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Key Sessions

Lucien Engelen

KEYNOTE: Is disrupting health(care) the next frontier?

Radboud University Nijmegen Medical Centre, The Netherlands

Greg Koski

KEYNOTE: Future of healthcare: Integration of healthcare and research to better understand disease and improve health

ACRES Associate Professor of Anesthesia, Massachusetts General Hospital, Harvard Medical School, USA

Ms Adama Ibrahim

KEYNOTE: Implementation of patient engagement in drug development

Biogen, UK

Matthew Bonam

KEYNOTE: Opportunities to innovate in the way we collect data in clinical trials and how to manage volume, variety and veracity in a clinical study setting

AstraZeneca R&D, UK

Alexander Masters

KEYNOTE: Patient funded trials

iCancer.org.uk, UK

Nov 29
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08:30 - 08:50

Morning Coffee and Networking

Showing of Streams
10:20 - 10:55

Morning coffee and networking

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

Opening remarks from the chairperson

  • Symposium ECD- Science in Early Phase Corina Dota - Director, AZ Cardiovascular Safety Centre of Excellence, AstraZeneca
  • Stream 5 Partnership Management Lesley Mathews - Global Development - Portfolio & Operations, Resource Management & System Integration,, Bayer Healthcare, UK
  • Stream 6 Patients as Partners Jean Edwards - Former Procurement Director, Europe, Australia & Japan, Former Eli Lilly, Cosultant, UK
  • Stream 8 Small to Mid-size Pharma and Biotech Anna Matranga - Strategic Sourcing R&D, Consultant, AMC Alliances & Consulting, France
  • Stream 7 Disruptive Innovation, Technology and Big Data John Gate - European Procurement Executive, Elanco, UK
  • Symposium ECD -Operational Strategies Wolfgang Eglmeier - Head Centre for Clinical Studies, Witten/Herdecke University
more
Showing of Streams
12:40 - 14:00

Lunch and networking break

Showing of Streams
16:00 - 16:05
End of Conference

End of Conference

16:05 - 22:35

Scrip Awards, London Hilton on Park Lane, London, UK

If you would like to join senior professionals to celebrate the wealth of innovations, dedication and hard work that the pharmaceutical and biotech industries have shown over the past year, the SCRIP awards are taking place in London after PCT Europe. For more information or to book your place visit: www.scripawards.com

