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Life Sciences 20 – 23 May 2013 | Grand Hyatt Shanghai, China 8th International China Pharmaceutical R&D Summit China Pharmaceutical R&D Summit 8th International Produced by: www.chinapharmard.com REGISTER NOW! Customer Service Hotline: +65 6508 2401 / +86 21 2326 3680 Supported by: International Marketing Partner: Panel Sponsors: CanBiotech R&D Outsourcing Capital Sourcing Competitive Intelligence Media Partners: Exhibitors: Bronze Sponsor: Harnessing the Best of East and West to Fuel Drug Development Harnessing the Best of East and West to Fuel Drug Development 2013 KEYNOTE SPEAKERS Alan Sheppard Principal, Global Generics, Thought Leadership, IMS Health, UK Jim O’Mara Vice President Corporate Development, Ironwood Pharmaceuticals, USA Barry Bernstein MD Divisional Vice President, Infectious Disease Development, Global Pharmaceutical Research and Development, AbbVie, USA WHY THIS IS A MUST-ATTEND EVENT: A fresh speaker panel and new case studies, ‘of the moment’ collaborations such as Ironwood- AstraZeneca and NeuroVive-Sihuan Key established and emerging domestic companies including Chipscreen, SK Biopharma, Genor, Hua Medicine and Shanghai Genomics Insights from leading investment experts including OrbiMed, FIL Capital Management, Sequoia Capital, KPCB and Goldman Sachs In-depth & interactive formats: Pharma Fireside Chat, CxO Panel and Industry Strategizing Session PLUS 4 NEW TOPICAL WORKSHOPS A B C Fundamentals of R&D Part 1: Creating the Right Environment for Innovation The Art of Guanxi – Principles for Successful Business in China Fundamentals of R&D Part 2: From Concept to Commercialization – A Roadmap for Success New Speakers at China Pharma R&D 2013 Include: Ka-Kit Hui, MD, FACP Professor, Founder & Director, Center for East-West Medicine, Department of Medicine, UCLA, USA Peter Peizhi Luo, Chief Executive Officer , Adagene Inc., China Cezary Statuch, MD, Vice President, Head of China R&D, Bristol-Myers Squibb, China Bon Chul Brian Ku, General Manager , SK Biopharm (Shanghai), China Robert Braithwaite, CEO, Luqa Pharmaceuticals, China Zhi-Qiang Ning, MD, PhD, Cofounder, VP R&D, Shenzhen Chipscreen Biosciences Ltd, China Pui-Kwong Chan, PhD, Professor, Department of Pharmacology, Baylor College of Medicine, USA Dr Zheng Li, General Manager , Lundbeck Research, China Zhen Zhang, Associate Director, Analytical and Bioanalytical Development, Bristol-Myers Squibb, China Mikael Brönnegård, MD, PhD, Associate Professor, and Chief Executive Officer , NeuroVive Pharmaceutical AB, Sweden Rahim Rezaie, Research Fellow, Rotman School of Management, University of Toronto and Asia Pacific Foundation of Canada (Vancouver), Canada Yajiong Xue, PhD, Director, Center for Healthcare Management Systems, Associate Professor of MIS, College of Business, East Carolina University, USA Yu-Ligh Liou, Vice President, Division of Regulatory Affair & Business Development, iStat Biomedical Co., Ltd., Taiwan D Gaining Biosimilars Approval in US and EU 2013

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Page 1: Harnessing the Best of East and Harnessing the Best of ... · Pharma Fireside Chat, CxO Panel and Industry Strategizing Session PLUS 4 NEW TOPICAL WORKSHOPS A Fundamentals of R&D

LifeSciences

20 – 23 May 2013 | Grand Hyatt Shanghai, China

8th International

China PharmaceuticalR&D SummitChina PharmaceuticalR&D Summit

8th International

Produced by:

www.chinapharmard.com

REGISTER NOW! Customer Service Hotline: +65 6508 2401 / +86 21 2326 3680

Supported by:

