Director, Business Development
Leadership in medical affairs can be challenging: we are often promoted through a pathway of technical expertise and lead teams with diverse responsibilities and deliverables. This talk endeavors to demystify leadership and provide a structure and actions which can delegates can use themselves and with their teams.
Classically, Medical Affairs remains focused in the post approval space. However, the relationships developed with provider, Key Opinion Leaders/Experts in the disease space can be critical for informing ongoing labeling issues, pharmacovigilance, investigator initiated trials and subsequent R&D projects related to the disease space. This is even more critical in the Rare Disease Space. Medical Affairs can leverage these relationships as well as scientific knowledge platforms to inform life cycle management.
No longer is the patient expected to be a silent bystander in the healthcare process. Increasingly, the patient stands at center stage, surrounded by healthcare providers, payers, educators, and other players. This new patient-centricity—so crucial to quality healthcare—elevates the role of COMMUNICATION in the pharmaceutical industry. COMMUNICATION—between physician and patient, between pharmaceutical company and physician, between pharma and external regulators, and more — and, as the hub of all that COMMUNICATION, Medical Affairs holds the reins to success, providing added-value to both internal and external stakeholders . This session will examine the factors that foster effective COMMUNICATION, both externally and internally, and will provide data-driven case-based insights and examples.
High deductible health plans, on-demand telemedicine and affinity patient apps are increasingly putting patients in control of their health. At the same time, provider burnout and increased use of physician extenders can jeopardize systems that are increasingly dependent on value-based reimbursement. In giving patients an active role, systems will need to support patient-initiated programs, understand when technology undermines health goals, and identify the biases in the medical industry that differ from patient perspectives. This talk will analyze how to meet patients where they are to maximize the success of patient engagement efforts of medical affairs.
How is it that nearly 40% of Patient Power’s (patientpower.info) growing base of cancer patient members have been or are currently in a clinical trial? In this session we will share:
Life sciences companies come to understanding diseases from a clinical perspective. At times, this serves to obfuscate the struggles that people have every day with their diseases. This can translate into evidence development that doesn’t take the patient perspective into account and falls short of convincing patients of the efficacy and usefulness of the treatment. By working more closely with patients suffering from the disease, life sciences companies can appropriately understand the patient journey and places where they are looking for support that can be provided. Through this effort, pharma can learn how to target endpoints that are appropriately responsive to patient concerns and design protocols that encourage trial participation.
Misunderstanding a simple comment—we’ve all been there. It happens because each of us brings our unique biases and baseline understandings to the table and we interpret what we hear through those biases and baselines. You can increase the chances that your message will be understood accurately by, first, understanding where your listener is coming from. This session will share data and insights regarding MSL training and about some of the beliefs and biases of MSLs and the physicians with whom they communicate.
Medical Affairs is increasingly important in relating real world experience of KOL's and the patient centered perspective to leadership. This is especially true in the Rare Disease space where the key external experts are often the same thought leaders contributing to disease state competitive intelligence and novel clinical trial development. In the ultra-rare disease case the patient population is definable and often dependent upon a single product solution to support of the disease symptom complex. This becomes an exceptionally important cornerstone for post approval Population Health initiatives.
As healthcare continues to transform so does the response from companies to ensure they engage appropriately with key customers, understand their needs and challenges, and provide optimal solutions. Increasingly, Medical Affairs is playing an important role in providing strategic guidance, leveraging clinical and scientific knowledge, providing medical perspectives, and fostering peer to peer relationships. As Medical Affairs evolves its role, key metrics need to be developed to manage and continuously improve the value we provide to both internal stakeholders and external thought leaders. The return on our investment can positively impact the translation of customer needs to optimal solutions that enable our customers to deliver the highest quality of care with efficient and broad access to patients. Key topics covered will include:
While the Medical Affairs model evolved from pharma, Med Tech has particular needs & challenges. Approval standards are different, real world evidence is critical, and product innovation (and evolving data generation needs) are constant. All of this makes nimble strategic planning and broad cross-functional collaboration critical to an organization’s success.
By the time you have completed this course, you will have learnt how to:
PHARMA & MEDICAL DEVICE: VPs, Directors & Managers of:
Medical Affairs, Medical Science Liaisons, Medical Education, Health Outcomes & Liaison, Medical Communications, Marketing, KOL & Stakeholder Engagement, Late Phase & Real-World Research, Investigator-Initiated Research, Field HEOR, Field Medical, Scientific Affairs, Medical Advisors and Patient-Centricity.
Vice President, Medical Affairs
Liz Clark is a pharmaceutical physician with over 25 years’ experience in the Pharmaceutical Industry. Having qualified in Medicine at Imperial College London, she undertook 4 years of general medicine prior to joining pharma. She has held both office and field based roles in Medical Affairs, Marketing and Sales Management, working with both medicinal products and devices. She is currently Vice President of Medical Affairs at Norgine Ltd. where she is responsible for leading Norgine’s patient engagement work. In her spare time Liz enjoys gardening, running and yoga.
