2018 Speaking Faculty

Transcription

1 2018 Speaking Faculty Hong Guo, Chief Medical Officer & VP of Clinical Development, Beijing Shenogen Biomedical China Michael Lee, Senior Vice President, Mab-Venture Bio China Tai Jung Wu, Senior Manager of CMC and Manufacturing, Gongwin Biopharm Taiwan DaeMan Moon, Team Leader, Development Supply Chain, Celltrion Korea Chih-Ping Liu, Vice President, TTY Biopharm Company Taiwan Sung Eun Kim, Executive Director, LSK Global Korea Seung Jun Yoo, Managing Director, KoreaBIO Korea Moon Hwan Kim, CTO, BiSiChem Korea Eddie Tam, Scientific & Clinical Regional Procurement Head - China, Asia, JPAC, Middle East,Turkey, Africa & Eurasia, Sanofi Singapore Main Fong Ang, HK Hub Lead, Development Operation Management, Amgen Hong Kong John Patava, Director of Global Clinical Affairs, Sirtex Australia Shunsuke Abe, Head of Scientific & Clinical Procurement, BMS Japan Hyun-Jin Yang, Medical Science Liaison, Synteka Bio Korea Hye Jung Lee, PhD, President & CEO, Caleb Multilab Korea Miyang Kim, Associate Director SROL, Merck Korea Korea Sung Hye Kim, Clinical Development Associate Director, Navipharm Korea Shau-Feng Chang, CEO, BELX Biopharmaceuticals Taiwan Bokjin Hyun, Regional Outsourcing Lead Asia, BMS Korea PJ Chen, President, United Biopharma China Taiwan John Moller, CEO, Novotech Australia Rong Chen, Chief Medical Officer, JHL Biotech Taiwan Akhilesh Sharma, President & Chief Medical Officer, Alkem Laboratories India Yu Ichige, Head of Clinical Operations: Japan, Korea and Taiwan, BMS Japan Chanmin Ahn, RA director, CGBio Korea Yan Wu, VP, Head of Clinical Operation, Hutchison Medipharm China Seonggu Ro, CEO, PiMedBio Korea Joan Shen, Head of R&D, I-Mab Biopharma China Seunghee Lee, Sr. CRM, Mundipharma Korea Jungwon Jung, QA Director, CJ Health Care Korea Cheol-Hee Lim, Associate Director, DreamCIS Korea Namshik Kim, CEO, PharmaCRO Korea Yoonjung Choi, Clinical Trial Management Director, SCM Lifescience Korea A Young Kim, Senior Global Clinical Trial Manager and Project Manager, CKD Pharma Korea Bev Thomas, GM Operations, PCI Clinical Services AUS Ian Hoban, Sales & Marketing director, Pilatus UK Victoria Maguire, Project Group Manager - Supply Chain Management, Almac UK Further Information For sponsorship opportunities please contact: Paul Adams PaulAdams@arena-international.com Tel: For programme enquiries please contact: Jisong Seo jisong.seo@arena-international.com Tel:

2 Conference Name: Outsourcing in Clinical Trials East Asia Conference Date: 5 th 6 th December Programme Day One 08:15 Registration and refreshments 08:50 Chair s opening remarks Assessing the changing clinical trial regulations in Korea and the integrated drug control system 09:00 Exploring the new regulation direction in Korea compatible with global standard Highlighting the importance of planning Drug Safety Information Management in early stage for easy access on IND approval Considering the impact of regulatory plans of narcotic drug approval in clinical trials for your study and building your timeline Accordingly Seung Jun Yoo, Managing Director, Korea BIO Investigating Australia's 43.5% R&D Refund and Simplified Regulatory Environment as a Gateway to Asia 09:30 Presenting how Australia s scientific talent, excellent medical infrastructure and lucrative 43.5% R&D cash refund scheme makes it a preferred destination for early phase clinical trials. Recognizing that patient availability makes Asia a key region to accelerate later phase development, at lower costs. Highlighting the partnership between regional specialists, an alternative to large global CRO to manage complex global trial while keeping the flexibility required for Mid-size Biopharma companies. John Moller, CEO, Novotech Developing methodologies for RBM(Risk Based Monitoring) and oversight 10:00 Exploring remote risk assessment to optimize clinical trial outcomes and creating a framework for risk based monitoring Leveraging experienced partners to enable risk based monitoring to ensure a successful clinical trial Implementing technologies and setting expectations with the partner in risk based monitoring to make a smooth run of trial Miyang Kim, Associate Director, SROL, Merck 10:30 Session reserved for Sponsor 11:00 Morning refreshments and networking Preparing global approval in a single trial: Detailing an overview of the FDA regulatory approval requirements and global standard 11:30 Overviewing the regulatory approval process and trial requirements for FDA and MFDS Supporting US and Korea clearance in a single trial: Harmonization of requirements to ensure trials efficiency Involving international vendors who are experienced in both markets from trial set up stage to kill two bird with one stone

