FACULTY

Get to Know Our Faculty

IFAPP Academy Faculty

Our expert faculty from academia, industry, research and regulatory agencies are willing to share their expertise so that our alumni could be part of the next generation of pharmaceutical leaders.

Ahmed Shelbaya

Faculty Columbia School of Public Health/Senior Director of Outcomes & Evidence, Pfizer, USA

Ahmed Shelbaya is a Senior Director of Outcomes & Evidence at Pfizer, and adjunct faculty at Columbia’s Mailman School of Public Health.

He trained as physician and practiced clinical pediatrics and neo-natal intensive care for nearly 14 years in developing country settings in the Middle East and Sub-Saharan Africa, before being involved in public health and public & global health policy. Before joining Mailman and Pfizer, Ahmed worked as a Senior Health Policy Analyst and Technical Coordinator for Health Sector Reform with several Ministers of Health in Egypt to support health policy generation and health sector reform. He was instrumental in the development of Egypt’s Basic Health Benefits Package of health services. That entailed calculating the burden of disease, as well as establishing a methodology for costing and cost effective analysis.

During his tenure he also designed and spearheaded the development of a health promotion, disease prevention national program “Healthy Egyptians 2010,” the National program was used in prioritizing limited resources towards cost-effective health interventions with greatest health impact. Ahmed’s public health activities also involved collaborating and working with the World Health Organization in Geneva on the Framework Convention for Tobacco Control, African Ministries of health as well as other international public health and multinational organizations in New York.

He has co-authored several publications related to anti-infectives, Malaria, HIV, Hepatitis C, CNS and Pain as well in the field of health policy. He holds a Medical degree, a Master of Science degree, and Master degree in Public Health.

Alan Boyd

Past President of the Faculty of Pharmaceutical Medicine, CEO & Founder of Boyds and Consultant Pharmaceutical Physician, UK

Professor Boyd is a Fellow and immediate Past- President of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians, UK. He is graduate in Biochemistry and Medicine from the University of Birmingham, UK. Following post-graduate medical training, he joined the pharmaceutical industry and worked for Glaxo and then ICI/Zeneca where he became the Global Head of Medical Research for the company. In 1999 he became the R&D Director for Ark Therapeutics Ltd in the UK, one of the first companies in the world devoted to the development of gene therapy products and took the first gene therapy through for consideration for regulatory approval in Europe.

In April 2005, he founded Boyd Consultants, the focus of which is to aid and support early-stage life-science based companies and universities develop their research ideas into potential medicines, particularly cell and gene therapy products. He currently works with a wide range of organisations across Europe, North America and Japan.

In November 2009 he was appointed an Honorary Professor at the Medical School at the University of Birmingham Medical School, in recognition of his expertise in medicines development. In April 2018, his consultancy company was awarded a ‘Queens Award for Enterprise’ for the work they had done in recent years on a global basis supporting the development of advanced medicinal products.

Most recently he was elected as a Fellow at the Academy of Medical Sciences in recognition of his contributions to clinical medicine and medical science.

Ana B Salgado

Board Member – IFAPP Academy; Global Pharma, Consultant & Advisor, USA

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.

Beate Schmidt

Regulatory consultant to the pharma and biotech industry, Germany

A biologist by training, Beate has 20 years of experience in the international development and licensing of pharmaceuticals. She has worked for biotech and pharmaceutical companies in Europe (Micromet AG) and North America (Aspreva Pharmaceuticals) before joining the European Medicines Agency (EMA) as a Scientific Administrator (2009-2012).

A biologist by training, Beate also holds Master’s degrees in Drug Regulatory Affairs (MDRA) and in Health Economics, Policy and Management (London School of Economics). Beate is RAC (EU, US) certified (Regulatory Affairs Professional Society, RAPS) and obtained a Market Access Certificate (European Business School).

Since 2012, Beate is a freelance regulatory consultant to the pharma and biotech industries, based in Mannheim, Germany. She is a lecturer for various regulatory affairs and market access programs.

Brenda Raphael

Senior Vice President, General Manager Bayer Consumer, USA

Brenda is currently the General Manager for the US Brands business within Pfizer’s Essential Health business unit where she is responsible for the U.S. marketing and commercialization of a portfolio of medicines across a diverse range of therapeutic areas from Women’s Health to ADHD medications for the pediatric market. Her team is accountable for the marketing strategies across all customer groups, as well as bringing to market everything from consumer advertising to physician education for the products in her portfolio. Most uniquely, her team develops strategies to maximize the value of the portfolio and to insure a strong transition plan and continuity of care for patients as the patent life nears. At Pfizer, Brenda is known as a keen strategist as well as someone dedicated to building strong teams that continue to grow personally and professionally.

Brenda comes to this work from a deep base of experience in marketing at Pfizer where she has held several roles of increasing responsibility across many categories, but always in vaccines and prescription pharmaceuticals. She’s no stranger to household names, however, having worked on mega-brands from Coca-Cola to Cheer laundry detergent at her previous roles at the Coca-Cola Company and Procter & Gamble where she has led teams in both digital and traditional marketing.

She is a graduate of Cornell University and holds an MBA from the Darden School at the University of Virginia. She lives in Westchester with her husband, children, and an adorable but slightly mischievous dog.

Charlotte Kremer

Executive VP and Head of Medical Affairs for Astellas, USA

Charlotte M. E. Kremer, MD, MBA is the Executive VP and head of Medical Affairs for Astellas. In this role, Dr. Kremer provides leadership for the Medical Affairs organization globally.

Dr. Kremer joined Astellas in 2012 with 20 years of experience in the pharmaceutical industry. Prior to Astellas, she held the position of Vice President, Therapeutic Area Head for Ophthalmology, PVD, Rare Diseases and Neuroscience at Pfizer. While at Pfizer, she successfully led and executed the clinical development and global medical programs in these respective areas. Prior to joining Pfizer, Dr. Kremer held positions of increasing responsibility in Medical Affairs roles at Organon Pharmaceuticals, both in the Netherlands affiliate and global office as well as in the United States.

Dr. Kremer currently serves as chair of the Board of the Medical Affairs Professional Society (MAPS) the non-profit society for MA professionals globally with more than 4,000 members where she is focused on advancing the Medical Affairs profession and increasing its impact across the Life Sciences industry.

A native of the Netherlands, Dr. Kremer received her medical degree from the University of Utrecht, The Netherlands. She went on to receive her Diploma Pharmaceutical Medicine (DPM) from Universite Libre de Bruxelles. After transferring to the United States, Dr. Kremer completed the Executive MBA program at New York University’s Leonard N. Stern School of Business.

Chieko Kurihara

Specially appointed Professor, Kanagawa Dental University Senior Researcher, National Institutes for Quantum and Radiological Science and Technology, Japan

Chieko Kurihara is Special Appointment Professor at Kanagawa Dental University, and Senior Researcher/Vice-Chair of the Certified Review Board, at the National Institutes for Quantum and Radiological Science and Technology, Japan. Her expertise is bioethics, especially research ethics.

After graduation in 1983 from Department of Economics, School of Political Science and Economics, Waseda University, she has been engaged in book/journal publications, editorial and theater works and then in bioethics study. Also she has been working long time as an Editorial Staff and then Editor of a Japanese journal Clinical Evaluation, which was established in 1972, dealing with science and ethics of clinical trial. Based on this experience she has been providing lecture on “Publication Ethics in the era of Open Science” in the series of Webinar by IFAPP Academy.

She has been a member of Working Group on Ethics, International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) (2017~). She has been also engaged in other international activities, as a member of Task Group 109, Ethics in radiological protection for diagnosis and treatment, International Commission of Radiological Protection (ICRP) (2018~), following the previous Task Group aimed for ICRP Publication 138 to identify ethical foundation of radiological protection system of the ICRP.

Her recent publication with Working Group on Ethics of IFAPP is to discuss data-driven research with an objective to make a proposal for future revision of the World Medical Association’s Declaration of Helsinki: Kurihara C, Baroutsou V, Becker S, Brun J, Franke-Bray B, Carlesi R, Chan A, Collia LF, Kleist P, Laranjeira LF, Matsuyama K, Naseem S, Schenk J, Silva H and Kerpel-Fronius S. Linking the Declarations of Helsinki and of Taipei: Critical Challenges of Future- Oriented Research Ethics. Front. Pharmacol. 2020. 11: 579714. doi: 10.3389/fphar.2020.579714

Christine Carberry

Certified Strategic Alliance Professional, USA

Christine Carberry is a biopharmaceutical leader with the unique ability to transform strategy into results through the power of collaboration. Most recently she was the Chief Operating Officer at Keryx Biopharmaceuticals. In her leadership role she served on the Executive Committee while leading initiatives in cross-functional integration, operational excellence, and program management. She headed the Manufacturing, Technical Operations, Quality, Human Resources, and Regulatory functions.

