30.12.2012 Views

REGISTER TOday! - Bentham Science

REGISTER TOday! - Bentham Science

REGISTER TOday! - Bentham Science

SHOW MORE
SHOW LESS

You also want an ePaper? Increase the reach of your titles

YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.

2012年亚洲生物仿制药会议<br />

23–26 April 2012, Grand Hyatt Shanghai, China<br />

2012年4月23-26 日,中国上海金茂君悦大酒店<br />

Partnership and Commercializing Strategies for Increased Market Uptake<br />

推进合作与商业化战略,拓展产品市场份额<br />

Featuring<br />

Regulatory Keynote<br />

Suzette Kox, Senior Director Scientific Affairs,<br />

European Generic Medicines Association<br />

(EGA), Belgium<br />

Investor Keynote<br />

Julie Seawall, Executive Director,<br />

Business Development, Merck<br />

BioVentures, USA<br />

Industry Leaders<br />

Other Industry Perspectives<br />

Thomas Moriarty, President, Global Pharma Strategies,<br />

Medco, USA<br />

Alan Sheppard, Principal, Global Generics, Thought<br />

Leadership, IMS Health, UK<br />

Co-Located with:<br />

第四届2012中国疫苗会议 china 2012<br />

Produced by<br />

dr Arthur Alston, Regulatory Affairs,<br />

Special Projects, Roche, Switzerland<br />

dr Subir Basak, Chief Executive Officer,<br />

Celestial Biologicals Limited, Chief Commercial<br />

Officer, Intas Biopharmaceuticals Ltd, India<br />

dr Stanley Hong, Senior Vice President, Research<br />

& Development, Celltrion, South Korea<br />

Michael Corbo, Vice President & Chief<br />

Development Officer, Bio-enhancement<br />

Development Unit, pfizer, USA<br />

an informa business<br />

Knowledge Partner<br />

Why bioSimiLarS aSia iS<br />

bio-better in 2012!<br />

Asia’s LARGEST meeting on Biosimilars: Over 30 speakers in 24 powerpacked<br />

sessions; over 150 attendees in 2011<br />

ONLY conference in Asia with multiple-player perspectives: Innovators +<br />

Biopharmas + Biosimilar players + Investor + Pharmacy Benefit<br />

Management + Regulatory<br />

2012 fOCuS is on: commercial viability, investment evaluations, strategic<br />

collaborations, prescribers’ acceptance<br />

uNIquE IN-dEpTH case studies by Industry leaders: Celltrion, Merck<br />

Bioventures and more in their quest for global biosimilars<br />

MORE pHARMERGING MARKET perspectives alongside GLOBAL<br />

speakers from US, Europe, Japan, Syria, Pakistan, China, India<br />

EXCLuSIVE IMS intelligence presented and explored during the<br />

conference and Post Conference Briefing<br />

Maximized networking and collaboration opportunities from<br />

3 CO-LOCATEd CONfERENCES under the same roof!<br />

pre-Conference<br />

full day Workshop<br />

23 April 2012<br />

post-Conference<br />

full day Strategy<br />

Briefing<br />

26 April 2012<br />

www.biosimilarsasia.com<br />

Literature Insertion Sponsor<br />

Media Partners<br />

PLuS! not to be miSSed!<br />

RegistRation hotline +65 6508 2401 / +86 21 2326 3680<br />

This conference will be simultaneously translated 此会议将会有中英同声翻译<br />

US Market Entry: A Regulatory, Legal, and Medical<br />

Communication Perspective<br />

Led By:<br />

Seth J Goldenberg, President, Asia pacific Bio Intelligence,& former uS fdA, pharmacology<br />

Michael platt, President, MedVal Communications<br />

Gary Smith, Founder, Enterprise Law<br />

Turning Strategies into Tactical Plans<br />

to Optimize Market Entry – Balancing<br />

Commercial, Regulatory and Investments to<br />

Deliver Successful Business Models<br />

Led By:<br />

Alan Sheppard, Global Head of Generics, Thought Leadership, IMS Health<br />

Richard diCicco, Chairman, Harvest Moon pharmaceuticals uSA, Inc<br />

dr Janet M McNicholas, Partner, K&L Gates LLp<br />

Official Associations<br />

Part of<br />

International Marketing Partner<br />

www.ibc-asia.com


The estimated US$80bn of biologics coming off patent by 2020 is not a sum the<br />

pharmaceutical industry can risk ignoring. In addition, the extended global financial crisis has<br />

increased pressure on healthcare regimes, regulators and pharma to bring more affordable<br />

and accessible drugs to market.<br />

Innovators are fighting to stave off losses and protect their market share against intensifying<br />

competition. Meanwhile, regulators and prescribers are forced to evaluate interchangeability,<br />

bioequivalence and quality compared to premium priced originator drugs. In these<br />

unprecedented times, the commercial viability, sustainability and market potential of<br />

biosimilars have become a point of contention.<br />

IBC’s 3rd Annual biosimilars asia 2012 is the largest and most anticipated meeting of its<br />

kind in Asia. Attended by biosimilars, innovators, generics and biopharma alike, the unique<br />

mix of attendees from all over the world will share their experiences and opinions about the<br />

future of biosimilars. Tough questions will be answered and positions will be challenged but<br />

all will walk away bristling with ideas, opportunities and be more informed. biosimilars<br />

asia 2012 continues to deliver a quality of speakers and discussions unmatched in Asia.<br />

1<br />

2<br />

3<br />

4<br />

5<br />

6<br />

7<br />

8<br />

9<br />

10<br />

1<br />

2<br />

3<br />

4<br />

5<br />

6<br />

7<br />

8<br />

9<br />

10<br />

2012年亚洲生物仿制药会议<br />

23–26 April 2012, Grand Hyatt Shanghai, China<br />

2012年4月23-26 日,中国上海金茂君悦大酒店<br />

Partnership and Commercializing Strategies for Increased Market Uptake 推进合作与商业化战略,拓展产品市场份额<br />

10 Reasons<br />

why Biosimilars asia is a<br />

‘mUsT aTTEND’<br />

Biosimilars Asia 2012 is Asia’s LARGEST CONfERENCE<br />

addressing complex strategy questions, attended by regional<br />

and global innovators, generics, biopharma and biosimilars<br />

companies<br />

STRATEGIC pLENARY KEYNOTE SESSIONS with delegates<br />

from Biosimilars Asia 2012, China Pharmaceutical R&D<br />

Summit & Vaccines China 2012<br />

dON’T MISS OuT on ‘no-holds-barred’ discussions featuring<br />

innovators, generics, biosimilars and industry thoughtleaders!<br />

Get a global point of view of the fuTuRE Of BIOSIMILARS<br />

with speakers from the USA, EU, Asia, MENA<br />

Meet the GREATEST NuMBER of Asian and pharmerging<br />

markets’ biosimilar companies under one roof<br />

With imminent global regulatory changes, find out the<br />

LATEST in the US, Europe and China<br />

Be privy to STRATEGIES in collaborations, countering<br />

aggressive price cuts and increasing market acceptance of<br />

biosimilars<br />

Determine the COMMERCIAL VIABILITY of biosimilars<br />

REVIEW the challenges, opportunities and success factors in<br />

launching biosimilars<br />

The ONLY EVENT featuring frank and honest debates,<br />

invaluable insights and unmatched collaboration<br />

opportunities<br />

2012 年亚洲生物仿制药会议<br />

“不容错过”的 十大理由<br />

2012年亚洲生物仿制药会议是亚洲地区致力于解决生物仿制药产<br />

业复杂战略问题的最大规模会议,本地区乃至全球的创新机构、<br />

仿制药企业、生物创新药和生物仿制药公司均会出席<br />

出席2012年亚洲生物仿制药会议、中国药物研发峰会和<br />

2012年中国疫苗会议的代表将共同出席战略性主题演讲<br />

千万不要错过与创新机构、仿制药企业、生物仿制药公司和业<br />

界思想领袖“无拘无束”探讨问题的机会!<br />

聆听美国、欧盟、亚洲、和中东地区演讲者的精彩发言,了解关<br />

于生物仿制药未来发展的全球观点<br />

在同一地点结识众多亚洲和新兴医药市场生物仿制药公司代表<br />

了解即将出现的全球监管变革,探索美国、欧洲和中国的最新<br />

监管趋势<br />

洞察业界合作、反击大幅度降价行为以及提高生物仿制药市场<br />

认同度的各项策略<br />

确定生物仿制药的商业可行性<br />

审视生物仿制药上市过程中所面临的挑战、机遇和成功因素<br />

这是唯一一个能够让彼此坦诚交流的会议,您可以在此聆听真<br />

知灼见,寻求无比宝贵的合作机会<br />

2012 gLOBAL SPEAkERS InCLUDE:<br />

Yariv Hefez<br />

Director, Global Business Development<br />

and Alliance Management, Merck<br />

Serono, Switzerland<br />

dr Yang Xu<br />

Chief Patent Counsel, Simcere<br />

Pharmaceutical Group, China<br />

dr Sunit Maity<br />

Associate Divisional Head,<br />

biopharmaceuticals, Avesthagen,<br />

India<br />

Youling Wu<br />

CEO, ZheJiang Teruisi,<br />

China<br />

PhARMERgIng REgIOnAL FORECAST<br />

Source: IMS Health, Nov 2011<br />

WhO ShOULD ATTEnD:<br />

By JoB TiTle<br />

CEO, CSO, VPs, Directors & Heads of<br />

• Research & Development<br />

• Business Development & Strategy<br />

• Follow-on Biologics/Follow on Proteins/<br />

Biosimilars<br />

• Biologics/Biotechnology/Biogenerics<br />

• IP Director/Counsel Lawyer & Patent<br />

• Sales & Marketing<br />

• Product Development<br />

• Strategy Planning & Development<br />

• Licensing<br />

• Procurement / Sourcing<br />

• External Manufacturing<br />

• Clinical Trials<br />

• Collaborative Research<br />

• CMO Account Management<br />

• External Resourcing<br />

• Quality Assurance<br />

• Technology Transfer Lead<br />

• Pharmacovigilance<br />

价值 800 亿美元的生物制剂产品专利将陆续在2020年之际到期。这一改变牵涉数额如此巨<br />

大,将对制药行业产生深远影响。与此同时,伴随全球金融危机影响范围持续扩大,医疗<br />

保健行业、监管机构和制药企业所面临的压力不断增加,促使其在市场上推出价格更便<br />

宜、更容易买到的药品。<br />

创新机构努力在日趋激烈的竞争中避免损失,并尽力维护其占有的市场份额。同时,监管<br />

机构和处方医师不得不以价格高昂的原研药作为参照,对药物的可替代性、生物等效性和<br />

质量进行评估。在这一前所未有的特殊时期,生物仿制药的商业可行性、可持续性和市场<br />

潜力成为了争论的焦点。<br />

由 IBC 主办的 2012年亚洲生物仿制药会议是亚洲地区同类会议中规模最大、参与程度最<br />

高的一次盛会。来自世界各地的生物仿制药企业、创新机构、仿制药公司和生物制药企业<br />

代表齐聚一堂,积极分享彼此的经验和对生物仿制药未来发展的看法。此次会议将深入探<br />

讨众多棘手的问题,积极汇聚业界各方的观点,所有与会者必能带着更多资讯、见解和机<br />

遇满载而归。2012年亚洲生物仿制药会议将沿袭以往的出色水准,汇聚亚洲地区最高级别<br />

的与会者与畅所欲言的热烈讨论。<br />

PhArMergIng cOuntry grOwth dynAMIcS<br />

Carl firth<br />

CEO, Aslan Pharmaceuticals,<br />

Singapore<br />

dr Mary Haak-frendscho<br />

President and Chief Scientific<br />

Officer, Takeda San Francisco,<br />

USA<br />

dr Shahzad Khan<br />

Director, Marketing & Sales,<br />

Getz Pharma, Pakistan<br />

Abdullah Baaj<br />

CEO, Boston Oncology,<br />

Syria<br />

Shirley Zhao<br />

General Manager,<br />

Genzyme, China<br />

dr Ming Wang<br />

Executive Director and Head of<br />

Diabetes Research, Amgen, USA<br />

dr Kyu don Kim<br />

Vice President, Strategic<br />

Business Development,<br />

Samsung, South Korea<br />

dr Junichi Koga<br />

Vice President<br />

Biopharmaceuticals,<br />

Daiichi-Sankyo, Japan<br />

<strong>REGISTER</strong> NOW! Online www.biosimilarsasia.com or call our Customer Service Hotline: +65 6508 2401 / +86 21 2326 3680<br />

Others 12%<br />

Part of<br />

By indusTry By counTry<br />

Regulatory<br />

authorities &<br />

Ministry of Health<br />

2%<br />

Contract<br />

Manufacturing<br />

Organizations<br />

4%<br />

Contract Research<br />

Organizations 4%<br />

Generics & Biosimilar<br />

Companies 30%<br />

Pharmaceuticals 25%<br />

Biotechnology &<br />

BioPharmaceuticals<br />

23%<br />

“In 2009, the combined biosimilars market<br />

size for the US and five major European<br />

markets was US$150m. With more than 30<br />

branded biologics with sales of US$51bn set<br />

to lose patent exclusivity between 2011 and<br />

2015, the global biosimilar market will grow<br />

from US$243m in 2010 to US$3.7bn in 2015.”<br />

Datamonitor, April 2011<br />

“2009 年,美国和欧洲五个主要市场的生物仿<br />

制药整体市场规模为 1.5 亿美元。在 2011 年至<br />

2015 年期间,销售额高达 510 亿美元的 30 多<br />

种品牌生物制剂将失去独家专利权,而全球生<br />

物仿制药市场规模将从 2010 年的 2.43 亿美元<br />

飙升至 2015 年的 37 亿美元。”<br />

Thailand 1%<br />

Syrian 2%<br />

Singapore<br />

9%<br />

Pakistan<br />

3%<br />

Malaysia<br />

1%<br />

USA 4%<br />

Taiwan 9%<br />

Korea 10%<br />

Japan 7%<br />

Iran 5%<br />

Datamonitor,2011 年 4 月<br />

Australia 2%<br />

Switzerland 4%<br />

China 30%<br />

India 9%<br />

Germany 1%<br />

United Kingdom 1%<br />

Hong Kong 1%<br />

Ireland 1%


Partnership and Commercializing Strategies for Increased Market Uptake 推进合作与商业化战略,拓展产品市场份额<br />

