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Nov 28
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07:30 - 08:50

Registration and morning coffee

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Showing of Streams
10:40 - 11:25

Morning coffee and networking

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Showing of Streams
Showing of Streams
15:30 - 16:00

Afternoon Break

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Showing of Streams
Showing of Streams
18:30 - 21:00
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PCT Masquerade Party

Grab a drink and enjoy the festivities at the well-renowned PCT Party taking place this year at Sala Comillas (Barcelona Maritime Museum). Plus, get some fun snaps of you and your colleagues in the PCT Party Photo Booth sponsored by DrugDev! Open for all participants.

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07:30 - 08:50 80 mins
Registration and morning coffee
08:50 - 09:00 10 mins
OPENING PLENARY
Opening remarks from the chairperson
  • Bruce Hellman - CEO, Co-Founder, uMotif, UK
09:00 - 09:40 40 mins
OPENING PLENARY
PATIENT’S AND DOCTORS JOINT STORY: Doctor and Patient working together to form OurBrainBank
  • Jessica Morris - Founder and Chair, OurBrainBank, SVP and Partner, FleishmanHillard, USA
  • Dr. Alexis Demopoulos - Director, Neuro-oncology, Northwell Health System, USA
09:00 - 09:10 10 mins
EARLY CLINICAL DEVELOPMENT
Chairperson Opening Remarks
  • Anna Matranga, PhD, MBA, CA-AM - Strategic Sourcing R&D, Consultant, AMC Alliances and Consulting
09:10 - 09:40 30 mins
Info
EARLY CLINICAL DEVELOPMENT
Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products
  • Dr. Maria Beatrice Panico - Medical Assessor, Clinical Trials Unit, Medicines and Healthcare Products Regulatory Agency, UK
  • Scope and background of the guidance
  • Main aspects
  • Dosing selection
  • Planning and conducting first-in-human and early clinical phase trials
09:40 - 10:40 60 mins
Info
OPENING PLENARY
PANEL: How to manage different goals of sponsor, CRO, Patients, Regulators and Investigators
  • Moderator Dr. David Bull - English Doctor, Television Host, Entrepreneur, David Bull, UK
  • Nicholas Brooke - Founder and Executive Director, PFMD (Patient Focused Medicines Development) and The Synergist, Belgium
  • Richard Stephens - Chair of the National Cancer Research Institute's Consumer Forum, NCRI, UK
  • Richard FitzGerald - Consultant Physician and Director, Clinical Research Unit, Royal Liverpool University Hospital, UK
  • Lewis Cameron - Head of Global Clinical Development, Covance
  • Paul MacDonald - Director, Solutions Consulting EMEA, Medidata
  • Jane Winter - SVP Strategic Alliance Management, Syneos Health
  • Optimizing the future of clinical trials
  • How can we achieve this goal for everyone?
  • Representing the patient in study design, planning and conduct
  • What are the tensions?
  • How to overcome the challenges?
  • What do patients (and the public) want from trials generally
  • What do participants want from their own trials and how can patients (or the public) help themselves and those running the trials
09:40 - 10:10 30 mins
Info
EARLY CLINICAL DEVELOPMENT
FiH Industry Perspective: First experiences with the new First in Human guideline
  • Henrik Forsman - Director Scientific Project Management, AstraZeneca, Sweden
  • Experiences on the impact on progression speed of early phase studies
  • Case examples of managing risk in FiH studies
  • Discussion of operational challenges related to the FiH guideline and how to overcome
  • Does the guideline have a positive effect on early phase clinical trials?
10:10 - 10:40 30 mins
Info
EARLY CLINICAL DEVELOPMENT
Role of PK/PD Modeling in supporting design of FIH-trials of high risk molecules
  • Dr. Youssef Hijazi - Expert Clinical Pharmacokinetics, Sanofi-Aventis, Germany
  • Recently, two tragic events in FIH trials have occurred: with TGN1412 in March 2006 and with BIA-10-2474 in January 2016, which have triggered enormous discussions and reform in the approaches used for FIH
  • Integration of all available in vitro and in vivo pharmacology findings and data on drug-target binding through PK/PD modelling can be used for staring dose selection.
  • The MABEL approach can support FIH design for high risk biologics e.g. agonist antibodies or bispecifics
  • PK/PD modelling can be useful to predict duration of drug action for drugs with covalent binding to target, where a disconnect between PK and PD exists, which could mitigate safety risks that might occur with molecules of similar nature to BIA-10-2474
  • The utility of two PK/PD modelling approaches will be presented
10:40 - 11:25 45 mins
Morning coffee and networking
11:25 - 11:30 5 mins
STREAM 1: Partnerships & Collaboration
Opening remarks from the Chairperson
