EVIDENCE FORUM - Key Persons
Job Titles:
- Executive Director, Global Operations, Senior Research Leader, Evidence Synthesis, Modeling & Communication
In her current position, Alex acts as principal investigator on a variety of pharmacoeconomic and pharmacoepidemiology studies. Over the past 20 years, she has led a wide range of research projects that have included cost-effectiveness models, budget impact models, retrospective database analyses, international surveys, literature reviews, and meta-analyses. She has extensive experience in the design and conduct of modeling projects across numerous therapeutic areas including acute bacterial infections, Alzheimer's disease, asthma, diabetes, migraine, multiple sclerosis, pain management, Parkinson disease, schizophrenia, stroke, smoking cessation, ulcerative colitis, and pacemaker devices. She also has significant experience working with less extensively studied rare diseases such as acromegaly, cystic fibrosis, cystinosis, Duchenne Muscular Dystrophy, Fabry disease, Gaucher disease, interstitial pulmonary fibrosis, myasthenia gravis, refractory nontuberculous mycobacterial (NTM) lung disease, Pompe disease, and thalassemia. Alex has also worked on translating models into computer interfaces used for marketing and educational purposes, and in developing models that can be adapted for use in different countries. She has published and presented extensively and has been an author on 55 publications in refereed journals.
Prior to joining Evidera, Alex was employed by Caro Research, until its acquisition by UBC in 2007. She also worked in regulatory affairs for nine years with Glaxo and practiced as a clinical pharmacist for five years in the UK National Health Service. Alex earned her bachelor of pharmacy degree (1st Class Honors) from Bath University, and remains a registered pharmacist in the UK (Member of the Royal Pharmaceutical Society of Great Britain). She completed her master of science degree in clinical pharmacy at the London School of Pharmacy, and holds a diploma in regulatory affairs from the British Institute of Regulatory Affairs and Cardiff University. Alex received a PhD from the School of Pharmacy at the University of Rhode Island.
Job Titles:
- Senior Director of Project Management, Interventional Studies
Ana has worked in the CRO industry for nearly 23 years, primarily in project management. She has extensive experience in delivery of clinical trials expanding from Phase II up through Phases IIIb and IV, including open-label extension and observational studies. Her more recent responsibilities included oversight of a large observational study in ophthalmology and a Phase IIIb program in diabetes.
Ana brings more than 20 years of experience working with CROs and the pharmaceutical industry. Formerly employed by Quintiles for over 17 years, she was responsible for the development and implementation of project management techniques and processes within the organization. In addition, her experience as director of clinical operations during her time at Covance offers a sound experience in leading and managing large teams. Within Evidera, Ana leads a team of directors and project managers responsible for project delivery; provides therapeutic specific operational consulting services; and, ensures and promotes implementation and compliance of best practices in project management.
Ana is based in Madrid, Spain, where she obtained her PhD at Universidad Autónoma de Madrid in Immunology and joined the clinical research industry after a postdoctoral collaboration at Oxford University in the UK.
Job Titles:
- Senior Research Scientist, Evidence Synthesis, Modeling & Communication
Ananth has more than 15 years of pharmaceutical consulting experience with expertise in modeling and simulation and its applications, including decision tree, state-transition (i.e., Markov), and discrete event simulation (DES) approaches to health economic modeling. Specifically, he has led the development of cost-effectiveness models for drugs for oncology and cardiovascular indications that were used to support HTA submissions to the National Institute for Health and Care Excellence (NICE), and the Canadian Agency for Drugs and Technologies in Health (CADTH), respectively. Among his former industry roles, Ananth was director of modeling and simulation development and a research scientist in Evidera's modeling and simulation group, where he led cross-functional teams responsible for the development of global cost-effectiveness and budget-impact models in multiple therapeutic areas, economic analyses alongside clinical trials, systematic literature reviews, and complex statistical analyses. He also led the development of initiatives within Evidera on novel simulation techniques, including clinical trial simulation. Ananth was formerly senior vice president, PhysioPD™ at Rosa & Co., LLC, and vice president of R&D at Entelos Inc. In both roles, he held wide-ranging executive management and program leadership responsibilities. Ananth's scientific expertise includes cardiovascular disease, cancer biology, and inflammation; he has also co-authored many published peer-reviewed manuscripts in life science, modeling, and health economic journals including Clinical Therapeutics, Postgraduate Medicine, Science, Blood, and Cancer Research.
Ananth completed his PhD in biomedical engineering at the University of Virginia, Charlottesville, Virginia, where he focused on the study of inflammation and mammalian vasculature. He then completed two postdoctoral fellowships at Massachusetts General Hospital and the University of California, San Francisco, focusing on oncology.
Job Titles:
- MRes, MRSB, CBiol, Executive Director, Business Optimization Lead, Interventional Studies
Andrew has worked in the CRO industry for over 20 years, 13 of which have been with PPD managing large international Phase III - IV cardiovascular and metabolic studies, as well as studies in pediatric and rare disease populations. He has held the position of project director for 6 years, with oversight responsibility for large peri- and post-approval interventional and non-interventional studies, delivering strong strategic leadership, cross-functional management, and a rigorous approach to risk management. As therapeutic area lead for cardiovascular, metabolic and renal, Andy leads a team of directors, associate directors, and project managers responsible for project delivery, provides therapeutic specific operations consulting services to internal and external customers, and drives the short and long-range corporate strategies within the therapeutic area through via close partnership with internal therapeutic and business experts.
Job Titles:
- Executive Director of Integrated Services, Market Access Consulting
Angela is responsible for the development of unique end-to-end integrated evidence solutions for targeted clients founded on core market access capabilities. She is focused on creating a cohesive and integrated strategy for the market access consulting practice area by working in conjunction with Evidera and PPD teams to develop new client relationships, explore and develop new product offerings, and further develop the sales pipeline.
Most recently, Angela was executive director of PPD Consulting, where she led the strategic drug development consulting group. The group's goal was to generate new client business for PPD, specifically aiming to form clinical development partnerships where PPD provides end-to-end programmatic support. She was also responsible for oversight of key client portfolios for sponsors with full product development programs. Angela has considerable experience within the pharmaceutical and biotech industry, leading strategic product development teams to major milestones, including global regulatory interactions, from preclinical stages through life-cycle management. She has a broad range of therapeutic experience, including oncology/hematology, immunology, diabetes, and infectious diseases. Angela established a strong background in corporate program management while at MedImmune-AstraZeneca and GlaxoSmithKline, where she led cross-functional product development teams in the oncology and inflammation therapeutic areas. During this tenure, she managed and co-led teams across all stages of pharmaceutical development (pre-clinical through post-marketing) for biologics and small molecule programs. Angela also spent two years outside of product development as a senior clinical scientist in oncology at MedImmune-AstraZeneca where she focused on expanding her experience in the clinical aspects of drug development. In that role, she was responsible for clinical development planning, synopsis and protocol development, KOL, investigator and site engagement, and clinical data review in solid tumour and hematologic malignancy programs.
Prior to her career in product development leadership and management, Angela worked as a bench scientist at both GlaxoSmithKline and Regeneron Pharmaceuticals where she focused on monoclonal antibody process development, optimization and research manufacturing. Angela earned a BS from North Carolina Agricultural & Technical State University, an MS in bio/chemical engineering from The Ohio State University, and an MBA from Saint Joseph's University.
