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Get to know IFAPP Academy Student, Dr. Epaïnète GAWA

IFAPP Academy Student Dr. Epaïnète GAWA, Global Medical Expert, Sanofi
  • What is your name and job title?

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.

International Perception of Competence, Education, and Training Needs Among Biomedical Professionals Involved in Medicines Development

The below excerpt is from an article originally published on the Frontiers in Pharmacology website. To check out the full article click here.

Medical Affairs Books

The development of new medicines today, requires a multi-professional workforce, both in industry and the clinical research arena. Pharmaceutical physicians (PPs) and medicines development scientists (MDS) need a certain level of competence, achieved through on-the-job experience, with a postgraduate education foundation and continuous professional development programs. In order to assess the self-perception of competence, education and training needs, an on-line questionnaire based on the seven domains of competence, developed by IFAPP-PharmaTrain, was prepared and distributed among PPs and MDS members of IFAPP’s affiliated professional associations in countries with facilities for postgraduate education. The data collection was run over a fixed period of three months in Japan, Italy, Brazil, and Spain during 2017. Results indicate low but variable levels of perceived competence for the various domains as well as seniority in the job. All respondents declared a significant need for continuing professional development in all domains. These results corroborate and support the continuous efforts, put in place by IFAPP and the PharmaTrain Federation, to foster the development of accredited education and training among professionals involved in medicines development.

Introduction

For some time now, the biopharmaceutical industry has been the key link between basic biomedical discovery and the emergence of novel medicines that prolong or improve life. However, the industry faces several ongoing and emerging challenges, including technical knowledge gaps, limitations in clinical testing, lowered productivity, higher development costs, increased regulatory requirements, growing payer pressures and patent expiration.

The lack of an adequately sized and appropriately trained multi-professional workforce, both in the industry and the clinical research field, is also a significant part of the problem. There is a perceived mismatch between the profiles and abilities of graduates from academic programs in healthcare professions, and the changing needs of the various health systems around the world. As a possible solution to achieving a transformative learning, an outcomes-based education, or competency-based education (CBE), has been proposed (Silva et al., 2013). Competent professionals would be able to perform their specific responsibilities effectively, such as bringing and maintaining new medicines to the marketplace. A need for competency-based education and training has been identified in the United States, Europe, and Latin America (Dubois et al., 2016).

These respective professional groups have been left with the responsibility to define the competencies needed to perform their function effectively. Competencies can be clustered in domains and can be learned through proper postgraduate education or continuing professional development (CPD) (Sonstein et al., 2014).

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP)1 and the PharmaTrain Federation (PharmaTrain)2 assumed the task of producing the defined core competencies to orientate Pharmaceutical Medicine and Medicines Development as a discipline and profession. Three areas, seven domains and 57 core competencies at the cognitive level, were identified (Silva et al., 2013). The domains have been summarized in a Statement of Competence.

In addition to serving as a template for job profiles and portfolios, the domains can be used to identify general education and training needs. Based on these premises, an international survey among members of the IFAPP national member association was designed using an online questionnaire. Stakeholders were asked about their self-perception of competence and the need for education and training. The results were then assessed to identify gaps, in order to address the potential need for future development of pharmaceutical physicians and medicines development scientists.

By:
Kyoko Imamura1*
Domenico Criscuolo2
Anna Jurczynska3
Gustavo Kesselring4
Peter Stonier5
Tatsushi Tsuda1 and 
Honorio Silva6

Copyright © 2019 Imamura, Criscuolo, Jurczynska, Kesselring, Stonier, Tsuda and Silva.

The IFAPP Academy welcomes Ana B. Salgado as the new Director of Strategic Planning

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.

Ana B. Salgado, IFAPP Academy Director of Strategic Planning

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.

R&D Costs & Drug Pricing

R&D Costs & Drug Pricing

An article from Kenneth Kaitin, PhD, Professor and Director at Tufts Center for the Study of Drug Development.

This article was originally published by Tufts CSDD Insider.

Kenneth Kaitin, PhD, Professor and Director at Tufts Center for the Study of Drug Development.

Earlier this week, I was interviewed by a National Public Radio affiliate for a segment to be aired in the coming days on whether high drug development costs justify the high prices of many new pharmaceutical products. As many of our readers are aware, Tufts CSDD is known internationally for its series of studies estimating the true cost of pharmaceutical R&D. Our latest study (DiMasi et al, J Health Econ 2016;47:20-33) determined that the fully-capitalized cost to bring a new drug to market, including the cost of failures, is $2.6 billion, a 145% increase in constant dollars over our previous report published in 2003.

At more and more public and professional forums these days, I find myself addressing a common misconception about the relationship between R&D costs and drug prices. Much of this misunderstanding, I believe, comes from confusing messaging by the pharmaceutical industry. For example, when asked to explain why drugs are so expensive, the response is often, because it costs so much to develop new drugs (“The Tufts Center says it costs $2.6 billion to develop a new drug!”). On the other hand, when asked to provide the actual cost data for a specific drug, the response is often, “The cost to develop a drug has no bearing on the price of that drug.” A sane individual might ask, “How can both of these responses be correct?” The bottom line is that they both ARE correct.

As I explain it, average R&D costs represent the cost to maintain R&D operations. In other words, across a company’s marketed drug portfolio, average prices must be high enough for the company to generate sufficient revenue to maintain its R&D operations and (hopefully) develop tomorrow’s breakthrough drug. An individual drug’s price, however, typically reflects that drug’s perceived therapeutic and economic value, the competitive landscape, and the ability to obtain reimbursement. In other words, drug pricing is not unlike pricing of any other product.

The public debate over drug prices and the cost of healthcare in general is certain to continue into the foreseeable future. Greater transparency on how companies determine drug prices and how that relates to R&D costs would go a long way toward improving public understanding and furthering the discussion.

IFAPP Academy 2019 Cohort Excelling!

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.

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: