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.

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.

Sanofi CEO Olivier Brandicourt Becomes PhRMA Board Chairman

This article excerpt was originally published on the PhRMA website.

On January 31st, 2019, the Pharmaceutical Research and Manufacturers of America (PhRMA) elected three new officers to its board of directors. Olivier Brandicourt, CEO, Sanofi, became chairman of the PhRMA board of directors. Giovanni Caforio, M.D., chairman of the Board and CEO, Bristol-Myers Squibb Company was named chairman-elect and David Ricks, chairman and CEO, Eli Lilly and Company assumed the role of board treasurer.

Brandicourt formerly held the position of chairman-elect of the board and succeeds Robert A. Bradway, chairman and CEO, Amgen Inc. as PhRMA board chairman.

Brandicourt has served as CEO, Sanofi, since April 2015. Brandicourt joined Sanofi from Bayer Healthcare AG where he served as CEO from 2013 until 2015. Prior to joining Bayer Healthcare, Brandicourt worked at Pfizer for 13 years, where he served as a member of the executive leadership team and as president and general manager of the emerging markets and established products business units. He is an honorary member of the Royal College of Physicians in London and a board member of the Children’s Aid Society in New York. Brandicourt studied medicine at the University of Paris V where he specialized in infectious diseases and tropical medicine and holds an advanced degree in cellular and immunological pathophysiology from the Paris Descartes University. Brandicourt also received a master’s degree in biology from the University of Paris XII.

Dr. Caforio has served as CEO of Bristol-Myers Squibb since May 2015 and became chairman of the board of directors in May 2017. Dr. Caforio received his medical degree from the University of Rome and joined Bristol-Myers Squibb in Italy in 2000. He advanced through a series of roles in Europe and the United States, becoming president of the U.S. commercial organization in 2011. He was named chief commercial officer in 2013 and became chief operating officer in 2014. Dr. Caforio is a member of the Board of Trustees of Hun School of Princeton and a member of the Business Roundtable and the CEO Roundtable on Cancer.

Ricks has served as CEO of Lilly since January 1, 2017 and became chairman of the board of directors on June 1, 2017. A 20-year Lilly veteran, he previously served as president of Lilly Bio-Medicines and as president of Lilly USA, the company’s largest affiliate. Ricks also served as president and general manager of Lilly China, operating in one of the world’s fastest-growing emerging markets, and general manager of Lilly Canada after roles as director of pharmaceutical marketing and national sales director in that country. He is the president of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and serves on the board of the Central Indiana Corporate Partnership, the Elanco Board of Directors and the Adobe Board of Directors.

Ricks is a graduate of Purdue University and earned his MBA from Indiana University.

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