Get to Know Our Faculty

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.

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.

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.

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.

Meet Braydon McCormick, Founder of Intempio and a seasoned entrepreneur with over two decades of experience in shaping disruptive tech ventures. Braydon has founded, nurtured, and led four successful businesses, specializing in crafting tailored solutions for the tech, data, and science industries. His leadership fosters loyalty and creativity, driving high-performing teams to achieve collective goals with precision.

In sales and marketing, Braydon is renowned for building enduring client relationships and scalable processes, seamlessly transforming ideas into tangible business realities. His strategic acumen enables swift execution, navigating complexities from P&L management to strategic partnerships with ease. Braydon’s expertise spans entrepreneurship, operations, marketing, and sales, showcasing a relentless pursuit of excellence across diverse domains.

Moreover, Braydon’s passion for science, IP, and HealthTech is palpable, with a track record of navigating regulatory landscapes and driving innovation in life sciences, pharmaceuticals, and health IT. A visionary leader and catalyst for change, Braydon McCormick continues to shape the future of tech-enabled ventures, driving positive impact in an ever-evolving world.

Charlotte M. E. Kremer, MD, MBA is currently the Chief Medical Officer for MAPS, the Medical Affairs Professional Society, a non-profit global membership-based organization representing the Medical Professionals in the pharmaceutical and MedTech industries.

Dr. Kremer had a distinguished career  of over 30 years in the Pharmaceutical Industry. Prior to joining MAPS, she was the Executive VP and head of Medical Affairs for Astellas Pharma, a Japanese pharmaceutical company headquartered in Tokyo. In this role, Dr. Kremer provided leadership of an organization of over 1,000 people across the globe,  ensuring the needs of patients, physicians and payers were met through Clinical Research, External Scientific Communication and Publications.

Prior to Astellas Pharma, she held the position of Vice President, Therapeutic Area Head for Ophthalmology, PVD, Rare Diseases and Neuroscience at Pfizer in NYC. 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 in roles at Organon Pharmaceuticals, starting in the Netherlands and continuing as expatriate in the US.

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

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 GMDP Academy.

She has been a member of Working Group on Ethics, International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (GMDP) (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 GMDP 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

Chloé Garay graduated as a pharmacist and has a master’s degree in international drug development and registration. She is a Senior Director in the Regulatory Intelligence and Policy team at Eli Lilly & Company and currently on secondment in the Regulatory Science team at EFPIA (European Federation of Pharmaceutical Industries and Associations). With more than 10 years of experience, Chloé Garay provides strategic guidance on the R&D regulatory environment to global teams at Eli Lilly and with special attention to the European policy environment.

Christian K. Schneider, M.D., is Head of Biopharma Excellence and Chief Medical Officer (Biopharma) at PharmaLex. Before joining Biopharma Excellence in September 2021, Christian was interim Chief Scientific Officer at the UK’s medical products regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).

Between 2016 and 2021, he was Director of the National Institute for Biological Standards and Control (NIBSC), a specialist center within MHRA.

Prior to his time at MHRA, Christian was Medical Head of Division Medicines Licensing and Availability at the Danish Medicines Agency; and formerly head of Division EU Cooperation/Microbiology at the Paul-Ehrlich-Institut, Germany’s Federal Agency for Vaccines and Biomedicines.

Christian has also held various senior roles at the European Medicines Agency (EMA) in a delegated capacity, including Chair of EMA’s Committee for Advanced Therapies (CAT), and member of EMA’s Committee for Medicinal Products for Human Use (CHMP). For nine years, he was Chair of EMA’s Biosimilar Medicinal Products Working Party (BMWP). He is also one of the key architects of EMA’s advanced therapies and biosimilars framework. As a regulatory scientist, Christian has published 50+ articles in international, peer-reviewed journals.

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.

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.

Dr. David Jefferys is an experienced and knowledgeable international regulator within the pharmaceutical and medical devices sectors.

David retired earlier this year as the Senior Vice President for Global Regulatory and Product Development Strategy, Patient Safety Healthcare Policy and Corporate Affairs for Eisai Europe and Chair of the Eisai Global Regulatory Council and a member of the Safety Executive Committee and Global Safety Board. He worked with Eisai for almost 20 years.

