Parexel’s expanded Managed Access Program allows bio-pharmaceutical organizations to offer compassionate access to patients as the sector faces a growing public demand for therapy choices.
Managed Access Programs offer accessibility to an investigational drug when individual enrollment in a clinical study is not possible. The programs are also commonly known as Expanded or Extended Access, Treatment IND, or compassionate use studies.
Vice President, Managed Access Programs, Peggy Schrammel said that,
Parexel’s program allows bio-pharmaceutical organizations fill the gap between product development and release in offering life saving therapies in challenging situations.
“Demands are growing on bio-pharmaceutical organizations developing therapies for unmet conditions to make them accessible to specific sufferers even prior to the drug is labeled, packaged and fully commercialized,” she said.
Although these demands are not new, they are much more frequent these days, driven by an unprecedented public attention of the different stages and status of product development,” stated Schrammel. This consciousness expands over and above the medical group and patient advocacy groups to sufferers and their family members themselves.”
Sufferers may lack accessibility to therapies for numerous reasons. Schrammel explained, They may be ineligible for an on-going trial, studies may not yet have started or regulatory or reimbursement procedures are still on-going.”
Usually, a physician or patient asks for accessibility because an alternative treatment is not accessible and the risk posed by the disease or problem is higher than the risk of taking part in a Managed Access Program.
However, as Schrammel described, these programs can be complicated. Aspects that add to this complexness include, figuring out appropriate patients and treating physicians; handling a limited drug supply; guaranteeing scalability; among many others.
The new program was developed after reviewing various physician and patient responses, which Schrammel stated were important.
We have designed technology for our Managed Access Programs that supports patient recognition and management of requests, along with physician registration, drug supply supervision, and resource determination, etc. “Physician responses were crucial to assist us create a simple and intuitive experience for doctors so that they can easily ask for access for patients in immediate need.”