Job Titles:
- Executive Director - Business Optimization, PPA & RWE, Real - World Evidence
Ann has 20 years of experience in clinical research and is responsible for providing strategic, operational, and day-to-day tactical support to the real-world evidence (RWE) team. Additionally, Ann is responsible for providing scientific oversight to studies, preparing study protocols, leading analysis, and writing deliverables.
Ann has worked at PPD as a clinical research associate, a biostatistician, and health outcomes scientist in a broad range of therapeutic areas as well as managing and acting as the lead epidemiologist on several pregnancy registries and numerous observational studies. Ann has significant experience in the therapeutic areas of infectious diseases, respiratory, oncology, obstetrics, and neurology.
Prior to her employment in the pharmaceutical industry, Ann spent several years in the public health sector working for the state health department of Georgia, Emory University, and Grady Memorial Hospital in Atlanta, Georgia. She has a Master's in Public Health with a concentration in epidemiology from Emory University.
Job Titles:
- Vice President and General Manager, Real - World Evidence
Anne is focused on the growth of Evidera's global real-world evidence database offerings, including the linkage between technology and consultative approaches, and the development and implementation of innovative offerings to better identify, anticipate, and support the needs of biopharmaceutical companies.
Anne's 25-year career in healthcare has focused on strategy development and deployment with an emphasis on technology-enabled analytics and business intelligence solutions. She has led and fostered international multidisciplinary teams, in both pharmaceutical companies and consultancies, to support the development and validation of strategic plans and commercial decisions for both specific treatment products and companies as a whole. With a keen understanding of client needs, Anne has proven success in developing and deploying innovative and commercially viable solutions to meet the changing demands in the marketplace.
She began her career at SmithKline Beecham (now GlaxoSmithKline) as an international product manager, and then spent several years with the Pharma Strategy Group in London. She then moved to Datamonitor Healthcare where she led a global team to develop compelling pharmaceutical market analysis data. Anne also held vice president roles in portfolio optimization and syndicated analytics for IMS Health, and joins Evidera from GlobalData where she recently held the position of Global Head of Pharma, responsible for the strategic direction and growth of the healthcare business.
Anne is a thought leader in the industry and has given numerous presentations on a variety of healthcare topics at conferences, government organizations, and client groups, including a keynote address to a group of biopharmaceutical clients in Japan titled "Changing Healthcare Dynamics and Implications for the Japanese Market." She received her master of business administration from the London Business School and her bachelor's degree in economics from Trinity College Dublin.
Job Titles:
- Member of the Who We Are Executive Team
- Chief Commercial Officer, Executive Vice President, Peri - and Post - Approval Services
Anshul joined PPD's executive team in 2016 to lead the company's biotech customer segment, with nearly 20 years of experience in the pharmaceutical and biotechnology industries, as a general manager, management consultant, and entrepreneur. In 2019, his responsibilities were expanded to include full commercial responsibilities across both of PPD's major customer segments: biopharma and biotech.
Before PPD, Anshul ran the global life sciences business unit at Gerson Lehrman Group (GLG), where he created a customer business model to serve the pharmaceutical and biotechnology industries. Prior to GLG, he worked at McKinsey & Company, where he was an associate principal in the health care practice, counseling senior management and CEOs of global pharmaceutical and biotechnology companies on critical topics including growth, strategy, research and development, business development, go-to-market approaches, and commercial models.
Anshul began his career as an engineer and researcher, earning undergraduate and master's degrees in biomedical engineering from Johns Hopkins University. He also earned an MBA from the Wharton School at the University of Pennsylvania. He leverages his passion for scientific research, and his expertise in entrepreneurship and business strategy, to drive the growth and success of many areas of our business.
Job Titles:
- Executive Director, Integrated Solutions, Real - World Evidence
- Principal Investigator at Evidera
Ariel serves as a principal investigator at Evidera and has experience across a wide range of therapeutic areas, including but not limited to pulmonary arterial hypertension, infectious disease, osteoarthritis, neuropathic pain, fibromyalgia, migraine headache, mental health disorders, and end stage renal disease.
Prior to joining Evidera, Ariel was a senior consultant with Policy Analysis Inc. in Boston for about 13 years, during which time he led numerous outcomes research studies, including retrospective database analyses; developed health economic models (both budgetary impact and cost-effectiveness models); performed literature reviews; and prepared product dossiers.
His work has been published in peer-reviewed journals including Surgical Infections, Pain Practice, Journal of Health and Productivity, American Journal of Managed Care, Infection Control and Hospital Epidemiology, Annals of Pharmacotherapy, and BMC Pulmonary Medicine. His work also has been presented at multiple conferences such as the American Thoracic Society (ATS), the European Society of Clinical Microbiology and Infectious Diseases (ECMID), the American Society of Nephrology (ASN), the Infectious Diseases Society of America (IDSA), and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Ariel has a master's in public health with a concentration in epidemiology and biostatistics from Boston University School of Public Health and a bachelor's from Syracuse University.
Job Titles:
- Senior Research Leader, Patient - Centered Research
A psychologist with more than 20 years' experience in health outcomes research, Asha has extensive experience in qualitative and quantitative research methods, incorporating clinical outcome assessments in drug and device development programs. She has developed and validated many clinical outcome assessments (COA), including two instruments now included in International Clinical Guideline documents, and has worked on COA instruments for use in clinical trials in adults and children in cardiovascular, dermatology, mental health, neurology, rare diseases, rheumatology, urology and respiratory conditions. She has engaged with U.S. and European regulatory agencies to discuss novel instruments for the collection of data for inclusion on label claims.
Prior to joining Evidera, Asha worked in outcomes research for Pfizer, and was responsible for providing strategic direction and implementing outcomes research activities in various therapeutic areas, especially obtaining labeling claims based on COAs. She developed white papers and playbooks for incorporating COAs in clinical trials and developed standard operating procedures for linguistic adaptation of instruments. She actively contributed to initiatives to raise the profile of and standards for the measurement of patient-reported outcomes (PROs) in health outcomes research in the pharmaceutical industry, including the Cochrane Collaboration Quality of Life Methods Working Group, the European Regulatory Issues in Quality of Life Research, ISPOR PRO Translations Task Force, the FDA PRO - Harmonization Group and the ISPOR task forces related to linguistic adaptation of PRO instruments. She also led the first European cross-pharmaceutical industry consortium for the development of a PRO tool as part of the Innovative Medicines Initiative of the European Federation of Pharmaceutical Industry Associations and European Commission. Asha has also served as a part-time lecturer at the Universities of Kent and Canterbury, teaching the MSc course in surgical practice.
After obtaining a degree in psychology, human physiology and statistics, Asha completed four years of postgraduate training in social work in medical and psychiatric settings and completed her PhD in "Quality of Life Research in Cardiovascular Diseases" at the National Medical and Mental Health Institutes in India. Asha regularly presents workshops and participates in panel discussions at international conferences regarding methodological issues related to COAs. Her work has been published in numerous publications including Stroke, Urology, Journal of Wound Care, Clinical Drug Investigation, HQLO, International Journal of COPD, Journal of Rheumatology, Respiratory Medicine and Value in Health. She has also co-authored a chapter on the measurement of dyspnea in clinical trials in a book on dyspnea mechanisms, measurement and management.