ExhIBITIOn FLOORPLAn<br />

Reserve<br />

your booths<br />

today!<br />

AM<br />

PM<br />

MON 23 APRIL TUE 24 APRIL WED 25 APRIL THU 26 APRIL<br />

Pre-Conference Workshops:<br />

US Market Entry: A Regulatory,<br />

Legal, and Medical Communication<br />

Perspective (Full Day)<br />

Expression Systems for Antibody and<br />

Vaccine Biomanufacturing (Full Day)<br />

LUNCH,<br />

AM & PM BREAKS<br />

US Market Entry: A Regulatory,<br />

Legal, and Medical Communication<br />

Perspective<br />

Expression Systems for Antibody and<br />

Vaccine Biomanufacturing<br />

Meet the Speakers Reception<br />

(by Invitation only)<br />

16<br />

Onsite<br />

Lab<br />

China Pharmaceutical R&D<br />

Summit<br />

• Regulatory Snapshots<br />

• R&D Leaders Panel<br />

• Investment & Funding<br />

• ‘Pharma Idol’: Innovation<br />

Showcase<br />

• CXO Panel Discussion<br />

• Funding for Innovation<br />

<strong>REGISTER</strong> <strong>TOday</strong>!<br />

1 2 3<br />

Biosimilars<br />

15<br />

Tea/ Coffee<br />

Station<br />

14<br />

PAST ATTEnDIng COMPAnIES InCLUDE:<br />

drug diScovery & deveLoPment Week event at a gLance<br />

China Pharma R&D, Vaccines & Biosimilars<br />

JOINT PLENARY SESSION<br />

Global and Regional Keynote Presentations<br />

On Pharma R&D<br />

Vaccines China<br />

• Market Trends & Outlook<br />

• Vaccines Quality Control &<br />

Compliance<br />

• Novel Development of Vaccines<br />

• Regulatory Snapshots<br />

• Visionary Panel Discussion<br />

Discussion Den:<br />

In depth roundtable discussions on Regulatory and<br />

Collaborations in Key Asian Countries<br />

4<br />

China<br />

Pavilion<br />

13<br />

NETWORKING RECEPTION<br />

EVENING DINNER (Optional)<br />

+65 6508 2401<br />

+86 21 2326 3680<br />

Tea/ Coffee<br />

Station<br />

12<br />

5 6 7<br />

Vaccines<br />

CRO<br />

Clinic<br />

China Pharmaceutical R&D<br />

Summit<br />

• Drug Development &<br />

Partnering Strategies<br />

• Emerging Business Models<br />

in R&D<br />

• Discovery & Early Stage Devt<br />

• Role of Academia in Drug<br />

Discovery & Development<br />

EXHIBITION & POSTER SESSION<br />

DISCUSSION DEN<br />

CRO Clinic / Onsite “Lab’ & Demonstrations<br />

China Technology & Services Pavilion<br />

Biosimilars Asia<br />

• Market Entry & Opportunities<br />

• Commercial Viability<br />

• Regulatory Snapshots<br />

• Visionary Panel Discussion<br />

Tea/ Coffee<br />

Station<br />

Networking<br />

Lounge<br />

GENENTECH • ASAHI GLASS • SINOPHARM • USV • JCR PHARMACEUTICALS • MAIN LUCK PHARMACEUTICALS •<br />

HANWHA CHEMICAL • SANDOZ • BOEHRINGER INGELHEIM • GLAXOSMITHKLINE • LUPIN • HOSPIRA • MYCENAX<br />

BIOTECH • MERCK & CO • DR REDDY’S LABORATORIES • SHENZHEN SCIPROGEN BIO-PHARMACEUTICAL •<br />

SHANGHAI CELGEN BIOPHARMACEUTICALS • ELI LILLY • TTY BIOPHARM • 3SBIO • JIANGSU CHIA TAI TIANQING<br />

PHARMACEUTICAL • PFIZER INVESTMENT • NIPPON KAYAKU • HENLIUS BIOPHARMACEUTICALS • SHANGHAI<br />

HENLIUS BIOTECH • RANBAXY • ASTRAZENECA • BECTON DICKINSON (BD BIOSCIENCES) • F HOFFMANN-LA<br />

ROCHE • CIPLA • GETZ PHARMA • MATRIX (MYLAN) • HISUN PHARMACEUTICAL • COBEL DAROU • SAMSUNG •<br />

SANOFI-AVENTIS • STADA • GENZYME • ADV BIOSCIENCE • BIOGEN IDEC • FOSUN PHARMA • DAIICHI-SANKYO<br />

SPOnSORShIP OPPORTUnITIES<br />

Raise awareness for your services available to<br />

Asian pharmaceuticals!<br />

• Do you find difficulty in reaching senior decision makers and<br />

successfully stimulating interest for your services?<br />

• Are you trying to raise awareness of the value of your company’s<br />

expertise and services?<br />

• Or are you finding it difficult to differentiate your company from<br />

your competition?<br />

Perhaps what you need is a branding opportunity at this event!<br />

Increase your reach through our extensive marketing campaign,<br />

targeted at your qualified business audience. For information about<br />

placing your brand & profile top-of-mind to key buyers, contact Yvonne<br />

Leong, Business development Manager on Tel: + 65 6508 2489 /<br />

yvonne.leong@ibcasia.com.sg<br />

11<br />

10<br />

“Great interaction between biosimilar<br />

companies, innovator, market<br />

consultants, regulations, patent<br />

attorneys etc”<br />

Rustom, R&D, Intas Pharmaceutical<br />

“This conference gave us many<br />

opportunities for networking”<br />

Jade, Business Development, Hanwha Chemical Corp<br />

“I enjoyed the knowledge & content from<br />

the presenters”<br />

Andrew, Director, Biosimilars Advisory Service &<br />

Oncology, BioTrends Research Group<br />

8<br />

9<br />

China Pharmaceutical R&D<br />

Summit<br />

• ‘Pharma Idol’: Innovation<br />

Showcase and Awarding<br />

• Clinical Development &<br />

Partnerships in Asia<br />

• Future Opportunities in<br />

Biosimilars & Biobetters<br />

• Closing Visionary Panel<br />

Discussion<br />

+65 6508 2407<br />

+86 21 2326 3699<br />

2012年亚洲生物仿制药会议<br />

23–26 April 2012, Grand Hyatt Shanghai, China<br />

2012年4月23-26 日,中国上海金茂君悦大酒店<br />

Part of:<br />

Take advantage of the synergy of 3 established events under<br />

one roof. Develop new contacts in drug development and<br />

enhance your overall networking experience by showcasing<br />

your capabilities to get your deals done. Don’t forget your<br />

business cards!<br />

Forging successful collaborations & ensuring Quality<br />

& compliance<br />

www.vaccineschina.com<br />

The most comprehensive event focused on vaccines development<br />

through to manufacturing. Good manufacturing practices and strategies<br />

will be reviewed, alongside potential block-buster technologies and<br />

R&D projects.<br />

Advancing r&d through innovation and collaborations<br />

www.chinapharmard.com<br />

China’s first and longest running international conference has brought<br />

together world-renowned thought-leadership from the West to Asia,<br />

to expedite and develop collaborations in pharma R&D. While global<br />

MNCs are firmly established in the region, increasing focus is on<br />

Asian enterprises, led by overseas returnee-led and China-supported<br />

companies emerging to research and develop new molecules. As the<br />

industry globally moves towards biologic medicines and the race to<br />

deliver affordable post-patent treatments intensifies, this annual<br />

meeting will highlight the winning pathways to successful Asian R&D<br />

and commercialization for the region and beyond.<br />

Combining the best of the West and East, traditional and biopharma, from<br />

discovery to clinical development and approvals, international, regional<br />

and Chinese pharma leaders will address the future of innovation and<br />

map the future growth potential for the industry in Asia as well as Asia’s<br />

contribution to global R&D.<br />

Vaccines China<br />

• Novel Vaccine Candidates for<br />

Tropical Diseases<br />

• Research and Clinical Updates<br />

for EV71 vaccines<br />

Vaccines China<br />

• Innovations & Technological<br />

Advancements<br />

• Future Opportunities<br />

for Sustainable Return on<br />

Investment<br />

Co-located with:<br />

第四届2012中国疫苗会议 china 2012<br />

打造成功合作关系,追求卓越质量 Forging successful collaborations and ensuring Quality & compliance<br />

Biosimilars Asia<br />

• External Collaborations &<br />

Commercial Value<br />

• Breaking into Protectionist<br />

Markets<br />

• Intellectual Property Legal<br />

Debate<br />

Biosimilars Asia<br />

• Mad about mAbs<br />

• Developing Biosimilars &<br />

Biobetters<br />

• Winning Buy-in<br />

• Closing Panel Debate<br />

Part of<br />

Post-Conference Workshops:<br />

Next Generation of Vaccine Facilities<br />

with Focus on Design & Containment<br />

Turning Strategies into Tactical<br />

Plans to Optimize Market Entry –<br />

Balancing Commercial, Regulatory<br />

and Investments to Deliver Successful<br />

Business Models<br />

register@ibcasia.com.sg www.biosimilarsasia.com


Partnership and Commercializing Strategies for Increased Market Uptake 推进合作与商业化战略,拓展产品市场份额<br />

0800 Registration & Morning Coffee / Tea<br />

0830 Chairman’s Opening Remarks<br />

Li Chen, President & CEO, Hua Medicine, China<br />

PlenAry KeynoTe sessions:<br />

GloBAl And reGionAl PHArMA r&d<br />

0840 Takeda’s R&D Collaboration Model for Targeted Medicine for Unmet needs<br />

dr Mary Haak-frendscho, President & Chief Scientific Officer, Takeda San francisco, USA<br />

0910 Extending Innovation network through Partnering<br />

Joe McCracken, Global Head of Business Development & Licensing, Roche, USA<br />

gLobaL<br />

keynote<br />

addreSS<br />

0940 Effectively Tackling R&D Productivity Challenge: Integration of External Research<br />

gLobaL<br />

keynote<br />

addreSS<br />

• Open innovation models<br />

• Improving innovation for sustainability<br />

• Innovation in China<br />

• Industry-Academia and Industry-Biotech partnerships<br />

• Effectively managing the integration of external research<br />

• Abandoned R&D assets: value or burden?<br />

dr Helmut Haning, Senior Vice President & Head Global Innovation Outsourcing, Bayer Healthcare pharmaceuticals, Germany<br />

1010 Is China Ready to Lead in global Drug Innovation and Development?<br />

• Is ROCE-led innovation transforming China’s pharma industry onto the world stage?<br />

• Partnering with China in vaccines research & development<br />

• Opportunities and challenges from biosimilars and biobetters from/for pharmerging markets<br />

