June 12-14 2017
The Westin Boston Waterfront, Boston, US
Register before Friday, April 7 to save up to $600!

Speaker Line-Up

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Austin Speier
Director
Emerging Technologies Precision For Medicine

Austin is Director, Emerging Technologies at Precision for Medicine, where he specializes in the design and execution of to-market clinical and regulatory strategies for innovative, first-in-class medical devices, diagnostics and digital health technologies. He has over 10 years of experience supporting innovation in the life sciences and has worked on over 200 medical devices, health apps, diagnostics and therapeutics across all clinical areas, with a focus on developing a strong evidence base, managing development risk, and securing product marketing approval. His experience includes both direct support of executive management teams, as well as work with VC firms, strategic partners and other investors to evaluate business opportunities and guide portfolio companies. Professional interests include personalized medicine, mobile and digital health, synthetic biology, bioinformatics, deep learning, advanced study designs, preventative and integrated care, user experience/product design, and branding and communicating innovation.

Day One

June 13, 2017

16.15 | Panel Discussion: Collection & Reporting from Wearable Devices Cloud, in Supplementing or Replacing Standard Measures in Clinical Trial Reporting?

15.45 | Reinventing mHealth Tool Validation

Charles Wolfus
Head of Digital Health and Technology
MyoKardia

Mr. Wolfus is a biopharma digital health leader committed to applying digital technologies to better understand disease.

Day One

June 13, 2017

16.15 | Panel Discussion: Collection & Reporting from Wearable Devices Cloud, in Supplementing or Replacing Standard Measures in Clinical Trial Reporting?

Craig Lipset
Head of Clinical Innovation
Pfizer

 Craig H. Lipset is Head of Clinical Innovation within Global Product Development at Pfizer.  Craig’s team is responsible for impacting clinical research through digital tools, improving patient engagement, and novel collaborations.  He serves on the Board of Directors for the Foundation for Sarcoidosis Research, the Board of Directors for the MedStar Health Research Institute, the Operations Committee for TransCelerate BioPharma, and as a Mentor at health tech accelerator Blueprint Health.  Craig also serves on the Editorial Board for Therapeutic Innovation & Regulatory Science, and has been listed among the  PharmaVOICE most inspiring people in the life sciences, Pharmaceutical Executive’s Emerging Leaders, and AlleyWatch Who's Who in eHealth. Craig previously served as Venture Partner in Pfizer Venture Investments as well as Senior Director in Molecular Medicine within Pfizer R&D.  Prior to Pfizer he served as Associate Vice President of Program Management at Adnexus Therapeutics (acquired by Bristol-Myers Squibb), and on the founding management team for Perceptive Informatics (now part of PAREXEL International).

Day One

June 13, 2017

09.40 | Panel Discussion: Innovation, Adoption, Implementation: Infrastructure Needed to Deploy Digital Tools in Clinical Trials

09.10 | mClinical: Technology and Culture to Make Mobile Tools “Business As Usual” in Development

Daragh Ryan
mHealth Program Manager
Actelion Pharmaceuticals Ltd

Daragh Ryan is a Clinical Trials Technology Consultant with 20 years of global experience gained in mobile technologies, software development and clinical trials. He has a passion for technology and its successful implementation in business. More recently, his focus has been the assessment and implementation of mobile technology for use in clinical trials.

Day Two

June 14, 2017

10.00 | Panel Discussion: Overcoming Barriers in mHealth Adoption: Digital Data Privacy, Security & the Implications of Globalizing mHealth Trials

09.00 | Moving Beyond the Hype. Operationalizing mHealth in Pharmaceutical Sponsored Clinical Trials

David Wang
Founding CEO
Striiv

Dave has over 15 years of experience leading marketing and product planning across wearables, consumer electronics, and non-determinstic sensor processing. His prior positions include VP of Marketing at Booyah, Senior Director of Marketing at SiRF and Centrality Communications, and engineering positions at Cisco Systems and the U.C. Berkeley Wireless Research Center. Dave graduated from Stanford University with a dual M.S. degree in Electrical Engineering and Management Science and Engineering, and he received a B.S. in Electrical Engineering and Computer Science from UC Berkeley.  

