Clinical Trials agenda

Clinical trials, 2017年3月22日(水)

09:00

Organiser's welcome remarks

09:05

Chairman's opening remarks

DIGITAL TRANSFORMATION IN BIOPHARAMA

Danny Yeung
09:10

The future of medicine and how it impacts patients, pharma, physicians and regulators.

In the digital age, with technology changing so rapidly, how can we make sure that we are prepared for the future? This exciting opening address for BioPharma Asia 2017 will explore the most exciting trends, ideas and technologies driving the future of our industry, including practical advice on how you can brace your business for the times ahead.
Danny Yeung, Chief Executive Officer, Prenetics
Vitalik Buterin
09:40

Blockchain meets Biopharma: How to prepare for the global data evolution

When you hear blockchain, you don't necessarily think biopharmaceuticals. But the applications of blockchain can do so much more than digital currency. For example, it can help to increase the efficiency of the drug development process, by providing better security and transparency. It allows you to indelibly record medicinal and genomic data to combat counterfeit pharmaceutical production and protect intellectual property. That's just a few applications. Join us as we uncover more and also consider some of the potential challenges that could be created, for example, around compliance and privacy.
Vitalik Buterin, Co-founder, Ethereum
Dr Suzanne Brewerton
10:10

Redesigning healthcare system with genomics, technology driven drug discovery

Advances in next generation sequencing (NGS) technologies over the last decade are beginning to have an impact on the amount and depth of sequencing data available to researchers in the pharmaceutical industry. In target identification and validation, the availability of human genetic data to link the target to the disease, can mean the difference between success and failure in phase II clinical trials. In this presentation, various techniques and drug discovery platforms will be discussed to help companies in improving efficiency of drug delivery products to drive the pharma industry towards the goal of personalized medicine.
Dr Suzanne Brewerton, Bioinformatics Lead, Human Longevity Inc
10:30

Exhibition Visit & Networking Refreshments

Mr Sebastian Bather
Clinical trials

Chair's opening remarks

Mr Sebastian Bather, Regional Managing Director, InVentiv Health

Clinical Development

Dr Josemund MENEZES
Clinical trials
11:30

Key considerations in designing clinical trials protocols for pan-Asia clinical studies

  • Where are the next clinical trial hotspots in Asia?
  • Exploring external R&D partnerships to accelerate new drugs to market
  • Discovering key preferred countries in conducting trials from pre-clinical, early phase to patient safety and consent
  • Strategies for navigating Asia's fragmented regulatory landscape
Dr Josemund MENEZES, Director, Medical Affairs, Sanofi
Dr Yee Leong Teoh
Clinical trials
11:50

Balancing costs and benefits when partnering with academic CRO

  • Exploring various partnership models available in conducting clinical trials in Asia
  • Discovering key considerations when selecting CROs- what should be expected and why?
  • Case study: Working with academic and commercial CRO for immuno-oncology clinical research in Asia
Dr Yee Leong Teoh, Chief Executive Officer, Singapore Clinical Research Institute Pte Ltd
Stephanie Liu
Clinical trials
12:10

Meeting the needs of patients: Practical advice for clinical developers planning pan-Asia trials

  • Ensuring patient centricity of your clinical practices, through close communication with CROs, trial sites and partners
  • Building the optimal communication methods with patients, for example, setting up apps or dedicated call centres
  • Working with patient advocacy groups to better understand patient needs
Stephanie Liu, Senior GCQA Advisor, Global CQA, Lundbeck Singapore
Mr Mario Bertazzoli
Clinical trials
12:30

Drawing parallels between EU and Chinese safety regulations

  • Understanding safety requirements in clinical Phase 1 to 4 trials
  • Developing cross functional teams to streamline safety operations
  • Ensuring compliance and adherence to relevant regulations in EU and Asia
Mr Mario Bertazzoli, Director, Head Corporate Drug Safety, Helsinn SA
13:00

Exhibition Visit & Networking Lunch

Regulatory Affairs

Panel discussion
Clinical trials
14:20

Overcoming registration and submission challenges in pan-Asia clinical studies

  • What has changed since last year's meeting?
  • How can RA representatives be more effective in navigating through the fragmented SEA market?
  • Exploring the possibility of using an adaptive regulatory submission system, customised from established markets
  • Established vs. emerging markets in Asia
Moderator: Professor John Lim, Executive Director, Duke-NUS Centre of Regulatory Excellence (CoRE)
Dr Yvonne Khoo, Senior Principal Assistant Director, U52 Biologics Section, Pharmaceutical Services Division Ministry of Health Malaysia
Vicky Han, Senior Director, Regulatory Policy Group Lead for Asia Pacific, Janssen Pharmaceuticals Inc
Dr I-Ning Tang
Clinical trials
15:00

Promoting regulatory innovation in Taiwan and the rest of Asia

  • Understanding the need for creating a simplified, innovative regulatory framework to support the exponentially-growing number of trials in Asia
  • Strategies for improving regulatory expertise and cross-nation support for promoting regulatory policy innovation
  • Discussing methods to remove or reduce regulatory complexity, and minimise the impact of regulatory diversity, to ensure timely access to safe, high quality therapeutic products
Dr I-Ning Tang, Senior Reviewer, Center For Drug Evaluation
Dr Bobby George
Clinical trials
15:20

India's latest biosimilars guidelines: Opportunities and threats to generics and innovation driven pharma

  • Understanding key concerns and considerations when working on biosimilars products in India
  • How do pharma companies leverage on India's regulatory landscape to launch biosimilars products?
  • Should biosimilar industry be worried over AbbVie's IPR success case vs Amgen in the US and most recently India's latest biosimilars guidelines?
Dr Bobby George, VP & Head Regulatory Affairs, Reliance Life Sciences
15:45

Exhibition Visit & Networking Refreshments

16:20

Roundtable Discussion Session

16:20

Table 1 Countries specific strategies in overcoming challenging green field regulatory landscape

Ms Pei Yin Tan, Associate Director, Asia Clinical Operations, Eisai Clinical Research Singapore Pte Ltd
16:20

Table 2 Performance based reimbursement- Why and how can we do that?

round tables
16:20

Table 3 Globalizing Clinical Trial Operations - Asia's emerging leadership role

Ms Lisa Palladino Kim, Director of Capstone / Lecturer, Rutgers The State University of New Jersey
Mr Robert Bruno, Director of Clinical Operations, Abbvie Japan
16:20

Table 4 Talent management and communication strategies in pharma landscape

Maggie Sy, Director - Asia Sourcing And Procurement, Mead Johnson & Company
16:20

Table 5 Maximising production output: Quality approach

16:20

Table 6 Strategies to overcome production challenges when starting new manufacturing project in Asia

Mr Shao Siong Chua, Head of Manufacturing, Novartis Singapore Pte Ltd
16:20

Table 7 Key considerations in implementing continuous single use platform in Asia production

16:20

Table 8 Key considerations and strategies in R&D outsourcing

Ms Jessica Thongcharen, Associate Director, Pharmacovigilance, Takeda
16:20

Table 9 IPR and patent related issues in biosimilars development

round tables
16:21

Table 10 Building sustainable innovation ecosystem in Asia

Dr Shridhar Narayanan, Founding Director and CSO, Foundation for Neglected Disease Research
Dong Hui Qin, Innovation Director, Ferring Pharmaceuticals
16:21

Table 11 Finding licensing and supply chain partner in Asia developing economy

Mr Paolo Rampichini, Head Supply Chain Asia Pacific, Roche Pharmaceuticals
16:21

Table 12 Partnership models for biotech startup

Ms Chervee Ho, Director Key Account Management, Asia Pacific, Vetter Pharma International GmbH

JLABS QUICKFIRE LAUNCH

Dr Stefan Hart
17:00

Overcoming metabolic diseases incidences in APAC

And how JLABS QuickFire Challenge can help
Details to be announced.

Session led by: j&j-innovation-centre
17:20

Networking Drinks Reception

last published: 17/Feb/17 02:17

Clinical trials, Thursday 23 March 2017

FOCUS ON LOCAL PHARMA AND BIOTECH

Dr Carl Firth
09:10

From ideas to international success: A real breakthrough story brought to you by an Asian biotech company

Starting from nothing to million dollar success, this biotech company currently employs thousands to benefit the healthcare industry. Hear from true blue biotech company in Asia on their success story in building the reach of their companies from domestic to international market
Interviewee: Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals
Interviewer: Ed Lane, Senior Editor, Fierce Pharma Asia
Panel discussion
09:30

Keynote Panel: Big pharma perspective in driving Asia biopharma innovation

With the highest amount of resources which can be invested into operation, big pharma companies are in the best position to lead the industry direction. When making a key decision, it is important to understand the impact in organisation and industry wide. How can big pharma avoid being "too-big-to-fail" and lead the industry to be more innovative?
Paul Song, Vice President, Business Development, Samsung Bioepis
Ms Melinda Richter, Head of JLABS, Johnson & Johnson
Atin Tomar, President, CPL Biologicals
Rajesh Krishna, Executive Director, Translational Pharmacology, MSD Singapore
Dr Francesco Berlanda Scorza
10:10

Strategies in providing affordable healthcare in developing countries

Developing countries are facing enormous challenges when it comes to dedicating natural funds and resources. In the dilemma between investing on more economy boasting industries, and providing better healthcare infrastructure and facilities for the people, the former often get more attention to promote overall growth of the country. In Asia, many countries depend on out-of-pocket to fund healthcare policies, the big question is, how can stakeholders work together in providing accessible and affordable healthcare in limited funding by the government and people to afford these services?
Dr Francesco Berlanda Scorza, Scientific Director of Influenza Vaccine Project, P.A.T.H.
10:30

Exhibition Visit & Networking Refreshments

Anthony Nguyen
Clinical trials
11:10

Chair's opening remarks

Anthony Nguyen, Director, Strategic Planning and Communication, Dong-A University Hospital Global Clinical Trial Center

Clinical Innovations

Rajesh Krishna
Clinical trials
11:15

Driving clinical innovations: A big pharma perspective

  • Discovering the adoption of emerging technology to improve clinical quality and efficiency.
  • Redefining SOP in clinical operations to integrate technology and encourage innovative practices without compromising trials quality
  • Discovering strategic plans to train staff in instilling innovation and moving towards digitalised practices
Rajesh Krishna, Executive Director, Translational Pharmacology, MSD Singapore
Anthony Nguyen
Clinical trials
11:35

Developing clinical trial infrastructure

™ Discussing key considerations with developing clinical trial capabilities, i.e. gene therapy.
™ Developing infrastructure for the leadership and oversight of clinical development program, including building in-house capabilities
™ Deciding which aspect to outsource and keep in house
™ Selecting providers and managing relationships and project
Anthony Nguyen, Director, Strategic Planning and Communication, Dong-A University Hospital Global Clinical Trial Center
Mr Kent Thoelke
Clinical trials
11:55

Leverage Real World Data to Make Better Decisions

  • Evidence-based approaches for protocol validation, study feasibility and patient access
  • Enhancing global accrual rates for clinical trials
  • Mining public and private databases to create a proprietary methodology for patient and site access
Mr Kent Thoelke, Executive Vice President, Scientific & Medical Affairs, Safety & Commercialization Services, PRA Health Sciences
Prof Marimuthu Palaniswami
Clinical trials
12:15

Innovation in action: Using remote sensing and IoT for stroke patient monitoring

  • Using IoT for real time patient monitoring
  • Discussing infrastructure limitation and potential solutions in overcoming these challenges
  • Sharing case studies on using remote sensing for patient monitoring off-sites
Prof Marimuthu Palaniswami, Professor, Director, The University of Melbourne
12:40

Exhibition Visit & Networking Lunch

Clinical Supply

Mr Eddie Tam
Clinical trials
13:50

Cost and considerations in selecting CRO for end-to-end operations and supply

  • Exploring the availability of high quality, cost effective CRO services in Asia
  • Working with CROs to implement best practices in clinical supply
  • Discovering strategies to innovate clinical supply practices
Mr Eddie Tam, Head of Regional Procurement, Scientific and Clinical, Sanofi
Ms Tracey Clare
Clinical trials
14:10

Driving patient centricity to optimize clinical supply

  • Understanding the evolution of the clinical supply model
  • Need a new approach: internal pressures to drive efficiency, quality and value while reducing risk
  • Case Study: a fundamentally different approach to other clinical supply models
Ms Tracey Clare, Site Director, Development & Clinical Services, Catalent Pharma Solutions
Patrik Jonasson
Clinical trials
14:30

Innovative supply chain strategies to improve agility and efficiency

  • Formulating strategies to ensure optimal process flow
  • Exploring various options to satisfy segmentation requirements with variable volumes and packaging needs
  • Using late stage customisation to overcome country specific regulations and requirements
  • Overcoming existing infrastructure limitations to fully utilise the potential of 2D barcoding in track and trace
Patrik Jonasson, Director, Public Policy Asia Pacific, G.S.1 Malaysia

Clinical Operations

Dr Vincenzo Teneggi
Clinical trials
15:40

Investigations in Healthy Volunteers (HVs) : Opportunities and issues

  • Understanding opportunities in global clinical development considering HVs in different geographical regions
  • Overcoming challenges in HV definition, identification and assessment
  • Case studies on overcoming operational challenges in investigations in HV in Asia
Dr Vincenzo Teneggi, Senior Medical Director, D3
Ms Maggie Lim
Clinical trials
16:00

Conducting quality clinical trials in China, a case study

The Chinese government has recently reformed its healthcare structure to improve quality of clinical trials and manufacturing. Find out more about the status quo of clinical operations in China and how global companies can help in ensuring quality operation by strictly enforcing GCP and other SOP in their respective team.
Ms Maggie Lim, Clinical Development Quality Assurance (Asia-Pacific), Global Quality & Compliance, GSK Pte Ltd
Dr Joseph Marialouis
Clinical trials
16:20

How can big pharma lead GCP implementation to promote quality clinical research in India?

Clinical trials in India have been plagued with scandals due to lack of compliance and ambiguous guidelines. While the CDSCO is renewing its policy to promote quality trials in the country, local companies need to learn from their overseas counterparts to regain international confidence in the market. Find out how big pharma in India can help in leading GCP within the country.
Dr Joseph Marialouis, Associate Director-Clinical Operations, Lupin
Ms Lisa Palladino Kim
Clinical trials
16:40

The art and science of patient recruitment - Strategies for emerging markets

™ Demonstrate how industry is expanding their engagement of the public, healthcare providers, and industry partners in order to increase patient recruitment.
™ Highlight the need for patient recruitment specialist roles and identify avenues to broaden current educational knowledge in this space.
™ Share lessons learned from current established markets in order for emerging markets to mitigate future challenges.
Ms Lisa Palladino Kim, Director of Capstone / Lecturer, Rutgers The State University of New Jersey

CLOSE OF BIOPHARMA ASIA 2017

last published: 17/Feb/17 02:18

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。