Global Field Based Medical Excellence Head
Sanofi Genzyme, USA
Robin Winter-Sperry, MD, Head, Global Field Based Medical Excellence & Insights, Sanofi Genzyme, has a distinguished career. She joined Sanofi in Global MS Medical Affairs, Strategy & Tactics and previous to that position, she was President and CEO of Scientific Advantage, LLC. She created Novartis’ MSL department of Scientific Operations and Sanofi-Synthelabo’s (predecessor to Sanofi) Medical Therapeutic Liaison division. She has pioneered the recognition of MSLs as a specialty in the biopharmaceutical and device industry and is responsible for creating and developing many of the industry’s leading Medical Affairs and Medical Liaison teams.
Vice President, North America Medical Affairs Drug Safety and Pharmacovigilance
Dr. Wiley is responsible for leading and managing Medical Affairs operations for Leadiant Biosciences. Dr Wiley directs the Medical Affairs strategic and operational initiatives and the Medical Science Liaison team, as well as providing medical and scientific support of clinical and regulatory affairs.
Dr. Wiley has more than 35 years of experience and leadership in the medical field, specifically in pediatric hematology-oncology.
Prior to joining Leadiant Biosciences, he served as the first Medical Director of Population Health at LifeBridge Health in Baltimore, Maryland after serving as Chairman of Pediatrics for 14 years. Previously, he has also served as the Interim Director, Cancer Institute at the Alvin and Lois Lapidus Cancer institute, Chairman of the Medical Executive Committee, Chairman of the Institutional Review Board and Chief of the Division of Pediatric Hematology-Oncology at Sinai Hospital of Baltimore.
Dr. Wiley has contributed to more than 100 publications and was honored as Pediatrician of the Year, Maryland Chapter, and American Academy of Pediatrics in 2013. He received his BA in Mathematics from Loyola College and his M.D. from the University Of Maryland School Of Medicine. He completed his Pediatric residency at The John Hopkins Hospital and a fellowship training in Pediatric Hematology Oncology at The Johns Hopkins Hospital. Dr. Wiley is a member of numerous scientific societies and serves as a Board Member for the Children’s Cancer Foundation in Maryland.
US Medical Affairs Lead for Women’s Health
Pfizer Internal Medicine
Dr. Rebecca Ashkenazy is the Pfizer Essential’s Health, US Women’s and Men’s Health Medical Affairs Lead, leading medical strategy, external engagement, and communication platforms. She is a leader with broad experience from R&D through commercialization. Dr. Ashkenazy joined Pfizer R&D in 2007, serving in Strategy and Business Operations. She held key roles in the Pfizer-Wyeth integration and has lead clinical operations, strategic sourcing, patient-centricity and organization transformation efforts. Prior to her career at Pfizer, Dr. Ashkenazy served as a healthcare consultant and biotechnology equity associate analyst. She holds Finance and Neurobiology BS undergraduate degrees, received her medical degree from Johns Hopkins and completed residency at Beth Israel Deaconess Medical Center.
Franchise Head, US Oncology Medical Affairs
Luca Dezzani is a medical doctor with more than 10 years’ experience in healthcare, both in clinical practice as a Physician, and in the pharmaceutical industry. He has covered roles at national, regional, and global level in both Europe and North America. Luca currently serves as Global Medical Director at Novartis Oncology and has an extensive experience in medical affairs.
Head of Global Publications, China & Emerging Markets Medical
Dr Svetlana Pidasheva is the Head of Global Scientific Communications and Publications at Sanofi. She is in charge of Sanofi Genzyme portfolio for China & Emerging Markets. She joined Sanofi from Allergan where she was in charge of global medical publications and communications for plastic surgery and medical dermatology. Prior Allergan, she was Assistant Medical Director at the Omnicom Group responsible for partnering with top pharma and biotech companies to develop scientific strategy and medical communications across multiple therapeutic areas. She began her biotech/pharma career at Genentech/Roche in R&D focusing on identification and characterization of biomarkers for inflammatory and autoimmune disorders.. She got her PhD in Experimental Medicine (Human Genetics) from McGill University and co-authored 7 peer reviewed publications. Svetlana’s key areas of interest are: digital health, mobile health (mHealth) technologies, digital medical communications, social media and stakeholder engagements.
CEO and Cofounder
E=MC2, no limits...
Erin is co-founder of E=MC2, no limits… A company that is dedicated enabling every individual in the world access to validated self-healing techniques. The programs empower individuals to adopt a multidisciplinary approach which is collaborative, comprehensive, and proven. She is also the Vice President of C3, no limits... a 501c3 organization committed to enhancing lives through empowerment and education.
Erin worked at Medtronic for 9 years and her most recent role was as Marketing Director for Aortic and Peripheral Therapies, Asia Pacific. She was a member of the Covidien acquisition integration team, focusing on the restructure of the international commercial organization for Peripheral Vascular.
Prior to this role Erin held the position of Business Director of Endovascular and Surgical Based Therapies Latin America. Her business responsibilities included Aortic, Peripheral and Surgical Based Therapies, working with sales, marketing, and functional teams to develop and implement plans and initiatives that will increase penetration of these therapies and continue to grow the businesses in all 46 countries of Latin America.
Erin was certified as a Transformational Flow Yoga Instructor (RYT 200) on the Big Island of Hawaii in July 2015. This training included: immersion in the philosophy of yoga, Ayurveda medicine, Pranayama, Plant-based healing, meditation, as well as the physical practice of yoga.
