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Tufts CSDD Partners with IFAPP Academy to Develop an Innovative Online Course: “Leadership in Medical Affairs”

Tufts CSDD partners with IFAPP Academy to create online course, "Leadership in Medical Affairs."
Figure 1: From left to right: Robert Franco, Lead Facilitator; Honorio Silva, CEO of IFAPP Academy; Ken Kaitin, Director of Tufts CSDD; Ana B Salgado, IFAPP Academy Director of Strategic Operations; and Gustavo Kesselring IFAPP Academy VP

Tuesday, August 13th, 2019 — Tufts Center for the Study of Drug Development (Tufts CSDD) will partner with IFAPP Academy to create a new course, “Leadership in Medical Affairs”, that will be offered in 2020 as a complement to the IFAPP Academy-King’s College London-Tufts CSDD Professional Certification Program “Medical Affairs in Medicines Development.” The planning activities for this innovative approach to education and training, in this critical area for the medical role within the biopharmaceutical industry, have already started.  Dr. Kenneth Kaitin, Professor of Medicine and Director of Tufts CSDD and Dr. Ana Salgado, IFAPP Academy Director of Strategic Operations will coordinate the initiative.  Dr. Kaitin has also been appointed a member of the IFAPP Academy’s Advisory Council. 

The partnership with Tufts CSDD will provide IFAPP Academy students and alumni the option to attend the six-week Course “Leadership in Medical Affairs.” This specialized leadership course will combine theoretical leadership principles, with relevance in Medical Affairs, and practical applications. Students will have the opportunity to learn from industry leaders while participating in business case discussions, lectures, webinars, forums, and panel discussions, entirely online.

IFAPP Academy President/CEO, Module Chair

This new Course will help in leveraging leaderships skills to provide strategic medical direction to the organization” said Honorio Silva, MD, IFAPP Academy Chief Executive Officer, “and enhance the stakeholders perception of the medical function as a key contributor to improving patient outcomes.

Benefits for Medical Affairs Professionals

There are also numerous benefits of this collaboration for Medical Affairs professionals. Individuals will be taught the steps needed to evolve from leading themselves to achieving results through others. They will gain the understanding needed to transition from a medical/science contributor to a company leader. The course will provide professionals with the principles needed for creating and leading highly effective teams; including specialized teams (matrixed, cross-functional, cross-geographies). Students will understand how to provide value to an organization by translating real-world data, clinical outcomes, and other data insights into innovative solutions for patient needs and pharmaceutical challenges to allow for improved business development.

IFAPP Academy Advisory Council member, Ken Kaitin

Tufts CSDD is excited to partner with IFAPP Academy in offering this new online course on Leadership in Medical Affairs,” said Dr. Kenneth Kaitin, Professor and Director of Tufts CSDD. “The program will be a fitting compliment to Tufts CSDD’s annual two day in-person course on Leadership for Drug Development Teams, now in its 18th year. Additionally, I look forward to serving on the IFAPP Academy’s Advisory Council and working with the organization’s staff as we develop this exciting new online program.”

Tufts CSDD partners with IFAPP Academy for Leadership in Medical Affairs

About Tufts Center for the Study of Drug Development (Tufts CSDD) at Tufts University

The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) at Tufts University provides data-driven analysis and strategic insight to help drug developers, regulators, and policy makers improve the efficiency and productivity of pharmaceutical R&D. Tufts CSDD also offers professional development courses, hosts workshops and public forums, and publishes the Tufts CSDD Impact Report, a bi-monthly newsletter focusing on critical drug development issues.

IFAPP Academy online medical affairs course

About IFAPP Academy

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy (https://ifappacademy.org/) is a non-profit organization based in the USA, affiliated with IFAPP, and is comprised of a unique partnership between academia, industry, and professional associations to foster competencies and improving performance in medical affairs and medicines development. The IFAPP Academy-Kings College London, Medical Affairs in Medicines Development, Certification Program was created to achieve this goal. The online Program aims to provide the core cognitive competencies for an effective performance in medicines development and medical affairs. The certification program is of particular value for those individuals already working in (or interested in joining) pharmaceuticals, academia, and regulatory agencies. Students successfully completing the course receive a Certificate granted by King’s College London and IFAPP Academy, a Professional Certification granted by IFAPP and the IFAPP Academy, and the use of post-nominal letters (CMD) to attest certification.