3 Hye Jung Lee, PhD, President & CEO, Caleb Multilab 12:00 Session reserved for Sponsor Leveraging global trials into winning regulatory strategies to get approvals across various regions 12:30 Outlining the main changes in clinical data collection in Europe with regards to GDPR and analyzing impact on your ongoing study Examining how data collected outside of Europe is classified under GDPR and how trial sponsors should manage this information to be compliant Identifying which data is not applicable to GDPR and how to utilise this to enhance trial operations Akhilesh Sharma, President & Chief Medical Officer, Alkem Laboratories 13:00 Lunch and networking Preparing your device to be tested in Europe under MDR to ensure smooth trial operations 14:00 Overviewing changes on the expectations on clinical data requirements for CE Marking Process and impact on your on-going study Determining effective methods of collecting sufficient clinical data for CE Marking Identifying a suitable active and systematic post-market surveillance method Chanmin Ahn, RA director, CGBio 14:30 Session reserved for Sponsor Exploring effectiveness on AI in new drug development in changing paradigm to Personalised Medicine 15:00 Minimising trial failure probability by reviewing the data collected prior to setting up the protocol for your study Identifying the best fit for your patient population in a personalised medicine trial by assessing the know side effects Reviewing real world case studies of new drug development in partnership with AI solution Hyun-Jin Yang, Medical Science Liaison, Synteka Bio 15:30 Afternoon refreshments and networking Exploring the role of Medical Affairs and how cohesive work with Clinical Operations can lead to successful execution of clinical trials 16:00 Considering the role of medical affairs in a successful investigator initiated study program Describing the use of the field based medical affairs group within the initiation of clinical trials Impacting clinical trial recruitment with direct medical affair involvement Ensuring appropriate compliance between medical affairs within a clinical trial program Shau-Feng Chang, CEO, BELX Biopharmaceuticals

4 16:30 Session reserved for Sponsor Global trend in patient recruitment: Designing patient-centric trials to attract patients and minimize drop-outs 17:00 Evaluating trial needs and clearly communicating your recruitment requirements to trial team and CRO from the outset Designing and implementing the patient friendly clinical trial Examining the process and outcomes from the patient s perspective Preparing attractive description for your trial to get investigators on board John Patava, Director of Global Clinical Affairs, Sirtex 17:30 Chair s summary and close of conference Conference Name: Outsourcing in Clinical Trials East Asia Conference Date: 5 th 6 th December Programme Day Two 08:15 Registration and refreshments 08:50 Chair s opening remarks A SME perspective: Engaging CROs as a study partner to make your trials their priority and ensure you keep to study timelines 09:00 Determining how to effectively manage CRAs internally to focus on your priorities and necessary work Identifying a person with expertise in your study and ensuring a single point of contact to maintain effective communication Investigating what current systems and tools exist to aid management of vendors in a cost and time-effective way Highlighting the long-term benefits of investing on internal training program to enable successful vendor management Sung Hye Kim, Clinical Development Associate Director, Navipharm 09:30 Session reserved for Sponsor 10:00 [Panel Discussion] Understanding the benefits of a strong partnership: CRO-sponsor perspective on cooperation and study management Assessing CRO selection and bid-process: the importance of transparency on both ends to avoid dispute over crisis Highlighting sponsor oversight & responsibilities and interaction with the CRO to ensure partnership Empasising CRO s ownership on study management to keep the study timeline and unification