International Marketing Partner:

Panel Sponsors:

CanBiotechR&D Outsourcing

Capital SourcingCompetitive Intelligence

Media Partners:

Exhibitors:Bronze Sponsor:

Harnessing the Best of East and West to Fuel Drug DevelopmentHarnessing the Best of East and West to Fuel Drug Development

2013 KEYNOTE SPEAKERS

Alan SheppardPrincipal, Global Generics,Thought Leadership,IMS Health, UK

Jim O’MaraVice President CorporateDevelopment,Ironwood Pharmaceuticals,USA

Barry Bernstein MDDivisional Vice President,Infectious DiseaseDevelopment, GlobalPharmaceutical Researchand Development,AbbVie, USA

WHY THIS IS AMUST-ATTEND EVENT:• A fresh speaker panel and new case

studies, ‘of the moment’collaborations such as Ironwood-AstraZeneca and NeuroVive-Sihuan

• Key established and emergingdomestic companies includingChipscreen, SK Biopharma, Genor,Hua Medicine and ShanghaiGenomics

• Insights from leading investmentexperts including OrbiMed, FILCapital Management, SequoiaCapital, KPCB and Goldman Sachs

• In-depth & interactive formats:Pharma Fireside Chat, CxO Panel andIndustry Strategizing Session

PLUS 4 NEW TOPICAL WORKSHOPS

A B CFundamentals of R&DPart 1: Creating theRight Environment forInnovation

The Art of Guanxi –Principles for SuccessfulBusiness in China

Fundamentals of R&DPart 2: From Concept toCommercialization –A Roadmap for Success

New Speakers at China Pharma R&D 2013 Include:

Ka-Kit Hui, MD, FACPProfessor, Founder & Director,Center for East-West

Medicine, Department of

Medicine, UCLA, USA

Peter Peizhi Luo, Chief Executive Officer, Adagene Inc., ChinaCezary Statuch, MD, Vice President, Head of China R&D, Bristol-Myers Squibb, ChinaBon Chul Brian Ku, General Manager, SK Biopharm (Shanghai), ChinaRobert Braithwaite, CEO, Luqa Pharmaceuticals, ChinaZhi-Qiang Ning, MD, PhD, Cofounder, VP R&D, Shenzhen Chipscreen Biosciences Ltd, ChinaPui-Kwong Chan, PhD, Professor, Department of Pharmacology, Baylor College of Medicine, USADr Zheng Li, General Manager, Lundbeck Research, ChinaZhen Zhang, Associate Director, Analytical and Bioanalytical Development, Bristol-Myers Squibb, ChinaMikael Brönnegård, MD, PhD, Associate Professor, and Chief Executive Officer, NeuroVive Pharmaceutical AB, SwedenRahim Rezaie, Research Fellow, Rotman School of Management, University of Toronto and Asia Pacific Foundation of Canada (Vancouver), CanadaYajiong Xue, PhD, Director, Center for Healthcare Management Systems, Associate Professor of MIS, College of Business, East Carolina University, USAYu-Ligh Liou, Vice President, Division of Regulatory Affair & Business Development, iStat Biomedical Co., Ltd., Taiwan

D Gaining BiosimilarsApproval in USand EU

2013

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REGISTER TODAY! +65 6508 2401 / +86 21 2326 3680 [email protected] www.chinapharmard.com

08.00 Registration and Welcome Coffee

08.30 Welcome and Opening Remarks from the ChairCarl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, Singapore

Drug Discovery and Development Week Plenary

08.40 State of Play: Where is the Pharmaceutical Industry Heading?• Defining the market factors which have influenced the growth or posed hindrance to the

pharmaceutical industry• The opportunities of new markets in the midst of an economic downturn• Managing clinical needs rather than cost in areas of terminal care where advances arises from

biologicals offering improved life expectancy

Alan Sheppard, Principal, Global Generics, Thought Leadership, IMS Health, UK

09.15 Integrative Medicine for the New Century: A US-China Perspective• Overview of Integrative Medicine in the U.S. and in China• Chinese healthcare system and its current development• Peeking into the emerging role of integrative medicine in global healthcare

