16th – 18th April, 2018

London, UK

Speakers

Expand/Collapse

Alain Bindels
Innovation Lab Director
Roche

Alain Bindels is an experienced Design Thinking facilitator, who leads an Innovation task force at Roche, supporting different business units to adopt innovation. He is interested in patient centric design of the healthcare industry, using new available technologies. He is applying the Design Thinking methodology to conduct workshops to test and implement new ways of working and new technologies. Alain Bindels is part of the Precision Medicine Group Basel Area, a local Swiss based network. He is working for more than 8 years at Roche in different roles. As Project Manager he was part of the Roche-Genentech Merger Integration team to harmonize and streamline processes across the company. He was responsible for strategic outsourcing activities in the clinical development area, for Safety, Regulatory and the Medical compliance office

Day Two

Wednesday, 18th April, 2018

14.25 | How Can Design Thinking Transform the Pharma Industry?

Alistair Stuart
Director, Clinical Projects & Digital Platforms
GlaxoSmithKline

Alistair has worked for over 16 years in Research and Development roles across the pharmaceutical and technology industries including at GlaxoSmithKline, Takeda and several start-ups focused on bringing technology solutions to healthcare. In 2015 he completed an MBA at London Business School where he gained concentrations in Marketing and Finance. It was during his time at London Business School that he discovered the nascent digital healthcare scene in London, working with an online doctor’s service, the commercial arm of Cancer Research UK and for a mHealth consultancy. He also worked with a charity working to build a voice for street children and with a low-carbon social enterprise on innovative solutions for social housing. Most recently, Alistair worked as Operations Director at uMotif, a London-based startup working with the NHS, US healthcare institutions and UK patient groups on a platform to support patients and capture patient-generated health data.

Day Two

Wednesday, 18th April, 2018

11.25 | mHealth Clinical Trials: From Potential to Performance

10.10 | Panel Discussion: Establishing Solid Framework for mHealth Implementation – Overcoming Operational Barriers, Implications & Biases

Anthea Mould
Head of AHP/Pharmacy and Continuous Improvement
NIHR Clinical Research Network

Anthea spent her early career as a practicing clinical pharmacist spending more than 15 years in Hospital, Industry and Community settings before moving into a variety of senior roles predominantly in health and research settings. Providing leadership for the communities of professional practice (outside of medicine and nursing) she sponsors or leads a wide range of projects and development initiatives to encourage professionals in stepping forward as investigators, and to lead innovative approaches to research delivery. Innovation and Improvement in healthcare has been a continued thread through Anthea’s work in translating change at scale into deliverable actions and impact. One of the pieces of work where this is taking place is the Accelerating Digital Programme for the CRN, where she is Programme Lead.  

Day One

Tuesday, 17th April, 2018

14.00 | Accelerating Digital – Overviewing the NIHR Clinical Research Network’s Endeavours To Support the Operational Embedding & Adoption of Digital Across the Research Network, NHS & Industry Partners

Day Two

Wednesday, 18th April, 2018

10.10 | Panel Discussion: Establishing Solid Framework for mHealth Implementation – Overcoming Operational Barriers, Implications & Biases

Bert Hartog
Senior Director, Janssen Clinical Innovation
Janssen Pharmaceuticals

Bert is a professional in the pharmaceutical and healthcare industry, with deep expertise in clinical operations and information technology. He holds a Masters Degree in Biomedical Sciences and a PhD in Medicine, and has broad international working experience. He is a strong networker and has learned how to master "managing the matrix". He has a strong track record of developing strategy, delivering outstanding results, implementing transformational change and coaching people for success and personal growth. Bert has worked in management positions in R&D and Clinical Operations, IT, Quality Assurance, and Project Management. He has managed diverse and global teams of up to 100 people and budgets up to 15 Mio USD. He has hands-on experience in operations management, change management, setting strategy, people development, process improvement, development and implementation of an innovation portfolio, and risk management/governance. Bert has an active interest in healthcare innovation, digital health and clinical research and development. He has a relentless focus on continuous improvement and enjoys coaching and managing people for top performance. He is a strong believer in lateral thinking and learning from people in other functions and industries. He is passionate about patient engagement in clinical trials and combining efficient clinical research with social responsibility.

