Featured Speakers include:

Choo Beng Goh,Medical Director,

GlaxoSmithKline, Taiwan 

Catherine Yi-San Lee,Executive Director, Area Head of

Clinical Trials Support and Compliance Asia,

Pfizer Inc., Taiwan

James Garner,  Vice President and General Manager,

Takeda Global Research and Development Center (Asia), 

Singapore

 Ko-Chung Lin, Founder and CEO,PharmaEssentia,

Taiwan

Lars Nelleman,Vice President, 

Clinical Development Center, Asia Pacific, Lundbeck A/S, Singapore

Chyong Huey Lai,Director,

Clinical Trial Center, Chang Gung Memorial 

Hospital, Taiwan

Benjamin Ing-Tiau Kuo,Chairperson,

Human SubjectProtection Association, 

Taiwan 

Churn Shiouh Gau,Executive Director,

Center for Drug Evaluation, Taiwan

Gregory Liu,Head of Medical

Department, Oncology Business Unit, TTY Biopharm, Taiwan 

and Clinical Research Director,TOT Biopharm, China 

Hojin  Oh,Assistant Director,

Clinical Trial ManagementDivision,  

Chin-Fu HsiaoDirector of the Division of Clinical Trials Statistics,

National Health Research Institutes, Taiwan

EARLY SPECIAL RATESave USD400if you register

by 14 Dec 2012!

Media Partners:

Marketing Partner:

Endorsing Organisations:

Imagine Your Impact

Media Partners:

W. http://bit.ly/Sq7p4b E. info@imapac.com T. +65 6493 1871 F. +65 6270 2792

Facilitate partnership for regional and global cost-effective clinical development in Taiwan

26 - 27 February 2013, Taipei, Taiwan

International Marketing Partner:

Exhibitor: Organised by:

Wing-Kai Chan,Director,

National Center of Excellence for Clinical Trial & Research,

National Taiwan UniversityHospital, Taiwan

Rosalind Lu,Asia-Pacific Regional Head for Roche

Product Development Global Operation Country Clinical

Operation, Roche Products, Taiwan

Hung Jen Lai,Medical Director

of Taiwan and Hong Kong,

Wim Swyzen,Regional Vice President for

Global Clinical Operations for Asia Pacific,

Yoshiya Oda,President of Biomarkers andPersonalized Medicine Core

Function UnitEisai Inc., USA

Carlos Linn,Regional Medical Director,

Oncology, AsiaEmerging Markets, Pfizer Inc., China 

Ming-Chu Hsu,Founder, Chairman and CEO, TaiGen Biotechnology, Taiwan

Min-Hsiung Kao,Clinical Operation Director,

Taiwan Liposome Company Ltd, Taiwan

Hui-Ling Shieh,Medical Director,

Yung Shin Pharm Ind. Co., Taiwan

Food and Drug Administration, Korea

Merck Sharp and Dohme, Taiwan

Janssen, Singapore

nawiaT ,iepiaT l 3102 yraurbeF 72-623102 slairT nawiaT

W. http://bit.ly/Sq7p4b E. info@imapac.com T. +65 6493 1871 F. +65 6270 2792

Taiwan Trials 2013 will be the ONLY focused clinical trial platform in Taiwan. It will bring together pharma, biotechs, CROs, regulators and hospitals as well as technology and solution providers from Taiwan and the rest of the world to assess and explore the opportunities and potentials of offshoring and outsourcing clinical trials in Taiwan, as well as to foster regional and global partnerships for cost-effective clinical development.

Agenda At A Glance2 yaD ecnerefnoC niaM1 yaD ecnerefnoC niaM

Networking Lunch

Afternoon Refreshments and Networking

Partnership:

Past, Present and Future

Leveraging on Clinical Development in Taiwan

Strategising for Effective Early Phase Trials in Taiwan

Optimising Trial Management and Quality Control for

Trials in Taiwan I

Optimising Trial Management and Quality Control for

Trials in Taiwan II

Collaboration Opportunities in Taiwan

Looking into Regional Clinical Regulatory

Harmonisation and the Potential Impact

Speed Networking

Morning Refreshment

esolC ecnerefnoCliatkcoC emocleW

Morning Refreshment and Networking

Dear friends and colleagues,

It is my pleasure to welcome you to Taiwan Trials 2013, to be held in Taipei city on the 26th and 27th of February 2013. The organising team at IMAPAC has brought together a leading team of speakers in the clinical trials industry to share their valuable experiences and knowledge, and discuss key issues through this platform.