more
08:30 - 08:50 20 mins
Morning Coffee and Networking
08:50 - 09:00 10 mins
PLENARY
Opening remarks from the chairperson
  • Bruce Hellman - CEO, uMotif, UK
more
08:50 - 09:00 10 mins
SYMPOSIUM: Clinical Trial Supply
Opening remarks from the chairperson
  • Frank Peeters - Managing Director, Tobeas bvba, Belgium
more
09:00 - 09:40 40 mins
PLENARY
KEYNOTE: Is disrupting health(care) the next frontier?
  • Lucien Engelen - Director, REshape Center for Health(care) Innovation, Radboud University Nijmegen Medical Centre, The Netherlands
more
  • We're facing serious challenges
  • Technology is speeding up exponentially
  • Citizens and patients are becoming increasingly tech savvy
  • We need to take the shift from a fix-it into a prevent-it system
  • Full service solutions might be one of the options of the future
09:00 - 09:40 40 mins
SYMPOSIUM: Clinical Trial Supply
Assessing latest advancements in Interactive Response Technology (IRT) and practically using this to improve efficiency of the clinical trial supply chain
  • Kate Chapman - Director, Clinical Technology Consultants Ltd, UK
more
  • Reviewing key ways in which IRT can be used to improve the clinical trial supply chain
  • Sharing experiences of how IRT was set up
  • Understanding how to ensure an efficient interface between IRT and electronic data capture
  • Successfully selecting and working with IRT service providers
  • Exploring any new developments or additional functionalities in IRT
09:40 - 10:20 40 mins
PLENARY
The advances of mobile health and clinical technology: What does it mean for clinical research and what are the barriers?
  • Moderator Bruce Hellman - CEO, uMotif, UK
  • Matthew Bonam - Director, Intelligent Pharmaceuticals, AstraZeneca R&D, UK
  • Marjan Faber - Senior Research Fellow in Patient Participation for Quality Improvement in Health Care,, Radboud University Medical Center, Netherlands
  • Anthony Costello - Vice President Mobile Health, Medidata, USA
  • Willie Muehlhausen - Head of Innovation, ICON, Ireland
more
  • Future of technology, mHealth, wearables and innovation for clinical trials
  • Exploring new technologies and working with CRO partners, how to integrate such innovations into partnerships?
  • Are consumer devices good enough for clinical trials?
  • Mobile health devices tackling therapeutics: Advances in this and changes to how clinical trials can be conducted
  • Address the disconnect between hype and evidence
  • How do you use multimedia and interactive technology to enrich and simplify the patient trial experience?
  • How do you use mobile technology to bring trials more seamlessly into patient's lives?
  • Are you measuring what matters to the patient?
09:40 - 10:10 30 mins
SYMPOSIUM: Clinical Trial Supply
Best strategies for managing the clinical trial supply chain in emerging markets
  • Amer Alghabban - Vice President GxP Quality Assurance, Compliance Training, Karyopharm Therapeutics Inc., Switzerland
more
  • Outlining examples of challenging clinical trial supply chain requirements in different countries
  • Success stories in emerging markets
  • Understanding how to work with external partners for clinical trial supply chain management in these regions
  • Overcoming the key challenges involved in managing the clinical trial supply chain in emerging markets
10:10 - 10:20 10 mins
SYMPOSIUM: Clinical Trial Supply
Q&A from the morning session
10:20 - 10:55 35 mins
Morning coffee and networking
10:55 - 11:00 5 mins
Opening remarks from the chairperson
  • Symposium ECD- Science in Early Phase Corina Dota - Director, AZ Cardiovascular Safety Centre of Excellence, AstraZeneca
  • Stream 5 Partnership Management Lesley Mathews - Global Development - Portfolio & Operations, Resource Management & System Integration,, Bayer Healthcare, UK
  • Stream 6 Patients as Partners Jean Edwards - Former Procurement Director, Europe, Australia & Japan, Former Eli Lilly, Cosultant, UK
  • Stream 8 Small to Mid-size Pharma and Biotech Anna Matranga - Strategic Sourcing R&D, Consultant, AMC Alliances & Consulting, France
  • Stream 7 Disruptive Innovation, Technology and Big Data John Gate - European Procurement Executive, Elanco, UK
  • Symposium ECD -Operational Strategies Wolfgang Eglmeier - Head Centre for Clinical Studies, Witten/Herdecke University
more
11:00 - 11:30 30 mins
STREAM 5: Partnership Management
KEYNOTE: Future of healthcare: Integration of healthcare and research to better understand disease and improve health
  • Greg Koski - Chairman, Co-Founder & President / Chief Executive Officer,, ACRES Associate Professor of Anesthesia, Massachusetts General Hospital, Harvard Medical School, USA
more
  • Health research and health care are traditionally conducted largely within separate domains
  • Current trends in medicine increasingly focus on data-driven decision making and personalization
  • Integration of health care with health research offers a new paradigm for progress
  • Modern technology enables capture, aggregation and analysis of massive data-sets, including real world data
  • This presentation describes a practical approach to modernize medicine through integration of healthcare and research that can be achieved today, dramatically impacting efficiency, effectiveness quality and cost of both care and research, as well as improve health and quality of life for patients. 
11:00 - 11:30 30 mins
STREAM 6: Patients as Partners
KEYNOTE: Implementation of patient engagement in drug development
  • Ms Adama Ibrahim - Senior Clinical Operations Lead, Biogen, UK
more
  • Introduce the concept of behaviour as part of Engagement using the Theory of Planned Behaviour and the Customer Engagement Model
  • Re-defining patient engagement based on wider industry practices
  • Offer metrics measures that span across a patient journey
  • Share some results from a primary research on internal stakeholders to identify firm based elements for Patient Engagement Behaviours
  • Propose Patient Engagement Implementation Plans that can be tailored to a Biotechnology Company
11:00 - 11:30 30 mins
STREAM 7: Disruptive Innovation, Technology and Big Data
KEYNOTE: Opportunities to innovate in the way we collect data in clinical trials and how to manage volume, variety and veracity in a clinical study setting
  • Matthew Bonam - Director, Intelligent Pharmaceuticals, AstraZeneca R&D, UK
more
  • The explosion of wearable technology and point of care monitoring creates a multitude of opportunities for clinical trials
  • Not least is the potential to collect richer data in support of existing endpoints and data from new sources to deliver differentiated endpoints
  • But this is not without challenge. For example:
  • How do we engage patients in this additional collection?
  • How do we ensure the veracity of data collected outside of the clinic, particularly using sensors which are not medical grade
  • What challenges are represented by the increased volume of data collected in real time.
11:00 - 11:30 30 mins
STREAM 8: Small to Mid-Size Pharma and Biotech
Cooperation of Academia with SME for orphan drug developments
  • Ruth Ladenstein - Senior Consultant in Paediatric haematology–Oncology, OKIDS, Austria
more
  • From bench to bedside
  • Orphan disease –Neuroblastoma
  • Monoclonal antibody
  • Academic development since 2000
  • EMA scientific advise to find an industrial partner
  • Apeiron May 2017 regulatory EMA drug approval of Dinutuximab beta
11:00 - 11:30 30 mins
SYMPOSIUM: Early Clinical Development: Science in Early Phase
The role of human models of disease state to accelerate early clinical development in healthy volunteers and patients
  • John Connell - Chief Research & Development Officer, MAC Clinical Research
more
  • Which disease states can be modelled in a clinical setting
  • Importance of validation, reproducibility and predictive validity
  • Patients v Healthy volunteers
  • Integration of human models into a FIH package