Job Titles:
- Senior Research Leader and Executive Director, Epidemiology, Real - World Evidence
In her role at Evidera, Beth serves as principal investigator on epidemiology and database analytics projects using claims and electronic medical record databases. Her studies have investigated such issues as treatment of chemotherapy-induced anemia, the epidemiology and costs of renal disease in HIV, treatment patterns in multiple sclerosis, and the prevalence of retinal diseases. She has led numerous post-marketing drug safety studies in a wide range of therapeutic areas, including oncology, neurology, rheumatology, and others; outcomes for these studies have also varied widely but include cardiovascular events, renal and hepatic outcomes, and development of cancer.
Prior to joining Evidera, Beth was an epidemiologist at i3 Drug Safety, a division of Ingenix. At i3, she designed and carried out numerous studies related to drug safety and outcomes, including investigations into treatments for HIV, influenza, glaucoma, and psychotic disorders, as well as studies of disease epidemiology in areas such as anemia, atrial fibrillation, and irritable bowel syndrome. Beth's previous experience includes working in smoking cessation research at Harvard University, running prospective studies of smokers attempting to quit and retrospective epidemiologic studies using data from the Normative Aging Study at the Boston Veteran's Administration.
Beth earned her a bachelor's degree from the Massachusetts Institute of Technology and graduate degrees in psychology and public health at Northeastern University and the University of Massachusetts at Amherst.
Job Titles:
- Senior Director of Project Management, Interventional Studies
Brenda provides leadership, operational expertise, and strategic direction for Phase IIIB/IV interventional studies. Brenda has extensive experience in working with diverse clients and stakeholders across multiple therapeutic areas spanning global Phase II-IV studies. Her understanding of the full drug development life cycle and her ability to embrace both complex and ever-changing regulatory requirements and evolving clinical research landscape ensures effective planning, collaboration, and quality execution that align with client's vision and expectations.
Brenda has over 25 years of industry experience. During her career, Brenda has held several positions and has led teams across more than 10 business units. These experiences, coupled with innovative initiatives and dedicated, strong operational teams, ensure clients are provided a unique, innovative, and cost-efficient operational model tailored specifically to their goals and objectives.
Brenda earned a bachelor's degree in Business Administration from the University of Mount Olive and has a professional certificate in international business from UCD Michael Smurfit Graduate Business School in Dublin, Ireland.
Job Titles:
- Scientist
- Senior Research Scientist, Patient - Centered Research
Carla is a scientist with over 20 years' experience in conducting health outcomes research studies, including instrument development and psychometric evaluation, design, and implementation of Clinical Outcomes Assessment (COA) endpoint strategies for clinical programs, quantitative and qualitative COA studies, and literature reviews. This work has been performed in a wide variety of disease areas, including skin diseases, pain, endocrinology, musculoskeletal disorders, respiratory diseases, oncology, rare diseases, and paediatric diseases. Carla also has experience implementing and conducting exit and embedded clinical trial interview studies, using mixed method research design and longitudinal qualitative research approach. She is co-chair of the International Society for Quality of Life Research (ISOQOL) Mixed Method Research Special Interest Group, and currently leads an ISOQOL program that aims to promote the use of longitudinal qualitative research in health outcomes research and defining best-practice methodologies.
Prior to joining Evidera, Carla worked at Mapi Patient Centered Outcomes Research (formerly Mapi Values) for 17 years. As associate research director, she was responsible for designing and conducting patient-centered outcomes studies. She has collaborated with patient advocacy groups, conducted studies using social media, and managed the development and validation of tools and screeners for use in clinical trials and clinical practice. She has authored several manuscripts that have been published in peer-reviewed journals and has delivered presentations at international scientific conferences, including ISPOR, ISOQOL, and the World Orphan Drug Congress.
Carla holds a master's degree in biology and physiology from the University of Lyon in France and a European Market Access University Diploma (EMAUD) from the Aix-Marseille University in France. She is fluent in French, Portuguese, and English.
Job Titles:
- Senior Director, Evidence Synthesis, Modeling & Communication
Christopher's role primarily focuses on leading the development of value stories, value dossiers, HTA submissions, and payer objection handlers. He has particular experience in oncology (including cell transfer technologies and immunotherapies) and orphan diseases, as well as in developing web-based interactive communication tools for a variety of clients.
Job Titles:
- Senior Research Scientist, Real - World Evidence
Dara is responsible for Evidera's Re al-World Access to Remote Data (REWARD) offering that enables rapid and repeatable real-world observational research through innovative technology driven data collection. She brings 12 years of observational, non-interventional study experience (ten years in industry and two in academia) and is a recognized industry expert in chart review and electronic medical record (EMR) study methodology and implementation. Dara offers applied experience in various therapeutic areas including oncology, hematology, neurology, cardiology, intensive care, infectious diseases, gastroenterology, and acute bleeding events. Her research portfolio includes evaluations of drug utilization, safety, burden of illness, treatment patterns and resource utilization (including direct and indirect cost of healthcare), and the collection of data from several compassionate use patient populations in North America and Europe. Dara has much experience working on FDA- and EMA- mandated and non-mandated chart review applications of post-authorization safety studies (PASS) in North America and Europe and is familiar with ENCePP requirements.
Prior to joining Evidera, Dara worked as a senior research scientist at UBC: An Express Scripts Company and as a research associate in the division of clinical epidemiology at McGill University Health Centre's Research Institute.
Dara holds a BSc in human kinetics from the University of Ottawa, and an MSc in human nutrition from McGill University. The results of her work have been published in peer-reviewed journals and presented at various scientific meetings.
Job Titles:
- Vice President, Endocrinology and Diabetes, Global Product Development
David is board certified in endocrinology and pediatrics, with a PhD in biochemistry. He came to industry after 25 years' experience in academic patient care, clinical and basic science research. His research program involved diabetic complications, with basic research into the role of extracellular matrix in diabetic kidney disease and clinical research including the pivotal Diabetes Control and Complications Trial or DCCT, which proved the role glucose control in their onset and progression in humans. The results of his continuously funded studies in diabetes and general endocrinology, including childhood obesity prevention, have been published in the highest rated medical journals.
Prior to joining PPD in June 2018, David was senior director of clinical development at MannKind Corporation where he led the inhaled insulin Afrezza Phase II-III approval program, including Food and Drug Administration (FDA) interactions on his protocol revisions, product labeling, and study timelines. His pharmaceutical career began in 2014 as senior medical director for a leading contract research organization.
David's diabetes pharmaceutical research experience includes participation in all phases of investigation product development for the treatment of pediatric and adult subjects with types 1 and 2 diabetes, including a wide spectrum of antidiabetic drug classes, treatments for diabetic complications, cardiovascular outcome trials in diabetic and hyperlipidemic subjects, insulin delivery systems (pump, closed loop), insulin clamp studies and continuous glucose monitoring (CGM) devices.
David has extensive clinical research and patient care expertise in general endocrinology, with understanding of adrenal disease, growth disorders, bone metabolism, and rare diseases in pediatrics. He was principal investigator and lead author on obesity intervention (anti-psychotic induced weight gain) and prevention trials (community-based interventions, Saipan and Cincinnati, OH). In addition, he is involved in metabolic rare disease, hyperlipidemia, and non-alcoholic steatohepatitis (NASH) drug development trials.