Moderator:<br />

Carl firth, CEO, Aslan pharmaceuticals, Singapore<br />

panelists:<br />

Ling Chen, Vice President of R&D China Operations, GlaxoSmithKline, China<br />

frank Shen, Vice President Global Data Management and Statistics, Global Pharmaceutical R&D, Abbott, USA<br />

Youling Wu, CEO, ZheJiang Teruisi, China<br />

dr Ming Wang, Executive Director & Head of Diabetes Research, Amgen, USA<br />

1100 Morning Refreshments<br />

Exhibition hall & Poster Session Opens<br />

End of Plenary Session<br />

1130 Chairperson’s Opening Remarks<br />

Richard diCicco, Chairman, Harvest Moon pharmaceuticals, USA<br />

THe FuTure oF BiosiMilArs: MArKeT enTry & oPPorTuniTies<br />

1140 The Commercial Viability of Biosimilars<br />

• What are the key considerations before deciding to invest in biosimilars?<br />

• Determining the commercial value of biosimilars<br />

• Is it feasible for small to medium sized companies to venture into biosimilars?<br />

• How has the non-conventional financial backing from the likes of Novartis, Henlius, Samsung Electronics etc changed the<br />

biosimilars landscape?<br />

Richard diCicco, Chairman, Harvest Moon pharmaceuticals, USA<br />

1210 Beyond Borders - Setting Sights unto Semi and Unregulated Pharmerging Markets<br />

• What are the key considerations to consider before expanding overseas?<br />

• Is the risk worth it?<br />

• Best practices to gain the greatest market access such as launch strategies to be first to market<br />

• Shared value strategies - increasing the odds of reaching more markets<br />

• What is the affordability of higher-value biosimilars in pharmerging markets with little or no government support and insurance?<br />

• How to structure an optimal concept development to take into consideration out of pocket investments such as initial licensing fees?<br />

Moderator:<br />

dr Tong Zhang, Director, Pan Regional Lead, Emerging Market Business Development, Merck, USA<br />

panelists:<br />

Abdullah Baaj, CEO, Boston Oncology, Syria<br />

Imtiaz Razzaq, Head of Business Development, Getz pharma, Pakistan<br />

dr peter qian, CEO, Reviva Biopharmaceutics, General Secretary, CBA, USA<br />

0900 Chairperson’s Opening Remarks<br />

Richard diCicco, Chairman, Harvest Moon pharmaceuticals, USA<br />

0910 Is it the Beginning of the End for Biosimilars as We Move Beyond 1st generation Molecules?<br />

• A review of the ever changing pharmaceutical landscape and its implications for the biosimilars business<br />

• Where and what are the market opportunities based on acceptance and therapeutic fit?<br />

• How do biosimilars fulfil the need for increasing access to medicines?<br />

Alan Sheppard, Principal, Global Generics, Thought Leadership, IMS Health, UK<br />

eXTernAl collABorATions & THe coMMerciAl VAlue oF BiosiMilArs<br />

0940 Shared Value Strategies – Partnerships to Strengthen Biosimilars Development<br />

• A look into global approaches to partnerships<br />

• An overview of the broad capabilities required for success in developing and commercializing biosimilars<br />

• How companies are utilizing partnerships to achieve these capabilities<br />

• Case Study Focus: Merck’s global alliance with Hanwha on etanercept<br />

• Collaboration Studies: clinical and manufacturing collaborations with Parexel and MedImmune<br />

Julie Seawall, Executive Director, Business Development, Merck BioVentures, USA<br />

1010 Outlasting the Competition – how Commercial Rights Deals are Evolving With The Times<br />

• Evaluating competition to in-license across different markets<br />

• How to ensure that the long-term view and goals are the same for all parties involved<br />

• Have the dynamics of a commercial licensing agreement changed?<br />

• How flexible do licensing agreements have to be now in the face of ownership rights, risk-sharing management etc?<br />

• Is it still possible to keep jewels through non-exclusive agreements?<br />

• As ROIs get harder to come by, how are in & out-licensing agreements working out?<br />

Moderator:<br />

Yariv Hefez, Director, Global Business Development & Alliance Management, Merck Serono, Switzerland<br />

panelists:<br />

Tadashi Matsumoto, President, ReqMed, Japan<br />

dr Karen Wen, President, Mycenax, Taiwan<br />

1050 Morning Refreshments<br />

1120 Breaking into Protectionist Markets<br />

• Protectionism abroad and locally – what it means for biosimilar companies<br />

• Identifying the local hurdles to new entrants<br />

• How does this fit with the global move towards healthcare cost reductions worldwide and how it translates to increased<br />

advocacy of biosimilars?<br />

Michael Corbo, Vice President & Chief Development Officer, Bio-enhancement Development Unit, pfizer, USA<br />

<strong>REGISTER</strong> <strong>TOday</strong>!<br />

ConferenCe Day one • TuesDay 24 april, 2012<br />

ConferenCe Day TWo • WeDnesDay 25 april, 2012<br />

+65 6508 2401<br />

+86 21 2326 3680<br />

Attend the<br />

Post Conference<br />

Briefing for more<br />

detailed analysis<br />

and discussion<br />

1250 Networking Lunch<br />

reguLatory<br />

keynote<br />

viSionary PaneL<br />

diScuSSion<br />

LegaL<br />

debate<br />

2012年亚洲生物仿制药会议<br />

23–26 April 2012, Grand Hyatt Shanghai, China<br />

2012年4月23-26 日,中国上海金茂君悦大酒店<br />

1400 Will China Take Centrestage in the Biosimilars Play?<br />

• Moving up from copy biologics to commercially viable biosimilars - why and how would this happen?<br />

PaneL<br />

diScuSSion<br />

• Valuing and defending the lion’s share of biologic drugs, what are the pros and cons for Chinese companies to enter overseas<br />

markets in view of the prestigious price policy?<br />

• How are the relatively small Chinese biotech companies reaching out globally to the big pharmas for greater strategic<br />

collaborations?<br />

• How can local Chinese companies leverage available funds and good manufacturing practices to achieve global biosimilars<br />

standards to gain entry to established markets?<br />

Moderator:<br />

dr Joe Zhou, CEO, Genor Biopharma, China<br />

panelists:<br />

Song Jun, Business Development Manager, Strategy & Business Development, pfizer, China<br />

Youling Wu, CEO, ZheJiang Teruisi, China<br />

dr Yingfei Wei, CEO, Elixirin Corporation, USA<br />

Shirley Zhao, General Manager, Genzyme, China<br />

dr Xiaodong Yang, CEO, Apexigen, USA<br />

KeePinG uP WiTH GloBAl reGulATory eVoluTion<br />

1440 China’s Biosimilars Regulatory Environment<br />

• An overview of China’s 5 year plans and what it means to the biosimilar/biologics industry<br />

• The opportunities and challenges of the current China Biotech market and how lessons from other developed markets can<br />

be applicable here<br />

Shirley Zhao, General Manager, Genzyme, China<br />

1510 Anticipating and Overcoming Regulatory hurdles of Biosimilar Development in US<br />

• Will President Obama’s proposed healthcare savings bill on shortening exclusivity and banning “pay for delay” deals be<br />

enacted soon and what would it mean for the biosimilars guidelines?<br />

• Deciding between ANDA, 505(b)(2) or PHSA – which route should Asian companies choose in order to enter US markets?<br />

• Will FDA publish a biosimilar guideline in favour of biosimilar companies?<br />

dr duu-Gong Wu, Executive Director, pharmaNet/i3, USA<br />

1540 Afternoon Refreshments<br />

1610 global Development for Biosimilars: The new Regulatory Paradigm?<br />

• An overview of the global regulatory environment for biosimilars<br />

• Key changes to expect in EMA’s revised biosimilar guidelines<br />

• What will be the impact on biosimilar developments?<br />

Suzette Kox, Senior Director Scientific Affairs, European Generic Medicines Association (EGA), Belgium<br />

1640 key Considerations in Developing a Practical Path From a Biosimilar Plan To Execution<br />

• What are the key issues needed to be addressed?<br />

• How to develop an integrated view of the biosimilar space?<br />

• What does it take to bring a biosimilar to the finish line?<br />

• Designing a viable path and executing based on interpretation of regulations<br />

dr Ming Wang, Executive Director & Head of Diabetes Research, Amgen, USA<br />

1710 has the Industry Learnt from Commoditized generics or Does it Foretell the Bloodbath Ahead for<br />

