Optimizing Clinical Development Plans Through Earlier Integration of Medical Affairs

Early involvement of Medical Affairs can be valuable to R&D by providing medical insights from HCPs to influence the TPP, go/no go decision, and optimize the clinical development program. Some biopharma organizations are hiring pipeline MSLs reporting to a Medical Affairs lead within the R&D organization to support clinical trial enrollment efforts and bring the voice of the customer to asset decisions. Defining disease areas of interest is also crucial, involving understanding diseases for which an emerging technology may have an application and determining the existing unmet medical need. Additionally, clarifying the patient journey informs the TPP, clinical feasibility of planned trials, and selection of clinical trial endpoints.

During the webinar, we will discuss considerations for the appropriate structure, resources, and timing to get Medical Affairs involved early enough in the process to optimize clinical development plans informed by medical customer insights. We will also have a dialogue around how early involvement of Medical Affairs can influence which indications should be pursued for a label versus investigator-initiated research.

Moderator:

Lori Klein

PharmD, Partner, Medical & Scientific Affairs Practice Lead

Putnam

Speaker:

John Yee

MD, MPH, Senior VP, Medical Affairs

Apnimed

Speaker:

Joseph Elassal

MD, MBA, Chief Medical Officer

Ankyra Therapeutics