Prior to Keryx, she served as a Senior Vice President at Forum Pharmaceuticals. At Forum, She established the Program & Alliance Management cross-functional matrix to integrate across the entire organization. She also led the CMC, Supply Chain, and Quality functions.

At Biogen for over 25 years, Christine held positions of increasing responsibility as the company advanced from a biotechnology pioneer to an internationally recognized Fortune 500 company.

Christine is a Certified Strategic Alliance Professional (CSAP). She holds an M.S. in innovation and technology management from Boston University, Certificates in Management and Biotechnology Strategy from Harvard University, and a B.S. in biochemistry from the University of New Hampshire.

Christopher-Paul Milne

Retired Director of Research at Tufts CSDD, USA

Dr. Christopher-Paul Milne joined the Center for the Study of Drug Development at the Tufts University School of Medicine (Tufts CSDD) in Boston over 20 years ago as a Senior Research Fellow and has published over 100 book chapters, white papers, and journal articles. His research interests include: disease, demographic, and market access factors in the emerging markets; incentive programs for pediatric studies, orphan products, and medical countermeasures (MCMs); and, tracking the progress of new regulatory and research initiatives such as facilitated regulatory pathways (FRPs), regulatory science, as well as regenerative medicine programs (RMAT & ATMP).

Dr. Milne became Director of Research at Tufts CSDD in 2011, and a Research Associate Professor at Tufts University Medical School in 2014. He served as a visiting fellow at the Innogen Center, University of Edinburgh, Scotland in the fall of 2006. More recently in the spring of 2015, Dr. Milne was a visiting professor at Kyushu University in Fukuoka, Japan.

Although Dr. Milne recently retired from Tufts University, he continues to serve as a Research Associate at the Innogen Center and remains on the editorial boards of Therapeutic Innovation & Regulatory Science (TIRS) and Pharma Focus Asia. Dr. Milne received a BA from Fordham University, an MPH from The Johns Hopkins University, and holds doctoral degrees in veterinary medicine and law, respectively from UNPHU and UNH, and is a licensed attorney in the state of New Hampshire.

Damian Largier

Vice President Medical Affairs – International Developed Markets at Pfizer, UK

Damian Largier is a South African born physician who completed a Masters in Obstetrics and Gynecology at the University of Cape Town with a focus on Developmental Endocrinology. After five years in clinical practice, he joined the pharmaceutical industry initially with Glaxo Welcome and then as Country Medical Director for Pfizer in South Africa.

He has held leadership positions for Pfizer Medical Affairs in Europe and the United States as well as at a Global level with a particular focus on medical communications and late-stage product development. He is now the Vice President Medical Affairs for the International Developed Markets (Europe, Japan and Developed Asia) for Internal Medicine.

Daniel García Molinero

Senior Regulatory Manager at Drug Development and Regulation (DDR), Spain

Daniel García is a pharmaceutical professional with a strong foundation in the life sciences and broad experience in a number of therapeutic areas. He earned his MsPharm degree in 2005 from the Salamanca University in Spain. In addition, he carried out a postgraduate qualification in pharmacoeconomics (Pompeu Fabra University) and studied a MSc in Pharmaceutical Industry´s Scientific Departments (University of Barcelona).

Prior to joining Drug Development and Regulation (DDR) in December 2014, Daniel worked as a community pharmacist in the UK from 2006 to 2010 and has held different positions in the pharmaceutical industry since 2011, including the areas of health economics, market access and more than five years in regulatory affairs.

Daniel García currently holds the position of Regulatory Manager at DDR, where he is in charge of Barcelona facilities. Additionally, he is involved in a number of drug development projects, scientific and regulatory activities with small and medium-size research-oriented pharma/biotech companies worldwide, taking regular part in Scientific Advice, Protocol Assistance, Orphan Drug Designation and Innovation Task Force meetings at the European Medicine Agency.

David Morgan

Statistical Consultant, UK

David Morgan gained degrees in Mathematics and in Applied Statistics from Oxford University. He had a thirty year career in the pharmaceutical industry, mostly within drug development, latterly with Ipsen Biopharm. His career included leadership of statistics and data management groups in UK and US and he spent 9 years in the CRO sector.

Since 2015 David has worked as a Statistical Consultant to the pharmaceutical industry and is also a Visiting Senior Lecturer within the Pharmaceutical Medicine Group at King’s College London. David has extensive experience in teaching statistics to non-statisticians, including 9 years early in his career lecturing at Cranfield University. In recent years he has taken part in training activities with industry professional bodies including TOPRA (Regulatory Affairs), ACDM (Data Management), the Faculty of Pharmaceutical Medicine and the Institute of Clinical Research, as well as with IFAPP. He has also been an External Examiner at Kingston and Cardiff Universities.

David is a former chair and Honorary Life Member of PSI (Statisticians in the Pharmaceutical Industry). He also served as President of EFSPI (European Federation of Pharmaceutical Industry Statisticians) and as Editor-in-Chief of the Pharmaceutical Statistics Journal. He has authored or co-authored over 20 peer-reviewed journal articles including a series of “PSI Expert Group” publications in the Pharmaceutical Statistics Journal.

Domenico Criscuolo

Past President of the Italian Association of Pharmaceutical Medicine and IFAPP, Italian SMD Team Lead, Italy

Domenico started as Clinical Research Physician at Lepetit Milano with the responsibility to develop European Phase II and III studies for original NCEs (antimicrobials, corticosteroids, respiratory, cardiovascular), working in cooperation with European affiliates. Afterwards he was appointed Director of International Clinical Research and Drug Safety at Roche Milano, responsible for building the Clinical Research Department in addition to include Italian and Greek sites as part of the pre-NDA clinical program, in order to contribute to the global NDA. The clinical development work undertaken for interferon alpha, doxifluridine, capecitabine, herceptin, rituximab in oncology and for tolcapone, moclobemide, aniracetam in CNS were of high value and contributed to a significant market success.

Then he assumed the position of VP Europe at ICON Milano. His tasks were to establish and organize the Milano office and to supervise ongoing activities in France (an office of 100) and in Israel (an office of 25). He is currently the President of Genovax, a start-up company exploring the clinical value of therapeutic vaccines in autoimmune diseases and in cancer. Two candidates are in preclinical and clinical development.

Dr. Criscuolo has been involved in several research areas: haematology (leukemias, lymphomas, blood coagulation, platelets, haemophilia); anticancer agents (chemotherapy, monoclonal antibodies); dermatology (psoriasis, acne, onychomycosis, melanoma, cutaneous lymphoma); CNS (Parkinson, senile dementia, depression); biotech products (IFN, IL 2, IL12, TNF, monoclonal antibodies); HIV (protease inhibitors, NNRTI); cardiovascular agents (hypertension, CHF, stroke); gastrointestinal agents (Crohn); respiratory agents (cough, asthma, cystic fibrosis); anti-infective agents (cephalosporins, antimycotics, quinolones); anesthesia; obesity ; rheumatology (NSAIDs, monoclonal antibodies); medical devices.

As Past President of the Italian Association of Pharmaceutical Medicine and IFAPP, Dr. Criscuolo was involved in the PharmaTrain program since its inception and currently leads the Italian SMD team.

Edward Power

Vice President, North America Medical Affairs, Hospital Business at Pfizer, USA

Dr Eddie Power is currently the VP, North America Medical Affairs, Hospital Business, Pfizer Biopharmaceuticals Group and has held positions of increasing responsibility during his career in the pharmaceutical industry. He started at Pfizer in September 2010 as the Team Leader, US Medical Affairs Infectious Diseases in SCBU, before assuming the position of Group Leader, US Medical Affairs, Vaccines and Infectious Diseases in 2012 and Head, US Medical Affairs, Vaccines in 2014.

Before joining Pfizer, Eddie served as the Global Medical Director for Cubist Pharmaceuticals since 2008, working internationally with alliance partners to develop Medical Affairs strategies for Cubist’s anti-infective portfolio. Previously, Eddie was the Therapy Area head at Schering-Plough leading the Anti-Infectives/Virology/ Addiction Medicine portfolio in Global Medical Affairs.

He was also with Bayer Healthcare, where he was Director of Global Scientific Affairs, responsible for global opinion leader interactions, scientific communications and overseeing a corporate antimicrobial stewardship program. Prior to joining Bayer in 2002, Eddie was Director, Strategic Microbiology at GlaxoSmithKline supporting GSK’s Infectious Disease portfolio. Eddie held a faculty position at United Medical and Dental Schools, Guy’s & St Thomas’ Hospitals, London, UK.

He holds a PhD degree from the Welsh School of Pharmacy, University of Wales and an MBA from Henley Management College, UK, and is a past recipient of the WH Pierce Memorial Prize (UK) for an outstanding contribution to microbiology. He is married with three children and enjoys sport and cycling in his spare time.

