Conference Day One: Thursday, 13 September 2012
PHARMA STRATEGIC SOURCING & OUTSOURCING ASIA
08.50 Welcome and Chairperson’s Opening Remarks
Dr. Gaurav Sharma, Senior Manager, Business Development, Strategic
Alliances & Licensing, Wockhardt Ltd, India
PARTNERSHIPS IN CLINICAL TRIALS ASIA
08.50 Chairperson’s Opening Remarks
Kyle Given, Senior Vice President, Clinical Operations, Training & Quality Control, RPS
TRENDS IN STRATEGIC SOURCING
KEYNOTE SESSIONS: GLOBAL AND REGIONAL EXPERTS IN CLINICAL DEVELOPMENT
8.55
Horizon Scanning: Global Strategic Sourcing Trends and Scoping the
Landscape for Future Sources
Vikas Bhadoria, Partner, McKinsey & Company, India
8:55
Mapping the Clinical Trial Landscape in Asia: Realities of Conducting Trials in
the Region
With Asia’s rapidly developing economies, their expertise in research and development
is improving by leaps and bounds. Estimates suggest that from now until 2015, over
50% of growth in global clinical trials can be directly attributed to the offshoring of
clinical trials to emerging markets. This session is a candid deep dive into the growing
clinical trial opportunities in Asia and current challenges of the region.
• Understand the trends for trial placement and insights on evolving cost per subject
• Define the best practices in quality management and training of investigators
• Hear a high-level overview of regulations and their global implications
• Discuss the demographics, challenges, opportunities and expertise of selected
individual countries within Asia
Yan Wu, General Manager, Division of Medical and Drug Development, Daiichi Sankyo
09.30 Is the Era of China/India Outsourcing Ending?
China and India used to provide a cost advantage, however with recent
economic growth, inflation and demand for higher salaries, are the benefits
diminishing? Are tax benefits in the West luring companies back for local
research, development and production? How do countries including China and
India intend to respond to this shift? Does the importance of alliances with
domestic partners override the inflation costs? In this interactive session, the
panelists will present their case For or Against the topic. The debate will then
be opened up for opinions across the audience.
For: There are Still Benefits to Reap from Outsourcing to India/China
Michael Choy, Ph.D., Principal, The Boston Consulting Group, China
Against: With the Shifting Landscape, Pharma Companies Should Move Back
to the West
Ralf Altmeyer, Director General, Institut Pasteur Shanghai, China
9:30
KEYNOTE: Increasing Innovation in Asia
Asia has been previously viewed simply as a low cost provider of clinical trials services,
but the true value of the region is far more strategic and apparent. This session
highlights innovations and opportunities currently being explored in the region, what
they mean for the future of R&D, changing business models globally, and the potential
impact of more strategic collaborations.
• Gain alignment on R&D Standards
• How to successfully accomplish R&D work in China
• What’s the future collaboration in R&D?
• How is the changing R&D model going to impact the CRO market?
Zhengqing Li, Vice President and Head of China Development, Merck Research Labs
10.05 – 10.35
Morning Networking Refreshments & Exhibition
PHARMA STRATEGIC SOURCING & OUTSOURCING ASIA
ADAPTING TO THE LOCAL MARKETPLACE:
STRATEGIES FOR SUCCESSFUL MARKET ENTRY
10.35 Driving Factors for Business Growth and Development in Asia
• Strategic overview of the major markets in Asia including:
• Legislation and government initiatives to encourage inbound foreign
investment
• Regulatory agency position and direction
• Pricing laws and impact on foreign investment
• Considerations for international companies to target the emerging
middle-class population in Asia
Ralf Altmeyer, Director General, Institut Pasteur Shanghai, China
PARTNERSHIPS IN CLINICAL TRIALS ASIA
10:35 Regional Expansion of Global Strategic Partnerships Shared Learning: LillyCovance
• Elements of a global strategic partnership that define the basis for the relationship
and set the stage for mutual success
• Foundation of the Lilly-Covance Strategic Partnership that have set the stage for
expansion of the relationship into regions around the world
• Expansion of global capabilities to regional capabilities and the approach being used
to assess opportunity and expand services
Christina Bodurow, Senior Director, External Sourcing and Business Management
Development Center of Excellence, Eli Lilly
11.10 Exploring Procurement Challenges and Opportunities When
Sourcing from China
• Lessons learned for sourcing-process best practices and challenges in
dealing with the Chinese market
• Strategies for managing Chinese vendors
• Identifying and overcoming specific risks
• Developing and maintaining relationships with Chinese suppliers
• Adapting to local cultural requirements
Petri Karvinen, Head of Purchasing & Sourcing (China Office), Orion, Finland
11:10 Overcoming the Legal Challenges in Outsourcing Clinical Trials
Legal challenges when outsourcing global clinical trials include control and monitoring,
safeguarding sponsor’s interest, resources, liability and claims, and anti-corruption
through ensuring intellectual protection is upheld. This session looks at strategies to
match your legal model to your business outsourcing model.
• Review various legal models of outsourcing and how to correctly match the legal
model to the business model
• How to overcome the biggest challenge of Anti Corruption under different applicable
laws and policies
• Understanding risk and benefits
Tali Guy, Senior Legal Counsel, Global Branded Products, Teva
11.45 Challenges and Opportunities for Sourcing from India
• Need of sourcing
• Make or buy decision
• Cheapest is not the best
• Skill sets required for effective sourcing
Dr. Chandrashekhar Nimkar, Director, Global Supply Chain, Alvogen Inc,
USA
11:45 PANEL: What’s the Most Effective Outsourcing and Partnering Approach for
Multinational Companies Conducting Trials in Asia?
With the cost of doing business and budget constraints on the rise, clinical professionals
need to do more with less- and do it faster- while still maintaining the highest levels of
quality. With increasing regulatory demands and decreasing productivity, successful
strategic partnerships are essential. Industry consolidation, increasingly strict regulatory
standards, and the economic climate has made strategic partnerships a top priority for
the industry. Here, sourcing leaders share different outsourcing and partnering
approaches that have been implemented at their companies and debate what model has
been most valuable.
PHARMA STRATEGIC SOURCING & OUTSOURCING ASIA
12.20 Forging Ahead: Business Growth and Development Potential in
Asia
This discussion will be represented by 2 perspectives:
• Large MNC
• Asian CMO
Each panelist will share their view on how they see the industry in Asia
developing and strategies they are implementing to prepare for business
growth in Asia
Moderator: Frank Floether, President, Dr Floether Consulting, Switzerland
Panellists: Harjinder Singh, Director, Global Procurement Asia Pacific,
Janssen Pharmaceuticals, Singapore
Scott M. Wheelwright, Chief Operating Officer, Innovent Biologics, Inc.,
China
13.00 – 14.00
PARTNERSHIPS IN CLINICAL TRIALS ASIA
Insourcing vs Outsourcing: Strategic sourcing approaches of East vs West
Outline the considerations for partnering with a regional CRO Vs. a Global CRO
Identify the challenges and benefits of changing CRO models
Setting the stage for success – What does each partner need to ask to ensure
alignment in terms of basic beliefs, core competencies and culture.
• Discuss sponsor concerns about quality control project management in global
studies- do sponsors prefer a ‘one stop shop’?
Moderator: James Cai, Medical Director, Roche
Panelists: Patricia Humphreys, Sourcing Consultant, Clinical Pharmacology Study Delivery
Solutions, Eli Lilly
Vinayak Krishna, Regional Sourcing Manager (Clinical) - Asia Pacific, Global Pharma R&D
Sourcing, Janssen
Patrice Hugo, Senior Global Director, Scientific Affairs, LabCorp Clinical Trials
Lesley Mathews, Global Strategic Sourcing, Bayer Healthcare
12.45 – 14.00
Networking Luncheon
14.00 How Technology Can Meet Today’s Clinical Development &
Partnership Challenges
• The current challenges faced by the industry in managing trial data
• The proportion of spend taken by IT in clinical development
• The move from point solutions to eClinical solutions
• What converged solutions look like today, and the benefits obtained
David Horsley, Senior Director, APAC Business Development, Account
Management, Perceptive Informatics, UK
RISK MANAGEMENT & MITIGATION
14.30 Novel Strategies to Prepare for Business Risk – Instilling
Confidence in Your Partnerships with Asia
Panelists will share experiences on risky situations faced, lessons learned
and how risk models have been adapted to manage/mitigate future risk.
Examples of risk can include:
• Natural disaster • Political unrest
• Counterfeiting
• Supplier failure • Currency volatility • Technology transfer
Moderator: Vikas Bhadoria, Partner, McKinsey & Company, India
Panellists: Petri Karvinen, Head of Purchasing & Sourcing (China Office),
Orion, Finland
Dr. Gaurav Sharma, Senior Manager, Business Development, Strategic
Alliances & Licensing, Wockhardt Ltd, India
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INNOVATIVE APPROACHES TO CLINICAL PARTNERING
14:00 Embedded Partnership as a Successful Approach
to Clinical Strategy in China
• “Own it (Embedded Partnership) vs Rent it
(Traditional CRO Outsourcing)” strategy in Clinical
Development
• Mitigating challenges in recruitment and staff
retention
• Risk sharing in a highly dynamic market
• Emphasis on program customization and operational
flexibility
Paul Dai, Senior Director, Novartis ICRO, AMAC, Novartis
14:35 Type 2 Diabetes Trials in China
• The growing clinical trial market in China
• Updates on the drugs, sites, investigators
• Leveraging third party data to aid in site selection
Simon Barker, Engagement Manager, Citeline
DISCUSSION DEN
14:00 Hurdling the
Obstacles in Going to
Europe
• Pre-Clinical: Complying
with the CMC & analytical
requirements, identify
needs of PK/PD testing
and evaluation of safety
concerns
• Clinical: Needs and
compound classification,
regulatory overview
Klaus Fischer, Chief
Executive Officer, Assign
Group
Emmanuelle Cornali, Head
of Business Development,
Aurigon
15.10 – 15.40
Afternoon Networking Refreshments & Exhibition
PHARMA STRATEGIC SOURCING & OUTSOURCING ASIA
PARTNERSHIPS IN CLINICAL TRIALS ASIA
INTELLECTUAL PROPERTY AND PATENT PROTECTION
15.40 Current Initiatives to Protect Intellectual Property and Encourage
Foreign Investment
• Typical consideration for investors while choosing the destination country
for investment
• Key regulations for protection of IPR
• Enforcement mechanisms for IP protection
Tushar Ajinkya, Partner, DSK Legal, India
16.15 Enforcing your Patent Rights in China
• Understanding the general process of enforcing patent rights
in China
• Key success factors in winning a patent litigation in the Chinese
courts
• Exploring alternative enforcement mechanisms to a court
battle
David Shen, Regional Legal Counsel, AstraZeneca, China
16.50 Practical Elements of Contract Management and IP Protection:
Legal Insights and Advice
• Protecting your IP if a partnership goes wrong
• Implementing measures for orderly wind up of relationship – IP
ownership, supply security, ongoing regulatory obligations
• Preparing secrecy agreements and ensuring your IP is protected
• Managing IP in light of divergent stakeholder interests
Tushar Ajinkya, Partner, DSK Legal, India
Qinghong Xu, Partner, Lung Tin International Intellectual Property Agent
Ltd., P. R. China
Benjamin Gaw, Director, Drew & Napier, Singapore
17.30
Closing Remarks from the Chair followed by
15:40 Capability Sourcing – A Strategic Approach to
Sourcing Decisions
Gopakumar Menon, Chief Executive Officer, SIRO
Clinpharm
16:15 Global Oncology Drug Development from
Japanese Company Perspective
• Successful development strategies for gaining
approval of novel products
• Conduct the best, and most appropriate study
design for global trials in oncology
• How to take the advantage as Asian pharma for
global trials
Tadashi Fujisawa, Chief Executive Officer, Mebiopharm
16:50 Clinical Strategies to Expedite Development of
Biosimilars
• Combining strengths through partnerships
• Opportunities and risks in biosimilars development
• Collaborating to minimize risks
Sandeep Athalye, Vice President and Head of Clinical
Development, Biocon
17:25
DISCUSSION DEN
15:40 How to Manage
Relations in Asia: Best
Practices in Sponsor-CROSite Collaboration to ensure
Quality Oversight
Christa Maurer, Regional
Quality Lead- Asia Pac,
Bristol-Myers Squibb
16:40 Ensuring GCP
Compliance in Asian-based
Studies through Efficient
Training
• Discuss the training gaps
that are most prevalent in
the clinical trials market
in Asia
• How to train staff so that
clinical trials conduct
adheres to the ICH-GCP
standards
• Define best practices in
efficient training of
investigators in the region
Eric Morfin, Senior Director
PMO, Group Leader Project
Management, Pfizer
Oncology
Asia Training Consortium Announcements followed by
Labcorp Clinical Trials Networking Reception (ends 19.00)
Conference Day Two: Friday, 14 September 2012
PHARMA STRATEGIC SOURCING & OUTSOURCING ASIA
09.00 Opening Remarks from the Chair
Dr. Gaurav Sharma, Senior Manager, Business Development, Strategic
Alliances & Licensing, Wockhardt Ltd, India
PARTNERSHIPS IN CLINICAL TRIALS ASIA
09.00 Chairperson’s Opening Remarks and Recap of Day One
Christina Bodurow, Senior Director, External Sourcing and Business Management
Development Center of Excellence, Eli Lilly
FORGING MEANINGFUL PARTNERSHIPS AND STRATEGIC ALLIANCES
09.10 BMS Selective Integration in China: Innovative Approaches and
Models
• Highlighting and discussing an innovative model put in place by BristolMyers Squibb with a reputable Contract Research Organization in China
• Outlining plans for the near and longer term future collaborations
utilizing the concept of selective integration (as opposed to outsourcing)
• Life science innovation opportunities in China
• BMS partnership to drive innovative science
Stephen Scypinski Ph.D., Vice President, Analytical & Bioanalytical
Development, Bristol-Myers Squibb Company, USA
Litao Zhang Ph.D., Executive Director, Lead Evaluation, Bristol- Myers
Squibb Company, USA
REGULATORY COMPLIANCE AND QUALITY ASSURANCE
9:10
Understand and Navigate the Changing Regulatory Landscape in Asia
Asia has been previously viewed simply as a low cost provider of clinical trials services, but
the true value of the region is far more strategic and apparent. This session highlights
innovations and opportunities currently being explored in the region, what they mean for
the future of R&D, changing business models globally, and the potential impact of more
strategic collaborations in the region.
Victoria Elegant, Vice-President, Medical & Regulatory Affairs and Pharmacovigilance,
Asia-Pacific, Baxter Healthcare
10.00 In China for China: Strategic Partnership with China CROs in
Pharmaceutical Development
• Reviewing opportunity and challenges for development collaborations
• Outlining the capability and investment considerations to ensure the
right business decision
• Tools & data analysis: Measure effectiveness the of your partnership
Dachen Cheng Ph.D., China Sourcing Team Leader, Pharmaceutical
Development, R&D Supply Chain, AstraZeneca, China
10.35 – 11.00
9:45
Regulatory and Operational Lessons Learned in Global Clinical Trial Supply
Chain Management
• Adapt to the changing nature of treatment and products as industry shifts to higher
cost biological with complex distribution requirements
• Implement clear strategies for handling global clinical logistics as you build your
global study protocol that can minimize the cost.
• Identify clinical trial supplies strategies as a key factor in preparing for clinical trial in
Asia
• Key distribution & import challenges in Asia
Scott Ohanesian, Vice President, Commercial Operations – Asia Pacific, Marken
10.20 – 11.00
Morning Networking Refreshments & Exhibition
11.00 Understanding and Optimizing the Legal Models of Outsourcing
11:00 How to Reduce Staff Turnover and Implement Quality, Standardized Training
• Defining the various business models of outsourcing
• Innovative pan-industry collaborative initiative to address training and quality issues
• Assessing the legal models of outsourcing
in Asia
• Strategies to correctly match the legal model to the business model
• Pharma, CROs, academia to develop core curricula, provide generic trainings and
• Reviewing the risks and benefits of the various models
standardize quality
Tali Guy, Advocate, Senior Legal Counsel, Global Branded Products, Teva
• Achieving cost effectiveness through collaboration
Pharmaceutical Industries Ltd, Israel
John Constantine, Chairperson, Asia Training Consortium, Executive Director, Merck
Polytechnic Institute
PHARMA STRATEGIC SOURCING & OUTSOURCING ASIA
11.40 Evaluating and Selecting a Strategic Partner
• Selecting partners for strategic & cultural fit
• Strategic due diligence for partner selection
• Negotiating partnership agreement
• Developing an alliance plan
• Engaging the partner according to product needs
• Managing intellectual property and branding
Dr. Gaurav Sharma, Senior Manager, Business Development, Strategic
Alliances & Licensing, Wockhardt Ltd, India
12.20 – 14.00
PARTNERSHIPS IN CLINICAL TRIALS ASIA
11:35 Leveraging Asia to Accelerate Clinical
Development of Innovative New drugs
Hua Mu, Executive Vice President & Chief Medical
Officer, Hutchison Medipharma
12:10 The “Dragon and the Elephant” (China & India):
Have They Lived Up to Expectations When It Comes to
Clinical Development?
