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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.
This webinar will focus on the role of Medical Affairs to lead patient engagement in clinical development.
Medical Affairs teams are uniquely positioned to be the ‘strategic conveners’ of all stakeholders to help strategically guide the clinical development pathway from trial conception through pre-commercialization preparation.
By the end of this webinar, attendees will learn...
This webinar will provide the Medical Affairs community with a differentiated and bold view to drive the future state of Medical Affairs and what “good” looks like regarding the role of Medical Affairs in Clinical Development.
While the value of patient engagement is increasingly recognised in the clinical and launch phases of drug development, it is still a relatively new concept to involve patients in the early discovery phase. By understanding the burden of disease and patient’s aspirations for new treatments from the outset, pharma companies can ensure they are developing medicines that matter to patients. As experts in the disease area and therapeutic landscape, Medical Affairs are well placed to initiate and develop effective patient partnerships to ensure that the patient voice is incorporated during early discovery and beyond.
In this webinar we will explore practical approaches to engaging patients in early development, introducing key resources and discussing best practices. These discussions will be tailored to meet the needs of all Medical Affairs colleagues, regardless of experience.
In this webinar, you will learn how to:
Early Access includes a variety of programs by which pharmaceutical companies make investigational therapies available to patients with life-threatening diseases. These patients have either exhausted available treatments or have no approved options. This presentation will review the processes and procedures to consider in the implementation of an Early Access Program and explore the opportunities and challenges posed therein.
At the end of this webinar the participant will be able to:
602 Park Point Drive, Suite 225, Golden, CO 80401 – +1 303.495.2073
© 2024 Medical Affairs Professional Society (MAPS). All Rights Reserved Worldwide.