Greg Koski

President & Co-Founder at Alliance for Clinical Research Excellence and Safety, ACRES; retired Associate Professor at Harvard Medical School, USA

Greg Koski, PhD MD, CEO of the Alliance for Clinical Research Excellence & Safety (ACRES), is also Associate Professor of Anesthesia, Harvard Medical School and Honorary Anesthetist, Massachusetts General Hospital, expert faculty for Partners HealthCare International (PHI), and Senior Scientist at the James Mongan Institute for Health Policy.

As the first director of the Office of Human Research Protections (OHRP) at the U.S. Department of Health and Human Services, Koski championed a “culture of conscience” in human research, emphasizing the values and processes of professionalism and quality improvement, moving beyond mere regulatory compliance and created the Program of International Activities within the OHRP to enhance its global effectiveness.

He has worked with many global organizations including the World Health Organization (WHO) and the World Medical Association to coordinate and strengthen global mechanisms for ethical conduct of human research and clarifying the intent and applicability of the Declaration of Helsinki and was influential in development of accreditation for human research protections programs and certification of physician investigators.

An internationally-recognized, scientist, speaker and author, Koski has received multiple awards for his inspiring leadership, most recently the Lifetime Service Award from Partnerships in Clinical Trials and was named in 2017 among PharmaVoice 100 “Most Inspiring Persons” for his many contributions to academic medicine and clinical research.
The Alliance for Clinical Research Excellence and Safety, a non-profit multi-stakeholder global collaborative, is working in the public interest to build a comprehensive integrated system for accelerating the discovery, development, and effective use of medicines worldwide.

Gustavo Kesselring

IFAPP Academy Vice President & External Affairs; Senior Lecturer, School of Cancer & Pharmaceutical Sciences, King’s College London, Brazil

IFAPP Academy Vice President & External Affairs; Senior Lecturer, School of Cancer & Pharmaceutical Sciences, King’s College London

Gustavo Kesselring received his medical degree from University of São Paulo, Brazil and pursued further postgraduate training in Gynecology, Obstetrics and Mastology. He also received postgraduate qualifications in Clinical Pharmacology, Drug Development and Regulation at the Tufts Institute for Professional Development, USA.

He was Director of Clinical Research for several multinational pharmaceutical companies and in 2009 was appointed as Director of the National Clinical Research Training Program for the Ministry of Health in Brazil while serving at the same time as Director of Clinical Research at the Science Institute, German Hospital Oswaldo Cruz, São Paulo, Brazil.

He served as the Brazilian Medical Association advisor for the revision of the World Medical Association’s Declaration of Helsinki (versions 2008 & 2013). He received awards by the American Academy of Clinical Research Professionals in 2011 and by the Drug Information Association in 2013 in recognition for his contributions to global clinical research and pharmaceutical medicine. In 2016 he became a Lifetime Academic Member for the Brazilian Academy of Pharmacy.

In 2019 he was elected Executive Board Member at CIOMS and in 2021 he became the official representative from the Brazilian Medical Association at the Ethics in Medicine Working Group at the World Medical Association.
Intimately involved in clinical research for both the public and private sector his focus has been education on clinical research and medicines development where he has published several papers and being speaker or chairperson at international conferences in USA, Europe, Latin America and Asia.

Currently Gustavo holds the following positions at nonprofit organizations:

  • Senior Visiting Lecturer at the Faculty of Life Sciences and Medicine- King’s College London
  • Vice President of IFAPP Academy
  • Executive Board Member at CIOMS
  • Board member of the Brazilian Association of Pharmaceutical Medicine

Helene Schluep

Global Medical Affairs, Pfizer, USA

Helene Schluep is a French-certified neurologist. She joined Pfizer in 2002 as a product physician for Lyrica & Neurontin. She has been developing expertise in Medical Affairs at Pfizer through various leadership roles either at the country level or at the regional level. In 2004, Helene moved to Ophthalmology as the medical team leader before joining the Regional European Team in 2006 working on Antifungals, Allergy, and Respiratory and setting up the Neurosciences platform as the medical team leader.

In 2012 Helene gained significant country experience when she took over the role as medical lead/medical director for Primary Care in France. In 2014 Helene moved to NYHQ, as Vice President, taking over responsibilities for Latin America and setting up the Medical Affairs structure including the Customer Facing Medical in the region. In 2016 her responsibilities expanded to include to AfMe and Emerging Asia. Helene brings robust knowledge and understanding of Medical Affairs through various national and international roles in diverse therapeutic areas.

Honorio Silva

IFAPP Academy President/CEO, Module Chair; Past President IFAPP Visiting Professor and Director, IFAPP-King’s College London Professional Certification Program, USA

IFAPP Academy President/CEO; Visiting Professor, Faculty of Life Sciences & Medicine at King’s College London; and Director, IFAPP-King’s College London Professional Certification Program

Dr. Silva served in the pharmaceutical industry for 30 years. He retired as Vice President, Science and Medical Professional Development, within the External Medical Affairs group of Pfizer, Inc. Dr. Silva began his career as Medical Director, Pfizer – Venezuela before transferring to Pfizer’s New York headquarters. He then served as Vice President, Medical and Regulatory Affairs, Japan, Asia, Africa & Latin America.

He began his medical education in Argentina, and received postgraduate training in internal medicine and clinical pharmacology in Argentina and Venezuela, respectively. He was actively involved in clinical research as part of his previous academic activities as Assistant Professor of Clinical Pharmacology, Razetti Medical School, Universidad Central de Venezuela, Senior Scientist at Harvard-MIT Center for Experimental Pharmacology and Therapeutics and Adjunct Assistant Professor at Rutgers University School of Health Professions

Dr. Silva has authored or co-authored more than 100 publications on cardiovascular disease, arterial hypertension, infectious diseases, clinical pharmacology, and outcomes-based medical education. He has also been co-editor of three books related to Cardiovascular Pharmacology and Pharmaceutical Medicine. While serving as President for both the Board of and the Venezuelan Society for Clinical Pharmacology and the Venezuelan Society of Pharmacology, he pioneered CME/CPD activities in Venezuela and Latin America. He also pioneered online postgraduate education and continuing professional development programs in Clinical Research, Cardiovascular Risk, and Pharmaceutical Medicine across continents.

He was pivotal in the creation and development of a number of International Medical Societies and non-profit organizations and has established multiple strategic alliances between medical associations, academic institutions, and the pharmaceutical industry aimed at advancing and improving health care internationally. He has received several awards for his contributions to clinical research and medical education.

Jacqui Piner

Scientific Director, GSK Fellow, GSK, UK

Dr Jacqui Piner is a Scientific Director representing nonclinical safety on drug development project teams with over 30 years of experience in the pharmaceutical industry. Currently working on novel medicines for malaria, TB, HIV, and Parkinson’s Disease and a past diverse portfolio across therapeutic areas and using small chemical entities or biopharmaceutical platforms.

Jacqui holds a PhD in Reproductive Toxicology from the University of Edinburgh, is a Chartered Biologist, Fellow of the Royal Society of Biology, and a GSK Fellow. She was elected in May 2019 to serve as a board member and charity trustee for the Royal Society of Biology (RSB) and is an active member of the British Toxicology Society (BTS).

 

Jan Petracek

Founder and Director of the Institute of Pharmacovigilance, Czech Republic

The founder and director of the Institute of Pharmacovigilance is Jan Petracek, a highly visible figure in the pharmacovigilance world for over 20 years.

Dr. Jan Petracek qualified as a physician from Charles University in Prague and holds a Master of Science with Distinction in Quality and Safety in Healthcare from Imperial College London.
Jan has enjoyed over 20 years of intensive work in all areas of pharmacovigilance, being former Head of Risk Management Section at the European Medicines Agency, Head of Pharmacovigilance in the Czech Republic, Head of Strategy and Development of the Czech National Authority, and member of CHMP Pharmacovigilance Working Party, CEO of PharmInvent and PrimeVigilance, and Board Director of a public company in London.

He was trained and contributed as an inspector within the Benchmarking of the European Medicines Authorities, assessing performance of regulatory authorities in the EU and helping to set benchmarks for regulatory approaches and performance. He also audited dozens of pharmaceutical companies, resulting in significant improvements of their pharmacovigilance systems.

He took part in the development of national, European, ICH and CIOMS guidelines. One highlight of his contribution was the EMA Guideline on Safety and Efficacy Follow-up – Risk Management of Advanced Therapy Medicinal Products, which was so visionary that even after 13 years it is still highly effective as it predicted future safety issues and suggested lasting solutions. He also enjoyed international regulatory diplomacy while representing the EU at the ICH E2F Expert Working group on Development Safety Update Reports.