Erin was certified as a Level 1 Qigong Instructor in June 2013. Qigong is an ancient Chinese health care system that integrates physical postures, breathing techniques and focused intention to enhance overall health and well-being. Erin has successfully led Qigong workshops throughout the United States. She leverages her unique Yoga and Qigong trainings by creating customized sessions that are fusion of both techniques. This fusion optimizes the breath and body work to create a powerfully meditative workout.
In 2017 Erin became certified in Mindfulness Based Stress Management (MBSR-T) as well as Level 1 Reiki.
Erin has also held business leadership, sales, and training roles with Medtronic, Boston Scientific, and Pfizer. In each of these roles she successfully managed multi-million dollar territories throughout the Northeast, Latin America, and Asia Pacific regions.
Erin earned an MBA from Villanova University, Pennsylvania. She has a B.S. in Marketing and a Minor in Spanish from Villanova as well.
Director, Global Scientific Communications
Jennifer Almekinder, Associate Director, Medical Communications manages the strategic medical communications and publication planning for all business units. Jennifer has been with Merz for 4 years. Before joining Merz, she worked for 11 years at GSK and later at Stiefel in Collaborative Research and Communication roles within Medical Affairs.
Global/US Field Medical Data Analytics Lead, Diabetes and Cardiovascular
Luisa has Doctor of Philosophy (PhD), Molecular Biology, Immunology, Hematology from the University of Dundee and the EMBL and previously a Masters in Pharmaceutical Biotechnology from the University of Bologna.
She joined the industry as a medical liaison at Genzyme and is currently at Sanofi, as the Global/US Field Medical Data Analytics Lead, Diabetes and Cardiovascular and Interim Global Diabetes Program Manager.
Medical Director - International and Partnerships
Bharat Amlani is the Medical Director for Brands and Lifecycle Management at Norgine. He graduated with a degree in Pharmacy from the School of Pharmacy (University of London) and later gained postgraduate qualifications in Pharmacovigilance (University of Hertfordshire) and Epidemiology (London School of Hygiene and Tropical Medicine). In his current role Bharat is responsible for the Medical Strategy of promoted brands and publications planning. He is also the Medical lead on major partnership collaborations with the US, the CIS markets (inc. Russia) and Central and Eastern Europe. Prior to this Bharat gained significant experience in the Medical and Regulatory environment in the Middle East Region, supporting the registration of products and the setting up of a Regional Medical Affairs department supporting Middle East and North Africa.
CEO, Head of Clinical Services, Senior Executive Coach
Pinnacle Wellbeing Services
Richard’s early career was as a Senior Consultant for a major multi-national business consultancy. This enabled him to observe and experience first-hand workplace issues such as management culture, stress and conflict.
His core areas of expertise include Emotional Intelligence and Resilience. Richard coaches C-Suite leaders on themes such as Charisma and Conscious Leadership, as well as helping management teams to work more effectively towards common goals and objectives.
As a practicing coach and qualified psychologist, he has advised organisations such as Google, PwC, KPMG, Ernst & Young, Cap Gemini and Reckitt Benckiser.
Richard is also recognised by the media where he is often asked for expert commentary, having appeared on Sky 1, BBC, Bloomberg, and Radio 5Live.
Sr. Medical Director, Medical Affairs
Healthcare executive with experience in medical and clinical affairs (and health policy) in pharmaceutical, device, imaging and laboratory diagnostic industries as well as quality experience in healthcare delivery (accreditation, medical management, quality measurement). Experience managing people and teams, working across cross-functional teams in a matrix organization, and contributing to senior leadership teams in both large organizations and small start-ups. Expertise in strategy, clinical research and trials, medical affairs and MSL management, product innovation and launch, publication strategy, market access, health policy/reimbursement, health economics and quality of life measures. Green belt in process excellence and six sigma. Adjunct Professor of Health Enterprise Management and strategy at Northwestern University, Kellogg Graduate School of Management. Therapeutic areas of expertise have included immunology, oncology, cardiology, GI/hepatology, urology, and surgery.
MMJ Labs Pain Relief
“2017 World 100 Top Disruptors”; “Top 40 Transformers in Healthcare MM&M” & “110 Women in HealthTech to Know”
Amy Baxter MD FAAP FACEP is founder and CEO of MMJ Labs Pain Relief, founded in 2006 with the mission to eliminate unnecessary pain. She invented and patented VibraCool® Vibrational Cryotherapy to treat tendinitis and decrease opioid use, and her disruptive Buzzy® device has been used to control needle pain for over 31 million needle procedures.
Federally funded for her work in needle pain management, she has published over 20 first author papers and textbook chapters and lectures nationally and internationally on health tech innovation, sedation, procedural pain management, and needle fear and fatigue. A founding member of the Society for Pediatric Sedation, Dr. Baxter reviews for multiple scholarly journals, conferences, and national and international grant boards. To develop her neuromodulation pain reduction platform, Dr. Baxter was awarded a 1.1MM Fast-Track SBIR by the NIH. She wrote the patents for cooling and vibration utilization to decrease pain, and prepared and filed the FDA 510K submission for medical devices, securing the FDA expansion of the utilization to include muscle pain and cosmetic injection pain control.
