About Arena s Clinical Trials Series Speakers Includes:

Transcription

1 About Arena s Clinical Trials Series The Clinical Trials Conference series launched over a decade ago and now runs in more than 14 locations worldwide. The acclaimed series is a platform for biopharmaceutical and medical device professionals to collaborate with service providers and other industry stakeholders to find innovative solutions to the most pressing challenges in managing clinical trial supply. Thousands of clinical professionals attend our conferences year after year. The Clinical Trial Supply East Asia conference has been developed specifically to meet the needs of the vibrant life sciences hub there. The agenda has been developed through direct collaboration with and support from the local industry to ensure the conference is content-driven and addresses the practical needs of our attendees Speakers Includes: Moon Hwan Kim, CTO, BiSiChem Eddie Tam, Scientific & Clinical Regional Procurement Head for APAC, Sanofi Main Fong Ang, Senior Manager Clinical Development Operations, Amgen John Patava, Director of Global Clinical Affairs, Sirtex Shunsuke Abe, Head of Scientific & Clinical Procurement, Sanofi Hyun-Jin Yang, Medical Science Liaison, Syntekabio Hye Jung Lee, President&CEO, CaleLab Multilab Miyang Kim, Associate Director SROL, Merck Min Young Lee, President of APAC region, SFJ Pharma Group Sung Hye Kim, Clinical Development Ass.Director, Navipharm Shau-Feng Chang, CEO&CSO, BELX Bio-Pharmaceutical Bokjin Hyun, Regional Outsourcing Lead Asia, BMS PJ Chen, Vice President of Clinical Development and President, United Biopharma John Moller, CEO, Novotech Rong Chen, Chief Medical Officer, JHL Biotech Tai Jung Wu, Senior Manager of CMC and Manufacturing, Gongwin Biopharma DaeMan Moon, Team Leader, Development Supply Chain, Celltrion Akhilesh Sharma, Senior Vice President & Global Head of Medical Affairs, Alkem Chih-Yi Weng, Chairlady & CEO, Charsire Biotechnology Corporation Yu Ichige, Head of Clinical Operations: Japan, and, Bristol-Myers Squibb Chanmin Ahn, RA director, CGBio Yan Wu, VP, Head of Clinical Operation, Hutchison Medipharma Hong Guo, Chief Medical Officer & VP of Clinical Development, Shenogen Michael Lee, Senior Vice President, Mab-Venture Bio Seonggu Ro, CEO, PimedBio Singapore Hong Kong Australia Japan Australia India Japan 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 Clinical Trial Supply East Asia 5 th 6 th December Programme Day One 08:15 Registration and refreshments 08:50 Chair s opening remarks Forecasting & Supply Planning Outlining the current challenges and innovations in clinical trial supply from manufacture to patient 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 each Discussing the role of your vendor in your clinical supply to build effective relationships and ensure 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 09:30 Session reserved for Durbin Establishing forecasting best-practice; minimizing cost associated with your supply chain through waste minimization 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 10:30 Session reserved for PCI 11:00 Morning refreshments and networking Labelling & Packaging Shortening global trial timelines: Comparing labeling requirements in and EU 11:30 Exploring new n labeling requirements on first packaging and the impact on your study budget Comparing expiry date update regulations - Annex VI and n directive Emphasising importance of close communication between manufacturing site and clinical sites to meet GMP requirements and labeling regulations Anticipating s changing regulations moving in the direction of EU

3 Assessing advantages and risk factors of E-labelling through real world case studies 12:00 Appreciating the benefits to patients and the risk factors associated with smart label Considering E-labelling as a solution for remote expiry date amendments required by Annex VI Anticipating global regulatory environment and designing protocols to comply with variances in international E-label regulation Drawing actionable insight from real world examples on the use of E-labels Session reserved for Sponsor Developing Just in Time labelling strategy to ensure efficient time distribution and reduce wastage 12:30 Exploring effectiveness of Just-in-Time labelling in improving flexibility to manage simultaneous clinical trials Investigating labelling and packaging requirements in your study sites and building protocols to be in line of work Assessing cost-effectiveness of regional labelling when trials are taking place in different regions Outlining technology systems available to aggregate data label information and expedite translation to streamline trial times 13:00 Lunch and networking Technology Demo Showcase Smart Technology in Clinical Trials The showcase will include a shortlist of leading technology providers revealing their disruptive and targeted technologies. The selected providers offer solutions to current challenges being faced by both small pharma and big pharma companies within the clinical supply space. Particular focus will be placed on illustrating how these technologies can be implemented within existing processes that are both rigid and flexible. 14:00 To include technologies such as: 222 documentation tracking VIP shippers as a form of reusable packaging Temperature controlled packaging Forecasting tools E-labels IVRS system Each innovative supplier will have 15 minutes to showcase their solution. The audience will have the opportunity to question and probe the benefits and challenges each innovation offers. Delegates will leave with new ideas on how to implement digitalisation in the their clinical supply chains. 15:00 Session reserved for Almac Discovering how mobile technology can be applied in clinical supplies to streamline supply process 15:30 Harnessing mobile phone infrastructure to enable real time management of your clinical supplies Developing portable software systems which can enable patients to enrol on trials and ensure sufficient drug is delivered at trial sites Exploring increasing growth in wearable devices and what this means for your clinical trial supply

