2018 Speaking Faculty

Transcription

1 2018 Speaking Faculty A Young Kim, Senior Global Clinical Trial Manager and Project Manager, Enzychem Lifesciences Korea Akhilesh Sharma, President & Chief Medical Officer, Alkem Laboratories India Bev Thomas, GM Operations, PCI Clinical Services AUS Ian Hoban, Sales & Marketing director, Pilatus UK Bokjin Hyun, Regional Outsourcing Lead Asia, BMS Korea Chanmin Ahn, RA director, CGBio Korea Chih-Ping Liu, Vice President, TTY Biopharm Company Taiwan Chris Greco, Account Director, Comparator, Catalent DaeMan Moon, Team Leader, Development Supply Chain, Celltrion Korea David Surjo, Executive Vice President, Nuvisan Eddie Tam, Scientific & Clinical Regional Procurement Head JPAC & MENA, Sanofi Singapore Fiona Xing, Global Clinical Trial Supply Manager, Merck China Hong Guo, Chief Medical Officer & VP of Clinical Development, Beijing Shenogen Biomedical China Hsiu-ling Hsiao, CSO, Ever Supreme Bio Technology Taiwan Hye Jung Lee, PhD, President & CEO, Caleb Multilab Korea Hyun-Jin Yang, Medical Science Liaison, Syntekabio Korea John Moller, CEO, Novotech Australia John Patava, Director of Global Clinical Affairs, Sirtex Australia Jungwon Jung, QA Director, CJ Health Care Korea Kristen DeVito, Global Director, Clinical Supply Services, Catalent Michael Lee, Senior Vice President, Mab-Venture Bio China Min Young Lee, Executive Consultant, Korea Health Industry Development Institute Korea Moon Hwan Kim, CTO, BiSiChem Korea Namshik Kim, CEO, PharmaCRO Korea Nikita Avdeev, Associate Director Import/ Export, IMP Logistics (a PRA Health Sciences company) PJ Chen, President, United Biopharma China Taiwan Rong Chen, Chief Medical Officer, JHL Biotech Taiwan Seonggu Ro, CEO, PiMefjoandBio Korea Seung Jun Yoo, Managing Director, KoreaBIO Korea Sung Eun Kim, Previously Executive Director, LSK Global Korea Sung Hye Kim, Clinical Development Associate Director, Navipharm Korea Todd Galles, Business Development Principal, Durbin USA Victoria Maguire, Project Group Manager - Supply Chain Management, Almac UK Yan Wu, VP, Head of Clinical Operation, Hutchison Medipharm China Yu Ichige, Head of Clinical Operations: Japan, Korea and Taiwan, BMS Japan 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 Outsourcing in Clinical Trials & Clinical Trial Supply East Asia 5 th 6 th December Programme Day One 08:15 Registration and refreshments OUTSOURCING IN CLINICAL TRIALS EAST ASIA CLINICAL TRIAL SUPPLY EAST ASIA 08:50 Chair s opening remarks Min Young Lee, Executive Consultant, Korea Health Industry Development Institute 08:50 Chair s opening remarks Shell Lee, Supply Chain and Logistics, Melinta Therapeutics Assessing the changing clinical trial regulations in Korea and the integrated drug control system Outlining the current challenges and innovations in clinical trial supply from manufacture to patient 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 09:00 Highlighting persistent operational challenges in the clinical supply process to pinpoint areas for essential improvements Investigating the differing approach to clinical supplies for companies large and small to overcome challenges associated with Discussing the role of your vendor in your clinical supply to build effective relationships Assessing the rise in technology innovation to determine what this could mean for you supply chain now and in years to come Recognising current trends to provide a roadmap for the future of clinical supply Sung Eun Kim, Previously Executive Director, LSK Global 09:30 Investigating Australia's 43.5% R&D Refund and Simplified Regulatory Environment as a Gateway to Asia 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, 09:30 Interaction of the Commercial Supply chain with the Clinical Trial supply chain Exploring the differences and similarities Determining the impact of Commercial Supply chain models to Comparator, Standard of Care and reference drug supply - REMS, restricted supply, global supply, licensing issues Transitioning from Clinical Supply to commercial supply an emerging area for CT

3 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. Todd Galles, Business Development Principal, Durbin John Moller, CEO, Novotech Preparing global approval in a single trial: Detailing an overview of the FDA regulatory approval requirements and global standard Establishing forecasting best practice: minimizing cost associated with your supply chain through waste minimization 10:00 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 Hye Jung Lee, PhD, President & CEO, Caleb Multilab 10:00 Exploring options for planning and forecasting technologies to determine how best to reduce clinical supply costs and react to fluctuations Evaluating which forecasting tools are available to enable you supply chain to quickly react when the unexpected happens Assessing regulatory requirements of trial locations to ensure accurate forecasting for clinical trial shipment Establishing quality control system in global trial supply to reduce impact on bottom line and time frame delays DaeMan Moon Team Leader, Development Supply Chain, Celltrion Speed, Quality & Cost - Why You Should be Conducting Your Clinical Trials in Australia 10:30 Morning Refreshments for Outsourcing in Clinical Trials Please take this time to visit the exhibit booths 10:30 Over the last 20 years Australia has grown to become a destination of choice for the conduct of early phase clinical trials. Rapid ethics approval and a simple notification to the Therapeutic Goods Administrations (TGA) means that from submission to FPFD it will only take on average 6 weeks. Coupled with the attractive R&D tax incentive program offered by the Australian Government this swift to study data can then be used to support an IND or IMPD application allowing companies to speed up their drug development process. Understanding the specific considerations required for Phase I trial design in Australia Having knowledge and understanding of Australia s R&D Tax incentive program your eligibility when conducting your trials in Australia

4 Having an understanding of the specific requirements for importing, manufacturing, compounding and labelling your product for Australian clinical studies. Bev Thomas, GM Operations, PCI Clinical Services Preparing your device to be tested in Europe under MDR to ensure smooth trial operations 11:15 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 postmarket surveillance method 11:00 Morning refreshments and networking for Clinical Trial Supply Please take this time to visit the exhibit booths Chanmin Ahn, RA director, CGBio Leveraging global trials into winning regulatory strategies to get approvals across various regions Clinical Ops and Supply Chain Management: Sharing Perspectives To Maximize Patient Benefits 11:45 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 11:45 Understanding the challenges of patient recruitment and the negative effect that insufficient drug supply can have on patients and the clinical team Reviewing fundamental strategies that supply groups can use to ensure adequate supply for study patients while limiting the negative impact of enrolment forecast variability Discovering how enhanced synergy between clinical operations and clinical supply groups can lead to increased drug optimisation even when things don t go as planned Victoria Maguire, Project Group Manager - Supply Chain Management, Almac 12:15 Finding the right partner for preclinical into phase I - Past and future outsourcing models What has changed in the outsourcing strategy over time? Does outsourcing really differ between large pharma and small innovative companies today? The future path to selecting the right partner in 12:15 [Interview] Building strategies for a risk-based auditing process in Korea Identifying the various risks to develop a plan for mitigation/ prevention Understanding the characteristics of a GMPcertified production site Describing preparation and implementation of

5 early development Case examples of what can go wrong during the transition in the early stages. strategies in preparation for an effective audit Jungwon Jung, QA Director, CJ Health Care David Surjo, Executive Vice President, Nuvisan Designing Study Protocols for Maximum Comparator Sourcing Flexibility and Efficiency 12:45 Lunch for Outsourcing in Clinical Trials 12:45 Understanding why input into protocol is highly desired and can reduce costs, timelines, operational complexity, and risk Discovering how consulting with an expert early is essential to support the collection of the best research and enhance the ability to consider all possible options Learning ways to ensure protocol design flexibility to support smarter commercial product sourcing Chris Greco, Account Director, Comparator, Catalent & Kate Rimmer, Customer Service Excellence Director, Catalent 13:15 Networking at Exhibition Booths 13:15 Lunch and Networking for Clinical Trial Supply Exploring effectiveness on AI in new drug development in changing paradigm to Personalised Medicine Key factors of success in preparing cgmp inspection 14:15 AI-driven predictive biomarker study to improve the likelihood of success of the clinical trials Genomic bigdata and AI-driven repurposing Patient stratification in trials for complex diseases 14:15 Overviewing how we manage the inspection for EMA, US FDA, PMDA and other health authorities Sharing control strategies for manufacturing process, input material and facility design which are the key factors of QbD Hyun-Jin Yang, Medical Science Liaison, Syntekabio Chih-Ping Liu, Vice President, TTY Biopharm Company Investigating challenges in the clinical development and supply of personalized medicine Streamlining the Import/Export process in a global study setting 14:45 Overviewing on the market and technological trends of personalized medicine Overviewing on the regulations for personalized medicine Discussing common challenges in biomarkers, Exploring import / export as a basic element of supply chain strategy Defining the role of an Importer of Record in a global study Budgeting for the customs tariffs and fees at