David has served on numerous grant review, editorial, and consensus development committees.
Job Titles:
- Senior Director at PPD
- Senior Director, Risk Management Programs, Real - World Evidence
Debbie Cheslow is a Senior Director at PPD remotely based out of Morrisville, NC. Debbie provides oversight for all REMS programs in the Peri and Post Approval Research Operations group at PPD. She also serves as line manager for management staff in the REMS Department.
Debbie brings nearly 15 years of project management experience to PPD, with expertise in Project Management Office standard methodologies, processes, and tools; and nearly 24 years of experience working in the late stage/commercialization arena at two of the world's largest CROs.
Debbie is responsible for the strategic design, development, implementation, and successful operations of risk management programs including survey assessments, elements to assure safe use (ETASU) components, and regulatory reports and submissions. She also is responsible for business development activities to obtain additional contracts by writing and reviewing proposals, making presentations to potential clients and representing the location/division at appropriate professional meetings and conferences. She has a bachelor of science degree in Psychology from Carnegie-Mellon University in Pittsburgh, PA and a master's degree in Community Service Administration from Alfred University in Alfred, NY.
Job Titles:
- Senior Research Leader, Real - World Evidence
Deborah provides leadership and strategic direction on registries and observational studies. She is also part-time faculty in the clinical research department at the University of North Carolina, Wilmington. Deborah offers more than 30 years of clinical research experience in epidemiology, observational studies, and registries. Her primary focus includes pregnancy registries and other patient-centric studies, studies employing secondary data sources (i.e., national databases and electronic records) and other post-marketing safety studies such as lactation studies and Risk Evaluation and Mitigation Strategies (REMS). She received her doctorate in public health from the University of North Carolina at Chapel Hill.
Deborah has served as a consultant to the World Health Organization and the FDA on various aspects of designing and conducting pregnancy-related studies. She has over 50 publications in the scientific literature and hundreds of presentations at professional conferences, including papers on best practices for conducting pregnancy registries, patient-centric studies, and lactation studies. She was invited to write chapters on pregnancy registries for Registries for Evaluating Patient Outcomes: A User's Guide commissioned by the U.S. Agency for Healthcare Research and Quality (AHRQ) as well as a noted textbook on pharmacoepidemiology. She serves as a reviewer for several scientific journals and professional societies. Deborah is a Fellow of the International Society for Pharmacoepidemiology and currently serves as the Chair of the Medications in Pregnancy and Lactation Special Interest Group within ISPE.
Job Titles:
- Vice President, Strategic and Scientific Affairs, Real - World Evidence
An internationally recognized expert in medical affairs, epidemiology, and ophthalmology, Debra brings more than 25 years' experience designing and leading research investigations spanning the spectrum of translational research, biomarkers, RCT, pragmatic trials, decentralized trials, and observational research through all aspects of real-world evidence (RWE) generation and integration. Debra works externally with clients, industry, and academics, and internally across the broader PPD organization, to advance scientific service offerings as well as to conceptualize and contribute to the commercialization of innovative RWE multi-method client solutions across the medical product lifecycle. Working with the Evidera research team and subject matter experts throughout the PPD enterprise, Debra is accountable for showcasing RWE methodological and scientific expertise and offerings to external audiences through scientific and commercial efforts and activities, as well as providing global product development therapeutic area expertise within PPD's ophthalmology pillar.
Prior to joining Evidera, Debra served for nearly 20 years on the faculty at Harvard Medical School and the Harvard TH Chan School of Public Health, where she was responsible for the leadership of a large innovative research program in eye disease epidemiology supported by investigator-initiated grants from NIH, industry, and private foundations. Subsequently, Debra was Professor of Ophthalmology and Visual Sciences at the University of Utah School of Medicine, where she held a senior leadership role in a large-scale multidisciplinary research effort focused on disentangling the biological pathways leading to macular degeneration and development of novel therapeutic targets.
Most recently, Debra served first as Global Medical Director for Ophthalmics, leading the launch strategy for Xiidra and Shire's ophthalmic medical affairs organization, and then as Head of Medical Evidence at Shire, developing and leading the evidence strategy for the medical affairs organization across all therapeutic areas. Debra has diverse experience with biotherapeutic start-ups, venture capital teams, and biopharma, and has worked in clinical development, medical affairs, and life-cycle management roles. She has authored hundreds of scientific publications, lectures, and scientific presentations.
Debra received her ScD from the Harvard TH Chan School of Public Health, an MPH from the Johns Hopkins Bloomberg School of Public Health, research fellowship at the Johns Hopkins University School of Medicine, and an OD summa cum laude from the Illinois College of Optometry. She is the recipient of numerous awards, is an elected Fellow of both the American Academy of Optometry and the American College of Epidemiology and is Adjunct Professor of Ophthalmology and Visual Sciences at the University of Utah School of Medicine.
Job Titles:
- Physician
- Senior Research Scientist and Senior Director, Real - World Evidence
Delphine, a physician specialized in public health and social medicine, offers over 15 years of applied experience in epidemiology and pharmacoepidemiology. Trained in medicine at the University of Paris V Descartes, Delphine also earned a master's degree in methodology and statistics in biomedical research from the Faculté de Kremlin Bicêtre, University Paris XI.
Immediately before joining Evidera, Delphine served as a global therapy area lead in the real-world evidence and epidemiology department at Lundbeck where she led psychiatry and neurology research. Prior to employment in the pharmaceutical industry, Delphine worked in academic research units, in semi-private health insurance companies, and in the French Drug Agency with a focus on occupational health, nutrition, genetic epidemiology, and psychiatric epidemiology. During her medical training, Delphine specialized in adult and pediatric endocrinology, genetic disorders, and cardiovascular diseases.
As a result of her diverse experience, Delphine has developed a deep understanding of strategic real-world evidence needs throughout drugs' development and lifecycle. She has developed and implemented various peri- and post-approval, real-world evidence plans to support successful market access. Her research methods expertise covers the collection of primary data as well as the use of electronic databases (European and U.S. claims and electronic medical records databases). It includes burden of illness evaluations, treatment patterns descriptions, PRO validations, and real-world effectiveness studies including the development of proxies for clinical outcomes in administrative databases. Delphine is also well versed in the design of post-authorization safety studies to meet European regulatory and pharmacovigilance evidence needs. Delphine regularly publishes her works in peer-reviewed journals.
Delphine teaches pharmacoepidemiology at the Paris-V René Descartes University. She is a native French speaker and fluent in English.
Job Titles:
- Senior Research Scientist and Director, EU APAC Database Analytics, Real - World Evidence
Dimitra focuses on two areas: cost-effectiveness analysis of therapeutic interventions using modeling techniques, and statistical and econometric modeling and secondary database analysis. Her past and ongoing research includes analyses of the effectiveness of healthcare interventions related to such areas as infectious diseases, diabetes, oncology, infertility treatment, antenatal care and women's health. At Evidera, her responsibilities include conceptualization of advanced study designs and statistical analysis plans and implementation of studies using advanced statistical and econometric methods.
Since April 2010, Dimitra has worked on a variety of projects, including retrospective database analysis in several European countries and the U.S., data collection studies and cost-effectiveness model adaptations.
