patient-representative-program
(3) The Milbank Quarterly, September 2019, Volume 97 “Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008–2015” https://www.milbank.org/quarterly/articles/association-between-food-and-drug-administration-advisory-committee-recommendations-and-agency-actions-2008-2015/
(4) www.ema.europa.eu/en/about-us/how-we-work/european-medicines-regulatory-network/european-experts/all
(5) www.ema.europa.eu/en/documents/other/about-us-european-medicines-agency-ema_en.pdf (page 14)
(6) As an example, this website contains the relevant information about the Oncologic Drugs advisory Committee https://www.fda.gov/advisory-committees/human-drug-advisory-committees/oncologic-drugs-advisory-committee
(7) www.ema.europa.eu/en/about-us/how-we-work/european-medicines-regulatory-network/european-experts/all
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