6 study design, clinical supply, and regulations Rong Chen, Chief Medical Officer, JHL Biotech 14:45 early stages Evaluating the do s and don ts of customs clearance process Highlighting the benefits of managing import/export with a regional service provider Planning and Conducting Early Phase Research in Asia: Growth and opportunities. Nikita Avdeev, Associate Director Import/ Export, IMP Logistics (a PRA Health Sciences company) Establishing SCM strategies for JIT supply of clinical material in compliance with global regulations 15:15 Over the past 3 decades there has been a rapidly growing level of experience in conducting clinical Trials in the Asian region This development of expertise is reflected in the volume and technical complexity of the Phase I research conducted in the region This growing level of expertise is and will continue to drive the development and commercialisation of new medical technologies by global and Asianbased companies John Patava, Director of Global Clinical Affairs, Sirtex 15:15 Reviewing strategies for in-sourcing manufacturing processes to ensure that deadlines are consistently met Exploring OPEX for in-house clinical manufacturing and supply Evaluating methods for continuous improvement in clinical manufacturing processes to maintain quality Considering outsourcing of clinical material: the partners-selection process & risk management Michael Lee, Senior Vice President, Mab-Venture Bio 15:45 Afternoon refreshments and networking Please take this time to visit the exhibit booths CRO selection and Management -- Under the new era of Regulatory revolution in China 16:30 Exploring macro and micro environment in China to anticipate the practical challenges for trial sponsors Strategy development for the changing world in China How to partner with local and / or international CROs when consider a clinical trial in China Yan Wu, VP, Head of Clinical Operation, Hutchison Medipharm Establishing best practice for getting through customs faster and smoothly 17:00 Exploring potential amendments in documentation to enable flexible planning Finding local partners specialised in customs to keep your products refrigerated in customs area Understanding regulatory changes of cfda similar to FDA what are the updates and challenges for conducting trials in China Learning local standard for import valuation and preparing proper documents to bring IMP into China Fiona Xing, Global Clinical Trial Supply Manager, Merck

7 17:30 Chair s summary and close of conference Min Young Lee, Executive Consultant, Korea Health Industry Development Institute Chair s summary and close of conference Shell Lee, Supply Chain and Logistics, Melinta Therapeutics 17:35-18:35 Drinks Reception and Networking Outsourcing in Clinical Trials & Clinical Trial Supply East Asia 5 th 6 th December Programme Day Two 08:15 Registration and refreshments 08:50 Opening of Outsourcing in Clinical Trials East Asia Please take your seats for the chairman s welcome 08:50 Opening of Clinical Trial Supply East Asia Please take your seats for the chairman s welcome 09:00 Special Address by Chairman To begin the second day of the Outsourcing in Clinical Trials East Asia Conference, our Chairman will draw some key insights from the first day of the conference and speak about the upcoming themes of Day 2. Min Young Lee, Executive Consultant, Korea Health Industry Development Institute 09:00 Exploring how Health and Functional Food (HFF) can be applied in Clinical Trials Understanding HFF in Korea Determining the difference between medicine and HFF Providing an overview of the HFF development process Considering the challenges of HFF in clinical trials Namshik Kim, CEO, PharmaCRO 09:30 [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 Emphasising CRO s ownership on study management to keep the study timeline and unification Identifying ways for a successful study conduct in regards to regular communication 09:30 Global Comparator Sourcing Practices Independent Market Survey Findings Overview of survey design Why is comparator sourcing challenging? How companies are meeting sourcing challenges Ian Hoban, Sales & Marketing Director, Pilatus Comparator Solutions