  • Estrella García - Director Global Clinical Operations, R&D, Almirall, Spain
11:25 - 11:30 5 mins
STREAM 2: Patients as Partners
Opening remarks from the Chairperson
  • Nicholas Brooke - Founder and Executive Director, PFMD (Patient Focused Medicines Development) and The Synergist, Belgium
11:25 - 11:30 5 mins
STREAM 3: Mobile Health & Wearables
Opening remarks from the Chairperson
  • Nicole Powell - Director Business Development, SDC
11:25 - 11:30 5 mins
STREAM 4: Governance, Quality, Oversight, Risk Management & RBM
Opening remarks from the Chairperson
  • Paul Bouten - Managing Director, PharmCMed
11:25 - 11:30 5 mins
STREAM 5: Investigator & Industry Partnerships
Opening remarks from the Chairperson
  • Viviënne van de Walle - Director PT&R – clinical research site, VivMedical - Life Science Consulting, Netherlands
11:30 - 12:00 30 mins
STREAM 1: Partnerships & Collaboration
JOINT PRESENTATION: Vendor selection for sponsors – how to utilise the Request for Proposal (RFP) data to achieve the best partner
  • Lara Silverstein - Operations Director,, Avillion, UK
  • Kieran Canisius - Co-Founder, Suess Consulting, The Netherlands
11:30 - 12:00 30 mins
Info
STREAM 2: Patients as Partners
PATIENTS STORY: 'Partners in research': Why patients should be part of the entire research process from bench to clinic - Insights from my personal journey through Parkinson’s research
  • Benjamin Stecher - Education Consultant, Writer and Parkinson's Disease Patient Advocate, Parkinson’s Research Advocacy Group, Canada
  • The pace of novel advances seems to be slowed down by a system that cannot move fast enough to keep up with our own neurodegeneration
  • The “average PD patient” is a statistical construct rather than a physical entity
  • Too often, these clinical trials seem to be conducted to support new patents rather than patients
  • As a first step towards ameliorating these problems, patients should become part of the clinical trial design process. Rather than just being told which hoops to jump through they should be recognized as partners in research
  • We need patient-scientist teams to work together to maximize the likelihood that studies are designed in a way that will ultimately best inform patient and clinician treatment decisions
11:30 - 12:00 30 mins
Info
STREAM 3: Mobile Health & Wearables
CASE STUDIES: "Ready Participant One": The patient-centric Clinical Trial of the future
  • Bruce Hellman - CEO, Co-Founder, uMotif, UK
  • Informed consent: Patients need to know what’s expected
  • Data ownership: Trust and balance across all partners
  • Data capture: Combination of a range of sources
  • And this future is now - case studies from across the industry
11:30 - 12:00 30 mins
Info
STREAM 4: Governance, Quality, Oversight, Risk Management & RBM
CASE STUDY: Exploring the transformation in clinical trials using the Risk Based Monitoring
  • Isabelle Naëije - Associate Global Trial Director, GDO Trial Management Oncology, Novartis Pharma AG, Switzerland
  • What are the recommendations from the regulators?
  • What can we put in place in our trials?
  • Which monitoring model for the future?
11:30 - 12:00 30 mins
Info
STREAM 5: Investigator & Industry Partnerships
CASE STUDY: Best Practices for Site Identification and Selection
  • Christian Milliet - Global Head Clinical Operations, Vifor Pharma, Switzerland
  • Major challenges in a competitive landscape
  • Available tools and sources for site identification
  • The Feasibility Study 2.0
  • Benefits of direct site contact
11:30 - 12:00 30 mins
EARLY CLINICAL DEVELOPMENT
A regulatory perspective on blood pressure assessments in phase I and II trials: Ambulatory blood pressure monitoring and other approaches
  • Colette Strnadova - Senior Scientific Advisor, Health Canada
12:00 - 12:30 30 mins
Info
STREAM 1: Partnerships & Collaboration
Discover – North West London data driving real world evidence through collaboration
  • Amanda Lucas - Programme Director, Imperial College Health Partners

•Role of Imperial College Health Partners in facilitating research collaborations
•Introduction to an exciting new new product launched earlier this year – Discover, which provides North West London data for driving real work evidence through collaboration
•Explain now Discover acts as a partner for realising potential of new products and can add value throughout the drug development cycle through effective and efficient study design and delivery and generation of a robust evidence base. It is cost effective and you can feel confident that you are investing back into the NHS by choosing us.
•Unique position enables us to bring together researchers, patients, industry and the NHS -  working relationships with NHS Trusts and universities, co-production and insights gained through engagement with patients and charities.