Day One

June 13, 2017

13.55 | Spotlight Presentation: Upcoming Wearables for Clinical Trials that are Consumer Friendly and Clinically Validated

Elena Izmailova
Senior Director, Capabilities and Devices, R&D Informatics
Takeda Pharmaceuticals Inc

Elena has a unique background of technology innovation, scientific strategy and business management. She is a Senior Director of Devices and Novel Data Streams at Takeda Pharmaceuticals Inc., working on implementation of innovative technologies in drug development.  Elena demonstrated a consistent record of achievement in pharmaceutical industry and academic research. She successfully lead teams, improved business processes, and delivered timely, impactful results. Elena has proven herself as an agent of change adept to driving teams to high performance in the complex, cross-functional, rapidly evolving environments.   Elena joined Millennium Pharmaceuticals, Inc. in 2003 where she has led scientific teams in Inflammation and Oncology therapeutic areas, representing Translational Medicine business in late preclinical and early clinical development.  The main focus of her work was on biomarker strategies, bioanalytics and clinical implementation. Elena continued expanding Translational Medicine business after Takeda’s acquisition of Millennium, adjusting to the global operating model and late stage programs. She developed scientific and business strategies that resulted in pharmacology and biomarker data included in several INDs, biomarker studies executed in more than 50 clinical trials. Elena implemented a new, cost and resource efficient, business model for clinical biomarker development, validation and global implementation.  Later, Elena transitioned into the R&D Informatics and Data Science group where she pioneered implementation of biosensors in clinical trials, evaluation of digital technologies and establishing partnerships.   Elena holds PhD in Biology.  She completed postdoctoral trainings at Massey Cancer Center/MCV and Children’s Hospital/Harvard Medical School; she also held a visiting scientist position at Whitehead Institute, MIT.

Morning Workshops

June 12, 2017

09.00 | Workshop A: Collecting Clinical Outcome Data Remotely: Advanced Analytics for mHealth Collected Data

Day Two

June 14, 2017

10.00 | Panel Discussion: Overcoming Barriers in mHealth Adoption: Digital Data Privacy, Security & the Implications of Globalizing mHealth Trials

Faith Gunning
Associate Professor of Psychology in Psychiatry
Weill Cornell Medical College

Dr. Gunning is the Vice Chair of Psychology and Director of Neuropsychology. In addition she is a co-PI on an NIMH funded study focused on using therapeutic video games to treat cognitive and mood symptoms.

Afternoon Workshops

June 12, 2017

13.00 | Workshop C: The Role of Games and Gamification in the Future of Clinical Trials

Georgia Mitsi
Senior Director, Search & Evaluation, Digital Healthcare Initiatives
Sunovion Pharmaceuticals Inc

Georgia Mitsi is currently responsible for leading the Digital Healthcare Initiatives at Sunovion Pharmaceuticals. Prior to this role, she was the Founder and CEO of Apptomics Inc., a company that focuses on developing scientifically validated software solutions that can be incorporated into clinical trials and also in the everyday care of patients who suffer of chronic neurological conditions. She has collaborated with the majority of pharmaceuticals companies conducting health outcomes and health economics research projects while working at United BioSource. She has also worked at Humana’s Innovation Center leading research focusing on claims database analysis. She also launched a major initiative “Games for Health” with focus on paediatric population and the impact of gamification in academic performance and absenteeism in Miami-Dade county. She started her career in pharmaceutical industry as a sales representative at Boehringer Ingelheim Hellas. She holds a PhD in Medical Science, MSc at Molecular Cytogenetics and an MBA (International Business). She authored several scientific publications and two novels. She remains very involved with the start-up community and has helped as a mentor at the MIT-Enterprise Forum  (Greece).