Clinical trials are critical processes in drug development. Each of us present at the conference will be coming from diverse cultures and hold unique perspectives of our own. Nonetheless, being part of the clinical trials industry brings us together to work towards a common goal: to create a positive impact on the lives of millions around the world. As we endeavour to bring better ethical drugs to patients worldwide, it is indeed a pleasure to be a part of the process that is working towards alleviating suffering and pain of people.

With that, I look forward to seeing you in Taiwan in February 2013 to meet, share and exchange ideas in order to encourage the growth of clinical trials in the region and beyond. I urge you to take the step forward and together contribute to the regional and global clinical development.Sincerely

James Garner. M.D.Taiwan Trials 2013 Conference Chairman

Chairman’s Letter

Taiwan Trials 2013 will provide the opportunity for us to further assess and explore the clinical outsourcing opportunities in Taiwan, address the challenges that are specific to the region, as well as discover and expand partnerships for clinical development to further benefit patients in the region and around the globe.

Understand Taiwan's Position in the Regional and

Global Trials Scene

Asia has emerged as a strong region for clinical trials. Over the years, Taiwan has shown its ability to participate in multi-national trials. Major topics such as how we should further leverage Taiwan and Asia for regional and global clinical studies and how we should further optimise the quality of clinical trials in the region deserve our attention and in-depth discussion. Hence, I strongly encourage you to join our leading team of industry experts at the Taiwan Trials 2013 for meaningful discussions and much-anticipated exchange of ideas.

Find out moreDiscuss your requirements at Taiwan Trials 2013 with:

Your business is about much more than just knocking on doors. Your marketing strategy is much more than a lead generator. To generate sales, you need brand credibility and a genuine leadership position. To generate awareness and response, you need targeted, decision-maker focused, geographically effective marketing. To generate profits, you need marketing service of Taiwan Trials 2013!

Why should you sponsor?

Taiwan Trials 2013 will provide commercial organisations with the opportunity to:

• Educate the market about what you offer• Position yourselves as leaders in your field alongside key industry figures• Raise brand awareness• Enjoy the option of privately arranged meetings and consultations with selected potential clients• Hold face-to-face meetings with your target profile

PLUS! Book early to take advantage of the world-class marketing campaign

• 50+ touch points over 7-months• 100,000+ individual communications• Integrated campaign featuring web, social media, direct mail, email,etc• Partnerships with leading international publications and associations

Who should sponsor?

World-class solution providers who need to position their products and services in front of decision makers from pharma and biotechs:

• Contract Research Organisations• Site Management Organisations• Central Laboratory Service Providers• Patient Recruitment Service Providers• Equipment Providers• Clinical Data Management Technology Providers• Clinical Supply and Cold Chain Logistics• GCP and GLP Compliance• Packaging• Medical Writing and Translation Services

Zhe Zhang

Conference Manager

Office: +65 6493 1872

Email: zhe.zhang@imapac.com

W. http://bit.ly/Sq7p4b E. info@imapac.com T. +65 6493 1871 F. +65 6270 2792

Your Opportunity to Capture Burgeoning Clinical Trials Market!

JOIN NOW BY TYPING “ASIA PACIFIC CLINICAL TRIALS NETWORK” ON THE GROUPS SEARCH BAR

The exclusive networking group for Asia's Pharma sponsors, CROs, clinical sites, patient recruitment

services and other associated vendors. Come and explore your next big partnership opportunity here!