Speaking venues include Exponential Medicine, Bloomberg, Converge, AARP Life at 50+, TEDx and TEDMED. Her primary scientific contributions to date are development of the hepatic enzyme algorithm to time child abuse, creating and validating the BARF nausea scale for children with cancer, and identifying the cause and consequences of the precipitous rise in needle fear. She has been named a 2017 Healthcare Transformer, Wall Street Journal “Idea Person”, Most Innovative CEO of the Year by GA Bio, a Top 10 Disruptors in Medical Tech, and “Top Women in Tech to Watch” by Inc. She is currently developing a wearable VibraCool Low Back pain reliever to accompany VibraCool Knee Pain and VibraCool Elbow Tendinitis Relief and exploring regenerative implications of thermal and vibratory energy. She is also known for turning down Mark Cuban, Robert Herjavec, and Mr. Wonderful on Shark Tank.
BTG International, UK
With a background in academic clinical medicine Nermeen is an experienced business leader who has founded, grown and exited from global life sciences businesses in start-up and corporate settings. She is a recognised expert and thought leader in the clinical development of pharmaceuticals and medical devices. With a strong interest in innovative and pragmatic approaches for the generation of clinical evidence to enable adoption of new treatments, Nermeen is developing BTG’s approach for utilising big data technologies including AI and Real World Evidence for the assessment of clinical outcomes.
Dr Varawalla completed her undergraduate and specialist medical training at the University of Mumbai, before receiving a Rhodes Fellowship to the University Oxford where she obtained her doctorate from the Institute of Molecular Medicine. She is a Fellow of the Indian College of Physicians & Surgeons and a Member of the Royal College of Obstetrics and Gynaecology.
As a SYLFF fellow, Nermeen completed an MBA at INSEAD, following which she worked at Accenture’s Strategy Consulting Practice. Since then she has worked in the clinical development industry with contract research organisations, pharmaceutical and medical device companies. She serves as a Trustee of the Malaria Consortium.
Vice President, Head of Medical Affairs
Jan Hartmann, M.D. leads the global Medical Affairs and Clinical Development team at Haemonetics. Prior to his current role, Dr. Hartmann was a strategy consultant with McKinsey & Company, where he was an Associate Partner in the Pharmaceuticals and Medical Devices Practice. He co-led the global Medical Affairs team and client service on this topic across Pharma and Med Tech. Dr. Hartmann received his medical degree from the University of Freiburg in Germany and he was a research associate at Yale University.
Senior Director, Global Medical Science Liaison
Philips Healthcare, USA
Kevin Appareti is Senior Director, Global Medical Science Liaison in the Chief Medical Office at Royal Philips. He leads the Key Thought Leadership Program and works across Philips’ businesses, markets, and research to build strong internal and external relationships with key thought leaders and influencers. Kevin partners with internal business, market, and research leaders to develop strategic Key Thought Leader (KTL) engagement programs to deliver strategic guidance, leverage clinical and scientific knowledge, foster peer-to-peer relationships, and support clinical and marketing evidence development in support of Philips meaningful innovations.
Prior to the 7 years he has been in the Chief Medical Office, he had 25 years of experience in the Ultrasound Business Unit where he held a variety of leadership positions. He was senior marketing manager of the global luminary program where he contributed to establishing a structured approach to thought leader management. He was also worldwide market development manager and director of product marketing for cardiovascular ultrasound where he brought to market many cardiovascular ultrasound products that set the standard in performance and reliability. He has held additional positions in marketing management for professional services, information technologies and clinical marketing.
He began his academic, research and clinical career as Program Director for Diagnostic Medical Ultrasound Education at the University of Colorado Health Sciences Center where he was involved in clinical research in fetal echocardiography, neonatal brain imaging, and ultrasound technology assessment. He has co-authored many scientific papers, book chapters and presented at numerous international scientific conferences.
He then moved to industry with various clinical and management roles with Hewlett Packard, Agilent Technologies, and now Royal Philips. Kevin holds a bachelor’s degree in physical science from Colorado State University and an MBA from Boston University and has been an adjunct professor at the University of Massachusetts at Lowell, Manning School of Business.
Kevin is married and has 4 boys. He enjoys basketball, road cycling, tennis and he is an avid photographer.
Corporate Vice President and Chief Medical Officer
Michelle Fox, RN BSN was named Vice President of Clinical and Medical Affairs in January of 2015.
She joined Teleflex in December of 2013 as the Senior Director of Clinical Affairs through the acquisition of Vidacare. She has more than ten years of medical device management experience. During her time at Vidacare, Michelle led many successful growth initiatives and acted as the spokesperson for the company resulting in practice change through the release of new guidelines and policies, collaboration in education, clinical research, professional development and advocacy.
She has been instrumental in strengthening the organization through the formation of our global Clinical and Medical Affairs division. Michelle and her leadership team set the clinical vision and strategy for the organization. She provides leadership to Medical Affairs which provides medical guidance for the company’s global product portfolio and assures compliance with global regulatory, legistlative and medical requirements. Clinical Affairs representatives lead the design of and implementation of multidisciplinary clinical development progams covering a broad range of products and therapeutic areas in collaboration with strategic business partners. Michelle also leads the scientific, clinical research and reimbursement arm of the organization.
