In Clinical Leader, Lorenzo D’Angelo discusses how to mitigate risks and maximize the benefits of pre-launch access programs to meet the intended goal to support patient access to treatment. Pre-launch programs can be be structured to provide additional safety and efficacy data that can support regulatory requirements, and can increase awareness of both a disease and progress in research among patients and clinicians and can highlight and reinforce a company’s commitment to patients. There are, however, some risks associated with pre-launch access programs, such as high costs and efficacy concerns. It is important that companies carefully assess both the potential benefits and risks associated with pre-launch access programs to determine the best structure to optimize benefit.
Read the full piece in Clinical Leader here.
Roundtable: Transitioning Medical Affairs to strategically co-lead clinical development and commercialization efforts
In May 2023, CRA’s Life Sciences Practice held a roundtable discussion with Medical Affairs leaders in Lisbon on best practices in transitioning from a...