Among many other significant achievements David has excelled as:

• Visiting professor in medicine at the University of Newcastle
• Chief Executive Director of the UK Medical Devices Agency.
• Director of the Licensing Division Medicines Control Agency (MCA)
• Acting CEO of MHRA
• Long standing CPMP/CHMP Member
• Founding Chair of the EU MRFG
• WHO Advisor
• Head of New Drugs and European Licensing.
• President of RAPS (Regulatory Affairs Professional Society_
• Chair and President of TOPRA
• Board member and Trustee of the Faculty of Pharmaceutical Medicine.

David Graduated in medicine from Guy’s Hospital Medical School and had postgraduate training in clinical medicine and cardiology, also in clinical pharmacology and toxicology. He worked as an NHS Consultant He has lectured and published extensively in Drug and Device regulation, also on Risk Management, Benefit/Risk Evaluation and Product Development.

He was a visiting professor in medicine at the University of Newcastle and was Chief External Examiner in Translational Medicines at Cranfield University and for the ICRI (Indian Clinical Research Institute)

He is Author of more than 150 publications in research, pharmaceutical and medical device regulation as well as ten chapters in books. He has received numerous awards for his contribution in these areas.

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 GMDP. 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.

I graduated in Medicine, with a Ph.D. in Haematology and Clinical Oncology.

I started my career in Medicines Development in 1975 as a Clinical Research Physician at Lepetit Milano. I had the responsibility of activating European Phase II and III studies on original NCEs (antimicrobials, corticosteroids, respiratory and cardiovascular agents), working in cooperation with my colleagues in the European affiliates. I was then appointed as Director of International Clinical Research and Drug Safety at Roche Milano where I had the responsibility of building the Clinical Research Department (which did not exist before my arrival). Our responsibility was to place in Italian and Greek sites part of the pre-NDA clinical program in order to contribute to the global NDA. In addition, based on my experience, my team had the responsibility of planning and executing the clinical development work for interferon alpha, doxifluridine, capecitabine, herceptin, rituximab in oncology and for tolcapone, moclobemide, aniracetam in CNS. Our studies were of high value and contributed to their global marketing approvals and saw significant success in the market. I then moved to the role of VP Europe at ICON Milano. My task was to establish and organize the Milano office (which ICON had not yet established) and to supervise the ongoing activities in France (an office of 150 people) and in Israel (an office of 25 people). At present, I am acting as President of Genovax, a start-up company exploring the clinical value of therapeutic vaccines in autoimmune diseases and in cancer. We have two medicines candidates in preclinical and clinical development.

My main research areas were: haematology (leukaemia, lymphoma, 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); anaesthesia; obesity ; rheumatology (NSAIDs, monoclonal antibodies); medical devices.

I am past President of SSFA (the Italian Association of Pharmaceutical Medicine) and of IFAPP (the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine). I was involved in the Pharmatrain program since its beginning, and I am actually leading the Italian Specialist in Medicines Development (SMD) team.

I devoted a significant part of my time to education, and I supported the establishment of several University master courses in Medicines Development in Italy (Milano, Ivrea, Pisa, Rome, Naples, Catania). Finally, I was nominated Visiting Professor at the King’s College of London.

I contributed to the success of the GMDP Academy from its very beginning. I am Chair of Module 4 (which deals with Clinical Trials, my main area of scientific interest), and I am a member of the Steering Committee, supporting the Academy in its evolution. I most enjoy the opportunity to have a global audience for our courses (we reach students from more than 60 countries in the 5 continents) and, despite our courses being virtual, I enjoy interacting with all students in the discussion forum.

Eddie Power PhD MBA GFMD is the CEO of emPower Medical, a medical affairs consultancy empowering pharmaceutical medical professionals and solution providers achieve their best potential.

With over 25 years’ experience in the pharmaceutical industry, he is a recognized expert in Medical Affairs strategy, organizational design, storytelling, and innovation, and has been invited to chair and speak extensively at pharmaceutical congresses. He is an advisory board member for several organizations.