11:00 - 11:30 30 mins
SYMPOSIUM: Early Clinical Development: Operational Strategies
Getting the balance right in the design of early phase patient studies
  • Stephen Harrison, - GSK Associate Fellow, Clinical Program Lead, Clinical Pharmacology Study Science and Operations UK, GSK
more
  • Addressing the challenges of recruiting patients to early phase studies, where there is no expectation of patient benefit
  • Challenge of multiple informative endpoints vs patient burden and limited recruitment
  • Seeking patient insight into the design of the study and content of patient information sheet
  • Case studies
11:00 - 11:30 30 mins
SYMPOSIUM: Clinical Trial Supply
GS1 perspective: Exploring how global standards can be used to address efficiency, accuracy and surety in the clinical trial supply chain
  • Tania Snioch - Director Healthcare, GS1 Global Office, Belgium
more
  • Understanding global standards for the commercial supply chain and how these can also be applied to the clinical trial supply chain
  • Reviewing what GS1 standards will look like for the clinical trial supply chain and how industry will apply these
  • Examining timelines for when these GS1 standards will come into place
  • Discussing the importance of industry feedback to help to shape these standards
11:30 - 12:00 30 mins
STREAM 5: Partnership Management
Maximizing outcomes in asset transfers
  • Ben Dudley - Vice President Strategic Account Leader,, PAREXEL, UK
more

In-licensing or acquiring assets offers tremendous opportunities and presents some risks for the pharmaceutical industry. This presentation will engage with the three phases of successful transfers; from the initial quality and commercial due-diligence before the deal, through the complex practicalities of managing the asset’s transition, to maximizing the development and commercial value of assets after the transfer is completed.

11:30 - 12:00 30 mins
STREAM 6: Patients as Partners
Real patient voices for better trial design. #HumanBehindEveryNumber initiative
  • Mike Jagielski - CEO, KCR
more
  • Introduction of #HumanBehindEveryNumber initiative – what is the idea behind?
  • A clinical trial journey from a patient perspective
  • Map of emotions – what are the true feelings of people in trials?
  • Different countries – different patients’ approach towards clinical studies
  • What does patient-centricity truly mean to the industry stakeholders?

               

11:30 - 12:00 30 mins
STREAM 7: Disruptive Innovation, Technology and Big Data
Why hasn't technology transformed clinical trial performance – Yet?
  • Rik Van Mol - VP Veeva Vault Europe, Veeva Systems, UK
more
  • The current state of clinical trials using current market data
  • Collaboration potential among CROs, regulators, sites, and sponsors
  • Unifying clinical operations and data management with next-generation EDC
11:30 - 12:00 30 mins
STREAM 8: Small to Mid-Size Pharma and Biotech
Better trial management through clarity and collaboration
  • Jenny Lohan - Product Manager, ERT, USA
more

It takes a village to successfully execute a trial, with multiple vendors and partners involved in data collection and information management – and multiple opportunities for inefficiencies and errors along the way.  With so many players, data inputs and tracking systems in place, how can you truly get a single, clear picture of how your trial is performing?  This presentation will share a real-world example of how sponsors and CROs are leveraging data, analytics and a cutting-edge CTMS to provide near real-time visibility into critical study trends, enable proactive operations, automate repetitive manual tasks across trials, and provide better visibility and collaboration across all trial stakeholders.

11:30 - 12:00 30 mins
SYMPOSIUM: Early Clinical Development: Science in Early Phase
Cell-based biomarkers as a means of confirming target engagement and mechanism in early clinical trials
  • Neil Williams - CSO, KWS BioTest
more
  • The use of PD biomarkers in early clinical trials has the potential to substantially de-risk projects and enhance value
  • For many novel therapeutics, soluble analytes are not sufficient as suitable markers of mechanism and proof of concept
  • While the use of cell based markers, and even functional assays, is logistically challenging, with suitable validation and expertise they can provide high quality confirmation of effect
  • By applying an ‘intelligent design’ approach from project initiation, KWS can determine therapeutic and potential toxicological effects of novel therapeutics on immune function in the clinic, adding value to development candidates


 

