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7:40 am 8:40 am (60 mins)

Main agenda

Registration and Morning Coffee

8:40 am 8:45 am (5 mins)

Main agenda

Opening Remarks from the Chairperson

  • Greg Koski - MD, President and CEO, Alliance for Clinical Research Excellence and Safety, ACRES, USA

9:30 am 10:15 am (45 mins)

Main agenda

The Future of Clinical Trials: Rethinking the R&D Clinical Process

  • Eliminating Division in Clinical R&D & Trial Design
  • Radically Changing Clinical Trial Processes to Streamline R&D & Lower Costs
  • Examining Real-World Examples & Methodological Thinking in Trials

   

  • Presenter Rohan Sonawane - Principal Clinical Marketing Specialist, Medtronic Diabetes, USA

10:15 am 11 am (45 mins)

Main agenda

Morning Coffee and Networking

11 am 11:05 am (5 mins)

Partnerships and Collaborations: Forming Alliances That Last

Opening Remarks from the Chairperson

  • Greg Koski - MD, President and CEO, Alliance for Clinical Research Excellence and Safety, ACRES, USA

11:05 am 11:40 am (35 mins)

Partnerships and Collaborations: Forming Alliances That Last

PANEL DISCUSSION: Collaboration and Partnerships with Sites: Interaction Between Sites, Sponsors, CROs and External Vendors

  • Contracting with sites: It can be challenging to negotiate a contract with the CRO or Sponsor--most contracts are standardized and don’t take current activities into account
  • How do we design studies? What can we do to improve?
  • Exploring new ways to work with sites. Examining better opportunities to improve the site selection process
  • How to increase the closer collaboration with health care professionals and the logistics of that
  • Complexity of studies is increasing more and more: Training requests for site staff is increasing
  • Why is there such a high site turnover? Are sites leaving clinical research and if so then why?
  • What is the economics of being an investigator site? 25% of trials is spent on investigator fees. How are we working out this fee?
  • Lorraine Rusch - President, High Point Clinical Trials Center, USA
  • Greg Koski - MD, President and CEO, Alliance for Clinical Research Excellence and Safety, ACRES, USA
  • Kimberly Kundert - Senior VP of Operations, Synexus, US
  • Keith Bradley - Chief Executive and Chief Medical Officer, The National Alliance of Research Associates Programs (NARAP)

11:45 am 12:20 pm (35 mins)

Partnerships and Collaborations: Forming Alliances That Last

INTERACTIVE HUB: Why Are There Always Complaints and What Can We Do to Fix It?

There is a lot of excitement surrounding significant partnership deals between CROs and Pharma companies. With all of this excitement, there still seems to be a lot of dissatisfaction from pharma and from CROs. The quality of delivery is not what pharma want, whether this is fact or a perception it still sullies the satisfaction around these landmark deals. CROs are again achieving margins which allow growth but is this at the cost of any real innovation being driven by the CROs as there was in the naughty’s? This presentation will address all sides of what we can do to fix the complaints rife in the outsourcing world.

  • Ms Julianne Hull - CEO, WenStar Enterprizes
  • Richard Young - VP, VaultEDC, Veeva Systems, UK

12:15 pm 12:45 pm (30 mins)

Partnerships and Collaborations: Forming Alliances That Last

PANEL DISCUSSION: Are Strategic Partnerships Living Up to What They Promised in Terms of Cost, Efficiency and Service Quality?

  • What is a typical partnership in the 21st Century?
  • Innovative strategic partnerships/collaboration and breaking silos within corporate organizations: HIVE collaboration (Helping Improving Volunteer's Experience)
  • How to improve transparency between CRO and sponsors: How to align systems, avoid duplicating work and manage mergers & acquisitions
  • What is the cultural difference between CRO and pharma? How do you bridge these cultural differences?
  • Why partnerships don’t always work: Why did it fail and what could have been done to avoid this?
  • Examples of partnerships that survived challenging times and how this was done
  • Panelist Christopher Pitcherella - Director, Clinical Trial Innovation, Global Clinical Operations, TEVA, USA
  • Deborah Profit - Leader, Otsuka Information Technology

11 am 11:05 am (5 mins)

Patients as Partners

Opening Remarks from the Chairperson

  • Albert Roy - Executive Director, Lupus Research Alliance, USA

11:05 am 11:40 am (35 mins)

Patients as Partners

PANEL DISCUSSION: Patient Centricity Should Be at the Core of All Trials – Is This the Case?