Taiwan Trials 2013 26-27 February 2013 l Taipei, Taiwan

W. http://bit.ly/Sq7p4b E. info@imapac.com T. +65 6493 1871 F. +65 6270 2792

nawiaT ,iepiaT l 3102 yraurbeF 72-623102 slairT nawiaT

Registration starts

IMAPAC’s welcome remarks

Chairman’s opening remarksJames Garner, Vice President and General Manager,Takeda Global Research and Development Center (Asia), Singapore

Conference Day 1 26 February 2013, Tuesday

8.00

15.05

14.10

13.45

14.35

8.55

9.00

9.05

9.45

10.10

10.55

11.35

12.00

13.20

Understand Taiwan’s Position in the Regional anGlobal Trials Scene

Regional trial debate: The role of Taiwan in thecompetitive regional and global trials scene• What kind of trials do global pharmas conduct in Taiwan and how these trials compliment or compete with the regional clinical development?• Taiwan vs. Korea: Pros and cons of these two emerging trial destination of Asia• How will Taiwan leverage on its own advantages to attract more global and regional trials?

Understanding the ever evolving trials landscape in Taiwan: from site’s perspective• Drivers that has shaped pharmaceutical trials in Taiwan in the past 10 years• NTUH as center of excellence for clinical trials in Asia- Pacific: how should we progress in the next 1-3 years? • How will trial numbers and types in Taiwan change? Wing-Kai Chan, Director, National Center of Excellence forClinical Trial and Research, National Taiwan University Hospital, Taiwan

Morning refreshment and speed networking

Panel discussion: Selecting the right partnership model for most cost-effective and efficient clinical development in Taiwan• Partnership models: In-house, outsource or co-development? • Who to partner: Local or international CRO? • Partnering with public organizations: Who, when and how?

Hung Jen Lai, Medical Director of Taiwan and Hong Kong, Merck Sharp & Dohme, TaiwanRosalind Lu, Asia-Pacific Regional Head of Roche Product Development Global Operation Country Clinical Operations, Roche Products,TaiwanMin-hsiung Kao, Clinical Operation Director, Taiwan

Partnership: Past, Present and Future

Leveraging on clinical development in Taiwan

Developing clinical strategy incorportating both outsourced and in-house resources• How do we include outsourced resources into our develop-ment strategy and what roles do CROs play in our clinical development plan? • What do we expect from CROs?• How do we benchmark and select the right CROs to integrate into our clinical development plan?

Lars Nelleman, Vice President, Clinical Development Center, Asia Pacific, Lundbeck A/S, Singapore

Taiwan in Asia-Pacific development strategy from pharma’s view• What role does Taiwan play for our multi-regional trials? • Leveraging Taiwan's clinical development for our multi- regional trials: What are the driving factors and challenges?• Future perspective: How we would continue to include Taiwan in our Asia-Pacific development strategy, with rise of emerging markets?

Case study: Conducting oncology study in Taiwan for global drug development• Why do we choose Taiwan for the study?• What are the concerns and challenges to conduct oncology trials in Taiwan and how we have dealt with them?• How to optimize the study in Taiwan for my pipeline development? Carlos Linn, Regional Medical Director Oncology, Asia Emerging Markets, Pfizer Inc., China

Afternoon refreshment

Strategizing for Effective Early Phase Trials in Taiwan

Optimising trial design: Adopting adaptive trial design for cost-effective clinical development in Asia• To adapt or not to adapt: compare and contrast the pros and cons of adaptive trial design and conventional design• How to reduce operational bias and keep trial integrity to ensure successful implementation of adaptive design?• How to make informed decision in adaptive trial?

Case study: Sponsor and CRO collaboration model evolution: from FSP model to strategic alliance partnership model• Changing needs of the trial sponsors: What is Pfizer’s strategic alliance partnership about and how has it evolved? • Is strategic alliance partnership model for my studies? Compare strategic alliance partnership model with full service partnership model and functional-service provider model. • Transforming the industry: What does it mean for other stakeholders?

Catherine Lee, Area Head, Clinical Trial Support andCompliance Asia, Pfizer Inc., Taiwan

Networking luncheon

Churn Shiouh Gau, Executive Director, Center for Drug Evaluation, Taiwan James Garner, Vice President and General Manager, Takeda Global Research and Development Center (Asia), SingaporeLars Nelleman, Vice President, Clinical Development Center, Asia Pacific, Lundbeck A/S, SingaporeWim Swyzen, Regional Vice President, Global Clinical Operations for Asia Pacific, Janssen, Singapore

Liposome Company Ltd, Taiwan

Wim Swyzen, Regional Vice President, Global Clinical Operations for Asia Pacific, Janssen, Singapore