Ka-Kit Hui, MD, FACP, Wallis Annenberg Chair in Integrative East-West Medicine, Chair,Collaborative Centers for Integrative Medicine, Professor, Founder & Director, Centerfor East-West Medicine, Department of Medicine, UCLA, USA

09.50 Emerging Trends in Investments: Alternative Funding Models and StrategicPortfolio Management• How can companies be attractive to investors?• Best practices for investors to choose the molecule to invest in• Diversifying the investment portfolio - How much should I invest in each portfolio?• Analyzing the biosimilars prospects and what is the true potential?

Moderator:Simone Song, Executive Director, IBD, Goldman Sachs (Asia) L.L.C, Hong Kong

Panellists:David G. Wang, MD, PhD, Senior Managing Director, OrbiMed Asia, China

Wu Chun, Partner and Managing Director, Boston Consulting Group, Hong Kong

Dianna Qian, Principal, FIL Capital Management, China

James Huang, Managing Partner, KPCB, China

10.35 Opening of Exhibits & Morning Refreshments

China Healthcare Policy – Impact on Innovation

Session ChairLi Chen, President and Chief Executive Officer, Hua Medicine, China

11.05 Implications of the 12th 5 Year Plan: Multinational Perspective on theOpportunities and Challenges for R&D in China• Industry interpretation of the Healthcare Reform and 12th 5 year plan: What this means for

R&D and innovation• Identifying the potential opportunities in China for domestic and multinational companies• Recognising the key challenges for R&D in China

Dr Zheng Li, General Manager, Lundbeck Research, China

11.35 Domestic CxO Perspective on the Future of Pharma in Asia: To what Extentis the Landscape Shifting to Support Innovation?• Generics play an important role given the limited government investment in healthcare –

is the government willing to spend on innovator drugs?• How will the research field in China be changing over the next decade?• Can there be a second wave of Eastern-researched blockbusters? If not, what needs to

change?• What is the ‘real’ impact of the $125 billion that will be spent:

~ Is there really an opportunity for the pharma industry or is the emphasis on tertiary care?• What impact will the health insurance reform have?

Moderator:Ming Guo, PhD, Co-Founder & Chief Operating Officer, Ascentage Pharma, andGeneral Manager, Small Molecule Drug R&D Center, China Medical City, China

Panellists:Bon Chul Brian Ku, General Manager, SK Biopharm (Shanghai), China

Li Xianzhong, Deputy General Manager, Biotech Pharmaceutical Co. Ltd, China

Chen Chen, Chief Executive Officer, Sundia MediTech, China

Sally Sha, Director Business Development, Tigermed, China

12.20 Venture and Private Funding for Drug Development in China• Overview of the Chinese companies that have been successful in gaining venture funding• Outlining Chinese companies which are successfully capturing venture and other private

funding• Considering what partnerships are driving drug development in Chinese companies• Who are the innovators among the partners versus development partners?• Contrast China with trends in the major markets

Ian Lloyd, Editorial Director, Preclinical Drug Information, Citeline, UK

CONFERENCE DAY ONETuesday 21 May 2013

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12.50 Networking Lunch

14.15 Pharma Fireside Chat with Dr Samantha Du, Managing Director,Sequoia Capital, ChinaModerator:Jason Mann, Head China Healthcare Equity Research, Barclays Capital, Hong KongIn this candid interview session, Dr Du will share her 20 years of experience in movingfrom a pharma executive to an entrepreneur to an investor. You will gain an insight intoher thoughts on the future of R&D in China, the role of domestic vs global players in theregion and advice to entrepreneurs.

