September 18-19, 2019
Boston, MA

                             Join us at the 7th Annual Summit

AboutSpeaker Faculty

Speakers

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Cathy Critchlow
VP, Center for Observational Research
Amgen

Dr. Cathy Critchlow leads the Center for Observational Research (CfOR), providing strategic leadership to the design of non-interventional studies to inform decision-making by stakeholders across the healthcare ecosystem. The CfOR Real World Data Platform provides access to patient health data and innovative visualization and analytic tools to aid Development, Regulatory, Medical Affairs, Value & Access and Global Marketing teams in the generation of real world evidence supporting drug development and commercialization. Dr. Critchlow earned her bachelor’s degree from Stanford University, and both a master’s degree in biomathematics and a doctorate in epidemiology from the University of Washington at Seattle.

Day Two

Thursday 19th September 2019

10:45 am | The Role of RWE in a Comprehensive Product Evidence Generation Plan

CJ Hameed
Senior Director, Real World Data & Analytics, Chief Digital Office
Pfizer

CJ Hameed is a biomedical informatician with diverse experience in healthcare, spanning from patient care, academia, clinical research and informatics. At Pfizer, he is leading several patient centric initiatives to utilize real world data (RWD) for end-to-end development for real world evidence (RWE) generation. In his earlier work, he was leading the Informatics initiative at the Quantitative Medicine and Neuroscience Research Unit and, later, steered the development of interoperable drug discovery & analytics platforms for real world and clinical trial studies at Digital Medicine group and Pfizer Innovative Research (PfIRe) Lab. Also, leading several outcomes based European Innovative Medicine Initiatives (IMI) projects and patient technology lead for TransCelerate. Prior to joining Pfizer, CJ led several clinical & informatics initiatives including multi-specialty evidence-based knowledgebase systems in partnership with several international healthcare organizations. He also held several academic positions in the past and currently teaches at Northeastern University, Boston. CJ holds a master's degree in health informatics from Northeastern University and a medical degree from Dow University of Health Sciences. He is a HIMSS - Health Information Management System Society & American Medical Informatics Association (AMIA) fellow.

Day One

Wednesday 18th September 2019

4:45 pm | What’s Driving Real World Data Utilization from Early to Late Phase Development

Danny Wiederkehr
Senior Director, Global HEOR Team Lead
Pfizer

Danny Wiederkehr is the Global Lead for the Health Economics and Outcomes Research (HEOR) Team supporting cardiovascular medicine at Pfizer. Danny believes we have only slightly tapped the potential of real world evidence to drive better decision making in healthcare, improve the efficiency of care delivery and improve patient outcomes. With Pfizer for 9 years, he has held several roles across Medical Affairs, Global Policy, and Real World Data and Analytics, developing a deep appreciation for the intersection of clinical expertise, policy knowledge, analytic tools that is driving innovation in real world evidence generation. Prior to joining Pfizer, Danny led several life science consulting teams and has published over 80 analyses using healthcare claims databases, electronic health records, and national health surveys. He holds an undergraduate degree in Mathematics and Gender Studies from the University of Notre Dame and a Masters of Public Health in Health Policy and Management from Columbia University.

Day One

Wednesday 18th September 2019

4:15 pm | Evolving Real World Evidence Strategy Across Lifecycle – Improving Evidence for Patient Care

David Anstatt
Executive Director, Observational Research & Data Sciences
Bristol-Myers Squibb

David Anstatt is Executive Director, Center of Observational Research and Data Sciences, which is part of Business Insights & Analytics at Bristol-Myers Squibb.  With deep experience in the development and use of real-world data resources serving outcomes research and the execution of non-interventional research studies, David is working to broaden data resources and research capabilities in order to improve insights for R&D business partners, deepen the evidence base for new therapies and apply advanced analytics to a broad array of R&D challenges to improve business decision-making and outcomes for patients.  David holds a MA in Economics from Wheaton College (IL), an MBA in Corporate Finance from Drexel University and an MPH in Epidemiology from the Johns Hopkins University Bloomberg School of Public Health.