He was formerly the VP, North America Medical Affairs, Hospital Business at Pfizer and has held positions of increasing responsibility during his career in the pharmaceutical industry, with deep expertise in medical affairs and medicines & device development.

He started at Pfizer in September 2010 leading US teams in Vaccines and Infectious Diseases before assuming before assuming US Medical Affairs leadership for Pfizer’s Essential Health business Unit. Before joining Pfizer, Eddie held Medical, Clinical Development positions at Cubist, Schering-Plough, Bayer and GSK.

Eddie is also a Global Fellow in Medicines Development and a Board Director and Faculty for the Global Medicines Development Professional Academy. He is also a Scientific Advisory Board  member and Visiting Faculty at King’s College London, Center for Pharmaceuticals Medicine Research.  

Before joining the pharmaceutical industry, 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, UK and an MBA from Henley Management College, UK.

Giles’ background is in software design and development, with over 25 years’ consultancy experience, working with global clients across a wide range of sectors including healthcare, life sciences, finance, logistics, education, and local and central government. Throughout his career, he has led technology teams, working closely with clients to design and deliver digital solutions that meet both their organizational needs and end-user requirements. He is a passionate believer in taking the complexity out of technology and delivering collaborative and innovative projects for all.

In 2020, Giles co-founded Axian Consulting, through a management buy-out of the digital solutions and drug safety teams from the Life Sciences practice at Huron Consulting, where he was a Principal Consultant and Head of Digital Solutions for four years. Prior to this, Giles was Managing Director for a software company specializing in digital solutions for the healthcare sector, working with both national and regional teams, including over eighty NHS healthcare trusts across the UK.

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.

Helene Schluep, MD is a neurologist with direct patient management experience. Her industry career spans over two decades in clinical development, business development , medical affairs and human resources. Her expertise in medical affairs is in country, region, and global across a variety of therapeutic areas and across the lifecycle of assets. She has set up effective medical affairs structures and teams with the strong belief in the pivotal strategic role of medical affairs in the industry. Her current role is Global Medical Strategy for Rare Diseases at Otsuka.

Hicham Naim is a Swiss-Moroccan strategist and innovator with a doctorate in pharmacy and an MBA, drawing on over two decades of experience in healthcare, life sciences, and consulting industries. Currently the Head of Strategy and Transformation, Data, Digital, and Technology at Takeda, Hicham has a wide spectrum of experience from strategy to business transformation and operations.

Hicham believes in societal advancement over sheer technological progression. This ethos is reflected in his writings and his active participation with Curated Health and as cofounder of Health Tech Without Borders, a nonprofit organization committed to delivering healthcare to individuals in need during critical situations.

His aim? To foster a better world and a brighter future, encapsulating the quintessence of balanced progress.

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).

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, 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.

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 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.

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 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.

Dr. Kennedy has provided consulting services to businesses and nonprofit organizations with clients including 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.

As a Quality Management practitioner, he has a broad perspective on management reform processes and the development of public and private collaborations. He was mentored by Phillip Crosby, the world-renowned Quality Management executive, who partnered with him in reaching out to the nonprofit world.

Larry 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. 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 both Joint Commission and C.A.R.F. criteria. He has trained nonprofit staff and volunteers for projects with as many as 20,000 participants.

He has served on numerous national and international colloquiums on management reform, leadership, and philanthropy including the Center for Strategic and International Studies, Washington, D.C., the Council on Foundations, Washington D.C., and the World Health Organization, Geneva, Switzerland.

As a foundation executive, 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 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.

He founded the Quality Management Institute and has created online learning with professional certifications in Systems Engineering, Clinical Research, and Business and Nonprofit Leadership along with enterprise-level Quality Accelerator Programs. QMI’s “Eight Attributes” have been adopted as “both a standard for performance and a standard for training that creates a positive quality management work culture” by the Site Accreditation and Standards Institute’s global standard for the Accrediting of Clinical Research Sites and the  International Council of Systems Engineering (INCOSE).

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.