12:00 - 12:30 30 mins
Info
STREAM 2: Patients as Partners
CASE STUDY: The journey of Santhera Pharmaceuticals to effectively engage with patient groups in clinical trials
  • Vanessa Dos Reis Ferreira - Head of Patient Advocacy Europe, Santhera, Switzerland
  • Preparation for and encouragement of feedback from patient groups
  • Challenges, obstacles and getting through them
  • Impact on company decisions after patient groups feedback
  • Recommendations
12:00 - 12:30 30 mins
Info
STREAM 3: Mobile Health & Wearables
CASE STUDY: First of Its Kind Smart Trial and Engagement Program Implemented on a phase II clinical trial with Alzheimer Patients
  • Dr Anna Bink - iSTEP study implementation lead,, Janssen, Belgium
  • Impact of personalized patient engagement and automated real-time data collection on patients, sites and company via smart phones, smart blisters and scanning devices
  • Ensuring the “right” kit and “right” pill is given to the “right” patient at all times
  • Improving patient’s understanding of drug information and all-in-one digital drug labels.
  • Value of engaging patients, sites, health authorities and ethics committees directly during the development of smart technologies
  • Transforming clinical trials by disruptive partnerships with technology, software, mobile and package vendors.
12:00 - 12:30 30 mins
Info
STREAM 4: Governance, Quality, Oversight, Risk Management & RBM
CASE STUDY: Operational risk management- A systematic approach to identifying risk in clinical trials upfront
  • Dr. Diana Sims-Silbermann - Senior Trial Manager, Early Development and Clinical Pharmacology,, Janssen-Cilag GmbH, Johnson & Johnson, Germany

Protocol risks:

  • Complicated IP preparation
  • IP with potential side effects (e.g. biologicals)
  • Extensive PK days
  • Complicated Trial specific activities
  • Timelines on processes that affect trial conduct (e.g.long TAT for certain lab assessments, timelines for entering data into IWRS to receive medication)

 Site risks:

  • Adequate site staff
  • Adequate site staff experience
  • PI oversight
  • Adequate equipment

What can sponsor /CRA do?

  • risk mamangement assessment of protocol taking site capabilities into account before trial starts
  • identify and mitigate possible “danger points” upfront
  • discuss these points with site staff at SIV
  • During trial
  • close contact with sites to  monitor identified risks in real time

   

12:00 - 12:30 30 mins
STREAM 5: Investigator & Industry Partnerships
CASE STUDY: Engagement with sites
  • Jeannett Dimsits - Senior Director, Trial Management Anchor, NovoNordisk, Denmark
  • Kate O’Brien - Senior Research Nurse, Freelance Site Consultant, UK
12:00 - 12:30 30 mins
EARLY CLINICAL DEVELOPMENT
CV vital signs and safety – In addition to blood pressure do we need to consider the heart rate as well in drug development?
  • Christer Gottfridsson - ECG Centre Cardiologist, Astrazeneca, Sweden
12:30 - 13:00 30 mins
Info
STREAM 1: Partnerships & Collaboration
Getting it right from the outset – Relationships before Partnerships
  • Elvira Klissourska - Senior Director,, Head Clinical Operations, Clinical Development & Medical Affairs,, Fresenius Kabi SwissBioSim GmbH, Switzerland
  • David MacMurchy - Executive Vice President, Europe Asia Pacific & Africa, PRA Health Sciences, UK
  • Early engagement between parties – consultative approach
  • Cultural alignment – values, priorities, “chemistry”
  • Commitments – managing expectations, building trust
  • Executive engagement – building foundation for “making bad times better”
12:30 - 13:00 30 mins
Info
STREAM 2: Patients as Partners
Direct engagements with Patients – where are the limits?
  • Mike Jagielski - CEO, KCR
  • View of different aspects on direct patient engagement in clinical trials
  • What is the potential impact and where are possible limitations?
12:30 - 13:00 30 mins
Info
STREAM 3: Mobile Health & Wearables
CASE STUDY: Use of technology to access isolated populations to improve lifelong health and education
  • Dr. Véronique Inés Thouvenot - Co-Founder CCO, & Scientific Director, Millennia2025 Women and Innovation Foundation, Switzerland
  • How isolated populations have access and use technologies for their health and education – case studies in Peru, Brazil, Nigeria, Nepal and Mongolia.
  • How technologies are used from birth to elderly
  • How local knowledge is collected and shared with technologies
  • What challenges have still to be overcome to enhance security in the communities
  • What can we learn from these examples to benefit clinical trial design and the promotion of long-term healthcare solutions
12:30 - 13:00 30 mins
Info
STREAM 4: Governance, Quality, Oversight, Risk Management & RBM
Beyond Risk-based Monitoring: Employing Risk-based Management
  • Christopher Allan, - Principal Solutions Consultant, Trial Oversight, ERT, USA

The volume and variety of data required in today’s clinical trials create significant challenges for trial sponsors and CROs alike — many of whom are still using spreadsheets and manual processes to understand performance, track status and manage risks. But these outdated approaches are time consuming, costly and increase the potential for human error.