Day Two

Wednesday, 18th April, 2018

15.25 | Panel Discussion: Innovation, Adoption & Implementation – What is Needed to Deploy Digital Tools in Clinical Trials

Bryan McDowell
Global Program Lead, Digital Development
Novartis

In his current role as Global Program Lead for Digital Development, Bryan continues to influence, drive and deliver on the pharma wide industry necessity for smarter, better, faster drug development and clinical trial execution. Beyond his responsibilities to provide leadership for the assessment, testing, and implementation of new technologies and methodologies into clinical trials and programs, Bryan is a thought leader and proponent for initiatives to integrate multiple technologies onto a single platform/device while continuing to push and leverage technologies that not only engage and involve patients in trials but, via decentralized trial settings, also vastly expands the reach and access of trials to more patients while in turn giving more patients access to trials and novel therapies.

Day One

Tuesday, 17th April, 2018

09.00 | Opening Keynote Panel Discussion: From Start, to Finish – How to Innovate the Conduct of Clinical Studies & Accelerate the Delivery of New Therapies to Patients with Mobile-Enabled Clinical Trials

Day Two

Wednesday, 18th April, 2018

09.30 | Decentralised Clinical Trials – Providing an Opportunity to Enable Radical Transformation in Clinical Trial Methodology

Carsten Spannhuth
Director, Clinical Project Physician
Idorsia Pharmaceuticals

Dr. Spannhuth is a psychiatrist by training. For almost twenty years, he has worked in clinical development leadership roles with a focus on neuroscience in companies like Sanofi, Novartis and - most recently - Idorsia. For some years now, he has taken on an additional role as strategic clinical lead for digital development.

Day One

Tuesday, 17th April, 2018

16.30 | Panel Discussion: Transforming the Clinical Development Paradigm With Digital Health Innovation

Charles Wolfus
VP, Digital Health & Business Operations
MyoKardia

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

Day Two

Wednesday, 18th April, 2018

13.25 | Presenting Digital Health Data from Substudy of PIONEER-HCM – a Case-study on Wearables & Machine Learning

10.10 | Panel Discussion: Establishing Solid Framework for mHealth Implementation – Overcoming Operational Barriers, Implications & Biases

Daragh Ryan
Clinical Trials Technology Consultant
Actelion Pharmaceuticals

Daragh Ryan is a Clinical Trials Technology Consultant with 20 years of global experience in mobile technologies and clinical research. He has a passion for implementing technology to help drive disease understanding and accelerate drug development. Currently, he is engaged in defining and implementing mobile health strategy at Actelion Pharmaceuticals in Switzerland, has a clinical trial consultancy business specializing in mobile health, is the co-founder Cureous, a new open-research health platform to enable high-powered research, and is a member of the board of the eClinical Forum.

Day One

Tuesday, 17th April, 2018

17.15 | Chair’s Closing Remarks

08.45 | Chair’s Opening Remarks

Day Two

Wednesday, 18th April, 2018

16.10 | Chair’s Closing Remarks

11.55 | The Road to mHealth: Observations, Insights & Expectations

08.50 | Chair’s Opening Remarks

David Goren
Strategic Consultant
Epione Strategy, Ltd.

David is a seasoned pharma executive with extensive experience in strategy, establishing new life science businesses, and most recently specializing in digital health. David has held various senior sales and marketing positions in the pharmaceutical industry since 1991. David is currently a strategy consultant to big pharma and start-ups with a focus in life sciences and digital. He recently left AstraZeneca (after 10 years) as VP Digital Health Strategy. David established AstraZeneca Israel in 2007, and served as Company President until 2014, when he led the global HR Transformation program. Prior to that, in 2011, David led AstraZeneca’s global initiative to revise the policy for ethical interactions with customers and partners. In 1997, David also created Pfizer’s Israel operation and became the CEO and General Manager of Pfizer Israel. David returned to Pfizer US Headquarters in 2004 to lead the Worldwide Strategy and Business Development Group. Prior to being in Israel, David served in various senior sales and marketing roles. David has an MBA from Columbia University, a Bachelors in Biology from Clark University, and has attended Harvard, MIT and INSEAD Executive Management Programs. David has served on various boards including the Raanana Symphonette Orchestra, Kids Kicking Cancer and the Business Ethics Center of Jerusalem.