Day One

Wednesday 18th September 2019

3:45 pm | Advanced Analytics in Clinical & Observational Research

David Thompson
SVP, RWE Advisory
Syneos Health

David is a health economist with 30+ years of experience in the health economics arena.  Prior to joining Syneos Health, he held leadership positions at Quintiles (2012-2016), i3 Innovus/OptumInsight (2000-2012) and PAI (1988-2000). He is also a current committee member of the Clinical Trials Transformation Initiative (CTTI) in real-world evidence (RWE). His areas of expertise include work in economic modeling, retrospective database analysis, trial-based economic evaluations and patient reported outcomes. David is a frequent presenter at and contributor to the International Society for Pharmacoeconomics & Outcomes Research (ISPOR). He is also Editor-in-Chief of Value & Outcomes Spotlight since 2008, and was a leadership member of ISPOR Task Forces for Good Research Practices on Indirect Treatment Comparisons (2009-2012) and Revision of ISPOR Code of Ethics (2015-2017). David has led over 35 workshops and issue panels at global ISPOR meetings, and published nearly 50 articles in peer-reviewed medical journals. He holds a BS in Economics from the University of California Riverside and both an MA & PhD in Economics from the University of Massachusetts. He is based in Massachusetts, US.

Day One

Wednesday 18th September 2019

2:45 pm | Biopharmaceutical Acceleration Model for Product Development & Commercialization

Dongmu Zhang
Director & Head of Epidemiology Data Analytics
AbbVie

Dr. Zhang currently is Director, Epidemiology Data Analytics Head at AbbVie. She leads the data analytics team to strategically partner with the epidemiologists to design and execute observational research studies to support pipeline throughout its lifecycle. Before joining AbbVie, Dr. Zhang was Director in Center for Observational and Real-World Evidence at Merck, 2011-2017. Before that, she was Senior Statistician/Methodologist at IMS Health (now IQVIA), 2006-2011. Dr. Zhang received her Ph.D. in Social and Administrative Pharmacy from the University of Minnesota.

Day One

Wednesday 18th September 2019

11:45 am | Using NLP to Improve Identification of Patients of Interest & Safety Events

Frank Zhang
VP, Head of Market Access
uniQure

Frank Zhang is currently VP, Head of Market Access at uniQure, a leading gene therapy company. Prior to joining uniQure, Frank was VP Market Access - Global Strategy and US at Alnylam Pharmaceticals, a Cambridge based company leading RNAi technology. He led the launch of Onpattro with over 15 innovative value-based agreements with major US plans. Frank was the Head of Global Pricing and Market Access for Immunology and inflammation franchise of Celgene Corporation from 2010 to 2017. His responsibilities covered five key global functions for Celgene I&I, including Pricing and Market Access, Global Health Economics, Global Outcomes Research, Patient Reported Outcomes (PRO), and Strategic Data Analytics. With his leadership, Otezla was approved for pricing and reimbursement in over 20 countries within 2-year of global launch, and was the most successful commercial launch in immunology at that time. Prior to Celgene, Frank led global Pricing and Health Economics for J&J’s Virology Franchise with successful launch of Incivo/Incivek and Intelence. He was US Outcomes Research lead for Concerta and Effexor in earlier part of his career. Frank is a physician by training with a Master of Public Health degree from Yale University.

Day Two

Thursday 19th September 2019

4:00 pm | ‘IMPACCT’ Panel Discussion: Looking Outwards – Demonstrating Product Value & Improved Care Delivery with Real World Evidence

3:30 pm | What Does it Take to Substantiate a Million-Dollar Price Tag in Gene Therapy?