Michelle’s work has focused on organizational and systems development. This includes interactive medical education as a means to making transformational change and supporting research that implements the best medical practices into bedside clinical care. She has lectured nationally and internationally on the impact of strong collaboration between Clinical and Medical Affairs and professional medical and nursing societies. She offers a rare blend of strong clinical practice and leadership, driven by her desire to improve patient outcomes, and tempered by a clear understanding of the challenges facing healthcare today.
Michelle received her Bachelor’s of Science in Nursing from Colby Sawyer College, a Dartmouth Affiliated program, and went on to complete a Harvard Affiliated Critical Care Residency Program at Beth Israel Deaconess Medical Center. She has served in advisory positions for medical and nursing societies, Board of Trustees and contributed to new standards of practice for specialty societies.
She is based in Boston, MA.
Senior Director, Global Scientific Affairs
Dr. Dunbar received a B.S. degree in Microbiology and Immunology from the University of Maryland, a Ph.D. in Medical Microbiology and Immunology from the University of South Alabama, College of Medicine, and a MBA from the University of Maryland. She completed post-doctoral fellowship training in Clinical and Public Health Microbiology at Baylor College of Medicine and was the Laboratory Director of Virus Reference Laboratory in Houston, Texas.
Dr. Dunbar joined Luminex as a Senior Scientist in 1999 and served as Senior Director of the Biology Research and Development group for eight years. She is currently the Senior Director of Global Scientific Affairs for Luminex. Dr. Dunbar has developed hundreds of multiplexed assay panels for proteins, nucleic acids and other biomolecules on the xMAP Technology platform. She has presented more than 20 abstracts at scientific conferences and has more than 30 publications in the peerreviewed literature.
Director of Medical Affairs Operations
Kate Pietrovito has worked as Director of Medical Affairs Operations at BTG, a growing international specialist healthcare company focused on Interventional Medicine, since April 2017. In this role, Kate directs tactical execution of the medical strategy across the Interventional Oncology business. Kate has a diverse medical affairs background, with experience in product strategy, clinical development, field medical management, medical information and communications, and management of investigator initiated trials.
Previous to BTG, Kate worked within Medical Affairs in roles of increasing responsibility at AngioDynamics, Cubist Pharmaceuticals, and Hologic. Kate holds a Bachelor of Science degree in Biology and Technical Communication from Worcester Polytechnic Institute in and a Master’s degree in Health Communication from Boston University, as well as a certification from the American Medical Writers Association. She is based in Sterling, Massachusetts, where she lives with her husband and their 7 year old son. Kate is an avid marathoner, and also enjoys triathlon, road cycling, and travel.
Director, Medical and Scientific Affairs
Roche Diagnostic Corporation
James M. Harris is currently a Director Scientific Affairs, Non-Cardiac with the Medical and Scientific Affairs team at Roche Diagnostics.
Jim provides oversight in implementing and directing programs for investigational and marketed products. Close alignment with global stakeholders is required as well as insight from US Clinical and Laboratory TAE’s as a Medical Plan is development. The Medical Plan then provides Objectives and Deliverables that allows for his team to compliantly manage prelaunch execution and post launch support. The result is then clinical and scientific leadership that supports successful activities with FDA cleared tests while providing clinical development with future tests.
Prior to joining the Medical and Scientific Affairs team Jim served in various roles in Clinical Development, Marketing, and Sales for Roche Professional Diagnostics. Jim began his career with Roche Diagnostics in 2001.
Vice President of Products
Inspire (Online Patient Communities)
Jeff brings over 10 years of experience designing, creating and managing the lifecycle of products supporting the healthcare industry. He has a specialization in data-oriented products and solving complex security challenges that accompany use of protected health information (PHI). At Inspire, Jeff is responsible for both developing the pipeline of existing and future commercial products and developing Inspire’s online community to ensure growth, retention, and engagement. Prior to Inspire, Jeff worked for a leading healthcare consulting firm where he conceptualized and launched successful data products for providers.
Founder and CEO
Lyfebulb, New York
Dr. Karin Hehenberger is the Founder and CEO of Lyfebulb, which aims to reduce the daily burden of chronic disease for patients and their caretakers across multiple disease states. Dr. Hehenberger previously served as an executive at Eyetech Pharmaceuticals and Coronado BioSciences and had strategic management roles at Johnson & Johnson (Vice President Metabolic Strategy), JDRF (Senior Vice President Strategic Alliances), and McKinsey, as well as senior partnership roles at multibillion dollar investment funds. She received her MD and PhD degrees from the Karolinska Institute and did her post-doctoral fellowship at the Joslin Diabetes Center of Harvard Medical School.
Founder and CEO
Debi Willis is the CEO and Founder of PatientLink Enterprises, a software company focused on creating products to meet the needs of the ever-changing healthcare industry. She was recently named by Health Data Management magazine as one of “11 Leading Innovators in Healthcare IT”. Her latest product, MyLinks, won first place in the recent ONC Consumer Health Data Aggregator Challenge. MyLinks is a health-focused platform which allows patients to gather and aggregate their medical records from all their health providers, transmit their records to anyone they desire, and link with family/friends and researchers. The main goal of MyLinks is to save lives and find cures faster by enabling patients to easily gather and share their records with research.
