Speakers

KEYNOTE SPEAKER

KEYNOTE SPEAKER

T.J. Sharpe

Cancer Blogger | Survivor | Advocate

 

 

T.J. Sharpe is a Stage IV melanoma survivor, writer, advocate, and patient expert who began sharing his journey through cancer in the Patient #1 Blog on http://www.philly.com/patient1/.  He was diagnosed in August 2012 with melanoma tumors in multiple organs; since then, he has undergone six surgeries and four immunotherapy treatments over two different clinical trials.  He remains on his second trial, for the anti-PD-1 drug pembrolizumab, with no detectable active cancer.  The initial failures, and subsequent response, have been chronicled in his blog posts since December 2012.

Now a speaker, writer, and patient expert consultant to the biopharma and clinical research industries, his efforts have been recognized by several organizations across the clinical and cancer research landscape; in December 2014, he shared his story on Capitol Hill in a special session promoting immunotherapy research to lawmakers.  As a speaker and consultant, he has presented to or worked with many of the top pharmaceutical companies and industry trade organizations, and his story has influenced an initiative to bring clarity and common language to clinical trial contracts.

He regularly participates in and speaks at conferences, bringing the latest melanoma and oncology research breakthroughs through his blog to help others avoid, detect, or educate themselves on cancer.  He is an active voice in the advocacy world, connecting patients across disease states with one another and with industry and regulatory contacts to help spearhead the concept of the patient as an equitable stakeholder in the entire healthcare ecosystem.  He also partners with advocacy and patient organizations to bring awareness to cancer research and developments, and support those living with cancer and their families.

Mr. Sharpe contributes to www.Novartis.com, his Patient #1 blog, and www.SkinCancer.net on a regular basis, along with ad-hoc online and print contributions to multiple media outlets.  He also serves on the Board of Directors of A Prom to Remember, a 501(c)3 charity providing pediatric oncology teens with the ultimate Prom experience.

A South Jersey native, T.J. lives in Fort Lauderdale with his wife Jennifer and two children, Josie and Tommy. He is active in health initiatives, including melanoma/cancer awareness runs and cycling rides, and is an avid yoga participant - when not coaching his kids' soccer and baseball teams or being Dance Dad.  Throughout his journey, he has, and still does, consider himself the luckiest person on the planet with cancer.

Sessions
Keynote
Panel: What Role Does Electronic Approaches Have in the Research of Patient-Focused Drug Development?

Alisa Heinzman, MFA

Senior Project Manager - eCOA, 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.

Sessions
Best Practices for Usability Testing to Improve the eCOA Patient Experience, Particularly in BYOD Studies


 

Ari Gnanasakthy, MBA, MSc

Head of Patient-Reported Outcomes, RTI HS

Ari Gnanasakthy, MBA, MSc, is Head of Patient-Reported Outcomes at RTI HS. Prior to RTI HS, Mr. Gnanasakthy was the Executive Director and Head of the Patient-Reported Outcomes Center of Excellence at Novartis Pharmaceuticals. He has almost 30 years of experience in the pharmaceutical industry. At Novartis, he worked in several departments, including Biostatistics, Health Economics, Pricing, and Outcomes Research. After receiving his bachelor's degree in mathematics, statistics, and computing, Mr. Gnanasakthy joined Rothamsted Experimental Station (UK), where he was responsible for the statistical analysis of survey data of agricultural soil in England and Wales. He then joined the Milk Marketing Board (UK), where he was a part of the team responsible for modeling lactation curves of dairy cows.

Mr. Gnanasakthy's extensive experience in the field of statistics and outcome research has resulted in numerous abstracts and almost 40 publications. Throughout his career, Mr. Gnanasakthy has developed and validated over a dozen patient-reported outcomes instruments and currently serves in the editorial board of Cancer Clinical Trials and a reviewer for many professional journals, including Value in Health.

