IFAPP Academy/MAPS Introduction to Medical Affairs in Medicines Development Course
In April we announced that IFAPP Academy and MAPS (Medical Affairs Professional Society) had partnered up to develop and deliver an online course, “Introduction to Medical Affairs in Medicines Development, ” to be launched this year, 2020. We are happy to announce that registration for this course is now available!
This course was designed for the Medical Affairs professional who wants to further learn the fundamentals of Medicines Development and how the various Medical Affairs functions contribute to bringing better medicines to the marketplace, meeting patient needs, and improving health in the general population.
This course was adapted from Module 1 of IFAPP Academy/King’s College London, Medical Affairs in Medicines Development Certification Program. It gathers together experts from the pharmaceutical industry, regulatory agencies, and academic institutions to offer the latest advances in all areas of Medicines Development. It provides tips for the effective practice of the Medical Affairs function through a state-of-the-art interactive online classroom.
From left to right: Kirk Shepard, MAPS Director; Travis Hege, MAPS CEO; Gustavo Kesselring, IFAPP Past President & IFAPP Academy Vice President; and Danie du Plessis, MAPS EMEA President
The IFAPP Academy is dedicated to providing high-quality education for medical affairs professionals. To achieve this goal, we have partnerships with two well known and highly respected academic institutions, King’s College London and Tufts CSDD in Boston. However, in effort to continue expanding our impact and support of the various functions in medical affairs, we have joined forces with MAPS for some exciting new initiatives.
MAPS and IFAPP Academy have signed a mutual agreement to facilitate the coordination and implementation of joint projects for the benefit of biomedical professionals in the development, testing, and monitoring of medicinal products. These undertakings will empower biomedical professionals to leverage their roles in the research, development, and commercialization activities conducted by the global biopharmaceutical industry. Initiatives will be developed to foster ethical conduct and the maintenance of professional autonomy to protect the safety and dignity of patients and research subjects.
“At the IFAPP Academy, we are enthused with the potential for this synergistic collaboration. This cooperative effort will allow biomedical professionals, serving in Medical Affairs related functions, better access to online, state of the art, competency-based education for professional development,” said Honorio Silva, MD, IFAPP Past President & IFAPP Academy Chief Executive Officer. “This opportunity could result in leveraged competence and improved performance in their functions for the benefit of patients, the sponsoring institutions, and society at large.”
Honorio Silva, MD, IFAPP Past President & IFAPP Academy Chief Executive Officer
MAPS and IFAPP Academy will cooperate in other areas of mutual interest, in particular, those concerning education and competency building in Medical Affairs. Soon both organizations will be able to work together on projects related to the capacitation of the various functions related to Medical Affairs within the biopharmaceutical and device industry and ensure that better medicines are available worldwide.
“This collaboration partners two global non-profit organizations with similar visions, experienced leadership, and proven track records of promoting excellence and fostering capability building for the Medical Affairs function. MAPS is excited to work with IFAPP Academy in the production and delivery of the highest quality competency-building offerings for our members and the Medical Affairs Community at large.”
Travis Hege, MAPS CEO
About the Medical Affairs Professional Society
MAPS (https://www.medicalaffairs.org) is a global non-profit [501(c)(3)] organization of Medical Affairs professionals with nearly 2,000 individual members from over 160 life sciences companies, as well as those who provide valuable support to Medical Affairs organizations. Its mission is to advance the Medical Affairs profession and increase its impact across the life sciences industry by:
Promoting excellence across Medical Affairs functions
Developing guidelines to support industry standards and best practices
Fostering advocacy for the Medical Affairs position
Providing education and encouraging professional collaborations that support the practice of Medical Affairs
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 and affiliated with IFAPP. The Academy is a unique partnership between academia, industry, and professional associations to foster competencies and improve 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 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 completing the course receive a Certificate granted by King’s College London and IFAPP Academy, a Professional Certification issued by IFAPP and the IFAPP Academy, and the use of post-nominal letters (CMD) to attest certification.
Want to learn more about the IFAPP Academy – King’s College London, Medical Affairs in Medicines Development, Certification Program?
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.
“Third Strategic Pillar” of the pharmaceutical industry
Learn what McKinsey & Company has to say about the future of Medical Affairs, “A Vision for Medical Affairs in 2025”.
Are you ready for the future of Medical Affairs? In A vision for Medical Affairs in 2025, a new report released by McKinsey & Company, Medical Affairs is cited as the “third strategic pillar”[1], right along with R&D, and commercial & market access1 in the pharmaceutical industry. Essentially, Medical Affairs professionals are no longer acting as the supporting cast, they are now co-starring in the production.
As the pharmaceutical industry evolves and changes, those within it must adapt and develop the skills and competencies needed to address the emerging needs. Patients and physicians are seeking high-quality and reliable information, products, and services. Pharmaceutical companies are acknowledging the primary role that Medical Affairs Professionals play in providing this, and ultimately bridging the gap between the company and its stakeholders (physicians and patients). The need for qualified, competent, and agile Medical Affairs Professionals to fill this primary role within organizations has become apparent.