Debi will be sharing the new laws, new healthcare technologies, and consumer expectations that will have a tremendous impact on research in the near future. An overwhelming majority of patients have indicated a willingness to directly share their data for medical research, fundamentally changing healthcare and research - making it truly “better, faster, cheaper”.
Founder, Health Collaboratory
Executive Director, Society for Participatory Medicine
Sarah Krüg is the CEO of CANCER101, a patient advocacy organization whose mission is to help patients and caregivers navigate the cancer journey and partner with their healthcare team to make informed decisions. Sarah is also the founder of the Health Collaboratory, a global innovations hub that paves the path for participatory co-design and collaboration in healthcare ,and is focused on amplifying the voice of the patient and caregiver in the design, development and continuous improvement of innovations created to serve them. Through the Patient Shark Tank ® , over 16,000 patients and caregivers across disease states have provided insights and perspectives to over 700 innovations across the globe, including research, technology, and education. She is the Executive Director and Past President of the Society for Participatory Medicine, a patient: clinician member driven organization whose mission is to enable collaborative partnerships between patients and healthcare professionals. Sarah serves on the board of the National Organization for Rare Disorders and is Research Chair of the Cancer Education Network.
She previously held the position of Global Education Director in the Medical Education Group at Pfizer, as well as patient advocacy relations. She also established the Global Investigator Initiated Research Program at Pfizer. Prior to joining Pfizer, Sarah spearheaded the development of the Pediatric Disease Management clinical pathways and conducted clinical research at Memorial Sloan- Kettering Cancer Center.
Board of Directors, Neurofibromatosis Northeast
Patient Representative, Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) International Collaboration
Alexandra Powers Cellucci was diagnosed with neurofibromatosis type 2 (NF2) at the age of 28, and has a strong family history on NF2. She is on the board of directors for the nonprofit advocacy organization Neurofibromatosis Northeast. She is also the chair of NF Northeast Families and Community Committee. This past November, she was selected as a patient representative member of the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) International Collaboration. REiNS is an international effort to develop new standardized response criteria for determining treatment response in patients with NF1, NF2, and schwannomatosis.
Co-Founder, Chief Marketing & Operations Officer
Patient Power LLC
Esther Schorr is Co-founder and Chief Marketing Officer of Patient Power, a leading online channel for cancer patients and family. She has worked with her spouse, Andrew Schorr, for more than 30 years and has supported him in his cancer journey since his diagnosis in 1996. Esther is a global advocate for empowering both patients and care partners through education and collaborative decision-making with medical teams, with the proven belief that this results in better treatment decisions and health outcomes. Esther’s expertise is in multi-channel health communications, with extensive marketing and business development experience working with pharmaceutical companies, medical device manufacturers, and biotech. She is part of the cross-functional team that launched the Precision Medicine for Me site to raise patient awareness/education about the importance of genetic testing for targeted therapy and clinical trial matching. Additionally, she and Andrew founded two not-for-profit foundations to support patient education initiatives globally – the Patient Empowerment Network (US-based) and the Patient Empowerment Foundation (based in Geneva). Esther is an avid blogger and contributing author to a variety of national and international healthcare-related publications and sites.
Professor of Medicine Director, GI Oncology Program & Leader, Experimental Therapeutics
Professor Wasif Saif has been recognized as an internationally renowned expert and Key Opinion Leader (KOL) in the fields of Gastrointestinal (GI) cancers, Experimental Therapeutics and Pharmacogenetics as well as an exemplary clinician. He is currently the Professor of Medicine and serves as the Director of the GI Oncology Program and Program Leader of the Experimental Therapeutics Program at the Tufts Cancer Center, Tufts Medical Center, Boston. Over the last two decades, he has served as the principal investigators for over 50 prospective cancer clinical trials, including investigator-initiated studies. Many of these clinical studies have also embedded innovative translational research components investigating host-, drug-, and/or tumor-based correlative studies and pharmacogenetics. Throughout his career, he remains extensively involved in the teaching, mentorship and career planning of all levels of medical training starting from medical school student to resident, fellow ad junior faculty. He has contributed to over 500 per-reviewed publications, and serves on editorial board member of many peer review journals. He has been asked to speak at both national and international conferences. He continues to serve on grant review committees, including NCI and holds membership in many societies and committees including ASCO and ESMO. Dr. Saif has won many awards and laurels including America’s Top Oncologist and Leading physicians of the World.
Assistant Director, Clinical Data Management and Quality Controls, Auditing and Training
University of Kansas Medical Center
Jeanna Julo is the Assistant Director for Regulatory & Clinical Data Management at the Research Institute of the University of Kansas Medical Center. She is responsible for the auditing, training, and educating of current clinical research administration staff. She also develops and enhances clinical policy, content, and procedure to ensure consistency and quality of studies, documents, and submissions to federal agencies that meet GCP requirements. Before that, Jeanna was a Senior Clinical Trials Project Manager for the same Research Institute. Jeanna has a Bachelor’s Degree in both Chemistry and Biology from the University of Missouri-Kansas City, and she has been CCRP certified since 2013.