He contributed to the development of new regulatory pathways as a member of the EMA Innovation Taskforce, including biosimilars, nanomedicines, and challenging combination products. He assessed borderline products and OTC switches and often found fresh new solutions to difficult questions.
Jan is a very active trainer on international courses and is an elected member of the Advisory Board – International Society of Pharmacovigilance. He also worked as EU QPPV for major innovative companies, performed complex audits, strategic consultancy, and has led fast growing organizations as entrepreneur and CEO for the last 10 years.

Jan is now dedicated to the building of the Global Pharmacovigilance Professional Certification, leading the Special Interest Group on the Pharmacovigilance Qualification Framework of ISoP, Scoping Group of ISoP, and many associated collaborations.

Jeff Duke

Consultant, Grove Lodge Consulting, UK

Jeff Duke, M.Sc, C.Chem, C.Sci, FRSC is Managing Director of Grove Lodge Consulting Ltd, supporting the pharmaceutical industry with Chemistry, Manufacturing & Controls (CMC) expertise. Major areas include Analytical Chemistry, General Chemistry, Manufacturing and Controls, product support and strategy development, Quality by Design, both as a product development strategy and as a trainer providing training to clients across Europe. Managing large global Departments and Projects particularly outsourced projects including those outsourced into Asian CRO/CMO’s.

Jeff worked at Pfizer Global R&D for over 20 years, most recently as head of the Materials Science & Oral Products group in both the US & the UK. Prior to this Jeff worked as Head of Strategy & Co-ordination for Pharmaceutical Sciences Asia Business Development Group, and before that, Jeff headed the European Pharmaceutical Sciences Analytical R&D group with departments in the UK and Freiburg, Germany. He now works with clients in the UK, Europe and Asia.

Jeffrey S. Cohen

Principal, Performance Leaders, LLC, USA

Accelerating the development of senior leaders and their teams has been a passion for Jeff throughout his career. Jeff has established a track record of helping leaders at all levels bring even more value to their organizations and to themselves. Jeff has been delivering executive coaching and business team development services since 1990. Established in 2001, Performance Leaders, LLC clients have included Pfizer (pharmaceuticals and consumer), Alnylam Pharmaceuticals, Astellas Pharmaceuticals, Bank of America, Boehringer-Ingelheim (pharmaceutical and veterinary), COTY, MW Industries, Pyxis Oncology, Richemont Group, Takeda Pharmaceuticals and WSP Flack+Kurtz.

Performance Leaders’ value-added is most frequently achieved with tightly focused coaching and/or leadership team development that accelerates individual and organizational performance and builds critical organizational capabilities applied to key business challenges. Nearly all aspects of leadership as well as strategy development and deployment, change management, organizational design and talent succession planning/development are areas of expertise Jeff brings to his work. Jeff’s coaching work is often with experienced line or staff leaders looking to expand their capabilities and demonstrate increased readiness for a current or more challenging assignment, and with leaders transitioning to new, and significantly more challenging positions. His team effectiveness work has recently been focused on helping senior management groups at the C-suite and in line and staff functions operate as a real leadership team when they need to be a team, understanding and delivering their unique value to the business. He works with all levels and types of teams, including co-promotion and alliance teams and has extensive experience working with leaders and teams inside and outside of the United States. An experienced facilitator, Jeff also does interesting work designing and facilitating complex international meetings that deliver on strategic goals.

Jeff’s practice is built on over 40 years of experience in the pharmaceutical, financial service and airline industries, both as a line manager and as a human resource development leader. As a Team Leader in the Organizational Effectiveness (OE) team of Pfizer Global Pharmaceuticals, he led a team focused on the development of key senior and mid-level leaders and their teams across Pfizer’s global pharmaceutical business. Jeff’s areas of focus included leadership development and coaching, succession and talent planning, OE and change management, merger integration, and cross-functional team development. Before Pfizer, Jeff held OE leadership positions with Rhône-Poulenc Rorer (RPR) where he worked closely with senior management on accelerating learning and building the global organizational and individual competencies RPR needed to achieve its strategic goals. Prior to RPR, Jeff focused on the development of first and second level managers at Chase Manhattan Bank. Before two years as a partner in an advertising specialty business, Jeff began his managerial career with People Express Airlines, where he held line management positions ranging from customer service to training to international operations, culminating in his last assignment as West Coast Regional Director.

Jeff holds a Masters in Organization Dynamics from the University of Pennsylvania and a Bachelor of Arts in Economics and Political Science from Drew University. He also holds certificates in advanced team building, instructional design, and a variety of leadership self-assessment and feedback instruments including the Herrmann Brain Dominance Inventory (HBDI), the Myers Briggs Type Indicator (MBTI) and EQ-I 2.0 Emotional Intelligence self and 360 assessment. A member of Forbes, Coaches Council, he is married with two adult daughters. He is active in his community as past president of his synagogue, has been a board member with the Painted Bride Arts center, was an active board member of his local food co-op and enjoys spring and summer weeknights and weekends as a volunteer umpire for Little League baseball and softball games.

John M. Kelton

US Medical Director, Oncology Biosimilars, Pfizer, USA

John Kelton is US Medical Director, Oncology Biosimilars for Pfizer, Inc. and has 25 plus years of experience in the pharmaceutical industry. Since 2000, John’s focus has been on Medical Affairs, serving in a variety of capacities, including management of Medical Communications and Training, Medical Review, Medical Education, Medical Science Liaisons, and Investigator Initiated Trials.

For the past seven years John has been actively involved in biosimilar development and educational efforts in the United States and Europe. John has collaborated with biosimilars experts that have expertise ranging from bench to bedside in Nephrology, Inflammation, and Oncology in order to capture and communicate the unique aspects of biosimilars and their development programs.

Prior to his roles in Medical Affairs, John functioned as Regional Pharmacy Manager for Abbott where he managed pharmacy operations for parenteral and nutritional products as well as key clinical relationships with major healthcare systems. John received his Doctor of Pharmacy from the University of Southern California. Before joining industry, John practiced as a clinical pharmacist, specializing in parenteral nutrition and oncology.

Kamlesh Thakker

Principal at Notting Hill Consulting LLC, USA

Dr. Kamlesh Thakker PhD, MBA is the Founder/Managing Partner/Principal of Notting Hill Consulting LLC, which provides consulting services for pharmaceutical, biotechnology, consulting, and financial services companies in the areas of Clinical Development and Medical Affairs, Phase I-IV Clinical Pharmacology, PK-PD, Bioequivalence, and Biopharmaceutics.

At Abbvie/Abbott, Kamlesh individually led/managed teams responsible for Medical Affairs strategy and tactics from clinical development to launch and on-market support, across several indications/products/development candidates in the Dyslipidemia, Renal, and Immunology Therapeutic Areas (TAs), including Trilipix, Niaspan, Simcor, Zemplar, Humira, upadacitinib, and bardoxolone. Prior to Abbvie/Abbott Kamlesh briefly worked as Medical Affairs and Clinical Development contractor/consultant for Sanofi for their Insulin franchise (Lantus/Apidra) in the US Diabetes Business Unit. Dr. Thakker also has on-market, pre-launch, and launch experience in Cardiovascular Medical Affairs and Clinical Development from his time at Pfizer with the Hypertension and Lipids on-market franchise products, specifically Norvasc and Caduet. While at Pfizer, Kamlesh also worked in a Pipeline Medical Affairs role for development and licensed candidates across many different TAs within the New Product Development Group.

Dr. Thakker also has Phase I-IV Clinical Pharmacology/Early Development/PK-PD/Biopharmaceutics experience from working with Pfizer, Ciba-Geigy (now Novartis) and at Softgel company Banner Gelatin Products. Kamlesh’s Clinical Pharmacology achievements while at these companies include leading/co-leading successful prosecutions of NDAs and sNDAs for several products across different TAs, like Zyrtec, Zithromax, Tegretol Oros, Habitrol, Zantac GelDose and others, and FIH studies for many CNS Neuroscience pipeline development candidates (at Pfizer).

Kamlesh also has academic and teaching experience from working as an Assistant/Adjunct Professor at the Colleges of Pharmacy of the University of Florida and the University of Southern California, respectively. Kamlesh has presented and published extensively during his career and has received numerous citations and awards over the years while working with Abbvie/Abbott, Pfizer, Ciba-Geigy, and Banner Gelatin.

Kenneth Kaitin

Professor and Senior Fellow, Tufts Center for the Study of Drug Development, Tufts University School of Medicine, USA

Kenneth Kaitin is a Professor and Senior Fellow at Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He previously served as the group’s Director for 23 years. In addition, he is an Advisory Professor at Shanghai Medical College at Fudan University, and he serves on the faculties of the European Center for Pharmaceutical Medicine at the University of Basel, and the American Course on Drug Development and Regulatory Science at the University of California, San Francisco.