Day Two

June 14, 2017

15.45 | The Need for Novel Endpoints in Neuroscience Clinical Trials

Gowri Murthy
Principal Scientist, Translational Medicine
Merck & Co, Inc

Gowri Murthy is a Principal Scientist at Merck, based in New Jersey. She is currently working within the Oncology Biomarker space in Translational Medicine, as well as on the core team for the Smart Trials Initiative (STI). As part of the Oncology Biomarker team, she leads an operations team to ensure the availability of biomarker specimens from clinical trials for genetic/genomic research as part of Merck’s Next Gen Sequencing initiatives. For the STI, Gowri was the Clinical Director for two capability pilots, demonstrating the use of mobile health technologies within clinical trials at Merck. The pilots included adherence technologies and sampling devices for at-home pharmacokinetic collections.  Gowri attended the University of Michigan for her Bachelor’s in Microbiology and Creighton University for her Doctor of Pharmacy and MBA.  She completed her post-doctoral fellowship at Merck in Translational Pharmacology prior to joining the company full time.  In addition, Gowri was selected for Merck’s Fellowship for Global Health and led a three month project in Delhi, India, working to scale utilization of an e-compliance device in patients treated for tuberculosis. Gowri continues to work with her Smart Trials Initiative team to drive innovation in drug development through the use of mobile health technologies.

Day One

June 13, 2017

14.05 | Mobile Health Technologies in Clinical Development: A Patient- Centric Approach

Jang-Ho Cha
Global Head Translational Medicine
Neuroscience Novartis IBR

Jang-Ho Cha joined Novartis Institute for BioMedical Research (NIBR) in 2015 as Vice President and Global Head of Translational Medicine, Neuroscience. Jang-Ho oversees early-stage clinical development in Neuroscience. Prior to Novartis, Jang-Ho was at Merck, in the departments of Clinical Pharmacology, Experimental Medicine, Late Stage Development (Neuroscience), and Discovery Medicine. Jang-Ho received his undergraduate degree at Harvard College and his MD/PhD (Neuroscience) at the University of Michigan. He completed residency in Neurology at Massachusetts General Hospital (MGH) where he remained as faculty, reaching the rank of Associate Professor at MGH and Harvard Medical School (HM. He was the course co-director for the Neurobiology of Disease course at HMS. His clinical specialties are Memory Disorders and Movement Disorders, with special attention to Huntington’s disease (HD). His NIH-supported laboratory studied molecular mechanisms of HD and made pioneering observations regarding transcriptional dysregulation in HD. Jang-Ho serves on the Scientific Advisory Board of the Hereditary Disease Foundation, Jang-Ho was one of the Huntington’s Disease Society of America’s Coalition for the Cure investigators and has served as the Chair of the HDSA Scientific Advisory Board. He currently serves as the Chairman of the HDSA Board of Trustees.

Day One

June 13, 2017

13.25 | Harnessing Big Data & Wearable Technology to Advise Clinical Readouts

Day Two

June 14, 2017

12.30 | Panel Discussion: Overcoming Barriers in mHealth Adoption: Digital Data Privacy, Security & the Implications of Globalizing mHealth Trials

Jeremy Sohn
Vice President & Head of Digital Business Development & Licensing
Novartis

Jeremy joined Novartis in 2015 as VP, Head of Digital Business Development & Licensing supporting Novartis’ Digital Medicines program. In 2016, Jeremy has also served as Global Head of Digital Development within Novartis Global Development Organization. Jeremy is a serial software entrepreneur with more than 15 years of experience founding and managing healthcare and technology companies. Prior to Novartis, Jeremy was Managing Director at MPM Capital where he led the firm's digital-health investment strategy. At MPM, Jeremy founded two companies, CentrosHealth (acquired by Clinical Ink) and TriNetX. In 2011, Jeremy co-founded GrapeVine, a software company that optimizes how organizations connect with their target communities. From 2007-2011, Jeremy was COO and VP, Strategy & Corporate Development for North Plains Systems, where he lead the company's growth and eventual sale to Accel-KKR. In 2000, he co-founded an open-source operating system company, Wasabi Systems.

Day One

June 13, 2017

09.40 | Panel Discussion: Innovation, Adoption, Implementation: Infrastructure Needed to Deploy Digital Tools in Clinical Trials

08.40 | Novartis’ Story: Overcoming Cultural Barriers to Achieve Wide Scale Organizational Adoption

Jyoti Mishra
Assistant Professor
University of California San Francisco

Dr. Mishra is a translational neuroscientist with expertise in attention, learning and brain plasticity. In her research, she has developed and implemented digital mental health technologies in both local and global community settings. Her interests lie in optimizing neurotechnologies for brain health, which target brain plasticity mechanisms and are also feasible to deploy at large scale. She has conducted clinical studies in healthy aging, children with attention deficit disorder and children with adverse early childhood experiences. Dr. Mishra’s research has been recognized by the Hellman award, Klingenstein foundation, NIH Fogarty institute, National Academies Keck Futures Initiative, amongst others.