11:30 - 12:00 30 mins
SYMPOSIUM: Early Clinical Development: Operational Strategies
Building unique partnerships to facilitate the transition from healthy volunteer to patient studies
  • Jim Bush - Medical Director, Covance Clinical Pharmacology Services, UK
  • Richard FitzGerald - Consultant Physician and Director, Clinical Research Unit, Royal Liverpool University Hospital
more
  • Evolving the early stage clinical trial design; more patient access earlier in development
  • Addressing the challenge of patient recruitment in early clinical development
  • Establishing and maintaining a network of doctors in hospitals to expand patient recruitment: What are the benefits and challenges?
  • Case Studies
11:30 - 12:00 30 mins
SYMPOSIUM: Clinical Trial Supply
Highlighting the importance of quality sample management in the development of immunotherapies
  • Jennifer Brandl - Associate Manager, Clinical Trials, Immune Design, USA
more
  • Bridging the gap between research and clinical operations teams to design custom sample management processes
  • Emphasizing the significance of real-time sample tracking to deliver high quality data
  • Exploring new innovations and partnerships to enable efficient and improved sample management
  • Reducing development timelines to bring effective immunotherapy to patients
12:00 - 12:40 40 mins
STREAM 5: Partnership Management
PCMG Oxford Debate: This house believes that strategic partnerships are not fit for purpose
  • Moderator Mr Carl Emerson - Managing Director, Inside Outside Solutions, UK
  • Gill Roberts - Strategic Sourcing, Global BP R&D Services, Medical Affairs & Commercialisation, Bayer AG, UK
  • Richard Scaife - Managing Director, OM360 Ltd, Chair of PCMG, UK
  • Mike Ryan - Senior VP International Business Development, Worldwide Clinical Trials, UK
  • Richard Young - VP Vault EDC, Veeva Systems, UK
more
  • A balanced but hard-hitting examination that considers sponsor and provider perspectives
  • Strategic Partnerships under the spotlight - can they really deliver in a fluid business environment?
  • Is the market polarising to huge and small companies that need to reconsider partnership management?
  • Did strategic partnerships ever really deliver or were they a publicity exercise?
  • Where next? Collaborations, consortiums, alliances or just more acquisitions?
12:00 - 12:40 40 mins
STREAM 6: Patients as Partners
How to incorporate the patient perspective into clinical trials execution and how to operationalise a process for this
  • Cathy Emmas - Patient Centricity Partnership Director,, AstraZeneca, UK
  • Bert Hartog - Senior Director Clinical Innovation, Janssen Pharmaceutica, Belgium
  • Veronica van Nederveen - Chair, Patients Organization Patientenstem.nu, Chair, Dutch Clinical Research Foundation-working group Recruitment Clinical Trial Subjects, The Netherlands
  • William van’t Hoff - Clinical Director for NHS Engagement, National Institute for Health Research Clinical Research Network, UK
  • Thierry Escudier - Head of Clinical Development,, Pierre FABRE Medicament, France
  • Sammy Ainsworth - Patient Research, Ambassador, UK
more
  • How do we engage our clinical operation colleagues?
  • Patient review protocols- does this make any sense or doesn’t it? Are patients qualified to review them? What does it mean?
  • Patients/ patients advocacy groups should be partners at very early stage of development of clinical trials: at drug development stage, before designing the trial, and being part of group discussion about new trials plan, design and outcomes (example: we are taking part in steering committee meetings for a natural history study ongoing across Europe)
  • How to set up a good collaboration with pharma: from a patients group perspective, it’s important to know the code, conditions and steps to develop an effective partnership
  • How to decrease the burden of a patient on a study
  • Patient consent leaflet- how much information is too much?
12:00 - 12:40 40 mins
STREAM 7: Disruptive Innovation, Technology and Big Data
Big Data - What to do with this data that is collected and how will it be analysed and leveraged?
  • Steven Anderson - Chief Scientific Officer, Covance, USA
  • Zeshan Ghory - VP Operations and Analytics, Antidote, UK
  • Alison Holland - Vice President & General Manager, Inflammation, Infectious Diseases, and General Medicine,, Covance, UK
  • Charles Tyzack - Director, Feasibility and Site Selection, Chiltern International, UK
more
  • What do you do with data that you’ve gathered from Apps?
  • Security of data when using an App- wearing a watch – this data goes through the cloud and picked up somewhere. Who else can get access to this?
  • Can you use Artificial Intelligence (AI) or machine learning- automated to analyse data?
  • The use of genome data to provide personalised healthcare/precision medicine
  • The use of this data to for improved patient recruitment, investigators and site location
12:00 - 12:40 40 mins
STREAM 8: Small to Mid-Size Pharma and Biotech
Outsourcing and finding the ideal partner for a small to mid-size sponsor
  • Diego Bersini - Clinical Outsourcing Manager, R&D Outsourcing Management, Chiesi Farmaceutici S.p.A., Italy
  • Dajana Bougie - Senior Outsourcing & Contract Manager, Grunenthal GmbH, Germany
  • Moderator Mr Paul Bouten - Consultant in Clinical Research, Operations & Outsourcing, PharmCMed, The Netherlands
  • Jennifer Emerson - Consultant,, Emerson Consulting & Clinical Research Services, Germany
  • Anna Matranga - Strategic Sourcing R&D, Consultant, AMC Alliances & Consulting, France
  • Rob ten Pas - Director Global Clinical Research, Am Pharma BV, The Netherlands
  • Wim J Tamminga - Vice President and Global Head of Early Phase Clinical, QPS, The Netherlands
  • Mike Jagielski - CEO, KCR
more
  • What’s new and what are the trends to higher prices and quality?
  • Finding the right partners for an affordable price and delivering the required quality
  • Experiences of switching from one CRO to another - How did they do it and how did they optimise and get the right quality? - What payments did they get?
  • Will larger CROs consider them and are the large global CROs a partner at all?
  • Is there an ideal size to match biotech and small pharma?
  • Marrying up with right partner for the size of the company - Establish an outsourcing model for smaller pharma- establish strategic partnerships
  • Oversight and governance model- Develop governance framework
  • Negotiating the best practice -Ensure pay appropriate price
  • Pre-qualification of vendor - Vendor oversight
12:00 - 12:30 30 mins
SYMPOSIUM: Early Clinical Development: Science in Early Phase
Working with patient groups for clinical research
  • Dr Julie Vallortigara - Research Officer, Ataxia, UK
more
  • Identifying unmet medical needs and priorities for patients
  • Research strategy and healthcare initiatives led by patient groups
  • How patient groups promote and facilitate research
  • Examples of partnerships with pharma companies
  • Extensive network of patients and collaborators
12:00 - 12:30 30 mins
SYMPOSIUM: Early Clinical Development: Operational Strategies
Recruiting patients in early clinical development through effective collaborations
  • Muna Kugler - Associate Director, GCO Group Leader, Clinical Development Operations, Actelion
more
  • Highlighting the importance of the vendor selection process and the early alignment of expectations
  • Pre-selecting countries and sites in collaboration with CROs
  • Establishing long lasting collaboration with the sites through the CRO for successful recruitment
  • Establishing and collaborating with a network of sites with regional support, i.e. facilities where patients can stay overnight
  • Providing support at an early stage to the CROs to achieve better engagement of investigators and the patients