14.45 The Road of 11 Years from a Research Institute to a Real PharmaceuticalCompany• Outlining the progression of a returnee-led company from a drug target discovery company

to first class 1.1 drug NDA approval• Highlighting key challenges and lessons learned:

~ IND package preparation ~ Clinical trial management ~ NDA filing ~ Human resources,financing and rising cost of operation

• Combining science with good business practice to receive optimal results

Dr Ying Luo, Chairman and Chief Executive Officer, Shanghai Genomics, Inc.,Chairman, Beijing Continent Pharmaceuticals, China

Reducing Uncertainty in Your R&D

15.15 Approaches to Reduce Cost and Time to Market in Drug Discovery ProgrammePresentation Hosted by Elsevier

15.45 Afternoon Refreshments

Science and Innovation Showcase

Session ChairFrank Shen, Divisional Vice President, Data and Statistical Sciences, Global Pharmaceutical R&D,AbbVie, USA

16.15 HCV Small Molecule Development from Bench to Clinic• Defining an opportunity• Identifying a differentiated development strategy• Implementing novel approaches to antiviral development

Barry Bernstein MD, Divisional Vice President, Infectious Disease Development, GlobalPharmaceutical Research and Development, AbbVie, USA

16.45 Chipscreen’s Development of a Novel Subtype-Selective HDAC InhibitorChidamide (CS055): From Bench to Bed• Overview of the first subtype-selective HDAC inhibitor ready for NDA in peripheral T-cell

lymphoma as an orphan drug designation in China• Describing the unique mechanism of action by enhancing cellular immunity against tumors;

mechanism-based improvement in safety profile comparing with other approved drugs• Development strategy as single agent and combination treatments in China and USA

Zhi-Qiang Ning, MD, PhD, Co-Founder, Vice President Research & Development,Shenzhen Chipscreen Biosciences Ltd, China

17.05 Application of Saponin – An Ingredient of Chinese Medicine - In OvarianCancer Therapy• Purification and characterization of anti-cancer saponins from herbal drug (Xanthoceras

sorbifolia)• In-vitro and in-vivo studies of active saponins• Chemical modification of the saponin• Application of active saponins for ovarian cancer therapy

Pui-Kwong Chan, PhD, Professor, Department of Pharmacology, Baylor College ofMedicine, USA

17.25 Therapeutic Antibody Development Driven by Innovative Technologies• Progress in research and technological innovation of therapeutic antibodies which aim to

revolutionize the therapy for cancer, autoimmune, and infectious diseases• Antibody generation and design technology used to tailor antibodies beyond their natural

limits to meet the challenge of developing more specific, safe, and potent therapeuticantibodies

Peter Peizhi Luo, Chief Executive Officer, Adagene Inc., China

17.45 New Biomarkers for Cervical Cancer Detection: Clinical Validation Trials inTaiwan and China• New clinical or pharmacogenetics biomarker research and development• The co-clinical study of new biomarker in China and Taiwan

Yu-Ligh Liou, Vice President, Division of Regulatory Affair & Business Development,iStat Biomedical Co., Ltd., Taiwan

18.05 Closing Remarks from the ChairEnd of Day 1 Followed by Networking Drinks Reception

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NCONFERENCE DAY TWOWednesday 22 May 2013

REGISTER TODAY! +65 6508 2401 / +86 21 2326 3680 [email protected] www.chinapharmard.com

Emerging Business Models: R&D Partnerships Between East and West

13.45 Ironwood and AstraZeneca PartnershipIn this insightful interview you will have the opportunity to hear from both sides of the partnership,learning about the strategies behind the business decisions, key challenges, successes and visionfor the future of the collaboration.