8 Shell Lee, Supply Chain and Logistics, Melinta Therapeutics & Bokjin Hyun, Regional Outsourcing Lead Asia, BMS 10:00 Selecting the right CMO for your specific manufacturing needs whilst ensuring product quality 10:15 Morning Refreshments and Networking for Outsourcing in Clinical Trials Please take this time to visit the exhibit booths Identifying the challenges in the CMO selection procedure such as overpromised capabilities to ac-count for these prior to Supply Agreement and Quality Agreement Accounting for the differences in CMO-small pharma relationships and CMO-big pharma relationships to identify the best way to achieve collaborative success Highlighting potential hiccups be-tween the CMO and sponsor to adequately have a preemptive solution Conducting an audit conducive to the alignment of CMO capabilities and the task in question to ensure the best outcome Daniel Wu, Director of Production Technology Division, Gongwin Biopharm Building strategies for selecting Eastern European sites for studies and reducing delay factors 10:45 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 10:30 Morning refreshments and Networking for Clinical Trial Supply Please take this time to visit the exhibit booths A Young Kim, Senior Global Clinical Trial Manager and Project Manager, Enzychem Lifesciences 11:15 A SME perspective: Engaging CRO as a study partner to make your trials their priority and ensure you keep to study timelines Systems and tools to aid management of Clinical trials & CRO Determining how to effectively manage CRO internally to focus on your priorities and necessary 11:15 Don't Let Anything Happen by Chance! Navigating Your Challenges with Data-Driven Decision, Risk Mitigation, & Contingency Planning Employing holistic supply chain planning strategies with streamlined tactical process flow to ensure timely and cost effective

9 work Identifying a person with expertise in your study and ensuring a single point of contact to maintain effective communication Highlighting the long-term benefits of training to enable successful CRO management Sung Hye Kim, Clinical Development Associate Director, Navipharm A Successful Sponsor-Service Provider Relationship to Support Clinical Development in the Next Decade execution. Clearly communicating your realistic expectations and proactively follow through on each step of the way. Building and maintaining a strong relationship with your partners and customers both internally and externally. Shell Lee, Supply Chain and Logistics, Melinta Therapeutics Developing outsourcing strategies for multinational clinical trials supplies in East Asia(Japan, Korea and Taiwan) 11:45 Different models of outsourcing to find the best fit Highlighting the importance of self-measurement to identify the needs that are most important when selecting a model Choosing an outsourcing model that is fit-forpurpose to ensure specific needs of your trial are met Building partnership at an equal level to cooperate and promote synergy throughout the clinical trial Eddie Tam, Scientific & Clinical Regional Procurement Head - China, Asia, JPAC, Middle East, Turkey, Africa & Eurasia, Sanofi 11:45 Differences in requirements for product marketing in Japan, Korea and Taiwan Identifying the special need for hybrid products Comparing competencies for clinical trial conduct in-house vs. competencies required from a CRO Analysing the challenge of CRO selection in multinational trials and building strategies to overcome it Investigating special needs for clinical trial conduct in Japan, Korea and Taiwan Yu Ichige, Head of Clinical Operations: Japan, Korea and Taiwan, BMS 12:15 Lunch for Outsourcing and Clinical Trial Supply 12:50 Networking at Exhibition Booths Discovering best practice for effective oversight of global partners to ensure smooth running of your global study 13:30 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

10 Interview: Considering the key challenges of conducting trials on a global level to overcome cultural, regulatory and other barriers 14:00 This session will be a short follow-up interview which will delve deeper into some of the points raised by the previous presentation. The audience will also have the opportunity to ask the presenter questions. PJ Chen, President, United Biopharma China 14:20 Afternoon refreshments and networking 15:00 Speaker Hosted Roundtables 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 Roundtable 1 Discussing best strategies to select global CROs and trial sites in global location for your study Moon Hwan Kim, CTO, BiSiChem Roundtable 2 Planning pre-clinical stage from Lab to Phase 2A trials to ensure conducting trials smoothly Seonggu Ro, CEO, PimedBio Roundtable 3 Building multilateral supply strategies to conduct Multiregional Clinical Trials in light of developing regulations Hong Guo, Chief Medical Officer & VP of Clinical Development, Shenogen Roundtable 4 Shortening global trial timelines: Comparing labelling requirements in East Asia Hsiu-ling Hsiao, CSO, Ever Supreme Bio Technology 16:30 Chair s summary and close of conference Min Young Lee, Executive Consultant, Korea Health Industry Development Institute Chair s summary and close of conference Shell Lee, Supply Chain and Logistics, Melinta Therapeutics