P46376 Cell and Gene Therapy
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Cell and Gene Therapy

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

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 – reguatory 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
  • Decelopments 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

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)

Regulatory Keynote Address

Ru-Yi He, Chief Scientist, Center for Drug Evaluation (CDE), China Food and Drug Administration (CFDA)

9:30 am

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

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

10:00 am

  • Chinese Biopharma leadership’s thoughts on local to global ambitions
  • Recent regulatory developments – obstacle or opportunity?
  • CDMOs and clinical trials market
  • China market scenarios on CAR-T & CRISPR technology – where is the market headed?
  • Growth prospects on cell line development market and therapeutics
  • Current state of affairs on – biologics, biosimilars pipelines and manufacturing quality
  • Digitalization of biopharma value chain – is China ahead of the game?

10:50 am

Morning Networking and Refreshment Break

Cell and Gene Therapy Summit Commences

CHINA MARKET AND REGULATORY DEVELOPMENTS

Chairperson’s Opening Remarks

11:20 am

  • 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

12:00 pm

Cell Therapy Manufacturing – Regulatory Requirements, Technology and Innovation

Senior Representative, Merck,

12:30 pm

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

1:00 pm

Networking Lunch

CELL THERAPY MANUFACTURING

2:00 pm

Scaling up Tech Platforms for Pipelines in Cell and Gene Therapy

Senior Representative, PALL® Biotech,

2:30 pm

From Bench to Bedside: Technology Platforms for the Translation of Cell and Gene Therapy

Senior Representative, Thermofisher,

3:00 pm

Afternoon Networking & Refreshment Break

3:30 pm

Panel Discussion: New Developments in Gene Therapy

Ryan Scanlon, Head of Viral Gene Therapy, Lonza Pharma & Biotech

CAR-T AND CRISPR TECH DEVELOPMENTS

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

4:20 pm

  • Hengrui’s approach in manufacturing CAR-T cell therapies
  • Insights and challenges to the CMC regulatory compliance for CAR-T in China
  • Comparing manufacturing standards and clinical trials for CAR-T in the US and China

4:40 pm

  • Advances in using gene-editing technology for novel therapeutics
  • Partnership updates with Fujifilm in the field of gene therapy drugs

5:10 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

5:40 pm

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

Wei Xu, President and Chief Executive Officer, Sibiono Genetech, China

6:00 pm

Chairperson’s Summary and End of Main Conference Day One

8:00 am

Coffee

PRICING AND COMMERCIALIZATION FOR CELL & GENE THERAPY

9:00 am

Chairperson’s Opening Remarks

  • How does MHRA work with the private sector to expedite approval process for CGT, while ensuring safety of its consumers?
  • Challenges surrounding commercialization of CGT in the UK
  • BREXIT’s impact on regulatory frameworks for CGT in the UK and EU

9:30 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?

10:00 am

  • Spark’s experience in the development and approval of LUXTURNA in the US and the EU
  • Challenges with obtaining Orphan Designation for the market authorization of LUXTURNA
  • How does the US FDA and EMA regulatory systems complement one another?

10:30 am

Morning Networking and Refreshment Break

11:00 am

  • Key points to note in Steminent’s successful expansion to North America and Japan
  • Latest updates on clinical trial results
  • A case study of Stemchymal® SCA
  • New technologies in CGT development and its impact on the biotech sector

11:30 am

  • Korea’s potential for Stem Cell development
  • Novel developments in MSC treatments and stem cell treatment technology
  • SCM’s commercialization strategy: New R&D areas, expansion opportunities and partnering for commercial licensing

SCIENTIFIC ADVANCEMENTS IN CELL AND GENE THERAPY

12:00 pm

Utilizing Fully Human Monoclonal Antibody Fragments for T-Cell Immunotherapy

He Ting, CEO, ImmunoChina, China

12:30 pm

  • Overview of CGT development in Singapore
  • Industry engagement and collaboration defining Singapore’s approach to regulating CGT
  • A-STAR’s R&D pipelines in CGT: New developments in biomanufacturing / technology for cultivating adult stem cells (MSCs)

1:00 pm

Networking Lunch

CHINA AND OTHER REGIONAL MARKETS FOR CELL AND GENE THERAPY

2:00 pm

  • 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
  • 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
  • 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
  • Latest updates on regulatory framework for Stem Cell Therapy in India
  • Ethical concerns surrounding CGT in India and perspectives on remaining policy gaps
  • Overview of Reelabs’ R&D pipelines: How far has stem cell development progressed?

3:30 pm

Afternoon Networking & Refreshment Break

BDP CHINA CLOSING PLENARY SESSION

4:00 pm

  • Chinese Regulatory perspectives – where do we see the shift
  • Manufacturing quality and compliance – going global strateg
  • 60 day CDE timeline for Phase 3 trials
  • CAR-T & CRISPR – how best is to price?
  • Technology investment in pipelines
  • Key takeaways for 2019

5:00 pm

Chairperson’s Summary and End of Main Conference Day One

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
  • 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 »

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speakers

Ru-Yi He

Chief Scientist, Center for Drug Evaluation (CDE), China Food and Drug Administration (CFDA)

Dan Gibson, Ph.D.

Vice President, DNA Technology, Synthetic Genomics Inc.*

Richard Wang

CEO, Fosun Kite Biotech, China

He Ting

CEO, ImmunoChina, China

Dong Wei

CEO, Edigene, 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

Zhou Mingdong

CEO and Chief Scientist, Zensun, China

Zonghai Li

President and Chief Executive Officer, CARsgen Therapeutics, China

Wei Xu

President and Chief Executive Officer, Sibiono Genetech, China

Shuyuan Yao

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

Senior Representative, Merck

Judith Li

Partner, Lilly Asia Ventures, Hong Kong

Bosun Hau

Head of Global Healthcare and Investment / Independent Director, Sailing Capital Advisors / Cellular Biomedicine Group, Hong Kong

Lynn Yang

Managing Director, Sequoia Capital, China

Chelsea Zhang

Healthcare Partner, Ping An Ventures, China

Senior Representative, PALL® Biotech

Senior Representative, Thermofisher

Ryan Scanlon

Head of Viral Gene Therapy, Lonza Pharma & Biotech

Jiansong Tong

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

James McBlane

Preclinical Assessor, Medicines and Healthcare Products Regulatory Agency, United Kingdom

Paolo Morgese

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

Daniel Takefman

Head of Regulatory Affairs, Spark Therapeutics, United States

Ryan Chang

Chief Executive Officer, Steminent Biotherapeutics, Taiwan

BG Rhee

CEO, SCM Lifescience, South Korea

Steve Oh

Institute Professor and Scientist at the Bioprocessing Technology Institute, A-STAR, Singapore

Chen-Yuan Lin

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

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

David Bekkers

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

Sandy Qlintang

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

Rohit Kulkarni

Vice-President / Director, Stem Cell Society of India / Reelabs, India

Morakot Papassiripan

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

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

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Speaking Opportunities
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+65 6508 2489

Yvonne.Leong@ibcasia.com.sg

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Eileen Tan
+65 6508 2462
eileen.tan@ibcasia.com.sg

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