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The Changing Face of Medical Affairs

Hot Topics in Medical Affairs

The Changing Face of Medical Affairs

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”.

Critical capabilities

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”.

This article is extracted from Trends in Medical Affairs. To download the magazine, click here.

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.

The IFAPP Academy is a non-profit organization whose mission is to promote, develop, and implement educational activities that support Pharmaceutical Medicine by enhancing the knowledge, expertise, and skills of pharmaceutical physicians and medicines development scientists worldwide. Partnered with King’s College London, the Academy offers Professional Certification for students successfully completing the course. Click here to learn more about the benefits of Professional Certification from the IFAPP Academy.

King’s College London: “From Molecules to Medicines”

News from IFAPP Academy


King’s College London: From Molecules to Medicine

King’s College London, IFAPP Academy’s academic partner, has a strong tradition in pharmaceutical science.

King’s College London has a strong tradition in pharmaceutical science, world-class pharmacology, clinical pharmacology, and therapeutics. This has led to the creation of a number of spin-out companies, including MedPharm and Proximagen Neuroscience plc.

The School of Cancer and Pharmaceutical Science was created to bring together the relevant research groupings across King’s College London.

Molecules to Medicine’s strategy is designed to capture and highlight the broad sweep of research at King’s ranging from pharmacological and chemical studies that can identify novel drug targets and new chemical entities, through formulation and drug development, to clinical trials and the use of medicines by patients. The all-embracing strategy is for researchers to work together towards the discovery of novel medicines and new formulations that can be evaluated in patients in the clinic.

To achieve this goal, and to provide focus, research activities are organized into three related themes: Drug Discovery, Medicines Development, and Medicines Use. Each of these themes includes clusters of research activity, some of which have evolved during the past decade (e.g. drug delivery, chemical biology, pharmaceutical biophysics, pharmacology), and some of which have joined King’s more recently such as enhanced activity in anticancer and anti-infective drug discovery, nanomedicines, substance abuse, health psychology, and clinical pharmacy. Researchers within and across the three themes interact both informally and via joint initiatives to promote cross-disciplinary research. For example, the drug delivery activities of Forbes, Jones, and Daily, working closely with colleagues in pharmacology (Page/Spina) have led to consortium funding and several Ph.D. studentships from the MRC to investigate the safety of nanoparticles in the airways.

This excerpt was originally published on the King’s College website at https://www.kcl.ac.uk/lsm/research/divisions/ips/about/index.aspx

The IFAPP Academy in partnership with King’s College London offers Academic and Professional Certification for students successfully completing the Medical Affairs in Medicines Development course. To learn about the benefits of Certification from the IFAPP Academy, visit us at https://ifappacademy.org/index.php/ifapp-academy-benefits/

Professor Peter Stonier, Co-director of the Medical Affairs Certification program says:

Do you know what PRIME is?

Hot Topics in Medical Affairs


Do you know what PRIME is?

“Paving the way for promising medicines for patients”
European Medicines Agency


Many patients with serious diseases have no or only unsatisfactory therapeutic options and should be able to benefit from scientific advancement and cutting-edge medicines as early as possible.

The European Medicines Agency (EMA) developed PRIME in line with the European Commission’s priorities and the common strategy to 2020 for the European medicines regulatory network. The goal is to foster research on and development of medicines for patients whose diseases cannot be treated or who need better treatment options to help them live healthier lives.

    1.  PRIME is driven by patients’ need.
    2. It focuses on medicines that address an unmet medical need, i.e. offers a major therapeutic advantage over existing treatments or benefits patients with no current treatment options for their disease.
    3. It helps to translate research into the development of medicines while meeting regulatory requirements.
    4. It aims to bring promising treatments to patients earlier, without compromising high evaluation standards and patient safety.


Benefits of PRIME for Medicine Developers

    1. PRIME helps developers of promising new medicines to optimize development plans.
    2. It fosters early dialogue with EMA to facilitate robust data collection and high-quality marketing authorization applications.
    3. It speeds up evaluation so that medicines can reach patients earlier.
    4. It encourages developers to focus resources on medicines likely to make a real difference to patients’ lives.

This article was originally published on the EMA website. To view the full publication please visit this direct link: http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2016/03/WC500202670.pdf

Want to learn more about the European Medicines Agency and its initiatives?

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals.

The IFAPP Academy is a non-profit organization whose mission is to promote, develop, and implement educational activities that support Pharmaceutical Medicine by enhancing the knowledge, expertise, and skills of pharmaceutical physicians and medicines development scientists worldwide. Partnered with King’s College London, the Academy offers Professional Certification for students successfully completing the course. Click here to learn more about the benefits of Professional Certification from the IFAPP Academy.


IFAPP Academy 2018 Steering Committee Meeting

News from IFAPP Academy

IFAPP Academy 2018 Steering Committee Meeting


The first IFAPP Academy Steering Committee meeting of 2018 was held in Barcelona, Spain at the end of January.  The 3-day agenda allowed committee members to discuss a wide range of topics and initiatives for the upcoming academic year and enjoy the beautiful country and delicious food.

A review of the previous academic year was conducted with a lot of focus directed on the lessons learned and the experience of the participating sponsors. This helped to provide great direction in developing improvements for the years to come.

An overview of the new student cohort showed that the IFAPP Academy now has students in 48 different countries.

 

The 2018 students are also employed by a larger array of pharmaceutical companies compared to the previous year.

The IFAPP Academy Steering Committee is excited to be expanding its outreach and working on the new initiatives to provide students with the best in Medical Affairs in Medicines Development education.


Importance of Big Data for Medical Affairs Professionals

Hot Topics in Medical Affairs


The Importance of Big Data for Medical Affairs Professionals

How harnessing the power of big data can give Medical Affairs Professionals the strategic edge.



The most competitive companies in pharma must inundate themselves with data to navigate and excel in an ever increasingly complex environment. But, according to Bain & Company, companies have difficulty explaining the science and data to stakeholders in an effective and meaningful way.1 Just imagine a chemical engineer trying to explain chocolate milk to a 3-year-old. According to Bain research, this shortfall is one attributing factor to the 50% of launches that fail to meet company expectations.

So how does a company manage this problem without losing sight of their main goal, the resulting product? This is where a Medical Affairs Professional comes to the rescue. The ability for a Medical Affairs Professional to collect, analyze, interpret and present data can help ensure the success of a company.

Why is big data so important? Drug development has become more focused on narrower and more personal indications resulting in a more involved treatment. This trend, along with rising costs, and a greater multiplex for physicians to navigate has left a gap that leading companies are filling with medical affairs teams to help them translate their data in a way that physicians, payers, and providers can understand. While the company can focus on their products, they can leave the Medical Affairs Professionals to sort and distribute their big data in a valuable, effective, and consumable way.

Want to learn how to leverage company big data throughout the drug development process?

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals.

The IFAPP Academy is a non-profit organization whose mission is to promote, develop, and implement educational activities that support Pharmaceutical Medicine by enhancing the knowledge, expertise, and skills of pharmaceutical physicians and medicines development scientists worldwide. Partnered with King’s College London, the Academy offers Professional Certification for students successfully completing the course. Click here to learn more about the benefits of Professional Certification from the IFAPP Academy.

To read more about big data in the world of Medical Affairs please check out this great article from Bain & Company: Reinventing the Role of Medical Affairs.

 

References:

  1. Plantevin L, Schlegel C, Gordian M. Reinventing the Role of Medical Affairs. Bain & Company. http://www.bain.com/publications/articles/reinventing-the-role-of-medical-affairs.aspx. Published March 15, 2017. Accessed January 11, 2018.