P46374 10th Annual Biosimilars Asia
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10th Annual Biosimilars Asia

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

China steadfastly continues to work regulations on biosimilars to help make the market easier to breakthrough, and the recent Priority Review legislation is a case in point. As the industry continues to evaluate cost, risk and incentives for Biosimilar development, new developments to promote R&D and adjustments to approval pathways are designed to help manufacturing and commercialization of biosimilars.

IBC’s 10th Biosimilars Asia is one of 5 conferences part of the 5th Biopharma Development and Production Week in China. It will address the business case, approvals, future manufacturing strategies  and commercialisation, in a market that is expected to be worth $20 billion globally by 2022.

Key Highlights

  • CFDAs priority review policy and impact on biosimilars
  • The current clinical trial landscape for new biosimilars, and expected pipelines
  • The oncology Biosimilars market
  • Future manufacturing strategies
  • Proving similarity
  • Managing product variations
  • Innovation and technology breakthroughs for biosimilar development
  • Pricing and Promotion strategies
  • Commercialisation strategies for the China biosimilars market
  • Anticipating investment across the value chain for successful biosimilar commercialisation

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

The BDP Party!

When: Wednesday, 15 May 2019 at 6.30pm
Where: Shanghai City Bistro, Level 1, Shanghai Marriott Parkview Hotel
Cost: CNY 350 / USD 50 net (inclusive of buffet dinner and free flow wine / beer)

  • Registration is not limited to conference participants and we encourage all who are in the BDP industry to attend.
  • Dinner will only proceed when we have reached 100 participants.
  • Payment is only required when the dinner is confirmed.
  • Participants list for the dinner will be made available online once the registration reaches 100 participants.

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)

9:05 am

Keynote Address Enabling the Future of Optimised Biologics for Novel Therapeutics and Drugs

9:30 am

Outlook for China’s BDP Market – Investments, Regulations, Innovation and Vision of Chinese Manufacturers

Senior Representative from Fosun Pharma*,

10:00 am

10:40 am

Morning Networking and Refreshment Break

10TH BIOSIMILARS ASIA COMMENCES

11:20 am

Chairperson’s Opening Remarks

  • Rapidly maturing R&D capabilities in the Chinese market – How can it be competitive globally?
  • Technological breakthroughs in biosimilar developments
  • The future of Chinese biosimilars market – Where does it lead to?
  • Supportive CFDA’s biosimilars policies
  • Current pipelines and what market can expect
  • Investments and going IPO in Hong Kong

12:00 pm

  • Monoclonal antibodies (mAbs) and the oncology market
  • Progression in monoclonal antibodies biosimilars
  • Demand and trends for oncology biologics
  • Innovative programs and partnership highlights for biologics development and CMC capabilities
  • Pipelines, clinical trials and investment updates

12:30 pm

Networking Lunch

NEW CLINICAL TRIALS IN BIOSIMILARS

1:30 pm

  • Market potential for Humira
  • R&D and clinical trial costs and outcomes experience in China
  • Working with CNDA’s requirement to review analytical, preclinical and clinical data
  • Compatibility and similarities for Adalimumab
  • Humira and Adalimumab pipeline update

2:00 pm

From China to the World- Strategies for Global Biosimilar Development

Dr. Manfred Weiler, Senior Vice President, Medical & Scientific Strategy, Syneos Health, UK

2:30 pm

  • Oncology biosimilars market outlook in China and globally
  • Similarity and clinical trials results
  • Meeting the National Medical Products Administration (NMPA) expectations
  • Practical approach to biosimilars clinical trials

3:00 pm

3:30 pm

Afternoon Networking & Refreshment Break

FUTURE MANUFACTURING AND TECH STRATEGIES

4:00 pm

4:30 pm

  • Scaling up and improving manufacturing quality
  • CDMO’s perspectives on innovative manufacturing
  • What opportunities and challenges exist in developing quality biosimilars in China?
  • Enhance biosimilar adoption by addressing sufficient manufacturing and clinical data to physicians’ acceptance
  • The trends in transformation to world-class GMP facilities

5:00 pm

  • What are new technology trend for biosimilars manufacturing?
  • Managing new technology and meeting GMP guidelines
  • Biosimilars products development and manufacturing – A spotlight on Enbrel Similar, Filgrastim Similar, Actemra Similar
  • Evaluating manufacturing technology for continuous process development and application to mAb production
  • Tech transfer management

5:30 pm

Chairperson’s Summary and End of Main Conference Day One

8:00 am

Morning Coffee

REGULATORY IMPACTS ON BIOSIMILARS

9:00 am

Chairperson’s Opening Remarks

9:10 am

  • China NMPA’s draft review guidelines and effects on commercial biosimilars markets?
  • Regulatory insights on R&D, Clinical Trials, Manufacturing and Pricing
  • A reformed clinical trial management system and its impacts on biosimilars trials
  • Review, approval, submission and dossier submission requirements
  • Regulatory and market access considerations to fuel biosimilar uptakes