In this discussion, we’ll share practical guidance on how trial leaders can proactively manage performance at the study, site and trial portfolio levels. Highlights include:

  • Exploring process, resource, and technology challenges in implementing risk-based management (RBM)
  • Overcoming challenges in data source variability, data latency and data aggregation
  • Moving beyond RBM: Incorporating study start-up metrics, milestone tracking and other KPIs
  • Complying with ICH E6 guidance: Sponsor / CRO roles in risk-based management and oversight
  • Finding the best model and solution for your organization: The value of pilots and proofs of concept (POCs)
12:30 - 13:00 30 mins
Info
STREAM 5: Investigator & Industry Partnerships
JOINT PRESENTATION: Global Site Payment Transformation
  • Joe Robbins - Senior Manager, Global Clinical Pricing & Payments, Amgen, UK
  • Jim Murphy - CEO, Greenphire

Attend this joint presentation to learn how Amgen chose Greenphire’s eClinicalGPS to automate its site payments for a more transparent, reliable process that eliminated as many manual points of intervention as possible.

  • How the holistic approach included standardization of global budget processes, creating an internal clinical payments database and implementing key integrations (ERP, EDC) to distribute payments to sites
  • Automating configuration improves controls, reduces errors and keeps the sponsor in the ownership role
  • Site payment automation allows the sponsor to eliminate holdback, pay more frequently, accurately with full transparency
  • Key findings from the pilot program, global implementation and worldwide payment transformation
12:30 - 13:00 30 mins
Info
EARLY CLINICAL DEVELOPMENT
Current challenges in running early phase studies in patients rather than healthy volunteers
  • Charlotte Chadwick - Head of Early Phase Unit and Pharmacy, MAC Clinical Research
  • The changing landscape of early phase trials
  • Advantages and disadvantages of including patients in trials earlier
  • The use of integrated protocols
  • Ethical and regulatory challenges
  • Operational and recruitment challenges.
14:30 - 15:00 30 mins
Info
STREAM 1: Partnerships & Collaboration
CASE STUDY: Out-Tasking
  • Lourdes López-Bravo - Executive Director, Clinical Research Director Spain and Portugal, Global Clinical Trial Operations, MSD, Spain
14:30 - 15:00 30 mins
Info
STREAM 2: Patients as Partners
CASE STUDY: A rare disease in clinical trial: The Duchenne parent project Spain strategy
  • Marisol Montolio del Olmo - Adjunct Professor at University of Barcelona, Scientific Director, of Duchenne Parent Project Spain
  • Clinical Trial Support: Save drugs from Valley of death
  • Patients' Registry
  • Collaboration with Pharma
  • Input to EMA
  • Inform to Patients
14:30 - 15:00 30 mins
Info
STREAM 3: Mobile Health & Wearables
CASE STUDY: Childhood Cancer Survivorship Passport: An integrated eHealth solution
  • Ruth Ladenstein - Senior Consultant in Paediatric haematology–Oncology, OKIDS, Austria
  • Continuity of Care and Advise
  • Survivorship Passport
  • Interoperable electronic Health Records
  • Patient Empowerment
  • Long Term Follow Up Research
14:30 - 15:00 30 mins
Info
STREAM 4: Governance, Quality, Oversight, Risk Management & RBM
CASE STUDY: RBM -key conditions in collaboration between Sponsor and CRO
  • Marion Wolfs - Director Risk Management and Central Monitoring, Janssen, The Netherlands

Although Risk Based Monitoring (RBM) high level definitions and processes are similar across the pharmaceutical industry, the practical implementation, organizational structures, naming of documents and processes, system capabilities, etc., can be different from company to company. Through an Alliance Level Relationship with our preferred CROs, we have gained experience and developed best practices with RBM operational deployment and assessing CRO RBM capabilities and competencies. Clarity around roles and responsibilities as well as a good understanding of system capabilities and data flows, especially where there are shared systems between the Sponsor and CRO, are found to be key success factors. Besides possible organizational changes and the development of mutual processes and system capabilities, the human element is not to be underestimated. Managing the changes in processes and change in mind set within both the Sponsor and CRO organization is crucial to successful implementation of RBM.

