Meet the Speakers
31, Cancer Survivor, Director of VINCIBLE
Kayla Redig was a competitive athlete and elementary school teacher before she was diagnosed with breast cancer at 24 years-old. After experiencing the isolation and uniqueness of being a young adult cancer patient, she grew determined to change the experience for fellow patients and survivors. “It felt really odd to me to walk into the transfusion center for chemo and see a room full of men my grandfather’s age and then go to a doctor's appointment in a different room covered in balloon stickers and children’s handprints on the walls. Even finding other patients with a similar age and diagnosis across the country was a struggle. Where did I fit in? I often felt very alone but I knew there had to be other young adult patients out there that felt the same. I knew this wasn’t the way the cancer experience had to be for us."
During her treatment, Kayla came up with creative ways to make her treatments bearable, and even fun. From these experiences, her passion for helping others do the same quickly developed. When not with friends and family, she enjoys public speaking, making pancakes, spending time outdoors, and doodling.
You can learn about her cancer journey here: Love Conquers All.
28, 2x Cancer Survivor, Community Engagement for VINCIBLE
Sarah Denger graduated from the University of Kentucky, and moved to Nashville, TN to pursue a career in social work. Her life came to a halt, when at 23 years old, Sarah was twice diagnosed with stage four Hodgkin’s Lymphoma. For three years, her time was monopolized in the hospital, receiving intensive chemotherapy treatments, including a stem cell transplant. It was during that time that she felt a debilitating isolation. Even when her loved ones visited/cared for her, she often felt even more lonely, knowing that they couldn’t possibly understand her unique circumstance.
It was the young adult cancer experience that Sarah decided to invest in her passions of activism work for the young cancer patient, as well as her pursuit in a career in fitness. Now at age 28, she states that these passions are the driving force behind helping others reach their potential, as their abled body will allow. Sarah teaches at many YMCA branches around Nashville, offering diverse styles of fitness including: barre, yoga, water aerobics, Silver Sneakers™, ballet sculpt, Glide Fit Core™ , abs express, circuits, sculpt, and dance. She hopes to continue connecting with young adults battling cancer, from all over, in hopes to show they are not alone. Sarah loves her cat, Petunia, and enjoys public speaking, drinking good coffee, reading, journaling, and having intelligent conversation.
“The Young Adult Cancer Experience” Keynote
Remember when being young made you feel like you had the world by the tail and everything was new? Your first love and your first job? Remember how it felt to drive a car for the first time, or to stay up all night with your friends?
Head of Digital Operations, AbbVie
Aman Thukral is the head of Digital Operations and eCOA at AbbVie. He has over twelve years of experience in clinical development, technology planning & business-technology alignment. In his current role, he is responsible for eCOA operations, wearables and sensors, piloting new technology initiatives & digital partner for patient engagement group. Before this position, he had worked in Deloitte, Cognizant & GlaxoSmithKline at various levels
The Best of Both Worlds: Bringing together Patient Engagement and eCOA
Amanda J Moore MSHS.
Head of the Sage Clinical Advancements & Technology Lab, Sage Therapeutics
Amanda Moore in an established contributor within the clinical research industry. She brings diverse perspectives to achieving operational excellence through novel approaches and patient-centric drug development. She has wide-ranging experience having advanced from coordinating at a research site, to working at a CRO, and now as a leader in biotech for over a decade. Amanda specializes in clinical development through full outsourced models and has developed innovative clinical trial designs and accelerated clinical development plans for rare diseases, as well as pioneering a new function focused on the future of drug development.
Alisa Heinzman, MFA
eCOA Solutions Lead, RWS Life Sciences
Alisa Heinzman is a Senior Project Manager specializing in eCOA processes at RWS Life Sciences. She has co-authored several research documents including upcoming poster Linguistic and Cultural Considerations when Implementing a Global ‘Bring Your Own Device’ (BYOD) Study.
Ms Heinzman has a background in frontend web development and brings a strong knowledge of human-centered design, accessibility guidelines, and best UX design practices to the RWS Linguistic Validation team. Her current work incorporates this technical knowledge into the development of best practices for the migration and usability testing of translated eCOAs, particularly regarding the responsive and mobile-friendly platforms used in BYOD studies.
