Practical Pointers for Drug Development and Medical Affairs

Drug Development

• It is often difficult to locate academic clinical research sites that are not already filled to capacity or who are so short-staffed that they cannot take on new projects.  This provides an opportunity to work with and help educate and train the lesser-known medical institutions that have both the medical expertise and specific patients but lack substantive experience in clinical trials. 

• Currently, there is a greater emphasis on enrolling additional populations that have not adequately participated in clinical trials such as minority, geriatric, and pediatric populations.  Investigators should ensure that these potential subjects fully understand the risks and benefits (the informed consent process) of participating in these studies. It. may be useful to have them answer a series of standardized questions to demonstrate that they understand the essential elements of the Informed Consent Form (ICF) (IRB approval should be obtained for the questions if in written form).

• The following are links to FDA webpages and documents relating to the pre-IND and IND process that should be reviewed when developing your pre-IND submission briefing package:

• Small Business and Industry Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting

• Investigational New Drug (IND) Application

• Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators

• Guidance for Industry: Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products

Medical Affairs

• New AI tools, ChatGPT for example, may be helpful in writing journal articles. This is especially true for providing an outline of the topics that you want to cover in the article.  It may also be useful in finding references to help produce your original material, but they should be checked for accuracy. 

• When launching a new product or introducing a new indication of an established product, we recommend that you have multiple review articles discussing your product from not only an efficacy and safety standpoint, but also from a pharmacoeconomic standpoint and potential position in the Health Care Provider (HCP) therapeutic regimen. 

• When promoting your product, you may want to emphasize the importance of the individual patient reaction to a specific medication.  Just because they reacted poorly or insufficiently to one drug in a specific class, does not mean they will react the same way to all drugs within that class.[1]

[1] Sundström J, Lind L, Nowrouzi S, et al. Heterogeneity in Blood Pressure Response to 4 Antihypertensive Drugs: A Randomized Clinical Trial. JAMA. 2023;329(14):1160–1169. doi:10.1001/jama.2023.3322