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Key Sessions

Stephane Garelli

KEYNOTE: The world in reset mode: The new world competitiveness landscape and its impact on the pharmaceutical industry

IMD Business School in Lausanne and University of Lausanne, Switzerland

Professor Kenneth Getz

KEYNOTE: New data and insights characterizing the changing CRO landscape and its role in integrating clinical research with clinical care

CSDD, Tufts University School of Medicine, USA

James Teo

KEYNOTE: Informed consent and participant engagement in the age of digital platforms

Kings College Hospital NHS Foundation Trust, UK

Daisy Daeschler

KEYNOTE: Experiences and lessons learned from conducting global mHealth enabled trials

The Michael J Fox Foundation, USA

Michael Mihut

KEYNOTE: Assessing the value of partnerships

World Health Organization, Switzerland

Marc Koska

INSPIRATIONAL: For decades, Marc Koska OBE fought to stop the reuse of syringes

Founder "LifeSaver", UK

Nov 28
Show Filter
07:30 - 08:50

Registration and morning coffee

Showing of Streams
10:20 - 10:55

Morning networking break

10:55 - 11:00
Opening remarks from the chairperson

Opening remarks from the chairperson

  • Symposium ECD- Science in Early Phase David Jones - Expert Pharmaco-Toxicologist, Clinical trials Unit, MHRA
  • Stream 1 Partnerships and Collaboration Raphaele Mary - Director, Capability and Strategy, Central Clinical Planning & Solutions, Global Clinical Operations, Bristol Myers Squibb, France
  • Stream 2 Investigator and Industry Paul Quinn - VP - Clinical Operations, Vectura Limited, a member of the Vectura Group of companies, UK
  • Stream 3 Mobile eHealth Nicole Powell - Director Business Development, SDC, USA
  • Stream 4 Governance, Oversight and Quality Estrella Garcia - Director Global Clinical Operations, R&D, Almirall, Spain
  • Symposium ECD -Operational Strategies Stephen Harrison, - GSK Associate Fellow, Clinical Program Lead, Clinical Pharmacology Study Science and Operations UK, GSK
more
Showing of Streams
12:30 - 14:00

Lunch and networking break

Lunchtime activities

  • Exhibition hall viewing




more
Showing of Streams
15:10 - 16:00

Afternoon Tea Break

Showing of Streams
17:10 - 17:15
Move to plenary room

Move to plenary room

Showing of Streams
07:30 - 08:50 80 mins
Registration and morning coffee
08:50 - 09:00 10 mins
PLENARY
Opening remarks from the chairperson
  • Anna Matranga - Strategic Sourcing R&D, Consultant, AMC Alliances & Consulting, France
more
09:00 - 09:40 40 mins
PLENARY
KEYNOTE: The world in reset mode: The new world competitiveness landscape and its impact on the pharmaceutical industry
  • Stephane Garelli - Professor of competitiveness (nations and enterprises),, IMD Business School in Lausanne and University of Lausanne, Switzerland
more
  • BREXIT and Trump- what impact this will have on the European and Global landscape of clinical research?
  • Skepticism about globalisation increases the complexity of managing enterprises globally.
  • Governments’ debt, escalating social expenses, low or negative yields, new international taxation rules, extensive compliance and market consolidation heavily impact on business prospects and confidence levels.
  • Many positive developments exist such as new players and new brands from emerging economies, new market segments and new technology-driven business models.
  • Competitiveness will also be a question of mindset. The management of efficiency, change, and complexity remain top priorities. A mindset of imagination (why not?), of energy (why not now?) and of commitment (why not me?) will also be decisive. How?
09:40 - 10:20 40 mins
PLENARY
The partnership landscape - New partnerships, new innovations, new processes
  • Moderator Phil Hammmond, GP and Broadcaster, UK
  • Sheryl Jacobs - Vice President, Global Development Operations, Amgen Inc, USA
  • Barbara Voith - Vice President, Head Global CS Operations,, Bayer HealthCare, Germany
  • Hanne Lang - Vice President, Clinical Systems and Data Management, NovoNordisk, Denmark
  • Emma Dean - Medical Science Director, Early Clinical Development, AstraZeneca, UK
  • Bryan Katz - Managing Director of Consulting, INC Research/inVentiv Health, USA
more
  • News flash over the 12 months: significant changes and news from the panels perspective
  • Industry’s and CRO’s greatest challenges and exploring the next generation of future collaborations that will be needed
  • Partnerships – are we seeing any new trends across industry when it comes to partnering strategy?
  • Across industry harmonisations: How can partnerships benefit from more standardization? Where is the competitive advantage?
  • CRO involvement with the world of ‘virtual trials’ - what is their role and will it evolve moving forward?
10:20 - 10:55 35 mins
Morning networking break
10:55 - 11:00 5 mins
Opening remarks from the chairperson
  • Symposium ECD- Science in Early Phase David Jones - Expert Pharmaco-Toxicologist, Clinical trials Unit, MHRA
  • Stream 1 Partnerships and Collaboration Raphaele Mary - Director, Capability and Strategy, Central Clinical Planning & Solutions, Global Clinical Operations, Bristol Myers Squibb, France
  • Stream 2 Investigator and Industry Paul Quinn - VP - Clinical Operations, Vectura Limited, a member of the Vectura Group of companies, UK
  • Stream 3 Mobile eHealth Nicole Powell - Director Business Development, SDC, USA
  • Stream 4 Governance, Oversight and Quality Estrella Garcia - Director Global Clinical Operations, R&D, Almirall, Spain
  • Symposium ECD -Operational Strategies Stephen Harrison, - GSK Associate Fellow, Clinical Program Lead, Clinical Pharmacology Study Science and Operations UK, GSK
more
11:00 - 11:30 30 mins
STREAM 1: Partnerships and Collaboration
KEYNOTE: New data and insights characterizing the changing CRO landscape and its role in integrating clinical research with clinical care
  • Professor Kenneth Getz - Director and Associate Professor, CSDD, Tufts University School of Medicine, USA
more
  • Overview of drug development enterprise trends and the necessity to move into clinical care
  • Insights into CRO segment strategies and their role in supporting the evolution of the drug development enterprise
  • Review of data characterizing structural CRO landscape changes
  • Profiles of innovative transactions redefining the positioning of major CROs
  • Discussion of patient engagement technologies and solutions supporting landscape evolution
11:00 - 11:30 30 mins
STREAM 2: Investigator and Industry How Can They Work Together?
Long term collaborations within a study program
  • Peter Van Der Ark - Clinical Research Manager, Experimental Medicine Neuroscience, Janssen – Pharmaceutical Companies of J&J, Belgium
more
  • Site collaboration instead of project contracts
  • Harmonisation of contracts, training and procedures
  • Roles in clinical research. The investigator investigates, the recruiter recruits and the coordinator completes documents.
  • Statistical rationale; why is it better to have 10 sites recruiting 10 subjects versus 50 sites recruiting 2 subjects
11:00 - 11:30 30 mins
STREAM 3: Mobile eHealth
Using patients own devices to capture quality of life and other health data
  • Bruce Hellman - CEO, uMotif, UK
more
  • the rise in patients tracking their own health data
  • use of validated mobile platforms to capture study-specific health data
  • engaging participants throughout studies
  • opportunities for direct-to-patient site-less studies
  • new forms of eCOA / ePRO data capture
  • combining smartphones, wearables and sensor data for new insight
11:00 - 11:30 30 mins
STREAM 4: Governance, Oversight and Quality
The Northern Health Science Alliance and application of real world data for clinical research.
  • Hakim Yadi - OBE, Chief Executive Officer,, Northern Health Science Alliance, UK
more