Javier Jimenez
VP & Global Head of RWE & Clinical Outcomes
Sanofi

Javier Jimenez is a Medical Doctor, Master in Public Health and Specialist in Preventive Medicine with more than 20 years of experience in epidemiology and 15 years in Pharmaceutical Industry at the country, regional and global level. Throughout his career, Javier has applied his In-depth knowledge of epidemiology and Real World Evidence to generate the required evidence to demonstrate the value of medicines for patients, health care providers and society. By staffing, training and development of high performing teams, collaboration with internal functions and partnering with scientific societies and providers Javier led the development of a world class RWE function responsible for design and implementation of high quality innovative RWE programs. Javier held the role of VP, Medical Evidence and Observational Research at AstraZeneca, where he was responsible for worldwide RWE strategy, Epidemiology support and delivery of Medical Evidence (RWE, Phase lllB-IV and External Sponsored Research) for the AstraZeneca portfolio. He was also a key representative on Global Medical Affairs Leadership team and Medical Affairs studies Governance committees. Most recently, Javier joined Sanofi in January 2017 to lead the RWE and Clinical Outcomes team reporting to Bernard Hamelin in the Evidence Generation team (CMO). The mission of the RWE and CO team is to build and maintain an integrated RWE platform, source key data sets and use of analytical capabilities and partners required to generate high quality medical evidence. Champion the use of innovative medical evidence generation capabilities by GBUs, function and countries by educating them on the use of new capabilities, enhancement and collaboration to ensure the integration of RWE strategy in all projects. Generate meaningful insights to support internal and external decision making required to ensure the best outcome for patients by appropr iate use of our products in clinical practice. Deliver innovative and impactful medical evidence required by healthcare decision makers to understand medical value of sanofi therapies by knowing our products and data best, identify gaps and potential challenges early on. Enhance external collaboration with healthcare decision makers, patients, and academic institutions to shape medical evidence generation methodology and policies

Day One

Wednesday 18th September 2019

9:15 am | Advancing the Use of Advanced Analytics in Real World Evidence

8:30 am | ‘IMPACCT’ Panel Discussion: Advancing the Generation & Utilization of Real World Evidence to Drive Patient-Centricity & Better Outcomes

John Graham
SVP, Value, Evidence & Outcomes
GlaxoSmithKline

John Graham is a Senior Vice President at GlaxoSmithKline and leads the Value Evidence and Outcomes (VEO) organization within GSK’s R&D division. The overall organization is accountable for providing strategic input into the progression of assets as well as ensuring the value demonstration through evidence generation of the assets that do progress. This evidence includes accountability for Real World Evidence, epidemiology, health outcomes and health economics across GSK products and across all regions globally. In addition, his organization is accountable for GSK’s Patient Centered Outcomes and the Patients in Partnership group who leads patient input into GSK programs and protocols. His interests include Real World Evidence (RWE) particularly the integration of traditional clinical evidence with non-traditional RWE to answer questions from patients, providers as well as payers. John sits on various Advisory Boards relating to Real World Evidence including the National Academies of Science working group on RWE, OPERAND, as well as the RWE Forum. He has published scientific communications across cardiovascular and metabolic diseases and across both clinical as well as RWE areas. In addition, John is a member of the R&D Inclusion and Diversity Council and has contributed as panellist and speaker of PA Conference for Women and numerous events organized by Women’s Leadership Initiative (WLI). John joined GSK in 2014 as the Vice President, CV/Met, NS, Rare Disease VEO and then was promoted to his current role as the Head of the organization in November of 2015. His located is at the GSK R&D HUB in Collegeville, PA. Prior to GSK, John worked for over 16 years at Bristol-Myers Squibb where he was most recently the Head of the U.S. HEOR group and previously had roles across R&D and commercial with both Global and local accountabilities. Prior to Industry John worked in academia most recently as Assistant Professor of Clinical Pharmacy at St. Louis College of Pharmacy. John holds a Doctorate of Pharmacy degree from Idaho State University and completed a Primary Care Residency at the University of Nebraska Medical Center.

Day Two

Thursday 19th September 2019

9:00 am | ‘IMPACCT’ Panel Discussion: Value Generation, Real World Evidence & Life Cycle Management – Distilling Strategy for Innovation

Judy Kando
VP, Head of Medical Affairs
Tris Pharma

Dr. Kando is currently the VP of Medical Affairs at Tris Pharma. She has over 20 years of combined experience in the pharmaceutical industry and in the pharmacy practice setting. In addition to Tris Pharma, she has worked at Adamas, Shire and Janssen where she had various roles including National and Regional MSL Director, Medical Director and MSL. Dr. Kando began her career as a clinical pharmacist at McLean hospital in Boston, then spent seven years at McKesson Medication Management in increasing roles of responsibility eventually serving as Corporate Director of Pharmacy Practice and Patient Safety. Dr. Kando received her Bachelor of Pharmacy from Duquesne University and her Doctor of Pharmacy from the Medical College of Virginia. She completed her pharmacy practice residency at the NIH and is a Board-Certified Psychiatric Pharmacist. Judy also held an adjunctive academic appointment at the Harvard Medical School from 1996-2002.