Lay Summaries of Clinical Study Results: An Overview

Lay summaries help to provide transparency and understanding of clinical study results to the general public

Benefits of lay summaries and how to write one

The below article was originally published online: 14 June 2019 https://link.springer.com/article/10.1007%2Fs40290-019-00285-0#copyrightInformation

Amber Barnes1, Susan Patrick © The Author(s) 2019

Abstract

The European Union Clinical Trials Regulation (EU CTR) 536/2014 includes a requirement for the submission of lay summaries. Study participants, advocacy groups, and, to a lesser extent, the general public have called for greater transparency in their quest for information on clinical studies. As a complement to other forms of clinical study disclosure such as registry postings and scientific publications, lay summaries may aid in the transparency of a sponsor’s clinical study results, thereby promoting trust, partnership, and patient engagement throughout the clinical study process. The data transparency field is changing rapidly; therefore, data owners should strive to stay abreast of the changes and deliver meaningful tools to their study participants and the public. Points to consider when developing lay summaries of clinical study results include regulatory drivers, the target audience, communication of complex data in a lay manner, and efficient processes for the development of lay summaries within one’s company.

Lay summaries help to provide transparency and understanding to the general public

Plain Language Summary

There is a rule in Europe that clinical studies (experiments in humans) must have a summary written in plain language. Summaries written in plain language help people who are not scientists or doctors understand complex medical information. People who participate in clinical studies, and others, may want to know information about clinical study results. Lay summaries are a way to share clinical study results, but they do not replace other ways that information is shared. Lay summary writers must think about how they can help readers understand the information. It is hard to describe the results of clinical studies in a way that everyone can understand. This article gives some ideas to think about when writing lay summaries.

Key Points
Lay summaries of clinical study results are a complement to other forms of clinical study disclosure that aid in the understanding of complex clinical study results.
The initial requirement for lay summaries began as a result of the EU Clinical Trial Regulation; however, evolving regulations and policies around the globe are shaping the future of clinical study disclosure.
Ensuring patient value should be of paramount importance when developing lay summaries.

1. What are Lay Summaries and Why are They Needed?

Lay summaries (also called layperson summaries, plain language summaries, lay language summaries, simple summaries, and trial results summaries) are plain language descriptions of the design and aggregate results of individual clinical studies (Fig.1)

Example of a lay summary

Fig. 1 Excerpted pages from a published lay summary

Lay summaries are one way for industry to provide greater transparency to those interested in learning about clinical study results [2]. These documents are written specifically for study participants and the general public who have an interest in clinical study results, but who may have limited health literacy or scientific expertise. Health literacy is defined as the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions [3]. The goal of a lay summary is to aid study participants and the general public in understanding clinical study results. Not only does this effort help to demystify the clinical study process but it also provides the main results of clinical studies in a manner directed specifically towards people with low health literacy. The target audience is any person interested in research, and, as such, the audience is broad and may include study participants, healthcare professionals, caregivers, and the general public.

Companies providing lay summaries in advance of requirements are communicating respect for the needs and desires of the community

The data transparency field is changing rapidly, with recognition that the desires of patients and the general public may go beyond those driven by regulatory requirements. Although regulatory agencies do not currently require submission of lay summaries, some agencies have provided additional statements on the topic, as summarized below, in preparation for when the regulations come into effect. The commitment of a sponsor company to provide lay summaries in advance of regulatory requirements provides a meaningful way of communicating respect for the needs and desires of the community, particularly study participants.

The push for increased transparency in the clinical study space has presented industry and academia with an interesting choice—to proactively engage or only meet regulatory requirements. Currently, some transparency activities are not required per regulations and are implemented solely based on a company’s own policies on clinical transparency and data sharing. For example, the proactive release of clinical documents and datasets can occur through various mechanisms such as portals (e.g. clinicalstudydatarequest.com, yoda.yale.edu), registration and results disclosure (e.g. clinicaltrials.gov), or posting lay summaries of clinical study results to publicly available websites. Other transparency activities are regulatory driven, such as the release of redacted or anonymized documents for European Medicines Agency (EMA) Policy 0070.

2. What are the Current Regulatory Requirements?

2.1 European Medicines Agency: EU Clinical Trial Regulation 536/2014

The EMA initiated the call for the submission of lay summaries through the European Union Clinical Trials Regulation (EU CTR) 536/2014. Among other elements described in the regulation, sponsors must submit a summary of the results of the clinical study, together with a summary and the Clinical Study Report (CSR), irrespective of the outcome of the study. The summary must be provided in a ‘format understandable to laypersons’, with posting to the portal 1 year after the end of the trial (EoT) for studies in adults, and 6 months after the EoT for studies in the pediatric population, in all the EU languages in which the study was conducted (Fig. 2).

EU Clinical Trial Regulation 536/2014 potential timeline
Fig. 2 EU Clinical Trial Regulation 536/2014potential timeline. EoT end of trial (defined as the last visit of the last participant in all concerned member states, or at a later point in time as defined in the protocol), LS lay summary, Peds pediatric patients, mos months

Once the regulation is in application, all new interventional clinical studies will need to comply; however, the regulation includes three phases of implementation. Assuming the dates currently projected by the EMA, this would provide the following timescale for sponsors to submit lay summaries:

  • Phase 1: A 1-year introductory period where regulations are optional.
  • Phase 2: Spanning the second and third year of the transitory period; the regulation will be mandatory for new studies.
  • Phase 3: After the 3-year transitory period described
    above, the regulation will be mandatory for all studies (both ongoing and new studies).