14:30 - 15:00 30 mins
STREAM 5: Investigator & Industry Partnerships
CASE STUDY: What it’s like to be an Investigator on a trial?
  • Richard FitzGerald - Consultant Physician and Director, Clinical Research Unit, Royal Liverpool University Hospital, UK
15:00 - 15:30 30 mins
Info
STREAM 1: Partnerships & Collaboration
Partnership to Realize FDA Recent Guidance on Integration of EHR and EDC Data
  • Gavin Nichols - Chief Information Officer & Executive Vice President, Technology, BioClinica

Gain insight into the recently updated guidance from the FDA as part of their drive to modernize clinical trials to increase access to drugs and treatments. Understand how collaboration between sponsors, EHR vendors and EDC systems, leveraging Blockchain can greatly improve the collection and quality of EDC data. Such collaboration will enable sponsors to become better aligned with this new guidance and provides an environment which improves research for patients, sites and point of care clinicians. Some of the key benefits to sponsors are:

  • Reduced site burden and overall costs
  • Greater transparency into operational activity
  • More control without additional overheads
  • Improved time management for all
  • Consistent, real-time and higher quality data
15:00 - 15:30 30 mins
Info
STREAM 2: Patients as Partners
Making it easier for patients to learn about and participate in clinical trials: A practical approach to patient centricity
  • Rosamund Round - Director, Patient Innovation Center, PAREXEL, UK
  • Benefits of the patient centricity phenomenon
  • Addressing literacy and health literacy to enhance clinical trial understanding
  • How to incorporate the patient perspective into the protocol design process
  • What can be done to reduce financial, geographical and practical challenges to trial participation
  • Through case studies and examples, understand the practical application of a patient centric approach to planning and implementing clinical trials
15:00 - 15:30 30 mins
Info
STREAM 3: Mobile Health & Wearables
BYOD: A Game-Changer for Sponsors, Sites and Patients
  • Chris Watson, PhD - Director of Product Strategy, eCOA, ERT

Electronic clinical outcomes assessments (eCOA) are no longer just about how the patients feel or function pre-approval. With recent technological advancements, eCOA has become a valuable tool that helps sponsors gain greater insight into patient experiences post-approval – especially in site-less trials. A bring-your-own-device (BYOD) approach, coupled with wireless integration with mobile medical devices, opens up a whole new world of data collection options for trial sponsors, sites and patients.

In this discussion, we’ll share BYOD and flexible provisioning success stories, as well as demonstrate why sponsors need to incorporate this approach into study protocols and post- marketing evidence programs:

  • Know what’s really meant by ‘BYOD’ and ‘flexible provisioning’
  • Understand how FDA, EMA and regional regulators view BYOD data
  • See how BYOD has moved beyond patient smartphones to include site tablets and workstations
  • Preview how exploratory endpoints and real world evidence may include wearables and even voice-assisted technology such as Amazon Alexa
15:00 - 15:30 30 mins
Info
STREAM 4: Governance, Quality, Oversight, Risk Management & RBM
Leveraging AI based platform and analytics for RBM, CM / RM, trial operations and improved outcomes
  • Dr Krishnan Rajagopalan - Chief Growth Officer, Navitas Life Sciences
  • Niranjan Rao, PhD FCP - Vice President, Clinical Development, Asana BioSciences

Several new models for transforming Clinical Trial operations are being pursued by the industry. While process, people / roles and standards are being refined to continue to be more efficient, the core requirement of “near real-time” data availability for decisions on quality, risk, compliance, cycle time, “go / no-go” on studies and cost of trials continues to remain critical.

We will cover some of the key topics below as part of the discussion:

  • An Overview of the Challenges in the Clinical Trials Landscape and the Drivers towards Innovations
  • Leveraging Operating Models - Risk Based Monitoring (RBM), Quality by Design (QdB) and CM/RM
  • Technology developments and considerations – AI, automation, Digital approaches etc.,
  • Case study on implementing innovative technology, OneClinical Integrated Clinical Enterprise Platform from Navitas Life Sciences and how it is leveraged to optimize data integration, analytics and data visualization and some pivotal decisions on the study
15:00 - 15:30 30 mins
STREAM 5: Investigator & Industry Partnerships
Please move to a different stream
15:00 - 15:30 30 mins
Info
EARLY CLINICAL DEVELOPMENT
Using adaptive designs to streamline early clinical studies: case studies across a number of study designs
  • Dr. Graham Wood - Chief R&D Officer, Altasciences

Adaptive study designs, across all stages of drug development, are helping to increase study efficiency. Early clinical pharmacology studies, such as first-in-human studies, are particularly well-suited for adaptive designs, since preclinical data can help guide the design, but may not perfectly predict what will happen in humans. Adaptations allow us to learn from the real-time data collected, and to make necessary changes to ensure safety is maintained or optimal dosing is achieved. We will review case studies where adaptations enabled studies to be completed more efficiently, with fewer protocol amendments or exposing fewer subjects. We will also present cases where the adaptations were insufficient to prevent protocol amendments, but did allow us to better prepare for potential adaptations in future studies. Finally, we will review feedback from regulators and IRBs regarding the optimal method of presenting adaptations in our protocols to ensure the limits of the adaptations are clear.

