The medical support needs of novel therapies necessitates a strategic evaluation of the medical affairs function. Previously, medical affairs disseminated medical information in response to unsolicited requests and facilitated unsolicited grant funding. Now, the function is strategic and cannot just be reactive.
The current medical affairs organization was established in response to legal and compliance requirements to remove commercial influence from decision-making in business areas requiring medical objectivity, including medical information, research and educational grants.
In today’s small molecule market, the medical support needs of patients, physicians and hospitals is much greater. The educational and research needs are different. The medical affairs team must be an advocate for the company and its commitment to stated therapeutic areas.
Ensuring that risk-based compliance controls are established is essential to establishing the proper boundaries between commercial and medical operations.
The modern medical affairs function has to support:
Medical affairs stands to serve as a strategic conduit for break-through medical dialogue, while also continuing to serve as a control against disproportionate commercial influence in medical interactions.
Baker Tilly works with organizations to develop and execute their medical affairs strategy and therapeutic area platform. Our capabilities and services include: