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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PAN
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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 [email protected]
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: [email protected]
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%