Moderator:Betty Su, Vice President, Boston Healthcare Associates, ChinaPanellists:Jim O’Mara, Vice President Corporate Development, Ironwood Pharmaceuticals,USAAugustine Yee, Head of Asia Pacific Corporate and Regional Development and ChinaVice President of Business Development, AstraZeneca, China

14.30 NeuroVive Pharmaceutical and Sihuan Pharmaceutical Collaboration DrugDevelopment Strategies for Evolving Marketplaces: Reinventing Biopharmathrough Strategic Alliances• Defining criteria for successful partnership• Strategies to cope with culture differences• Challenges in harmonizing clinical trials and regulatory affairs in conducting international

clinical trial programs• How to build long-term success and a sustainable business

Mikael Brönnegård, MD, PhD, Associate Professor and Chief Executive Officer,NeuroVive Pharmaceutical AB, Sweden

15.05 Start-ups, SMEs and China: Large Gains for Niche Players• Real experience on successful partnerships between start-ups and SMEs in China• Share and understand how to evaluate product potential from a China point of view• Building on proven science to create innovative niche product opportunities in China's

vast market

Robert Braithwaite, Chief Executive Officer, Luqa Pharmaceuticals, China

15.40 Afternoon Refreshments

16.10 Assessing the Co-Development Partnering Model between East and West:A Recipe for Success or Failure?• Outlining the key challenges in a co-development collaboration• Strategies to ensure success in a co-development partnering model• Highlighting the benefits and risks for each party• Discussing the impact of a co-development partnering model on innovation on a

global scale• Opportunities vs risks: Is this a sustainable partnering model for the future?

Moderator:Yariv Hefez, Vice President, Business Development and Alliance Management,Biosimilars, Merck Serono, SwitzerlandPanellists:Binhui (Ben) Ni, Head of Scouting & Partnership, Sanofi Aventis, ChinaRobert Chen, Senior Director, Global Strategy & Partnering, Genor Biopharma,ChinaZhi-Qiang Ning, MD, PhD, Co-Founder, Vice President Research & Development,Shenzhen Chipscreen Biosciences Ltd, ChinaJim O’Mara, Vice President Corporate Development, Ironwood Pharmaceuticals,USAZhen Zhang, Associate Director, Analytical and Bioanalytical Development,Bristol-Myers Squibb, China

The Future of Medicine and Direction of R&D

16.55 Translating Innovation to the Market• How to strengthen collaborations between academia, clinical research institutes, pharma

and biotech industry to achieve cost effective delivery of affordable medicines to thegeneral population

• What is the future for integrating medicine between the East and West?• What is the role and benefits of translational medicine to enhance R&D?• Current situation of Orphan Drugs development in China and future policy & investment

environment?• Development of novel biologics and home-grown biobetters in China for treating

complicated diseases

Moderator:Prof. Aamir Shahzad, MD, Director of Administration, International Societyfor Translational Medicine (ISTM), AustriaPanellists:Guoqing Cao, Vice President of Biology, Jiangsu Hengrui Medicine, ChinaJimmy Zhang, PhD, Managing Director, MSD Early Investments – Greater China,Merck & Co., Inc., ChinaKa-Kit Hui, MD, FACP, Professor, Founder & Director, Center for East-WestMedicine, Department of Medicine, UCLA, USAPeter Peizhi Luo, Chief Executive Officer, Adagene Inc., China

17.40 Closing Remarks from the Chair & End of Conference

08.30 Welcome and Opening Remarks from the Chair

Ming Guo, PhD, Co-Founder & Chief Operating Officer, Ascentage Pharma, and

General Manager, Small Molecule Drug R&D Center, China Medical City, China

The Role of Asia in Global Drug Development

08.40 Globalization of Innovation: Could the Growing Innovation Capacity in the

East Save the Western Drug Development Model?• Discussing globalization of innovation and the growing role of China and India

• Assessing types of collaborative innovation models between companies in China/India

and their global counterparts & benefits that flow to respective partners

• Identifying areas of significant potential:

~ Leveraging innovation capacity in Asia for addressing prevalent diseases in the

developing world

~ Cross-border SME-SME linkages, a potent force for innovation, but yet underutilized

Rahim Rezaie, Research Fellow, Rotman School of Management, University of

Toronto and Asia Pacific Foundation of Canada (Vancouver), Canada

09.15 Horizon-Scanning: Who Will Lead Innovation in 2020?Each panellist will provide a 10 minute overview of innovation landscape in their region