The Northern Health Science Alliance (NHSA) is a front door to the North of England’s health research ecosystem. As a partnership established by the leading Universities and NHS Hospital Trusts in the North of England the NHSA provides a portal to its internationally recognised health science excellence. We work across a population of 15 million bringing together research, health science innovation and commercialisation. The NHSA works directly with commercial partners to provide access to researchers, universities, hospitals and leading health research institutions. The NHSA is a focal point for our members and partner organisations to work collaboratively on projects that leverage the combined potential of the North.  Our 20 members, including four Academic Health Networks, work as one to harness the resources, infrastructure, intellectual capital and experience of the whole ecosystem. This session will include:

1) The scale and clinical research potential of the North of England.

2) Scaling up the potential of real world data, going beyond the Salford Lung Study

 3) Transforming health and social care with real-world insight, the potential for next generation real world studies

11:00 - 11:30 30 mins
SYMPOSIUM: Clinical Trial Supply
Exploring latest status and timelines of the EU Clinical Trial Regulation (CTR) and implications for industry
  • Cristiana Spontoni - Partner, JONES DAY®, Belgium
more
  • Understanding the EU CTR and implications for industry
  • Reviewing the timelines
  • Overcoming key challenges with CTR implementation
11:00 - 11:30 30 mins
SYMPOSIUM: Early Clinical Development: Science in Early Phase
Dual Dialogue: Examining the impact of the FIH guideline update: Sponsor experience
  • Sam Hariry - Head of Clinical Strategy, Novartis
  • Jeroen Bos - Global Therapeutic Area Lead - Drug Regulatory Affairs, Novartis, Switzerland
more
  • First in human studies in Novartis

–             General considerations and country selection

–             Evolving from Single part to Multi-part studies

–             Healthy volunteer versus patient FIH studies 

–             Timelines

  • First in human guideline update

–             Novartis participation in public debate

–             Some themes of focus: sentinel dosing, maximal dose and results required prior to escalation

–             Case studies on recurring themes

  • Horizon: going forward with conduct of first in human studies
11:00 - 11:30 30 mins
SYMPOSIUM: Early Clinical Development: Operational Strategies
Adapting to the new landscape for early clinical development: where are we now?
  • Muna Kugler - Associate Director, GCO Group Leader, Clinical Development Operations, Actelion
  • Marc Hoffman - Chief Medical Officer, Celerion
  • Emma Dean - Medical Science Director, Early Clinical Development, AstraZeneca, UK
more
  • Adapting to more complex early clinical studies
  • Biomarkers
  • Pricing and reimbursement
  • Segmenting patients and personalised healthcare
  • Examining the increasing use of patient cohorts in early clinical development
  • Innovation in trial management and data collection


11:30 - 12:00 30 mins
STREAM 1: Partnerships and Collaboration
Developing a risk and reward based clinical outsourcing strategy - “make or buy “process for the optimal definition of the outsourcing strategy
  • Ms Lidia Cappellina - Head of Outsourcing Management, Chiesi, Italy
more
  • Current Drug Development framework
  • The “Make or Buy” decision in context
  • Key process steps
  • Core competencies analysis
  • Risk analysis
  • Costs and Resources analysis
  • Risks and rewards of your outsourcing strategy
11:30 - 12:00 30 mins
STREAM 2: Investigator and Industry How Can They Work Together?
The importance of patient retention - recruit to retain
  • Ms Kate O’Brien - Study Nurse, Albany House Medical Centre, UK
  • Amanda Perry - Research Practitioner, Albany House Medical Centre, UK
more
  • Importance of a thorough informed consent
  • What motivates patients to take part in Clinical Trials
  • What motivates patients to remain in a trial if IMP is discontinued
  • Patient incentives
11:30 - 12:00 30 mins
STREAM 3: Mobile eHealth
Lessons learned: mHealth for biopharma
  • Vanessa Reddy - Strategic Innovation Leader, Roche, Switzerland
more
  • Overview of digital and mobile health uses cases in drug development
  • Deep dive on patient education and symptoms management projects
  • Summary of lessons learned in designing and implementing mHealth initiatives
11:30 - 12:00 30 mins
STREAM 4: Governance, Oversight and Quality
Using regulatory inspection trend data to optimize vendor qualification and management programs
  • Jennifer Emerson - Consultant,, Emerson Consulting & Clinical Research Services, Germany
more
  • What are the most significant and relevant trends in the regulatory inspection data for Vendor qualification and management?
  • What changes to Vendor qualification processes are needed to address the identified risks in the regulatory inspection trend data?
  • How can analysis of regulatory inspection trend data guide companies toward a more targeted use of their resources when it comes to Vendor management?
  • What are some best practices to address the risks identified from regulatory inspection trend data?
  • How can Sponsors ensure that their Vendor qualification and management programs are addressing the most important risks?

   

11:30 - 12:00 30 mins
SYMPOSIUM: Clinical Trial Supply
Combined strengths: How partnership in transport and packaging leads to reduced temperature deviations and cost for IMP supplies
  • Roland Schütze - Director Healthcare, Marketing International, TNT, The Netherlands
  • Marcel Walraven - Product Manager Healthcare, TNT, The Netherlands
  • Christopher Storch - Global Head of Sales, va-Q-tec Group, Germany
more
  • Re-usable packaging is a trend. The industry needs reliable systems and a guaranteed return process;
  • va-Q-tec and TNT developed an all in one solution, delivering high quality and lowering cost;
  • What are benefits and challenges of such a solution?
  • Why is partnership important?
11:30 - 12:00 30 mins
SYMPOSIUM: Early Clinical Development: Science in Early Phase
An update on the FIH guideline: Where are we now?
  • David Jones - Expert Pharmaco-Toxicologist, Clinical trials Unit, MHRA
  • Jeroen Bos - Global Therapeutic Area Lead - Drug Regulatory Affairs, Novartis, Switzerland
  • Kirsty Wydenbach - Senior Medical Assessor and Deputy Unit Manager, Clinical Trials Unit, Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Jan Willem van der Laan - Senior Pharmacological-Toxicological Assessor, Medicines Evaluation Board
  • Sam Hariry - Head of Clinical Strategy, Novartis
more
  • Assessing the extent to which the FIH guideline update is focused on HVs vs. patients
  • FIH guideline update: is it fit for purpose?
  • Examining the outcome of the whitepaper
  • Oncology and the FIH guideline update
  • Non-clinical data to support FIH: more emphasis on pharmacology
  • How will the FiH guideline impact how studies are design in the future?
11:30 - 12:00 30 mins
SYMPOSIUM: Early Clinical Development: Operational Strategies
How to operate in different contract models
  • Ms Dorte Pedersen - Senior Outsourcing Manager, Lundbeck, Denmark
more
12:00 - 12:30 30 mins
STREAM 1: Partnerships and Collaboration
A partnership/collaboration from Bayer through setting up and implementing a global FSP strategy on a local level
  • Gill Roberts - Strategic Sourcing, Global BP R&D Services, Medical Affairs & Commercialisation, Bayer AG, UK
  • Keith Francis - Strategic Alliance Management, Global Clinical Development Operations,, Bayer AG, UK
  • Chris Eastwood - Director of Clinical Operations, PRA Health Sciences, UK
  • Kish Khan - Senior Director, Strategic Development, Strategic Solutions,, PRA Health Sciences, UK
more
12:00 - 12:30 30 mins
STREAM 2: Investigator and Industry How Can They Work Together?
Cost savings realised with an integrated budget to payments solution
  • Viviënne van de Walle - Director,, VivMedical - Life Science Consulting, The Netherlands
  • Ruth Wessendorff - Senior Director, Finance, INC Research/inVentiv Health, UK
  • Joe Robbins - Senior Manager, Global Clinical Pricing, Amgen, UK
  • Moderator Michael Hughes - Medidata, Solutions, USA
more
  • Investigator Payment challenges realised by each stakeholder (sites, CROs and Sponsors)
  • How each stakeholder can benefit from a true end-to-end budget to payment solution
  • Process cycle time reduction
  • Manual or duplicate data entry elimination
  • Support for visit and procedure based negotiations and payments
  • Traceability and reporting clarity with one data stream between budget negotiation, EDC and payment
  • Auditable, real-time tracking of accrued costs against the budget schedule
  • On-demand funding to eliminate cash escrow account
12:00 - 12:30 30 mins
STREAM 3: Mobile eHealth
Innovation Den
  • Moderator Ms Julianne Hull - CEO, WenStar Enterprizes, UK
  • Dominique Demolle - Chief Executive Officer,, Tools 4 Patient, Belgium
  • Jonas Billing - Co-Founder, Trialbee, Sweden
more
  • What are the advances of technology and for supporting the patient?
  • Using technology for patient recruitment
  • Using technology to improve the patient outcome
  • New technology systems to review and monitor data – companies provide these solutions.

Hear 3 x Sponsored Talks at 10mins


Characterization of individual patient placebo response: Positive impact on clinical trial results

  • Placebo effect in clinical research problem statement
  • Development of methodologies to predict individual patient placebo response score (IPPRS)
  • Deployment of these methodologies in clinical research and analysis of and control for IPPRS 
  • Demonstrated impact on clinical study power, Type II error, and sample size
  • Potential positive impact on therapeutic development time and cost

Dominique Demolle, Chief Executive Officer, Tools 4 Patient, Belgium    


Digital transformation of clinical research

  • Pivot to patient - Meeting the needs of patient-consumer behaviour
  • Holistic End-to-End solutions -Integrate new technology across the value chain
  • Embrace digitalization -Extract full value from digital solutions

Jonas Billing, Co-Founder, Trialbee, Sweden


12:00 - 12:30 30 mins
STREAM 4: Governance, Oversight and Quality
The EU Clinical Trials Regulation: Are you prepared for its implementation?
  • Panellist Dr Martine Dehlinger-Kremer - Vice President, Global Medical and Regulatory Affairs, SynteractHCR, USA
more
  • How the evolving needs within the industry drive momentum towards the implementation of the regulation?
  • What are its key changes and challenges?
  • What is the impact to your organisation?
  • What are the changes you can start to make now to be ready?
  • How are both Sponsors and CROs preparing?
  • What impact will this have on vendor relationships?
  • Where does the responsibility reside for regulatory submission, with the Sponsor or the CRO?
12:00 - 12:30 30 mins
SYMPOSIUM: Clinical Trial Supply
Q&A Session: A chance for any questions from the morning session
12:00 - 12:30 30 mins
SYMPOSIUM: Early Clinical Development: Science in Early Phase
FIH Cannabis Trial: Overview of the pharmacokinetic and pharmacodynamic results from single- and multi-ascending doses of dried cannabis delivered by smoking/inhalation
  • Marc Lefebvre - Vice President Scientific and Regulatory Affairs, Altasciences Clinical Research
more
  • Does this fixed THC and Cannabidiol dose format provide adequate information for future therapeutic use?
12:00 - 12:30 30 mins
SYMPOSIUM: Early Clinical Development: Operational Strategies
What’s HAP-pening: A Current Primer in the Assessment of Human Abuse Potential
  • Ryan Turncliff - Senior Director, Global Scientific Affairs, PRA
more
  •  Overview of the latest regulatory guidance
  • Human Abuse Potential Study Design elements including selection of positive controls in HAP and identifying the subject population
  • Two case studies: evaluation of a stimulant and an abuse deterrent formulation


12:30 - 14:00 90 mins
Lunch and networking break
more

Lunchtime activities

  • Exhibition hall viewing




14:00 - 14:30 30 mins
STREAM 1: Partnerships and Collaboration
Eli Lilly and Covance clinical pharmacology: A partnership that has existed for more than 10 years
  • Ms Tamzin Blagbrough - Sourcing Consultant, Clinical Pharmacology Study Delivery Solutions, Eli Lilly & Co Ltd, UK
  • Dave Simpson - Executive Director, Clinical Pharmacology Services, Covance, UK
more
  • Historical review of how the partnership started
  • Success of the partnership (including some key metrics)
  • Issue management and challenges
  • What makes this a unique relationship
  • Why is this successful Lilly and Covance point of view?
  • Potential for the future
14:00 - 14:30 30 mins
STREAM 3: Mobile eHealth
KEYNOTE: Experiences and lessons learned from conducting global mHealth enabled trials
  • Daisy Daeschler - Research Partnerships Officer, The Michael J Fox Foundation, USA
  • Marjan Faber - Senior Research Fellow in Patient Participation for Quality Improvement in Health Care,, Radboud University Medical Center, Netherlands
more
  • Through a collaboration between The Michael J. Fox Foundation (US), Radboud University Medical Center (Netherlands) and Intel Corporation (Israel), a mobile application with a paired wearable device was developed to collect data from the daily lives of people with Parkinson’s disease.
  • Multiple longitudinal, observational studies have utilized this platform, including trials in the US and the Netherlands.
  • The focus of these trials vary from assessing the feasibility of using this platform in large populations over long periods of time to assessing wearable sensor data utility in clinical care management.
  • Additional studies have also explored the utility of remote monitoring tools for PD patients’ disease management.
  • This presentation will discuss findings, lessons learned, and key take aways from these efforts.
14:00 - 14:30 30 mins
STREAM 4: Governance, Oversight and Quality
Implementation of a global governance structure to manage and oversee SOPs/training distribution to global and local external partners
  • Oliver Fink - Head Global QM Systems & Operations, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
more
  • Performing a gap analysis
  • Identify and define standards for services incl. global and local SOPs/trainings
  • How to manage distribution to >200 vendors?
  • Using a risk based approach, but increasing quality and compliance
  • What are the expectations from the regulators regarding: - Timeliness of provision of training - Handling of new hires at the vendor - Oversight on vendor training implementation
  • Use of external access to LMS and DMS vs. “manual” distribution
  • Reduction of internal administration efforts àfocus on content related processes
  • Outsourcing of administrative SOP distribution tasks to support SOP/training distribution to vendor
14:00 - 14:30 30 mins
SYMPOSIUM: Early Clinical Development: Science in Early Phase
Translation of animals to humans: business as usual?
  • Liesbeth Heijink - Scientific Director, Astellas Pharma
more
  • Prediction of human efficacy, off target pharmacology and adverse effects
  • Animals are not small humans


14:00 - 14:30 30 mins
SYMPOSIUM: Early Clinical Development: Operational Strategies
Choosing the right CRO with the right sites for your early clinical study
  • Lorraine Rusch - President, High Point Clinical Trials Center, usa
more
  • Finding a CRO that has experience of using patients in their early clinical studies - do you know if the site you’ve chosen can produce the patients?
  • Establishing what’s important for early development: Multiple sites, standard PK sampling and having patients overnight
  • Niche providers or generalist? What are the opportunities and limitations?
  • The changing nature of early clinical studies – how does this impact CRO/sponsor relationships?


14:00 - 15:00 60 mins
SYMPOSIUM: Clinical Trial Supply
INTERACTIVE ROUND TABLE DISCUSSION: Discussing the challenges of and technology to monitor patient compliance
  • Nina Cianfanelli Svennum - Clinical Supply Specialist, H. Lundbeck A/S, Denmark
more
  • What technology is available and what are people using to enhance or monitor patient compliance?
  • What are the key challenges that have been faced with patient compliance?
  • How have these challenges been overcome?
14:30 - 15:10 40 mins
STREAM 1: Partnerships and Collaboration
Are partnerships living up to what they promised in terms of cost, efficiency and service quality?
  • Ms Julianne Hull - CEO, WenStar Enterprizes, UK
  • Nicole Jansen - Senior Outsourcing and Contract Manager,, Grunenthal GmbH, Germany
  • Ms Isabelle Naeije - Clinical Trial Head, GDO Trial Management Oncology, Novartis Pharma AG, Switzerland
  • Birgitte Sogaard - Divisional Director – Clinical and Quantitative Pharmacology, H Lundbeck AS, Denmark
  • Arjan Ooms - Clinical Research Manager, MSD, The Netherlands
  • Bryan Katz - Managing Director of Consulting, INC Research/inVentiv Health, USA
more
  • What is a typical Partnership in the 21st Century?
  • How to improve transparency between CRO and sponsors: How to align systems, avoid duplicating work and manage mergers and acquisitions
  • Delivering a clinical trial? Do we both have the same goal – CRO-Pharma? How can we improve
  • What are the cultural difference between CRO and Pharma? How do you bridge these cultural differences?
  • Why partnerships don’t always work: Why did it fail and what could have been done to avoid this?
  • What type of communication is needed to get the best of the partnership?
  • Vendor oversight and expectations to degree of outsourcing.
  • Examples of partnerships that survived challenging times and how this was done
14:30 - 15:10 40 mins
STREAM 2: Investigator and Industry How Can They Work Together?
Recruitment from the perspective of an investigative Site – pitfalls and strategies
  • Philipp Badorrek, - Head of Department,, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Germany
  • Bettina Bergtholdt - Chief Executive Officer, Emovis GmbH, Germany
  • Ms Helena Sigal - Managing Director, Sigal Site Management and Support, Germany
  • Diana Sims-Silbermann - Senior Trial Manager, Early Development and Clinical Pharmacology,, Janssen-Cilag GmbH, Johnson & Johnson, Germany
  • Ms Joana Claverol - Clinical Research Unit Manager, Barcelona Children’s Hospital Sant Joan de Déu, Spain
  • Hans van Dijk - Chief Operating Officer, Julius Clinical, The Netherlands
  • Moderator Fraser Inglis - Consultant Physician & Director,, Glasgow Memory Clinic, UK
more
  • Recruitment Feasibility Process from CRO/Sponsor: Why are recruitment estimates so often incorrect?
  • Importance of feedback opportunities to In/Ex in the feasibility process
  • Recruitment strategies for sites with pros/cons - patient database, advertisements (newspaper, radio, web), social media, referrals from other doctors (hospitals, private practices)
  • Importance of an open discussion about state of recruitment with CROs/Sponsors
  • Problems in recruitments and especially the reasons should be discussed early on and without hesitation.
14:30 - 14:50 20 mins
STREAM 3: Mobile eHealth
Putting IoT to work for caregivers in clinical trials with 3G-enabled medical devices.
  • Patrick Murray - Quality Assurance and Control Manager, Medisanté AG, The Netherlands
more

Moving away from Bluetooth connected devices to intelligent connected care

  • The current trend of eHealth and fitness devices is to use mobile apps for connecting consumers to their health data. Unfortunately, this patient-generated health data is not readily available to the caregivers. At Medisanté, we are focused on making it easy for patients and caregivers to share data and react in a timely manner using 3G-enabled medical devices and a powerful software interface. For stage 3 and 4 of clinical trials, this technology will allow researchers to have real-time information about patient vital signs such as blood glucose levels, blood pressure, body weight, body composition, and ECG recordings without requiring the patient to visit the hospital or clinic.
  • This presentation will describe the requirements for moving from an era of consumer-driven Bluetooth devices to the next generation of a caregiver-driven, medical-grade connected care service that puts IoT to work for caregivers in clinical trials. There is no better way to implement and scale the tele-monitoring of patients and properly support clinical trials.
14:30 - 15:10 40 mins
STREAM 4: Governance, Oversight and Quality
Focus on operational risk based approaches to oversight and quality management with the new ICH E6R2 guidelines - How to interpret this and how are companies dealing with it?
  • Moderator Patricia Leuchten - President & Chief Executive Officer,, Avoca Group, USA
  • Hayley Jewell - Regional Director Clinical Operations,, Eli Lilly, USA
  • Geoff Taylor - Director, Clinical Quality Assurance,, Eisai Product Creation Systems, UK
  • Mr Michael Zörer - Head of Clinical Operations, AOP Orphan Pharmaceuticals AG, Austria
  • Van Zyl Engelbrecht - Director, Clinical Research,, UBC, UK
  • Melissa Bomben - Vice President, Global Alliance Management, Strategic Resourcing, INC Research/inVentiv Health, USA
more
  • What do you do to achieve FFP (fit for purpose) affective sponsor, CRO and third party oversight in light of the ICH E6 and what does it look like?
  • Evaluate whether the perceptions of quality in outsourced trials has improved or declined. This data will be a catalyst for the discussion.
  • How should we as an industry interpret and put into actions what is in the guidelines?
  • How are companies approaching risk management both from a pharm and CRO perspective?
  • Do they fill equipped to be able to deliver- skill set, tools and capabilities?
  • What is the dynamics between sponsor and CRO: How well do they work together?
  • How are people looking at risk when selecting vendors?
  • How do they ensure that they are working with oversight?
  • How do they regulate the oversight? What do they look for in audits?
  • How do you maximise the value and effectiveness of governance and achieving the balance of oversight between a sponsor and a CRO?
14:30 - 15:00 30 mins
SYMPOSIUM: Early Clinical Development: Science in Early Phase
Safety assessment during early phase development
  • Gezim Lahu - Senior Director and Global Head of Pharmacometrics, Takeda Pharmaceuticals
more
  • How to transfer knowledge from non-clinical studies into the design for clinical studies
  • Biomarker in FiH/ early patient studies supporting safety assessment and dose-escalation decision
  • Dose selection in FiH-studies: from starting dose to maximum dose – and dose schedule “in-between”


 

14:30 - 15:00 30 mins
SYMPOSIUM: Early Clinical Development: Operational Strategies
Towards greater use of collaboration between industry and academia to expedite early clinical development
  • Wolfgang Eglmeier - Head Centre for Clinical Studies, Witten/Herdecke University
more
  • Examining the need for earlier access to patients in drug development
  • How might collaboration between industry and academia help get compounds into development?
  • The obstacles for such a collaboration and how to overcome those
  • Risk assessing industry academic partnerships
  • How can industry/academic partnerships help to offer targeted therapies? (personalised/stratified medicine)
14:50 - 15:10 20 mins
STREAM 3: Mobile eHealth
Sponsored Talk TBC
more

Sponsored Speaking Slot Available

Please contact: Alexander Zenonos +44 (0) 207 017 7742

Alexander.zenonos2@knect365.com

15:10 - 16:00 50 mins
Afternoon Tea Break
16:00 - 16:30 30 mins
STREAM 4: Governance, Oversight and Quality
Vendor oversight, challenges and regulatory frameworks
  • Christian Langelueddecke - Global Clinical Operations Vendor Manager,, Boehringer Ingelheim RCV GmbH & Co KG, Germany
more
  • Vendor oversight scope due to regulations
  • Regulatory derived oversight challenges
  • Development of vendor oversight principles
  • Translation into governance
  • Exemplary fictional case discussion
16:00 - 16:30 30 mins
STREAM 3: Mobile eHealth
Supercharging clinical trials - utilising longitudinal linked patient level data to improve the commercial and academic research environment in the NHS
  • Shirlene Oh - Senior Director, Imperial College Health Partners, UK
  • Ian Riley - Director of Business Intelligence, North West London Collaboration of CCG’s, UK
more
  • North West London is building the first Consent to Contact database in England that will significantly reduce the costs of running clinical trials
  • It will consent patients once enabling repeat feasibility studies and sits on top of the largest longitudinal linked data in the UK bringing together EPR systems from primary, secondary, and community care as well as some social care and prescribing data.
  • There is significant interest from academia and industry to work with this data and we are also exploring how to link into user generated data e.g. from smartphones
16:00 - 16:30 30 mins
STREAM 2: Investigator and Industry How Can They Work Together?
Future of investigator and industry collaboration
  • Panellist Mr Mark Turner - Chair, European Network of Paediatric Research, European Medicines Agency and Liverpool University, UK
more
  • Collaboration will reduce costs and promote quality through:
  • Improved understanding of natural history and realistic feasibility assessments, particularly for stratified medicines and rare diseases
  • Standardised procedures and shared infrastructures
  • Early involvement in the design of trials and planning implementation
  • The enthusiasm among regulators to engage with research networks
16:00 - 16:30 30 mins
STREAM 1: Partnerships and Collaboration
KEYNOTE: Assessing the value of partnerships
  • Michael Mihut - Portfolio Management Officer, The Special Programme for Research and Training in Tropical Diseases, World Health Organization, Switzerland
more
  • Partnerships in the context of globalisation and SDGs
  • Are partnerships evaluable?
  • Value for money and value for people
16:00 - 16:30 30 mins
SYMPOSIUM: Clinical Trial Supply
Exploring the practicalities of Investigator initiated trials (IIT) and clinical trial supply chain considerations
  • Samantha Carmichael - Lead Pharmacist Clinical Trials / R&D, NHS Greater Glasgow & Clyde, UK
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  • Outlining different strategies for managing the clinical trial supply chain for IIT
  • Reviewing the practicalities of IIT storage and sites
  • Establishing a robust sponsor/investigator relationship during IIT and ensuring clear communication channels
  • Best practice for handling drugs, ancillary products and hardware during IIT
16:00 - 16:30 30 mins
SYMPOSIUM: Early Clinical Development: Science in Early Phase
An update on the clinical trial regulation: Regulatory authority feedback
  • Lene Grejs Petersen - Senior Adviser, Danish Medicines Agency
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  • The latest on the Clinical Trial Regulation: how should industry prepare for implementation?
  • When will the Clinical Trial Regulation be implemented?
  • What will the impact be on early development?
  • What are the opportunities and threats to early medicines development?
  • How will the UK implement? What impact will Brexit have?


 

 

16:00 - 16:30 30 mins
SYMPOSIUM: Early Clinical Development: Operational Strategies
Automating early phase clinical trials in an evolving technology landscape
  • Duncan Kemp - Executive Director of UK Operations, Development, OmniComm Systems, Inc., UK
more
16:30 - 17:10 40 mins
STREAM 4: Governance, Oversight and Quality
Assessing the performance of oversight and governance models: How much is enough?
  • Marco Salami - Head of Clinical Outsourcing Management,, Chiesi Farmaceutici SpA, Italy
  • Barbara Voith - Vice President, Head Global CS Operations,, Bayer HealthCare, Germany
  • Mary Mueller - Vice President Strategic Alliance Management, ICON, USA
  • Patricia Moenaert - AD, Portfolio Sourcing and Relationship Management (PSRM), Celgene Intl, Switzerland
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  • Matching the right model with the size of your company and outsourcing strategy
  • How do you define what is the right level of oversight?
  • What can you gain by assigning the right resources vs inappropriate resources?
  • Which specific tools have worked best for fulfilling the sponsors requirements and obligations?
16:30 - 17:10 40 mins
STREAM 3: Mobile eHealth
What are the quality, regulatory and privacy implications from acquiring data from wearables and smartphones
  • Nadir Ammour, - Head Patients & Partner Management,, Sanofi, France
  • Michel Arnoult - Chairman,, Arnoult.org, France
  • Frits Lekkerkerker - Chairman at the Research Ethics Committees in Netherlands,, Medical Ethical Testing Committee (METC) Twente, The Netherlands
  • Peter Coe - Founder,, Tudor Reilly, UK
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  • What is the level of accuracy and validation that is needed to use this data?
  • Overcoming the lack of regulatory guidelines at the moment- what is needed in clinical trial and does it fit my needs?
  • What are the implications for improved consent – from a quality point of view?
  • What are the issues with data security?
  • Sponsor responsibilities- what should they be looking for when qualifying the mhealth providers?
  • How do you maintain inspection readiness?
  • What should the monitors be looking for to be sure about the quality of the data?
16:30 - 17:10 40 mins
STREAM 2: Investigator and Industry How Can They Work Together?
Site support- How to drive down administration whilst ensuring compliance
  • Tim Lee - Director, European Cystic Fibrosis Society Clinical Trial Network, Leeds Children's Hospital, UK
  • Viviënne van de Walle - Director,, VivMedical - Life Science Consulting, The Netherlands
  • Lesley Mathews - Global Development - Portfolio & Operations, Resource Management & System Integration,, Bayer Healthcare, UK
  • Donato Bonifazi - Chief Executive Officer, Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF), Project Coordinator, EPTRI – European Paediatric Translational Research Infrastructure, Italy
  • Moderator Ms Jeannett Dimsits - Senior Director, Trial Management Anchor, NovoNordisk, Denmark
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  • Every company entering new systems, implementing e systems- how to design the systems so they are value adding to the sites team- plan or requirement
  • How to design training for sites to use electronic equipment and devices, in a way that is appealing and time conscious
  • Site initiation visit- send someone who can explain and train in the use of the electronic devices- connections work- programme
  • Raising invoices and receiving payments- the pain of time consuming and error prune site payment process, is automation the solution?
16:30 - 17:10 40 mins
STREAM 1: Partnerships and Collaboration
Defining the resourcing strategy and the end to end process for vendor management
  • Anne Merritt - Director, R&D Supplier Governance and Clinical Pricing,, Amgen, UK
  • Dr Stephen Walker - Outsourcing Programme Director, AstraZeneca, UK
  • Laurent Zecchinon - Strategic Partners & Resourcing Strategy Manager,, GlaxoSmithKline Vaccines, Belgium
  • Dr MaryAnne Rizk - Global Vice President, CRO & Biopharma Business Partnerships & Alliances, Oracle, USA
  • Mark Scullion - SVP, Strategic Resourcing,, INC Research/inVentiv Health, USA
  • Klaus Peter Kammerer - Head of Vendor Management/Knowledge Management/QC, Boehringer Ingelheim GmbH, Germany
  • Chris Hamilton - Chief Commercial Officer, CROS NT, UK
more
  • How to select the right type of service that you want to outsource
  • What are the strengths and weaknesses of the main service models - FSO (Full Service Outsourcing) versus FSP (Full Service Provider)
  • How to qualify vendors and ensure they deliver on what they promise
  • How to define and implement the right oversight (including performance measurement)
  • How to manage multiple vendors
  • What makes a good performance measures and how do you assess quality?
  • How can you check up front whether a CRO can deliver on what they promise?
16:30 - 17:10 40 mins
SYMPOSIUM: Clinical Trial Supply
Clinical pharmacy perspective: Cooperation with industry at early stages of clinical trial supply and working successfully with partners
  • Marija Tubic Grozdanis - Lead Pharmacist Clinical Trials, University Medical Center of the Johannes Gutenberg University Mainz, Germany
more
  • Interpreting the clinical pharmacy perspective
  • Cooperating with industry at early stages of clinical trial supply
  • Working successfully with partners
16:30 - 17:00 30 mins
SYMPOSIUM: Early Clinical Development: Operational Strategies
Examining outsourcing models in early clinical development: What are the challenges and opportunities?
  • Birgitte Sogaard - Divisional Director – Clinical and Quantitative Pharmacology, H Lundbeck AS, Denmark
  • Moderator John Gate - European Procurement Executive, Elanco, UK
  • Wolfgang Eglmeier - Head Centre for Clinical Studies, Witten/Herdecke University
  • Kieran Canisius - Managing Partner, Suess Consult, The Netherlands
more
  • How much early clinical work should be outsourced?
  • Understanding the cost saving associated with outsourcing
  • Establishing a preferred list of sites for early phase work and maintaining a close relationship with the sites
  • Which model should you use? What are the limitations and opportunities?
  • Improving communication between sponsor and CRO: defining the parameters and highlighting where to focus
  • Why should we do it internally?
  • Overcoming the challenge of privacy breaches and inadvertent un-blinding
  • Contracts and budgets – what are the issues?
  • Data sets: What are the challenges and how can they be overcome? Internal issues and external requirements
17:10 - 17:15 5 mins
Move to plenary room
17:15 - 17:25 10 mins
PLENARY
The lifetime achievement award
  • Chair Graham Belgrave - Independent Clinical Research, Consultant
more

Do you have a colleague who has achieved great things in their career? Have you worked with someone who you think has revolutionised the field of clinical trials? 

The PCT Lifetime Achievement Award in association with mdgroup recognizes such pioneers and we are now taking nominations for the 2017 prize to be presented at Partnerships in Clinical Trials Europe in November.

About the Award

Now in its third year, the prestigious award went to Jean Edwards, Procurement Director for Europe, Australia & Japan at Eli Lilly, last year. Back in 2015, it was Professor Kenneth Getz who took the inaugural prize for his work as Director and Associate Professor at Tufts Center for the Study of Drug Development.

Once the submission period closes, nominations will be reviewed by the PCT Advisory Committee who will choose a winner based on the span and scope of the nominees’ careers as well as any additional awards or honours received.


17:25 - 18:00 35 mins
PLENARY
INSPIRATIONAL: For decades, Marc Koska OBE fought to stop the reuse of syringes
  • Marc Koska - OBE, Founder "LifeSaver", UK
more

For decades, Marc Koska OBE fought to stop the reuse of syringes. One of the most impressive and inspirational entrepreneurs in the world, Marc faced and broke down bureaucratic barriers to fight one of the most virulent contributors to the spread of AIDS, with his non-retractable syringe, which was endorsed by the World Health Organisation in 2015. Marc's prolific work is truly inspirational and uplifting.