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IFAPP & SIMeF present the 20th International Conference on Pharmaceutical Medicine (ICPM)

Save the date for the 20th International Conference on Pharmaceutical Medicine

IFAPP (the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine) and SIMeF (the Italian Association of Pharmaceutical Medicine) are proud to announce the forthcoming 20th ICPM (International Conference on Pharmaceutical Medicine). The Conference, Patients Centered Medicines Development: Facts and Expectations, will be jointly organized with the first SIMeF National Conference in March 2020 in Rome.

Mark your calendars for March 25 – 27, 2020 for the 20th ICPM and 1st National SIMeF

IFAPP President, Kyoko Imamura, MD, DrMedSci, PhD

“ICPM has been the important opportunity for us as professionals in pharmaceutical medicine, and we are delighted to develop it in Rome, where decades-long efforts have generated dedicated pharmaceutical physicians and medicines development scientists.”

IFAPP President Dr. Kyoko Imamura

20th ICPM: Patients Centered Medicines Development: Facts and Expectations

The International part of the Conference will cover the first two days, with 2 keynote speeches (CIOMS Secretary and Telethon Director), a round table of education in Pharmaceutical Medicine, 2 plenary sessions on the role of patients in drug development and the modern vision of Medical Affairs, and 8 parallel sessions during the two afternoons.

IFAPP President-elect, Marco Romano

“I have the privilege and the pleasure to host both the XX ICPM and the I SIMeF Conference in Rome: it is a unique opportunity for my country and especially for my Italian colleagues who may meet international speakers and collaborators.”

Dr. Marco Romano, SIMeF President, and IFAPP President-elect

1st National SIMeF Conference

The National part of the Conference will be held on the third day, March 27, and will have a morning session devoted to a round table on the status of clinical research in Italy. In the afternoon the General Assembly will take place, with the nomination of the new SIMeF President, and then a session devoted to Medical Devices.

See you in Rome, March 2020!

International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine

About the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP)

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) is a non-profit organization based in The Netherlands, whose mission is to promote Pharmaceutical Medicine by enhancing the knowledge, expertise and skills of pharmaceutical physicians and medicines development scientists world-wide.  The IFAPP Academy is a non-profit organization based in the USA affiliated with IFAPP and is responsible to run its educational activities.

The National Institute of Health: All of Us Research Program

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/

Tufts CSDD Partners with IFAPP Academy to Develop an Innovative Online Course: “Leadership in Medical Affairs”

Tufts CSDD partners with IFAPP Academy to create online course, "Leadership in Medical Affairs."
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.

IFAPP Academy President/CEO, Module Chair

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.

IFAPP Academy Advisory Council member, Ken Kaitin

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.”

Tufts CSDD partners with IFAPP Academy for Leadership in Medical Affairs

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.

IFAPP Academy online medical affairs course

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.

Lay Summaries of Clinical Study Results: An Overview

Lay summaries help to provide transparency and understanding of clinical study results to the general public

Benefits of lay summaries and how to write one

The below article was originally published online: 14 June 2019 https://link.springer.com/article/10.1007%2Fs40290-019-00285-0#copyrightInformation

Amber Barnes1, Susan Patrick © The Author(s) 2019

Abstract

The European Union Clinical Trials Regulation (EU CTR) 536/2014 includes a requirement for the submission of lay summaries. Study participants, advocacy groups, and, to a lesser extent, the general public have called for greater transparency in their quest for information on clinical studies. As a complement to other forms of clinical study disclosure such as registry postings and scientific publications, lay summaries may aid in the transparency of a sponsor’s clinical study results, thereby promoting trust, partnership, and patient engagement throughout the clinical study process. The data transparency field is changing rapidly; therefore, data owners should strive to stay abreast of the changes and deliver meaningful tools to their study participants and the public. Points to consider when developing lay summaries of clinical study results include regulatory drivers, the target audience, communication of complex data in a lay manner, and efficient processes for the development of lay summaries within one’s company.