  

Sessions
Panel: Leveraging Patient-Reported Outcomes in Oncology


 

Ashley Deane, MSc, BSc

Account Manager Team Lead - Clinical Outcome Technologies, ICON plc

Ashley leads the Clinical Outcomes Technology proposal team at ICON plc, a global clinical research organisation. Her team manages incoming RFPs and RFIs that require eCOA, rater training, wearables, sensors, cognitive batteries and other related services. The group also consults and provides insight on possible paper v. electronic solutions and offers study-specific recommendations based on industry guidelines and best practices. Ashley has been with ICON for over 3.5 years where she began in Language Services, ICON’s internal translation group that manages on average 2,000 projects a month. She transitioned to Clinical Outcomes Technology and started the proposals group over 2 years ago, which now has doubled in size and manages on average 40 proposals a month.

Ashley earned her dual-master’s degree of global innovation management from North Carolina State University, USA and IAE Aix-Marseille Graduate School of Management, France. She is also part of the RTP Young Professionals group and UNC Rex Young Professionals Group.

Sessions
Best Practices for Licensing and Translation Activities During an eCOA Study Startup


 

Ashley F. Slagle

Principal - Scientific and Regulatory Consulting, Aspen Consulting, LLC

Ashley F. Slagle provides strategic regulatory and scientific advice to drug product developers on matters related to patient focused drug development, with a particular focus on endpoints and Clinical Outcome Assessments (COAs), including patient reported outcomes (PROs), to support drug approval and labeling claims.

Dr. Slagle’s experience includes over 17 years of pharmaceutical outcomes research, policy analysis, and COA development, implementation, and analysis to evaluate treatment benefit for regulatory purposes. Previously, Dr. Slagle served as the Scientific Coordinator for the FDA/CDER Drug Development Tool (DDT) COA qualification program, where she advised instrument developers on scientific and regulatory matters related to patient-focused outcome assessments and development. In addition, she provided oversight on review and recommendations related to the development and use of patient-focused outcome assessments submitted to the FDA/CDER, and worked closely with the therapeutic review divisions across CDER to make drug product approval and labeling decisions. Dr. Slagle participated in FDA policy and guidance development and legislative activities related to study endpoints and patient-focused drug development.

Dr. Slagle has advised pharmaceutical companies on issues related to COAs, including the selection and/or development of patient reported outcome (PRO) assessments for use in clinical trials as well as related study design issues. She has participated in the design, implementation, and analysis of both qualitative and quantitative research studies, instrument modification and development, translation and linguistic validation, and migration of paper instruments to electronic platforms. She received her MS and PhD in Pharmaceutical Health Services Research from the University of Maryland, Baltimore.

Sessions
Panel: What Role Does Electronic Approaches Have in the Research of Patient-Focused Drug Development?
Panel: Leveraging Patient-Reported Outcomes in Oncology


 

Dr. Bill Byrom

VP, Product Strategy and Innovation, CRF Bracket

Bill leads product strategy and innovation at CRF 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.

  

Sessions
eCOA Forum Host

Migration Evidence to Support Use: Case Study Workshop


 

Chris Crucitti

Chief Commercial Officer, CRF Bracket

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.

  

Sessions
eCOA Forum Host


 

David Stine

David Stein

eClinical Consultant, D. Bartley Consulting

David Stein, president and owner of D. Bartley Consulting, is an eClinical Consultant with over 25 years of leadership and entrepreneurial experience ranging from successful start-ups and M&A to managing clinical technology product portfolios for large corporations.  He has specialized in bringing new products, technologies and software to the eClinical market.  He was also co-founder at President of Provenda Biometrics, an early eCOA company, which he and the partners sold to Phase Forward (now part of Oracle).  Before that, he led Data Management and Biostatistics for a CRO.  David has authored a number of articles, as well as some book chapters and is often invited to speak at conferences and events.

Sessions
Panel: Future Trends


 

Dan Debonis

Principal - Endpoint Solutions, CRF Bracket

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.dan deb

  

Sessions
Enhancing Data Quality and Rater Reliability with eClinRos


 

Dr. Emil F. Coccaro

Ellen C. Manning Professor - Department of Psychiatry & Behavioral Neuroscience, Pritzker School of Medicine at University of Chicago

Dr. Emil F. Coccaro is the Ellen C. Manning Professor in the Department of Psychiatry & Behavioral Neuroscience at the Pritzker School of Medicine, University of Chicago. He is a Distinguished Fellow of the American Psychiatric Association (APA) and a Fellow of the American College of Neuropsychopharmacology (ACNP). His work involves neurobiologic and treatment studies of impulsive aggressive behavior in humans.