General Health Scientist, Senior Scientific Program Manager
Dr. Torosyan is an interdisciplinary MD/PhD scientist with clinical background and extensive biomedical expertise, who is working at the Center for Devices and Radiological Health, Food and Drug Administration (CDRH/FDA). She is interested in translational research with health care applications pertaining to use of medical devices and biomaterials. Her current projects are focused on developing new evidentiary approaches for more predictive and cost/time-efficient device evaluation, which includes pharmacogenetic/pharmacoepidemiologic applications using pre-existing data and in silico discovery of biomarkers indicative of real-world device performance in patient subpopulations.
Director Of Research
Tufts Center for the Study of Drug Development
Tufts University School of Medicine
Dr. Christopher Milne joined the Center for the Study of Drug Development at Tufts University (Tufts CSDD) in 1998 as a Senior Research Fellow and has published over 100 book chapters, CSDD reports, white papers, and journal articles. Dr. Milne received a BA from Fordham University, an MPH from The Johns Hopkins University, and holds doctoral degrees in veterinary medicine and law, respectively from the UNPHU and UNH School of Law. His research interests include: economic, policy, market access and public health implications of FDA regulations and initiatives; US, EU and Japanese government incentive programs to promote innovation; and, global disease prevalence, demographic and market access factors. He is currently Director of Research at Tufts CSDD, Research Associate Professor at Tufts University School of Medicine, formerly a visiting professor at Kyushu University in Japan and the University of Edinburgh, and serves on the editorial boards of Therapeutic Innovation & Regulatory Science and Pharma Focus Asia.
Steven Marchette completed his Ph.D. at the Johns Hopkins University where he studied the human brain. He then did his post-doctoral fellowship at the Center for Cognitive Neuroscience at the University of Pennsylvania before completing the Insight Data Science Fellowship. In his work as a Data Scientist at Compass Medical, he works with the Compass team to deliver the best patient outcomes possible while adapting to the constantly changing landscape of healthcare.
Senior Medical Director
Blue Cross Blue Shield of North Carolina
As Senior Medical Director Janet is responsible for comprehensive clinical and health system leadership for enterprise-wide and external activities, including innovative coverage design, emerging technology analysis, strategic provider partnerships, and clinical and cost-effectiveness assessment.
Before Janet worked as Senior Medical Director, Medical and Reimbursement Policy. She was responsible for: strategy, implementation, and supervision of staff for corporate medical and reimbursement policy for independent Blues plan. Janes was managing team of 11 medical directors devoted to utilization management, quality improvement, program development, and appeals.
President & Chief Medical Officer
James Mault, MD, FACS, is the Vice President and Chief Medical Officer of Qualcomm Life after its 2013 acquisition of HealthyCircles, a Care Coordination and Remote Patient Monitoring Platform Company founded and led by Dr. Mault since 2009. His leadership responsibilities at Qualcomm Life include Strategic Planning and Business Development, Mergers and Acquisitions, New Product Innovation including Intelligent Care Analytics, Clinical Program and Regulatory Oversight, Global Health Policy, Government Affairs and External Affairs, Global Spokesperson and Public Relations. Prior to starting HealthyCircles, Dr. Mault was the Director of New Products, Business Development and Clinical Programs for the Health Solutions Group at Microsoft. Dr. Mault has more than 30 years of experience in senior executive positions in the Health IT and Medical Device industry as well as clinical medicine. Dr. Mault has founded multiple Health IT and medical device companies, raising over $100 million in working capital and leading these companies to develop novel devices and software technologies, FDA approvals, and strategic partnerships with numerous Fortune 500 companies, culminating in M&A and IPO exit transactions. He is the named inventor of over 80 issued and pending US Patents for a variety of novel health information and medical device innovations. He has been board-certified in both General Surgery and Cardiothoracic Surgery, having specialized in heart and lung transplantation, thoracic oncology and critical care. He has conducted academic medical research under numerous grant awards from the National Institutes of Health, American Cancer Society, and others. He is the author of more than 60 scientific articles, chapters and books in the published medical literature. Dr. Mault holds a B.S. in Biology and a Medical Degree from the University of Michigan, and conducted his General Surgery and Cardiothoracic Surgery residency training at Duke University Medical Center. Dr. Mault provides global thought-leadership on the future of technology and healthcare delivery, serving on numerous Boards and leadership positions including the Consumer Technology Association’s (CTA) Executive Board and Chairman of the CTA Health & Fitness Technology Board, the American Telemedicine Association, the Advanced Medical Technology Association, the National Science Foundation Nanosystems Engineering Research Center, and the World Economic Forum Healthcare Working Group. Dr. Mault also serves on the University of Michigan Medical School’s Admission Committee and is a member of the Board of Trustees for the Astronaut Scholarship Foundation.
Senior Director, Medical Affairs Strategic Solutions
Dr Peters serves as Senior Director, Medical Affairs Strategic Solutions, a division of Medscape. She brings over 35 years of experience in medical affairs, medical education, research, and publishing to her work. After 15 years as a researcher focusing on immunological and oncological disorders, Pam turned her attention to the data-driven optimization of healthcare at which time she joined Medscape Education. Pam has a doctorate in immunology and genetics from Yale University and completed her post-doctoral work in immunology at University of California, Berkeley
President & CEO
Accreditation Council for Medical Affairs
An experienced senior executive with several years of experience in the Pharmaceutical & Biotechnology industry, Dr. Soliman has held key positions where he was instrumental in launching a variety of innovative platforms in medical affairs. He speaks frequently regarding the ever changing role of medical affairs at major medical affairs conferences. He currently the Executive Chair, President on the board of the Accreditation Council for Medical Affairs (ACMA) whose primary mission is to create industry standards and goals for medical affairs professionals.
