P46376 Cell and Gene Therapy
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Cell and Gene Therapy

18 – 20 May 2020, Shanghai, 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

The cell therapy market is exploding with opportunities, and the total market volume for CAR-T therapy alone is expected to reach USD 1 trillion by 2030. China boasts more cell therapy trials than the US, and it is increasingly leveraging its strategic advantage in context to labour costs, precision manufacturing, and now also a more accommodating regulatory regime for this sector.

Part of the 5th Biopharma Development Week, IBCs Cell and Gene Therapy summit will be one of 5 colocated events straddling the entire biopharma value chain. Focusing on investment, regulation, trials and development, the cell therapy market segment will be adrressed as a whole, alongside pricing and commercialisation developments.

Discussion themes

  • Regulatory developments in the region, and China
  • Working with CFDA guidelines on Research and Evaluation of Cell Therapy Products
  • Best practice as defined by regulation for selection of animal models for non-clinical studies and clinical data collection
  • The in’s and out of CAR-T trials
  • Cell therapy manufacturing – regulatory requirements, technology and innovation
  • Improving, manufacturing, development and quality control capabilities
  • Testing benchmarks for product quality release and drug clearing procedures
  • Approval process and guidelines for cell therapy products
  • CAR-T therapy market outlook, and CD19 developments
  • Commissioning CAR-T cell preparation facilities in China
  • Developments in viral and nonviral vectors for gene delivery
  • Innovative applications of CRISPR technology
  • Government opinions on medical insurance and pricing for cell therapy products
  • Defining the growth path of cell therapy in future

 

For more information, visit www.biopharmaproduction.com >>

agenda

8:00 am

Main Conference Registration and Morning Coffee

9:00 am

Chairperson’s Opening Remarks

Judith Li, Partner, Lilly Asia Ventures, Hong Kong

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)

9:05 am

Investor Talk by Lilly Asia Ventures: China’s Great Leap Forward in Biotech

Judith Li, Partner, Lilly Asia Ventures, Hong Kong

9:30 am

  • Recent regulatory developments – obstacle or opportunity?
  • The clinical trials market
  • China market scenarios on CAR-T & CRISPR technology
  • Growth prospects on cell line development market and therapeutics
  • Current state of affairs on biosimilars
  • Digitalisation of biopharma value chain – is China ahead of the game?
  • How are new business models creating opportunities?

10:30 am

Morning Networking and Refreshment Break

CELL AND GENE THERAPY SUMMIT COMMENCES

CHINA MARKET AND REGULATORY DEVELOPMENTS

11:20 am

Chairperson’s Opening Remarks

Dr. Jimmy Zhang, Venture Partner, Lilly Asia Ventures, China

  • Outlook for biotech investments in China and upcoming trends in the CGT/ATMPs space
  • Acing the Shark Tank: What do investors look for in biotechswhen investing in CGT/ATMPs?
  • How does the CGT investment landscape in China and the US compare?
  • Overview of HKEx’snew listing rules for Chinese biotechs

12:00 pm

The first SFDA Approved Gene Therapy: Sibiono’s Journey with the R&D and Commercialization of Gendicine

Dody Bautista, Chief Scientist, Sibiono GeneTech, China

12:30 pm

Networking Lunch

1:30 pm

MANUFACTURING FOR CELL AND GENE THERAPY

Chairperson’s Opening Remarks

Jieyu Zou, Vice President, Lilly Asia Ventures, China

  • How has China’s State FDA (SFDA) guidelines evolved in the research and evaluation of CGT?
  • Working with CFDA guidelines on research and evaluation of Cell Therapy products
  • Perspectives from the private sector: Challenges in meeting SFDA’s regulations for CGT
  • Drug approvals in perspective: How does SFDA compare with US FDA in terms of drug registration?
  • Key considerations operating in the CGT space in China – in clinical trials, quality control and commercial licensing issues

2:15 pm

Scaling Up Adherent Viral Vector Manufacturing

Jun Wang, Marketing Manager, PALL® Biotech, China

2:45 pm

  • Advances in applying gene-editing technology for novel therapeutics
  • Progress of gene-editing therapeutics in China and the US

3:30 pm

Afternoon Networking & Refreshment Break

4:00 pm

  • Updates on the production and commercialization for KTE-C19 and Fosun-Kite’s two other developing TCR-T cell products
  • Fosun’s regulatory and approval strategy for its CAR-T R&D pipelines in China

4:30 pm

  • Developments in manufacturing for GMP-grade plasmids
  • Overview of industrial-scale production for lentiviral vectors
  • Commissioning CAR-T cell preparation facilities in China
  • Overcoming challenges of manufacturing cell therapies towards the commercial phase

5:00 pm

Chairperson’s Summary and End of Main Conference Day One

8:00 am

Morning Coffee

PRICING AND COMMERCIALIZATION FOR CELL & GENE THERAPY

9:00 am

Chairperson’s Opening Remarks

Paolo Morgese, Director for EU Market Access and Member Relations, Alliance for Regenerative Medicine, Switzerland

9:50 am

  • Development of a novel primary clinical endpoint
  • CMC challenges for approval
  • Discussion of the FDA and EMA regulatory process

10:30 am

Morning Networking and Refreshment Break

11:00 am

  • ARM’s work with policy-makers/regulators to advance the development of and improve access to CGT treatments
  • How does the US and Europe compare in terms of public attitudes, reimbursement and pricing strategies for CGT treatments?