Dr. Kaitin is an internationally recognized authority on drug development science and policy. He has provided public testimony before the U.S. Congress, and currently he consults, speaks, teaches and writes on global trends in pharmaceutical development and regulation. A former President of the Drug Information Association, Dr. Kaitin recently served as Editor-in-Chief of Expert Review of Clinical Pharmacology, and as a consultant to the U.S. Department of Defense on bioterror countermeasures. In 2011, he received the Dr. Louis M. Sherwood Award, granted by the Academy of Pharmaceutical Physicians and Investigators, and in 2020 he was named a Global Fellow in Medicines Development by the International Federation of Pharmaceutical Physicians.

Dr. Kaitin is a director on the boards of Curis, Inc. (NASDAQ: CRIS), Bio-Tree Systems, Inc., and QCDx LLC. He earned his BS from Cornell University and MS and PhD in pharmacology from the University of Rochester.

Larry Kennedy

CEO, Quality Management Institute; Executive Director, Site Accreditation and Standards Institute, USA

Dr. Kennedy has provided consulting services to businesses and nonprofit organizations since 1985. His clients have also included criminal justice, educational, health care, and government leaders. His interdisciplinary background in engineering and business, together with his practical experiences as a nonprofit trustee and foundation executive have uniquely prepared him to evaluate and train managers.

With over thirty years of Quality Management experience in aerospace, business, and as a management consultant and trainer, he has a broad perspective on management reform processes and the development of public and private collaborations. He was also mentored by Phillip Crosby, the world-renowned Quality Management executive, who partnered with him in reaching out to the nonprofit world.

He held systems engineering positions in Apollo Spacecraft Operations and Flight Crew Training where he first practiced Quality Management disciplines. This scientific background honed his practical expertise in systems analysis. His later experiences as a manager and business owner broadened his understanding of process management principles. He also gained national recognition for his sales and marketing expertise.

As a human services developer, he has organized and directed the certification of residential and outpatient substance abuse services, mental health services, and inmate work release and aftercare programs using J.C.A.H.O. and C.A.R.F. criteria. He has trained nonprofit staff and volunteers for projects with as many as 20,000 participants.

He was the lead consultant to the National Institute of Corrections (NIC) to coordinate and write the Management Reform Plan for the Washington, D.C. Department of Corrections, under mandate from the U.S. Congress. He also represented the NIC in the implementation of the reform plan which included extensive leadership training.

He has served as the Chair, Co-Chair, or lead facilitator of numerous national and international colloquiums on management reform, leadership, and philanthropy including: Center for Strategic and International Studies, Washington, D.C.; Council on Foundations, Washington D.C.; National Cathedral, Washington, D.C.; St. Petersburg State University School of Medicine, St. Petersburg, Russia; and the World Health Organization, Geneva, Switzerland.

As a foundation executive and consultant he has performed numerous on-site program evaluations and has developed innovative approaches to grant making and technical assistance for recipients in a broad range of social issues. He has also managed and given oversight to humanitarian projects on a local, national and international scale.

Dr. Kennedy has lectured extensively in business, educational, government, and humanitarian venues on the integration of effective management principles into business and human services processes. His books, Keeping the Promise: A Work Ethic for Doing Things Right and Quality Management in the Nonprofit World have been widely referenced by business, nonprofit and academic leaders.

 

Laurent Pacheco

Life Sciences Head (London), BearingPoint, UK

Dr. Laurent Pacheco is the London head of the Life Sciences practice at BearingPoint, a global management consultancy. As a physician, Laurent has over 20 years of experience in healthcare and life sciences. He was trained and practiced in Paris University Hospitals before moving to strategy consulting. For 13 years, he has led a wide range of projects on commercial strategy for biopharma, developing expertise in HTA, pharmacoeconomics, market access, and pricing strategies. Prior to joining BearingPoint, Laurent was Vice-President of GfK Market Access Europe, based in London; he also held consulting positions with Navigant in London and PwC in Paris.

His projects have covered all major European markets as well as the US, Canada, Japan, and emerging markets. Laurent currently lectures at King’s College London on HTA and pharmacoeconomics. Laurent has carried out research on the internationalization of HTA and the impact of HTA networks (EUnetHTA, RedETSA, and HTAsiaLink) on new product access strategies. He also researched early consultations offered by HTA agencies to biopharma companies and their role and dynamics as risk minimization strategies for the industry.

Laurent received his MD from UPMC-Paris (specialized in Public Health) and his PhD in Economics from the University of Paris-Dauphine. He also holds an MSc in pharmacology (Paris Diderot University), an MSc in Health Systems Administration from R.I.T., New York, USA, and an MBA from ESSEC Business School, Paris. He is an affiliate member of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians in the UK and a registered physician with the French Medical Council.

Lisa Egbuonu-Davis

VP, Medical Innovations, DH Diagnostics, LLC, USA

Lisa Egbuonu-Davis, MD, MPH, MBA, Vice President, Medical Innovations, Danaher Diagnostics Platform, provides medical and clinical input to the innovation strategy, projects, and investments across the Diagnostics platform. She leads the MD Council of diagnostic physicians, which enhances the medical value of our solutions by influencing strategy and investment decisions, driving engagement, and sharing best practices to support product research, development, and commercialization. She leads the COVID Diagnostic Platform clinical strategic initiative.

Previously, Lisa was Vice President, Global Patient-Centered Outcomes and Solutions at Sanofi, Inc, where she created innovative patient programs, services, and tools to enhance patient self-management, adherence, and health outcomes in diabetes, cardiovascular, immunologic, and other chronic conditions. She led a pilot in multiple sclerosis, leveraging machine learning to assess patterns of clinical effectiveness. During her tenure at Pfizer, as Vice President of Medical Affairs and Vice Present of Global Outcomes Research, she built and led functions in medical affairs and outcomes research and developed evidence from clinical trials, observational studies, and “real world” analyses to support product value assessment throughout the product life cycle. Earlier in her career, she practiced pediatrics and led maternal and child health public health programs.

Lisa has a BS in biology from MIT and an MBA in health care management from Wharton; she earned an MD and MPH (epidemiology) degrees from Johns Hopkins, completed her pediatric residency at Children’s Hospital of Philadelphia (board-certified in pediatrics).

Mark Lightowler

Founder and CEO, Phorix Limited, Switzerland

Phorix was founded by Mark Lightowler, who has more than twenty-five years of experience in science-based industries. Originally trained as a Medicinal Synthetic Chemist, he has also spent time in clinical development, sales, marketing, medical affairs, and digital innovations with global and country pharmaceutical companies. He has led the development, marketing, and sales of multiple global brands.

Maureen Doyle-Scharff

Team Lead, Global Medical Grants at Pfizer, USA

Maureen Doyle-Scharff, PhD, MBA, CHCP, FACEHP is Team Lead, Global Medical Grants at Pfizer Inc. She has worked in the field of medical education, CPD, quality improvement and behavior change in a variety of capacities for nearly 30 years.

Active in the CME and CPD communities around the world, Maureen has served as President of the Global Alliance for Medical Education (GAME), President of the Commission for the Certification of Healthcare CPD Professionals (CCHCP), is a former member of the National Task Force on Provider/Industry CME Relationships, is founder and past president of the Ohio Chapter of the Healthcare Businesswomen’s Association, and served for six years on the Board of Directors for the Alliance for Continuing Education in the Health Professions (ACEHP), including serving as Secretary/Treasurer in the final two years. Maureen received her undergraduate degree from the University of Michigan, her MBA from St. Joseph University, and her PhD in Higher Education Leadership at Ohio University. She lives in Columbus, OH with her husband and three children.

Mike Collins

Owner at Mike Collins Consulting LLC, USA

Mike graduated from the University of Sheffield in the UK with a degree in Genetics. After an MSc in Applied Genetics; he completed his doctorate at the University of Birmingham on the quantitative genetics of behavior in fruit flies.

Originally a statistician by training he has extensive experience in all phases of clinical development at Hoechst, Pfizer & Alexion.

Most recently Mike was Head of Global Clinical Operations & R&D Vendor Management at Alexion focusing on the development of medicines for ultra-rare diseases.

He currently provides clinical development consulting services to a range of biotech clients.

Mike is passionate about meeting the needs of patients and in optimizing the operational aspects of clinical programs to ensure high-quality data delivery.

