SSFA was one of the 12 founding members of IFAPP, the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine. Indeed, it was during a Conference held in Florence in September 1975 that IFAPP was officially launched, as the first name of the federation was IFAMAPI (International Federation of Associations of Medical Advisers to the Pharmaceutical Industry). It is our pleasure to report a conversation we had with the current IFAPP President, Dr. Honoria Silva.
DC: Honorio, many thanks for your time to answer to our questions, First of all, can you tell us which is your professional experience as pharmaceutical physician?
HS: …. I joined the pharmaceutical industry in my mid-twenties as Medical Director for Pfizer Venezuela. At that time, I was the youngest medical director Pfizer ever had taking into account I had just finished my postgraduate training in Internal Medicine and Clinical Pharmacology. Since my first days in the job I was fascinated by the challenging world of medicines development and the possibility of making contributions by fostering clinical research and continuing medical education (CME) whilst contributing to the pharmaceutical business. Pfizer was a pioneer in supporting these activities in emerging countries and helped in creating a good reputation in the medical and scientific arenas. At those times I was also able to develop an academic career as Assistant Professor at the Clinical Pharmacology Department at the Universidad Central de Venezuela Medical School. I participated as an independent investigator at the Cardiovascular Pharmacology Unit, Vargas Hospital in Caracas and had the opportunity to get deeply involved in non-sponsored clinical trials. After several years consolidating the medical function in my country I was transferred to the Pfizer Headquarters in New York and took responsibility for the Pfizer Medical and Regulatory Affairs in Latin America and Canada. A few years later my role was expanded to also include Asia/Australia, Africa/Middle East and Japan. This was a rewarding experience both personally and professionally. A number of successful medical and regulatory initiatives were codeveloped in the various jurisdictions and best practices among countries and regions were shared. Our team in New York Headquarters strived to underscore the contributions of the medical and regulatory function group to the local business operations and communities we served. I retired from Pfizer in 2008 after 30 rewarding years. My latest responsibilities within the organization were again related to fostering Science and Medical Professional Development across the world within the External Medical Affairs Group. I am convinced Education in Medicines Development is key for a better understanding and leveraged communication among internal and external stakeholders in pharmaceutical medicine. The Pfizer sponsored Hibernia College Masters Program in Pharmaceutical Medicine was the result of this intended close collaboration between the pharmaceutical industry and academia.
DC: … and when did you join IFAPP?
HS: After my retirement from Pfizer I decided to continue serving in nonprofit organizations focusing on Medical Education and Continuing Professional Development (CPD). I was invited to attend the IFAPP Council of Education in Pharmaceutical Medicine (CEPM) teleconferences, representing the Pan American Federation of Medical Schools. Again, I was immediately attracted to join a team of highly experienced colleagues sharing the same vision and goals. IFAPP was a key contributor to the PharmaTrain consortium aimed to harmonize postgraduate education in Pharmaceutical Medicine. As a result the CEPM then morphed into the IFAPPPharmaTrain Collaboration Working Group that I had the honor to coordinate. As an outcome of our team discussions the IFAPP-PharmaTrain Competencies in Pharmaceutical Medicine were defined at the cognitive level and subsequently published in Frontiers in Pharmaceutical Medicine and Outcomes Research. This is a highly referenced article. Our further work resulted in the identification of the IFAPP full set of competencies including the applied knowledge, skills and behaviors needed to effectively perform as a pharmaceutical physician or a medicines development scientist. I was then invited to join the IFAPP Board as President Elect for the period 2014-2016. Again I was fortunate to work with a group of highly talented colleagues willing to re-define Pharmaceutical Medicine as a discipline and profession, and not simply as performing in a job. The mission and goals for the period 2014-2020 were accepted by our membership. Several deliverables of our ongoing work are already in place. My role as IFAPP President for the period 2016-2018 will end in September with the celebration of the International Conference in Pharmaceutical Medicine to be held in Tokyo. Dr. Kyoko Imamura will continue with the reins of the Federation and the good work started by Gustavo Kesselring in 2014. Our team is already working on the identification of the IFAPP leadership after 2020. We are sure the Federation will be in good hands at that time with the support of our membership and particularly from SSFA.
DC: Honorio, as you know SSFA is a very active association, and is an important reference body for all Pharmaceutical Professionals. Is there in the US a similar National Association?