Dr. Coccaro is the recipient of various awards and research grants and serves on the editorial boards of several journals. He is also the Editor of Behavioral Neuroscience Reports and has been the Impulse Control and Personality Disorders Section Editor for Current Psychiatry Reports. He is the author of more than 225 peer-reviewed journal articles, over 40 book chapters and has edited five books. He lectures widely on topics such as mood and personality disorders and the neuropsychopharmacology, genetics, and treatment of impulsive aggressive behavior.

He has a Bachelor of Science in Biology from Fordham University and his MD from New York University School of Medicine. In 1989, Dr. Coccaro moved to Philadelphia to found and direct the Clinical Neuroscience Research Unit at the MCP Hahnemann School of Medicine.

Sessions
Case Study: eCOA Version of the OAS-M


 

Jeff Lee

President - eCOA and Patient Engagement, CRF Bracket

Jeff Lee is President, eCOA and Patient Engagement, at CRF Bracket, a leading clinical trial technology and specialty services provider. Jeff joined CRF Bracket in 2017, following the acquisition of his company, mProve Health, which he founded 2010. As CEO of mProve Health, a leading provider mobile technologies for patient recruitment, engagement, and data collection in clinical research studies, Jeff grew the company globally. Today, its applications are used by 18 of the top 20 pharmaceutical companies, 15,000 clinical research sites in over 60 countries, and they are translated in over 50 languages.

Sessions
The Power of Integrated Patient Engagement


 

Jennifer Goldsack, MChem, MA, MBA, CPHQ

Patient Partnerships and Strategic Alliance Manager, monARC Bionetworks

Jen Goldsack is Patient Partnerships and Strategic Alliance Manager at monARC Bionetworks. Previously, Ms. Goldsack spent several years at the Clinical Trials Transformation Initiative (CTTI) where she led development and implementation several projects within CTTI’s Mobile Program; the MCT Novel Endpoints and MCT Mobile Devices projects.

Ms Goldsack spent five years working in research at the Hospital of the University of Pennsylvania, first in Outcomes Research in the Department of Surgery and later in the Department of Medicine. More recently, Ms Goldsack helped launch the Value Institute, a pragmatic research and innovation center embedded in a large academic medical center in Delaware. Ms Goldsack earned her master’s degree in chemistry from the University of Oxford, England, her masters in the history and sociology of medicine from the University of Pennsylvania, and her MBA from the George Washington University. Additionally, she is a certified Lean Six Sigma Green Belt and a Certified Professional in Healthcare Quality. Ms Goldsack is a retired athlete, formerly a Pan American Games Champion, Olympian and World Championship silver medalist.

Sessions
Optimizing the use of Mobile Technologies in Clinical Trials
Panel: Future Trends

 

Jill V. Platko, PhD

Senior Scientific Advisor, CRF Bracket

Dr. Jill V. Platko is a Senior Scientific Advisor and expert in electronic Clinical Outcome Assessment (eCOA) systems at CRF Bracket. She began her career in biology-based scientific research and over 16 years lead projects at institutions such as: Cornell University, Genome Therapeutics Corporation, Whitehead Institute Center for Genome Research, and Massachusetts General Hospital.

Before joining CRF Bracket Dr. Platko was an Associate Director at Covance within the Global Health Economic and Outcomes Research group for 2 years. Prior to that, she was a Senior Scientific Advisor at PHT Corporation. In these roles, she provided scientific guidance and review of clinical trial protocols to determine eCOA data collection design and project complexities. Before joining PHT in 2007, Dr. Platko served as Lead Business Analyst on the Autism Consortium Informatics Team and DNA Laboratory Manager within the Psychiatric and Neurodevelopmental Genetics Unit at Massachusetts General Hospital. In these roles, Dr. Platko was responsible for gathering and communicating data and process requirements from scientists to technologists, a practice that she continues at CRF Bracket.

Dr. Platko completed her PhD in Genetics and Development at Cornell University, and she received a BS in Biology from the State University of New York at Albany.