To read this entire article you can download the PDF here:

Frequently Asked Questions

Learn more about the IFAPP Academy/King’s College London, Medical Affairs in Medicines development, Certification Program

Presented by Dr. Gustavo Kesselring

Want to learn how to expand your skill set and continue your professional development in 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.

IFAPP Academy Meeting in Budapest

Budapest 2018

In November 2018, the IFAPP Academy was invited by Sandor Kerpel-Fronius to hold the annual face-to-face Steering Committee meeting at the prestigious Semmelweis University in Budapest, Hungary.

Just a few of the Academy’s Board members and operational team

The IFAPP Academy Board Members, stakeholders, IFAPP’s secretariats, and the operations team gathered the first evening in Budapest to share a light dinner, a couple of drinks, and some good conversation.  

The first morning of meetings kicked off with Professor Sandor Kerpel-Fronius, faculty at the Semmelweis University, giving us a history of the University, insider tips to the city, and an overview of the meeting agenda. 

Professor Sandor Kerpel-Fronius inviting us inside the Semmelweis University for our first meeting.

The Academy was excited to welcome Tim Aldwinckle, UCB representative, to the meeting. He was able to provide some great perspective in several areas of the discussion.

After a full day of presentations, the team enjoyed an amazing dinner at Budapest’s Museum Restaurant.

The IFAPP Academy meeting attendees gather for dinner at the Museum Restaurant

Day 2 of the meeting – Gustavo Kesselring and Xavier Luria discussed the strategic collaborations that the IFAPP Academy will be fostering in 2019. Peter Stonier also presented the updated contract with King’s College London. The afternoon was concluded with coffee and the recording of video testimonials starring some of the key representatives of the Academy.

It was a great few days in Budapest and wonderful for the team to be able to spend some quality time together and workout the logistics for a successful 2019 and beyond!

Check out some more of the pictures from the Budapest Steering Committee Meeting:

The Shared Ethical Responsibility of Medically and Non-medically Qualified Experts in Human Drug Development Teams

3 Reasons why medical affairs professionals need to be savvy with social media

Hot Topics in Medical Affairs

3 Reasons why medical affairs professionals need to be savvy with social media.

The worldwide reach of social media has changed how people communicate. Social media platforms are becoming the go-to source for communication.  Patients are more likely to share their medication side effects, such as the itchy rash they got on their butt or the achy joints that prevented them from playing golf with friends, on social media than to their doctor. Social media channels not only have the potential to act as a way of reporting adverse events but also help companies understand the wants and needs of patients.

Therefore, with the ever-increasing importance of patient centricity and personalized medicines, more and more companies are relying on social media to provide them with answers. These are just some of the many ways that companies are leveraging social media.

1.  Creating a truly patient-centric approach

“There has been a lot of talk in recent years of a need to increase patient-centricity within the pharmaceutical industry. Indeed, there have been many great steps towards a more patient-centric approach, and a greater recognition of the value of patient choice and the need for increased self-management across healthcare systems” (Rees, Sumira, & Morton, 2018).  However, to put this into practice companies must provide patients with the necessary tools and education. Companies are now relying on data from social media sites to help them learn how to provide patient-friendly information.  “Listening to social conversation can add layers of insights. Online conversations can uncover valuable insights about the audience, whether this be patients, healthcare professionals or key opinion leaders.” (Rees, Sumira, & Morton, 2018)

[caption id="attachment_2000" align="aligncenter" width="845"] Figure 1 Sciformix Corp. “The Impact and Use of Social Media in Pharmacovigilance”

2. Product Vigilance (PV)

In a whitepaper by Sciformix, “social media has the potential to become an added new-age tool to monitor data in real-time, making it an early indicator of potential safety issues for further investigation. Further, this would enable companies to generate more robust product safety profiles by leveraging the additional social media information” (Sciformix Corporation).

3.  Clinical trial recruitment

According to Medrio.com, “Social media has the potential to be a powerful tool in the clinical trial recruitment process because of its low cost and ability to reach a diverse and broad audience. In 2014, Facebook boasted over 1.2 billion monthly active users, Twitter had 255 million, LinkedIn was at 187 million.  These numbers outweigh the traditional recruiting numbers in every way.  This capability is something that one-sided print/TV ads or even clinician/patient referrals cannot provide: access to diverse cultures, age groups, gender, and income levels” (Medrio, 2015).


Want to learn how to expand your skillset and continue your professional development in 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.