15:30 - 16:00 30 mins
Afternoon Break
16:00 - 16:30 30 mins
Info
STREAM 1: Partnerships & Collaboration
CASE STUDY: Managing Outsourcing Risk: The global and regional picture
  • Edouard Masurel - Head of Third Party Resourcing (TPR) - Regions and LOCs, GlaxoSmithKline, UK
  • How can we better mitigate, control or reduce risk associated with outsourcing?
  • How to do it?  Getting control of all outsourcing that is happening in the regions
  • How to achieve smarter resourcing in a global context
16:00 - 16:30 30 mins
Info
STREAM 2: Patients as Partners
Delivering meaningful patient centricity in clinical trials: The patient organisation perspective
  • Panellist Chris Macdonald - Head of Research, Pancreatic Cancer UK
  • Hear how UK medical research charities have been successfully integrating patient insight in to their activities for over 10 years
  • Find out how they strike a practical balance of delivering effective research outcomes whilst ensuring relevance through principled and meaningful patient involvement
  • Through case studies and examples, explore how industry and medical research charities can learn from one another and collaborate for mutual benefit in clinical trials
  • Discuss the body of evidence and moral imperative that is quickly making patient centricity a key focus of those delivering clinical trials and regulators
16:00 - 16:15 15 mins
Info
STREAM 3: Mobile Health & Wearables
CASE STUDY: Electronic eSource of data
  • Jennifer Nielsen - Transcelerate eSource, Novo Nordisk A/S
  • What is source data, what isn’t?
  • Multi Esource data- how to tackle that?
  • What are the emerging methodologies?
  • How do you prove the electronic source is the data you are reporting for your clinical trial?
  • How to go from eSource to reporting?
  • Validation of the data from eSource
16:00 - 16:30 30 mins
Info
STREAM 4: Governance, Quality, Oversight, Risk Management & RBM
CASE STUDY: Quality Tolerance Limits – implementation in a large pharmaceutical company
  • Morten Thorup Pedersen - Risk Based Monitoring Specialist, NovoNordisk, Denmark
  • Introduction to Quality Tolerance Limits (QTLs)
  • What does ICH-GCP require the industry to do
  • What is TransCelerate’s approach to QTLs
  • How to establish a framework for implementing QTLs
  • How to define QTLs and for which parameters
  • How to monitor QTLs
16:00 - 16:30 30 mins
STREAM 5: Investigator & Industry Partnerships
The NCRI Consumer Forum - How patient partners can help Investigators and Industry
  • Richard Stephens - Chair of the National Cancer Research Institute's Consumer Forum, NCRI, UK
16:00 - 16:30 30 mins
Info
EARLY CLINICAL DEVELOPMENT
The uses and abuses of Adaptive Clinical Trial Designs
  • Martin Lunnon - Clinical Pharmacologist, Specialist in Early Clinical Development and Visiting Senior Lecturer, King's College London
  • The 60 to 90s were a golden time for drug development, many of these were based on classic receptor/enzyme pharmacology:

ßBlockers/ ßAgonists/ Ca++ antagonists/ACE inhibitors/Statins (HMGCoA reductase inhibitors)/SSRIs/5-HT3 antagonists

