Outsourcing in Clinical Trials East Asia 2019

Biography: Dr. Akhilesh Sharma is M.D., in Clinical Pharmacology with further training in Clinical Research and Global Pharmacovigilance at Berkley Extension, California State University, USA and Luton Medical Centre, UK and is Fellow of Royal Liverpool hospital society-U.K.. He has more than 25 years of worldwide experience in areas of Clinical Research, Medical Affairs, Regulatory, Pharmacovigilance, Translation Medicine, Biomarkers, Clinical Pharmacology across various multinational pharmaceutical companies based at US & in India. He is currently President & Chief Medical Officer for Alkem Laboratories Ltd. He also co-founded biomarker research organization GeneXY in Philadelphia, USA jointly with Wistar institute, Pennsylvania university campus.

Session Details: Pharmacoeconomic assessment through market approval and beyond: theory and operations 12-12-2019, 10:00 am Pharmacoeconomic assessment through market approval and beyond: theory and operations 12-12-2019, 10:00 am View In Agenda

Biography: Yu Ichige Head of Clinical Operations Japan, Korea and Taiwan Bristol-Myers Squibb Tokyo, Japan Yu Ichige has more than 25 years’ experience in the Pharmaceutical Industry working in the drug development space. During his career, he has held number of positions at several global pharmaceutical companies as follows.

• Pharmacia Clinical Operations Manager
• Merck/Schering-Plough Regulatory Strategy Manager, Head Project Management
• Boehringer-Ingelheim Head of Project Management

Session Details: Keynote: Building a successful partnership with a CRO to bring a life-changing product within budget and specified timeframes 11-12-2019, 9:00 am View In Agenda

Biography: Dr. Heidi Wang received her Ph.D. from University of Notre Dame in Indiana, USA. She is the Vice President and Head of Global Regulatory Science-China and Hong Kong, Bristol-Myers Squibb Company (BMS). She has led the teams to obtain three first-in-class drug approvals in China, including HCV direct acting agents (Daklinza and Sunvepra) and an Immuno-Oncology PD-1 inhibitor (Opdivo). Prior to China, Dr. Wang had over 20 years of experience working in BMS US headquarter with responsibilities in the US and 38 other countries.

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Biography: Hyangrim (Mia) Kim is a vendor alliance & operations manager in the clinical study unit at Sanofi Aventis Korea. She is responsible for collaboration and communication in clinical operations at country level in the resourcing models such as functional service providers, outsourcing at project level. She received B.S. and M.S. from Ewha Womans University, College of pharmacy, Seoul, South Korea and Pharm.D from Nova Southeastern University, FL, US.

Session Details: Considering the myriad of factors of selecting a CRO to ensure they are the right fit for your trial 11-12-2019, 10:00 am View In Agenda

Biography: Education: Ph.D., Dept. of Biological Systems Engineering, University of Wisconsin-Madison MS, Biological Engineering, University of Missouri-Columbia EMBA, Business Administration, National Taiwan University Work and Academic Experience: President, TCM Biotech International Corp. (4/2014-present) EVP/CSO, TCM Biotech International Corp. (6/2003-3/2014) Experience: Taiwan Executive Program, (GE program, 2009) Taiwan TFDA, US FDA, Mainland China CFDA New Drug IND Director of ITDP grant Clinical trial conducting and coordination Strategy partnering development Establishment of fermentation manufactory Establishment of R&D center R&D Director, PhytoHealth Corporation (4/1999-11/2002) Experience: New drug development First Botanical Investigational New Drug (IND) approval from TFDA Pre-clinical study (Chemistry, Manufacture and Control (CMC), Pharmacology, Pharmacokenitic, Toxicity) New product/technology evaluation IPO in Taiwan stock exchange Company value evaluation SBU Manager, United Biotech Corporation (10/1998-11/2002) Experience: Chinese new drug development Dietary supplement, Healthy Food development Post Doctor, University of Wisconsin-Madison Selected Presentations and Publication: 1996~2019 total 31 patents, Presentations and Publication articles Wang, Y-C., Cell-free junctional DNA fragment from hepatitis B virus integration in HCC for monitoring post-resection recurrence and clonaltiy, 2019 ASCO annual meeting, Chicago, US.

