I recently attended the Medical Affairs Professional Society’s (MAPS) inaugural annual meeting to learn more about this newly established non-profit global society of Medical Affairs professionals. Its mission: Elevate the role of Medical Affairs to be a partner with its Commercial and R&D colleagues and lead the industry in the education of customers on the safe and appropriate use of products for the benefit of patients.
“Medical Affairs is increasingly recognized and being held accountable to support critical success factors within the business,” said Thérèse McCall, PhD, MBA and member of the MAPS Executive Leadership committee. Dr. McCall gave several examples of new capabilities that need to be developed and driven by Medical Affairs to build a world class Medical Affairs organization,” including being patient access champions and driving “one scientific voice” for company assets across the business.
“We also need to embrace new technologies, be innovation seekers, and partner with our cross-functional teams on new issues to support these deliverables,” she added. “If we do this well, we will play a greater leadership role in informing data needs and its interpretation, thus ensuring availability of more relevant data and high-impact communication to truly address patient needs.”
Another presentation that caught my attention focused on driving medical communications toward a new future. Celgene Corporation’s Executive Director and Head of Global Scientific Communications, Robert Matheis, PhD, MA, shared current trends that are helping drive medical communications into a redefined future.* Dr. Matheis cited several seminal trends within medical communications:
1. Integration
According to Dr. Matheis, publication planning and development must be conducted with broad functional integration. All medical professionals, from Health Economic Outcomes Research (HEOR), Medical Information, Compliance, Medical Publications, and those in the field, must contribute to the plans for developing and disseminating data to customers. It is critically important for these different functions to work together and think across the board.”
“It is not optimal to consider a publication or abstract in isolation. Individual medical and scientific publications are just one part of a comprehensive story that provides evidence for how and when to use treatments with patients. Cross-functional collaboration is necessary for effective communication. When we work together, we reap the benefits of insights, consistency, and smart tailoring.”
“Internal collaboration with medical information (MI) departments ensures that companies communicate highly scientific information to healthcare professionals in response to unsolicited queries,” explains MAPS member, Patrick Reilly, CEO of phactMI™—a non-profit consortium of pharmaceutical medical information departments. “To ensure consistent communication of safe and appropriate use of medicines, we developed the MI Code of Practice (bit.ly/2AhqWG2) which is timely given the increase in the size of Medical Affairs organizations across multiple functions in anticipation of the variety of formats across multiple channels.”
2. Strategy and Tactics Focused on Impact
Dr. Matheis believes that medical communications and medical affairs professionals need to focus on delivering true value, not simply completing a tactic or a task, such as execution of a congress presentation or publication of a manuscript. It is not about the number of engagements, or number of times the phone was answered. It’s about achieving the mission of delivering optimal patient care. This can include how medical evidence has been incorporated into healthcare decision making, thereby reaching patients and improving their health.
“Medical affairs professionals need to develop a healthy obsession with understanding how every tactic they develop will impact patients and their health, starting with the endpoint in mind. It won’t be acceptable to only ask what goal we want to have achieved. We need to ask ourselves, ‘When I finish this, what will happen?’”
3. Market Access and Real-World Evidence
“While not a new trend, market access and health economic outcomes research has yet to realize their full value, particularly when it comes to medical publishing to support the cost efficiency of treatments,” Dr. Matheis explained. Often times, market access publications are considered an additive component of a clinical/medical communication plan. In actuality, HEOR evidence should be an integrated component of a broader communication plan where a story of safety, efficacy, and effectiveness is delivered to support product use and access. To this end, careful consideration must be taken to develop medical communications tailored for specific audiences, acknowledging that payers require different evidence than providers.
4. Patients as Healthcare Decision Makers
In the future, Dr. Matheis believes that medical affairs and medical communications professionals must address the communication requirements of patients, which represent an important stakeholder in healthcare decision making. It will not be sufficient to merely state that we are patient centric. We must demonstrate a patient perspective by actively considering where in the development of communication tactics there should be patient contribution. For example, medical affairs professionals will need to consider the option of including patients as contributors to studies, as authors on publications, etc.
“There is a near-term opportunity for medical affairs professionals to advance how they engage the medical community in supporting evidence-based care for patients,” stated Dr. Matheis.
5. Compliance as a Medical Affairs Partner
Collaboration between medical affairs and compliance professionals ensures companies drive medical communications toward a new future with a full understanding of recent settlements and CIA trends. According to compliance veteran, Eve Costopoulos, “Settlements reflect the government’s desire to see companies demonstrate independent medical judgments to ensure research integrity, unbiased science, and patient safety.”
Life sciences attorney and CCC Advisory Board member, Kerry Rothschild agrees that collaboration between medical affairs and their compliance colleagues is essential. “Communication of medical and scientific information to healthcare providers and patients requires a clear understanding of the relevant regulatory and enforcement framework.”
“It is imperative that the focus remain on enhancing scientific understanding of the therapy and, ultimately, improving patient care,” Rothschild concludes. “Companies must avoid the appearance that their medical communications may be commercially motivated. Thus, Compliance input is essential when developing and executing communication plans.”
*Disclaimer: The thoughts, views and opinions expressed within this presentation, stated or implied, are those of the presenter and are not necessarily reflective of the perspectives of Celgene Corporation.