12:00 - 12:30 30 mins
SYMPOSIUM: Clinical Trial Supply
Round Tables: Sharing experiences with using latest strategies and tools for clinical supply chain forecasting and planning
  • Anuja Shukla - Clinical Supply Lead, UCB, Belgium
more
  • Are there any new ways to implement clinical trial supply chain forecasting and planning?
  • What forecasting tools are available for supporting more complex clinical trial designs?
  • How can you ensure cross-functional optimisation and efficient communication with all stakeholders?
  • How can you overcome the key challenges and pitfalls?
12:40 - 14:00 80 mins
Lunch and networking break
14:00 - 14:30 30 mins
SYMPOSIUM: Clinical Trial Supply
Identifying comparators for clinical trials in China: Challenges and resolutions
  • Jasmin Hellwig - Sr. Comparator Sourcing Specialist, Merck MSD, Switzerland
more
  • Practically identifying comparators for clinical trials in China
  • Exploring the challenges and resolutions
14:00 - 14:30 30 mins
STREAM 5: Partnership Management
Engaging early to maximize value: The benefits of unifying technology and service partners early in protocol development
  • Adam Halbridge - Co-Founder of Parallel6, a PRA Health Sciences Company, USA
more

The value of including partners and vendors early in the protocol development stage is quite often overlooked.  Forming tight collaborative relationships is critical in the successful delivery of a combined technology and services offering.

  • Early engagement and collaboration
  • Showcase: Clinical6 and the patient journey


14:00 - 14:15 15 mins
STREAM 6: Patients as Partners
Working with patient groups for clinical research
  • Dr Julie Vallortigara - Research Officer, Ataxia, UK
more
  • Identifying unmet medical needs and priorities for patients
  • Research strategy and healthcare initiatives led by patient groups
  • How patient groups promote and facilitate research
  • Examples of partnerships with pharma companies
  • Extensive network of patients and collaborators
14:00 - 14:30 30 mins
STREAM 7: Disruptive Innovation, Technology and Big Data
The use of mHealth to study musculoskeletal disease
  • William Dixon - Chair in Digital Epidemiology, The University of Manchester, UK
more
  • Overview of ‘Cloudy with a Chance of Pain’
  • Recruitment and engagement in mHealth studies
  • Smartphones to support remote monitoring of rheumatoid arthritis, with integration into clinical care
  • Opportunities for developing new outcome measures using smartwatches: example of osteoarthritis
14:00 - 14:30 30 mins
STREAM 8: Small to Mid-Size Pharma and Biotech
KEYNOTE: Patient funded trials
  • Alexander Masters - Author, Campaigner and Co-Founder, iCancer.org.uk, UK
  • Dominic Nutt - Author, Campaigner and Co-Founder, iCancer.org.uk, UK
more
  • A Plutocratic Proposal: A new, ethical way for rich patients to pay for a place on a clinical trial?
  • Particularly suited to rescuing neglected drugs (and other interventions) for rare diseases
  • Discussed in the current issue of Journal of Medical Ethics, the No 1 journal of bioethics.
  • Online and open access at:  http://jme.bmj.com/cgi/content/full/medethics-2016-104050
  • A way to raise millions of euros of new money for research into orphan diseases?
14:00 - 14:30 30 mins
SYMPOSIUM: Early Clinical Development: Science in Early Phase
ECD - Medical Device Development - on a shoestring!
  • John Shillingford - Director, Orsus Medical, UK
more

