MA is set to become a fully-fledged strategic partner. But what has driven this change & what can we expect in years to come?
By: Deirdre Coleman on Nov 22, 2016, originally posted here: https://social.eyeforpharma.com/clinical/changing-face-medical-affairs
The remarkable surge in the size and importance of the Medical Affairs function within pharma companies has roots going back decades. Over many years, pressure from regulatory agencies, payers and healthcare professionals, as well as public sentiment, has led to a clearer separation between the Medical and Commercial functions. It was between these separating tectonic plates that Medical Affairs emerged.
As the traditional single-customer pharma engagement model is replaced by a village of interconnected stakeholders, Medical Affairs is uniquely placed to engage with them. It is equipped to understand the challenges pharma’s stakeholders face and to work as a genuine partner to find solutions, improving patient care and creating value for all stakeholders.
“We are now looking at the medical community as an ongoing strategic investment, a long-term, mutually beneficial partnership, whereas before it was more transactional, more sporadic,” says Keith Allan, former Medical Director at Novartis. “The customer base is far broader now, with payers and regulators looking for evidence of the medical, clinical and economic value of our medicines. The needs of the medical community has expanded enormously, together with the technical complexity associated with the interactions. The [Medical Affairs] function is more strategic as we act as ambassadors and facilitators of information exchange, delivering insights back into Development. It calls for a broader set of capabilities, more business acumen and greater alignment with the commercial goals of the company.”
“Companies have to become the trusted scientific partner. Earning that trust comes through the science, not just pumping out commercial messages. If we’re not able to do this well, we will struggle. “
For Michael Zaiac, Head of Medical Affairs at Celgene, it is long-term engagement within a therapeutic area that builds and maintains long-term strategic partnerships with key opinion leaders. “To move from transaction to true partnership, you need to be in it for the long haul,” he says. “We develop a 15-year plan for what we’re going to do in each therapeutic area. We listen to HCPs and interpret what they want and produce items in partnership with them. We have to understand what our partners want to hear and generate the information they want to hear. We are the mediators – we are there to work with people”.
An expansion of capabilities is required if companies are to understand the patient experience, access, and influence a broad array of external healthcare stakeholders, and act as a liaison between the medical community and the internal research organization.
Medical Affairs teams need a wide range of capabilities, says Danie Du Plessis, Head of Medical Affairs at GlaxoSmithKline. “As part of our new business model, which puts Medical staff increasingly at the forefront of HCP interactions, we have emphasized four areas of medical competency and capability: scientific and product expertise, value and access, governance, and communications skills. We really recognize the need to bring those areas together into the ability to translate information into value – to be an engaging communicator, able to moderate and facilitate a conversation between peers with credibility and balance – a considerable skill in itself. They also need to have business acumen, understanding commercially what we need to do and translating the scientific data in a strategic way that would genuinely improve outcomes for patients,” he says.
However, the critical capability is a deep scientific knowledge in order to address unmet need and advance the treatment of the disease, says Gundula Schneidewind, VP, Medical Affairs, Europe and Canada at Takeda. ““In particular, this is true for specialty treatment; companies have to become the trusted scientific partner, earning that trust through the science not by pumping out messages. We owe it to the patients to generate knowledge and, in collaboration with external partners, help advance science.” This starts with deep therapeutic insight, including a better understanding of the epidemiology across geographies right through to data generation, she says. “Starting by recognizing unmet needs and working towards patient-centric solutions, companies can find ways to provide genuine value to those we serve. It’s our job to spread this top-notch knowledge and make it available to the wider community of treating physicians.”