The IFAPP Academy/King’s College London, Medical Affairs in Medicines Development, Certification Program provides the training needed for Medical Affairs Professionals to not only become successful in their careers but ultimately provide a higher standard of care and service to patients and healthcare providers.
Around the turn of the century, a rather simple classification of public-private-partnerships (PPPs) in the world of medicine development sufficed. These PPPs consisted primarily of bilateral collaborations between pharmaceutical companies and academic institutes. Since then, these “simple” bilateral PPPs have been complemented by different and more diverse types of PPPs. On the one hand, PPPs emerged such as the Medicines for Malaria Venture (MMV) or the Drugs for Neglected Diseases Initiative (DNDI) with as major drivers charities, country donors, industry, and academic groups. These so-called product development partnerships (PDPs) focus on developing products for specific communicable diseases impacting health of patients in less affluent countries. On the other hand, Pharma-PPPs, such as the Innovative Medicines Initiative (IMI), emerged that focused on jointly tackling specific -precompetitive- issues in medicine development. The major players in the last category consisted of the pharmaceutical industry (large pharma), small, and medium sized enterprises (SMEs), academic institutes and–again- governmental funding programs (1, 2). Since then the background of participating stakeholders of PPPs has greatly diversified. Important new stakeholders joined the PPP consortia, including patient organizations, regulatory bodies, health technology assessment agencies, insurance companies, and IT-companies (see articles in this special issue, e.g., Aartsen et al.) All have their unique incentives to join, which makes the PPP concept more difficult to define and to evaluate in terms of its benefits. Nowadays, many PPP-flavors exist and the number and diversity continues to grow. Contributions to this special issue exemplify this current development in the PPP-world.
Added value: in the eye of the beholder or more concrete impact measures?
Early on, questions were raised about the assessment of performance and success-failure of PPPs (1–3). Performance indicators to look at were identified as: the input, the process, the output, the short-term outcome, and impact. See Figure 1 for details. The basis for this methodology was already developed and tested in other fields. What makes the Pharma-PPP case so special are the long timelines–years- to measure “impact.” The classical PPP projects have a typical running time of 4–6 years. The long-term outcome-and impact e.g., in terms of concrete new medicines can only be measured many years after finishing the project and on top of that there are many “diluting” contributing factors in the post-PPP years. Moreover, simply looking at the number of medicines developed based on the activities of a PPP significantly underappreciates the additional impact from knowledge transfer, ongoing collaborations, patents, spin-off companies formed, and last but not least the educational aspect PPP initiatives offer (See Figure 1). The true impact of the first generation of PPPs now becomes visible and we can review that according to the key performance indicators set out from the start [cf. (4, 5)].
Figure 1. Reported performance indicators to be considered in a research PPP performance measurement system, classified into 5 categories. Figure adapted from (2). 2. De Vrueh RL, Crommelin DJ. Reflections on the future of pharmaceutical public-private partnerships: from input to impact. Pharma Res. (2017) 34:1985–99. doi: 10.1007/s11095-017-2192-5 PubMed Abstract | CrossRef Full Text | Google Scholar
In that light, there is one question that was often raised in the early days and that can now be answered, i.e., the concern about the quality of the research output -read publications- of PPPs. Several studies made it clear (3, 4) that the impact of publications measured in terms of impact factor of scientific journals and number of citations of IMI and TI Pharma consortia was comparable–if not higher- than of articles published through “regular” academic groups efforts.
Sustainability: to stay or to perish?
What is the chance for a consortium to survive after finishing the first funding round? Before answering this question it should be clear whether the project, topic-wise, is supposed to be continued at all? Some projects simply do not have a horizon beyond their running time. They are set up to solve a particular -often concrete- problem. However, what if a prolonged existence is foreseen? Experience teaches us that then already in an early stage the question of sustainability should be addressed. For instance, in case infrastructure has been built up, such as databanks or test facilities, further strategies to continue activities after the first funding round should be subject of discussion early on. The article by Aartsen et al. in this special issue discusses various sustainability strategies developed for IMI projects in detail and lists “lessons learned.”
Evolution: PPP Quo Vadis?
The adoption of the “open innovation model” by the pharmaceutical industry has given the PPP concept a big push. Originally, the public partners were mainly academic and national or international public funding organizations. The large pharmaceutical industry with or without SMEs took care of the private side. Over time, the background of stakeholders in PPP consortia has diversified. Patient organizations and health insurance companies joined the consortia. Regulatory bodies such as EMA and FDA are becoming partners as well, although these institutions are very cautious to safeguard their independence from large pharma and other private stakeholders. Big IT organizations such as Google and Amazon (cloud-computing services) expanded the spectrum on the private side (Moreno et al.) as did medical device-diagnostics companies such as Siemens, Agilent, and Philips in the context of IMI. This expanding source of partners will change the character of PPP consortia. Also, the scope of activities evolved. As partners in first PPPs were jointly exploring science and collaboration in a truly pre-competitive field, a shift toward projects where partners share their strategic assets is now observed. E.g., in the IMI—European Lead Factory (see this issue: Karawajczyk et al.) industry decided to share some proprietary assets allowing competitors and public partners to boost their drug discovery programs. It demonstrates that the PPP concept has become a trusted way of working and partners now seem comfortable to evolve the model with activities closer to their core business.