Afternoon Workshops

June 12, 2017

13.00 | Workshop C: The Role of Games and Gamification in the Future of Clinical Trials

Lauren Bataille
Associate Director
Michael J. Fox Foundation for Parkinson’s Research

Lauren Bataille joined The Michael J. Fox Foundation in August 2015. In her role, she leads the Foundation’s strategy around mobile-technology and Parkinson’s research, including the development and implementation of new clinical studies utilizing smart phone apps and watches. Prior to joining MJFF, Lauren was the Director of Programs at Basic Health International where she managed pilot programs and clinical trials focused on cervical cancer prevention in low-resource settings. Lauren also worked at the consulting firm Global Health Strategies where she created advocacy and communications campaigns for health-focused foundations and nonprofits.

Day Two

June 14, 2017

12.30 | Panel Discussion: Overcoming Barriers in mHealth Adoption: Digital Data Privacy, Security & the Implications of Globalizing mHealth Trials

11.30 | A Collaborative Approach to End-to-End Algorithm Development and Validating Project Data for Parkinson’s Disease Research

Marc Foster
COO
Transparency Life Sciences, LLC

Marc brings 16 years of biotech and 15 years of high-tech experience to TLS. Prior to Transparency, he worked in business development for FoldRx Pharmaceuticals, where he helped craft and implement the business development strategy of the company's protein misfolding pipeline and discovery platform, leading to an acquisition by Pfizer in 2010. Marc began his biotech career working on behalf of Schrodinger in product development. Subsequently he co-founded and built Reify Corporation, developer of high-content assay systems for pre-clinical discovery and toxicology. During his high-tech career Mr. Foster held operating, co-founding, and advisory roles with numerous firms that created substantial shareholder value through acquisition or public offering, including NETBot, Apropos, and InTouch Systems. Mr. Foster holds a BS in Electrical Engineering and a BA in English from Brown University, and a MBA in Finance from The University of Chicago Booth School of Business. He served as a Research Fellow at BIDMC/Harvard Medical School in Endocrinology.

Morning Workshops

June 12, 2017

09.00 | Workshop B: Combining Crowdsourced Protocol Design & Digital Study Execution - Putting Patients & Clinicians at the Center of the Clinical Development Process

Matthew T. Roe
Professor of Medicine, Division of Cardiology – Faculty Director
Global Outcomes Commerical Megatrials Duke Clinical Research Institute (DCRI)

Dr. Matthew T. Roe received his MD degree from Duke University School of Medicine from 1989-1993 and his MHS (Masters of Health Sciences in Clinical Research) degree in 2001 from the same institution. Dr. Roe completed an Internal Medicine residency at Duke University Medical Center from 1993-1996 and a Cardiovascular Fellowship at the Cleveland Clinic Foundation from 1996-1999. Dr. Roe has served as the faculty director of the Global Outcomes Commercial Megatrials group at the DCRI since May, 2013. Dr. Roe has been the principal investigator for numerous phase II-IV cardiovascular clinical trials investigating anti-thrombotic and lipid modifying therapies for acute and chronic cardiovascular disease. Dr. Roe is the co-principal investigator of the ADAPTABLE trial (theaspirinstudy.org) which is the first, large-scale pragmatic trial being conducted in the PCORnet network.  Additionally, Dr. Roe has also served in leadership roles for observational registries focusing upon patients with acute myocardial infarction, patients undergoing percutaneous coronary intervention, and patients with familial hyperlipidemia.  