She’s launched curriculum development and community outreach for local chapters of Girls Who Code, a national non-profit working to closing the gender gap in technology.
eCOA Best Practices for Linguistic Validation in Global Clinical Trials
Director, Clinical Labs & Data Sciences (CLDS), Eli Lilly and Company
Ben Henderson is a Director in the Clinical Labs and Data Sciences (CLDS) organization at Eli Lilly and Company. He has been with Lilly for nearly 20 years holding positions in oncology clinical project management, oncology clinical operations, external sourcing/vendor management, and serving as a Six Sigma Black Belt before moving into his current role where he oversees Lilly’s 65+ external vendor partners within the lab & diagnostic space. Additionally, he has operational oversight responsibilities for eCOA and connected devices across Lilly’s clinical research portfolio. Ben holds a BS degree in Biology from Harding University and an MS degree in Cell & Molecular Biology from Purdue University.
Becoming Sponsor of Choice - Lilly's Journey
Dr. Bill Byrom
VP, Product Strategy and Innovation, Signant Health
Bill leads product strategy and innovation at Signant Health. He has worked in the Pharmaceutical industry for over 25 years and is the author of over 70 publications and an industry textbook on ePRO. His recent scientific work includes the use of wearable technology and BYOD eCOA in clinical trials. Bill is Vice Director of the C-PATH ePRO Consortium and a member of the DIA Study Endpoints Community.
eCOA Forum Host, Wearables: Focus on Activity & Sleep Monitoring,
Endpoints in Motion: The Practical Trial Applications of Wearables and Sensors, Today's Horizon, Tomorrow's Biomarkers: Emerging Trial Technology
Chief Commercial Officer, Signant Health
Christopher L. Crucitti, MS, leads the commercial functions of the organization, as well as the go-to-market strategy, to drive the continued growth of our already market-leading clinical technology solutions platform. Chris brings significant experience and expertise in the clinical and R&D domains. He has led organizations to significant revenue and profitability growth, while maintaining a high level of customer service and quality delivery. He joined from Science Exchange, having served as Chief Commercial Officer for the world’s largest enterprise platform to manage outsourced R&D services. Prior to Science Exchange, he held various senior executive-level positions and oversight of commercial functions within the CRO industry (most notably Worldwide Clinical Trials and inVentiv Health Clinical) overseeing solutions spanning technology, consulting, strategic resourcing, clinical development and R&D.
Chris holds a Master of Science from American University and a Bachelor of Science from Ithaca College.
eCOA Forum Host
A patient advocate and cancer survivor with decades of health policy, communications and capacity-building experience, Cindy Geoghegan founded Patient & Partners to ensure that the patient perspective is strategically integrated into industry, academic, government and non-profit efforts focused on patient outcomes and clinical benefit. She has founded, transformed and grown several patient-led non-profit organizations, and represents the patient perspective on research projects sponsored by government, academia and industry. She currently serves as an individual patient/caregiver representative on CTTI’s Steering Committee and as a team lead for CTTI’s Mobile Clinical Trials Stakeholder Perceptions project.
Engaging Patients & Sites: Updates on CTTI Recommendations
Principal, Endpoint Solutions, Signant Health
Dan DeBonis is one of the pioneers in the field of in study data analytics and quality control. He was the founder Concordant Rater Systems in 2001, which became part of Bracket in 2010. Throughout his career at Concordant and Bracket, he has designed and implemented technology driven data monitoring solutions for trials ranging from pivotal worldwide programs to NIMH studies. Dan is a graduate of Yale University.
AI and ML and Panel Session
Beyond Buzzwords: How AI & Machine Learning are Impacting the Next Era of Clinical Trials
Elan Cohen, PHD
Principal Investigator, Hassman Research Institute
Elan Cohen, PhD is Principal Investigator and Lead Psychometrician at Hassman Research Institute (HRI), a private research company conducting Phase I-IV CNS, healthy volunteer, and medically-focused clinical trials in two New Jersey locations. Dr. Cohen, a New Jersey and Pennsylvania Licensed Psychologist, joined HRI in 2016 after over 17 years of robust experience providing clinical care to patients, psychometrically rating study subjects, psychiatric scale management of various modes and rater training services, as well as writing clinical trial protocols, integrating regulatory compliance matters with rater training programs, and producing various scale training videos. These skills were developed from Dr. Cohen’s director level positions at several prestigious companies, notably MedAvante, Worldwide Clinical Trials (a Contract Research Organization), the University of Pennsylvania, and a previous HRI-affiliated clinical trial site.
Further, Dr. Cohen’s empirical investigations have generated multiple presentations at several international pharmaceutical conferences on such topics as placebo and nocebo effect mitigation interventions, execution of pragmatic rater training programs, electronic data capturing devices, and methodological implications of psychiatric measures within clinical trials.
Dr. Cohen has an MA from Ball State University in Counseling Psychology, PhD from Indiana State University, and his post-doctoral work was completed at the University of Pennsylvania.
The Research Site eCOA Experience
Elizabeth Yohe Moore
COA Process Development Lead, RWS Life Sciences
Elizabeth Yohe Moore is a clinical outcomes assessment (COA) researcher working to implement a patient-first approach to linguistic validation of COA data collection instruments. With specialization in both Public Health (MPH) and Business (current MBA candidate), Elizabeth’s work focuses on creating and improving LV production processes that maximize the global validity of COAs. Past speaking credits include the Food Allergy Research & Education Ambulatory Care Summit, and guest lectures on Linguistic Validation survey research methods.
eCOA Best Practices for Linguistic Validation in Global Clinical Trials
Jeremy Wyatt is the President of ActiGraph, an industry leading global provider of physical activity and sleep monitoring solutions for the pharmaceutical and academic industries. Jeremy’s 20 years of experience in working with low-power micro-electro-mechanical systems and related cloud technology have given him a unique perspective on the challenges and opportunities of deploying wearable technology to produce meaningful patient data. He has an undergraduate degree in electrical engineering from the University of Florida and an MBA from the University of West Florida and is a member of the Digital Medicine (DiMe) Society. ActiGraph’s ecosystem of of medical-grade physical activity monitors and cloud software ensure clients are collecting pure, raw signal data from patients for small and large studies. ActiGraph’s long-standing history in academic research gives the company a unique foundation for helping clients derive novel, meaningful insights from wearable sensor data.
Wearables: Focus on Activity & Sleep Monitoring
Jennifer Repella Gordon, MS
Associate Director in Clinical Management , Otsuka Pharmaceutical
Jennifer Repella Gordon, MS, is an Associate Director in Clinical Management at Otsuka Pharmaceutical Development and Commercialization, Inc. Jennifer has been in the clinical research industry for over 20 years with positions at the Behavioral Science Unit of the FBI, the Biological Psychiatry Branch at the National Institutes of Mental Health, a start-up Biotechnology company, and a niche-CRO, before joining Otsuka in 2009. During her past ten years with Otsuka, Jennifer has overseen all early development clinical trials globally across multiple compounds. In this role, she has been able to pilot many novel innovations to support clinical research initiatives including eConsent, eSource, as well as other technologies to improve the clinical trial experience for patients.
eConsent & Patient Engagement Panel
Trial Expertise & Delivery Center Leader/Central Services Expert, Sanofi
In Sanofi Khadija began her career in Medical Regulatory Affairs Direction in 2001 then she integrated Global Medical Affairs and Methods and Support units in 2003. In 2010 she joined Sanofi TIM (Technology Information Management) as a Vendor Manager and subsequently joined ITS (Information Technology & Solutions) where she has occupied various functions since 2014 mainly supporting all Business units by providing Investigators and patients support services.
Her recent position was eCOA (Electronic Clinical Outcomes Assessment) services manager and Vendor manager in ITS organization for the sourcing of electronic clinical services in Clinical trial portfolio from Trial Operations. She has a strong experience as Digital Innovation Expert, also on vendor management activities, e-services management cross functional team-leadership and knowledge in clinical development and outsourcing best practices.
She is now the Trial Expertise and Delivery Center Leader – Central Services Expert. The service lines she does cover in her role are eCOA, Imaging, Cardiac Safety and Respiratory.
Khadija has a Master’s Degree in International Marketing from the University of Paris I, additionally she has been followed a qualification of Clinical Research Assistant. She works within Sanofi organizations since 18years. Khadija YHUEL is based in Chilly Mazarin, France.
Best Practices for eCOA Implementation
CEO, Signant Health
Mike Nolte joined in 2018 as the Chief Executive Officer. Mike is a seasoned operational leader whose career spans the healthcare, technology and financial services industries. Mike recently serving as Chief Executive Officer at Influence Health. Prior to that position, Mike served as President, Chief Operating Officer and Director of the public company MedAssets (MDAS), prior to which he spent 7 years at General Electric (GE), including roles as Vice President and General Manager of Americas Services for GE’s Healthcare IT business, where he led more than 1,700 teammates focused on GE’s $900 million healthcare software portfolio, VP and GM of GE’s $230 million enterprise revenue cycle software business and VP and GM of marketing and product management for GE Healthcare IT’s ambulatory segment. He also spent five years with McKinsey & Company and started his career as a U.S. Army Officer, finishing up as a Captain and Company Commander for an airborne, rapid deployment, medical supply chain and maintenance organization. Mike holds a Master of Business Administration from The University of Chicago Booth School of Business and a Bachelor’s Degree from the University of Notre Dame.
What are you doing to improve the patient journey?
Dr. Pravin Jadhav
Senior Director, Otsuka Pharmaceutical Development and Commercialization (OPDC), Inc.
Dr. Pravin Jadhav is Senior Director of Applied Innovation and Process Improvement within Otsuka Pharmaceutical Development and Commercialization (OPDC), Inc. He leads a multi-disciplinary team of data, information and knowledge experts to create science-driven, technology-enabled solutions of clinical and economic utility. The team is focused on clinical trial transformation and new business model by leveraging digital technology to bring therapeutic solutions for customers.
Before joining Otsuka, Dr. Jadhav was Director of Modeling and Simulation at Merck for 4 years. He was a leader of scientific network on Predicting Competitive Advantage for all therapeutic areas. The group was charged with providing quantitative input for go/no-go decisions and key study design elements of head-to-head studies as well as quantitative assessment of competitive advantage for the key assets. He was also therapeutic area lead for immunology to plan and execute advanced research for high quality and cost effective drug development programs from discovery through commercialization.
Before joining Merck, he was Team Leader and Expert Regulatory Scientist in the Division of Pharmacometrics of the Office of Clinical Pharmacology (OCP) at the US food and Drug Administration (FDA). He has worked on more than 100 New Drug Applications and 150 Investigational New Drug applications covering aspects of exposure–response to aid in important regulatory decisions. He covered various therapeutic areas such as anti-viral, anti-infective, transplant, reproductive and urology, cardiovascular and renal, dermatology, and medical counter measures (MCM) products in 9 years at FDA. Pravin represented OCP as an internal expert on clinical pharmacology issues in pediatric drug development advising all the Office of New Drugs (OND) divisions as an appointed member of the Pediatric Review Committee (PeRC), a committee mandated by the congress. He has more than 150 publications in peer reviewed journals and presentations at international conferences. He has received several awards and honors at the FDA, including outstanding service award in 2008 and special citation for innovative analysis on telaprevir and boceprevir new drug applications in 2011.
Pravin received his BPharm and MPharm from India, PhD in Pharmaceutical Sciences from the Medical College of Virginia Commonwealth University (VCU) and MPH from Johns Hopkins University, Bloomberg School of Public Health. He has an adjunct faculty appointment in the College of Pharmacy at University of Florida and member of the Graduate Advisory Board of VCU School of Pharmacy.
New frontiers in measurement and endpoint for mental health drug development
Senior Vice President, Product Management, Signant Health
Rauha Tulkki-Wilke leads cross-functional design and development of eCOA solutions for client and therapeutic area needs, combining science and patient experience with leading technology. Rauha has close to 20 years of experience with all that eCOA encompasses and has a genuine interest in digital health. Prior to moving to the pharmaceutical industry, she developed solutions for anesthesia management and neonatal intensive care. Rauha holds a Master of Science in Biophysics and Biomedical Engineering.
Building the Patient eSource Platform of the Future
Principal-Patient Centered Outcomes, ICON
Saeid Shahraz joined ICON in 2018 as a Patient-Reported Outcomes (PRO) expert. Saeid has a solid background in health measurement methods spanning a wide range of techniques including survey design and analysis and real-world data analytics. As a physician and health services researcher, he has led many research projects requiring an ensemble of statistical methods to produce results. Saeid's primary interest is to use current and advanced psychometrics techniques for assessing clinical outcomes.
Before joining ICON, Saeid worked as an assistant professor at Tufts Medical Center and Heller School of Social Policy at Brandeis University as a scientist. In both roles, he has completed various research projects and published a wide range of papers in prestigious medical journals including Lancet, NEJM, and JAMA. Saeid works at ICON’s San Francisco office.
Breaking the Barriers to BYOD Adoption
Clinical Vice President, Internal Medicine, Signant Health
An Innovator, educator, and leader in the pharmaceutical and biotechnology industries with over 23 years of experience in the practice of medicine and over 12 years of experience in clinical research. Board-certified in Internal Medicine and a Fellow of the American College of Physicians, he has worked in all phases of clinical development in numerous therapeutic areas and is an expert in medical monitoring, medical data review, data visualization, data analytics, and technology adoption.
Data Analytics / Endpoint Quality
Clinical ePRO Manager, Ferring Pharmaceuticals
Vesna Malmberg has worked within big pharma for 19 years and with eCOA for 17. Worked with all major eCOA providers. At Ferring she is on a global level solely responsible for all eCOA solution(s) in clinical studies, from vendor selection to study decommission. In the current task she is also responsible for creating an eCOA platform and strategy for Ferring.
Dealing with Complexity in Patient Diaries – Perspectives from Case Studies Using ePRO