Day Two

Thursday 19th September 2019

9:00 am | ‘IMPACCT’ Panel Discussion: Value Generation, Real World Evidence & Life Cycle Management – Distilling Strategy for Innovation

Kara Dennis
SVP & General Manager, Life Sciences
Clarify Health Solutions

Kara Dennis is a Senior Vice President and the General Manager of Life Sciences at Clarify Health Solutions. She leads the development and delivery of an integrated data and analytics platform that provides insight into longitudinal patient journeys for life sciences companies. Previously, Dennis was Managing Director of Mobile Health at Medidata Solutions, an industry-leading provider of SaaS solutions for clinical research and development. She was responsible for the creation and delivery of a comprehensive mobile health offering, leading a team to scale clinical trial technologies for patient engagement, electronic patient reported outcomes (ePRO) and wearable sensors. Under her leadership, the Medidata Mobile Health team acquired a virtual trials software company in 2017 and won several prestigious industry awards. Dennis is a frequent speaker on clinical trials and real world evidence, and her perspective is sought out regularly by key publications that cover the spaceShe was named among the 100 most inspiring leaders in life sciences by PharmarVOICE  in 2015 and a Rising Star by the Healthcare Businesswomen’s Association that same year. Before joining Medidata, Dennis spent four years in McKinsey & Co's healthcare practice, and subsequently worked in corporate development for Ikaria, a biotech later acquired by Mallinckrodt. She holds an MBA from Harvard Business School and a BA from Yale University.

Day One

Wednesday 18th September 2019

8:30 am | ‘IMPACCT’ Panel Discussion: Advancing the Generation & Utilization of Real World Evidence to Drive Patient-Centricity & Better Outcomes

Keith Friend
Global Medical Director, Cardiovascular
Bristol-Myers Squibb

Keith Friend is currently Global Medical Director in the Cardiovascular Franchise at Bristol-Myers Squibb. He has published extensively about real world data analyses in the cardiovascular space, particularly with respect to the effectiveness and safety of anticoagulation in non-valvular atrial fibrillation. Data from these studies were pooled from multiple large, nationally-representative claims databases in order to obtain adequate sample sizes of patient types that were not common in randomized controlled studies.  Previously, Keith has served in academic medical positions at the University of Virginia and the University of Texas M.D. Anderson Cancer Center.  He received his medical degree from the University of Maryland.

Day One

Wednesday 18th September 2019

11:15 am | Using Real World Data to Augment the Cardiovascular Drug Development Process

Leona Bessonova
Director – HEOR
Alkermes

Leona Bessonova, Ph.D. joined Alkermes in Spring 2019 as a Director of Health Economics & Outcomes Research, leading HEOR projects for ALKS 3831. Leona is a trained epidemiologist, experienced with non-interventional research and real world evidence generation, including registries and studies incorporating patient perspective. She has worked in Safety and Medical Affairs functions at a number of pharmaceutical companies, focusing on a range of disease states from ophthalmologic & dermatologic conditions at Allergan Inc, to cystic fibrosis at Vertex Pharmaceuticals, and now schizophrenia and serious mental illness at Alkermes. Leona received her doctoral training at the University of California, Irvine, where she focused on breast cancer epidemiology.

Day One

Wednesday 18th September 2019

12:15 pm | Patient Perspective of Disease Burden & Prevailing Unmet Need in Serious Mental Illness Treatment Landscape

Mandeep Kaur
Vice President, Head of North America Medical Affairs, Immunology
Sanofi

Mandeep Kaur, MD, MS is the Vice President, Head of North America Medical for Immunology at Sanofi Genzyme with over 15 years of research and development experience in both drug and device development and supported  multiple INDs, NDAs, BLAs, IDEs, 510(k)s and PMAs in North America and Europe and programs ranging from Phase 1 to Phase 4. She has extensive  experience in drug development, clinical research, safety and medical affairs. Before joining Sanofi she was the Therapeutic Lead for Inflammation and Immunology at Pfizer. She has a strong ability to leverage well established relationships within both physician and patient communities and a comprehensive understanding of the complex  approval environment with regulatory and payers to drive successful product launches.