Sessions
Use of eCOA Metadata to Detect Fraud, Develop Risk Indices and More: Presentation and Audience Discussion


 

Joseph Kim

Senior Advisor, Patient Experience and Design Innovation, Eli Lilly

Joseph Kim serves as a Senior Advisor in Patient Experience and Design Innovation at Lilly, focusing on developing and implementing innovative patient engagement solutions. He has spent nearly 20 years in the Pharma industry utilizing a unique approach that integrates his experiences working for Sponsors such as Shire and Merck, CROs, and technology vendors. He has a robust combination of experience that includes early and late phase clinical research, and a well known history of innovation in the clinical research industry, recognized as one of “Top 100 individuals on the 2015 MedicineMakers Power List, and “20 Innovators Changing the Face of the Clinical Trials Industry” by CenterWatch in 2013.

He holds a BS in Molecular Biology from Lehigh University and an MBA from Villanova.

 

Sessions
Keynote: What does Harry Potter Have in Common with eCOA?


 

Mark Wade

Executive Director, Transperfect Life Sciences

Mark P. Wade is currently Executive Director at Transperfect Life Sciences. The largest translation company globally. Mark has held a number of Senior Management positions over a career spanning 20 years in Life Sciences. Mark was International Regional Director for EMEA at Ethicon and Ethicon Endo Surgery, a Johnson & Johnson companies (NYSE: JNJ). For almost 10 eight years Mark was Global Practice Leader at another global clinical translation company. He is a published expert of Electronic Clinical Outcomes Assessments (eCOA) including two eBooks, numerous articles and published posters at industry symposia. Mark is a regular ‘talking head’ for major trade publications for both best practice in clinical translation and Cultural Adaptation for COA instruments. He has significant experience in IMP Label translation, Patient Recruitment and Site Selection. Mark has sat on numerous boards and committees, including ISOQoL (IAC), ISPOR (Special Interest Group for Language Translation and cultural adaptation) and DIA Endpoint Study Group

Sessions
Panel: Wearables & Sensors


 

Michelle K. White, PhD

VP, Outcomes Insight Consulting and Senior Scientist, Optum

For the past ten years, Dr. White has led a team of patient-reported outcomes measurement scientists. She has conducted dozens of patient-focused studies using qualitative and quantitative research designs to evaluate treatment, understand the burden of disease and treatment, and to develop, modify, or validate surveys. She has also co-authored several survey instrument manuals. Previously, Michelle spent a decade conducting addiction treatment outcome studies and developing and implementing surveys for addiction and mental health treatment. Michelle has also held adjunct positions at Illinois State University and the University of Illinois, where she earned her master’s degree and PhD in sociology, respectively.

Sessions
Approving Library Versions of Instruments That Can be Applied, Under License, Without Further Author Approvals


 

Nikunj B. Patel, PharmD

Director, Patient Reported Outcomes (Oncology) - Global Medical Affairs, AstraZeneca

Nikunj is passionate about developing new medicines and technologies that will improve how patients feel, function, and survive. As a PRO Director, he sets and leads PRO measurement strategies in oncology TA medical product development at AstraZeneca.

Prior to AstraZeneca, Nikunj was a clinical outcome assessment (COA) reviewer at the US Food and Drug Administration where he advised pharmaceutical companies on COA measurement strategies and reviewed marketing applications (INDs, NDAs, BLAs) across TAs. While at FDA, Nikunj also led FDA scientific policy development initiatives related to patient outcomes.

Before FDA, Nikunj was a visiting scientist at Eli Lilly & Company and an adjunct professor at Butler University. He also practiced pharmacy in hospital and retail settings. Nikunj received his Doctor of Pharmacy degree from the University of Maryland Baltimore and Bachelor of Science (biochemistry) from the University of Maryland College Park.

Outside of work, Nikunj enjoys traveling, reading, and spending time with family and friends.

Sessions
Industry Perspective on FDA’s Patient-Focused Drug Development Guidance Series
Panel: What Role Does Electronic Approaches Have in the Research of Patient-Focused Drug Development?


