The Medical Affairs Company (TMAC), a full-service CRO for the medical device and pharmaceutical industries, has recently been acquired by Parexel, a worldwide biopharmaceutical clinical trials company. Parexel intends to utilize many of the current services offered by TMAC, including medical science liaisons (MSLs) and clinical nurse educators.
Josef von Rickenbach, the chairman and CEO of Parexel, described the reason behind the February 2017 acquisition: “The commercialization-outsourcing market continues to grow as biopharmaceutical clients increasingly require medical affairs solutions to optimize awareness and understanding of their products in development.”
Diana Martin, director of Corporate Communications at Parexel, explained that the decision to acquire TMAC was to enable new growth and to capture opportunities in commercialization, regulatory, pharmacovigilance, market access and medical outsourcing.
“By acquiring TMAC,” said Martin, “Parexel gains new and distinct medical affairs outsourcing capabilities that will strengthen and expand its commercialization and market access offerings. This will give Parexel access to new customers and enable the company to compete for a broader range of business opportunities within the growing commercialization-outsourcing market.”
The outsourcing of medical affairs and MSL needs has risen, representative by the success of both TMAC and Parexel. In addition to trying to reduce fixed costs while also demonstrating the reimbursement and therapeutic value of their products, Martin cited a number of motivating factors to explain why pharmaceutical companies are outsourcing.
She said, “Companies must comply with more stringent industry regulations that limit the breadth of discussions their sales representatives can have with key stakeholders about established and new products. In addition, the increasingly complex nature of new products is creating demand for credentialed healthcare professionals such as MSLs, who can lead clinically robust dialogues with key medical stakeholders on a peer-to-peer level.”
Along with clinical nurse educators, MSLs represent one of the most intriguing and surprisingly valuable medical professionals employed by TMAC. MSLs assist in bridging the gap between clinical trial professionals and prescribing physicians, helping to initiate awareness of information gained in clinical trials as well as new therapeutic approaches to many diseases.
MSLs embody a growing field of scientific potential, particularly in the CRO space. Essentially, a MSL is a scientific and/or medical professional who helps with the flow of scientific information between clinical trial professionals and the medical community at large.
According to Dr. Peter Rutherford, vice president of Integrated Market Access at Quintiles, MSLs can help identify and communicate a new clinical need or mode of action of a new therapy to physicians, assisting in improving the knowledge of new therapies and interventions. “A MSL is a skilled scientific communicator who can engage with prescribing physicians in a non-promotional way about a new mode of action of a new therapy and clinical data from a drug-related trial. She or he is someone who is a real conduit in peer-to-peer scientific communications,” said Rutherford.
In regard to MSLs, Parexel plans on harnessing the extensive knowledge, experience and resources TMAC provides in an effort to expand their global offering. “Parexel will utilize TMAC’s MSLs,” Martin said, “to help biopharmaceutical companies build awareness and understanding of their investigational and marketed products in a flexible and customizable manner.”
The value of MSLs has been increasingly recognized in medical communications as well as scientific research, and the demand for these professionals in the medical community is expected to grow. According to Quintiles’ Rutherford, “There are several drivers for this growth. A positive clinical driver for the growth of MSLs is the need for professionals to communicate things like clinical trial data, mode of action of a new therapeutic drug, etc.”
Rutherford also noted that the increasingly stringent regulatory process has made the need for MSLs, who are specialized to educate the medical community on new therapies in a non-promotional way, grow steadily. Rutherford said, “The MSL is the key insight for the pharmaceutical organization and enhances the active listening system. This insight, coming from the medical affairs team, really helps the medical team in the pharmaceutical organization develop a medical plan and strategy that is ultimately aligned with the commercial plan.”
MSLs also play a pivotal role even before the launch of a new therapy. According to Rutherford, “At prelaunch, the MSL is discussing an unmet need, a therapeutic area and is heavily involved in the clinical trial. Even during the clinical trial program, the MSL can play a role as a scientific liaison in clinical trial sites to help physicians understand the drug in the trial and the new therapy.”
By communicating new therapies to physicians effectively and unbiasedly, MSLs are a component in the patient care improvement process. “Today, we have molecular-targeted drugs, personalized medicines and complex therapies in terms of their modes of actions. Therefore, this communication of evidence, of therapy positioning, of biomarkers and choice of the right drugs for the right patients, is imperative,” said Rutherford. “If the prescribing physician is more aware of the mode of action and therapeutic target, the physician is more likely to use the right therapy for the right patient at the right time. That’s where the MSL can really focus in—to educate the physician and ultimately benefit the patient.”
Parexel’s acquisition of TMAC is expected to close by the end of February 2017.
This article was reprinted from Volume 21, Issue 06, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »