Why hold an advisory board meeting?
Pharma invest heavily in bringing new therapeutic drugs to the doctors and their patients to help them manage, treat and sometimes even cure their diseases. These new agents are undergoing expensive phase 1, 2, and 3 clinical trials to establish that these drugs (or devices) are safe, tolerable, efficacious, more convenient and/or better (or no worse) than the current standard of care (SOC). Pharma companies want to make sure that what they are developing is actually seen as being a valuable addition to the doctors, their patients and their disease. And also, to understand if the market is ready for this new product, and if it is not yet, what needs to be done and put in place in the (near) future in order to have a successful launch of the drug. Pharma companies therefore ask advice from local key opinion leaders (KOLs) during an advisory board (ad board) meeting. As a Medical Science Liaison (MSL) you can (and should) be involved in this process.
When would you hold an ad board?
It is common that companies run multiple advisory board at different stages of the life cycle of the drugs to address different objectives in the product life-cycle of the drug. The first local medical advisory board is often held 12-18 months prior to the expected registration of the drug to get a broad understanding of the below mentioned topics (although this can differ from company, to country, to therapeutic area and/or the drug and the company’s history and knowledge in this therapeutic area).
What to discuss at an ad board?
There can be many topics discussed at an ad board to prepare your drug for the launch into the market and these can include the following:
- Understanding the current treatment landscape and algorithm that doctors use for treating a given disease
- Get input on the company’s latest clinical trial data and understand how the KOLs perceive this data in light of your competitor data
- Understanding where your drug will fit into this treatment algorithm (i.e. upfront, second or third line).
- Are there any (local) data gaps in your clinical trials that need to be addressed with Investigator Initiated Studies (ISS)
- Understanding how doctors should best manage the side effects of your drugs.
- How does your drug address the unmet medical need of the patients?
- Are there any barriers to prescribing your drug (long infusion, difficult to manage side effects, fast turn-around time of genetic test required etc.)?
- Understanding the referral pathway of patients. Who refers to whom and is this the best pathway for the patient?
- Validate assumption about epidemiology and explore if there are any local registries that can be accessed to support your reimbursement submission.
- Getting (written) endorsement from KOLs to support your regulatory approval and/or reimbursement submission.
- Understanding the barriers for quick turn-around time of genetic testing to allow patients timely access to life changing medicines.
- Obtaining advise on the type of medical education and resourced required for doctors or patient support programs that need to be initiated and the list goes on and on and on
How to prepare for an ad board meeting?
Ad board meetings in the pipeline phase are always led by the medical affairs team (MSL/medical manager/advisor/director) and you as an MSL can provide a lot of value and input. First, (often) the medical advisor/manager must clearly state the objectives of the advisory board, this is for compliance reasons. Next, the medical advisor/manager drafts a detailed agenda to ensure that all the questions of the internal stakeholders (regulatory, market access, clinical, commercial, medical etc.) have been addressed. With your MSL in-field insights from the doctors and knowing their area of expertise you are an important source to provide input into the topics on the agenda and the attendees list for the ad board. Furthermore, picking the right chair for the ad board is crucial. He/she should have the respect of the other KOLs, and be a good moderator managing a large group of people to get all the answers you need as a company. The medical advisor/manage will discuss the agenda, attendee list, date and location with him/her and get further input for the day. Once the agenda and the attendee list have been finalized you as the MSL are often involved in the implementation phase. Sending out invitations, briefing speakers, organizing flights and accommodations, reviewing the presentations and having contracts signed and returned. (Of note, some MSLs do almost everything for an ad board).
Why is it so important to have an ad board planned early and have the right people attend it? Imagine your drug has come to the market and during the ad board you were told that the turn-around time of the diagnostic test that is required for the patient to get access to the drug, would only take 5 days. But you forgot to invite a KOL/pathologist from a large regional hospital, who would have told you all regional hospitals struggle with turn-around times of genetic testing and it would actually take them 30+ days to obtain the data. I can tell you, quite a few people inside and outside the company will not be happy when you tell them that a majority of the patients will not have access to your new drug at launch.
In conclusion, being involved in an ad board is exciting and gives you a much bigger picture of a drug launch. One is surrounded by top leaders in their field who are (sometimes heatedly) discussing and debating the topics and challenges you are facing in your drug launch. They provide you with views and solutions that you might have never thought of and that are crucial to launching your drug faster and better and that will give these KOLs earlier access to practice-changing medicines for their patients and their diseases.
Now that the ad board is finished, you as the MSL can start testing some of the assumptions of the ad board meeting with a wider audience of health care providers and start implementing some of the suggestions provided to you by the KOLs to get ready for the launch of your drug.
Dr Martijn Bijker, PhD MSc
Founder of “from SCIENCE to PHARMA” – the only global online Medical Science Liaison (MSL) training platform helping Bachelors, Masters, PhDs, MDs, and PharmDs to maximize their chances of becoming an MSL.
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MEDICAL SCIENCE LIAISON (MSL) – ADVISORY BOARD MEETINGS last edit: 2017-11-26T12:34:58+00:00 da