- Medical Device - start up procedures

- New Medical Device Regs - requirements

- Strategies to minimise vendor costs

- The future of Med Devs

14:00 - 14:30 30 mins
SYMPOSIUM: Early Clinical Development: Operational Strategies
Examining the trend towards adaptive trial design: Where are we now?
  • Stuart Oliver - Medical Director (Early Clinical Development), Quintiles, UK
more
  • Why is adaptive trial design becoming more popular in early clinical development?
  • What are the challenges and opportunities?
  • Clarifying regulatory requirements around adaptive trial design
  • Designing and executing trials to deliver on multiple end points – how does this affect traditional phase I units? How does it affect individual studies?


14:15 - 14:30 15 mins
STREAM 6: Patients as Partners
TransCelerate’s Patient Engagement Initiative
  • Tanja Keiper - Director GCO External Innovation, Biopharma, Merck, Germany
more
14:30 - 15:00 30 mins
SYMPOSIUM: Clinical Trial Supply
Overcoming the challenges in designing the clinical trials for complex generics and innovative generics (new therapeutic entities)
  • Siddharth Chachad - Vice President & Head - Global Clinical Management, Dr.Reddy's Laboratories, India
more
  • Discussing different types of complex generics, line extensions and label expansions (new therapeutic entities)
  • Outlining the clinical requirement guidelines and understanding the grey areas in regulations
  • What are the clinical trial supply challenges and regulatory challenges in the clinical development of complex generics and innovative generics?
  • Overcoming challenges and globalizing the clinical trial design approach
14:30 - 15:00 30 mins
STREAM 5: Partnership Management
Implementation and ongoing oversight of a new global clinical program management Functional Service Provider (FSP) model from both a CRO and a sponsor perspective
  • Jon Harris - Vice President DOCS Operations, ICON, Spain
  • Eleanor Clark - Senior Manager, Amgen, USA
more
14:30 - 15:00 30 mins
STREAM 6: Patients as Partners
The importance of choosing the right partners and technologies to create the most efficient clinical trials
  • Nicole Powell - Director Business Development, SDC, USA
more
  • Journey through an insight on best practices in choosing the correct service partner to fit Sponsor needs when costs and resources are such a large constraint.
  • Explore the internal areas Sponsors need to have a thorough understanding of before moving forward in finding the right partner.
  • Discuss drivers for what a partner should be able to offer and create an understanding from the beginning of the relationship.  Also looking into why many chosen partners don’t work and how to remedy the issue. 
  • Further explore the idea of a need to find established strategic partnership network of specialty providers to create a seamless experience for the Sponsor as well as a commitment to establishing a long-standing relationship.
  • Discussion and overview of supporting partnered technologies to create efficiencies in trials.
14:30 - 15:00 30 mins
STREAM 7: Disruptive Innovation, Technology and Big Data
Unleashing the Power of IRT with embedded forecasting solution and rapid deployment
  • Steve Rawbone - Associate Director, Regional Operations and Client Onboarding, Bracket, USA
more
  • Transformative IRT deployment methodology
  • Achieving competitive edge in study start-up time
  • Integrated forecasting module to drive demand planning and supply chain optimization
  • ROI for Biopharmaceutical companies large or small
14:30 - 15:00 30 mins
STREAM 8: Small to Mid-Size Pharma and Biotech
Too big / too small / just right: Guidelines for choosing a clinical technology partner
  • Mike Lange - Senior Director, Product Marketing, Bioclinica
more
  • Why CROs are getting out of the technology business - and what that means for small and mid-sized biotechs
  • How fast you should start running when vendors talk about eClinical “platforms”
  • The pros and cons of integrated point solutions and services to meet business requirements (i.e. a “pragmatic platform”)
  • How to find a clinical technology partner in the “Goldilocks” zone
    • 5 questions to ask a technology vendor
    • 5 questions to ask your CRO about their technology choices