  • Real-life examples of how pharma and CROs are engaging with patients
  • Are we researching the questions that matter most to patients?
  • Are we developing interventions that meet patients' needs?
  • Are we measuring the outcomes that matter most to patients?
  • How early on should pharma and CROs involve patients?
  • What are common complaints from patients involved in a trial and how can we learn from this?
  • What are we currently doing to demonstrate patient-centricity and are we doing enough?
  • How patient-centric are we for pediatric trials? How can we improve?
  • The ethics involved and how to ensure ethical issues are considered
  • Panelist Albert Allen - Senior Medical Fellow, Pediatric Capabilities, Global Medical Capabilities and Development, Medicines Development Unit, Eli Lilly and Company, USA
  • Panelist Kenneth Farber - Co-President and CEO, Lupus Research Alliance, USA
  • Sharon Dill - MBA, SPHR, Variegate Porphyria Disorder Patient, USA

11:45 am 12:20 pm (35 mins)

Patients as Partners

CASE STUDY: Patient Advocacy Groups, Pharma and CROs: What Can Be Done Better?

  • Lupus Research Alliance’s role in clinical trials
  • Current activities
  • Lesson’s learned
  • Opportunities for both LRA and other advocacy organizations
  • Panelist Albert Roy - Executive Director, Lupus Research Alliance, USA

12:15 pm 12:50 pm (35 mins)

Patients as Partners

EDC Innovations and Integrations – Case Studies

  • Risk Based Monitoring – what has been achieved
    • Dynamically selecting data for SDV – overview of functionality
    • Some statistics from production trials
  • EHR to EDC Integration – what has been achieved
    • Implementation Options, Benefits & Challenges
    • Case Studies
  • Neil Vivian - Director of Business Solutions and Product Manager, OmniComm Systems, USA

12:45 pm 2:05 pm (80 mins)

Main agenda

Lunch and Networking

2:05 pm 3:05 pm (60 mins)

Main agenda

Inspirational Speaker: Personalized Medicine: Fighting to Cure Castleman Disease When Every Second Counts

Dr. David Fajgenbaum, MD, MBA, MSc is the co-founder/Executive Director of the Castleman Disease Collaborative Network (CDCN) and a patient battling the same rare and deadly disease--idiopathic multicentric Castleman disease (iMCD)—that he studies. He was diagnosed with iMCD while in his third year of medical school. He spent nearly 5 months hospitalized with multiple organ system failure, received his last rites (which he considers the start of “overtime”), and needed multi-agent chemotherapy to save his life. 

When he returned to medical school, he began studying iMCD and realized that it was very poorly understood and that the process to advance research was fractured and inefficient. Between subsequent life-threatening relapses, Dr. Fajgenbaum created the CDCN and has grown it into a model for international collaboration. He has published research that has changed the way iMCD is researched and treated. In fact, he is currently in his longest remission ever thanks to a precision treatment that he identified through his research at Penn that had never been used before for iMCD. He will share lessons from living in overtime and how information technology has helped to enable groundbreaking advances.

  • David Fajgenbaum - MD, MBA, MSc, Co-founder & Executive Director,, Castleman Disease Collaborative Network, USA

3:05 pm 3:40 pm (35 mins)

Main agenda

Coffee Break and Networking

3:40 pm 4:10 pm (30 mins)

Partnerships and Collaborations: Forming Alliances That Last

OXFORD DEBATE: Why Pharma and Biotech Companies Need CROs vs Companies Who Do Not Outsource

There will be two opposing viewpoints. One side will put forward the notion that CROs are vital for clinical trial success and that partnerships between pharma/biotech add great value to all those involved in the trial. The other side put forward a case that it is more effective not to outsource and will showcase the benefits of keeping everything in house.

  • Debater Nancy Meyerson-Hess - Associate Partner, admedicum Business for Patients,, Previously, Head Clinical Operations & Compliance, Grünenthal, Germany
  • Chairperson Ms Julianne Hull - CEO, WenStar Enterprizes
  • Debater William Jacobson - Senior Scientific Director, Global Clinical Science, Takeda, USA
  • Debater Frank Leu - CEO & Co-Founder, Novapeutics, USA
  • Richard Young - VP, VaultEDC, Veeva Systems, UK

4:50 pm 5:25 pm (35 mins)

Partnerships and Collaborations: Forming Alliances That Last

PANEL DISCUSSION: Third Party Vendor Oversight: Who Is Liable for the Sub-Contract Work?

  • Oversight- sponsors are required to “GCP” oversee the CROs. Oversight is tricky when working with contractors--can this be delegated to CRO, or do we need to audit the CRO?
  • Sponsor and CRO to agree on governance structure, KPIs and required changes within the partnership as of day 1 after award
  • The importance of clear responsible metrics--how do we ensure that we have got that clarified with 3rd party vendors?
  • Hear from Pharma – how they manage the CRO’s third party providers with regards to oversight and how do we get CROs to accept more risk?
  • Rick O'Hara - Associate Director, Clinical Outsourcing, Endo Pharmaceuticals
  • Nancy Meyerson-Hess - Associate Partner, admedicum Business for Patients,, Previously, Head Clinical Operations & Compliance, Grünenthal, Germany

3:40 pm 4:15 pm (35 mins)

Patients as Partners

CASE STUDY: Patient Centricity: Practical Tips for Involving the Public in Research Design and Delivery

  • What do we mean by involvement in research?
  • Why is involvement in research important?
  • Why do patients want to be involved?
  • What is the opportunity for Patients in R&D and beyond?
  • How can patients be brought at the center?
  • Where can involvement play a part in the drug development process?
  • What do we know about the impact of patient and public involvement in research?
  • Planning involvement: what needs to be taken into account?
  • Evaluating the impact of involvement
  • What support and resources are available?
  • Patricia Roselle - Patient Network Manager, Sanofi, USA

4:15 pm 4:45 pm (30 mins)

Patients as Partners

The Adoption and Implementation of an Artificial Intelligence Technology to Track and Improve Subject Compliance During Clinical Trials

Clinical trials are undertaken to evaluate safety, tolerability and efficacy of new investigational drugs. Although a drug may, in fact, be safe, effective and tolerable, a number of factors may intervene and prevent or impair accurate determination of these properties. Amongst these are study design, selection of inappropriate population, high placebo response and many others. One of the key factors contributing to this uncertainty is often adherence to or compliance with investigational product use, as per the requirements of the study protocol. Compliance is a measure of how well a subject adheres to a specified treatment regime. The issue of adherence has received more attention as researchers find ways to reduce the higher failure rate of clinical trials. Assessment of subject compliance may determine whether a negative clinical trial resulted from subject failure to take IP or from other influencing factors. The consequences of poor compliance can be significant – under compliance can lead to trials being under-powered, compromising a sponsor's ability to demonstrate a treatment effect, and an under-reporting of safety and tolerability, while over-compliance can lead to the opposite. Over the years many approaches have been used to assess compliance with study medication, including self-report, diaries, pill counts, and the use of some technologies such as Medication Event Monitoring Systems (MEMS). This presentation will examine novel digital and mobile compliance technologies, and focus on the introduction and utilization of an Artificial Intelligence platform that visually confirms medication ingestion.

  • William Jacobson - Senior Scientific Director, Global Clinical Science, Takeda, USA

4:50 pm 5:25 pm (35 mins)

Patients as Partners

Implications of a Community-Based Outreach as a Research Physician

Medical science cannot move forward without clinical research, but we all know that subject recruitment delays many of our current efforts. Perhaps it is time to consider some new approaches to this dilemma. Community-based recruitment or outreach, either on its own or paired with traditional recruitment methods may open the doors to new subjects for your research studies. This session will include a discussion on how an investigator volunteered at a local community clinic and realized not only is this a means to improve recruitment but is an effective strategy to engage, educate and support your local community and potentially open their options for new therapies.

  • Jonathan Austin - MD, CPI, High Point Clinical Trials Center, USA

5:25 pm 5:55 pm (30 mins)

Patients as Partners

ICH E6 Addendum: Risk Based Monitoring: What Will This Mean for Clinical Trials?

This Addendum is proposed to modernize ICH E6 to enable implementation of innovative approaches to clinical trial design, management, oversight, conduct, documentation, and reporting that will better ensure human subject protection and data quality. This is the biggest revision for 20 years.

  • What does this mean? What are we going to do with it?
  • How does this build on guidance already there?
  • How to interpret it and how are they reacting to it?
  • What gaps are there?
  • Are we going to be fast enough? What speed do we need to introduce things?
  • What’s the regulatory agency position on this document?
  • What’s the CRO’s view?
  • Directive within ICH E6 stating that if service providers subcontract they have to keep sponsor companies informed. How do you interpret this?
  • Quality Management systems at sight
  • Tolerance limits of clinical trials: Statistical colleagues will say this is important
  • Error limits for clinical trials: Statistical colleagues will say this is important
  • Discuss regulatory view of the Addendum
  • Look at the future vision of what it means.
  • How will we conduct trials in the future?
  • John Mann - Vice President, Project Management, PRA Health Sciences, USA

6 pm 8 pm (120 mins)

Main agenda

Partnerships Bar and Drinks Networking Reception