Day One

June 13, 2017

11.25 | Electronic Facilitation of Clinical Trials Using mHealth Technologies to Enhance Patient Engagement and Trial Conduct

Mohammed Ali
Director, R&D Operation Innovation Leader
Janssen Pharmaceuticals

Mohammed (Mo) Ali is currently a Director within the R&D Operations and Innovations group at J&J Pharmaceuticals. He previously served within the digital development group and Strategic Program Office at Novartis, responsible for several "E" initiatives within Digital Health. These programs aim to serve the needs of patients by creating a digital footprint and platform which would assist in the overall tracking, delivery and enrichment of their experience. He has a MS in Pharmacology from Michigan State University.

Day One

June 13, 2017

11.55 | Building in Stakeholder Perspectives To Enhance Trial Design

Patricia Areán
Professor in Psychiatry and Behavioral Sciences
University of Washington School of Medicine

PATRICIA A. AREÁN is a Professor in the Department of Psychiatry and Behavioral Sciences at University of Washington and is an international expert on effectiveness of technology based behavioral interventions for mood disorders in adults and older adults. Her work combines latest information from mobile technology, cognitive neuroscience, and implementation science in the design of interventions

Day Two

June 14, 2017

16.15 | Retaining Remote Clinical Samples

Ray Dorsey
David M. Levy Professor of Neurology; Director,
CHET University of Rochester

Dr. Ray Dorsey is the David M. Levy Professor of Neurology and Director of CHET, a center that seeks to advance knowledge and improve health through ground-breaking research, at the University of Rochester Medical Center.   Through novel applications of technology, he and his colleagues seek to enable anyone anywhere to receive care, participate in research, and benefit from therapeutic advances. Dr. Dorsey previously directed the movement disorders division and neurology telemedicine at Johns Hopkins and worked as a consultant for McKinsey & Company.  Dr. Dorsey’s research has been published in leading medical, neurology, and economic journals and has been featured on National Public Radio and in The New York Times and The Wall Street Journal.  In 2015 he was recognized as a White House “Champion for Change” for Parkinson’s disease.

Day Two

June 14, 2017

14.45 | Studies of mHealth in Clinical Trials

Rob Dicicco
VP, Clinical Innovation
GSK

Rob DiCicco is currently the Vice President of Clinical Pharmacology Sciences and Study Operations at GlaxoSmithKline. He is also the Work Stream Leader for the Common Protocol Template Project sponsored by TransCelerate BioPharma. Rob has more than 25 years of experience in clinical development in a variety of leadership positions in CRO, mid-sized and large pharmaceutical companies. He received his Doctorate of Pharmacy degree at the University of the Sciences of Philadelphia. Over the course of his career he has had a key role in the development of a number of successful new medicines. Rob’s area of expertise includes clinical pharmacology and experimental medicine, innovative clinical trial design, project management and ethics in human research.

Day One

June 13, 2017

09.40 | Panel Discussion: Innovation, Adoption, Implementation: Infrastructure Needed to Deploy Digital Tools in Clinical Trials

Day Two

June 14, 2017

09.30 | Clinical Research and the Internet of Things: Leveraging Connected Devices to Gain Patient Insight

Rosalind Picard
Professor, MIT Media Laboratory & Director of
Affective Computing Research MIT

Professor Rosalind W. Picard, Sc.D. is founder and director of the Affective Computing Research Group at the Massachusetts Institute of Technology (MIT) Media Lab, co-director of the Media Lab's Advancing Wellbeing Initiative, and faculty chair of MIT's Mind Hand Heart Initiative. She has co-founded Empatica, Inc. creating wearable sensors and analytics to improve health, and Affectiva, Inc. delivering technology to help measure and communicate emotion. Picard holds a bachelor's degree in electrical engineering with highest honors from the Georgia Institute of Technology, and master's and doctorate degrees, both in electrical engineering and computer science, from MIT. She is a top-cited computer scientist, best known for authoring the book Affective Computing, which became instrumental in starting a new field by that name. Picard also served as a founding member of the IEEE Technical Committee on Wearable Information Systems in 1998, helping launch the field of wearable computing. Picard is an active inventor and her group's inventions have been twice named to "top ten" lists, including the New York Times Magazine's Best Ideas of 2006 for their Social Cue Reader, used in autism, and 2011's Popular Science Top Ten Inventions for a Mirror that Monitors Vital Signs. Her inventions have applications in autism, epilepsy, depression, PTSD, sleep, stress, dementia, autonomic nervous system disorders, human and machine learning, health behavior change, market research, customer service, and human-robot interaction.