  • Since the Millenium life has in general become more difficult - Developing drugs for stroke or Alzheimer’s Disease
  • However, some success: Oncology, (Neuro) Inflammation: MS, RA
  • How to tackle this: New Targets /Biologicals/Gene Modification/‘New’ CT Designs
  • Examples to Follow: Oncology/Stroke /Alzheimer’s/Migraine/Osteoarthritis
16:15 - 16:30 15 mins
Info
STREAM 3: Mobile Health & Wearables
CASE STUDY: Digital Biomarkers – The Use of Digital Technology to Empower Clinical Trials Data
  • Judith Kornfeld - Chief Business and Operations Officer, Oregon Health & Sciences University, USA
  • Unobtrusive, continuously collected in-home data using sensors and sensor embedded devices are increasingly becoming useful in detecting gradual health changes that are often not noticeable or cannot be accurately collected during periodic in-clinic visits due to self-reporting validity limitations and/or the missing data between in-clinic visits.
  • An example of an in-home sensor based digital technology and the data collected using this platform will be demonstrated.
16:30 - 17:30 60 mins
Info
STREAM 1: Partnerships & Collaboration
PANEL: The evolution of outsourcing strategies: Managing change through M&A in stakeholders during outsourcing and strategic partnerships
  • MODERATOR: Graham P Belgrave - Senior Vice President, European Operations, Advanced Clinical
  • Varun Grover - Clinical Contracts and Finance, Senior Associate, Gilead Sciences, UK
  • Lan Bandara - Global Head of Outsourcing, Eisai Limited, UK
  • Lidia Cappellina - Head of Outsourcing Management, Chiesi Pharmaceuticals, Italy
  • Impact of mergers and acquisition of the CRO’s on the Pharma Industry, risks and opportunities from M&A, a sponsor’s perspective? CROs should maintain a high level of performance, CRO staff turnover as result of M&A?
  • Mergers and Acquisition of CRO- how do you still take forward the partnership? How does this impact the trial? How to keep fresh and on-track when this happens? How well is the integration managed? Business continuity and risk management during M&A period
  • Real-life experience of what can go wrong in a partnership and how can this be avoided? CROs to be aware of the new sponsors culture, how to remain versatile, preferred provider for Sponsor?
  • Quality oversight during a fully outsourced study, including pitfalls and solutions
  • Is this the death of small specialist CROs?
  • How to manage change after M&A, the impact on contracts and budgets with CRO/Sponsors, exploring other types of contracting models best suited to adapt to change, what constitutes a change in scope?
  • Monitoring supplier performance, introducing KPI’s
16:30 - 17:30 60 mins
Info
STREAM 2: Patients as Partners
PANEL: Patient Engagement – discussing the value and has it actually made a difference to the Pharmaceutical companies?
  • MODERATOR: Andrew Benson - Senior Director at Trialtrove, Citeline
  • Jennifer Preston - Patient and Public Involvement & Engagement Priority Lead, Dept. of Women's and Children's Health, Alder Hey Children's NHS Foundation Trust University of Liverpool, UK
  • Dr. Vanessa Spalding - Clinical Development Advisor, Clinical Pharmacology, Clinical Pharmacology, Eli Lilly and Company Limited, UK
  • Russell Wheeler - Trustee, Leber's Hereditary Optic Neuropathy Society (LHON Society), UK
  • Almenia Garvey - Director of Site Alliances, ICON Clinical Research Services
  • Mike Jagielski - CEO, KCR
  • Has the focus on Patient Centricity really sped up the development of molecules?
  • What costs implications are there being patient centric?
  • Is it really changing protocols? Is it delaying start-up times?
  • Have they recruited faster? Is it actually delivering on recruitment better retention?
  • Compare recruitment and retention from a study 5 years ago to now- do we see a difference?
  • What are companies doing? What’s the value in it
  • Involving patients from start to finish - Engage for protocol development  through to end
  • Engaging patients to talk to regulators?
  • Have they got better data? Have they got faster approval? What is the feedback from regulators?
  • Holistic made people feel good, helping with pharma industry profile
  • Has it had a positive feedback?
  • What are the Regulators viewpoint on this? Engaging with patients- how will they respond to that? FDA has done patient engagement… how do they view patient engagement? Study design or end points have been requested by patients? How do they react to that?
  • Experience of patients may be better but is it speeding up clinical research?
  • Multiple different consortia: Transcelerate, EFPIA , IMI (International Medicine? industry funded)
16:30 - 17:30 60 mins
Info
STREAM 3: Mobile Health & Wearables
PANEL: Wearables and sensors - Innovative ways to collect clinical data- what does it mean for patients and clinical trials?
  • Moderator Francesca Martinelli - Specialist in Quality of Life - Quality of Life Department, EORTC, Belgium
  • Melissa Menke - Founder and CEO, Access Afya
  • Dr. Pierre Peeters - Chief Operations Officer, CHDR
  • Emilio Vandelli - Managing Director, Arithmos (part of PM Holding)
  • Kai Langel - Director, Janssen Clinical Innovation (JCI), Janssen-Cilag GmbH, Johnson & Johnson, Belgium
  • Mobile Health - Taking clinical trial to the patient - Shifting clinical research from hospital to home – when will this happen?
  • What do you do with all the data? How much do you use? How will companies analyse that data? How will agencies accept the data?
  • Choosing the right device for your trial - what are the requirements?
  • How to look at it in a risk-based manner?
  • What extent are people, using them? What results have been submitted?
  • Experiences – who has done it? What did they found out? What are the difficulties?
  • What evidence is there with regulated trials?
  • How do you generate more value for your clinical programme by using wearables? How to translate into the real world?
  • Can I trust the technology?
  • Making trials accessible for many more people – allow people to participate who can’t get to hospitals
  • What is the opportunity for mobile/ wearables in emerging markets?
16:30 - 17:30 60 mins
Info
STREAM 4: Governance, Quality, Oversight, Risk Management & RBM
PANEL: Optimising the Sponsor-CRO partnership: Quality oversight in outsourced clinical trials
  • MODERATOR: Paul Bouten - Managing Director, PharmCMed
  • Geoff Taylor - Director, Clinical Quality Assurance,, Eisai Product Creation Systems, UK
  • Dr. Raphaele Mary - former Director Capability, Quality & Strategy, Global Clinical Operations, Bristol Myers Squibb
  • Marion Wolfs - Director Risk Management and Central Monitoring, Janssen, The Netherlands
  • Jeana Norwick - Executive Director, Corporate Quality Relationships, Syneos Health
  • Helen Whitelegg - VP and Global Portfolio Head Immunology, Project Leadership, IQVIA