Prior to her current role, Dimitra worked as a health economist at the National Institute of Health and Care Excellence (NICE) in London on medical clinical guidelines and the National Health Service (NHS) Economic Evaluation Database at the University of York, England.
Dimitra holds a doctorate in health economics from the University of Macedonia, Thessaloniki-Greece and a master's in health services management at the University of London School of Hygiene and Tropical Medicine and London School of Economics and Political Science. She also studied pharmacy at the Aristotle University of Thessaloniki, Greece.
Job Titles:
- Senior Research Scientist, Patient - Centered Research
Don has over 20 years' experience in global clinical and health outcomes research, specializing in instrument development and validation. He has recently supported scientific work on symptom measures of depression (Symptoms of Major Depressive Disorder Scale, SMDDS) and non-small cell lung cancer (Non-Small Cell Lung Cancer-Symptoms Assessment Questionnaire, NSCLC-SAQ); both having been qualified by the FDA's Center for Drug Evaluation and Research. He has been on the development team and provided psychometric validation for well-known measures such as the Psoriasis Symptom Inventory (PSI), Incontinence-specific Quality of Life (I-QOL), the World Health Organization Quality of Life (WHOQOL), the Parkinson's Disease Questionnaire (PDQ), the Irritable Bowel Syndrome Quality of Life (IBS-QOL), the Obesity and Weight Loss QOL Measure (OWLQOL) and Migraine Treatment Satisfaction measure (MTS). Don has designed and supported the data management and analysis for a variety of large international studies including the Longitudinal Investigation of Depression Outcomes (LIDO). He has also conducted extensive research in the area of electronic data capture (EDC) and equivalence on numerous different platforms.
Don received his Masters of Arts degree from the University of Washington (UW). He served as the data manager and analyst for the CDC-funded Northwest Prevention Effectiveness Center at the UW from 1986 until 1995 before becoming the director of data management and analysis at HRA, Inc.
Don has authored and co-authored numerous quality of life publications and has both supported and presented a wide range of research findings. He is a member of the International Society for Quality of Life Research, the International Society for Pharmacoeconomic Outcomes Research as well as a peer reviewer for the journals Quality of Life Research, Journal of Clinical Epidemiology, and PharmacoEconomics.
Job Titles:
- Vice President and General Manager, Medical Writing and Healthcare Communications
Donny brings over 20 years of global peri- and post-approval research and medical affairs experience. Donny provides direction and oversight to a global team of medical writing professionals who deliver holistic document development support across the spectrum of peri- and post-approval studies, medical information, medical affairs, and healthcare communications. As the department lead, he defines the vision and sets the strategic direction for his team in the context of client, industry, and organizational expectations. Donny has been published in peer-reviewed journals and has contributed to 30+ abstracts, posters, and speaking engagements at scientific conferences.
Previously, Donny served as the executive director of Real-World Evidence at Evidera, with commercial responsibilities over the registries and non-interventional studies business. Prior to joining Evidera, Donny worked as senior director of project management at Evidera's parent company PPD; as senior project manager at ICON Clinical Research, a global contract research organization; as senior manager at Ovation Research Group, a boutique medical affairs consultancy; and as a researcher in breast cancer at the University of Chicago Medical Center.
Donny graduated Phi Beta Kappa from the University of Chicago with concentrations in economics and pre-medicine. He received his MBA from the University of Chicago Booth School of Business with concentrations in strategy, finance, and entrepreneurship.
Job Titles:
- Director, Medical Writing and Healthcare Communications
Elizabeth has over 20 years of medical information and medical writing experience. She is responsible for the oversight and coordination of medical writing activities for the team, including business development, recruiting, resourcing and budget allocation, process improvement, performance metrics, and risk assessments and mitigation plans for medical writing projects. She has experience authoring and reviewing standard and global response letters, custom response letters, frequently asked questions, Academy of Managed Care Pharmacy (AMCP) dossiers, and slide decks. Elizabeth has supported medical information deliverables for a variety of therapeutic areas, including psychiatry, neurology, cardiology, pain management, and endocrinology.
Prior to joining Evidera, Elizabeth was employed by PPD. Her roles included associate director, manager, senior medical writer, and medical writer. Prior to joining the medical writing group at PPD, Elizabeth served as a consultant pharmacist in the medical communications department, where she provided medical and drug information with high-quality customer service, researched and responded to medical information inquiries, and identified and recorded adverse events and product complaints. She began her career in pharmacy as a staff pharmacist at Eckerd Drug.
Elizabeth's educational background includes a BS in pharmacy and a PharmD from the University of South Carolina College of Pharmacy. She is a member of the American Medical Writers Association (AMWA) and the Drug Information Association (DIA).
Job Titles:
- Chief Financial Officer
- Executive
- Finance
- Member of the Who We Are Executive Team
Eric is an experienced finance executive with a successful track record of building world class finance teams across multiple industries. In his role he oversees all global finance and accounting functions and is responsible for driving business performance and growth while leading the organization through acquisition and system integration initiatives.
Prior to joining Evidera, Eric spent 11 years at Walmart where he led many finance and strategy organizations through rapid change by leveraging technology to drive critical business insights. In his last role as head of finance for the services and digital acceleration group his responsibilities included financial planning and analysis, strategy and decision support, and data analytics. Prior roles of increasing responsibility included financial support for marketing, operations, logistics, and FP&A. He has also served as CFO of SamsClub.com. Earlier in his career Eric held finance and corporate leadership roles at Michael's, FedEx, and IBM across a career spanning 20 years.
Eric received his Bachelor of Science degree in finance from the University of Louisville and most recently served on the board of directors of the Arkansas Single Parent Scholarship Fund. Eric is based out of PPD's headquarters in Wilmington, North Carolina.
Job Titles:
- Senior Research Leader, Patient - Centered Research
Gale has extensive experience in designing, coordinating, and supervising health-related quality of life (HRQL) and outcomes research studies, including the development and evaluation of new HRQL measures and the incorporation of HRQL measures into Phase III trials in a wide range of therapeutic areas. Gale's experience also includes all aspects of survey data collection, using a variety of methods, training site coordinators at investigational meetings, and coordinating data collection efforts across multiple sites.
Prior to joining Evidera, Gale worked as a project manager/senior consultant at Policy Analysis Inc. in Brookline, Massachusetts. She received her bachelor's degree in economics and political science from James Madison University and her master's degree in economics from Tufts University.
Job Titles:
- Senior Research Leader, Patient - Centered Research
Heather has over 15 years' experience in designing and conducting health outcomes research. Her responsibilities include the direction, design, management, and analysis of health-related quality of life and other patient-reported outcomes projects. Heather's experience includes PRO instrument development and validation, and patient preference studies. She has experience conducting research in a variety of therapeutic areas including oncology, respiratory, endocrinology, rheumatology, sexual health, mental health, and urology.
Trained in a variety of statistical methods including structural equation modeling, multivariate techniques, longitudinal data analysis, and item response theory (IRT), Heather's interests include the application of advance statistical methodology to practical problems in the health sciences. Prior to joining Evidera, Heather lectured in the department of psychology at the University of Colorado teaching courses in statistics, multivariate analysis, general psychology, critical thinking, and behavioral genetics. In addition, Heather worked from 2005-2008 as a research associate and family therapist with the University of Colorado School of Medicine. Her work has been published in peer-reviewed journals such as the Journal of Patient Reported Outcomes, Journal of Sexual Medicine, Journal of the American Academy of Child and Adolescent Psychiatry, Value in Health, The Patient, Haemophilia, Diabetes, Obesity and Metabolism, Assessment, Comprehensive Psychiatry, Clinical Therapeutics, Journal of Learning Disorders, and Patient Preference and Adherence among others.