Day Two

June 14, 2017

12.30 | Panel Discussion: Overcoming Barriers in mHealth Adoption: Digital Data Privacy, Security & the Implications of Globalizing mHealth Trials

12.00 | Using Machine Learning to Enable the Next Generation of Mobile Health Tools

Spyros Papapetropoulos
VP & Global Head, Neurodegenerative Diseases, Movement Disorder & Clinical
Research Transformation Teva Pharmaceuticals

Spyros is a recognized researcher, an experienced biopharmaceutical and healthcare executive and a digital health expert. He is currently Vice President and Global Head of Neurodegeneration, Movement Disorders and Clinical Research Transformation at TEVA Pharmaceuticals. Prior joining TEVA he held positions of increasing responsibility at Biogen’s Experimental Neurology Unit, Allergan’s Global Medical Affairs and Pfizer’s Neuroscience Research Unit. He has filed multiple INDs and has overseen a wide spectrum of pharmaceutical development programs leading to successful regulatory filings and new product launches. He has led in-licencing efforts and corporate partnerships with profit, non-profit organizations and academic institutions. Spyros has proven people skills, is a strong leader focused on innovation, organizational excellence and efficiency. Spyros is a board-certified Neurologist and a Movement Disorders specialist trained at the University of Patras in Greece and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK. He holds appointments as Consultant with Massachusetts General Hospital and Voluntary Professor of Neurology with the University of Miami, Miller School of Medicine. Spyros’s primary academic interests remain in -omics and digital health. He has authored impactful peer-reviewed publications, book chapters, presented and chaired scientific meetings since 1998. Spyros is currently co-chairing the International Parkinson’s Disease and Movement Disorders Society’s (IPMDS) Taskforce on Technology and is a member of various US government and non-profit committees on healthcare and biomedical research innovation.

Day One

June 13, 2017

08.30 | Chairman’s Opening Remarks: Where Are We Now & A Vision for the Future

Day Two

June 14, 2017

14.15 | Re-wiring Clinical Development in CNS: Biometric Monitoring, Smart & Virtual trials

08.50 | Chairs Opening Remarks

Stella Stergiopoulos
Research Fellow
Tufts Center for the Study of Drug Development

Ms. Stella Stergiopoulos manages multi-sponsored and grant funded research projects at Tufts CSDD. She has experience conducting research on pharmaceutical industry practices and trends affecting pharmacovigilance, non-clinical drug development, pharmaceutical outsourcing practices, cycle time metrics, resource management, and protocol design. She has also been a speaker at conferences and has published articles in peer-reviewed and trade journals. Prior to joining Tufts CSDD, Ms. Stergiopoulos was a research associate at The Brattle Group and a researcher at Massachusetts General Hospital. She holds a BA from Brandeis University, and an MS and MPH from Tufts University.

Afternoon Workshops

June 12, 2017

13.00 | Workshop D: Best Practices in Assessing Clinical Trial Quality to Drive Clinical Trial Performance

Todd Townsend
Principal Investigator & Staff Fellow
FDA

Pending final approval Todd Townsend is a regulatory scientist and pharmacologist with direct experience as an academic biomedical researcher and consultant in the fields of epigenetics, cardiology, immunology, oncology and bioinformatics.  Currently a Fellow and Principal Investigator with the U.S. FDA, his recent work attempts to build innovative technologies, develop novel strategies and utilize existing resources to streamline and accelerate multiple aspects of safety assessment and clinical development protocols.  Additionally, Todd advises on data analytic strategies and policy initiatives aimed at defining the best practices for delivering positive health outcomes to patients.  Todd has won numerous awards, including a 2016 FDA Outstanding Service Award, has authored multiple peer-reviewed publications and is a frequently invited speaker for diverse professional society meetings and scientific conferences.

Day One

June 13, 2017

16.15 | Panel Discussion: Collection & Reporting from Wearable Devices Cloud, in Supplementing or Replacing Standard Measures in Clinical Trial Reporting?

15.15 | Exploring Opportunities to Address Gaps in the Regulatory Environment for mHealth Technologies