Dr. Liberti, PhD, RPh, RAC, has worked in the fields of pharmaceutical regulatory affairs, communications, and clinical R&D for the past four decades. He began his career at Wyeth Laboratories working in product development, then as a regulatory writer in clinical R&D, and manager of safety surveillance in medical affairs. He served as the editorial director for the North American operations of ADIS international after which he founded PIA Ltd, a company specializing in regulatory writing and consulting; he co-founded Astrolabe Analytica under which he helped develop, patent and commercialize the Astrolabe Message Mapping System™.

From 2009 to 2019, he served as the Executive Director of CIRS (the Centre for Innovation in Regulatory Science), and from 2019 to 2021 as Head of Regulatory Collaborations. From 2021, he has served as an adjunct in the graduate school of pharmacy, Temple University. He has been actively involved in promulgating best practices in the regulatory aspects of medicines development, especially in the emerging markets. He is a volunteer Director of the Erudee Foundation, a non-profit which has as its goals supporting local post-secondary educational opportunities in the health sciences for students in the Caribbean and East Africa and to inform the effective use of healthcare systems.

Dr. Liberti received his doctorate in International Regulatory Policy through the WHO Collaborating Centre for Pharmaceutical Policy and Regulation based in the Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the Netherlands, where his research centered on expedited regulatory pathways with applicability in the emerging markets. He received both his Bachelor of Science in Pharmacy and Master’s degree in pharmacognosy from the Philadelphia College of Pharmacy and Science (now the University of the Sciences in Philadelphia). He was awarded an honorary Doctor of Science degree by his alma mater. He attained the status of Regulatory Affairs Certified (RAC) with the Regulatory Affairs Professional Society and serves on its Board of Directors. He is a Fellow of the American Medical Writers Association and is a recipient of their Golden Apple award for excellence in teaching.

Lisa Egbuonu-Davis, MD, MPH, MBA currently serves as an independent board member and strategic advisor.  She has broad strategic and operational experience in pharmaceuticals, public health, and consulting, with expertise in implementing research, commercialization and investment strategies for innovative products and services.  She is currently a board director for three publicly traded companies: Omega Healthcare Investors (a REIT focused on skilled nursing facilities), Avanos Medical (a med tech company with products for pain and digestive health),and Phreesia (a software company supporting patient intake, payment processing and patient activation). In addition, she serves on the Johns Hopkins Medicine Board of Trustees.

In her prior role of Vice President, Medical Innovations, Danaher Diagnostics Platform, she provided medical advice to influence innovation strategy, partnerships, and investments across the diagnostics platform. She led the MD Council of diagnostic physicians, served as interim Chief Medical Officer to Leica and Beckman Coulter, subsidiaries of Danaher and led strategic initiatives in Covid-19 and Alzheimer’s.

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).

Marie-Claire is an Engagement Manager at Axian Consulting with nearly 15 years’ experience of life science consulting across a range of pharmaceutical companies and business areas. Recently she has focused on product risk management, looking at new ways for MAHs to achieve their risk management goals whilst also improving patient outcomes. Marie-Claire’s background is in clinical medicine, having trained at the University of Cambridge and the Royal Free and University College Medical School, London.

Mark Duman MRPharmS brings over 30 years of clinician, management consultant and patient perspectives to the healthcare, life sciences and digital health sectors. Working in the NHS, The King’s Fund, the BBC, and as a Founder of the Patient Information Forum, Mark endeavours to make healthcare more person-centric. As the Chief Patient Officer for MD Healthcare, he works with organisations such as AstraZeneca, Diabetes UK, Google Health, Innovate UK, JnJ, Macmillan Cancer Support, Microsoft, Pfizer, Novartis & Siemens Healthineers to harness digital health, develop markets and improve patient engagement.

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, PhD, MBA, CHCP, FACEHP is a visionary change agent who is an expert in brokering public-private partnerships that drive changes in the global healthcare ecosystem. Recently retired from Pfizer Inc, she spent nearly 25 years leading a cross-functional team focused on enabling healthcare communities to advance science and close gaps in care through independent and collaborative grants and partnerships. In addition, she spent the last few years leading Pfizer’s Institute of Translational Equitable Medicine (ITEM), focused on the science behind health disparities and translating new data and information to improve patient outcomes globally.

