P46377 4th Annual Clinical Trials
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4th Annual Clinical Trials

14 – 16 May 2019, Shanghai Marriott Hotel Parkview, China.

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LOCAL CHINA COMPANIES RATES AVAILABLE. 中国企业可享有独家优惠价!
SPECIAL GROUP RATES FOR 2 OR MORE. 2名及以上代表注册立享团队优惠价。SEE PRICING BELOW.

overview

Recent regulatory developments have invigorated China’s clinical trials industry. Greater flexibility to encourage innovation, the 60 day CDE timeline for Phase 3 trials, site accreditation process revamp, acceptance of foreign data towards new drug applications, are just some of the measures expected to generate renewed enthusiasm amongst foreign and local sponsors.

IBCs 4th Annual Clinical Trials conference is part of the 5th Biopharma Development and Production Week in China. It will address market opportunities, growth trends, process innovation, technology and digitization. The hottest developments in relation to CAR-T trials and the oncology market will get additional focus.

Discussion themes

  • Trends and growth opportunities in China’s trial activities in context to therapeutic areas, disease burden, and impact of top industry sponsors
  • Interpreting and working with recent regulations
  • Sponsor perspectives on market outlook and expectations from CROs
  • The emergence of CDMOs and implications for the clinical trail industry
  • Digitalization touch points in clinical trials
  • AI in drug discovery and dealing with clinical data
  • Process and technology innovations in the Oncology trial space
  • CART-Trials, opportunities, requirements and best practice
  • Biosimilar trails – innovation, new developments and future direction for this market
  • Authorization procedures in various jurisdictions
  • Working with standards for good clinical practices
  • Reporting and disclosure requirements
  • Informed consent obligations
  • Insurance requirements
  • Data protections issues

Part of

5th Annual BioPharma Development and Production Week »

With demonstrated success year on year, IBCs BDP Week in China enjoys unparalleled industry support. Known for generating knowledge, creating business opportunities, and bringing innovative ideas to the table, the BDP Week is now more impactful than ever with 5 high level conferences, learning seminars, focused trade show and business matching to boot.

Co located conferences

agenda

8:00 am

Main Conference Registration and Morning Coffee

9:00 am

Chairperson’s Opening Remarks

5TH BIOPHARMA DEVELOPMENT AND PRODUCTION WEEK 2019 JOINT OPENING PLENARY SESSIONS (8TH CELL LINE DEVELOPMENT, 9TH BIOMANUFACTURING, 10TH BIOSIMILARS, 4TH CLINICAL TRIALS, CELL & GENE THERAPY)

Biopharma Innovation Keynote Enabling the Future of On-Demand Production & Transformative Medicines

Dan Gibson, Ph.D., Vice President, DNA Technology, Synthetic Genomics Inc.

10:30 am

Morning Networking and Refreshment Break

CLINICAL TRIALS SUMMIT COMMENCES.

CHINA’S CLINICAL TRIALS REGULATIONS REFORM

Chairperson’s Opening Remarks

11:20 am

  • Processes associated with entry into the China market
  • How do we work with 60-day CDE timeline for Phase 3 trials?
  • Potential and investing opportunities for pharmaceutical companies in the Chinese market
  • Clinical trial globalisation and the harmonisation of frameworks and requirements across regions

11:50 am

  • Regulations and policy updates for clinical trials conducted in the US
  • Potential regulatory challenges in international clinical trials
  • Transparency in clinical trials and data protection – efforts in the FDA context
  • Clinical trials results disclosure and compliance
  • How will it affect China market from global perspectives?

12:30 pm

Networking Lunch

1:30 pm

  • Speeding Up Approval Process to 60 Days for Clinical Trials
  • Acceptance of Overseas Clinical Trial Data
  • Clinical Trial Data Self-Inspection before Submission of Inspection Report – What to Expect
  • Opportunities and Challenges for Global Biopharma Companies Choosing to Conduct Clinical Trials in China
  • “Made in China 2025”: Trends and Potential Controversies

THE EMERGENCE OF CROS AND CDMOS

2:10 pm

  • Reasons for the M&As, trends and implications for the clinical trial industry
  • Bridging the Gap: The future for biopharma companies relying on CROs and CDMOs
  • Building a CRO giant: standing out amongst the other players in the market
  • Managing Costs of Clinical Trials for CROs

For speaking opportunity, please contact Yvonne.Leong@ibcasia.com.sg

2:40 pm

  • Partnerships and M&A – How will it add value to pharma companies?
  • Determining the qualities and standards of the best CRO for Clinical Trials
  • Differentiation from Competitors
  • The Value of the Right Partner

Speaking opportunity, please contact Yvonne.Leong@ibcasia.com.sg

3:10 pm

Afternoon Networking & Refreshment Break

DIGITALISATION IN CLINICAL TRIAL STUDIES

4:40 pm

  • Accelerating Research with Tablets, Mobile Technology, mHealth, Smartphone Apps, Clinical Grade Wearables, Sensors and Cloud Computing
  • Into the Future: New Generation of Clinical Trial Studies
  • Adopting Technology for Data Management and Integration
  • Data Privacy and Informed Consent Issues