Heather earned her MA and PhD in psychology from the University of Colorado and her BS in natural science and psychology from Loyola Marymount University in Los Angeles, California.
Job Titles:
- Senior Director and Senior Research Leader, Evidence Synthesis, Modeling & Communication
Irina is responsible for the planning and implementation of statistical analyses for health economics and pharmacoepidemiology studies, secondary analysis of clinical trials to provide inputs for discrete event simulation and Markov models, and data collection studies. She is knowledgeable in areas such as survival analysis, analysis of longitudinal data, generalized linear models, resource use analyses, and analyses of compliance and persistence with treatment. Irina has extensive experience in processing and analyzing administrative databases such as Saskatchewan Health, RAMQ, Medtronic, Protocare, and PharMetrics. She took part in variety of projects that focused on disease areas such as oncology, diabetes, hypertension, cardiovascular disease, osteoporosis, schizophrenia, multiple sclerosis, and Parkinson's disease.
Irina graduated with an MSc degree in Biostatistics from McGill University. She has co-authored 12 peer-reviewed publications and more than 35 scientific abstracts.
Job Titles:
- Member of the Who We Are Executive Team
- MDCM, FRCPC, FACP, Chief Scientist
Jaime advances Evidera's leadership in developing and applying novel techniques in simulation, health economics, epidemiology, and clinical trials. He is also professor in practice at the London School of Economics and professor of medicine, epidemiology, and biostatistics (adj) at McGill University.
Jaime continues to pioneer new methodologies. Recent work involves leveraging hybrid growth and decay functions to forecast highly local COVID-19 trajectories. As part of the IMPACT-HTA grant, he is working with colleagues at LSE, NICE and HAS on DICE 2.0, the new version of a unified approach to modeling that he created in 2016. This will enable rapid, standardized, and less error-prone development of forecasting models. This methodology is also being leveraged to create disease models, particularly in regenerative medicine, and it is being extended further to simulate the design of clinical trials. He has also applied the technique in simulated treatment comparison to provide comparative efficacy information in the absence of control arms. To provide an alternative to the well-known cost-per-QALY technique and avoid many of the latter's problems, he is developing a broader approach to valuing health benefits, the BADI.
On behalf of the German health technology assessment agency, Jaime proposed an innovative approach to the assessment of health technologies, involving the efficiency frontier. As part of his work with governments, he has helped the World Bank Institute and the InterAmerican Court for Human Rights address the growing problem of Supreme Courts overriding health care system decisions and ordering them to provide treatments that had been considered unwarranted. After leading the ISPOR-SMDM Good Modeling Practices Task Force, Jaime also chaired the Quality Assurance for Modeling Studies Task Force. Jaime is co-chair of the ISPOR Science and Research Committee and has been awarded the Marilyn Dix Smith Leadership Award. In 2021, he will co-chair the ISPOR international meeting in Montreal.
Job Titles:
- Vice President
- Vice President, Immuno - Oncology, Global Product Development
Jaikrishna is vice president of immuno-oncology in global product development and is the visionary behind the creation of the PPD Immuno-oncology Center of Excellence. With more than 27 years' experience in both clinical practice and clinical research, Jaikrishna is committed to capitalizing on advances in the rapidly changing therapeutic landscape to establish PPD as a world-class partner in advancing immunology-oncology studies. His personal immunology-oncology and cell therapy experience includes treating patients with advanced melanoma, kidney cancer and non-Hodgkin lymphoma with adoptive cell therapies and vaccines either with or without gene modification. He developed one of the first immunotherapy programs in Northern California for treating advanced melanoma and kidney cancer patients with high-dose IL-2 in addition to providing National Cancer Institute-sponsored clinical trials to patients. At PPD he provides medical, scientific and product development guidance to both external clients and internal PPD clinical operations and business development teams. He also consults on investigational new drug submission and clinical input toward protocol development, including adaptive designs when feasible.
With extensive clinical oncology experience and as a senior executive in the pharmaceutical and biotech industries, Jaikrishna joined PPD in 2013 after previously working at Genentech and Oxigene in South San Francisco where he was vice president of clinical research.
Jaikrishna holds a bachelor of science in biology from Beloit College in Wisconsin and a medical degree from Howard University College of Medicine in Washington, D.C. He completed a surgical oncology and immunotherapy fellowships at the National Cancer Institute (NCI) in Bethesda, Maryland working with both Dr. Steven Rosenberg and Dr. Suzanne Topalian in the Surgery Branch.
Job Titles:
- Senior Research Scientist, Real - World Evidence
Javier is a healthcare professional with more than 20 years of experience, 11 of which were spent working for two major pharmaceutical companies, mainly in the areas of pharmacoepidemiology and drug safety. He worked as a senior epidemiologist, medical advisor and study medical expert, with global responsibilities in the areas of neuroscience (neurology and psychiatry), anti-inflammatories, hematology and solid tumor oncology.
Javier has contributed to several therapeutic risk management plans and has interacted with health authorities internationally, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Agence française de sécurité sanitaire des produits de santé (AFSSAPS). He has experience in the planning, implementation and analysis of several drug and disease registries and databases, as well as in the development and implementation of signal detection for pharmacovigilance. He has a particular interest in gerontology and comparative effectiveness research. His work has been presented at professional scientific conferences and published in numerous leading industry journals, including The Journal of the American Medical Association (JAMA), Medicina Clinica (Barc), The Journal of the American Dietetic Association, The American Journal of Clinical Nutrition, Public Health and Revista Española de Salud Pública.
Javier received his MD from the University of Zaragoza Medical School in Zaragoza, Spain; his MPH from the National School of Public Health in Madrid; his DrPH from Johns Hopkins University School of Hygiene and Public Health in Baltimore; his corporate MBA from the ESADE Business School in Barcelona; and his MSc in health economics and pharmacoeconomics from the Universitat Pompeu Fabra in Barcelona. He is also a certified specialist in preventive medicine and public health.
Job Titles:
- Senior Director of Project Management, Interventional Studies
Jodie has worked in the CRO industry for nearly 25 years, primarily in project management. She has extensive experience working in peri- and post-approval research, mainly in Phase IIIB/IV studies and expanded access/compassionate use, extended access programs, and extension/roll-over studies. Her more recent oversight responsibilities include a global named patient program (NPP) in melanoma; five expanded access programs (EAPs) in myeloid leukemia, multiple myeloma, melanoma and squamous cell non-small cell lung cancer; an extended access program (XAP) in breast cancer; and an open-label extension (OLE) study in epilepsy.
In her current role as the lead for Access Programs, Jodie manages a team of associate directors and project managers responsible for project delivery, ensures compliance with corporate project management procedures and best practices of assigned teams, helps coordinate and implement the short and long-range corporate strategies within the access program team via close partnership with internal operations and business experts, and provides access program specific operations consulting services to internal and external clients.