(China, India, Rest of Asia), followed by a candid discussion about the future of innovation

• Comparing and contrasting R&D policy, strategy and government support

• Hypothesizing where each of these countries will be in 2020, and where your investment

will be justified

• Predicting where the majority of innovation will come from in 2020 – The West/China/

India/Rest of Asia

Moderator:

Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, Singapore

Panellists:

Yajiong Xue, PhD, Director, Center for Healthcare Management Systems, Associate

Professor of MIS, College of Business, East Carolina University, USA

James Garner, MD, Vice President and General Manager, Takeda Global Research

and Development Center (Asia), Singapore

Rahim Rezaie, Research Fellow, Rotman School of Management, University of

Toronto and Asia Pacific Foundation of Canada (Vancouver), Canada

10.15 Morning Refreshments

11.00 How to be Successful in Bringing Innovative Products to China• Discussing strategies for international companies to successfully bring a product to China

• Addressing key questions:

• Do you partner with a domestic company or enter alone?

• Do you repeat phase 1-3 clinical studies or skip this phase?

• Assessing the role of domestic companies and scope for future partnership opportunities

Moderator:

Jun Bao, Director of Worldwide Business Development, GlaxoSmithKline, China

Panellists:

Cezary Statuch MD, Vice President, Head of China Research & Development,

Bristol-Myers Squibb, China

Dr Zheng Li, General Manager, Lundbeck Research, China

Frank Shen, Divisional Vice President, Data and Statistical Sciences, Global

Pharmaceutical R&D, AbbVie, USA

Zhihao Yu, Analyst, Lux Research Inc., China

11.45 Pharma Fireside Chat with Li Chen, Chief Executive Officer, Hua Medicine, China

Moderator:

Ian Haydock, Asia Editor, SCRIP Intelligence, Japan

In this ‘tell-all’ interview, Dr Chen will share his personal experiences as an R&D leader

in both USA and China. Discussing the key differences in attitude and infrastructure,

how he has seen the landscape for R&D in China change and predicts where it’s

heading in the future.

12.15 Spotlight Session

Raise your corporate profile by sponsoring or exhibiting at IBC’s 8th International

China Pharmaceutical R&D Summit. For details on speaking in this session or

other sponsorship opportunities, please contact Yvonne Leong: Tel: +65 6508 2489;

Email: [email protected]

12.45 Networking Lunch

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Session ChairRahim Rezaie, Research Fellow, Rotman School of Management, University of Toronto andAsia Pacific Foundation of Canada (Vancouver), Canada

Page 4: Harnessing the Best of East and Harnessing the Best of ... · Pharma Fireside Chat, CxO Panel and Industry Strategizing Session PLUS 4 NEW TOPICAL WORKSHOPS A Fundamentals of R&D

Strategy/Commercialisation/Licensing 15%

By Industry:

Originators 35%

Biotech10%

Legal 10%

Solution Providers 5%

Generics &Biosimilars 30%

Academic10%

By Country:

China 40%

SE Asia5%

USA 10%

Rest of World 5%

India 15%

Europe10%

Rest of NorthAsia 15%

By Job Function:

R&D/Innovation20%

BusinessDevelopment15%

Regulatory 5%

Academia 5%

Biomanufacturing 15% Legal 10%

Clinical5%

Sales andMarketing10%

WORKSHOPS

REGISTER TODAY! +65 6508 2401 / +86 21 2326 3680 [email protected] www.chinapharmard.com

The Art of Guanxi – Principlesfor Successful Business in China

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C Fundamentals of R&D Part 2: From Conceptto Commercialization – A Roadmap for Success

PROMOTIONAL OPPORTUNITIES: SPEAK • SPONSOR • EXHIBIT • NETWORK

Use IBC’s Drug Discovery and Development Week to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience.Gain access to 300+ key decision-makers from local, regional and multinational pharma and biotech companies.