14:30 - 15:00 30 mins
SYMPOSIUM: Early Clinical Development: Science in Early Phase
ICH guideline E14: Regulatory perspective on cardiac safety assessment
  • Colette Strnadova - Senior Scientific Advisor / Health Products and Food Branch, Health Canada
more
  • Understanding the current status of the ICH E14 guideline
  • Assessing the latest developments
  • Opportunities and challenges
14:30 - 15:00 30 mins
SYMPOSIUM: Early Clinical Development: Operational Strategies
Patient recruitment presentation
  • Sue Pavitt - Professor Translational & Applied Health Research, University of Leeds
more
15:00 - 15:30 30 mins
SYMPOSIUM: Clinical Trial Supply
Exploring different blinding options for comparators
  • Denise Hager - Senior Scientist, Pfizer, USA
more
  • Outlining the pros and cons of different blinding approaches
  • Understanding the strategies behind deciding which way to blind comparators
  • Discussing methods used for qualifying blinding approaches
  • Reviewing whether there are any new and upcoming blinding techniques available
  • Assessing the pitfalls experienced with blinding comparators and how these can be overcome

Presentation to be delivered via teleconference

15:00 - 15:30 30 mins
STREAM 5: Partnership Management
Real RBM: A hype or common sense?
  • Artem Andrianov - CEO, Cyntegrity, Germany
  • Igor Stefanov - CEO, Synergy, Russia
more
  • The importance of integrity in the implementation of Risk-based Monitoring programs
  • Risks perception differences in risk assessment between a sponsor and a CRO
  • People. Processes. Tools – how to unite them in a holistic Risk-based Quality Management Ecosystem
  • The main challenges and pitfalls of the RBM program launch
15:00 - 15:30 30 mins
STREAM 6: Patients as Partners
Moving glioblastoma from terminal to treatable, powered by patients
  • Jessica Morris - Co-founder, OurBrainBank, SVP and Partner, FleishmanHillard, USA
more
  • constructively deconstructing the patient-centred model
  • being ideologically pragmatic
  • back to the future: carpe diem and amor vincit omnia
  • #I'mbankingonOurBrainBank
15:00 - 15:30 30 mins
STREAM 7: Disruptive Innovation, Technology and Big Data
Innovations in terms of clinical trial designs – the use of precision medicine in oncology
  • Ms Isabelle Naeije - Clinical Trial Head, GDO Trial Management Oncology, Novartis Pharma AG, Switzerland
more
  • What are the opportunities on the critical path to new medical products? To go from stagnation to innovation?
  • How does precision medicine fit in these opportunities?
  • Precision medicine in clinical development of treatments against breast cancers
  • Prevision medicine in clinical development of treatments against renal cancers
15:00 - 15:40 40 mins
STREAM 8: Small to Mid-Size Pharma and Biotech
How to attract funding of rare disease - How to engage more pharma companies in this field?
  • Dr Julie Vallortigara - Research Officer, Ataxia, UK
  • Begonya Nafria Escalera - Patient Advocacy Manager in Research, Hospital Sant Joan de Déu, Spain
  • Moderator Ruth Ladenstein - Senior Consultant in Paediatric haematology–Oncology, OKIDS, Austria
  • Stephan Dressler, European Aids Treatment Group, Germany
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  • How to attract Pharma’s to invest in the rare disease field and run trials
  • Highlighting the knowledge and resources available from patient’s groups (centre of excellence, connections with academics and clinical researchers, patient’s registry)
  • How to engage more pharma companies in this field?
  • Using the patient advocacy groups to support the trial
  • Commercial investment that needs to be done?
  • Specificities of young patient advocacy and the collaboration with the stakeholders involved in paediatric drug development
  • The role of the families to funding research addressed to rare diseases
  • Patient centricity in the research and clinical trials in rare diseases
  • Repurposing drugs
15:00 - 15:30 30 mins
SYMPOSIUM: Early Clinical Development: Science in Early Phase
Cardiac safety and the use of early trials data instead of the TQT trial
  • Corina Dota - Director, AZ Cardiovascular Safety Centre of Excellence, AstraZeneca
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  • What QT data from early trials can replace the TQT study?
  • How to design, collect and analyze the data?
  • When is the right time to submit the data?


15:00 - 15:30 30 mins
SYMPOSIUM: Early Clinical Development: Operational Strategies
Panel discussion: Patient-centric trial design: Involving patient groups in early clinical development
  • Michael Binks - VP Rare Disease Clinical Research, Pfizer
  • Uwe Gudat - Head of Safety, Biosimilars, Merck Biosimilars, Switzerland
  • Moderator Peter Van Der Ark - Clinical Research Manager, Experimental Medicine Neuroscience, Janssen – Pharmaceutical Companies of J&J, Belgium
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  • What does the current landscape look like for the pharma industry to use patient groups?
  • What are the benefits of involving patient groups in early clinical development?
  • What are the risks of involving patient groups in early clinical development?
  • Lessons for industry


 

15:30 - 16:00 30 mins
SYMPOSIUM: Clinical Trial Supply
Using risk assessments and mapping tools for effortless temperature mapping studies
  • Frank Peeters - Managing Director, Tobeas bvba, Belgium
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  • Thermal mapping is a requirement of the GDP’s. This has to be performed prior to commencement of use of a warehouse or transportation system, and when making modifications to the facility or temperature controlling equipment. Risk assessments can hereby help to handle the different mapping operations in order to reduce the workload and still assure GDP compliance
  • What are the parameters to take into account when performing a temperature mapping study? Can we assume that a transportation system is a warehouse on wheels, or do other factors play a role? How to we cope with the multitude of situations and their possible combinations?
  • Performing a temperature mapping can therefore become a very tedious operation. We achieve effortless temperature mapping by combining IoT loggers with a performant processing tool. We’ll give you a glimpse of the future
15:30 - 16:00 30 mins
STREAM 5: Partnership Management
Paediatric specificities for clinical research
  • Mr Mark Turner - Chair, European Network of Paediatric Research, European Medicines Agency and Liverpool University, UK
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20% of clinical trials involve at least one child or young person: it is important to account for the needs of children and their families when designing and conducting paediatric trials

Children and their families need to be at the heart of each trial

Growth and development affect key features of trials (formulations, eligibility, assessments, outcomes)

Ethics and blood sampling can be problematic

Experienced clinical teams can overcome all these challenges

15:30 - 16:00 30 mins
STREAM 6: Patients as Partners
Exploring and challenging those common obstacles to meaningful patient involvement in clinical research
  • Nathalie Bere - Patients Relations Coordinator, European Medicines Agency (EMA), UK
  • Dr Julie Hapeshi - Associate Director R&D, Gloucestershire Research Support Service, UK
  • Marleen Kaatee - Founding President, PSC Patients Europe, Netherlands
  • Claire Nolan - Research Involvement Manager, Parkinsons UK
  • Dr Andrew Gibson - Associate Professor in Patient and Public Involvement (PPI), University of West England, UK
  • David Spillett - Key Account Director, World Courier UK, UK
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  • Challenge 1: Where’s the evidence?
  • Challenge 2: Knowing where to start
  • Challenge 3: Getting the right expertise in patients and researchers!
  • Challenge 4: Navigating the regulators and codes of practice
15:30 - 16:00 30 mins
STREAM 7: Disruptive Innovation, Technology and Big Data
Commercialisation and business strategy: Delivering clinical evidence to support reimbursement and market access
  • Mr Peter Bogaert - Partner, Covington and Burling LLP, Belgium
  • Nermeen Varawalla - Head Clinical Development, BTG International, UK
  • Vanessa Reddy - Strategic Innovation Leader, Roche, Switzerland
  • Pall Jonsson - Associate Director Research and Development, National Institute for Health and Care Excellence (NICE), UK
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  • The Clinical, health economic and cost effectiveness data required to enable reimbursement and wide product adoption
  • Real world data, randomised controlled trials and registries remain the source of the required clinical evidence
  • Incorporating novel treatments into standard of care guidelines
  • The extent and volume of data required
  • How does it impact investment and commercialisation strategies?
  • What are the regulators asking for and is it different?
  • · What are the tools or methodologies to effectively collect real world data in primary and secondary care settings?
  • How to make this process as efficient as possible?
  • · How to best access, analyse, evaluate and apply real world data
  • How to best incorporate reimbursement objectives into clinical trial designs?
15:30 - 16:00 30 mins
SYMPOSIUM: Early Clinical Development: Science in Early Phase
QT Prolongation: Implementation guidance for industry
  • Corina Dota - Director, AZ Cardiovascular Safety Centre of Excellence, AstraZeneca
  • Colette Strnadova - Senior Scientific Advisor / Health Products and Food Branch, Health Canada
  • Borje Darpo - CSO, Associate Professor of Cardiology, iCardiac Technologies, Sweden
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  • Examining the ICH Q&A doc to support the guideline
  • When is it appropriate to perform concentration-response modelling and when isn’t it? How can it best be done? Is there a standardised convention that is followed?
  • Strategies for modelling the process
  • Assessing the additional weight given to non-clinical studies using it in induced in silico simulations
  • Increasing the predictive value of non-clinical assays and confirming them in clinical QT studies
  • Exploring case studies: situations in which the concentration-response approach was useful or misleading
  • Strategies for collecting the right amount of data to support and clear the drug from CV safety effects
15:30 - 16:00 30 mins
SYMPOSIUM: Early Clinical Development: Operational Strategies
Gene therapy for monogenic rare diseases: Early clinical development challenges
  • Michael Binks - VP Rare Disease Clinical Research, Pfizer
more
16:00 - 16:05 5 mins
End of Conference
16:05 - 22:35 390 mins
Scrip Awards, London Hilton on Park Lane, London, UK
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If you would like to join senior professionals to celebrate the wealth of innovations, dedication and hard work that the pharmaceutical and biotech industries have shown over the past year, the SCRIP awards are taking place in London after PCT Europe. For more information or to book your place visit: www.scripawards.com