She has worked in the fields of medical education, continuing professional development, grants, quality improvement, and behavior/systems change in a variety of capacities for over 30 years. Her passion and current work focus on empowering health equity through education and innovation; bridging care gaps with evidence-based approaches; and driving sustainable change via collaborative partnerships.

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 AMA 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).

Maureen received her undergraduate degree from the University of Michigan, her MBA from St. Joseph University, and her PhD in Higher Education Leadership from Ohio University.

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.

My diverse experiences spanning over two decades at several companies with roles in Research, Legal, Medical Education, Digital and Medical Affairs enable me to lead and drive results across a variety of departments, geographies and situations. My contributions and leadership have improved the capability development, operational effectiveness, role scope and governance of medical people, processes, and technology, globally. Early in my career I 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 Medical Affairs teams. I joined Pfizer as Field Medical Effectiveness in Medical Governance. Following my role in Governance I built and led the first Field Medical organization in Pfizer Essential Health, with a unique operating model for their needs. To diversify my skills and perspectives I took on leadership of a Client Partner function in Digital which developed and implemented global initiatives for both Commercial and Medical Affairs. Currently, I lead a Global Medical Enablement Team which develops and deploys Medical Affairs capabilities around the world. To share my experience I also deliver lectures and webinars on the MSL function as a faculty and a module coordinator in Medical Affairs for the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (GMDP) Academy, a non-profit organization based in the USA and co-chair a Medical School Pharmaceutical Elective offered by Pfizer.

Otfried Kistner is currently working as a Senior Consultant for several international and national companies and organisations. Otfried is conducting scientific research in the fields of virology for 40 years and has more than 30 years of experience in industrial vaccine development. He also has extensive experience in industrial vaccine development. He also has extensive experience in leadership and employee management including a broad working knowledge in cross-disciplined matrix environments.

In his role as a Consultant, Otfried has successfully supported several activities and projects, namely:

• Major contributions to the Clinical Development Program of an MRNA COVID-19 vaccine resulting in licenses in various countries and regions globally including the USA, Europe, Australia, and Asia
• Major contributions to the development of assays for serological analysis of non-clinical and clinical studies for COVID-19 vaccines produced with different platforms including mRNA, Vectors, Virus-like particles, recombinant technologies, or classical inactivated whole virus vaccines produced in cell culture
• Support of several vaccine projects utilizing novel technology platforms against influenza, HPV, HSV with respect to strategies, large-scale production, or Clinical Development
• Biological Safety evaluations and development of segregation concepts for cell and vector-based immunotherapies against different cancer targets
• WHO Consultant and Collaborator on influenza, pandemic preparedness, and emerging viruses including partiipcation at workshops as moderator, rapporteur, or scientific expert.

In his former, different executive R&D management positions, Otfriend had the main responsibilities in the development of a far range of viral vaccines such as influenza (seasonal and pandemic), SARS Coronavirus, smallpox vaccines of 2^nd and 3^rd generations, West Nile, Ross River, and Chikunguny as well as novel antigen delivery and adjuvant technologies. His responsibilities included the strategy and organisation of the serological evaluation of clinical studies. He was also the R&D point of contact for internal and external relationships. In these roles, he was one of the main contributors in the development, production, and licensure of cell culture-derived seasonal and pandemic influenza vaccines including H5N1 (Mockup and pre-pandemic) and 2009 pandemic H1N1.

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 (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.

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.

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.

Dr. Vandenbroucke serves on the Boards of the American Federation for Aging Research, the World Demographic and Aging Forum and the GMDP 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 a GMDP 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.

Chief Executive Officer

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, even while building teams and nurturing talent.

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.

A Global Fellow in Medicines Development (GFMD), with the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP), Pravin is an independent biopharmaceuticals advisor. Additionally, he is Visiting Senior Lecturer, at the School of Cancer & Pharmaceutical Sciences, Faculty of Life Sciences & Medicine, King’s College London, and Member, Council for International Organizations of Medical Sciences (CIOMS) Working Group on Recommended Standards of Education and Training for Health Professionals Participating in Medicines Development.