16.45

16.35

15.55

15.30

Collaboration Opportunities in Taiwan

W. http://bit.ly/Sq7p4b E. info@imapac.com T. +65 6493 1871 F. +65 6270 2792

Taiwan Trials 2013 26-27 February 2013 l Taipei, Taiwan

9.45

11.20

10.40

10.10

11.45

13.00

Benjamin Kuo, Chairperson, Human Subject Protection Association, TaiwanCatherine Lee, Area Head, Clinical Trial Support and Compliance Asia, Pfizer, Taiwan

Panel discussion: Is Taiwan a springboard to a bigger market in China? • Taiwan as springboard: Actions speak louder than words or No Action Talk Only? • How will the CROs and trial sponsors leverage on the strategic location and link between Taiwan and mainland China? • Looking into the future: what other actions are required to further bridge Taiwan and China?

Ko-chung Lin, Founder and CEO, PharmaEssentia, Taiwan

Conference Day 2 27 February 2013, Wednesday

Optimising Trial Management and Quality Control for Trials in Taiwan

Panel discussion: Improving collaboration with sites for trials in Taiwan• How to better understand the individual hospital review processes after joint-IRB? • What action is required for trial sponsors, CROs and sites to standardize contracting process with different hospitals in Taiwan? • How to maintain long-term effective collaboration with sites in Taiwan?

IMAPAC’s welcome remarks

Chairman’s opening remarks

8.55

9.00

9.05

Panel discussion: Strategizing to overcomechallenges to conduct trials on healthy subjects in Taiwan• What are the current socio-cultural challenges to conduct early phase pharmaceutical studies in Taiwan and Asia? • How to ethically enlarge the trials on healthy subjects? • What can we learn from other countries’ experiences?

Benjamin Kuo, Chairperson, Human Subject Protection Association, Taiwan Huiling Shieh, Medical Director, Yung Shin Pharm, TaiwanYoshiya Oda, President of Biomarker and Personalized Medicine Core Function Unite, Eisai Inc, USA

Chairman’s closing remarks

James Garner, Vice President and General Manager, Takeda Global Research and Development Center (Asia), Singapore

End of conference day 1 | Welcome Cocktail

Morning refreshment

Panel discussion: Managing your relationship with CROs in Taiwan to achieve success of regional and global studies• What roles does our Taiwan office play in managing regional and global trials? • What is the difference to manage CRO and in-house staff? • How to further facilitate effective communication between trial sponsors and CROs on a country level to ensure success of global studies?

Rosalind Lu, Asia Pacific Regional Head Product Develop

-

ment Global Operations - Country Clinical Operations, Roche Products, TaiwanHung Jen Lai, Medical Director of Taiwan and Hong Kong,Merck Sharp & Dohme, Taiwan

Optimizing clinical supply for regional and global studies• Lessons learnt: What are the major distribution and import challenges that specifically matters to Taiwan and Asia?• Meeting the changing distribution requirements: What are the key clinical supply strategies for regional and global trials as the industry requirements shifts? • Working closely with the trial sponsors: Why and how to integrate clinical trial supply strategy into regional and global study design to maximize quality and minimize logistics cost?

Networking luncheon

Relevance and application of innovative clinical data management solutions to meet today’s clinical development challenges• What are the current challenges faced in clinical data management by the industry?• How are eClinical solutions going to evolve in the next few years to cater to the evolving needs of the industry?• How can pharma companies and solution providers work together on clinical data management?

Integration of biomarkers in oncology studies to facilitate decision-making• Understand biomarkers and how effective is the approach?• How to establish reasonable endpoints in different studies? • What is the benefit of biomarkers on risk management and safety control of oncology drug development?

Yoshiya Oda, President of Biomarker and Personalized Medicine Core Function Unit, Eisai Inc, USA

Gregory Liu, Head of Medical Department, Oncology Business Unit, TTY Biopharm, TaiwanWing-kai Chan, Director, National Clinical Trials and Research Center, National Taiwan University, Taiwan

Chin-Fu Hsiao, Director, Division of Clinical Trials Statistics, National Health Research Institute, Taiwan

Gregory Liu, Head of Medical Department, Oncology Business Unit, TTY Biopharm, TaiwanCarlos Linn, Regional Medical Director Oncology, Asia EmergingMarkets, Pfizer Inc., China

16.20

16.10

15.30

14.50

14.20

13.40

•What are the advantages of Taiwanese hospitals for clinical development?• Looking into future: How will this collaboration benefit Taiwan and the region?