5:10 pm

  • Advanced Machine Learning and Artificial Intelligence for Pharmaceutical Drug Discovery
  • Incorporating Technological Advancement in Big Data Analysis to Deliver New Medical Solutions

5:40 pm

Chairperson’s Summary and End of Main Conference Day One

8:00 am

Morning Coffee

NEW DEVELOPMENTS IN THE ONCOLOGY TRIAL SPACE

9:00 am

Chairperson’s Opening Remarks

Dr. Alvin Luk, Senior Vice President and Chief Medical Officer, Shanghai Henlius Biotech, Inc., China

9:10 am

  • Process and Technology Innovations in the Oncology Trial Space
  • Insights on Emerging Trends for the Oncology Trial Space
  • Strategies to Reduce Clinical Trial Timelines and Prevention of Failures
  • Clinical Data Requirements for Oncology Trials

9:40 am

  • Progress of Clinical Studies in Oncolytic Viral Therapy
  • Challenges of IOV Therapy
  • Synergistic Use of IOV Therapy with Other Immunotherapeutic Regimes

10:10 am

  • Summary of the Status of Multiple Clinical Trials in the Immuno-Oncology Field with a Focus on Combination Trials
  • Design features of the Clinical Trials in the Immuno-Oncology Area, Major Successes, Failures and Challenges
  • Future Directions of Clinical Development in Immuno-Oncology

10:40 am

Morning Networking and Refreshment Break

THERAPEUTICS TRIALS

11:10 am

  • RTK Research for Tumour Suppression
  • Cardio-Oncology Treatment Challenges
  • Hopes and Hurdles: Developments in Clinical Trials for Alpha Radiation Therapy by Alpha Tau Medical
  • Potential Effective Methods of Cutting Medical Costs for Cancer Treatment
  • Progress and Limitations of Clinical Trials for Neoantigen Vaccines
  • Challenges of Exploiting Neoantigen Vaccines
  • Future Direction and Application of Research
  • Progress and Limitations in Battling NASH Disease: Current phases of Clinical Trial Studies for Fatty Liver Disease
  • Pipelines and Considerations for Further Studies

HIV Vaccines Trials: Challenges in Clinical Trials for Preventive HIV Vaccines

Dr Jean-Louis Excler, Program Director, New Initiatives, International Vaccine Institute, Republic of Korea

12:40 pm

Networking Lunch

1:40 pm

  • The Current and Future Landscape of CAR-T Cell Therapy in China
  • The Development and Latest Findings of CAR-T targeting Diffuse Large B-Cell Lymphoma (DLBCL)
  • Foreseeable Challenges of CAR-T Cell Clinical Trials
  • Meeting Regulation Policies and Compliance for CAR-T trials

WINNING WITH BIOSIMILARS TRIALS

2:10 pm

  • Building and Assembling the Right Teams for the Development and Implementation of Clinical Trials
  • Regulatory and Trial Oversight Functions
  • Patient Centricity and Site Requirements for Therapeutic Trials

2:40 pm

3:00 pm

  • Understanding the Challenge with Microheterogeneity: Demonstrating the Safety and Efficacy of the Therapeutic in Clinical Trials
  • Barriers to Entry to the Market: Proprietary Naming, Branding and Marketing Costs
  • Improving Cycle Times, Constrain Costs and Reducing Risks
  • Clinical Data Requirements for Biosimilar Products

3:30 pm

Afternoon Networking & Refreshment Break

BDP CHINA CLOSING PLENARY SESSION

5:00 pm

Chairperson’s Summary and End of Main Conference Day Two

9:00 am

China’s biopharma industry continues to grow rapidly  and hails as a major investment region in the world. With tides of tech innovation, market growth in CRO, CMO and CDMO, a numerous clinical trials projects lined-up, newly discovered therapies to the market and upgrading manufacturing facilities to name a few. This workshop aims to provide a strategic snapshot of the investment landscape for biopharma medicine, and covers practical aspects on how biotech companies can navigate the investment and pricing options for related drugs and treatments to generate better returns.

You will learn:

  • Financing clinical trials operations
  • R&D investment and financing models
  • Manufacturing financing
  • Financial partnership with Chinese pharma and biotech
  • Biosimilars products financing
  • Going Public and Listing insights
  • Deal, debt and equity structuring

1:00 pm

End of Workshop

pricing

Packages Price
2 Day Conference - International Companies, Global HQ Located Outside ChinaUS $1895US $1695Early BirdEarly Bird
2 Day Conference - Local China CompaniesUS $977US $827Early BirdEarly Bird
Group Rate of 2 or more delegates - International Companies, Global HQ Located Outside ChinaUS $1495Early Bird
Group of 2 or more delegates - Local China CompaniesUS $752Early Bird
Group of 4 or more delegates - Local China CompaniesUS $676Early Bird
Group Rate of 4 or more delegates - International Companies, Global HQ Located Outside ChinaUS $1295Early Bird
Extras Price
Pre Conference Workshop - International Companies, Global HQ Located Outside China US $300
Pre Conference Workshop - Local China Companies US $150