Previously, Jodie worked for several CROs, initially as a clinical research associate (CRA) and then as a project manager (PM) and associate director of project management. She has a bachelor's degree in biology from Cornell University and is based in Research Triangle Park, North Carolina.
Job Titles:
- Senior Director of Project Management, Interventional Studies
John has over 15 years of clinical research industry experience in peri- and post-approval research (Phase II - IV) and has worked in the pharmaceutical industry for over 25 years. He has extensive experience working in peri- and post-approval research and has overseen many different types of studies, including observational, PASS, marketing studies, expanded access, and Phase IIIb / Phase IV studies in most therapeutic areas, and is now responsible for Respiratory and Infectious Diseases.
Prior to his current role, John started his career in clinical trial supplies for Beecham Pharmaceuticals. He then moved to Wyeth Laboratories and worked in several departments from quality control to process development, as well as over-the-counter new product development for Whitehall New Product Development Centre (part of the Wyeth group). John then worked at Link Pharmaceuticals initially as their technical manager, subsequently becoming the development manager where he was responsible for product development. At that point, he became interested in clinical research while outsourcing clinical studies to CROs and moved to Kendle CRO.
John has an MSc in Pharmaceutical Sciences from the University of Manchester.
Job Titles:
- Vice President, Project Management and Operational Excellence
John is responsible for building and leading a team of project management professionals for Evidera, a PPD business, that will drive operational delivery for client projects, including managing the quality, timelines, and budgets.
John joined PPD in 2010 as part of the product development team, eventually utilizing his strong cross-functional project management skills to provide leadership for the operational excellence team where he focuses on internal projects that drive improvements and efficiencies in processes/systems throughout the company.
Prior to joining PPD, John served as the associate director of corporate project management for MedImmune where he managed and developed strategies for the oncology therapeutic area team, which was responsible for prioritizing programs and business development opportunities. He was also responsible for managing cross-functional product development teams across the stages of pharmaceutical development.
John received his Bachelor of Science in accounting at Towson State University and a Master of Science in finance from John Hopkins University. He is Lean Six Sigma certified at the Green Belt level.
Job Titles:
- Vice President, Value & Development Consulting
Jonca works to advance clinical development programs to ensure that new medical therapies are made available to patients in a rapid and cost-efficient manner beginning with early phases of clinical development throughout the product life cycle.
Based in PPD's Washington, D.C., area office, Jonca joined PPD in 2017 following a career with the U.S. Food and Drug Administration (FDA) and in the pharmaceutical industry. She has significant therapeutic experience in clinical regulatory development consulting for biopharmaceutical products across a range of therapeutic areas with a specific interest in ensuring that clinical trials are patient centric in addressing unmet needs. Prior to joining PPD, Jonca served as assistant commissioner at FDA with a focus on diverse populations and clinical trials; vice president for U.S./North American regulatory policy for Novartis Pharmaceuticals; and director of clinical regulatory policy for Genentech. From 1994 to 2005, Jonca held various senior leadership roles with the FDA across various disease areas and programs. From 1982 to 1994 she cared for patients at a medical/surgical practice in the Washington metro area. She is a diplomat of both the American Board of Ophthalmology and the National Board of Medical Examiners.
Jonca holds an undergraduate degree from Princeton University, a medical degree from Duke University, and she completed residencies in general medicine and ophthalmology at George Washington University Hospital in Washington, D.C., where she also serves as an assistant clinical professor. She is a recipient of a 2017 Year of Women Award in recognition of great accomplishment to the field of ophthalmology by Women in Ophthalmology.
Julie is based out of the London, UK, office and holds an MSc from the French National School of Statistics (ENSAI, Rennes, France) with a major in health economics. Her two main areas of expertise are decision modeling and methods associated with meta-analysis and indirect comparison, which she taught at ENSAI for four years. Julie has experience in multiple types of models (including cohort, patient-level simulations, and dynamic transmission models), meeting various objectives, such as health impact, cost-consequence, cost-effectiveness, and budgetary impact. She has worked in multiple indications, with a particular interest in infectious diseases and economic evaluation of vaccination programs, including influenza, varicella-zoster virus, pertussis, cytomegalovirus, hepatitis A and B, and sexually-transmitted diseases. She also has experience in cardiovascular disease (ACS, MI, VTE, AF), ophthalmology, CNS, and oncology. Julie has contributed submissions to various HTA bodies, including NICE and SMC, ACIP, IQWiG and HAS. Before joining Evidera, Julie was director of UK operations for another health economics consultancy, and prior to that she was a global HE senior specialist for GSK Vaccines.
Job Titles:
- Principal
- Principal Data Analyst, Patient - Centered Research
Jun's responsibilities include statistical design, data analysis, and SAS programming to support a variety of healthcare research projects. He has 20+ years' experience with the information technology and healthcare industry, including data analysis, data management, software development, and programming. Before joining Evidera, he worked for CRO company eClinical Solutions as a senior consultant supporting clinical SAS programming and data analysis, providing service to various pharmaceutical companies and medical device manufactures in clinical trials.
Jun frequently serves as principal statistician/analyst on outcome research projects and provides the insights and delivery of results to a variety of stakeholders in the clinical research industry. He has an extensive publication list and has published in such journals as Expert Review of Pharmacoeconomics & Outcomes Research, Journal of Patient-Reported Outcomes, Value in Health, Pain Research and Treatment, and American Journal of Obstetrics and Gynecology. His expertise in therapeutic areas include COPD, diabetes, pain medication side effects and management, drug abuse, asthma, women's health, psoriasis, schizophrenia, and cancer.
Jun holds a Master of Science degree in biostatistics from Medical College of Virginia, and seven professional certifications from Harvard, SAS Institute, and Microsoft.
Job Titles:
- Vice President, Modeling Technologies, Evidence Synthesis, Modeling & Communication
Jörgen specializes in simulating complex systems and played a key role in simulating the re-design of the Swedish national postal distribution system, the extension of Stockholm-Arlanda Airport, and the utilization of surgical theatres at Eskilstuna Hospital. Jörgen is also an Honorary Visiting Associate Professor with the Saw Swee Hock School of Public Health, National University of Singapore.
Intrigued by the dearth of simulation in pharmacoeconomics and outcomes research, Jörgen joined Caro Research (now part of Evidera) in 2003 as a specialist in discrete event simulation (DES) and has been instrumental in implementing DES as a modeling tool in HTA. His focus has been on translating methods from operations research to pharmacoeconomics and on developing guidelines for this type of modeling. Jörgen has created more than thirty DES models in the areas of devices and pharmaceuticals. Since discretely integrated condition-event modeling was devised by Dr. J. Jaime Caro in 2016 Jörgen has been deeply involved in the development of the technical platforms for the Discretely Integrated Condition Event (DICE) simulation. He also conducts advanced training courses in DES, the ARENA-software, and DICE. Jörgen received an MSc-degree in mechanical engineering at Lund University, Sweden.