HS: No. Regrettably at the present time there is a very limited awareness on Pharmaceutical Medicine in the USA. Let me share details of the interesting involution of our discipline in this country as a result of infortunate events. In 1993, a group of core founders lobbied the later named Pharmaceutical Research Manufacturers Association and with its support the American Academy of Pharmaceutical Physicians (AAPP) was formed. The AAPP was modelled after the European organizations with members to be physicians only. In 1995 the bylaws were changed to include physicians outside the pharmaceutical industry and subsequently the membership grew rapidly to over 1000 members with diverse places of employment including; pharmaceutical companies, biotechnology companies, regulatory authorities, universities, consultants and contract research organizations. Despite its active lobbying with the American Medical Association the dream of getting Pharmaceutical Medicine as a distinct medical specialty was not achieved. In 2005 a new entity with a broader membership was formed as the Academy of Pharmaceutical Physicians and Investigators (APPi) which was particularly active through an evolving program of meetings in response to expressed needs. A strategic alliance with the ACRP (Academy of Clinical Research Professionals) was established and the focus gradually moved to clinical research related CPD. Finally, by 2010 APPi changed its name to Academy of Physicians in Clinical Research (APCR) and pursued its affiliation to ACRP. This management decision induced a massive exodus of pharmaceutical physicians. APCR is still our formal affiliate organization in the USA, though limited efforts have been made to revitalize the participation of pharmaceutical physicians in its membership. The US based Medical Affairs Professional Society is a relatively new organization still in early stages of development. Initial contacts have been made aimed to explore opportunities for collaboration. In the meantime, the DIA has also evolved and gradually has become an international exchange forum for all disciplines and professionals involved in medicines development. However, DIA is not a professional organization. Different to other established biomedical disciplines the lack of required formal Certification to work in clinical research and/or medicines development is a significant obstacle to the advancement of Pharmaceutical Medicine in the USA. We are working actively with key stakeholders to create awareness on the needs and benefits of global certification.
DC: In the last 40 years, the pharmaceutical industry faced significant changes. Is there still a place for a global Federation like IFAPP?
HS: .. . lndeed. The traditional business model in pharmaceuticals has been disrupted with the emergence of new concepts such as Patient Centered Healthcare, Patient Centered Medicines Development and new disciplines such as Translational Research and Health Economics are gaining relevance. As a result, education and training of biomedical personnel working in the pharmaceutical industry have become a critical need. On the other hand, Medical Affairs organizations have emerged over the past decades in response to federal regulations around the separation of medical and commercial activities within drug companies. Many companies chose to move R&D resources on developing new products and moved post launch activities, such as finding new indications for existing products into the medical affairs function. Continued pressures from regulatory agencies and public sentiment have pushed more and more activities into Medical Affairs Organizations. Therefore, competent professionals in the disciplines of medical affairs and clinical development are also urgently needed. IFAPP intends to become the umbrella organization that gathers all disciplines involved in medicines development and to provide an integrated perspective for all stakeholders. The realization of our evolution to becoming members of a established profession and the creation of a professional identity are crucial to ensuring the long term viability of pharmaceutical medicine.
DC: .. and which is your vision of IFAPP for the future?
HS: I envision IFAPP as a global network of member organizations and affiliated individuals willing to work collaboratively to establish Pharmaceutical Medicine as a discipline and a profession worldwide. The sequential programs on Professional Certification in Medicines Development (CMD) followed by Specialization (SMD) developed by IFAPP and PharmaTrain are key steps to make it happen. We look forward to working with other established organizations such as the Faculty of Pharmaceutical Medicine, the pharmaceutical industry, academic institutions and regulatory agencies to align our efforts in a synergistic approach. This would result in having better medicines available for the communities worldwide and will make us proud of our contributions to patients and lay public in the countries we operate.
DC: Finally, you were a strong champion for the formation of the IFAPP Academy: can you explain the scope of this body?
HS: .. … The IFAPP Academy (www.ifappacademy.org) is a nonprofit non-member organization based in the USA charged with providing the educational services needed to achieve our long-term goals. The Professional Certification on Medical Affairs in Medicines Development offered in collaboration with King’s College London is the result of a close collaboration involving experienced faculty from the pharmaceutical industry, regulatory agencies and academic institutions to develop an online modular program aimed to provide the competencies at the cognitive level and effectively perform in the various related functions. The preliminary results from our pilot experience in 2017 and feedback received are very encouraging. The second cohort starting in January 2018 would confirm the value we intend to provide to our membership and the community at large.
Many thanks, Honorio, for your interesting ideas about IFAPP and its future.
A cura di Domenico Criscuolo