4 management as a method to acquire Recognizing how adopting new technologies can reduce overall trial costs and minimize growing financial pressures on industry 16:00 Afternoon refreshments and networking Logistics & Temperature Maintenance Pinpointing difficulties in transportation of Cell & Gene therapy products 16:30 Overviewing Cell therapy products traits and why they need to be managed differently Maintaining temperature control and oversight during transit new shipping and monitoring solutions Building Cell therapy supply strategies with vendors to ensure entire teams understand the product profile and minimise waste Highlighting importance of close relationship between clinical sites and manufacturing sites to ensure your product safety Providing insight into how to manage import and export better to minimize delays and additional cost 17:00 Session reserved for IMP Logistics (A PRA Company) Supporting temperature excursions throughout the product life cycle 17:30 Discussing quality of different temperature monitoring solutions to apply the right one to your specific product Handling humidity issues properly so that your products are not affected and can reach end users in the right state Studying guidelines to know exactly when to lower drugs' temperature to keep them safe Analyzing industry trends to develop tactics to have degradation systems which can react immediately to ever changing temperatures 18:00 Chair s summary and close of conference Clinical Trial Supply East Asia 5 th 6 th December Programme Day Two 08:15 Registration and refreshments 08: Speaker Hosted Roundtables Chair s opening remarks 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

5 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 Roundtable 2 Roundtable 3 Roundtable 4 Roundtable 5 Analysing extra cost factors in conducting clinical trials in East Asia region focusing on Japanese budget point system and VAT in Discussing best strategies to select global CROs and trial sites in global location for your study Moon Hwan Kim, CTO, BiSiChem Planning pre-clinical stage from Lab to Phase 2A trials to ensure conducting trials smoothly Seonggu Ro, CEO, PimedBio Building multilateral supply strategies to conduct Multiregional Clinical Trials in light of developing regulations Hong Guo, Chief Medical Officer & VP of Clinical Development, Shenogen Discussing best practice to assess supply cost accurately and to compare available forecasting tool Roundtable 6 Developing communication channel with supply vendors to react real-time to supply crisis Morning refreshments and networking Vendor Relationship & Management Developing strategies for enhancing co-operation within clinical operation teams for successful supply chain planning 11:00 Ensuring close communication between study stakeholders to set trial goals early and successfully forecast clinical supply needs steps for successful implementation Avoiding miscommunication through the dissemination of a clear first label and packaging plan to all study partners Engaging operational teams in shipping strategies to ensure study needs are feasible 11:30 Session reserved for Pilatus [Panel Discussion] Best practice to engage supply vendors in your study to stick to your timeline 12:00 Identifying which part to outsource and vendor criteria to find suitable partner for your study Designing study protocol and timeline with your vendors to set realistic goals and ensure all of your team member understand your priorities Exploring various communication channels to ensure close reporting system in global studies Ensuring documentation is fully understood by all parties engaged to prevent misinterpretation and preventable errors 12:45 Lunch and networking Manufacturing & Distribution Investigating changing supply chain requirements in light of new trend of personalised medicine model 13:45 Reviewing what is required for personalised medicine supply chain to ensure your products are delivered to

6 the patients on time Exploring how a reduced shelf life will require a more local approach to drug distribution to ensure trials are successful Uncovering manufacturing requirements needed to ensure trial drugs can be personalised and manufacturing costs associated with this Designing labels which can be easily interpreted by patients to ensure adherence and trial success Rong Chen, Chief Medical Officer, JHL Biotech Establishing in-source clinical manufacturing strategies from a small company perspective 14:15 Reviewing strategies for in-sourcing manufacturing processes to ensure that deadlines are consistently met Establishing what is needed to set up in-house clinical manufacturing processes in an efficient and costeffective manner Evaluating methods for continuous improvement in clinical manufacturing processes to maintain quality Outlining important criteria that you need to consider when you select a GMP manufacturing facility Michael Lee, Senior Vice President, Mab-Venture Bio Selecting the right CMO for your specific manufacturing needs whilst ensuring product quality 14:45 Identifying the challenges in the CMO selection procedure such as overpromised capabilities to ac-count for these prior to agreements 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 pre-emptive solution Conducting an audit conducive to the alignment of CMO capabilities and the task in question to ensure the best outcome Tai Jung Wu, Senior Manager of CMC and Manufacturing, Gongwin Biopharma 15:15 Afternoon refreshments and networking Shipment & Delivery Establishing best practice for getting through Chinese customs faster and smoothly 15:45 Understanding regulatory changes of cfda what are the updates and challenges for brining products into Unpacking Chinese standard for import valuation and document requirements to bring API into Exploring potential amendments in documentation to enable flexible planning Finding local partners specialised in Chinese customs to keep your products refrigerated in customs area A route to patient centric trials: Direct to Patient shipping 16:15 Highlighting effectiveness for DtP shipping in terms of patient recruitment and retention Steps for adhering to GMP regulations and ensuring standards are met in the delivery chain From door to door to central pharmacy steps for reducing the cost of DtP Investigating DtP availability in remote locations and navigating strategies to implement it 16:45 Discussing efficient comparator sourcing strategies to avoid delays in your study timeline Exploring various clinical supply chain options to ensure timely provision of IMPs

7 Overviewing the updates of document requirements of Investigational Medicinal Products and challenges of not getting enough information on it Deconstructing documents requirements in certain destinations to bring in IMPs Exploring alternative solutions in the event that you do not meet IMP information requirements 17:15 Chair s summary and close of conference