Day One

Tuesday, 17th April, 2018

16.30 | Panel Discussion: Transforming the Clinical Development Paradigm With Digital Health Innovation

Derek Stewart
Associate Director - Patient & Public Involvement
NIHR Clinical Research Network

Born too many years ago in Ayr, Scotland I was treated successfully for throat cancer in 1995.  A former teacher I became involved in numerous aspects of patient involvement and advocacy at a local, regional and national level being the founder Chair of the Consumer Liaison Group for the National Cancer Research Institute. From 2005-2010 I became a Trustee and Vice Chair of onCoreUK , the National Cancer Tissue Resource a joint charity with Department of Health and Cancer Research UK.  In 2008 I was asked to become the lay patient Chair of the UK Confederation of Cancer Biobanks,which helped establish good working principles, shared learning and agreeing standard operating procedures. Currently I am the Associate Director for Patient & Public Involvement and Engagement at the National Institute for Health Research - Clinical Research Network (NIHR CRN) for England. I have recently been asked to become an interim Director of the NIHR Nottingham Biomedical Research Centre which include the local Bioresource. In the charity sector I am a Member of Cancer Research UK and a director at Derek C Stewart Associates Ltd.

Day One

Tuesday, 17th April, 2018

16.30 | Panel Discussion: Transforming the Clinical Development Paradigm With Digital Health Innovation

16.00 | Promoting the Patient as a Partner & Not a Subject of the Study

Hilde Vanaken
Director, Janssen Clinical Innovation
Janssen Pharmaceuticals

Hilde is a Director of the Janssen Clinical Innovation department at Janssen. She has more than 16 years of experience in pharmaceutical companies and Clinical Research Organizations, where she held various leading positions in clinical operations, data management, safety management, professional affairs, quality management, strategic business improvement and clinical trial innovation. Prior to clinical research, Hilde worked as a research scientist for 6 years. Hilde has a passion for complex and mission impossible projects and has a track record to transform them into success stories. In her current role, Hilde laid the foundation of several transformational projects, such as eConsent, eSource and Integrated Smart Trial and Engagement Program (iSTEP), to modernize Janssen’s clinical trials and improve the experience of patients and investigators. Next to her role in Janssen, Hilde also leads the cross-pharma Transcelerate eConsent initiative to facilitate the cross-industry adoption of eConsent in close collaboration with external stakeholders such as patients, sites, IEC/IRBs and HAs. Hilde holds a degree in Engineering in Chemical and Agricultural Sciences, a Master in Environmental Sciences and a PhD in Medical Sciences, all from the Catholic University of Leuven in Belgium.

Day Two

Wednesday, 18th April, 2018

13.55 | Value Creation Through Collaboration: Smart Technologies Implemented in a Phase II Clinical Trial

Jess Radcliffe
Improvement and Programme Manager
NIHR Clinical Research Network

Jess Radcliffe is Improvement and Programme Manager at the Clinical Research Network. With a strong personal commitment to improvement, she is passionate about the transformative potential of digital within the NIHR and wider NHS, managing the CRN’s Accelerating Digital programme. Jess also supports the development of future leaders in clinical research, as part of the faculty for the Advanced Leadership Programme.  

Day One

Tuesday, 17th April, 2018

14.00 | Accelerating Digital – Overviewing the NIHR Clinical Research Network’s Endeavours To Support the Operational Embedding & Adoption of Digital Across the Research Network, NHS & Industry Partners

Kai Langel
Director, R&D Operations Innovation
Janssen Pharmaceuticals

Since 2000, Kai has been a pioneer in patient-facing solutions for clinical trials working with young innovative technology companies. In 2012, Kai co-founded eClinicalHealth, the developers of the Clinpal remote clinical trial platform. Through his involvement in technical, operational and scientific roles, he has gained an in-depth understanding of all aspects of the patient journey in clinical trials from recruitment and engagement through data capture. Kai is a Director in the Janssen Clinical Innovation group, working within the digital health team delivering scalable solutions for digital transformation of clinical trials. In his role, Kai leads digital health innovation projects, focusing on decentralized and remote trial methods, remote patient monitoring and digital data capture and endpoints.

Day One

Tuesday, 17th April, 2018

09.00 | Opening Keynote Panel Discussion: From Start, to Finish – How to Innovate the Conduct of Clinical Studies & Accelerate the Delivery of New Therapies to Patients with Mobile-Enabled Clinical Trials

Day Two

Wednesday, 18th April, 2018

09.00 | Discussing the Current State of Decentralised / Remote Clinical Trial Methods

Lucien Rapp
Senior Consultant
Watson Farley & Williams

Lucien specialises in regulatory and contract issues, administrative & public law and competition and anti-trust matters. He advises clients in the telecommunications, media, technology, public utilities, space and aviation sectors in particular. Lucien has acted as legal consultant to the Commission of the European Communities, and to the United Nations (I.L.O; World Bank; W.H.O.) and he continues to act as an expert / specialist adviser for the International Telecommunications Union (ITU). In addition, Lucien is a member of the Arbitration Commission of the International Chamber of Commerce and is listed by them as an expert in this domain. He has been appointed as an arbitrator in several international disputes. Lucien, who is regularly named among the world’s leading experts in communications and regulatory law, has received several distinctions including the prestigious Légion d’Honneur.

Luigi Visani
President & CEO
Exom Group

Luigi Visani is a cardiologist who has spent more than 30 years in clinical drug development, first as Director of Clinical Research at Boerhinger Ingelheim Italy and then, as owner of an European based CRO, Hyperphar Research, later Pierrel Research. In 2014 he has been the Founder and CEO of Exom Group, the first digital technology driven CRO . During his long professional career he has always been striving for the introduction of technological and innovative solutions to improve the clinical operations processes and the study data quality.

Day One

Tuesday, 17th April, 2018

10.15 | The Cloud & Mobile Clinical Trial: the Experience of an European Digital CRO

Michelle Longmire
CEO
Medable

Dr. Longmire is currently the Chief Executive Officer at Medable. She is a Stanford-trained physician-entrepreneur dedicated to transforming healthcare through innovation. Dr. Longmire has a background in epigenetics, novel diagnostics, and imaging. She has published over 20 peer reviewed articles and holds patents in machine learning as applied to mobile health applications. Dr. Longmire's vision is to enable health technology to be as adaptive, seamless, and integrated as the human body.

Day Two

Wednesday, 18th April, 2018

10.00 | Patient Generated Data & the Human Digitome in Clinical Trials

Mikael Eliasson
Global Head, Strategic Innovation
Roche

Mikael wants to live in a world filled with innovations that keep people healthy and provide him time to indulge in the art and science of cooking, endurance sports, and galaxy hitchhiking. As a healthcare innovator and strategist with more than 20 years of experience, Mikael has traveled (figuratively) the healthcare value chain and (literally) the world in search for innovative opportunities.  He is educated as a molecular scientist and neurosurgeon (Harvard/Johns Hopkins) and has worked for Brigham and Women’s Hospital, Boston Children's Hospital, Novartis, General Electric, Amgen, Boston Scientific, Aetna, Partner's Health Care, Monitor Ventures, Aditya Birla Group, Jubilant, Shanghai-Pudong Government, Ostersund’s Municipal Home Care Services and more in search of disruptive innovation. On this journey, he has helped create a handful of multi-billion dollar businesses that improve people's health. Mikael has now arrived at Roche as the AI Global Head of Strategic Innovation for Product Development where he continues to explore uncharted territories to make things happen.  

Day One

Tuesday, 17th April, 2018

09.45 | Going Digital – Accelerating Clinical Development

09.00 | Opening Keynote Panel Discussion: From Start, to Finish – How to Innovate the Conduct of Clinical Studies & Accelerate the Delivery of New Therapies to Patients with Mobile-Enabled Clinical Trials