11:30 am

  • Overview of Taiwan’s new Cell and Gene Therapy Bill
  • Challenges and opportunities for cell therapy research in Taiwan
  • Role of academia and research institutions in the clinical translation of CGT

SCIENTIFIC ADVANCEMENTS IN CELL AND GENE THERAPY

12:00 pm

  • Offshore expansion and partnership opportunities for Kalbe Farma’s CGT development
  • Indonesia’s regulatory environment for R&D and clinical trials for CGT
  • Kalbe Farma’s R&D pipelines in autologous stem cell therapy and other opportunities in CGT currently explored

12:30 pm

Networking Lunch

1:30 pm

Chairperson’s Opening Remarks

Dr. Steve Oh, Institute Scientist and Director, Stem Cell Bioprocessing, Bioprocessing Technology Institute, A*STAR, Singapore

  • Overview of companies developing cell and gene therapies in Singapore
  • Industry engagement and regulations
  • A*STAR’s R&D pipeline in biomanufacturing of allogeneic stem cells (MSC and iPSC)

CHINA AND OTHER REGIONAL MARKETS FOR CELL AND GENE THERAPY

3:00 pm

  • Overview of the state of CGT development in the Netherlands
  • Lessons from the Dutch Model: Integrated approach to innovation in life sciences
  • Opportunities for collaboration in Regenerative Medicine between China and the Netherlands

3:30 pm

Afternoon Networking & Refreshment Break

BDP CHINA CLOSING PLENARY SESSION

5:00 pm

Chairperson’s Summary and End of Main Conference Day One

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
Group Rate of 2 or more delegates - International Companies, Global HQ Located Outside ChinaUS $1495Early Bird
Group Rate of 4 or more delegates - International Companies, Global HQ Located Outside ChinaUS $1295Early Bird
2 Day Conference - Local China CompaniesUS $977US $827Early BirdEarly Bird
Group of 2 or more delegates - Local China CompaniesUS $752Early Bird
Group of 4 or more delegates - Local China CompaniesUS $676Early Bird
Extras Price
Pre Conference Workshop - International Companies, Global HQ Located Outside China US $300
Pre Conference Workshop - Local China Companies US $150
Gala Dinner US $50

Early Bird Rate: Register & Pay by 27 March 2020

  • 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 »

CNY Pricing

  • 2 Day Conference: CNY 6,500
  • Group of 2 or more delegates: CNY 5,000
  • Group of 4 or more delegates: CNY 4,500
  • Pre Conference Workshop: CNY 1,000
  • Gala Dinner: CNY 350

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

Judith Li

Partner, Lilly Asia Ventures, Hong Kong

Feng Tao

Founding Partner, Biotrack Capital, China

He Ting

Chief Executive Officer, ImmunoChina, China

Dong Wei

CEO, Edigene, China

Peter Luo

CEO, Adagene Pharma, China

Jonathan Zhao 4th Annual Bioprocess and Technology 2018

Jonathan Zhao

Co-Founder and Executive Chairman, TRANSCENTA HOLDING, China

Dr. Jimmy Zhang

Venture Partner, Lilly Asia Ventures, China

Chelsea Zhang

Partner, Ping An Ventures, China

Amy Tang

Venture Partner, Healthcare, Qiming Venture Partners, China

Dr. Kevin Li

Managing Partner, LYZZ Capital Advisors, China

Dody Bautista

Chief Scientist, Sibiono GeneTech, China

Jieyu Zou

Vice President, Lilly Asia Ventures, China

Dr. Alvin Luk

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

Shuyuan Yao

General Manager, Wuxi ATU Co., Ltd., China

Jiansong Tong

Director and Head of CAR-T Cell Therapy, Shanghai Hengrui Pharmaceutical, China

Jun Wang

Marketing Manager, PALL® Biotech, China

Richard Wang

CEO, Fosun Kite Biotech, China

Paolo Morgese

Director for EU Market Access and Member Relations, Alliance for Regenerative Medicine, Switzerland

Sumimasa Nagai

Deputy Director of the Translational Research Centre / Clinical Expert Advisor at the Office of New Drug V (Oncology) and Companion Diagnostics Working Group, University of Tokyo Hospital / Pharmaceuticals and Medical Devices Agency, Japan

Daniel Takefman

Head of Regulatory Affairs, Spark Therapeutics, United States

Chen-Yuan Lin

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

Sandy Qlintang

Deputy Director of Stem Cell and Cancer Institute, PT Kalbe Farma, Indonesia

Dr. Steve Oh

Institute Scientist and Director, Stem Cell Bioprocessing, Bioprocessing Technology Institute, A*STAR, Singapore

Morakot Papassiripan

Pharmacist at the Professional Level at the Biological Sub-Division, Bureau of Drug Control, Food and Drug Administration of Thailand, Thailand

David Bekkers

Officer for Innovation, Technology & Science, Holland Innovation Network in China, Netherlands

Dr Jerry Dong

Vice President of CMC and Regulatory Affairs, Shanghai Henlius Biotech, Inc.

Dr Lin Shiwen

Vice President of Downstream Process Development, WuXi Biologics, China

Dr. Jerry Yang

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

Xiaodi Su

Senior Investment Manager, Lilly Asia Ventures, China

when & where

18 - 20 May 2020

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/

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