We are able to tailor a sponsorship solution to your needs. To find out more please contact Yvonne Leong, T: +65 6508 2489 E: [email protected]

2013 Sponsors:

WHO YOU WILL MEET AT DRUG DISCOVERY AND DEVELOPMENT WEEK 2013

Led by: Seth Goldenberg, Senior Principal Scientist, NAMSA, USAAngela Luo, Senior Partner, Beijing Long An Law Firm ShanghaiBranch, China

The success of your business in China is significantly dependent on your personalrelationships and careful planning at the beginning to meet your long-term goals.Your ability to maintain successful partnerships, develop a balanced market entryplan, and overall success in China will depend on your understanding of the cross-cultural differences and unique legal and regulatory framework.

This workshop will provide critical insights on:• How to do business locally• How to setup the right business structure to meet your goals• How to expand your company in the region• How to attract and retain the right staff• How to build commercial and distribution channels

Led by: Al Dampier, Chief Executive Officer, Dampier Consulting Group LLC, USA

A staggering number of start-ups fail within the first three years. Understanding the stagesof the drug development process, the decisions and the risks of each stage in the process isvital to give your pharma start-up a chance.

This workshop is designed to provide start-ups and entrepreneurs with an overview of theskills and resources required to take your NCE/NBE from concept to commercialization. Froma meaningful business and risk management plan, to a product launch and post-marketstrategy, this workshop will advise on how to avoid unnecessary costs and risks, and is a mustfor all new start-up leaders.

In this participative workshop, you will switch your hat from a scientist to a business person.You have a great idea or a great product, but that's not enough. What does it take tocommercialize a product?

Topics of discussion will include:• The Business Plan• Creating a Strategic Framework for Growth• Demystify VC and Angel Networks• Hiring a Team – Who do you need on your team to be successful

PRE-CONFERENCE WORKSHOPS:Monday | 20 May 2013

POST-CONFERENCE WORKSHOPS:Thursday | 23 May 2013

Registration begins 30 minutes prior to each workshop. Half-day workshops include a refreshment break and lunch is catered for delegates attending a full day ie morning + afternoon workshop.

Fundamentals of R&D Part 1: Creatingthe Right Environment for Innovation

A

Led by: Al Dampier, Chief Executive Officer, Dampier Consulting Group LLC, USA

A focus on innovative R&D is essential for companies in China to remain competitivein the market and to take advantage of the government’s investment in innovation.This workshop is designed for prospective innovator companies and establishedgeneric companies moving to an innovator model.

Topics of discussion will include:• Organizational structures and practices that promote innovation• Barriers to innovation• How to develop skills, capabilities and attitudes conducive to innovation• An experiential exercise to get you thinking in an innovative manner• Moving from an ‘imitation to innovation’ mindset

• Creativity and change management models• Sustainable change• Leading innovation and change

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DLed by: Dr Anita O’Connor, Managing Partner, Anita O’Connor Consulting, USA

Workshop Objectives:To provide an overview of the regulatory requirements for marketing approval of biosimilarsin the US and EU, along with the challenges that sponsors face in developing a biosimilar.

Workshop Agenda:• Introduction to biosimilars• Analytical and functional studies recommended by EU and US regulatory authorities• Animal studies to include pharmacodynamic, pharmacokinetic and toxicology studies• Clinical trials for biosimilars to include pharmacovigilance

Gaining Biosimilars Approval in US and EU

• • •

Page 5: Harnessing the Best of East and Harnessing the Best of ... · Pharma Fireside Chat, CxO Panel and Industry Strategizing Session PLUS 4 NEW TOPICAL WORKSHOPS A Fundamentals of R&D

REGISTER TODAY! +65 6508 2401 / +86 21 2326 3680 [email protected] www.chinapharmard.com