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.

After obtaining a degree in Pharmacy, Roberto started his career as Pharmacist in a private pharmacy, before deciding to move into the clinical research world.

His education in this discipline started by completing a Master’s course in Clinical Research in 2009 at the University of Milan before working in November 2009 as CRA in OPIS, an Italian Contract Research Organization, providing support to Roche and Pfizer trials. He was promoted to the Project Manager Role in the areas of Oncology and Haematology in 2012.

In 2014, he moved to Novartis Oncology as a Local Study Manager, where he later obtained the promotion to Head of Study Management in 2016 in Breast Cancer and Renal Cancer Teams.

In 2018, he moved to GSK Italy as Clinical Operations Head in the Vaccines Team; in 2020 he was promoted to Clinical Operations Director at GSK, leading a team of 60 people, working in Oncology, Vaccines, Cardiovascular, Infectious Disease, Respiratory, and other therapeutic areas.

Roberto is very passionate about clinical research and highly committed to his role. It’s a double commitment: for his career, but also for the support offered to patients who can get support in their diseases. Since life is not only hard work Roberto spends his free time as a sports blogger and traveling around the world.

Roz is a physician pioneer of human-centered design in biopharmaceutical research, development, and healthcare. That is, intentional listening, partnering, and co-creating with people living with various conditions to accelerate positive outcomes. She is an experienced board member, currently serving as Chair of the Board of the GMDP Academy, Chair of the Advisory Board of Chair of Legacy Strategies, co-Chair of the Patient Engagement Professionals Society, and past-Chair of the American Lung Association’s New Jersey Chapter Board.

The consistent thread through Roz’s career is aligning planning, practice and policy with what people articulate they need and want in their lives. In the first half of her career, she integrated that into her clinical practice in Internal Medicine, Pulmonary, and Critical Care Medicine, hospital administration, academia. She then drove changes embedding those principles in collaborations across the biopharmaceutical industry, with patient organizations, as she established the office of Global Patient Affairs at Pfizer, and held roles at Theravance, BioMarin, and now in her independent consulting. She’s co-created guidance, tools, and calls to action toward making person-inclusiveness standard practice across the industry.

Roz received her MD from Mount Sinai School of Medicine, and Masters in Pharmaceutical Medicine from Hibernia College in Ireland. She practiced and led postgraduate medical training for 20 years at Beth Israel Medical Center in New York and was a Clinical Professor of Medicine at the Albert Einstein College of Medicine.

Roz values the impact mentoring has had on her career and has consistently mentored and sponsored others during their professional journeys. Roz has held leadership roles in professional associations and their initiatives focused on gender equity and advancement of women, and is a member of Women Execs on Boards and the Exceptional Women Alliance.

She was awarded Global Fellowship in Medicines Development by GMDP Academy in 2023, is a fellow of the American College of Physicians, American College of Chest Physicians, recognized in in 2023 by CUNY School of Medicine with their Dean’s Distinguished Alumna Service Award, and in 2021 with their Strong Women in Medicine Award, and won a PharmaVoice100 Award as one of the 100 most inspiring people in Life Sciences in 2018.

Saad Shakir is a pharmacoepidemiologist and drug safety physician.  He has worked in the fields of pharmacovigilance, pharmacoepidemiology and risk management for 30 years, initially at the UK Regulatory Authority, then the international pharmaceutical industry and as the Director of the Drug Safety Research Unit in Southampton.

The DSRU is an academic unit associated with the University of Portsmouth.  At the DSRU Saad leads a research team with an active program for monitoring and studying the safety of medicines in populations.  He has led many important drug safety studies and has worked and advised on many drug safety issues including product withdrawals, major restrictions and important safety hazards.  Saad serves as a chairman or member of Safety Advisory Boards and Data Safety Management Committees.  He is an author of many book chapters and publications in scientific journals on pharmacovigilance, pharmacoepidemiology and risk management and is a member of the editorial boards for the journals Drug Safety and Pharmacoepidemiology and Drug Safety.