Biosimilars?<br />

• Is there really a market for biosimilars post 2020 and before the next round of patent expires?<br />

• Balancing risks with returns from biosimilar vs biobetter – which holds greater commercial potential in the long term?<br />

• How will the industry prevent unsustainable price competition for biosimilars and biobetters?<br />

Moderator:<br />

Alan Sheppard, Principal, Global Generics, Thought Leadership, IMS Health, UK<br />

panelists:<br />

dr Kyu don Kim, Vice President, Strategic Business development, Samsung, South Korea<br />

dr Ming Wang, Executive Director & Head of Diabetes Research, Amgen, USA<br />

dr duu-Gong Wu, Executive Director, pharmaNet/i3, USA<br />

Tim Oldham, President, Asia Pacific, Hospira, Australia<br />

1750 Chairperson’s Remarks and End of Conference Day One<br />

Followed by Networking Reception<br />

1150 Strategies to Counter Aggressive Price Cuts in Biosimilars in Emerging Markets<br />

• Responding to innovators’ counterstrategies<br />

• Ensuring that there’s a balance between profitability and market penetration<br />

• How can biosimilar companies engage competitive pricing to compete with the originator?<br />

dr Subir Basak, Chief Executive Officer, Celestial Biologicals Limited, Chief Commercial Officer,<br />

Intas Biopharmaceuticals Ltd, India<br />

1220 Intellectual Property Opportunities and Challenges for Biosimilar Commercialization in Asia<br />

• Are patents irrelevant to the commercialization of 1st generation biosimilars in Asia?<br />

• Are process patents possible and valuable?<br />

• How do companies approach acquiring/building patent portfolios and assessing freedom-to-operate issues in Asia?<br />

• Will patents and other intellectual property drive deals in Asia?<br />

• Will patent enforcement play a significant role in driving company/product value in Asia?<br />

• How does intellectual property impact global commercialization strategies?<br />

Moderator:<br />

dr Janet McNicholas, Partner, K&L Gates LLp, USA<br />

panelists:<br />

Ye Hua, Senior Corporate Counsel, pfizer, China<br />

dr Yang Xu, Chief Patent Counsel, Simcere pharmaceutical Group, China<br />

dr Mandar Kodgule, Associate Vice President & Head, Global Intellectual Property & Strategic Planning, Wockhardt, India<br />

Anne dollard, Deputy General Counsel, Takeda San francisco, USA<br />

1300 Networking Lunch<br />

Part of<br />

MAd ABouT MABs – deVeloPinG BiosiMilArs & BioBeTTers<br />

1400 Biosimilars mAbs as the next “holy grail”? Winning the global Race for Markets<br />

• An overview of mAbs development globally<br />

• How big are the stakes for global biosimilar mAbs?<br />

• Is it really the “holy grail” or is it due to an arid R&D pipeline that companies are turning to mAbs for profits?<br />

• How will innovators defend against launches in emerging and established markets?<br />

dr Sunit Maity, Associate Divisional Head, Biopharmaceuticals, Avesthagen, India<br />

1430 Strategies for global Clinical Development of Biosimilars<br />

• Case Study: Celltrion’s global development of mAb biosimilars<br />

caSe<br />

Study<br />

+65 6508 2407<br />

+86 21 2326 3699<br />

• How to achieve the structural and functional comparability?<br />

• Key challenges during the trial and how they were overcome<br />

• Is it possible for a globally accepted biosimilar mAbs?<br />

dr Stanley Hong, Senior Vice President, Research & Development, Celltrion, South Korea<br />

register@ibcasia.com.sg www.biosimilarsasia.com


Partnership and Commercializing Strategies for Increased Market Uptake 推进合作与商业化战略,拓展产品市场份额<br />

1500 Achieving Quality Biosimilars<br />

• How similar to the originator is acceptable?<br />

• What are the major concerns?<br />

• Detailed comparability and key markers to attain<br />

• Utilizing other indications to ensure the best quality of biosimilars is manufactured<br />

Youling Wu, CEO, ZheJiang Teruisi, China<br />

1530 Afternoon Refreshments<br />

WinninG Buy-in FroM PrescriBers & sTAKeHolders<br />

1600 Changing Market Perceptions: What Biosimilar Companies can do to Increase Acceptance<br />

• The current perception of biosimilars – does high acceptance equal high confidence?<br />

• Overcoming fears raised by innovators’ counter-detailing strategies through strategic investments in pre-launch marketing<br />

• Understanding and actively engaging public policy makers and payers to resolve the acceptance gap<br />

dr Shahzad Khan, Director, Marketing & Sales, Getz pharma, Pakistan<br />

1630 gaining greater Traction in the US – a Pharmacy Benefit Management (PBM) View on Biosimilars<br />

• Does being cheaper mean more attraction towards biosimilars?<br />

• What are the financial incentives and requirements for PBMs to start actively prescribing biosimilars<br />

• Under what conditions will PBMs offer a large co-pay to the patients<br />

Thomas Moriarty, President, Global Pharma Strategies, Medco, USA<br />

0800 签到及早茶<br />

0830 药物创制和开发周大会主席致开幕词<br />

Li Chen, President & CEO, Hua Medicine, China<br />

<strong>REGISTER</strong> <strong>TOday</strong>!<br />

大会主题演讲<br />

全球药物研发与区域合作发展现状<br />

0840 武田制药的研发合作模式创新 - 贴近医患需求,积极推进靶向药物开发<br />

Dr Mary Haak-Frendscho, President & Chief Scientific Officer, Takeda San Francisco, USA<br />

全体小组讨论 全球主题 全球主题 主题演讲<br />

演讲<br />

演讲<br />

0910 通过合作扩展创新网络<br />

Joe McCracken, Global Head of Business Development and Licensing, Roche, USA<br />

0940 有效应对研发生产力挑战:整合外部研究<br />

Dr Helmut Haning, Senior Vice President & Head Global Innovation Outsourcing, Bayer Healthcare Pharmaceuticals,<br />

Germany<br />

1010 中国是否做好准备,领导全球药品创新与发展?<br />

主持嘉宾:<br />

Carl Firth, Chief Executive Officer, Aslan Pharmaceuticals, Singapore<br />

讨论嘉宾:<br />

Frank Shen, Vice President Global Data Management and Statistics, Global Pharmaceutical R&D, Abbott, USA<br />

Ling Chen, Vice President of R&D China Operations, GlaxoSmithKline, China<br />

Ming Wang, Executive Director & Head of Diabetes Research, Amgen, USA<br />

Youling Wu, CEO, ZheJiang Teruisi, China<br />

1100 上午茶歇<br />

药物创制和开发周联合会议时段结束<br />

1130 2012 年亚洲生物仿制药会议主席致开幕词<br />

Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals, USA<br />

生物仿制药的未来:市场准入与机遇<br />

1140 生物仿制药的商业可行性<br />

Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals, USA<br />

1210 突破常规思维 — 进军监管法规不健全或无成熟监管体系的新兴医药市场<br />

主持嘉宾:<br />

Dr Tong Zhang, Director, Pan Regional Lead, Emerging Market Business Development, Merck, USA<br />

讨论嘉宾:<br />

Abdullah Baaj, CEO, Boston Oncology, Syria<br />

Imtiaz Razzaq, Head of Business Development, Getz Pharma, Pakistan<br />

Dr Peter Qian, CEO, Reviva Biopharmaceutics, General Secretary, CBA, USA<br />

小组讨论<br />

0900 大会主席致开幕词<br />

Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals, USA<br />

生物仿制药的外部协作与商业价值<br />

0910 生物仿制药是否已踏上终结之路?<br />

Alan Sheppard, Principal, Global Generics, Thought Leadership, IMS Health, UK<br />

0940 价值共享策略 — 展开合作,加强生物仿制药的开发<br />

Julie Seawall, Executive Director, Business Development, Merck BioVentures, USA<br />

小组讨论 小组讨论 投资者专题<br />

1010 在竞争中脱颖而出 — 商业权利交易如何与时俱进<br />

主持嘉宾 :<br />

Yariv Hefez, Director, Global Business Development & Alliance Management, Merck Serono, Switzerland<br />

讨论嘉宾:<br />

Tadashi Matsumoto, President, ReqMed, Japan<br />

Dr Karen Wen, Vice President, Mycenax, Taiwan<br />

1050 上午茶歇<br />

1120 敲开贸易保护大门<br />

Michael Corbo, Vice President & Chief Development Officer, Bio-enhancement Development Unit, Pfizer, USA<br />