 

References

Medrio. (2015, August 6). Using Social Media to Recruit Subjects in Phase I Clinical Trials. Retrieved from Medrio: https://medrio.com/blog/using-social-media-to-recruit-subjects-in-phase-i-clinical-trials/

Rees, N., Sumira, D., & Morton, A. (2018, June 13th). The Patient Journey. Retrieved June 19, 2018, from PM LiVE: http://www.pmlive.com/pharma_thought_leadership/the_patient_journey_1239641

Sciformix Corporation. (n.d.). The Impact and Use of Social Media in Pharmacovigilance. Retrieved June 19, 2018, from Sciformix: https://www.sciformix.com/wp-content/uploads/Social_Media_in_PV_Whitepaper.pdf

World Pharma News. (2017, October 9). Social Media in the Pharmaceutical Industry. (SMi Group) Retrieved June 6, 2018, from World Pharma News: http://www.worldpharmanews.com/events/4139-social-media-in-the-pharmaceutical-industry

What are the benefits of earning a professional certification?

Hot Topics in Medical Affairs


What are the benefits of earning a professional certification?

Despite the career, employees from construction to IT to Pharmacy have found enormous advantages in obtaining a professional certification within their field. Here are 5 advantages of earning professional certification.



  1. Gain a competitive edge. Because let’s face it, competition can be stiff when it comes to the job market. Whether you’re applying for a new job, wanting to be considered for a promotion, or crossing your fingers for an end-of-year raise a professional certification will help to distinguish you from the pack. When considering two individuals with similar backgrounds, a professional certification may get your resume that second look. Certifications can differentiate you from other professionals in your field or company, showing that you have a demonstrated commitment to understanding and excelling in your profession and a desire to learn more.[1]

2.  Increased competency. The success of a team depends on the knowledge and experience of each of its members, which is why professional certifications have become increasingly important in the field of medicine.[2] After all, the primary criteria for employers is to have professionals on their team that are up-to-date with industry standards, norms, and best practices which are in a constant state of flux.[3] E-learning allows providers, such as the IFAPP Academy, to provide the most current and relevant information in an accessible, convenient, and cost-effective manner.

3. Professional credibility. Earning a certification provides immediate credibility with employers and colleagues. Who is going to question a Cisco Certified Internetwork Expert (CCIE), a Microsoft Certified Solutions Expert (MCSE) or a Red Hat Certified Architect (RHCA)? Earning a certification from an internationally recognized organization demonstrates your dedication and motivation to professional development. Many companies will actively support their employees in earning these certifications that may even lead to promotions and raises.[4]

  1. Networking opportunities. Working hard to earn a certification allows you to join a unique group of certified and skilled professionals that share similar goals and ambitions. This can prove to be an invaluable peer resource group that can be a boon when looking for answers to a particularly tough problem or when moving from one company to another. The IFAPP Academy encourages students to network and learn from each other through the student forums and live interactive webinars, providing additional viewpoints from an international perspective.

5.  Increased confidence, because confidence is KEY! In a study conducted by the University of Melbourne, Participants were asked to describe their level of confidence at primary school, high school, university, and present day. Those who self-reported higher levels of confidence earlier in school earned better wages and were promoted more quickly.  Lead author Dr. Reza Hasmath, from the University’s School of Social and Political Sciences, said the research demonstrates a crucial ingredient of workplace advancement.  “The implications are tremendous in terms of the personality employers should look for when it comes to hiring or promoting staff,” Dr. Hasmath said.”[5]

Want to learn how to earn a Professional Certification in Medicines Development in Medical Affairs?

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals, resulting in the Professional Certification, CMD (Certified Medicines Development).

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.

Resources/References

[1] Laurinavicius, T. (2017, December 07). Why Online Certifications Are Key To Professional Success. Retrieved March 28, 2018, from https://www.huffingtonpost.com/tomas-laurinavicius/why-online-certifications_b_11081630.html

[2] Rewards of Certification. (n.d.). Retrieved March 28, 2018, from https://www.bpsweb.org/impact-of-bps-certification/rewards-of-certification/

[3] Laurinavicius, T. (2017, December 07). Why Online Certifications Are Key To Professional Success. Retrieved March 28, 2018, from https://www.huffingtonpost.com/tomas-laurinavicius/why-online-certifications_b_11081630.html

[4] 10 Benefits of IT Certification for You (and Your Employer). (n.d.). Retrieved March 28, 2018, from https://www.globalknowledge.com/us-en/content/articles/10-benefits-of-it-certification-for-you-and-your-employer/

[5] Hasmath, D. (2012, October 18). Self-confidence the secret to workplace advancement. Retrieved April 09, 2018, from http://newsroom.melbourne.edu/news/self-confidence-secret-workplace-advancement

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.