These recent developments raise the question whether the original, rather narrow definitions of a PPP as mentioned at the beginning of this editorial will properly describe the PPPs in medicine development in the future. Partners outside pharma now join the game and change the dynamics and “culture.” The walls between the classical “silos” disappear rapidly.
The remaining question is then. PPP concept in the world of medicine development: Quo Vadis?
References
1. Denee TR, Sneekes A, Stolk P, Juliens A, Raaijmakers JA, Goldman M, et al. Measuring the value of public–private partnerships in the pharmaceutical sciences. Nat Rev Drug Discov. (2012) 11:419. doi: 10.1038/nrd3078-c1
2. De Vrueh RL, Crommelin DJ. Reflections on the future of pharmaceutical public-private partnerships: from input to impact. Pharma Res. (2017) 34:1985–99. doi: 10.1007/s11095-017-2192-5
3. Gunn M, Lim M, Cross D, Goldman M. Benchmarking the scientific output of the Innovative Medicines Initiative. Nat Biotechnol. (2015) 33:811–2. doi: 10.1038/nbt.3305
Keywords: editorial, public-private parternships, healthcare, innovation, medicine
Citation: de Vrueh RLA, de Vlieger JSB and Crommelin DJA (2019) Editorial: Public-Private Partnerships as Drivers of Innovation in Healthcare. Front. Med. 6:114. doi: 10.3389/fmed.2019.00114
Received: 02 May 2019; Accepted: 07 May 2019; Published: 31 May 2019.
Edited and reviewed by:Michel Goldman, Free University of Brussels, Belgium
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.
Epaïnète GAWA, Global Medical Expert in Sanofi Consumer Healthcare
What do you feel is your greatest achievement?
My professional development in recent years. It’s a real opportunity to be part of the global medical team of Sanofi consumer healthcare. Indeed I have joined Sanofi at the local level by working on transversal projects, medico-marketing, pharmacovigilance, and clinical studies. Today I have a specific medical position, with close interaction with regulatory and pharmacovigilance teams. As a partner, I give my best, and I also learn from others to face future challenges.
What is your favorite hobby and/or activity outside of your work?
Football, scrabble, cinema, reading
What do you enjoy most about being a Medical Affairs Professional?
As a physician, my greatest satisfaction is to contribute to the well-being of the patient through an assessment of products based on their efficacy and safety datas, and to propose a risk mitigation plan. In addition i like the medical strategy because it helps to identify the real needs of patients and to propose the appropriate actions.
What has been the most beneficial aspect of the IFAPP Academy Program?
This program gives a broader view of the medical affairs function, and the skills required. The role of the medical affairs professional is well highlighted in all activities of the pharmaceutical industry, and this helps to better understand how we can be a key partner of other functions.
How has your view of the medical affairs profession altered and/or improved?
I limited the medical affairs to my personal experience but this program has shown me the evolution of the profession and the added value of our role in the life of the drug. Some topics that were abstract are now concrete for me. It is a specialty that deserves to be recognized in view of the complexity of the various skills required to be a professional in medical affairs. This profession has a major role in all decisions concerning the life of the product, from the discovery of the molecule to the monitoring and innovation of the mature product. The professionals must be multi-skilled and have a critical judgment in all discussions hence the extensive knowledge provided by this program.
Any additional comments that you would like to make about the Program?
This program is an opportunity to exchange with experts and other professionals from the pharmaceutical industry through webinars and forums. In addition to deepening our knowledge, it is a professional network that is created.
Thanks to Sanofi which is a partner of this program, and thanks to the IFAPP team for your expertise.
The 2019 Cohort has just completed the first of six Modules required to earn their Medical Affairs in Medicines Development Certification (CMD). In the past month students have learned about the purpose and identity of medical affairs, received an introduction to pharmacology, overviewed the clinical trial process, networked with their fellow students during webinars and lesson discussions, and much more!
We are proud to announce that we have a few students who received perfect scores for their work in Module 1! This means they attended all lectures, webinars, and achieved full marks in participation for each activity. This is by no means a small feat. Their dedication to the Program has not only exceeded expectations through their academic achievements but also through their interactions with their fellow students.
We look forward to sharing with you the continued success of each one of the students in this Cohort.
Want to learn more about the IFAPP/King’s College London, Medical Affairs in Medicines Development, Certification Program?
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.