1150 应对新兴市场生物仿制药大幅削价的策略<br />

Dr Subir Basak, Chief Executive Officer, Celestial Biologicals Limited, Chief Commercial Officer,<br />

Intas Biopharmaceuticals Ltd, India<br />

1220 生物仿制药相关知识产权在亚洲的面临的商业化机遇和挑战<br />

主持嘉宾:<br />

Dr Janet McNicholas, Partner, K&L Gates LLP, USA<br />

讨论嘉宾:<br />

Ye Hua, Senior Corporate Counsel, Pfizer, China<br />

Dr Yang Xu, Chief Patent Counsel, Simcere Pharmaceutical Group, China<br />

Dr Mandar Kodgule, Associate Vice President & Head, Global Intellectual Property & Strategic Planning, Wockhardt, India<br />

Anne Dollard, Deputy General Counsel, Takeda San Francisco, USA<br />

ConferenCe Day TWo • WeDnesDay 25 april, 2012<br />

+65 6508 2401<br />

+86 21 2326 3680<br />

cLoSing PaneL<br />

diScuSSion<br />

+65 6508 2407<br />

+86 21 2326 3699<br />

2012年亚洲生物仿制药会议<br />

23–26 April 2012, Grand Hyatt Shanghai, China<br />

2012年4月23-26 日,中国上海金茂君悦大酒店<br />

1700 ThE Biosimilar Question: Will We be able to Witness the Inception of a global Biosimilar?<br />

• What will it take for global biosimilars to exist?<br />

• The showdown between the rise of Asian mega-companies with deep pockets and long-term views vs Big Pharma<br />

• Will biosimilars be commercially successful in the marketplace or be beaten into 2nd place by the innovators ‘Established<br />

Products’ at unbeatable prices in emerging markets?<br />

Moderator:<br />

Richard diCicco, Chairman, Harvest Moon pharmaceuticals, USA<br />

panelists:<br />

Abdullah Baaj, CEO, Boston Oncology, Syria<br />

dr Arthur Alston, Regulatory Affairs, Special Projects, Roche, Switzerland<br />

dr Junichi Koga, Vice President Biopharmaceuticals, daiichi-Sankyo, Japan<br />

dr Mary Haak-frendscho, President & Chief Scientific Officer, Takeda San francisco, USA<br />

1740 Chairperson’s Closing Remarks and End of Conference<br />

会议第一天 • 2012年4月24日, 星期二<br />

1250 联谊午宴<br />

会议第二天 • 2012年4月25日, 星期三<br />

1400 中国企业应如何把握生物仿制药浪潮,扬帆前行?<br />

主持嘉宾:<br />

Dr Joe Zhou, CEO, Genor Biopharma, China<br />

讨论嘉宾:<br />

Song Jun, Business Development Manager, Strategy & Business Development, Pfizer, China<br />

Youling Wu, CEO, ZheJiang Teruisi, China<br />

Dr Yingfei Wei, CEO, Elixirin Corporation, USA<br />

Shirley Zhao, General Manager, Genzyme, China<br />

Dr Xiaodong Yang, CEO, Apexigen, USA<br />

小组讨论<br />

1440 中国的生物仿制药监管环境<br />

Shirley Zhao, General Manager, Genzyme, China<br />

监管专题<br />

小组前瞻讨论<br />

小组讨论<br />

紧跟全球监管变革的步伐<br />

1510 分析预测美国的生物仿制药开发监管障碍并探寻可行解决之道<br />

Dr Duu-Gong Wu, Executive Director, PharmaNet/i3, USA<br />

1540 下午茶歇<br />

1610 生物仿制药全球发展环境:监管新思维?<br />

Suzette Kox, Senior Director Scientific Affairs, European Generic Medicines Association (EGA), Belgium<br />

1640 制定可行方案,将生物仿制药计划付诸实践时应注意的重要事项<br />

Dr Ming Wang, Executive Director & Head of Diabetes Research, Amgen, USA<br />

1710 如何从化学仿制药的发展中吸取经验教训?生物仿制药行业如何才能避免重蹈覆辙,脱离成本血<br />

战的残酷命运?<br />

主持嘉宾:<br />

Alan Sheppard, Principal, Global Generics, Thought Leadership, IMS Health, UK<br />

讨论嘉宾:<br />

Dr Kyu Don Kim, Vice President, Strategic Business Development, Samsung, South Korea<br />

Dr Ming Wang, Executive Director & Head of Diabetes Research, Amgen, USA<br />

Dr Duu-Gong Wu, Executive Director, PharmaNet/i3, USA<br />

Tim Oldham, President, Asia Pacific, Hospira, Australia<br />

1750 大会主席致词,第一天议程结束,随后举行联谊酒会<br />

1300 联谊午宴<br />

开发生物仿制药和生物改良药<br />

1400 单克隆抗体生物仿制药是否会成为市场的下一个“圣杯”? 领跑全球市场份额之争<br />

Dr Sunit Maity, Associate Divisional Head, Biopharmaceuticals, Avesthagen, India<br />

1430 生物仿制药全球临床开发策略<br />

Dr Stanley Hong, Senior Vice President, Research & Development, Celltrion, South Korea<br />

1500 研发高效生物仿制药<br />

Youling Wu, CEO, ZheJiang Teruisi, China<br />

1530 下午茶歇<br />

赢得处方医师和利益相关者的支持<br />

1600 改变市场观念:生物仿制药企业可以采取哪些措施提高市场认同度<br />

Dr Shahzad Khan, Director, Marketing & Sales, Getz Pharma, Pakistan<br />

1630 如何在美国占有更多市场份额?——生物仿制药医药福利管理 (PBM) 分析<br />

Thomas Moriarty, President, Global Pharma Strategies, Medco, USA<br />

1700 有关生物仿制药的终极疑问 : 我们有生之年是否能有幸目睹生物仿制药进入全球大发展的新<br />

时代?<br />

主持嘉宾:<br />

Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals, USA<br />

讨论嘉宾:<br />

Abdullah Baaj, CEO, Boston Oncology, Syria<br />

Dr Arthur Alston, Regulatory Affairs, Special Projects, Roche, Switzerland<br />

Dr Junichi Koga, Vice President Biopharmaceuticals, Daiichi-Sankyo, Japan<br />

Dr Mary Haak-Frendscho, President & Chief Scientific Officer, Takeda San Francisco, USA<br />

1740 大会主席致词, 会议结束<br />

register@ibcasia.com.sg www.biosimilarsasia.com<br />

Part of


Partnership and Commercializing Strategies for Increased Market Uptake 推进合作与商业化战略,拓展产品市场份额<br />

DISCUSSIOn DEn<br />

Industry experts will facilitate discussions on top challenges to foster the sharing of experience and best practices. This is a rare opportunity to engage in a candid, interactive setting<br />

focused on ongoing and emerging mutual challenges. Groups are limited and advance signup onsite is encouraged to ensure your seat. These discussions will run simultaneously with the<br />

main conferences and is open to all attendees.<br />

Pre-conference day Workshop:<br />

23 April 2012, Monday<br />

This full-day workshop will run from 09:00 – 17:00,<br />

with mid-morning and afternoon refreshment breaks<br />

and lunch. Registration begins from 08:30<br />

会前研讨会:2012年4月23日,<br />

星期一 (上午9:00 — 下午5:00)<br />

A: U.S. Market<br />

Entry: A Regulatory,<br />

Legal, and Medical<br />

Communication<br />

Perspective<br />

进入美国市场:从监管、<br />

法律和医学交流角度进行<br />

分析<br />

Post-conference day Briefing:<br />

26 April 2012, Thursday<br />

This full-day workshop will run from 09:00 – 17:00,<br />

with mid-morning and afternoon refreshment breaks<br />

and lunch. Registration begins from 08:30<br />

会后通报会:2012年4月26日,<br />

星期四 (上午9:00 — 下午5:00)<br />

B: Turning Strategies<br />

into Tactical Plans to<br />

Optimize Market Entry –<br />

Balancing Commercial,<br />

Regulatory and<br />

Investments to Deliver<br />

Successful Business<br />

Models<br />

运筹最佳上市时机 — 生物<br />

仿制药推向市场的思考与<br />

机遇<br />

TuesDay 24 april, 2012 WeDnesDay 25 april, 2012<br />

1130 Partnering in Biosimilars mAbs<br />

Robert Chen, Director, Global Strategy & Partnering, Genor Biopharma, China<br />