Nikolas Karkanias

Global Digital Lead, Hospital Business Unit and Enterprise Medical Affairs at Pfizer, USA

Nik is currently the Global Digital Client Partner Lead for Hospital Businesses and Medical Affairs. Nik received his B.S. in biochemistry at Rutgers University and his Ph.D. in neuroscience at the University of Florida. Nik has over 20 years of diverse experiences from roles in research, legal, medical education, and medical affairs at several companies. Nik joined Pfizer in June 2011 in field medical governance to further develop Pfizer as a leader in field medical. Nik has worked on various projects and policies globally to improve the operational effectiveness, role scope and governance of field medical people, processes, and technology. Nik built and led the first field medical organization in Pfizer Essential Health before moving over to Oncology to lead field medical biosimilars engagements and oncology landscape strategy projects. Before coming to Pfizer, Nik worked as a medical science liaison in various therapeutic areas, as a scientific advisor for a patent law firm, in risk management and compliance for promotional and non-promotional functions and led franchise operations and communications for US Medical Affairs teams.

Otfried Kistner

Senior Consultant & Independent Vaccine Expert, Austria

Otfried Kistner is currently working as Senior Consultant for several international and national companies and organizations.

  • 30+ years of experience in conducting scientific research in the fields of virology and 25+ years of experience in industrial vaccine development.
  • Areas of expertise include infectious diseases, virology, vaccine development; viral safety, immunology, regulatory affairs, cell culture, bioassay development and validation, animal models, GXP (GLP, GMP, GCP, GDP, GCLP), quality control, biological safety, strategic planning, technical due diligence and strategic market positioning.
  • Team player, and extensive experience in leadership and employee management.
  • Broad working knowledge in cross-disciplined matrix environment.

In his different executive R&D management positions he had also main responsibilities in defining and organizing the serology of clinical studies and being the R&D point of contact for internal and external relationships. His responsibilities included the development of a range of viral vaccines such as Influenza (seasonal and pandemic), SARS Coronavirus, Smallpox vaccines of 2nd and 3rd generation, West Nile, Ross River, and Chikungunya as well as new antigen delivery and adjuvant technologies. Otfried was one of the main contributors in the development, production and licensure of cell culture-derived seasonal and pandemic influenza vaccines i.e. H5N1 (Mock Up and pre-pandemic) and 2009 pandemic H1N1.

Otfried has authored or co-authored more than 60 publications in peer-reviewed journals and has given more than 200 presentations at International Scientific Conferences, International Expert Meetings and Workshops. He also acts as reviewer of a number of scientific journals as well as Chair or as member of scientific committees of international conferences.

In addition, Otfried is lecturer at the University of Natural Resources and Applied Life Sciences, Vienna, Austria and at the IMC University of Applied Sciences, Krems, Austria on Virology, Vaccinology as well as vaccine development and industrial scale production.

Paula Tully

Principal, Escentia, Ltd, UK

With a passion for developing people and expertise in human capital management and growth, Paula Tully integrates academic theory with her own executive management experience in her work across the UK, Ireland, and Europe. Paula is committed to cultivating clear, focused leaders who build trust, compassion, and stability within their organizations. She has served for more than 25 years in numerous executive roles within the pharmaceutical industry. Her longest tenure was at Pfizer, where Paula served as European VP in Marketing, UK General Management, as well as VP of the UK and Central Europe. During her business career, Paula successfully led teams of as many as 500 colleagues and held P & L responsibility for a billion-dollar business. Paula is a business consultant and qualified mentor and coach for Escentia, Ltd. – a company created by Paula to help develop clear focused leaders and teams.

Paula expertly combines her passion for leadership development with her extensive business experience and she applies this expertise to each of her consulting and coaching roles. Her philosophy for success comes from a deep-rooted belief that leading a business, team or organization is not something that is done to people, rather, it is a two-way relationship that requires mutual understanding, consistent language, and action. She believes the critical ingredients for success are clarity, self-awareness, connection and sustainability. Paula fervently advocates that every topic and situation requires insight, action planning, and measurement. She consults, mentors and coaches individuals and groups, allowing time for pause and self-reflection. Her approach to counseling senior executives is pragmatic, business-grounded, and outcomes-oriented.

Her areas of professional focus are coaching for senior executives, leadership acceleration of highest-potential emerging leaders, executive team dynamics consultation, and colleague engagement and loyalty. Paula is also experienced at facilitating workshops to bring business clarity to working teams. She holds several accreditations in tools to build deeper individual and team understanding, which in turn enhances communication, influence, and effectiveness.

Paula earned a BSc in Pharmacology at Liverpool University and in 2016 earned a Masters in Consulting and Coaching for Change from Oxford University and HEC Business School. She is a fully qualified executive coach through the University of Wolverhampton, an accredited Resilience Practitioner, HeartMath Practitioner, as well as Herrmann Brain Practitioner. She lives in Surrey with her husband and teenage sons.

 

Penelope Ward

Chair, Education and Standards Committee, FPM and Visiting Professor in Pharmaceutical Medicine, King’s College London, UK

Penelope (Penny) Ward qualified in medicine from University College Hospital Medical School, London. Following a 15 year career in clinical and academic practice in obstetrics and gynaecology, she moved to the pharmaceutical industry in 1991. Her career has since included senior management positions in several companies, including Pharmacia and Upjohn, Roche and GSK. Her work has resulted in the worldwide licensure of multiple therapeutics for the treatment of female healthcare conditions, bacterial and viral infections, inflammatory disorders, osteoporosis and cancer. She chairs the Education and Standards Committee of the Faculty of Pharmaceutical Medicine and is also a Visiting Professor in Pharmaceutical Medicine at Kings College London.

Peter Šajben

Vice President, Regional Head Medical Affairs, Africa & Middle East Region, Pfizer Essential Health, USA

Dr. Peter Šajben holds a Medical Degree from Comenius University in Bratislava (Slovakia) and is board certified in internal medicine and clinical oncology.

Before joining Pfizer, Dr. Sajben worked at the Institute of Experimental Oncology, National Institute of TB, Respiratory Diseases and Geriatrics and the National Cancer Institute in Bratislava (Slovakia). After joining Pfizer he held positions with increasing responsibilities in medical affairs, business development and marketing. He worked as Country Medical Director, Regional Marketing Director, Senior Director Medical Affairs & Clinical Development Oncology for Canada, Latin America, Africa and the Middle East, and later as Regional Head Medical Affairs for specialty and oncology portfolio for Latin America, Africa, the Middle East, Emerging Markets Europe and Asia.

Dr. Šajben is currently the Regional Lead Medical Affairs for Africa and the Middle East with Pfizer Essential Health and Country Medical Departments report to him. He is an author and co-author of multiple poster presentations and publications.

Petra Dörr

Executive Director at Petra Doerr Consulting Ltd, former Deputy Executive Director at Swissmedic, Switzerland

Since July 2019, Petra Dörr is the executive director and owner of a consultancy firm, providing services to non-for profit organisations in areas such as regulation and governance, strategic and change management or training and mentoring.

From January 2014 to June 2019, Petra Dörr held the position of Head of Communication and Networking and Deputy Executive Director at Swissmedic. Amongst other responsibilities in external relations, she oversees the international activities of Swissmedic with other agencies and international organisations. She is a member of the ICH Management Committee and the IPRP Management Committee and of the Scientific Advisory Council of the Centre for Innovation in Regulatory Science. Between June 2013 and September 2016, she served as the chair of the International Pharmaceutical Regulators Forum (IPRF; now: IPRP). In November 2018, she was elected Vice-chair of the ICH Assembly.

Petra Dörr received her approbation as a pharmacist in 1990 and was awarded her PhD at the Institute of Pharmaceutical Chemistry, Faculty of Pharmacy at the University of Heidelberg in 1995. She has ten years of experience in international regulatory affairs. Before joining Swissmedic, she held the position of Vice President Regulatory Affairs in Europe, Africa and Asia at Valeant Pharmaceuticals, Inc. In October 2004, she started at Swissmedic as the Head of International Affairs. She has been Head of Management Services & Networking and Member of the Management Board at Swissmedic, Swiss Agency for Therapeutic Products, since July 2007.

Pol Vandenbroucke

Chief Medical Officer Pfizer Hospital Business Unit, USA

Dr. Vandenbroucke serves on the Boards of the American Federation for Aging Research, the World Demographic and Aging Forum and the IFAPP Academy; He is a member of the Advisory Board of the Steve Biko Centre for Bioethics, a member of Medicines for Malaria Venture’s External Scientific Advisory Committee, a Fellow of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Medicine of the United Kingdom and an IFAPP Academy Global Fellow in Medicines Development. A frequent speaker on health, aging, and health policy issues, he is also a Visiting Senior Lecturer at King’s College London.

Dr. Vandenbroucke’ s career has been dedicated to Clinical Development and Medical Affairs and has included stints in the U.S., Europe, Asia, and Latin America. Before his current position, he has been Chief Development Officer for Pfizer Essential Health, Head of Medical Strategy for Pfizer Inc. and VP Medical Affairs of Pfizer’s Essential Health portfolio in North America. He previously also led the Clinical Development of all Pfizer compounds in Asia, Central/Eastern Europe, Latin America, and Africa-Middle East and of Pfizer’s Established Products globally. He was also responsible for developing compounds specifically for diseases of the developing world, such as malaria and river blindness.