Session Details: Speaker Hosted Roundtables 12-12-2019, 2:30 pm View In Agenda

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Biography: Liu, Chih-Ping was graduated from Kaohsiung Medical College with a bachelor degree of pharmacy in Taiwan. He was later graduated from University of Leicester with a master degree. Liu, Chih-Ping has held leadership roles across several different pharmaceutical industries, such as China Chemical & Pharmaceutical Company limited, Taiwan Cynamid Company Limited, Pfizer Inc., and Winthrop-Sterling Inc. Liu, Chih-Ping joined TTY in 1996 and had integrated all production lines. During his term of service, he successfully transformed the traditional generic pharmaceutical facility into a PIC/S GMP professional manufacturer which is dedicated in developing technology of liposome commercial production, not only for domestic sales in Taiwan but also to export to global markets such as Europe, USA and Asia.

Session Details: Data Integrity: examining the requirements for a GMP compliance data life cycle 11-12-2019, 2:45 pm View In Agenda

Biography: Ms. Juhee Jeon graduated from Korea University with a Master’s of Science in Medical Microbiology (Immunology). She has been working in the field of marketing, medical information, clinical trial drug safety, pharmacovigilance and post-marketing surveillance at pharmaceutical companies and CROs for more than 13 years. In a CRO, Juhee managed the safety monitoring of a global oncology clinical trial. Currently, she is responsible for managing drug safety monitoring in clinical trials and pharmacovigilance covering RWE/RWD at Yungjin Pharm in Korea.

Session Details: Speaker Hosted Roundtables 12-12-2019, 2:30 pm View In Agenda

Biography: Dr. Decheng Ma is currently the Director of Global Clinical Supply at MSD R&D China.  He is responsible for managing clinical supplies for China clinical trials and external manufacturing partners in APAC area.  Decheng has been working at Merck Research Laboratories  since 2000. He has spent 7 years working in analytical chemistry, 7 years in formulation development, and 4 year in clinical supply. He has been working on numerous Merck products from preclinical to phase III, including Emend^®, Isentress^®, Januvia^®, Janumet^®, etc. Decheng has extensive experiences and built up his expertise in formulation development, analytical chemistry, and clinical supplies. He has authored over 10 peer-reviewed papers and given more than 20 presentations at pharmaceutical conferences. Decheng received his BS in polymer science & chemical engineering from Tsinghua University in China, MS in chemical engineering from Tufts University, and PhD in chemical engineering from Lehigh University in the US.

Session Details: Leveraging the Free-trade-zone for clinical supplies in China and APAC countries to enable swifter import and export 11-12-2019, 2:15 pm Leveraging the Free-trade-zone for clinical supplies in China and APAC countries to enable swifter import and export 11-12-2019, 2:15 pm View In Agenda

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Session Details: EMA vs FDA pre-approval GCP inspection: Process and Frequent Findings 12-12-2019, 11:15 am View In Agenda

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Session Details: Case Study: Determine which IRT vendor is the right one for your company to ensure your supply chain is adequately monitored 12-12-2019, 9:00 am View In Agenda

Biography: Present CEO of Vming Bio Company Experience

1. Sr. VP of Mab-Venture Bio, Shanghai.
2. Director of GZ New Facility Project, BeiGeneBio
3. Plant Director, JHL Bio
4. Sr. VP, Shanghai Biomabs
5. Director of Bio MFG Facility Projects, Merial (JV of Merck & Sanofi)
6. VP of Shanghai Roche
7. Technical Director of ScinoPharm
8. Plant Director of Boehringer Ingelheim;
9. Plant Director of GSK

Session Details: A macroscopic insight into running clinical trials in China 12-12-2019, 9:30 am View In Agenda

Biography: 2001.09 ~ Present CJ HealthCare Quality Assurance & Technical development

• 1~Present
• Cell&Gene Therapy (Car-T) Project Team

• 06~2018.12
• New Plant Plan Project of Large Volume Parenteral

• TF team in strategic administration
• 09~
• Overseas CMO control by contact person
• New CMO business developments and technical transfer from Japan

• Analysis Lab

Session Details: Successfully building a CAR-T manufacture factory in Korea 11-12-2019, 2:45 pm Successfully building a CAR-T manufacture factory in Korea 11-12-2019, 2:45 pm View In Agenda

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Session Details: Global standards for identification of investigational drugs to help streamline operations and improve patient safety 11-12-2019, 10:00 am View In Agenda

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Session Details: Accelerating Clinical Trials in Asia-Pacific 11-12-2019, 9:30 am The Big Discussion - Early-Phase Clinical Trials: Protocol, Management and Oversight 12-12-2019, 11:15 am View In Agenda

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Session Details: Exploring Best Practice for Medical Device Trial Registration and Approvals 11-12-2019, 2:15 pm View In Agenda

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Session Details: Uncovering how data and analytics can improve clinical trial feasibility 12-12-2019, 9:30 am Discovering the Use of Electronic Patient-Reported Outcomes (ePRO) to Analyse Big Data for Better Quality and More Concise Results 11-12-2019, 4:00 pm Uncovering how data and analytics can improve clinical trial feasibility 12-12-2019, 9:30 am View In Agenda

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Session Details: Case Study: Determine which IRT vendor is the right one for your company to ensure your supply chain is adequately monitored 12-12-2019, 9:00 am View In Agenda

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Session Details: How to Create Effective CRO Relationships through Oversight 11-12-2019, 4:00 pm View In Agenda

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Session Details: Keynote: The Fourth Industrial Revolution – Digital Drug Development and Supply 11-12-2019, 9:00 am View In Agenda

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Session Details: Quality by Design in Clinical Trials 11-12-2019, 4:30 pm View In Agenda

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Session Details: The Big Discussion - Early-Phase Clinical Trials: Protocol, Management and Oversight 12-12-2019, 11:15 am View In Agenda

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Session Details: What multinational/ international pharmaceutical companies should consider in terms of tax when importing 12-12-2019, 11:45 am View In Agenda

Biography: Dr. Chih-Jung Chang is currently the CDMO Unit vice president of EirGenix, Inc. His responsibilities CDMO business includes R&D, production, QC, PM and BD functions now. He got Ph. D. degree in National Taiwan University and studied on business program in UW of Unit State. Before EirGenix he works as director of TOT Oncology Business Unit at TTY Biopharm. He was creating business and drug development strategies for licensing and collaboration in global/China NCE (Specialty)/Biologics (NBE/Biosimilars) projects. With both technical knowledge and business acumen, Dr. Chang has extensive experiences building up new biologics and specialty pipelines that fit the company’s development strategy. In addition, Dr. Chang has extensive experiences managing international networking and relationships for value-added bridge between early to late stage drug development.

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Biography: Christian holds a master degree in molecular biology earned at the University of Wuerzburg (Germany). He looks back at 25+ years in life sciences, of which Christian spent 20 years in the CRO industry. Before PSI CRO, Christian served with other CROs in senior sales and marketing positions. Among those employers were Parexel, PRA and other global CROs. Assigned responsibilities covered leading teams up to 20 men strong and up to US$500+ million sales targets. Christian’s track record demonstrates consistent sales growth that has been achieved through structured account management, planning and execution, a vision and energy to build and lead teams from the front and a passionate commitment to the client. Christian now leads the European / Asian sales team at PSI CRO. Christian is set to expand the client base in Asia and help Asian clients to succeed in their drug development goals.

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Session Details: Bridging the physical and digital connect: one unified clinical trial supply solution 11-12-2019, 9:30 am View In Agenda

Biography: Sandrine Antoniotti is currently the Executive Vice President of Pharmaceutical Services for Nuvisan Pharma Services. She is responsible for the GMP Pharmaceutical Analytical and Clinical Trial Supplies Teams among Germany and France. She has obtained a Master Of Science Degree in Molecular Chemistry from University Of Sciences in Nice and extended her education with a Master Degree in Business. She then started directly her career in Pharmaceutical Industry in France and developed expertise in Drug Development based on more than 15 years of experience working for big pharma players like Theramex (Merck group) and Galderma (Nestlé group),  in several key positions from Logistics, Supply Coordination, Technical Regulatory support, CMC Project Management and Drug Development from R&D till Market positioning. Now within Nuvisan, one of the largest European CRO/CDMO, her experience is used to serve in the best way possible client needs by defining what is appropriate to support the development of drugs in Europe, in the United States and in Asia.

Session Details: Organizational considerations in Phase 3 trials for Europe : combine & harmonize operating & logistical support to perform efficient clinical trials 11-12-2019, 12:15 pm View In Agenda