Drug Discovery and Development Week: Programme at a Glance

Wednesday22 May 2013

CONFERENCE DAY 2

JOINT NETWORKING LUNCHEON

Successful Scaling up Conditions Compliance With Latest Pharma Legislation

CHINA PHARMAR&D SUMMIT

BIOSIMILARS: STRATEGYBIOSIMILARS:

BIOMANUFACTURINGPHARMA LEGAL

AFFAIRS ASIA

PRE-CONFERENCE WORKSHOPSMonday20 May 2013

Tuesday21 May 2013

CONFERENCE DAY 1

China Healthcare Policy – Impact on Innovation Biosimilars Plenary: Successful Navigation of the Evolving Biosimilars LandscapeRegional Legal Framework Update

JOINT NETWORKING LUNCHEON

SPONSORED EVENING COCKTAIL RECEPTION

The Role of Asia in Global Drug Development

Developing Sustainable Competitive Strategies

Increasing Cost Efficiencies

Thursday23 May 2013

POST-CONFERENCE WORKSHOPS

China Pharma R&D and Biosimilars Joint Plenary Session: The Global Pharmaceutical Landscape

Science and Innovation ShowcaseProduct Development & New Market Expansion

Risk & Returns to Consider Before Entry

Preparations Before Embarking onBiomanufacturing

IP Loss Prevention and Enforcement

Strategic Collaborations to StrengthenValue Chain

Biosimilars Plenary: Global Regulatory Guidelines Overview

Legal Issues in Pharma Commercial Contracts

R&D Partnerships Between East and West

The Future of Medicine and Direction of R&D

Who Should Attend:• CEO/CSO/COO/VP from Domestic Chinese Companies

• VP/Head/Group Leader of R&D, Drug Discovery, External Collaboration, Business Development from InternationalSME and MNC Pharma and Biotech

• Professor/Head of Department from Academic and Research Institutions

• Business Development/Sales and Marketing Executive from CROs, CMOs, Drug Discovery Research Services,Laboratory Services

Now in its 8th year, IBC’s China Pharmaceutical R&DSummit continues to be a leading industry gathering,reputed for its quality content, high-caliber speakerpanel and invaluable networking opportunities.

Featuring 100+ attendees, 35+ topic experts, 20+ hoursof structured and informal networking over 4 days, plusa comprehensive agenda covering the policy, regulatory,legal and funding environment in China and the futureof pharmaceuticals globally. If you can only attend oneChina R&D and partnering event in 2013, make it IBC’sChina Pharmaceutical R&D Summit!

Harnessing the Best of East and West to Fuel Drug Development

Part of:

IBC Life Sciences’ Drug Discovery & Development Week bringstogether international and regional decision makers to addressthe industry’s most pressing concerns. Whether frominnovators in pharmaceutical R&D to developers of biologicsand biosimilars, this is China’s most targeted world classforum providing the latest strategies, expertise, technologiesand solutions.

Co-located With:

21 – 23 MAY 2013 | GRAND HYATT SHANGHAI, CHINA

Developing Market Share & Asset Protection in Emerging Market Frameworks

Register & Pay by 8 March to save up to US$300 / CNY1,000 each

IBC’s 2nd Pharma Legal Affairs Asia features a distinguishedspeaker faculty of pharmaceutical and biotech counsel coupledwith legal experts. It provides a unique forum for dealmakersand legal minds to address the industry’s most compelling andcurrent legal issues.

www.pharmalegalasia.com

IBC’s 4th Annual Biosimilars Asia is the region’s largestgathering of leading and future stakeholders. Lively debates,insightful case studies and in-depth market analysis providemaximum learning. Highlighting the latest in biosimilarsdevelopment, commercial strategies and know-how inbiomanufacturing to bring affordable medicines to market.

www.biosimilarsasia.com

C: Fundamentals of R&D Part 2: From Concept to Commercialization – A Roadmap for SuccessD: Gaining Biosimilars Approval in US and EU

A: Fundamentals of R&D Part 1: Creating the Right Environment for InnovationB: The Art of Guanxi – Principles for Successful Business in China