Prior appointments also include Vice President, Medical and Regulatory Affairs, Canada/Latin America/Africa-Middle East, Senior Vice President, Medical Division Pfizer Japan, based in Tokyo, Director of Medical Operations, Asia and Australia/NZ for Pfizer, based in Hong Kong, and Medical Director, Lipitor based in New York, responsible for the international clinical development program of Lipitor.

He holds a Medical Degree from the Catholic University of Louvain (Belgium), an MBA degree from the Instituto Tecnológico Autónomo de México (ITAM), and an MSc (First Honors) from Hibernia College (Ireland). He is fluent in Dutch, Spanish, English, French, and German.

Pravin Chopra

Global Medical Executive, Biopharmaceuticals Advisor; Head, Scientific Affairs, IFAPP Academy, USA

Global Medical Executive, Biopharmaceuticals Advisor; Head, Scientific Affairs, IFAPP Academy

Advocating improved patient outcomes and optimized access across international markets, Pravin brings a worldwide, stakeholder-oriented perspective of the healthcare and biopharmaceutical landscape. While spearheading global medical affairs strategy, development operations, clinical research, and commercialization activities, over the years, in medical leadership roles at Pfizer, Sanofi, Amgen, and Boehringer Ingelheim, Pravin has facilitated the delineation of regional treatment practices, guidelines, and healthcare policy.

Trained as a physician in India, Pravin takes keen interest in promoting ethics, transparency, medical education, and consumer awareness, and believes in advancing globally-aligned regional innovation and sustainable therapeutic solutions, and forging public-private partnerships, while emphasizing patient voice and value.

With the IFAPP Academy, Pravin is Head, Scientific Affairs, and Director, Board of Officers. Additionally, he is Visiting Faculty at the School of Cancer & Pharmaceutical Sciences, Faculty of Life Sciences & Medicine, King’s College London.

Pravin’s network and learnings span biopharmaceuticals, consumer healthcare, nutraceuticals, and rare diseases, driving scientific direction and strategic business development for regional needs and priorities, shaping medical expertise and capabilities, and engendering stakeholder engagement, as an imperative for underserved patient communities.

Robert Hider

Institute of Pharmaceutical Science, King’s College London, UK

As an undergraduate at KCL, studied Chemistry and Physics followed by studies for PhD Chemistry (1961 – 1967). Post-doctoral fellow at St. Thomas’s Medical School (1967 – 1970). Took up an academic position at Essex University (1970 – 1987). Returned to KCL in 1987 as Professor of Medicinal Chemistry. The research focus of Professor Hider’s research is centered on iron and gallium chemistry. The research group is involved in transnational research, having introduced deferiprone, CP94, CN128 iron maltol and galiprost into man. One current interest is the targeting of iron chelators to mitochondria.

Rory O’Connor

Former SVP, Chief Medical Officer, Internal Medicine, Pfizer Innovative Health, USA

Dr Rory O’Connor entered the pharmaceutical industry in 1989 designing and executing Phase 2/3 studies in Europe, following a career in medical practice. He joined Pfizer Clinical Development in 1994, working in neuroscience with responsibility for antipsychotic and neuroprotective agents. In 1996 he moved to Pfizer HQ in New York as Medical Director Neuroscience, leading the strategic development and launch of a novel antipsychotic, including direction of the associated global Phase 3b/4 clinical program.

In 2000 he assumed responsibility for Medical Affairs for Pfizer’s European operations, and has since held medical positions of increasing responsibility, including oversight of clinical operations and regulatory affairs.

He is currently Senior Vice-President and Chief Medical Officer for Pfizer BioPharmaceuticals, Internal Medicine. His interests include development and augmentation of medical colleagues’ skills and capabilities and the use of information technology to enhance effective and responsible relationships with healthcare providers.

Rory qualified in Medicine from the University of Liverpool in 1978 and practiced initially in internal and family medicine. He is a Fellow of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians (UK).

Roslyn F. Schneider

VP, Scientific, Medical and Patient Affairs at Theravance Biopharma, USA

Roslyn F. Schneider is a physician transforming healthcare quality and efficiency through human-centered design. Partnering with patients who are experts in what they need and want, is a thread running through her distinguished career in clinical practice, academia, roles at Pfizer where she created and led Global Patient Affairs, and as an independent consultant. Her clients ranged from large, global companies to start-up biopharmaceutical and health technology firms, and she remains active in patient-centered workstreams with not-for-profit think tanks, professional, and patient organizations.

Sam Salek

School of Life & Medical Sciences, University of Hertfordshire, UK

Sam Salek is Professor of Pharmacoepidemiology in the School of Life and Medical Sciences, University of Hertfordshire, UK where he leads the Public Health & Patient Safety research group. He is also the Director of the Institute of Medicine Development, Cardiff, UK, a visiting Professor at the State of Hessen, Germany and Vice-President of the PharmaTrain Federation. Professor Salek is the co-founder and the past chair of the Patient Engagement Special Interest Group of the International Society of Quality of Research, co-chairs the European Hematology Association Scientific Working Group for Quality of Life and Symptoms and chairs the EHA SWG ‘Gaucher’s Disease Task Force’.

Professor Salek completed his undergraduate degree at the University of Oklahoma in 1978. He later moved to Cardiff where he studied for his PhD, 1985–1989. Since completing his PhD, Professor Salek has held a number of academic posts on both sides of the Atlantic. His major research interests include: pharmaceutical regulatory science to improve patient access to new medicines; benefit-risk assessment of medicines; development, evaluation and application of instruments to assess patient-reported outcomes and health-related quality of life (HRQoL); and pharmacoeconomics/ health economics. Over the past four decades he has received a number of government and industry research grants for projects in the areas of pharmaceutical regulatory science covering jurisdictions such as Middle East, Far East, Africa, India, South and North America.

Professor Salek has developed a few undergraduate, postgraduate diploma and MSc programmes over the past 35 years which they continue to be successful. Of noteworthy: he developed and modernised the 2-year part-time Postgraduate Course in Pharmaceutical Medicine (Dip Pharm Med) and was the Course Director of the same for 30 years; he is the founder of the MSc in International Pharmaeconomic & Health Economics in 2007 and was the Programme Director of the same until 2015; he is the founder of the Integrated Master of Regulatory Science (an undergraduate programme) which received approval from the University of Hertfordshire Validation Board in April 2017 and commenced in September 2018.

Professor Salek is a fellow of the Royal College of Physicians, the Royal Pharmaceutical Society of Great Britain, European Society of Clinical Pharmacy, Global Fellow of the IFAPP in Medicines Development and member of the Cardiff Medical Society. He is a member of five Editorial boards and has published 19 books and over 650 journal articles and abstracts. He has developed and validated 11 general and disease-specific patient-reported HRQoL measures, a quality decision making tool (QoDoS), a quality outpatient discharge information checklist, whilst also collaborating with the pharmaceutical industry to design HRQoL protocols for clinical trials. Increasingly, Professor Salek is shifting his emphasis towards the practical applications of HRQoL measures in clinical decision-making and policy, quality decision-making and patient engagement in research as partners/collaborators.

Sandor Kerpel-Fronius

Department of Pharmacology and Pharmacotherapy. Semmelweis Medical University, Hungary

Dr. Kerpel-Fronius obtained medical diploma and board certifications in Clinical Laboratory Sciences and Clinical Pharmacology at Semmelweis University. He developed an extensive work experience in experimental research in neurobiology at the Semmelweis University, then at Karolinska Institute, Stockholm and later on as Sloan Fellow at the Maryland Psychiatric Research Center in the US. Later he organized a clinical pharmacology research group at the National Institute of Oncology in Hungary and worked on a sabbatical year at the Cancer Center of the Wayne State University, Detroit, US. He obtained PhD and later D.Sc. degrees from the Hungarian Academy of Sciences.

Dr. Kerpel-Fronius has worked extensively in clinical drug development both at the Hungarian National Institute of Oncology and later within the international pharmaceutical industry in Europe. In 2001 he became Professor of Clinical Pharmacology at the Department of Pharmacology and Pharmacotherapy of the Semmelweis University, Budapest, Hungary. For a short time he also worked as the General Director of the Hungarian Drug Regulatory Agency (Hungarian National Institute of Pharmacy). Presently retired but participates actively in post-graduate education both in Hungary and in several international pharmaceutical medicine courses in Europe. In 2016 he became visiting professor at the King’s College, Faculty of Pharmaceutical Medicine, London.

In addition to his academic activities he has been member of the Educational Subcommittee of the European Association for Clinical Pharmacology and Therapeutics, the Executive Board of the IMI-PharmaTrain, later PharmaTrain Federation. He served as member in the IFAPP Board of Officers, heading the IFAPP Working Group of Ethics from 2009 to 2021. In 2016 he was elected to become Honorary Fellow of the Faculty of Pharmaceutical Medicine (FFPM) of the Royal Colleges of Physicians of the United Kingdom.