Saad Shakir has led and coordinated many post graduate educational and training programs including the MSc program in Pharmacovigilance at the DSRU.  He supervises post graduate students for higher degrees and has been involved with a number of international initiatives to promote and develop pharmacovigilance and pharmacoepidemiology.

Saad Shakir is a Fellow of the Royal Colleges of Physicians in Glasgow, Edinburgh and London; a Fellow of the Faculty of Pharmaceutical Medicine; a Fellow of the International Society of Pharmacoepidemiology and a Member of the Royal College of General Practitioners in the 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 GMDP Academy 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.

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 GMDP Board of Officers, heading the GMDP 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 has over 28 years of global experience in pharmaceutical leadership with a proven ability to develop and lead international, multidisciplinary teams. She has extensive global experience in all phases of drug development for targeted therapeutic areas and Business Unit portfolios for developing and executing strategy in Health Economics and Outcomes Research (HEOR), Real World Evidence, Health Technology Assessment and Market Access and adding value to the business.

Seema received her MSc in Social and Preventive Medicine from the 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.  In 1998, seema joined Pfizer Inc., where with escalating responsibilities, she was Group Head HEOR for the Pfizer Essential Health Business Unit from 2013-2019, and Cluster Head HEOR for the Upjohn Business Unit from 2019-2020. She then spent 2 years at a healthcare technology startup, Dorsata Inc., as VP RWE and HEOR. Currently, Seema is Head Emerging Markets, Value Evidence and Outcomes at GSK.

Seema’s 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 with her family and will be relocating to Dubai in the near future.

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.

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.

Dr. Smit J. Patel, PharmD serves as the Clinical Innovation Lead at the Digital Medicine Society (DiMe), a 501(c)(3) global non-profit organization dedicated to advancing digital medicine to optimize human health. Smit’s work focuses on applied approaches to the safe, effective, ethical, and equitable use of digital technologies to advance clinical research, clinical care, and public health.

Smit is an Advisory Board member for the Brown-Lifespan Center for Digital Health and the Digital Therapeutic Alliance (DTA) and serves on advisory committees for digital health program(s) at the Association of Community Cancer Centers (ACCC), American Pharmacists Association (APhA), and HealthXL. He also serves on the steering committee for the APACMed Digital health reimbursement alliance. More recently, Smit is co-leading the partnership with the U.S. Department of Veterans Affairs (VA), the largest healthcare system in the US to develop a consistent approach in deploying digital-health technologies at scale by designing approaches to cultivate successful VA-industry collaborations and building frameworks to evaluate, adopt, and scale successful integration of digital solutions into the VA system.

Smit was a founding member for IMPACT, Virtual-First Medical Practice Collaboration co-hosted by DiMe and the American Telemedicine Association (ATA) to expand access to high quality, evidence-based virtual first care. Previously, Smit also co-led an external partnership with the health innovation hub (hih) of the German Federal Ministry of Health to define global priorities to advance innovation in evidence generation for the broad acceptance of digital health applications. He has spent the last five years working at the intersection of innovative medicine, technology, and healthcare from the health tech, pharmaceutical industry, and consulting space.

Smit earned his Doctrate in Pharmacy (PharmD) from the Ohio State University. He currently holds a faculty position for the Digital Health Innovation Certificate Program at the Brown University School of Professional Studies. Additionally, he is a Global Shaper at the World Economic Forum, a Forbes 30 under 30 scholar, a TEDx speaker, and MIT-Harvard Health Innovation alumnus.

Sreeram (Ram) Ramagopalan, PhD, MSc, MBA is a consultant for life science companies and a senior lecturer at King’s College London. Ram has previously held leadership roles for real-world evidence/health economics and outcomes research teams at Roche and Bristol Myers Squibb. Ram’s work is focused on the use of real-world evidence for market access and reimbursement. Dr. Ramagopalan holds a PhD in Epidemiology from the University of Oxford, as well as an MSc in Health Economics and MBA from the London School of Hygiene and Tropical Medicine. He is an international expert in real-world evidence with over 340 peer-reviewed publications.

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 – GMDP.

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.