DAY 2 THURSDAY 7TH JUNE
08:30 Welcome and introduction to the conference
08:35 Review of the PCMG year
What’s changed, what hasn’t, and what needs to for our industry? What is PCMG doing to support its members? Key trends, learnings & leanings from the PCMG Committee
Richard Scaife, PCMG Chair
Gill Roberts, PCMG Vice-Chair
08:55 Introduction to morning session
09.00 The Biotech journey from start-up to exit: The importance of outsourcing
The role of Biotechs has changed with greater access than ever before to funding that has changed from 'hand to mouth' existence into full development pathway and ownership
Dan O’Connor, CEO – OncoSec Medical
09:45 Strategic outsourcing applied in a small Biotech
The pressures for a small biotech with tight budgets, timelines and commitments to investors can be intense and leave little or no room for error. A CEO faced with the challenges of strategic outsourcing, challenges of device vs. 'normal' study requirements and getting it right will share their experience and lessons learned working with a CRO to navigate this minefield.
Heather DiBenedetto - Head of Therapeutic Operations, Moderna Therapeutics
10:30 Networking break
Sponsored by Worldwide Clinical Trials
11:15 Time, Quality, Cost - The race to faster, better & cheaper?
When the demand to reduce timelines, meets the need to increase quality, meets the ever reducing budget, who wins?
Our expert panel share their particular perspectives on this conundrum, including presumed wisdom, published research, practical experience and perhaps a touch of personal opinion. The panel will present three scenarios, describing their own conflicting priorities, challenging the audience to re-consider their own pre-conceptions and beliefs. Be prepared to have your mind changed.
Dermot Kenny - Novartis, Chris Moore & Richard Young - Veeva
12:15 Achieving operational excellence: Are you competent?
How do you REALLY know who has the competence to work on your clinical trials?
How do you REALLY know that you are a competent outsourcing professional?
Clinical Outsourcing covers an increasing range of responsibilities required to achieve clinical trial success and outsourcers come into the role from various backgrounds.
PCMG have joined with IAOCR to help us professionalize the role of R&D outsourcing professionals, and to develop the PCMG OUTSOURCING ESSENTIALS training course into a 3-star accredited program. Find out about our journey . What lessons can you apply to Sponsor and CRO resource management?
Change is afoot – ensure you’re ready!
Jacqueline North & Martin Robinson - IAOCR, Antje Hindahl - PCMG Director
12:45 Lunch and networking break
Sponsored by DrugDev
14:00 Introduction to the afternoon session
14:10 Strategic choices when choosing an outsourcing model
There are 3 fundamental issues to consider when choosing an outsourcing model: standardization, flexibility and cost. Standardization of systems and processes is the most important factor and is too often ignored by both small and large companies when deciding how to outsource clinical trial activities. Standardization can be achieved in both the Full Service and Functional Service Provider models but requires careful consideration and evaluation of the risks and benefits. After deciding on how to achieve standardization the other filters of flexibility and cost can be applied to make a final decision.
Adrian Otte – Independent Consultant (formerly Amgen)
14:50 LIFE v 2.0.18 - Artificial Intelligence: Giving data life
Can Artificial Intelligence have real application to Pharma and clinical research? Powerhouses such as IBM, Google, Apple and Microsoft, plus other specialist technology providers have been working with large Pharma to innovate data analytics, visualisation and robotics. How and when will AI deliver meaningful and insightful data in real time which will impact and improve the way we conduct clinical trials in the future? We lift the lid on AI’s impact, lessons already learned and where we go from here in both theoretical, and practical, clinical outsourcing.
Andrew Fried - IBM UK Limited
15:30 Networking break
Sponsored by Vitalograph
16:15 "Do good relationships facilitate project delivery?" The importance of instilling the right behaviours to build effective relationships
From AI perfection to the spectrum of human nature. Despite the mechanization of communication and decision making, there are still humans involved at every step of the outsourcing process. Our panel put aside their preconceptions to consider how teams’ behavior can produce productive or destructive relationships.
Facilitator: Carl Emerson
Panel: Christian Buhlman - PSI, Adrian Otte - Independent Consultant, Heather DiBenedetto - Moderna Therapeutics, Chris Crucitti-Bracket Global
17:00 PCMG’s Room 101: email CC to EVERYONE or 50-page RFI: What is YOUR pet hate?
Join the end of day debate by helping decide what the worst practice in our outsourcing lives is and… what CAN we do to prevent it ruining our working day ever again? The panel will review usual and unusual suspects to gain the audience vote to decide the worst offences to be cast into the PCMG pit.
Chair: Graham Belgrave
Rob Aticheson - Ono Pharma UK
Chris Moore - Veeva
Mark Bee - Covance
17.45 Adjournment of conference day 2