Seema Haider

Senior Pharma Executive in Access/HEOR & Business Impact, USA

Seema Haider has over twenty-two years of experience in leading and managing international, multidisciplinary teams for the lifetime management of developing and executing Outcomes Research (OR) and Access Product and Therapeutic Area Portfolio strategies, studies and publications. Seema received her MSc in Social and Preventive Medicine from University of Montreal in 1992. From 1993 through1995, Seema completed PhD course work in Social and Preventive Medicine, specializing in Pharmacoeconomics, led a prospective, multicenter, Pharmacoeconomics substudy in COPD patients at the Randomized Clinical trial Unit at McGill University and was Project Director at the Interdisciplinary Health Research Group, Heath economics Unit at the University of Montreal. From 1995 to 1998, Seema was Country Manager of Pharmacoeconomics and Quality of Life Research at Schering Plough Canada for all products. Seema joined Pfizer Inc., 19 years ago and with escalating leadership positions, she leads Outcomes and Evidence, Patient & Health Impact, for the Pfizer Essential Health Business Unit. Her work has been extensively presented and featured at conferences worldwide and in publications in high impact peer reviewed journals. Outside of work, Seema is passionate about the non-profit community work she does through GraceCares in rural India. She currently resides in Boston, MA, USA with her family.

Shayesteh Fürst-Ladani

CEO of SFL Group of Companies, Switzerland

Shayesteh Fürst-Ladani is the CEO and founder of SFL. She leads the team at SFL and provides global strategic support for the development of drugs, medical devices, in vitro diagnostics (IVDs), combination products, and borderline products. Shayesteh is President of the Swiss Association “Rare Disease Action Forum” (RDAF) as well as the “Medtech & Pharma Platform” Association.

Before founding SFL, Shayesteh hold senior positions in various biotech and major pharmaceutical companies as Head of Global Regulatory Affairs and Head of Regulatory Affairs for Development Products. Shayesteh is Adjunct Instructor for Regulatory Affairs at the George Washington University School of Medicines and Health Sciences.

She received her MSc in Microbiology from the University of Vienna, Austria, and a MBA from the Open University Business School, Milton Keynes, UK.

Shoibal Mukherjee

Former VP & Head, Asia Medical Sciences Group at Quintiles, India

Dr Shoibal Mukherjee has postgraduate qualifications in Medicine and Pharmacology, with over 30 years of experience in drug development and pharmaceutical medicine. He has headed medical and research departments in Pfizer India, Ranbaxy Laboratories, GVK Biosciences and Quintiles Asia. He is a founder and first President of Indian Society for Clinical Research. Currently he is involved in assignments across the pharmaceutical research and medical start-up domains as an independent consultant with assignments in tropical disease, biologicals, vaccines, and phytopharmaceutical research. He has been guest faculty for training and doctoral programs at leading medical institutions in India and is a member of research advisory boards of various private and public sector organizations.

Stefano Bonato

Pharmacovigilance Country Head, Bayer S.p.A., Italy

Degree in Medicine and Surgery with Specialization in Gastroenterology and Digestive Endoscopy at the University of Padua. After the ward experience for almost 7 years, where he mainly dealt with hepatology and liver transplant, he entered pharmaceutical industry in 1990 in the Medical Direction, at first in Schwarz Pharma (later merged into UCB) and then in FIDIA Farmaceutici before joining Bayer in 1993, with the title Pharmacovigilance Country Head, along with, over the years, other responsibilities starting from that of Pain Therapeutic Area Medical Manager to that of Prescription Drugs Regulatory Affairs and lastly, that of Farmindustria (Italian Pharmaceutical Industry Association) Quality Certification as Code Compliance Officer. Adjunct professor of Pharmacovigilance in 10 Italian Universities, he is a founding member and national secretary, since 2012, of Italian branch of International Society of Pharmacovigilance (ISoP) and currently elected Councilor for the three-year period 2020-2023 of Italian Society of Pharmaceutical Medicine – SIMeF. In March 2020 he was awarded the title of Global Fellow in Medicines Development – GFMD by the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine – IFAPP.

Susy Davis

Director, SLD Solutions Ltd, UK

Susy graduated from University of Leeds with a BSc Hons and joined Zeneca Pharmaceuticals as a trainee Data Manager. During her time at Zeneca Susy was the Lead Data Manager for the successful submission of two key oncology products.

In 1999 Susy joined PAREXEL International in Sheffield as a Data Management Project Manager and Operational Manager where her teams were responsible for delivering quality databases in a variety of indications for a range of customers.

In 2007, Susy led the Data Management and Biostatistics Quality Management group working across North American, Europe and Asia Pacific regions. Her role and group supported operational teams and their projects in all aspects of process review, standardization and management, training, and audit support (including EDC, electronic document management system and clinical trial management system implementation).

Nine years ago Susy established a consultancy business and has been working with a variety of organizations involved in clinical trials to review, analyze and improve their roles and processes; provide interim leadership capabilities; support them during audit and inspection activities; and develop scalable coaching and training solutions.

Tamas Suto

Senior Vice President, Head of Global Medical Affairs Oncology Merck Group, Germany

Dr Sütő is dedicated to improving people’s well-being and public health meaningfully.

He obtained his MD from the Semmelweis University Medical School in Budapest, Hungary and his PhD from University College London (UCL), UK. Apart from clinical duties in England and Hungary, Dr Sütő also held faculty appointments as a Wolfson Scholar in Biochemistry at UCL, an assistant professor in Pathophysiology and Clinical Chemistry at the Semmelweis University, and a visiting professor in Physiology at West Virginia University, US.

During his tenure in academic medicine, Dr Sütő conducted research on the role of vasoactive mediators in the pathogenesis of pregnancy-induced hypertension and renal diseases. He developed a novel concept of cellular defense in acute renal tissue injury and elucidated the renal tubular metabolism of Endothelium Derived Relaxing Factor/Nitric Oxide. As a passionate teacher, Dr Sütő has mentored and trained medical students, specialists, and scientists in various medical and scientific disciplines.

Before his current role, Dr Sütő was the Head of Global Medical Affairs at Sanofi Oncology, the Therapeutic Area Head for Hematology/Oncology and Head of International Medical Affairs at Amgen, and a clinical development team leader at Roche/Genentech. During his work in clinical research Dr Sütő developed and launched practice-changing medicines in the treatment of various cancers. He has published his scientific and clinical research work in leading scientific journals including the New England Journal of Medicine, Journal of Clinical Oncology, and Journal of Immunology.

Xavier Luria

CEO at Drug Development and Regulation, Spain

Dr. Luria was Head of Safety and Efficacy of Medicines at the European Medicines Agency (EMA) during 2005-2012, and previously held leadership positions in the biopharmaceutical industry for more than eighteen years, covering international clinical development, pharmacovigilance, biostatistics, and medical affairs.

In addition to Dr. Luria’s specialty in internal medicine, pharmaceutical medicine and biostatistics (University Autonomous Barcelona), he has developed expertise in several specific therapeutic areas, carried out postgraduate qualification in clinical pharmacology, drug development and regulation (Tufts University School of Medicine, Boston), he is a recognized expert on regulatory systems and benefit-risk assessment (modeling, development, and methodologies) and has been lecturer at the UCSF.

Furthermore, he is a consultant for governments in Europe and Latin America and professor of Regulation of Life Science Industry at the IE Business School and lecturer at several other academic institutions in Europe and the USA.

He is currently member of the Kinesys Advisory Board (https://www.kinesysconsulting.com), scientific and regulatory advisor at TFS (https://www.tfscro.com), Premier Expert Consultant at NDA Partners (http://www.ndapartners.com), Senior Advisor and UK representative of SFL (https://www.sfl-services.com/en/home), and he is also a member of the European Advisory Board of RAPS (https://www.raps.org).

Zaide Frias

Head of Regulatory Affairs at EMEA, UK

Zaïde Frias has degrees in Pharmacy and Business Administration. Prior to joining the European Medicines Agency, she worked in Pharmaceutical Industry. She joined the EMA in 1999; she was appointed Head of Regulatory Affairs in 2009 and became the Head of Human Medicines Research and Development Support Division in 2013.

In September 2016, she was appointed as Head of Human Medicines Evaluation Division.

This Division is responsible for activities related to the scientific, regulatory and procedural management of human medicines evaluation, including risk management and product information. For centrally authorised products it provides support to Scientific Committees, Working parties and SAGs on product life-cycle activities across therapeutic areas, covering pre-submission to the post-authorisation phase. In relation to nationally authorised products it is in charge of coordinating referral and PSUR procedures.

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