  • What is meant by oversight - Do we mean the same if using oversight?
  • Balance between micromanagement and oversight
  • Developing and implementing the right tools parties involved in oversight (sponsor and CRO/third party) - How to label it as quality oversight?
  • Makes RBM oversight easier
  • What is the effect from RBM on Quality, Risk Management and how captured during oversight
  • How much oversight is overkill?
  • Governance and Oversight – the difference if any?
16:30 - 17:30 60 mins
Info
STREAM 5: Investigator & Industry Partnerships
PANEL DISCUSSION: Site budget in Clinical Trials – What is “fair market value?
  • Dr. Diana Sims-Silbermann - Senior Trial Manager, Early Development and Clinical Pharmacology,, Janssen-Cilag GmbH, Johnson & Johnson, Germany
  • Philipp Badorrek - Head of Department,, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Germany
  • Dr. Wolfgang Seibold - Clinical Operations, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
  • Dmitry Manuilov - Head of Clinical Development, MYR GmbH, Germany
  • Offered budget for set up is often far too low, especially in multi-centre trials. (ever increasing training requirements and document  reviews (lab manual, procedure manual, protocol, CRF)
  • Why is there so often a marked difference in budgets between early phase and late phase trials? The need for training and the level of quality is the same!!
  •  Activities outside the mere procedure costs are often not recognised, like time to enter CRFs, communication time with sponsor/CRO, internal team meetings, etc.
16:30 - 17:30 60 mins
Info
EARLY CLINICAL DEVELOPMENT
PANEL DISCUSSION: Patient recruitment for special populations: paediatrics, geriatrics, and oncology
  • Javier Garcia-Corbacho - Head of Clinical Trials Unit of Clinic Institute of Haematological and Oncological Diseases (ICMHO), Early Phase Clinical Trials, Hospital Clinic, Spain
  • Siru Virtanen - ECMC Programme Office, Research and Innovation Directorate, Cancer Research UK
  • Shaila Shabbir - Clinical Development Manager, Respiratory Global Clinical Sciences & Delivery (GCSD), R&D Projects, GlaxoSmithKline
  • Explaining the need for specific recruitment for paediatric, geriatric, or oncology studies
  • How to effectively and efficiently recruit healthy volunteers and patients for these studies
  • Understanding the importance of applying patient centricity for children, geriatrics, and oncology patients and the best methods to do this
17:30 - 17:35 5 mins
CLOSING PLENARY
Opening remarks from the Chairperson
  • Dr. Tamzin Blagbrough - Sourcing Consultant, Clinical Pharmacology Study Delivery Solutions, Eli Lilly and Company Limited
17:35 - 17:40 5 mins
CLOSING PLENARY
Lifetime achievement award
17:40 - 18:30 50 mins
Info
CLOSING PLENARY
Innovation and Technology -Exploring possibilities where humans and technology collide
  • Mark Pollock - Explorer, Innovator &, Collaboration Catalyst, Ireland
  • Adversity and challenges - Resilience and attitude under pressure
  • Leadership and motivation - Goal setting and leading through a crisis
  • Collaboration and teamwork - Creating and motivating dispersed teams across disciplines and geographies
18:30 - 21:00 150 mins
Info
PCT Masquerade Party

Grab a drink and enjoy the festivities at the well-renowned PCT Party taking place this year at Sala Comillas (Barcelona Maritime Museum). Plus, get some fun snaps of you and your colleagues in the PCT Party Photo Booth sponsored by DrugDev! Open for all participants.