Early Bird Rate: Register & Pay by 8 March 2019

  • Multiple Bookings Discount pricing is applicable to groups of 2 or more delegates from the same organisation registering for the same event, at the same time.
  • Fee stated is the discounted price PER DELEGATE. Only one discount applies; either the early bird rate OR group rate.
  • All fees stated include luncheons, refreshments and complete set of documentation. It does not include the cost of accommodation and travel.
  • All delegates from Singapore-based companies are required to pay an additional 7% GST (SINGAPORE EVENTS ONLY)
  • View payment terms and bank transfer details, click here »

Sponsorship

Partnership and Profile Building Opportunities are Now Available!
Contact us today to find out how you can position your company as a market leader at this event, and to explore the range of branding and marketing opportunities available.

speakers

Dan Gibson, Ph.D.

Vice President, DNA Technology, Synthetic Genomics Inc.

Richard Wang

CEO, Fosun Kite Biotech, China

He Ting

Chief Executive Officer, ImmunoChina, China

Dong Wei

CEO, Edigene, China

Zonghai Li

President and Chief Executive Officer, CARsgen Therapeutics, China

Peter Luo

CEO, Adagene Pharma, China

Ruirong Yuan

President, Chief Medical Officer and Board Director, Adlai Nortye Biopharma, China

Eddy Wu

China Head/Vice-President, Terns Pharmaceutical, China

Jonathan Zhao 4th Annual Bioprocess and Technology 2018

Jonathan Zhao

PhD, Co-founder and Chief Executive Officer, Hangzhou JUST Biotherapeutics, China

Xiaorui Wang

VP of Regulatory Affairs & Clinical Development Zensun, China

Zhengyu Yuan

President & Chief Executive Officer, MicuRx Pharmaceuticals Inc., China

Dr. Xin Zhang

Vice President of Global Clinical Operations and Affairs, Shanghai Henlius Biotech, Inc., China

Audrey Jia

Former FDA CMC Biologic Reviewer, U.S.

Senior Representative, Innovent Biologics

Don Van Dyke

Chief Operating Officer, Cloud Pharmaceuticals, USA

Dr. Alvin Luk

Senior Vice President and Chief Medical Officer, Shanghai Henlius Biotech, Inc., China

Joanne Chio

Head, Clinical Trials - Healthcare services, National University Hospital Singapore, Singapore

Hei Yongjiang

Chief Medical Officer, Oncology, Zai Laboratory, China

Zhou Mingdong

CEO and Chief Scientist, Zensun, China

Chen Chien Shing

Executive Director, Cancer Center, Shanghai Jiahui International Hospital and Clinics, China

Liu Baorui

Medical School of Nanjing University, Clinical Cancer Institute of Nanjing University, China

Dr Jean-Louis Excler

Program Director, New Initiatives, International Vaccine Institute, Republic of Korea

James Cheng-Chung Wei

Professor, Institute of Medicine, Chief, Division of Allergy, Immunology and Rheumatology, Director, Chinese Medicine Clinical Trial Center, Chung Shan Medical University Hospital, Taiwan

Jennifer Harmon

Director, Clinical Affairs, SynAgile, Singapore

Rong Chen

Chief Medical Officer, JHL Biotech, China

Chen-Yuan Lin

Ward Director and Attending Physician at the Division of Hematology and Oncology, China Medical University Hospital, Taiwan

Dr Lin Shiwen

Vice President of Downstream Process Development, WuXi Biologics, China

Dr. Senyon Choe (Teddy)

Professor Biology, University of California San Diego (UCSD), USA, President/Director of joint Center for Biosciences, Korea

Jerry Yang

Senior Vice President, Process & Product Development, Hangzhou JUST Biotherapeutics Co., Ltd. China

Xiaodi Su

Senior Investment Manager, Lilly Asia Ventures, China

Jieyu Zou

Vice President, Lilly Asia Ventures, China

when & where

14 - 16 May 2019

Shanghai Marriott Hotel Parkview
333 Guang Zhong Road West, Jing’an District
Shanghai, 200072 China
Phone:+86 21 3669 8888
Fax:+86 21 3669 8668

Cartrina Wang 王洁琼 | Senior Sales Manager-EBC
mhrs.shamp.catering.asstmgr1@marriott.com
T: 86 21 3669 8666 | M:13585605981

https://www.marriott.com/hotels/travel/shamp-shanghai-marriott-hotel-parkview/

contact

Still have a question?

Speaking Opportunities
Sheralin See
+65-6508 2442
 
sheralin.seekaili@ibcasia.com.sg

Sponsorship Opportunities
Yvonne Leong
+65 6508 2489

Yvonne.Leong@ibcasia.com.sg

Media & Association Partnership Opportunities
Tham Ruohyi
+65 6508 2463

ruohyi.tham@ibcasia.com.sg

Partners

Conference Partner Conference Partner

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