v IBCLIFE SCIENCES

Part of

www.patientcentricclinicaltrials.com

KEY CONFERENCE THEMES: Clinical Trial Protocol for Patients

Patient Selection & Recruitment Strategies

Patient Retention, Engagement & Experience

Patient Safety & Informed Consent

Patient Data & Patient-Reported Outcome (PRO)

Clinical Trial Innovation & Technologies for Patients

THE ONLY CLINICAL TRIALS EVENT IN CHINA FOCUSED ON PATIENTS

2017 SPEAKERS INCLUDE

George Guo GMO Country

Head, Novartis Pharmaceuticals

(China) Oncology, China

Jun Wang, Head of Development

Operations, Takeda Development Center

Shanghai

Tom Tang Chief Medical Officer &

Board Member, Generon (Shanghai) Corporation

Ltd, China

Maggie Gu Director, Clinical Development, AstraZeneca

China

Ivan Eng Kien Lau Medical Director-

Shanghai Jiajing Clinic, Chief of Family Medicine,

Shanghai Jiahui International Hospital

China

Eddy Wu Executive Director, Medical and

Scientific Affairs Allergan, China

Xinhai Qui Medical Director

AbbVie China

James Creeden Medical Director, Roche

Molecular Information – APAC, Roche, China

Wu Tai Xiang Chairman

Chinese Clinical Trial Register China

27 - 30 March 2017 • Grand Kempinski Hotel Shanghai, China

Produced by International Marketing Partner Media Partners

“VERY NICELY DONE. LOOK FORWARD TO

PARTICIPATING AGAIN NEXT YEAR”

Vice President, Business Development and General Manager, Asia, Indipharm

ATTRACTIVE GROUP DISCOUNTS AVAILABLE! SEE REGISTRATION PAGE FOR DETAILS!

www.patientcentricclinicaltrials.com

08:00 Registration Starts & Morning Coffee

09:00 IBC Opening & Ice Breaker

PHARMACON CHINA OPENING PLENARY SESSIONS

09:10 Strategies for Transparency of Clinical Trials: Registration & Standardisation of Data Management • What are the latest developments relating to the China

Clinical Trial registration and its impact on transparency?• What are the common drawbacks in clinical trials

registration, and how can it be overcome?• Sharing of case studies to leverage best practices on

implementation of clinical trial disclosure• Discussing data management standardisation strategiesWu Tai Xiang, Chairman, Chinese Clinical Trials Registry, China

09:30 Commercial, Regulatory and Operational Outlook for Clinical Trials in China • Trends and expectations in Pharma spend for clinical

trials in China• How conducive is the Chinese regulatory environment

today to trials?• Can sites accommodate complex trials and meet global

standards; and how does site infrastructure cater topatients enrolling in clinical trials?

• Discussing issues related to patient population in Chinafor different therapeutic areas

• What’s the role of each stakeholder to improve thequality of clinical trials in China?

• Return of investment vs. prioritising patients in trialModerator:Simon Hedgecock, Head of Project Management and Clinical Operations, Novartis, China

Panelists:Yao-Chang Xu, CEO, Abbisko Therapeutics Co., Ltd., China Joe Zhou, CEO, Genor BioPharma, Walvax Bio Group and Visiting Professor, Peking University, ChinaWu Tai Xiang, Chairman, Chinese Clinical Trials Registry, China

10:30 Morning Networking & Refreshment Break

11:20 Chairperson’s Opening Remarks Dan Paulson, Vice President, Global Clinical Development, Group Head, Cardiometabolism Risk Management and Anti-infectives (1), Bayer HealthCare Pharmaceuticals

CLINICAL TRIAL PROTOCOL FOR PATIENTS

11:30 Designing Patient Centric Clinical Trial Protocol • Designing the flowchart to make the procedure feasible• Ensuring its design is accordance with regulations• How to measure the sample size?• Investigator’s information needs for technological support

for eligibility criteria design• What questions do stakeholders need to answer before

the protocol is written?• Other innovative approaches to clinical trial planning to

minimise loss to follow-up over timeModerator: Tom Tang, Chief Medical Officer & Board Member, Generon (Shanghai) Corporation Ltd, China Panelists:Xinhai Qui, Medical Director, AbbVie, China Chenguang Li, Clinical Study Manager, Evidence Generation & Clinical Research, RB, China John L. Xu, Chief Scientific Officer, Mab-Venture Biopharm Co., Ltd, China

