10:00 Examining the Challenges with Sourcing the Right CRO and Vendors for Global Trials

Transcription

1 Outsourcing in Clinical Trials East Asia 6 th December 2017 Program Day One 08:30 Registration and Refreshments 08:50 Chair s Opening Speech 09:00 The Key Elements to Success: Learning about the Essential Areas to Consider When Choosing a Vendor The experience tells all looking at past vendor performance as the main area to consider for compatibility Examining the quality and capabilities of the trial team determining their suitability to your trial Debating the importance of training and development is your vendor equipping their team with the skills to deliver your trial on time and on budget? Developing SOPs and a quality metric system to rank your preferred vendors and choose the right partner for your trial Speaker: PJ Chen, Vice President, Global Clinical Development, United Neuroscience 09:30 Utilizing an Electronic Data Capture System to Manage Vast Amounts of Data Easily and to Visualize Data Analysis Gathering and analyzing study data to support safety and integrity Testing usability of the EDC system to determine if it is user-friendly for your site staff and to avoid data delivery delays Increasing work productivity by implementing an EDC system that can support the complexity of your study design Exploring key areas to consider when sourcing an EDC vendor such as compatibility, interoperability and team support Reserved for Covance 10:00 Examining the Challenges with Sourcing the Right CRO and Vendors for Global Trials Assessing the international capacity of your local vendors can they effectively manage your international trials from their local base? Getting local recommendations when struggling to find a vendor pool in the country Partnering with local CROs to get updates on regulatory changes and support at the local level Referencing past international study experiences of the team and project manager to examine their suitability to execute the study

2 Speaker: KwanGoo Cho, CEO, Quratis 10:30 Morning Refreshments and Networking 11:00 Improving Trial Progress and Data Quality by Promoting Engagement with your Vendors Outlining the growing needs of pharma to work with multiple vendors and recognize their important role as partners in clinical trial delivery Addressing difficulties early when working with vendors - improving communication to suggest solutions to small issues before they become serious problems Emphasising the importance of engaging with all vendors and developing a partnership rather than a customer model to support trial success Building rapport and acknowledging communication as the key to ensuring good quality rather than a mere way to exchange information Speaker: Eddie Tam, Head of Scientific & Clinical Procurement, Asia & JPAC, Sanofi 11:30 Visualising Trial Timelines to Effectively Forecast Budgets and Quality Expectations Throughout the Study Understanding time means money steps to reduce delays and save unanticipated costs Having a detailed discussion to determine each party s responsibilities and accurately budget time and resources Consistently having open communication during the study for both parties to be aware of any delays Utilising a performance checklist to examine the progress and ensure all tasks are complete on time and on budget Reserved for Event Sponsor 12:00 Setting Expectations Early in Contract Negotiations to Avoid Miscommunication and Unmet Needs Contracting vendors with previous success in your therapeutic area or the suitable experience to deliver your trial successfully Getting a mutual understanding on quality expectations at the contract writing stage to minimize problems down the line Planning more accurate timelines by fully understanding the required work level and scope of work Developing performance metrics and KPIs to review the quality of work frequently to minimize unmet expectations 12:30 Lunch and Networking

3 13:30 Managing Global Sites with Clear and Open Communication to Meet Expected Timelines and Quality Exploring communication barriers with international partners and steps for determining effective ways to communicate Examining the benefits of regular face to face meetings with your CRO rather than virtual communication to build strong relationships Promoting as the main communication platform to have clear delivery of messages avoiding miscommunication by keeping a paper trail The role of technology in facilitating 24 hour communication and helping sponsors have clearer oversight over vendor performance Speaker: Joan Shen, VP, China Development Head, Janssen (session TBC) 14:00 Sharing Approaches to Motivation Getting the Most from Your CRO Treating your CRO as partner to give them ownership over the study and build engagement Addressing how to approach reviewing work quality and the consequences of under-performance Are financial incentives effective in improving CRO performance exploring alternative options for performance management Steps for requesting for further resources and staff members if you feel your trial isn t progressing as expected Speaker: Carrie Duan, Head of Clinical Project Management and Operations, Baxter 14:30 New drug development strategy using genome big data and AI The paradigm shifts from the Evidence based medicine era to precision medicine. The key to the precision medicine related drug development is genome big data Genetic Big Data, Hospital big data Speaker: Tyson Kim, Managing Director, SyntekBio 15:00 Afternoon refreshments and networking 15:30 Speaker Hosted Roundtables Each roundtable session lasts for 45 minutes, and delegates may attend 2 roundtable topics.

4 Roundtable 1 Identifying approaches to effectively source comparators in accordance with trial timelines Genexine (Session TBC) Roundtable 2 Ensuring avoidance of temperature and quality excursions at warehouses to minimize supply chain disruption Mark Taegon Baik, Vice President R&D Yuyu Pharma (Session TBC) Roundtable 3 Considering different approaches to minimize cost during shipment and maximize quality Suyoun Yang, Clinical Research Head, Mundipharma Roundtable 4 Professional and Efficient Resolution How to Manage Business Continuity SOUSEIKAI Global (Session TBC) Roundtable 5 Getting to Know Your CRO Finding Synergy to Work in Sync EunJu Lee, Senior CRA, GL Pharm Tech Roundtable 6 17:00 Improving the ways to communicate with your CRO Lee Young Lee, Administration Manager, Medpacto Chair s Closing Remarks Outsourcing in Clinical Trials East Asia th December 2017 Program Day Two 08:30 Registration and Refreshments 08:50 Chair s Opening Remarks 09:00 Where Should We Run Our Global Trial? Key Areas to Consider When Determining Trial Destination Analyzing the full cost of conducting a trial based on cost, quality, speed

5 and how clinical trial friendly the environment is Evaluating your knowledge and competitive position in the country such as language and network to see how fast you can set up a trial Deciding the trial destination based on priority cost, speed or patient population Recognizing language competency as a key factor to communicate with the local CRO effectively Speaker: Cristina Chang MD, PhD, Vice President, Clinical Development/Operations and Medical Affairs, ObiPharma 09:30 Let s Talk Money: How to Minimize Hidden Costs at the Beginning and During the Trial Can we avoid hidden costs with meticulous contracts steps for reducing surprises Exploring commonly overlooked areas to allocate sufficient budgets determining areas of the trial which may need a contingency budget Understanding the different requirements and scope of service you need for each stage of the trial Assigning excess budget in case of protocol amendments and timeline delays Ensuring sustainable sources for funding in case of additional costs required for the trial Session reserved for Event Sponsor 10:00 Exploring and Overcoming the Challenges of Planning a Trial in China Assessing the benefits of working with regulatory agencies or specialist companies to streamline complying with local regulation Examining how to make the most from working with local vendors who are familiar with the local environment and have strong local networks Sourcing infrastructure in China such as labs and sites to meet local regulatory requirements How is China developing as a Phase 1 destination - strategically organising resources and a team of experts to plan phase 1 trials in China Speakers: ChangGun Kim R&D Business Manager & ChunSan An, Chief /International Business & Development, GNT Pharma 10:30 Morning Refreshments and Networking 11:00 Developing Outsourcing Models for Small Pharma Overcoming Challenges Specific to this Part of the Industry Addressing the limited resources to search and plan global trials how to

6 make your resources stretch Promoting working with comparable smaller CROs to meet the expectation in cost and size Considering virtual trials as a cost-saving method and to reduce timelines How should small pharma approach risk-sharing models with CROs? Steps for winning support and funding from government and research funding organisations Speaker: Shunsuke Abe, Scientific & Clinical Procurement Head of Japan, Sanofi (session TBC) 11:30 Clinical trial preparation using Oncolytic Virus The first oncolytic ReoCure (Reovirus) clinical trial in Asia The First gastric cancer trial using ReoCure (Reovirus) Bio-innovative drug development using oncolytic virus in Asia Speaker: Manbok Kim, CEO, ViroCure 12:00 Choosing your Outsourcing Model - Finding your Fit-for-Purpose Outsourcing Strategy Thoroughly analysing your internal resources to manage the clinical trial to see where you need to outsource and what you can keep in-house Reviewing the study design and characteristics to identify where you need to work with specialised vendors Planning the outsourcing strategy at each stage to ensure you have the capacity to meet each requirement Comparing different outsourcing approaches to find the right model for your trial comparison of full-service to multiple outsourcing The role of outsourcing in enhancing capacity and global reach Reserved for Artemida Pharma 12:30 Lunch and Networking 13:30 Speaker Hosted Roundtables Each roundtable session lasts for 45 minutes, and delegates may attend 2 roundtable topics. Roundtable 1 How often do we need to change our vendor? Young-Lim Kim, Site relationship and operations Lead, Merck

7 Exploring the latest technology to enhance patient recruitment Roundtable 2 ChunSan An, Chief /International Business & Development, GNT Pharma (Topic TBC) Roundtable 3 What is the best way to source a vendor when your company size is small? Moon Hwan Kim, Vice President, Aribio Roundtable 4 Exploring efficient labelling strategies for global trials YongKwan Kim, Clinical Trial Manager, Janssen 15:00 15:30 Roundtable Summary Each host will take 5 minutes to summarise the key lessons learned from the discussion. Chairman s summation and close of conference