Job Titles:
- Vice President, Statistical Methodology and Strategy, Evidence Synthesis, Modeling & Simulation
Jack is responsible for ensuring Evidera remains the scientific leader in statistics, ensuring the application of best practices, developing novel methodologies, fostering flexible and integrated responses to client priorities, and promoting best-in-class capabilities and training internally. Working from Evidera's office in Montreal, Canada, Jack specializes in predictive analyses to model disease processes that serve as the core of economic evaluations, treatment comparisons, and simulations of clinical trials. This involves capturing the dynamic relationships between various disease markers with statistical models for time-to-event or longitudinal data, possibly with time-dependent variables to capture correlated change patterns over time. Jack also works extensively in the analysis of outcomes in oncology trials; more specifically, relating progression and survival, dealing with crossover using novel techniques (e.g., rank-preserving structural failure time models, inverse-probability weighted models), projection of incomplete survival curves, and sequential modeling of treatment lines. Other areas of expertise include exploratory analyses, methods for measuring the effect of compliance or persistence with chronic treatments, and the design and analysis of observational studies.
Jack is also engaged in methodological research and teaching of statistics in the context of economic evaluations and related areas. He has been involved in methodological developments in indirect treatment comparison (simulated treatment comparisons), complex method for modeling time-to-event curves, crossover adjustment methods in oncology, and novel study designs (e.g., evaluating the benefits of Bayesian adaptive designs in the context of comparative effectiveness research). His methodological and substantive papers have been published in peer-reviewed journals.
Jack received his undergraduate degree in statistics from Concordia University and obtained his master's and doctoral degrees in biostatistics and epidemiology from McGill University.
Job Titles:
- Executive Director, Data Analytics, Real - World Evidence
Karen contributes to Evidera's real-world evidence strategic and operating plans and has played a key role in the integration of operational and scientific delivery to better serve our clients' needs. She has over a decade of experience in the consulting industry with a focus on non-interventional study design involving primary data collection and retrospective methods. Methodologies have included real-world evidence data collection, spanning multinational retrospective chart reviews, patient and physician surveys, registries, and post-approval safety studies.
Karen has experience in the fields of chronic pain, constipation, allergy, oncology, migraine, smoking cessation, acne, rosacea, cystic fibrosis, heart failure, mental illness, and rare diseases. She has co-authored publications in peer-reviewed journals such as the Journal of Clinical Psychopharmacology, Journal of Managed Care & Specialty Pharmacy, Pain Medicine, ClinicoEconomics and Outcomes Research, British Journal of Haematology, Journal of Clinical and Aesthetic Dermatology, International Journal of Clinical Practice, and Cephalalgia, and has presented at conferences worldwide.
Prior to joining Evidera, Karen worked as a senior manager and senior research scientist at UBC: An Express Scripts Company. Prior to that, she worked for four years in PR&D at Merck Frosst.
Karen completed her BSc at McGill University with an emphasis in biochemistry and is fluent in English, French, and Spanish.
Job Titles:
- Vice President, Patient - Centered Research
Karin has over 25 years' experience in clinical and health outcomes research specializing in instrument development and validation, as well as design and management of research focused on clinical outcome assessment (COA). Her therapeutic areas of expertise include cardiovascular, urology, gastrointestinal, diabetes, and women's health. Karin has extensive experience in qualitative and quantitative methodologies and expertise in regulatory strategy regarding the inclusion of COA as primary or secondary endpoints in clinical trials. She has participated in preparing and defending successful FDA submissions of COAs.
Karin earned her PhD from Johns Hopkins University, an MPH from San Diego State University, and a BSN from Xavier University. She has authored over 130 publications which have appeared in Journal of Urology, European Urology, Circulation, Journal of American College of Cardiology, British Journal of Urology International, Journal of Sexual Medicine, Quality of Life Research, and Value in Health, among others.
Job Titles:
- Executive Director, Commercial Strategy and New Product Development, Patient - Centered Research
Job Titles:
- Senior Director of Project Management, Real - World Evidence
Job Titles:
- Vice President, Oncology, Global Product Development
Job Titles:
- Vice President, Global Head, Peri - and Post - Approval Studies and Real - World Evidence
Job Titles:
- Senior Research Scientist and Executive Director, Patient - Centered Research
Job Titles:
- Vice President, Cardiovascular, Global Product Development
Job Titles:
- Senior Director of Project Management, Real - World Evidence
Job Titles:
- Executive Medical Director, Global Product Development
Job Titles:
- Senior Research Leader, Patient - Centered Research
Job Titles:
- Senior Director of Project Management, Real - World Evidence
Job Titles:
- General Manager and Executive Director, Evidence Synthesis, Modeling & Communication
Job Titles:
- Senior Vice President and Global Head, Patient - Centered Research
Job Titles:
- Senior Research Leader, Real - World Evidence
Job Titles:
- Vice President and Head Consumer Health & PPA Study Innovation, Real - World Evidence
Job Titles:
- Vice President, Vaccines Lead, Global Product Development
Job Titles:
- Senior Director, Patient - Centered Clinical Operations
Job Titles:
- Executive Director of HTA Strategy and UK Practice Lead, Market Access Consulting
Job Titles:
- Global Head, Value & Development Consulting
Job Titles:
- Senior Research Scientist, Real - World Evidence
Job Titles:
- Senior Research Leader, Patient - Centered Research
Job Titles:
- Senior Research Leader, Patient - Centered Research
Job Titles:
- Vice President and Global Head, Evidence Synthesis, Modeling & Communication
Job Titles:
- Senior Vice President, Scientific Affairs and Patient - Centered Research
Job Titles:
- Senior Director of Project Management, Real - World Evidence
Job Titles:
- Senior Director of Project Management, Real - World Evidence
Job Titles:
- Senior Director of Project Management, Real - World Evidence
Job Titles:
- General Manager: Evidence Synthesis, Evidence Synthesis, Modeling & Communication
Job Titles:
- Executive Director, Evidence Synthesis, Modeling & Communication
Job Titles:
- Senior Research Scientist, Patient - Centered Research
Job Titles:
- Senior Director of Project Management, Interventional Studies
Job Titles:
- SVP, Commercial, Peri - and Post - Approval Services
Job Titles:
- Vice President, Science, Evidence Synthesis, Modeling & Communication
Job Titles:
- Senior Research Scientist, Patient - Centered Research
Job Titles:
- Vice President, Evidence Synthesis, Modeling & Communication
Job Titles:
- Executive Medical Director, Global Product Development
Job Titles:
- Vice President, Real - World Evidence
Job Titles:
- Senior Research Scientist, Evidence Synthesis, Modeling & Communication
Job Titles:
- Director, Patient Preference, and Research Scientist, Patient - Centered Research
Job Titles:
- Executive Director, Medical Writing and Healthcare Communications
Job Titles:
- Vice President, Patient - Centered Research
Job Titles:
- Executive Director, EMC Scientific Affairs, Senior Research Leader, Evidence Synthesis, Modeling & Communication
Based in Evidera's Budapest office, Agi directs economic evaluation projects, including advanced modeling studies, burden of illness studies, and modeling studies. She has worked on several advanced post hoc statistical analyses of trial data to better understand the impact of treatment. She also led several studies investigating the relative effectiveness of products using novel indirect comparisons techniques. Agi has developed submissions, including cost-effectiveness analyses for international economic submission to respective authorities in England, the Netherlands, Scotland, and many other European countries, and also for Australia. She has been involved in designing a utility study and collecting health state utilities in the UK. She has worked in several areas of oncology, including metastatic colorectal cancer, renal cell carcinoma, breast cancer, multiple myeloma, and beyond. She also has experience working in the areas of rheumatoid arthritis, depression, and cardiovascular disease.