The Trends Driving the Growth of Medical Affairs:
Physicians seeking peer-peer interaction; Physicians requesting greater scientific and evidence driven dialogue information on innovative medicines from industry; conventional commercial interactions are decreasing; customer-facing model is becoming increasingly ‘medicalized’
Tougher regulatory controls; societal expectation; Impacting relationships with HCPs & HCOs, with public scrutiny. Harsher compliance measures, with complex changing guidance, regulations & laws that differs between countries & carries risk of harming reputations through heterogeneity of approaches & leading to severe fiscal penalties
Increased transparency expectations; Rapidly emerging world-wide regulations demanding greater transparency on data from trials, publications, data disclosure, HCP financial transparency, non-HCP interactions, oversight of patient engagement
Increasing safety concerns; Growing concern about safety of medicines and requirement to increase the early signal detection, the speed of response on safety issues, utilization of big data approaches to better understand benefit-risk and encompassing social media as a source of safety information
Rising development costs; Impacting time & ability to deliver locally relevant evidence in a timely and cost-effective manner; increasing pressure on medical plans for local data. Adaptive licensing will require new approaches including need to innovate more early on for efficient in Life Cycle Management
Greater requirements for post- marketing evidence; Most approvals accompanied by Post-Marketing Surveillance and Risk Management Plan requirements. Creating capabilities and focus on developing and executing low-cost efficient observational studies is an imperative
Payors pushing for Real World Evidence; There is a rapid shift towards the requirement of community-based local evidence and higher hurdles for proving product value and defining relevant patient outcomes. In parallel with the increased availability of local data on outcomes and big-data analyzing capability, the shift towards mastering RWE is fundamental
Vocal patient populations; Influence of patients is fundamentally changing, with increased empowerment and social media rise of “consumerism”. Impact of Influential POLs blogging on trials & products, rapidly forming patient advocacy groups, alter perception of marketed drugs. Patient groups could also become critical sources of development /medical funding, and providing insights into shaping programs and educational needs
Shifting global demographics; Understanding heath care systems in rapidly developing countries will be essential to ensure the medicines can fit into the new system and ethnography. Building the evidence into the development programs will be challenging. Medical teams will need to address gaps and have local capabilities to execute studies
Source: Sanofi Medical Affairs Roadmap Presentation
The future for medical affairs
Medical Affairs has to become more proactive about bringing insights from a broader range of external medical decision-makers and influencers into early clinical development. Furthermore, it must also take a lead in demonstrating improved comparative efficacy and cost-effectiveness to payors by employing the real-world evidence and data generated by others. At the same time, it is important for Medical Affairs to re-establish pharmaceuticals’ integrity and credibility by communicating higher quality medical information that is of the highest relevance to customers. The time is right for Medical Affairs organizations to earn their place at the leadership table by creating opportunities to deliver new value for both patients and the healthcare ecosystem.
Nicola Smith, Regional Head of Operations, Field Medical Affairs at QuintilesIMS emphasizes the scope that exists for MA to add huge value to the development and commercial teams. “Their strength lies in their ability to gather insight and to help the organization understand how this information can be translated into strategy and value for stakeholders, the greater the level of actionable insights from the medical affairs teams, the better for everyone. Where could the function go? A long way. MA needs to stand up strongly for its strengths in and around the translation of research evidence into clinical practice in a compliant environment, with strong communication and scientific engagement which, like any scientific method, is listening, iterating, testing, and is flexible to both internal and external stakeholders, while meeting all the regulations. MA needs to strengthen its reach back into clinical development starting at the planning stage and be critically involved. It needs to reach in an appropriate way into the commercial organization – giving advice and inputting into the plan. Who knows the patient pathway better than MA? Is it the answer to every question? Absolutely not and there needs to be mutual respect of other team members including marketing, market access, clinical therapy teams and of the need to work together as a team. The challenge in the future will be maintaining a strong external focus, listening to the prescribers and taking that insight back into the organization to guide future strategy and future development”.
A fundamental challenge going forward will be to ensure that medical affairs as the public face of the organization is seen as a strategic leading partner with external and internal stakeholders, according to Antonio Tataranni, SVP, Head of Medical Affairs, Sanofi. “It means a number of things. MA need to have the right attitude – after all, what brought us here won’t get us there. It’s about taking ownership and leading certain strategic decisions. It’s crucial that we commit to providing the right data at the right time, moving from clinical trials increasingly into the Real World Evidence sphere – we need to own that. The future that we can create as an innovating function is largely dependent on talent and anticipating future needs, identifying knowledge gaps and filling them. I am profoundly convinced that the MA function needs to evolve with a constant reassessment that the offer matches the needs of the marketplace”.
Want to learn more about the many faces of Medical Affairs?
The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals.
IFAPP Academy provides an online, continuing professional development course, Medical Affairs in Medicines Development, resulting in the Professional Certification, Certified Medicines Development (CMD).