Lay summaries help to provide transparency and understanding to the general public

Plain Language Summary

There is a rule in Europe that clinical studies (experiments in humans) must have a summary written in plain language. Summaries written in plain language help people who are not scientists or doctors understand complex medical information. People who participate in clinical studies, and others, may want to know information about clinical study results. Lay summaries are a way to share clinical study results, but they do not replace other ways that information is shared. Lay summary writers must think about how they can help readers understand the information. It is hard to describe the results of clinical studies in a way that everyone can understand. This article gives some ideas to think about when writing lay summaries.

Key Points
Lay summaries of clinical study results are a complement to other forms of clinical study disclosure that aid in the understanding of complex clinical study results.
The initial requirement for lay summaries began as a result of the EU Clinical Trial Regulation; however, evolving regulations and policies around the globe are shaping the future of clinical study disclosure.
Ensuring patient value should be of paramount importance when developing lay summaries.

1. What are Lay Summaries and Why are They Needed?

Lay summaries (also called layperson summaries, plain language summaries, lay language summaries, simple summaries, and trial results summaries) are plain language descriptions of the design and aggregate results of individual clinical studies (Fig.1)

Example of a lay summary

Fig. 1 Excerpted pages from a published lay summary

Lay summaries are one way for industry to provide greater transparency to those interested in learning about clinical study results [2]. These documents are written specifically for study participants and the general public who have an interest in clinical study results, but who may have limited health literacy or scientific expertise. Health literacy is defined as the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions [3]. The goal of a lay summary is to aid study participants and the general public in understanding clinical study results. Not only does this effort help to demystify the clinical study process but it also provides the main results of clinical studies in a manner directed specifically towards people with low health literacy. The target audience is any person interested in research, and, as such, the audience is broad and may include study participants, healthcare professionals, caregivers, and the general public.

Companies providing lay summaries in advance of requirements are communicating respect for the needs and desires of the community

The data transparency field is changing rapidly, with recognition that the desires of patients and the general public may go beyond those driven by regulatory requirements. Although regulatory agencies do not currently require submission of lay summaries, some agencies have provided additional statements on the topic, as summarized below, in preparation for when the regulations come into effect. The commitment of a sponsor company to provide lay summaries in advance of regulatory requirements provides a meaningful way of communicating respect for the needs and desires of the community, particularly study participants.

The push for increased transparency in the clinical study space has presented industry and academia with an interesting choice—to proactively engage or only meet regulatory requirements. Currently, some transparency activities are not required per regulations and are implemented solely based on a company’s own policies on clinical transparency and data sharing. For example, the proactive release of clinical documents and datasets can occur through various mechanisms such as portals (e.g. clinicalstudydatarequest.com, yoda.yale.edu), registration and results disclosure (e.g. clinicaltrials.gov), or posting lay summaries of clinical study results to publicly available websites. Other transparency activities are regulatory driven, such as the release of redacted or anonymized documents for European Medicines Agency (EMA) Policy 0070.

2. What are the Current Regulatory Requirements?

2.1 European Medicines Agency: EU Clinical Trial Regulation 536/2014

The EMA initiated the call for the submission of lay summaries through the European Union Clinical Trials Regulation (EU CTR) 536/2014. Among other elements described in the regulation, sponsors must submit a summary of the results of the clinical study, together with a summary and the Clinical Study Report (CSR), irrespective of the outcome of the study. The summary must be provided in a ‘format understandable to laypersons’, with posting to the portal 1 year after the end of the trial (EoT) for studies in adults, and 6 months after the EoT for studies in the pediatric population, in all the EU languages in which the study was conducted (Fig. 2).

EU Clinical Trial Regulation 536/2014 potential timeline
Fig. 2 EU Clinical Trial Regulation 536/2014potential timeline. EoT end of trial (defined as the last visit of the last participant in all concerned member states, or at a later point in time as defined in the protocol), LS lay summary, Peds pediatric patients, mos months

Once the regulation is in application, all new interventional clinical studies will need to comply; however, the regulation includes three phases of implementation. Assuming the dates currently projected by the EMA, this would provide the following timescale for sponsors to submit lay summaries:

  • Phase 1: A 1-year introductory period where regulations are optional.
  • Phase 2: Spanning the second and third year of the transitory period; the regulation will be mandatory for new studies.
  • Phase 3: After the 3-year transitory period described
    above, the regulation will be mandatory for all studies (both ongoing and new studies).

To read this entire article you can download the PDF here:

Frequently Asked Questions

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.

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 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: