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09:00 - 09:40 40 mins
Main agenda
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
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  • BREXIT and Trump- what impact this will have on the European and Global landscape of clinical research?
  • Skepticism about globalization 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 - 10:40 60 mins
Main agenda
Panel: The Partnership Landscape - New partnerships, new innovations, new processes
  • Phil Hammmond, GP and Broadcaster
  • Sheryl Jacobs, - Vice President Global Site Operations,, Amgen Inc,
  • Barbara Voith, - Vice President, Head Global CS Operations,, Bayer HealthCare, Germany
  • Bryan Katz - Managing Director of Consulting, INC Research/inVentiv Health, USA
  • Emma Dean - Medical Science Director, Early Clinical Development, AstraZeneca, UK
  • Hanne Lang - Vice President, Clinical Systems and Data Management, NovoNordisk, Denmark
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  • News flash over the 12 months: significant changes and news from the panels perspective
  • What updates can you share with industry? New partnerships, new innovations, new processes, new challenges- what has changed over the past 12 months?
  • Industry’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?     
10:55 - 11:00 5 mins
STREAM 1: Science in Early Phase
Chairperson's Opening Remarks
  • Mr David Jones - Expert Pharmaco-Toxicologist, Clinical trials Unit, MHRA, UK
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10:55 - 11:00 5 mins
STREAM 2: Operational Strategies
Opening remarks from the chairperson
  • Stephen Harrison, - GSK Associate Fellow, Clinical Program Lead, Clinical Pharmacology Study Science and Operations UK, GSK
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11:00 - 11:30 30 mins
STREAM 1: Science in Early Phase
Dual Dialogue: Examining the impact of the FIH guideline update: Sponsor experience
  • Sam Hariry - Head of Clinical Strategy, Novartis, Switzerland
  • Jeroen Bos - Global Therapeutic Area Lead - Drug Regulatory Affairs, Novartis, Switzerland
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  • 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
STREAM 2: Operational Strategies
PANEL DISCUSSION: Adapting to the new landscape for early clinical development: where are we now?
  • Muna Kugler - Strategic Sourcing Manager, Global Operations, Idorsia Pharmaceuticals, Switzerland
  • Marc Hoffman - Chief Medical Officer, Celerion
  • Emma Dean - Medical Science Director, Early Clinical Development, AstraZeneca, UK
  • Moderator Wolfgang Eglmeier - Head Centre for Clinical Studies, Witten/Herdecke University, Germany
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  • 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 - 12:05 35 mins
STREAM 1: Science in Early Phase
PANEL DISCUSSION. An update on the FIH guideline: Where are we now?
  • Jan Villem van der Laan - Senior Pharmacological-Toxicological Assessor, Medicines Evaluation Board, Netherlands
  • Mr David Jones - Expert Pharmaco-Toxicologist, Clinical trials Unit, MHRA, UK
  • Jeroen Bos - Global Therapeutic Area Lead - Drug Regulatory Affairs, Novartis, Switzerland
  • Kirsty Wydenbach - Senior Medical Assessor and Deputy Unit Manager, Clinical Trials Unit, MHRA, UK
  • Sam Hariry - Head of Clinical Strategy, Novartis, Switzerland
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  • 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 - 12:05 35 mins
STREAM 2: Operational Strategies
How to operate in different contract models
  • Dorte Pedersen - Senior Outsourcing Manager, Lundbeck
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12:00 - 12:30 30 mins
STREAM 1: 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, US
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  • Does this fixed THC and Cannabidiol dose format provide adequate information for future therapeutic use?


12:00 - 12:30 30 mins
STREAM 2: Operational Strategies
What’s HAP-pening: A Current Primer in the Assessment of Human Abuse Potential
  • Ryan Turncliff - Senior Director, Global Scientific Affairs, PRA, US
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  • 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 - 13:55 85 mins
Main agenda
Networking lunch
14:00 - 14:30 30 mins
STREAM 1: Science in Early Phase
Translation of animals to humans: business as usual?
  • Anja Slikkerveer - Scientific Director Translational Science, Astellas Pharma, Netherlands
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  • Prediction of human efficacy, off target pharmacology and adverse effects
  • Animals are not small humans
14:00 - 14:30 30 mins
STREAM 2: Operational Strategies
Choosing the right CRO with the right sites for your early clinical study
  • Lorraine Rusch - President, High Point Clinical Trials Center, US
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14:30 - 15:00 30 mins
STREAM 1: Science in Early Phase
Safety assessment during early phase development
  • Gezim Lahu - Senior Director and Global Head of Pharmacometrics, Takeda Pharmaceuticals, Germany
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  • 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
STREAM 2: 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, Germany
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  • 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)
15:00 - 16:00 60 mins
Main agenda
Afternoon networking refreshments
16:00 - 16:30 30 mins
STREAM 1: Science in Early Phase
How to mitigate risks and uncertainties identified in the preclinical setting in a first in human protocol
  • Ann Marie Janson Lang - Expert, Clinical Trials and Special Permissions, MPA, Sweden
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16:00 - 16:30 30 mins
STREAM 2: Operational Strategies
Automating early phase clinical trials in an evolving technology landscape
  • Duncan Kemp - Executive Director of UK Operations, Development, OmniComm Systems, Inc., UK
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16:30 - 17:00 30 mins
STREAM 1: Science in Early Phase
An update on the clinical trial regulation: Regulatory authority feedback
  • Lene Grejs Petersen - Senior Adviser, Danish Medicines Agency, Denmark
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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?


 

16:30 - 17:00 30 mins
STREAM 2: Operational Strategies
PANEL DISCUSSION: 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
  • Wolfgang Eglmeier - Head Centre for Clinical Studies, Witten/Herdecke University, Germany
  • Birgitte Sogaard - Divisional Director – Clinical and Quantitative Pharmacology, H Lundbeck AS, Denmark
  • Kieran Canisius - Managing Partner, Suess Consult, The Netherlands
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  • 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
17:15 - 17:20 5 mins
Main agenda
The lifetime achievement and innovation den awards
17:20 - 18:00 40 mins
Main agenda
INSPIRATIONAL: For decades, Marc Koska OBE fought to stop the reuse of syringes
  • Marc Koska - OBE, Founder "LifeSaver"
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