PATIENT SELECTION & RECRUITMENT STRATEGIES

12:10 Selection of Right Patients for Clinical Trials • Accelerating the recruitment rate• Sample size of the Chinese patient in multiple regional

clinical trials• Financial consideration in recruitment• Meeting the timeline• What kind of strategies or methods to use: promotion

material, social media etc.?George Guo, GMO Country Head, Novartis Pharmaceuticals (China) Oncology, China

12:50 Networking Lunch

14:00 Comprehensive Genomic Profiling for Cancer Patient Selection in Adaptive Basket & Umbrella Studies• Overview of comprehensive genomic profiling and

experience of Foundation Medicine in the US• Overview of basket and umbrella studies using genomic

profiling and some examples of outcomes• Recommendations for such studies in ChinaJames Creeden, Medical Director, Roche Molecular Information – APAC, Roche, China

14:40 Establishing Good Relationship with Principal Investigators to Help Profile & Recruit Patients• Current landscape and changes in the regulatory

requirements• Transforming the clinical development by high

technology• SWOT analysis of MNCs in China and the Asia Pacific

area in the Patient Centric clinical development• Discussing strategies and tacticsJun Wang, Head of Development Operations, Takeda Development Center Shanghai

15:20 Afternoon Networking & Refreshment Break

16:00 Patient Centric Recruitment Approach for Clinical Trials • Discussing the patient recruitment challenges• What are the emerging models and technology to

accelerate patient recruitment rate?• Exploring the opportunities in ChinaMaggie Gu, Director, Clinical Development, AstraZeneca, China

16:40 Evidence Based Patient Recruitment Projection Strategy• What are the patient recruitment challenges?• The role of literature review in patient recruitment• Discussing the background and objective of the case

study and its research methodology• Discussing its enrollment strategies and how to create an

ideal action planJames Fan, Vice President of Clinical Development and Regulatory Affairs, Generon (Shanghai) Corporation, China

17:20 Chairperson’s Summary & End of Main Conference Day One

CONFERENCE DAY ONE TUESDAY 28 MARCH 2017

CASE STUDY

CASE STUDY

CASE STUDY

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www.patientcentricclinicaltrials.com

09:00 Chairperson’s Opening RemarksEddy Wu, Executive Director, Medical and Scientific Affairs, Allergan, China

PATIENT RETENTION, ENGAGEMENT & EXPERIENCE

09:10 Incorporating the Patient Voice for Heightened Patient Participation• Understanding that patient engagement is key

throughout all steps in the development process• Setting a global standard for patient engagement• Sharing UCB’s growing experience in engaging patients

and contributing to the development of standardsFor speaking opportunity, please contact Ariel.Tan@ibcasia.com.sg

PATIENT SAFETY & INFORMED CONSENT

09:50 Best Practices on Informed Consent Process• Information and risk disclosure - How much information

would be considered sufficient for the patient to make aninformed consent?

• Who should be taking the consent?• Language matters – practicing in an international settingIvan Eng Kien Lau, Medical Director- Shanghai Jiajing Clinic, Chief of Family Medicine, Shanghai Jiahui International Hospital, China

10:30 Morning Networking & Refreshment Break

11:10 Informed Consent Process – Managing Vulnerable Populations or Cognitive Impaired Populations • What are challenges in obtaining informed consent• The role of an investigator / delegated study personnel in

obtaining personnel• Safeguarding the well-being of these group of

populationsJaclyn Yuen Yeng Ong, Senior Clinical Research Coordinator, Institute of Mental Health, Singapore

11:50 Innovative Practices in the Informed Consent Process• Informed consent as a process not a form• Role of education, multimedia and eConsents• Investigator responsibilities and integrity in consentBarbara E. Bierer, Faculty Co-Director, Multi-Regional Clinical Trials Center of Harvard and the Brigham and Women’s Hospital (MRCT Center), and Professor of Medicine, Harvard Medical School, United States

PATIENT DATA & PATIENT-REPORTED OUTCOME (PRO)

12:30 QA Strategies towards Quality & Validity of Patient Data • Audit activities identified common study related issues at

the investigation site• Quality approaches in tackling issues management –

what can metrics and data reports tell us?• How can sponsors and sites collaborate to ride the wave

of study issues to be inspection ready?Steve Zhao, Ethics & Compliance Director, Glaxosmithkline R&D, China

13:10 Networking Lunch

14:10 Identifying What Works & What Doesn’t for Patients through Comprehensive Real World Data • Patient-reported outcome (PRO) - Why to Bother?• How to use the results?• PRO measures in practiceEddy Wu, Executive Director, Medical and Scientific Affairs, Allergan, China

14:50 e-PRO: Increasing Patient Acceptability & Engagement• Introduction to PRO and ePRO• Paper PRO vs ePRO• Identifying the pros and cons of ePRONa Guo, Real World Data Scientist, Roche, China

15:30 Afternoon Networking & Refreshment Break

PHARMACON CHINA CLOSING PLENARY SESSIONS

INNOVATION AND TECHNOLOGY

16:10 e-Clinical Solution to Improve the Quality & Efficiency of Clinical TrialCharles Yan, Senior Director, Clinical Data Management, Shanghai Hengrui Pharmaceuticals, China

16:50 Latest Clinical Trial Innovation in Medical Device• The Chinese medical device GCP call for innovation in

clinical trial• Innovative workflow in Chinese medical device clinical

trial• New trends in IVD clinical studyLu Jian (Jimmy Lu), Senior Clinical Research Specialist, Roche Diagnostics Shanghai Ltd., China

17:20 Chairperson’ Summary & End of Main Conference

CONFERENCE DAY TWO WEDNESDAY 29 MARCH 2017

CASE STUDY

CASE STUDY

CASE STUDY

“I FOUND THE MEETING QUITE ROBUST AND CERTAINLY HAD A GOOD AND HEALTHY EXCHANGE OF KNOWLEDGE. I WOULD CERTAINLY BE HAPPY TO PARTICIPATE IN FUTURE INITIATIVES AND EXPLORE HOW THESE GREAT MEETINGS CAN BE MADE MORE INTERACTIVE AND REWARDING.”Regional Medical Leader, Oncology, Asia Pacific Medical Affairs, Roche Pharmaceuticals

AGENDA AT A GLANCE

Clinical Trial Protocol for Patients

Patient Selection & Recruitment Strategies

Patient Retention, Engagement & Experience

Patient Safety & Informed Consent

Patient Data & Patient-Reported Outcome (PRO)

Evidence Based Patient Recruitment Projection Strategy

PharmaCon China Opening Plenary SessionsStrategies for Transparency of Clinical Trials: Registration & Standardisation of Data Management

Panel Discussion: A Commercial, Regulatory and Operational Outlook for Clinical Trials in China

PharmaCon China Closing Plenary SessionsInnovation and Technology

e-Clinical Solution to Improve the Quality & Efficiency of Clinical TrialLatest Clinical Trial Innovation in Medical Device

Site Selection and Feasibility

Technology and Trial Support Quality

Site Operations and Management

Clinical Trial Quality

Sites as Partners

How to Find the Right Site, Right Location?

www.patientcentricclinicaltrials.com

IBC Asia’s Patient Centric Clinical Trials China Conference is the only focused-event for clinical leaders in China to share best practices, gather inputs on how to overcome challenges, and discover new and innovative technologies on how to design protocol, recruit, engage, and retain patients.

This 2017, the 2nd Annual Pharmaceutical Congress China, part of IBC’s PharmaCon Series will co-locate 3 events; 3rd Pharmaceutical Compliance, Patient Centric Clinical Trials, and Clinical Trials Site Selection & Quality. From addressing pharmaceutical compliance challenges and issues, driving clinical operation efficiencies and discovering new clinical design technologies, to clinical trials site selection and quality assurance, PharmaCon China 2017 promises to cover in-depth issues pertaining to compliance and clinical trials in China’s pharmaceutical industry.

3 CO-LOCATED EVENTS

Pre Conference Workshop – 27 March 20179.30am – 4:00pm

Patient Profiling, Site Selection and Best Practices in Recruiting PatientsWhen international pharma companies have the plans to market in China, it is wise to run the clinical trials there to reduce time and accelerate products into market. In addition, the size of the market and scale of the hospitals are impressive with the ability to draw large number of patients. Patient profiling, enrollment, recruitment, retention, and engagement are keys to success. However, selecting a right clinical trial sites, keeping trials moving forward smoothly and keeping patients happy may be a challenge.

This hands on workshop will address:• How clinical trials leaders’ recruitment expertise work for you?• Optimizing patient recruitment• Best practices that can be used to ensure patients prospective

and enrolled patients to remain informed and active participationin the clinical trial space

• Best practices in selecting sites• Highlighting commercially and strategically important to

understand the Chinese authorities supplementing their currentregulations around clinical trials with new mandates for thehospitals that conduct the studies

• What are the best practices should pharma be employing toeffectively engage patients?

Post Conference Workshop – 30 March 20179.30am – 4:00pm

Designing Patient – Centered Clinical Trial Protocol for Patients Designing Patient – Centered Clinical Trial Protocol for Patients addresses the latest trends and innovations in clinical trial management from a patient- centric perspective. The industry is moving toward the trends of understanding the presence and involvement of several patients and patient advocates that shaped the trial process and expanded pharma companies’ strategic thinking. This workshop will facilitate industry best practices and offer solutions to reinforce patient centricity and creating an effective patient – centered clinical trials protocol. In addition, you will be able to strategise your commercial plans to become more patient – centered in practical ways.

Discussion points you will hear are:• Understanding the patient- centered clinical trial• What should and would the process of the trial look like?• What it takes to have a patient – centered clinical trials protocol?• How can we gain the trial resulting positive patient experience,

better outcomes and higher recruitment and retention?• Managing cost of overall patient care• Designing and conducting the trials

SPONSORSHIP & EXHIBITION OPPORTUNITIES AVAILABLE! WHO SHOULD SPONSOR?

Contract Research Organisations (CROs)e-Clinical Solutions: Cloud Computing, Data Management, Data Service Companies Patient Recruitment ProvidersClinical Trial Logistics and Supply Chain Laboratory ServicesTranslation CompaniesWearables / Mobile Health SolutionMarket Research Companies / ConsultantsLaw Firms

www.patientcentricclinicaltrials.com

For more information about how you can leverage on our events to optimise your

marketing budget, and reach your target audience, please contact:

Ms. Yvonne Leong atTel: +65 6508 2489 Mobile: +65 9852 3282

Email: Yvonne.Leong@ibcasia.com.sg

WHAT THEY SAY ABOUT US!

“THANK YOU FOR PROVIDING THE PLATFORM WHICH ALLOWS ALL EXPERTS TO EXCHANGE AND DISCUSS THOUGHTFUL VIEWPOINT INSIDE OF CLINICAL TRIALS INDUSTRY. YOUR ORGANIZATION ALWAYS IMPRESSES ME.” Vice Chairman, Asia Pacific, PAREXEL International

“VERY FRIENDLY AND SUPPORTIVE STAFF - MADE THE EVENT A “HIT” FOR US!”Director, Business Development, Asia, INC Research

“COMPREHENSIVE CONFERENCE COVERED MOST AREAS CONCERNED BY PHARMACEUTICS, CRO AND CLINICAL TRIAL CENTERS IN CHINA. DIFFERENT FROM CLINICAL TRIAL EVENT, WHICH OFTEN FOCUS ON ONE OR TWO ASPECTS OF CLINICAL TRIAL. “Director, Clinical Operations, TenNor Therapeutics

“A VERY DIVERSE PANEL OF SPEAKERS AND ATTENDEES.”CEO, BARC Central Labs

WHO YOU WILL MEET

BY COUNTRY BY INDUSTRY

KEY HIGHLIGHTS Harness the benefits of patient centricity on clinical trial planning and managementFind solutions on how you will overcome patient selection, recruitment and retention issues by understanding the needs of the marketFind ways on how to leverage the use of technologies and social media platforms within your clinical trial Discover how each stakeholder can contribute to achieve a Patient Centric operation for all phases of clinical trialBenchmark your clinical trial strategy from the case studies presented by clinical industry leaders

TOP REASONS TO ATTEND100%Clinical Trials event focused on patients

20+C-Level Speakers from China to learn from and network with

2-DAYSof in-depth focus on patient recruitment, engagement and experience management

Co-located with Clinical Trials Site Selection & Quality China Conference

China ...................................................................70%

Other Asian Countries .................................. 15%

Europe / US ........................................................10%

Other Region .......................................................5%

Pharma/ Biopharma/ Biotech .....................................................45% Hospitals / Other Trial Sites ............................................................ 20% CROs ........................................................................................................... 15% Technology & Service Providers .....................................................10% Medical Device Companies ...............................................................5% Academics / Research Institutes / Consultancy.......................2% Government Agencies .........................................................................2%