9:40 am

10:30 am

Morning Networking and Refreshment Break

11:00 am

11:30 am

  • Updates on Central Drugs Standard Control Organisation (CDSCO) on biosimilars
  • Regulations on import, export, carrying out research and preclinical permission
  • How can China and India learn from each other to grow in global markets?
  • Streamlining commercial strategies to meet guidelines in various regulations – EU, US, China and India

12:00 pm

  • Innovatives and biosimilars CMC development (fast track to clinical stage)
  • Pathway for parallel submission
  • Challenges in CMC
  • Case Study for FDA/NMPA CTA
  • Global clinical strategy

12:30 pm

Networking Lunch

PRICING AND PROMOTION

1:30 pm

  • Marketing and channel strategies for biosimilars in China
  • Ensuring speed-to-market while maintaining a high quality biosimilars of clinical data
  • Realising maximum uptake of biosimilar products to realise marketing and R&D ROI
  • How do we ensure physicians and patients better appreciation of biosimilar products?
  • Pricing mechanisms and market access

2:00 pm

  • Government biosimilars reimbursement plans that are encouraging local and overseas market developments – Is this as expected?
  • Impacts on the reformed drug reimbursement plans
  • Commercial strategies on pricing and marketing of approved drugs
  • Product differentiation with originators
  • Managing non-drug-related costs

PROVING SIMILARITY AND DEVELOPMENT PLATFORMS

2:40 pm

  • Managing structural similarities for bioequivalence
  • Ensuring similar amino acid sequences
  • Case studies – tech, R&D, data and similarity analysis

3:00 pm

  • Samsung Bioepis’ biosimilar pipelines and developments
  • Introduction of 3rd wave of biosimilars into pipeline
  • Case study: Samsung Bioepis’ clinical process

3:30 pm

Afternoon Networking & Refreshment Break

BDP CHINA CLOSING PLENARY SESSION

4:00 pm

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 $1895Early 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 $977Early Bird
Group of 4 or more delegates - Local China CompaniesUS $676Early Bird
Group of 2 or more delegates - Local China CompaniesUS $752Early 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 8 March 2019

Group Rate – Local China Companies

  • Group of 2 or more delegates  = US $752
  • Group of 4 or more delegates  = US $676

Group Rate – International Companies, Global HQ Located Outside China

  • Group Rate of 2 or more delegates   = US $1495
  • Group Rate of 4 or more delegates  = US $1295

For Group Registrations : email info@ibcasia.com.sg or call +65 6508 2477

 

  • 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.

Partners

View Partners profile >>

speakers

Senior Representative from Fosun Pharma*

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

Zhou Mingdong

CEO and Chief Scientist, Zensun, China

Zhengyu Yuan

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

Dr. Scott Liu

President and CEO, Shanghai Henlius Biotech Inc., China

Dr Wu Youling

Chief Executive Officer, ZheJiang Teruisi Biopharmaceutical, China

Lin Jian

Vice President of Regulatory Affairs, Bio-Thera Solutions, China

Dr. Manfred Weiler

Senior Vice President, Medical & Scientific Strategy, Syneos Health, UK

Senior Representative, Innovent Biologics

Jim Cucinotta

Senior Director, Global Clinical Operations, Oncology/Hematology & Biosimilars, Head of Clinical Supply Chain, Teva Pharmaceuticals, USA

Dr Lin Shiwen

Vice President of Downstream Process Development, WuXi Biologics, China

Hark Chen

Vice President, Process Development, Mycenax Biotech Inc, Taiwan

Ou Huilan

Director of Regulatory Affairs, Shanghai Henlius Biotech, China

Wang Yongzhong

President of Pharmaceuticals, Executive Vice President, Simcere Pharmaceutical Group, China

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

Dr Abhay Sinha

Regional Director, Pharmaceuticals Export Promotion Council of India, India

Dr. Allen Ho

Head of Regulatory Affairs CMC, JHL Biotech Inc.

Brian Hosung Min

Senior Vice President, Samsung Bioepis, South Korea

Dr Jiang Weidong

Vice President and Chief Scientific Officer, Shanghai Henlius Biotech, China

Dr. Alvin Luk

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

Chen-Yuan Lin

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

Dr. Senyon Choe (Teddy)

Professor, Biology, University of California San Diego (UCSD), U.S. and President and Director of Joint Center for Biosciences, South 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/

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contact

Still have a question?

Customer Service
register@ibcasia.com.sg
+65 6508 2401

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

sponsors

Bronze Sponsor

exhibitors

Partners

Conference Partner Conference Partner

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