Regulatory panel: Understanding clinical regulations in important Asian countries in the region• What will be the direction of regulatory change in the next three years and how does it affect regional and global trials? • Update on the intra-regional effort to streamline clinical trials conduct

Invitation to:Taiwan Food and Drug AdministrationChina State Food and Drug AdministrationJapan Pharmaceutical and Medical Devices Agency

Panel discussion: Understanding potential impact arising from cross-striat clinical regulatoryharmonization• What form of collaboration or competition might harmonization bring about to Taiwan? • What opportunities and challenges might harmonization bring about to trial sponsors, CROs and technology and solution providers?• How should stakeholders strategize to leverage on the opportunities arising from regional regulatory harmonization?

Churn Shiouh Gau, Executive Director, Center for Drug Evaluation, TaiwanMing-Chu Hsu, Founder, Chairman and Chief Executive Officer, TaiGen Biotechnology, Taiwan

Chairman closing remarks

End of conference day 2

Looking into Regional Clinical Regulatory Harmonizationand the Potential Impact

• Why do we choose to set up clinical R&D center in Taiwan?• How does the collaboration with Taiwanese hospitals align with our strategy and how does it facilitate our drug development regionally and globally?

Afternoon refreshment

W. http://bit.ly/Sq7p4b E. info@imapac.com T. +65 6493 1871 F. +65 6270 2792

nawiaT ,iepiaT l 3102 yraurbeF 72-623102 slairT nawiaT

Biologics World Taiwan provides the ONLY biologics and biosimilars focused platform in Taiwan that brings together Taiwanese and international biopharma leaders, innovative biotechs, and technocrats.

> The most targeted platform to meet Taiwanese and international biologics manufacturers > Case studies and discussions from senior level decision makers who will influence the direction of Taiwan's biologics industry > Both strategic and technology-focused biologics development in Taiwan

IMAPAC has been the organizer of Biologics World events in various countries such as Korea and China. Our most recent Biologics World China 2012 event has been a resounding success.

Biologics World Taiwan 2013 brings you:

Taiwanese clinical research collaboration with the pharma industry – realities and opportunities

Pharma’s perspective

Hospital’s perspective

Gung Memorial Hospital, Taiwan

HoJin Oh, Assistant Director, Clinical Trial Management Division, Food and Drug Administration, Korea

Choo Beng Goh, Medical Director, GlaxoSmithKline, TaiwanChyong Huey Lai, Director, Clinical Trial Center, Chang

IMAPAC will be holding Biologics World Taiwan2013 concurrently with Taiwan Trials 2013 on 26 February 2013 at the The Landis in Taipei, Taiwan.

Past Attendees’ Testimonials

“Good diversity of conference programme and well planned”

“The conference was nice as a whole, compact and it was a very interactivemeeting”

“High quality presentations, excellent organization. One of thebest conferences I attended”

- Dan adams, Executive Chairman, Protein Sciences, USA

- Antonio SJ Lee, Associate Director,Busiiness Development and R&D Strategy,

Medipost, Korea

- RIchard Somberg, Strategic CollaborationManager, Promega, USA

W. http://bit.ly/Sq7p4b E. info@imapac.com T. +65 6493 1871 F. +65 6270 2792

Taiwan Trials 2013 26-27 February 2013 l Taipei, Taiwan

IMAPAC – Creating business conferences with a cause

IMAPAC is a social enterprise based in Singapore that is on an unrelenting mission to make a difference in businesses of today.

We believe that businesses are not only meant to do well, but also to do good. We want companies to find business opportunities at our conferences as well as something good to aim for.

IMAPAC’s international conferences are where you join other organizations such as governments, NGOs, businesses, academics, and other stakeholders who are standing up collectively to make a difference, to attest to the fact that businesses can and do make a positive impact to the world we live in.

Imagine Your Impact