He has held several management roles across the industry within medical affairs such as at Retrophin, Eisai, Gilead Sciences, Abbott Laboratories, Boehringer-Ingelheim, and Merck. Dr. Soliman previously also served as Vice President of Medical & Scientific Affairs at CME LLC, a leading provider of CME to health care providers nationwide. He also has worked on the strategic management consulting side with companies such as Veeva systems, and is often brought in as a subject matter expert on medical affairs for healthcare investment and advisory firms.
He has published extensively & led a number of initiatives focusing in the areas of ischemic heart disease, dyslipidemia, diastolic heart failure, type 2 diabetes, and obesity where he has collaborated with some of the nation's top research institutions such as the Pennington Biomedical Research Center, the Washington Center for Weight Management & Research, the Yale School of Medicine Digestive Diseases Program and the University of Pennsylvania's Center for Weight & Eating Disorders. Dr. Soliman was most recently invited to speak at the Center for Medical Technology & Policy's (CMTP) conference on Comparative Effectiveness Research to help inform payers, healthcare policy makers, physicians and patients on the most effective ways to design clinical trials to better address gaps in medicine. He also recently presented at the 2014 annual American Diabetes Association (ADA) Conference on preventing the progression of type 2 diabetes among pre-diabetic overweight and obese individuals. In 2008, Dr. Soliman published a book entitled The Rise of Chemistry: Implications for Industry & Education.
Dr. Soliman is featured in the media and news often for his perspective and views on the evolving role of medical affairs/MSLs in the pharmaceutical industry. He has been featured in Forbes, the Pharmaceutical Executive, ABC News, the Pharmacy Podcast, and most recently on Relentless Health Value with well-known host Stacey Richter who focused on healthcare thought leaders.
He has also held several academic appointments at Seton Hall University's School of Health & Medical Sciences, New Jersey City University, Kean University's College of Natural & Applied Sciences, and Touro Colleges of Osteopathic Medicine, Pharmacy & Physical Therapy teaching a variety of courses including clinical therapeutics, pharmacology, pathophysiology, and epidemiology.
Dr. Soliman earned his PhD, MPhil from Columbia University, his Bachelor’s degree from New York University and a Masters Degree from St. Peter's University. He completed post-doctoral training at Harvard University’s T.H Chan School of Public Health.
Managing Director, Health Analytics
With several years of focused effort inside the pharmaceutical vertical, Badal Shah, B.Pharm, M.S. MBA, has pioneered a framework for achieving effective medical communications and optimizing field sales force activities pre- and post-launch for pharmaceutical products. With his revolutionary approach to Key Opinion Leader (KOL)/HCP engagement, Badal established and leads the KOL practice and serves as the Managing Director, Health Analytics at QPharma. His ability to create cohesive tools for interlocking compliance and commercial solutions within the KOL/ Healthcare Practitioner (HCP) targeting space, has made QPharma one of the market leaders in this space. A Pharmacist and business graduate of Rutgers University, Shah is a member of the Advisory Board of Directors for the American Pharmacy Purchasing Alliance.
Vice President, Business Partnerships,
Michael Kirby is Vice President, Business Partnerships, at Within3, where he’s spent the past five years introducing virtual engagement to dozens of pharma and biotech clients. Prior to that he spent 15 years working for a variety of sales organizations focused on building digital solutions for HCP engagement.
Executive Director of Scientific Affairs, Real World Solutions
PRA Health Sciences
Dr. Meg Richards joined PRA Health Solutions with over 30 years' experience as an epidemiologist and health services researcher in both the public and private sectors. Immediately prior to PRA HS, Meg served for a year as the Vice President of Data Analytics & Epidemiology/Real World Strategy and Analytics at Mapi Group (now ICO at ICON plc); prior to that, she served nearly seven years as an Executive Director of Epidemiology/Real World Outcomes at PPD Inc. Before joining PPD, Meg served for three years as Director, Global Patient Safety & Risk Management at the Genzyme Corporation. Meg also worked as a safety epidemiologist and outcomes researcher at Abbot Labs and TAP Pharmaceutical Products, respectively, for a total of six years. At both Abbott (now Abbvie) and Genzyme (now a Sanofi company), Meg managed the quarterly data mining and ‘signal’ (safety issue) detection and evaluation programs for each company’s post-marketed product lines.
Meg received her BS in Nutrition from the University of New Hampshire and her MPH and PhD from the University of Illinois at Chicago's School of Public Health, after which she served a two-year tour of duty with the US Public Health Service as a member of the Centers for Disease Control and Prevention's Epidemic Intelligence Service.
Business Development Director
Dominic first joined Adelphi Communications in January 2011. He graduated from the University of Manchester Institute of Science and Technology with a Bachelor’s degree in Biochemistry. He subsequently completed his PhD at the University of Sheffield. Prior to joining Adelphi, Dominic was a postdoctoral researcher in oncology. He currently focuses on driving innovation in medical communications.