Day Two

Thursday 19th September 2019

4:00 pm | ‘IMPACCT’ Panel Discussion: Looking Outwards – Demonstrating Product Value & Improved Care Delivery with Real World Evidence

Marla Curran
Executive Director, Head of Biometrics & Medical Writing
Paratek Pharmaceuticals

Marla Curran joined Paratek Pharmaceuticals in March 2018 as the newly created Head of Biometrics, reporting to the Chief Development Officer. Dr. Curran has a strong track record in drug development and medical affairs, actively promoting innovative study methodology, including Bayesian design, and emphasizes integrated strategic planning. She is executing all scientific and operational aspects of Statistics, RWE and Medical Writing, which are critical in the design and implementation of development programs, regulatory submissions and interactions with global health authorities. Before joining Paratek, Marla spent 2 years at Teva and 10 years at GSK, where she was Head of Medical Affairs Statistics, Director of Statistics, and RWE Director. Marla holds a DrPH and MS in Biostatistics, with emphasis in Epidemiology, from UNC-Chapel Hill, and a BS in Statistics from NCSU. Marla is an active mentor, participates in cross-industry initiatives and is passionate about scientific education and women’s leadership.

Day Two

Thursday 19th September 2019

11:15 am | Impact of Real World Evidence Across the Life Cycle

Melvin Olson
Global Head, RWD Strategy & Innovation
Novartis

Skip Olson is currently the Global Head of RWD Strategy and Innovation at Novartis. As such, he is responsible for promoting the very best in research methodology and applications of Real World Data across all therapeutic areas and around the globe to drive better decision making. He comes from a background in HE&OR where he has led the use of RWE to transform the generation of patient insights and value for money assessments. He earned a PhD in Biostatistics from Harvard University and has worked in the pharmaceutical industry for over 25 years as a clinical statistician, HE&OR director, and RWE expert.

Day One

Wednesday 18th September 2019

8:30 am | ‘IMPACCT’ Panel Discussion: Advancing the Generation & Utilization of Real World Evidence to Drive Patient-Centricity & Better Outcomes

Day Two

Thursday 19th September 2019

9:45 am | Can Pharma Save $1 Billion Through the Strategic Use of RWE?

Michael Lees
Head of Value, Evidence & Portfolio Strategy
Takeda

Michael is the Head of Access-Centred Evidence Planning at Takeda Pharmaceuticals. He is responsible for ensuring that evidence generated in support of Takeda's medicines meets the needs of HTA and access decision makers, and therefore supports patient access to medicines. Prior to joining Takeda in September 2017, Michael led the HEOR Europe and Canada Oncology team at Bristol-Myers Squibb for seven years.

Day One

Wednesday 18th September 2019

8:30 am | ‘IMPACCT’ Panel Discussion: Advancing the Generation & Utilization of Real World Evidence to Drive Patient-Centricity & Better Outcomes

Day Two

Thursday 19th September 2019

1:30 pm | Making Choices in Evidence Development: Using Local Insights to Drive a Truly Global Evidence Base

Ravi Iyer
Director, Global HEOR
Teva Pharmaceuticals

Ravi Iyer Ph.D. is a Health Economics and Outcomes Research professional with over 15 years of experience in developing and synthesizing quantitative and qualitative research that supports the value proposition of pharmaceutical therapies from peri-launch to launch and life cycle management. Ravi joined TEVA pharmaceuticals 2016 as a Director of Global Health Economics & Outcomes Research leading HEOR initiatives for launch assets in Huntington’s disease and Migraine. Prior to TEVA, he has supported a range of TAs from primary Immune deficiency, alpha1 anti-trypsin deficiency at Baxter International to Multiple Sclerosis in Biogen Inc. Ravi now supports the early phase assets and life cycle management of approved products at TEVA. Ravi holds a PhD in Pharmacy administration and MBA from University of Louisiana at Monroe.