1230 Aligning R&D and Drug Safety<br />

协调研发与药品安全<br />

James Yan, Executive Director, Hutchison Medipharma, China<br />

1415 Understanding the Virtual Drug Development Model<br />

Stephen porter, CEO, VddI pharmaceuticals, USA<br />

1500 Successful Licensing Strategies for the Chinese Biotech<br />

中国生物技术的成功许可策略<br />

Allan Riting Liu, Vice President/Senior Advisor, Wanbang Biopharmaceutical Group,<br />

Vice President, fosun pharmaceutical, China<br />

1610 R&D Project Management & Strategy<br />

研发项目管理与策略<br />

Kumar penmetsa, Senior Director, Project Management and Strategic Operations,<br />

Bristol Myers Squibb, China<br />

Objectives:<br />

To understand the opportunities and challenges for entering the U.S. Market from<br />

a Regulatory, Business Development, Law, and Communications perspective. It is<br />

important to take these issues into consideration together to create a successful<br />

market entry strategy.<br />

Who Should Attend:<br />

Anyone interested in entering the U.S. market to understand the challenges involved<br />

and how to position themselves to succeed in entering the U.S. market.<br />

Outline:<br />

• Introduction: Case Study of Entering U.S. Market<br />

• Regulatory Considerations for R&D: Strategies to Save Time and Money Towards<br />

Future FDA Approval<br />

• Protecting your IP in the U.S.: When to File for IP with Changing U.S. Law<br />

• Filing for Regulatory Approval: Approaches for Handling New FDA<br />

• Communications Strategies: Medical Communications to Support Commercial<br />

Success<br />

• Developing Partnerships: Mergers and Acquisitions, Joint Ventures, Capital<br />

Raises<br />

• Clinical Trials: Strategies for Successful Trials<br />

• Launching your Product: Case Study, Getting your Product into the Hands of<br />

Clinicians<br />

Workshop Agenda:<br />

• An overview of the challenges and opportunities in the biosimilars market<br />

~ Tactics employed by originator companies to counter biosimilars<br />

~ Selecting country of origin in certain market tenders to facilitate registration<br />

~ Impact of second generation molecules being launched prior to availability of<br />

first generation biosimilars<br />

~ Requirement and access to an EU CPP for qualification in tendering<br />

• Biosimilars in the Asian pharmerging markets, positioning and opportunities<br />

~ China ~ Philippines ~ Bangladesh<br />

~ India ~ Malaysia ~ Taiwan<br />

~ Vietnam ~ Singapore ~ Hong Kong<br />

~ Thailand ~ South Korea<br />

~ Indonesia ~ Pakistan<br />

• What are the various market entry strategies for Biosimilars in the above<br />

markets?<br />

• Tailoring targeted launch strategies<br />

• Strategic pricing strategies used by originators to retain volume sales and reduce<br />

attraction of biosimilars<br />

~ Implications of such actions in MENA, LATAM and APAC emerging markets<br />

• What intellectual property challenges lie ahead?<br />

~ Potential for an Invalidation Strategy for 8,063,182 Roche patent on etanercept<br />

expiring 11/22/28<br />

~ Cabilly II and III: An insurmountable hurdle or a reason for negotiation?<br />

• What is the recommended legal due-diligence needed before entry into<br />

pharmerging countries?<br />

• The importance of an essential drug’s list and inclusion<br />

• The acceptance by regulators of a global development programme for biosimilars<br />

to speed access to markets and harmonise requirements<br />

0915 Biocomparability in Biosimilars: Conducting BA/BE studies<br />

Chichang Lee, Vice President of Preclinical & Cell line Development, ZheJiang Teruisi,<br />

China<br />

1135 Dealing with Legal and IP Issues in Entering the US Market<br />

打入美国市场需要应对的法律和知识产权问题<br />

Gary Arlen Smith, Founder, Enterprise Law, USA<br />

Part of<br />

2012年亚洲生物仿制药会议<br />

23–26 April 2012, Grand Hyatt Shanghai, China<br />

2012年4月23-26 日,中国上海金茂君悦大酒店<br />

1320 Innovative Drug Development in China<br />

中国创新药物开发<br />

Jingzong qi, Vice President & Director of Clinical Research Center, fusoGen<br />

pharmaceuticals, China<br />

1400 Leading a China Team Towards Drug Development: Medical Director’s<br />

Perspective<br />

Jean denis Shu, Medical Director, Sanofi pasteur, China<br />

Led By:<br />

Seth J. Goldenberg, President, Asia Pacific Bio Intelligence, former u.S.<br />

fdA, pharmacology<br />

Seth is a former Regulatory Chemist with the FDA and current President of<br />

APBI. He holds a PhD in Pharmacology from the University of Washington<br />

and a M.S. from the School of Biomedical Engineering at Drexel University. He has<br />

a strong record in drug development, FDA, business development, product licensing,<br />

grant writing, scientific patents, medical communications, and collaborations with<br />

academia and industry. Dr Goldenberg understands not only what it takes to carry out<br />

scientific study, but also the importance of communicating it with the global scientific<br />

community to foster partnerships and collaboration.<br />

Michael platt, President, MedVal Communications, USA<br />

Michael comes to MedVal from Fission Communications, a New York-based<br />

medical education and communications company he co-founded in 2001.<br />

He has over 16 years of industry experience and a broad knowledge of the<br />

pharmaceutical, biotechnological, and healthcare marketing fields, as well as additional<br />

expertise in cardiology, allergy and asthma, infectious disease, gastroenterology,<br />

urology, rheumatology, oncology, and HIV.<br />

Gary Arlen Smith, Founder, Enterprise Law, USA<br />

Gary is founder and principal of Enterprise Law Associates, LLC, a boutique law<br />

firm serving life science and technology companies in all stages of their life cycles<br />

from pre-startup through exit. Prior to founding ELA, Gary was Vice President<br />

and General Counsel of Tengion, Inc., served as Vice President and General Counsel of<br />

Enzon Pharmaceuticals, Inc., was engaged in private law practice for 15 years and was a<br />

partner in the law firms Morgan, Lewis & Bockius and Ballard Spahr and Saul Ewing.<br />

Led By:<br />

Alan Sheppard, Global Head of Generics, Thought Leadership, IMS Health<br />

Alan has over 35 years’ experience within the pharmaceutical industry covering<br />

the full spectrum of innovative medicines, generics, biologicals, vaccines and<br />

OTC medicines. His previous career positions include Executive VP, Europe<br />

Generics, Dr Reddy’s Laboratories and VP, Global Corporate Strategy, Pliva. Alan was a<br />

long serving member of the Prescription Medicines Code of Practice Authority Appeals<br />

Board, Fellow of the Institute of Management, Member of Chartered Marketing and<br />

Fellow of the International Doctors’ Association.<br />

Richard diCicco, Chairman, Harvest Moon pharmaceuticals uSA, Inc<br />

Co-founded in 2007, with a proven pipeline of products developed since 1984,<br />

HMP develops and licenses-out to the trade, worldwide, complex generic drug<br />

products, copy bio products and biosimilars. Rich is a member of the Editorial<br />

Board of the Journal of Generic Medicines, a member of the Licensing Executives<br />

Society and is widely published in generics and biosimilars.<br />

Janet M McNicholas, Partner, K&L Gates LLp<br />

Janet has headed the biotechnology patent practice at McAndrew, Held and<br />

Malloy, the Life <strong>Science</strong>s Patent Group of Cooley Godward in Palo Alto and<br />

served as patent counsel for XOMA, a biotechnology company known as a<br />

leader in the development of therapeutic antibodies. Prior to practicing law, Janet<br />

conducted research in immunology, molecular biology, biochemistry and genetics<br />

at Stanford University and at the California Institute of Technology through a postdoctoral<br />

fellowship.<br />

Featuring Latest Updated Intelligence from:


If undelivered, please return to:<br />

1 grange road,<br />

#08-02, Orchard Building, Singapore 239693<br />

tel: +65 6508 2400 Fax: +65 6508 2408<br />

ReseRve youR place today! 今天预定席位!<br />

SAVE WITh ThE EARLy BIRD<br />

& SPECIAL RATES!<br />

享受预定优惠价和特别优惠价<br />

3 Rd annual BiosimilaRs asia 2012 2012年亚洲生物仿制药会议<br />

This label contains your priority booking code. To expedite registration, please do not remove label. If you have already received a copy of this brochure,<br />

we apologise. For reasons of confidentiality, your full particulars were not available to IBC Asia (S) Pte Ltd for dedupulication prior to mail drop.<br />

q yes! i/We will attend 3rd annual Biosimilars asia 2012, 23– 26 april 2012, Grand Hyatt shanghai, china<br />

q I would like to purchase the conference presentations at USD$688 per log in.<br />

fees peR deleGate eaRly BiRd<br />

Register and pay before<br />

10 Feb 2012<br />

p46189<br />

enJoY sUBstantial saVings With<br />

oUR MUltiPle BooKing DisCoUnt!<br />

Register 3 delegates from the same company and the<br />

4th delegate attends FREE!<br />

5 easy Ways to ReGisteR 5种便捷的报名方式<br />

MAIl the attached registration form with your cheque to<br />

将随附的登记表及支票邮寄至<br />

iBc asia (s) pte ltd c/o informa Regional Business services<br />

1 Grange Road, #08-02, orchard Building, singapore 239693<br />

Customer Service Hotline 客户服务热线<br />

+65 6508 2401 (sinGapoRe)<br />

+86 21 2326 3680 (cHina)<br />

Email 电子邮件<br />

register@ibcasia.com.sg<br />

• 6% Business Tax is applicable to all companies paying in CNY.<br />

• Multiple Bookings Discount pricing is applicable to groups of 3 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<br />

discount applies – either the early bird rate OR special rate or group rate.<br />

• All fees stated include luncheons, refreshments and complete set of documentation. It does not include the cost of accommodation and travel.<br />

delegate 1 details<br />

Name: Dr/Mr/Ms<br />

Job Title:<br />

Department<br />

Tel: Mobile No.:<br />

Email:<br />

delegate 3 details<br />

Name: Dr/Mr/Ms<br />

Job Title:<br />

Department<br />

Tel: Mobile No.:<br />

Email:<br />

Who is Head of your Department?<br />

Who is Head of Training?<br />

delegate 2 details<br />

Name: Dr/Mr/Ms<br />

company information<br />

Company Name: Main Business/Activity:<br />

Address: Postal Code:<br />

Payment Method (please tick): I enclose my bankers draft / cheque payable to IBC Asia (S) Pte Ltd<br />

I am paying by bank transfer (copy attached)<br />

Payment by credit card. (AMEX, VISA or MasterCard accepted)<br />

credit card Payments<br />

The best way to pay by credit card is through our secure on-line registration process, simply log on to the website at www.biosimilarsasia.com and click “Register On-line”.<br />

If you would prefer to pay over the phone please complete the contact name and details and our Customer Services Team will call within 24 hours to take payment. As we treat<br />

your credit card information in the strictest confidence, please do not send payment details by email.<br />

Job Title:<br />

Department<br />

Credit card contact: Department:<br />

Direct phone number: Email:<br />

Tel: Mobile No.:<br />

Email:<br />

delegate 4 details<br />

Name: Dr/Mr/Ms<br />

Job Title:<br />

Department<br />

Tel: Mobile No.:<br />

Email:<br />

special Rate<br />

Register and pay before<br />

16 Mar 2012<br />

noRmal Rate<br />

Register and pay after<br />

16 Mar 2012<br />

GRoup Rate<br />

GRoup Rate<br />

(3 oR moRe)<br />

q 4 Day Pass: Conference + Workshops A + B USD 2,695 USD 2,895 USD 2,995 USD 2,495<br />

q 3 Day Pass: Conference + q Workshop A or q Workshop B USD 2,295 USD 2,495 USD 2,595 USD 2,095<br />

q 2 Day Pass: Conference only USD 1,695 USD 1,895 USD 1,995 USD 1,495<br />

to attend 1 additional co-located event, additional fee: usd 250 (cny 1,600) peR additional event which includes access to event documentation.<br />

the multi access pass is not transferable and allows access to 2 or more named events<br />

domestic cHina companies only<br />

fees peR deleGate<br />

eaRly BiRd<br />

Register and pay before<br />

10 Feb 2012<br />

special Rate<br />

Register and pay before<br />

16 Mar 2012<br />

noRmal Rate<br />

Register and pay after<br />

16 Mar 2012<br />

GRoup Rate<br />

GRoup Rate<br />

(3 oR moRe)<br />

q 4 Day Pass: Conference + Workshops A + B USD 1,795 USD 1,995 USD 2,095 USD 1,895<br />

q 3 Day Pass: Conference + q Workshop A or q Workshop B USD 1,595 USD 1,795 USD 1,895 USD 1,695<br />

q 2 Day Pass: Conference only USD 1,195 USD 1,295 USD 1,395 USD 1,295<br />

Please photocopy for additional delegates<br />

<strong>REGISTER</strong> NOW! FAX BACK TO +65 6508 2407 立即报名! 传真到 +65 6508 2407<br />

Fax 传真<br />

+65 6508 2407 (singapore)<br />

+86 21 2326 3699 (china)<br />

Web 网络<br />

www.biosimilarsasia.com<br />

Hotel infoRmation<br />

Grand Hyatt shanghai, china<br />

Jin Mao Tower, 88 Century Boulevard,<br />

Pudong, Shanghai 200121<br />

Tel: 86 21 5047 1234 Ext. 8550<br />

Fax: +86 21 5049 8381<br />

Contact Person: Juno Zhu<br />

Email: Juno.Zhu@hyatt.com<br />

payment teRms<br />

Payment must be received 10 business days prior<br />

to the event. To take advantage of discounts with an<br />

expiry date, registration and payment must be received<br />

by the cut-off date.<br />

• payment by bankers draft or cheque in us$<br />

should be made in favour of IBC Asia (S) Pte ltd<br />

and mailed to: IBC Asia (S) Pte ltd<br />

c/o Informa Regional Business Services<br />

111 Somerset Road, TripleOne Somerset #10-06<br />

Singapore 238164<br />

Attn: The Accounts Receivable Team<br />

• Payment by bank transfer in US$ made payable<br />

to: IBC Asia (S) Pte ltd<br />

A/C No.:147-059513-001 (S$)<br />

A/C No.:260-457866-178 (US$)<br />

The Hongkong and Shanghai Banking Corporation<br />

limited<br />

21 Collyer Quay, HSBC Building Singapore 049320<br />

Bank Swift Code: HSBCSGSG<br />

Bank Code: 7232<br />

• Payment by CNY<br />

Account Name: 艾毕思会务服务(上海)有限公司<br />

Account No. 720-031103-001<br />

Beneficiary Bank: 汇丰银行(中国)有限公司上海分行<br />

Bank Address: No.1000 lujiazui Ring Road,<br />

Pudong, Shanghai 200120 P.R.China<br />

• Payment by credit card in US$<br />

(AMEX, VISA or MasterCard)<br />

The best way to pay by credit card is through our<br />

secure portal built into the website. To pay by phone<br />

please indicate the contact name and details below<br />

and our Customer Services Team will call within 24<br />

hours to take payment. Please do not send credit<br />

card information by email.<br />

cancellations / suBstitution<br />

Should you be unable to attend, a substitute delegate<br />

is welcome at no extra charge. Cancellations must be<br />

received in writing at least 10 business days before<br />

the start of the event, to receive a refund less 10%<br />

processing fee per registration. The company regrets<br />

that no refund will be made available for cancellation<br />

notifications received less than 10 business days<br />

before the event.<br />

impoRtant note<br />

Please quote the name of the delegate, event title and<br />

invoice number on the advice when remitting payment.<br />

Bank charges are to be deducted from participating<br />

organisations own accounts. Please fax your payment<br />

details (copy of remittance advice, cheque or draft to<br />

+65 6508 2407. Attendance will only be permitted upon<br />

receipt of full payment. Participants wishing to register<br />

at the door are responsible to ensure all details are<br />

as published. IBC Asia will not be responsible for any<br />

event re-scheduled or cancelled.<br />

data pRotection<br />

The personal information entered during your<br />

registration/order, or provided by you, will be held on<br />

a database and may be shared with companies in the<br />

Informa Group in the UK and internationally. Sometimes<br />

your details may be obtained from or shared with<br />

external companies for marketing purposes. If you<br />

do not wish your details to be used for this purpose,<br />

please contact the Winnie Seah (Database) on<br />

winnie.seah@ibcasia.com.sg Ph: +65 6508 2468 or<br />

Fax: +65 6508 2408.<br />

REG NO. 200108203N

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!