5 Identifying ways for a successful study conduct in regards to regular communication Mainfong Ang, HK Hub Lead, Development Operation Management, Amgen Bokjin Hyun, Regional Outsourcing Lead Asia, BMS [Reflection Workshop] Redefining best practice for partnering in lights of each perspective 10:45 In this session, participants will be separated into small groups and discussing about best strategies of outsourcing model and how to effectively oversight your partners considering lessons learned from sessions above. 11:00 Morning refreshments and networking Sharing trend and regulatory requirements of clinical trials in Japan for non-japanese players 11:30 Analyzing issues on setting up clinical studies in a few different Asia region and building protocol on it Reviewing Japan s ethical standard and clinical data requirements to avoid conducting additional trials for Japan Finding out what cultural difference should be considered in Patient recruitment to ensure project timeline Sharing common challenges of outsourcing model in local community and selection process to ensure smooth communication Shunsuke Abe, Global Procurement Site Lead Japan, Korea and Taiwan, BMS Building strategies for selecting Eastern European sites for studies and reducing delay factors 12:00 Investigating special needs for clinical trials conducted in Eastern European countries Identifying the special need for hybrid products Building regulatory strategies to access unknown market with single trial Analysing the challenge of CRO selection in local market and building strategies to overcome it A Young Kim, Senior Global Clinical Trial Manager and Project Manager, CKD Pharma CRO selection and Management -- Under the new era of Regulatory revolution in China 12:30 Exploring the Chinese regulatory environment to anticipate the practical challenges for trial sponsors Developing strategies for partnering with local and international CROs when considering a clinical trial in China Debating whether a regulatory evolution is needed to support developing clinical trial operations in China and to amplify drug development Yan Wu, VP, Head of Clinical Operation, Hutchison Medipharm 13:00 Lunch and networking Discussing challenges of conducting Multiregional Clinical Trials(MRCT) and how to select global clinical sites to ensure getting valid clinical data 14:00 Highlighting the challenges of working with multiple parties for global clinical trials and building effective communication platform Appreciating advantages of working with local experts who can provide qualified services to ensure you meet respective requirement Building strategies to negotiate better terms with vendors by explaining prospective development opportunities Introducing criteria that you need to consider to choose sites in global locations to ensure smooth operations

6 Eddie Tam, Scientific & Clinical Regional Procurement Head - China, Asia, JPAC, Middle East, Turkey, Africa & Eurasia, Sanofi Discovering best practice for effective oversight of global partners to ensure smooth running of your global study 14:30 Emphasising the importance of having face to face meeting with your international partners to double-check their work and keep your study a priority Considering having a full-time employee or partner in your clinical site to oversee vendors Ascertaining the impact of cultural differences to ensure vendors are in same line with you and do have the capabilities to meet your expectations Underlining the importance of translation of protocol, contract and the written materials to ensure accurate communication PJ Chen, President, United Biopharma China 15:00 Afternoon refreshments and networking Speaker Hosted Roundtables 15:30 Roundtable 1 Roundtable 2 Roundtable 3 Roundtable 4 17:00 Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each roundtable session lasts for 45 minutes, and delegates may attend up to 2 roundtables Building pre-clinical stage early from Lab to Phase 2A trials to ensure conducting trials smoothly Seonggu Ro, CEO, PiMedBio Discussing best strategies to select global CROs and trial sites in global location for your study Moon Hwan Kim, CTO, BiSiChem Developing communication channel with supply vendors to react real-time to supply crisis Seunghee Lee, Senior CRM, Mundipharma Building multilateral supply strategies to conduct Multiregional Clinical Trials in light of developing regulations Hong Guo, Chief Medical Officer & VP of Clinical Development, Beijing Shenogen Biomedical Chair s summary and close of conference