A study that will provide much-needed insight for healthcare providers and pharmaceutical companies, allowing for a truly patient-centric approach with precision medicine.
“The ultimate goal of the All of Us Research Program is to collect information to lead to incredible discoveries in biomedical research and precision medicine, but along the way, we are going to transform lives. We are going to provide opportunities for people that historically have not had the opportunity to participate in research, and I think that’s a really important part of the program, and something that I feel really honored to get to be a part of.”
—Amy Taylor, regional vice president, Community Health Center, Inc.
What is the Precision Medicine Initiative?
The Precision Medicine Initiative (PMI) is a bold research effort to revolutionize how we improve health and treat disease. The PMI aims to leverage advances in genomics, emerging methods for managing and analyzing large datasets while protecting privacy, and health information technology to accelerate biomedical discoveries.
What is the All of Us Research Program?
NIH’s All of Us Research Program is a major piece of the PMI. All of Us will engage one million or more volunteers living in the U.S. to contribute their health data over many years to improve health outcomes, fuel the development of new treatments for disease, and catalyze a new era of evidence-based and more precise preventive care and medical treatment.
The above information, videos, and quotes were provided by the NIH, All of Us website. For additional information please visit: https://allofus.nih.gov/
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.
“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.
“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.”
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.
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.
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
Ana B has extensive professional experience in Medical Affairs, Marketing, and senior Business Management. We look forward to her contributions to the sustained growth of the Academy and achieving our mission and goals.
Dr. Ana B. Salgado is a highly motivated and energetic pharmaceutical business executive with extensive global experience.
A physician by training, after three years of practicing medicine in the emergency room setting, Dr. Salgado started her pharmaceutical career as Medical Affairs Manager in Roche- Colombia. Her high affinity for change and continuous learning took her career into marketing and the commercial business. She joined Pfizer, where she occupied positions of increasing responsibility in marketing at a country level (Colombia) and later, at regional (Latin America, Europe) and global levels. She worked on products and portfolios across several therapeutic categories including anti-infectives, anti-inflammatories, and neuroscience in collaboration with multi-disciplinary teams around the world. Dr. Salgado was responsible for the launch of Celebrex in Latin America, several neuroscience launches in Europe (Zeldox, Relpax, Lyrica) and she led the Global Team for Aricept (in an alliance collaboration with Eisai – Japan).
Expanding her knowledge into the commercial business, Dr. Salgado served in business operations roles at regional and global level. She became the Chief of Staff for the Established Products/ Emerging Markets Business Unit at Pfizer, a business unit with a $25B yearly turnover. In these roles, Dr. Salgado led and participated in several large and complex corporate initiatives including the mergers of Pfizer with Warner Lambert, Pharmacia and Wyeth; several company reorganizations and the creation of the Established Products Business Unit. Before leaving Pfizer, Dr. Salgado led a global transformation to a customer centric – digitally enabled marketing model.
Dr. Salgado received her medical degree from Pontificia Universidad Javeriana in Colombia. She is currently pursuing a Certificate in Financial Planning.
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:
