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Nov 27
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09:00 - 16:00 420 mins
BRIEFING DAY A: The Outsourcing and Partnering Forum
Briefing Day A: The Outsourcing and Partnering Forum
  • Ms Nancy Meyerson-Hess - Associate Partner, admedicum Business for Patients,, Previously Head of Clinical Operations & Compliance, Grunenthal, Germany
  • Lan Bandara - Global Head of Outsourcing, Eisai Limited, UK
  • Caroline Potts - Head of Research and Development, Northumbria Healthcare NHS Trust, UK
  • Dr Stephen Nabarro - Head of Clinical Operations and Data Management, Cancer Research UK Centre for Drug Development, UK
  • Marleen Kaatee - Founding President, PSC Patients Europe, Netherlands
  • Bettina Bergtholdt - Chief Executive Officer, Emovis GmbH, Germany
  • Ms Dorte Pedersen - Senior Outsourcing Manager, Lundbeck, Denmark
  • James Muller - Head QMs Oversight, Medical Quality Assurance, Member of TransCelerate Biopharma Inc. – Quality Management System Initiative, Pfizer, UK
  • Dmitry Manuilov - Project Director, Maxwell Biotech Group, Russia
more

09:00     Registration

09:55     Chairperson Opening Remarks

Dmitry Manuilov, Project Director, Maxwell Biotech Group, Russia

10:00     CASE STUDY: Patient engagement: What you need to know and what you need to do

  • Engaging patients in clinical development needs to start early on
  • Although there is not a straight forward recipe for success, there are key areas to focus on
  • Patient Organizations can provide very useful input to support the planning and execution of clinical trials
  • What are some of the considerations for involving patients in clinical trials
  • How does indication and organizational size play a role in this? 

Nancy Meyerson-Hess, Previously Head of Clinical Operations & Compliance, Grunenthal, Associate Partner, admedicum Business for Patients Germany

10:30     CASE STUDY: Partnerships with Pharma, CRO, and the NHS, with access to patients, ideas, data 

Caroline Potts, Head of Research and Development, Northumbria Healthcare NHS Trust

11:00     Morning Break

11:30     CASE STUDY: Patient centricity in action at the largest fundraising medical research charity in the world – Cancer Research UK

  • Implementation of an organisation-wide patient involvement strategy
  • Challenges and opportunities for a patient centric approach in the early phase oncology trial setting
  • Patients as key stakeholders in the development of trial protocols and informed consent documents

Dr Stephen Nabarro, Head of Clinical Operations and Data Management, Cancer Research UK Centre for Drug Development, UK 

12:00     CASE STUDY: The Accidental HTA case

Marleen Kaatee, Founding President, PSC Patients Europe, Netherlands

12:30     Lunch 

13:30     CASE STUDY: Home care visits in clinical trials – reduce the burden of study participation for your patients!

  • How home care visits can be organized
  • Which tasks can be offered in the home of the patients
  • Benefits for patients and sites
  • Effects on recruitment rates and retention

Bettina Bergtholdt, Managing Partner, Emovis GmbH, Germany

14:00     CASE STUDY: An industry perspective on third party contracting from PCMG

Lan Bandara, Global Head of Outsourcing, Eisai Limited 

14:30     Afternoon Break 

15:00 How to operate in different contract models

            Dorte Pedersen, Senior Outsourcing Manager, Lundbeck, Denmark

 15:30  CASE STUDY: Clinical QMS- a conceptual framework.

The TransCelerate Quality Management System Initiative has identified potential benefits that could be captured from the development of a proactive and flexible conceptual framework focused on assisting an organization in creating a quality management system (QMS) designed to better manage and navigate its complex clinical trial environment. The Clinical QMS Conceptual Framework will ultimately serve as a resource to help expedite the drug development process and improve quality across the spectrum of clinical activities by:-

  • Accelerating delivery of new products to patients
  • Reducing delays in clinical development
  • Improving issue management across the enterprise
  • Encouraging a “get it right the first time” approach to avoid preventable re-work

A Clinical QMS provides an integrated and harmonized system throughout an organization and better enables quality. Most importantly, a Clinical QMS can improve performance within an organization.

James Muller, Head QMs Oversight, Medical Quality Assurance, Member of TransCelerate Biopharma Inc. – Quality Management System Initiative, Pfizer, UK

16:00     End of Workshop

09:00 - 16:00 420 mins
WORKSHOP B: Making the Development of New Treatments More Patient Focused - Why It’s Important and How and When to do it
Workshop B: Making the Development of New Treatments More Patient Focused - Why It’s Important and How and When to do it. An interactive and practical training session for industry
  • Claire Nolan - Research Involvement Manager, Parkinsons UK
  • Nicholas Brooke - Chief Executive, PFMD (Patient Focused Medicines Development) and The Synergist
  • David Gray - Senior Director, Neuroscience Research Unit, Pfizer, USA
  • Ben Cromarty - North Yorkshire AIDS Action (NYAA), UK Community Advisory Board (UK-CAB), Medical Research Council Clinical Trials Unit at University College London Patient and Public Involvement Group, UK
more

Patient engagement, patient-centric and patient-focused are all terms that are now frequently used in the context of developing new treatments. But what do they mean? There is increasing evidence that effective patient engagement can improve the quality, relevance and success of research but often a lack of support, guidance and training to do so is a barrier to meaningful patient engagement. Many initiatives are now in place both nationally and internationally to break down the barriers to industry and patients working collaboratively to develop new treatments but there is more to be done. European Patients’ Academy of Therapeutic Innovation (EUPATI) is one of many training initiatives that have been developed to support patients to engage and work with the research and development community as well as with regulators and Health Technology Assessment (HTA). To compliment this type of exemplary training, Patient Focused Medicines Development (PFMD) and Parkinson’s UK have worked with a group of stakeholders including patients, pharmaceutical representatives, researchers and experts in the field of patient engagement to develop a practical and interactive training session to support industry representatives to work with patients.

This workshop will present evidence that patient engagement improves medicines research and development processes and benefits the stakeholders involved when done right, draw on case studies of best practice, and tackle practical questions of how to effectively involve patients to produce more targeted outcomes.


Topics to be covered: 

• What do we mean by patient engagement and why is everyone talking about it?

• When to involve patients in R&D and how?

• What do we know about the practical impact of patient engagement?

• Planning your own patient engagement.

• What support and resources are available?


Who should attend:

Anyone involved in the planning and design of research studies and clinical trials, and in particular, those who are not sure where to start patient involvement and engagement in medicines development continuum. This may also be suitable for people responsible for patient involvement and engagement as a tool to support their work.

What will you gain from attending?

The participants in the workshop will gain an understanding of the importance of involving patients in developing ideas in different aspects of research. They will gain some insight into the challenges and benefits of working with patients as well as practical information, advice and tools into how to meaningfully work with patients in this way.


Workshop Leaders:

Claire Nolan, Research Involvement Manager, Parkinson's UK

Nicholas Brooke, Chief Executive, PFMD (Patient Focused Medicines Development) and The Synergist

Guest speakers/co-leaders:

David Gray, Senior Director, Neuroscience Research Unit, Pfizer, USA


09:00 - 16:00 420 mins
WORKSHOP C: Project Management in Clinical Trials and Conflict and Communication
Workshop C: Project Management in Clinical Trials and Conflict and Communication
  • Christine Unterhitzenberger - DBA Programme Leader, Liverpool John Moores University, UK
  • Simon Taylor - Chief Operating Officer, Th3rd Curve, UK
  • David Bryde - Professor in Project Management, Liverpool John Moores University, UK
  • Moderator Roger Joby, R. & N.R. Consulting Ltd., UK
  • Anna Matranga - Strategic Sourcing R&D, Consultant, AMC Alliances & Consulting, France
  • Jennifer Emerson - Consultant,, Emerson Consulting & Clinical Research Services, Germany
more

09:00     Registration

MORNING: ADVANCES IN PROJECT MANAGEMENT FOR CLINICAL TRIALS

09:55     Chairperson Opening Remarks

Roger Joby, R. & N.R. Consulting Ltd.

 

10:00     CASE STUDY: Organisational Justice, (the perception of fairness), and its impact on project performance

  • Outsourcing in the construction industry
  • Christine Unterhitzenberger, DBA Programme Leader, Liverpool John Moores University

 

10:30     JOINT PRESENTATION: Pain and gain risk sharing contracts 

  • what can clinical research learn from the HS2 (High Speed Railway line)
  • How to introduce this contract into clinical research.
  • What can clinical research learn from HS2?

Simon Taylor, Head of Programme Planning, HS2 Ltd and Roger Joby, R. & N.R. Consulting Ltd.

 

11:00     Morning Break

 

11:30     CASE STUDY: Agency problems and their impact on outsourced projects

  • Strategies for dealing with difficult stakeholders
  • 4 case studies 2 from construction and 2 from clinical research

Professor David Bryde, Professor in Project Management, Liverpool John Moores University

12:00     Ask the Expert: Question and Answer

Current Project Management Research

  • Ideas on project success
  • Principle Agent Theory
  • Fairness in the workplace

PM Tools

  • Earned Value Management
  • Risk Analysis
  • Planning
  • Scheduling
  • Stakeholder engagement

Communication

  • The art of good communication
  • Leadership
  • Motivation

Outsourcing Models

  • Types of contracts
  • Lessons from other industries
  • Risk sharing models

PM Trends

  • Agile project management
  • The Digital Revolution

12:30     Lunch 


AFTERNOON: IMPROVING COMMUNIVATION AND CONFLICT AWARENESS TO BETTER MANAGE YOURSELF AND YOUR PARTNERSHIPS

13:30 to 16:30 

 Aim of the workshop session 

As a participant to this workshop, we would like you to come prepared mentally with some prior examples of disputes and miscommunications. We will apply theses to processes and tools in order to increase awareness of yourself when in disputes, how to manage your emotions and demonstrate that you are actively listening. Communicate what is important to you beyond blame or positions, with the objective to improve your communication and its impact both in and outside of the conflict circle.

Content: 

  • Communication – perception vs reality vs our identity/values
  • Engaging with the complexity of conflict- Understanding the nature of disputes
  • Conflict Disorientation - How people respond in conflict and how our communication changes -looking beneath the surface of disputes to understanding the impact on yourself and others
  • Dispute exploration utilising the conflict circle– How conflict is expressed through our emotions, cognitions, behaviour and our verbal communication & Identifying core fears and elements that distort our interaction
  • Strategic questions to ask yourself/other at stages of the circle, how to practically increase information between parties, overcome conflict and optimise your understanding in a dispute
  • The value of communication in re- framing the dispute
  • Ingredients to enhance communication based on scientific and psychological principles- To constructively engage, manage, and resolve disputes

16:00 to 16:30 Communication for Successful Negotiation – Jennifer Emerson

All successful negotiations have one thing in common, nobody leaves the bargaining table feeling like they were taken advantage of. But how do you get there in today’s competitive environment where critical conversations sometimes focus more on personal agendas rather than on collective goals?

In this workshop, participants will learn actionable strategies. We will begin with the 3 steps all successful negotiators take to prepare for negotiations, including questions you should answer before you even sit down at the bargaining table. You will learn techniques to use during the negotiations to help you understand the other party’s position. This content also includes material to help participants understand the ways that Culture can affect negotiations. This workshop offers strategies for before, during, and after the time you meet your negotiation partner at the bargaining table.

Workshop Objectives

Participants will be able to: use questions to prepare for any negotiation situation; evaluate which negotiation tools and techniques to use for best effect during different negotiation situations; and identify important follow up steps to ensure successful future negotiations

 

Anna Matranga, Strategic Sourcing R&D, Consultant, AMC Alliances & Consulting

Jennifer Emerson, Consultant, Emerson Consulting & Clinical Research Services, Germany

09:00 - 16:00 420 mins
WORKSHOP D: Clinical Trial Budget Management and Forecasting
Workshop D: Clinical Trial Budget Management and Forecasting
  • Dr Frank Berger - Head, Study Budget CoE, Clinical Operations, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
more

09.00     Registration

09.50     Opening remarks from the chairperson:

Introduction:

The Pharmaceutical industry experiences difficulty in predicting spending for its most costly area - clinical development - and struggles to create accurate, realistic and stable clinical study budgets. This results in very high cost variances from baseline forecast to actual.

 Topics to be covered:

  • Trial Design – underlying cause of problems
  • Feasibility and Patient recruitment – underinvested step
  • Single study budget versus portfolio budget management
  • Trial site negotiations – investigator needs
  • Trial Site Compensation – What Trial Sites have to consider to work cost-effectively?
    • Site compensation: investigator perspective
    • Exploring budgeting, direct costs and indirect costs
  • Change control and budget monitoring – to keep on track

What will you gain from attending?

During this workshop we will look into key aspects of clinical trial design and conduct and discuss what common mistakes are usually made that lead to failure of budget forecasting and how we can avoid it. We will discuss how to prepare and implement more strategic approach to budgeting and we will share best practice and knowledge from successful trials.

09:00 - 16:00 420 mins
WORKSHOP E: Biomarkers in Early Clinical Development
WORKSHOP E: Biomarkers in Early Clinical Development
  • Sidath Katugampola - Biomarker Development Specialist, Centre for Drug Development, Cancer Research UK
  • Thomas Joos - Deputy Managing Director, NMI
  • Maria Burian - Associate Director, Innovation Unit Speciality Therapeutics, Grünenthal Group, Germany
  • Adam Cohen - CEO, CHDR
more

09:00 Registration 

10:00 Opening remarks from the Chair

Maria Burian, Associate Director, Innovation Unit Speciality Therapeutics, Grünenthal Group

10:15  Challenges of implementing biomarkers to early clinical development 

  • Why we need biomarkers in early clinical development
  • Case studies where biomarkers have made a significant contribution to early phase studies
  • Challenges; scientific for pharmacodynamics and patient selection
  • Challenges; logistical, operational, sponsor, analysing lab and beyond

Sidath Katugampola, Biomarker Development Specialist, Centre for Drug Development, Cancer Research UK

11:00 Morning break 

11:30 A new tool to translate data from an IB into an overview of potential risks. The connection of collected preclinical data

  • Clinical investigators and regulators involved in early drug and device development projects get exposed to a large collection of preclinical data and have to make an independent assessment of benefits and risks of a new health care intervention for humans by translating these data in some integrated manner
  • Connecting this collection of data is the key and there is no standardized methodology available to evaluate and communicate the data in a concise manner
  • We propose a standardized and generic approach that gives a risk-coded overview of the data

Prof Adam Cohen, CEO, Centre for Human Drug Research (CHDR), The Netherlands

12:15 Lunch

13:15 Biomarkers and translational research: Using biomarkers for early phase clinical trials to demonstrate the drug is doing what it is supposed to be doing 

  • Biomarker qualification process and regulatory data submission
  • Biomarker utilization in stratified medicine

Maria Burian, Associate Director, Innovation Unit Speciality Therapeutics, Grünenthal Group

14:00  Immunoassay validation for a biomarker qualification process

  • The IMI SAFE-T consortium approach for drug induced organ injury biomarker qualification in a public-private partnership
  • Immunoassay validation for the quantification of biomarkers in clinical samples
  • A generic scientific qualification strategy for translational safety biomarkers

Dr Thomas Joos, Deputy Managing Director, NMI

14:45 Panel discussion and extended Q&A

15:50 End of workshop