Myriam Cohen
Clinical Sciences Operations - Alliance & Partners Leader
Sanofi

After a Master degree in Pharmacotechny, Myriam Cohen joined Parexel in 1998 in Clinical Operations to integrate a newly created service in Clinical Research, ‘Data & Medical Surveillance’ at Paris. After 4 years of increasing responsibilities, she integrated Sanofi, first in Data Management, then participated actively to Trial Operations re-organization while managing both international teams & projects delivery. In 2012, she was then proposed to be in charge of the office of the Clinical Sciences & Operations (CSO) Deputy Head of Sanofi to facilitate the interactions between the functions within the CSO platform and lead strategic initiatives. Today, for 3 years, she is CSO Alliance & Partners Leader, responsible for ensuring optimal functioning between the Clinical Sciences Operations at Sanofi R&D the Services providers/ partners for clinical operations activities. Her primary focus is on phase II-IV strategic relationships and governance. In charge of developing and implementing strong & consistent governance through different partnerships, she also ensure promotion of best practices & tools to enable excellent interfaces between Sanofi functions, and, in parallel, with the CRO partners in order to meet the common goals.

Day Two

Wednesday, 18th April, 2018

15.25 | Panel Discussion: Innovation, Adoption & Implementation – What is Needed to Deploy Digital Tools in Clinical Trials

Philipp Hespe
Managing Consultant
PA Consulting

Mr. Philipp Hespe is part of PA’s Life Science sector and co-leading PA’s Regulation & Compliance service proposition. He helps organizations to drive cost and risk out of their organizations while enabling them to respond nimbly to emerging local and global regulations, e.g. in the areas of GxP and data protection. Mr. Hespe believes that quality approaches should serve as a catalyst to improve business performance beyond compliance and foster innovation. Prior to PA, Mr. Hespe worked for a world-leading life science company acting in senior quality leadership roles. He has been an Associate Professor at Swiss Universities of Applied Science and held lectures for risk management and compliance. He holds a MS in natural sciences from the ETH Zurich and a MS in economics from the University of St. Gall.

Seleen Ong
Clinical Sciences Group Lead & Clinical Program Lead for Clinical Trial Innovation
Pfizer

Seleen is a Clinical Sciences Group Lead and Clinical Program Lead for Clinical Trial Innovation at Pfizer. She manages a team of Clinical Scientists responsible for designing and delivering late phase clinical trials for Pfizer whilst also providing strategic leadership for Pfizer’s Clinical Trial Innovation initiatives.  During her 7 years at Pfizer she also served as the European Digital Medicine Medical Director and held various positions in European Medical Affairs supporting Pfizer’s cardiovascular products. Seleen qualified in Medicine from King’s College London and attained her Membership of the Royal of College of Physicians (UK) in 2006 whilst working in the NHS, before joining Pfizer in 2007. She is a Fellow of the Faculty of Pharmaceutical Medicine in the UK.

Day One

Tuesday, 17th April, 2018

16.30 | Panel Discussion: Transforming the Clinical Development Paradigm With Digital Health Innovation

11.45 | Right Patient, Right Trial – Leveraging Technology For Recruitment, Enrolment & Consent in Clinical Trials

Shiyan Caan
Marketing & Business Development Coordinator
SQN Clinical

Shiyan Caan has been heavily involved in the development of SQN’s recent innovative technology. With a degree in Psychology, Shiyan approaches patient centricity from a cognitive perspective, understanding what is required both for compliance and for patient engagement. With a drive to improve clinical research through innovation, he works alongside the SQN management team to ensure that SQN remain at the forefront of this evolving paradigm.

Day One

Tuesday, 17th April, 2018

12.45 | Elevating Patients to the Centre of Clinical Research - an Innovative Approach

Tim Cave
VP - Head Strategic Planning & Digital Practices, Global Medical Affairs
GlaxoSmithKline

Tim Cave is VP, Medical Affairs Strategic Planning & Digital Practices at GSK, where he has been leading the Medical digital transformation. He trained in medicine at St Thomas’s Hospital Medical School and then after working in surgery in the UK he completed a Fellowship at Boston University USA.  He has 25 years experience in pharmaceutical medical affairs.  Before taking up his current position, he was UK Medical Director for Novartis and has been a Medical Assessor at the Medicines and Healthcare products Regulatory Agency (Dept of Health).  He represents the pharmaceutical industry on the UK Clinical Research Collaboration Board which is led by the Chief Medical Officer and aims to improve the UK clinical research environment.  

Day One

Tuesday, 17th April, 2018

12.15 | Promoting the Patient as a Partner & Not a Subject of the Study