 

Rachel Ballinger, Ph.D

Principal, ICON, plc

Rachel Ballinger is a Principal in the Patient Centred Outcomes group at ICON plc., a global clinical research organisation. Ms. Ballinger has 20 years’ experience in health and medicine-related research settings. With a background in Medical Sociology, she is interested in the ways in which people experience health and illness, communicate such understandings to one another and the basis on which decisions are made at micro and macro levels (from clinical decision-making, to clinical outcome assessments and policy formation). Since joining ICON in 2011 she has led on or been involved with the design, conduct and execution of a range of studies across disease areas, methodologies and geographies. This includes a large multi-site evaluation study of four selected performance outcome assessments in orthopaedics, about which she has presented as part of a conference workshop, been an invited speaker and has recently published in Value in Health. Ms. Ballinger is also co-author on a recent ePRO Consortium recommendations article on wearables.

Doll H, Gentile B, Bush EN, Ballinger R. Evaluation of the measurement properties of four performance outcome measures in patients with elective hip replacements, elective knee replacements, or hip fractures. Value in Health. 2018:21(9):1104-1114

Ballinger R, Kerr C, Mowbray F, Bush EN. Evaluating the Content Validity of Four Performance Outcome Measures in Patients with Elective Hip Replacements and Hip Fracture. Value in Health. 2018:21(9):1115-1123

Byrom B, Watson C, Doll H, Coons SJ, Eremenco S, Ballinger R et al. Selection of and Evidentiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO Consortium. Value in Health. 2018;21(6):631-639

Sessions
Evaluation of Measurement Properties of Selected Physical Performance Outcome Assessments: Case Study and Lessons Learned


 

Rebecca Grimes, MChem

Senior Research Associate, Patient-Centered Outcomes, Adelphi Values

Rebecca works as a Senior Research Associate with Adelphi Values UK in the Patient Centered Outcomes team and has been with the company for 2 years. In this role, Rebecca has been involved in several studies assessing the feasibility and usability of eCOAs as both patient-reported outcomes (PROs) and observer-reported outcomes (ObsRos). Additional recent work includes leading an Oncology Innovation Group developing scientific communications to evaluate measurement properties of commonly used PROs in oncology clinical trials.

Prior to this, Rebecca earned a master’s in Chemistry with Analytical Chemistry from the University of Leeds.

Sessions
Equivalency testing of a clinician administered observer-reported outcome (ObsRO) for use in Autism following migration to eCOA: Case Study


 

Serge Bodart

Senior Advisor - Outcomes Science, CRF Bracket

Mr. Bodart is currently Senior Advisor, Outcomes Science at CRF Bracket, a clinical trial technology and specialty services provider based in Wayne, PA. He leads CRF Bracket’s scientific efforts related to its Electronic Clinical Outcomes Assessment technologies.

Serge has extensive experience working in patient outcomes and new technologies. He founded SYMFO, a European based ePRO provider, with Dr. Bruno Pornel in 2000. As the Co-founder and Chief Executive Officer of Symfo, Serge has been involved in all aspects of the eCOA life cycle from concept to commercialization.

Prior to his work in eCOA, he served as a Major and helicopter pilot for over 20 years in the Air Component of the Belgian Army. He is based in Montreal, Canada and holds a master’s degree of Science in Telecommunications from the Polytechnic Division of the Royal Military Academy in Brussels, Belgium.

Sessions

Migration Evidence to Support Use: Case Study Workshop


 

Willie Muehlhausen

Chief Innovation Officer, Muehlhausen Ltd (Ireland)

Willie has been in the eCOA business since 1998, when he took his first job in the clinical trial industry. In recent years Willie led teams that conducted extensive original research in the fields of machine learning, BYOD in eCOA, Actigraphy and Wearable devices, Gamification and drug adherence systems to support decentralized Clinical Trial scenarios. Results have regularly been published and presented at industry conferences to challenge the status quo. A special focus was put on research around Bring Your Own Device (BYOD) scenarios and how BYOD will fit in with the current processes and expectations.

These efforts have been honored by his peers in the Clinical Trial industry, when Willie was recognized as a PharmaVoice100 Global Innovation Leader (2015) and when he was included in the Centerwatch Monthly´s Top 20 Innovators (2018).

  

Sessions
“BYOD or not to BYOD”, Recent Research Results and Their Implications for eCOA
Panel: Future Trends