Day Two

Thursday 19th September 2019

2:00 pm | Use of Real World Data Outside of Traditional Comparative Effectiveness Research

Sandy Leonard
Former VP, Medical Evidence & Observational Research
AstraZeneca

Sandy Leonard is the former Vice President, Medical Evidence and Observational Research at AstraZeneca where she led a team of RWE scientists and study delivery professionals who together delivered impactful evidence for the entirety of the AstraZeneca portfolio. Sandy believes the value of evidence is linked inextricably to the ability to improve the lives of patients.  She has challenged the teams she works with to deliver scientific insight, seek strategic collaboration and ultimately drive innovative, impactful and efficient medical and payer evidence generation.  This passion has carried through to her current consulting practice. Throughout her career, Sandy has developed and implemented key corporate strategies focused on the development and application of evidence throughout the healthcare system, including the evolution of evidence generation capabilities, establishing RWE strategy and collaboration initiatives, as well as leading market access and government reimbursement programs during the implementation of the Medicare drug benefit. Sandy holds an undergraduate degree in Psychology from the University of Wisconsin – Madison and has a Masters in Public Health, from the University of Tennessee – Knoxville.

Day Two

Thursday 19th September 2019

4:00 pm | ‘IMPACCT’ Panel Discussion: Looking Outwards – Demonstrating Product Value & Improved Care Delivery with Real World Evidence

3:00 pm | Evidence Planning: Leveraging Innovation for Impact

Sebastian Schneeweiss
Professor
Harvard Medical School

Sebastian Schneeweiss, MD, ScD, is a Professor of Medicine and Epidemiology at Harvard Medical School and Chief of the Division of Pharmacoepidemiology, Department of Medicine, Brigham and Women’s Hospital. His research focuses on the comparative effectiveness and safety of biopharmaceuticals. He has developed analytic methods to improve the scientific validity of epidemiologic analyses using complex longitudinal healthcare databases for newly marketed medical products. The overarching theme of his research is applying advanced real-world data analytics for regulatory decision making transparently and in rapid cycles. His work is published in >400 articles. His work is funded by NIH, PCORI, Arnold Foundation, IMI, and FDA where he is also a voting consultant. Dr. Schneeweiss is Director of the Harvard-Brigham Drug Safety Research Center funded by FDA/CDER and Methods Lead of the FDA Sentinel program. He is Past President of the International Society for Pharmacoepidemiology and is Fellow of the American College of Epidemiology, the American College of Clinical Pharmacology, and the International Society for Pharmacoepidemiology. He received his medical training at the University of Munich Medical School and his doctoral degree in Pharmacoepidemiology from Harvard.

Day One

Wednesday 18th September 2019

1:45 pm | Real World Evidence to Support Regulatory Submissions

Tony Hebden
VP
HEOR, AbbVie

Dr. Hebden joined Abbvie in 2013 as Vice President of Global Health Economics and Outcomes Research. As a senior leader at Abbvie, he sits on a number of key decision making bodies responsible for defining the current and future direction of the company. Prior to joining Abbvie, Tony held several leadership roles at Bristol Myers Squibb in Princeton New Jersey, including Executive Director, Health Economics and Outcomes Research and Global Head of Medical Affairs for Clopidogrel (Plavix). Dr. Hebden attended The University of London where he received a BSc (Hons) in Physiology and MSc in Applied Physiology, and The University of Nottingham where he received a PhD in Pharmacology. Following this he completed a post-doctoral fellowship at The University of British Columbia, Canada and a second at Tripler Army Medical Center, Hawaii, before taking a faculty position at the University of Ottawa Heart Institute. He has over 100 scientific publications in the areas of cardiovascular and renal physiology and pharmacology as well as Health Economics and Outcomes Research.

Day One

Wednesday 18th September 2019

2:15 pm | Lesson Learned from The Development & Implementation of an Integrated Data & Evidence Strategy at AbbVie

Day Two

Thursday 19th September 2019

9:00 am | ‘IMPACCT’ Panel Discussion: Value Generation, Real World Evidence & Life Cycle Management – Distilling Strategy for Innovation

Speaker to be Announced Soon

Deloitte

Deloitte provides industry-leading audit, consulting, tax and advisory services to many of the world’s most admired brands, including 80 percent of the Fortune 500 and more than 6,000 private and middle market companies.

Day One

Wednesday 18th September 2019

9:45 am | Session Reserved for Deloitte