• Progress on the regulatory front
• Availability of experienced investigators; high quality
sites and research infrastructure: where they are vs.
where they need to be
• Availability of skilled resources and talented
leadership
• What is the final goal: A clinical research destination
vs. An R&D hub that will drive future innovation?
Moderator:
Mubarak Naqvi, Director Clinical Research, Sanofi
Aventis
Panelists:
Helen Jiang, Vice President Clinical, Jiangsu Hengrui
Medicine Company
Sally Sha, Director Business Development, Tigermed
Vinayak Krishna, Regional Sourcing Manager(Clinical) –
Asia Pacific, Global Pharma R&D Sourcing, Janssen
13.00 – 14.00
Networking Luncheon
PUSHING BOUNDARIES TO ACHIEVE TRUE VALUE & COST REDUCTION
14.00 Exploring Analytics for Better Investment
• Strategies for using data to improve the value of procurement
• Outlining the specific data collection requirements by procurement
• Reviewing the changing role and new functions of the procurement
department
• Analyzing ROI from a procurement perspective and benefits to the
company
Hanson Wang, Head of Procurement, Alcon (a Novartis company), China
14:00 REGIONAL ROUNDTABLE: Prospects and
Challenges of Bringing Clinical Trials to Access Asia’s
Emerging Markets and Highly Developed Territories
• Identifying clinical trial opportunities in emerging
markets in Asia
• Are there areas of the biopharmaceutical value
chain that highly developed territories should focus
on?
• What needs to be done to increase competitiveness
or remain relevant?
DISCUSSION DEN
12:00 Pre-Clinical
Development and Safety in
Asia
• Current outsourcing
models for preclinical
studies in Asia
• Safety signal
identification and
reversibility
• FIM dose selection from
preclinical data
• Strategic alliances for
process improvements
and efficiencies
Yi Yang, Director of PreClinical Safety, China R&D,
Sanofi Aventis
14:15 How to Adopt
Opportunities and Growth in
Asia for Translational
Research
• Operational strategies to
reduce costs in R&D
• Drug response and
toxicity during the drug
discovery process
PHARMA STRATEGIC SOURCING & OUTSOURCING ASIA
PARTNERSHIPS IN CLINICAL TRIALS ASIA
Understand the challenges around cultural
compatibility, compliance concerns, and standards
of care
Moderator:
Melvin Toh, Vice President Pharmaceutical
Development, CK Life Sciences
Panelists:
SungIn Hong, Senior Director, Integrated Clinical
Programs in AP, RPS Research
Danny Soon, Managing Director & Principal Investigator,
Lilly-NUS Centre for Clinical Pharmacology
Joan Catherine Manalo, Head of Clinical Operations,
Pfizer
Carlo Bertorelli, Director: Global Supply Chain Services,
Fisher Clinical Services
•
14.35 Maximizing Sourcing’s Contribution to the Organization and
Aligning with Finance Objectives
Rajesh Desikan, Head of Finance, Pharma Global Sourcing, Novartis Pharma
AG, Switzerland
DISCUSSION DEN
Innovative approaches to
accelerate the drug
development process
Vincenzo Teneggi, Senior
Director, Head Early
Development and Clinical
Pharmacology, R&D China,
GlaxoSmithKline
•
15.10 – 15.40
Afternoon Refreshments
TRENDS IN OUTSOURCING ACROSS THE PHARMA VALUE CHAIN
15.40 Offshoring of Chemical & Pharmaceutical R&D to Asia
• Reasoning, drivers, benefits and risks for Big Pharma to “Go East”
• India, China and Singapore as key destinations – their pros and cons in
terms of R&D opportunities and challenges
• Domestic industry and specifics of Asian key destinations
• Options for various business models to set up a R&D presence in Asia
Frank Floether, President, Dr Floether Consulting, Switzerland
15:40 Improving Quality Management through Risk
Based Approach to Monitoring Strategies
New guidance from the US Food and Drug
Administration recommends adoption of more riskbased methods by sponsors to monitor clinical
investigations. Existing regulations require sponsors to
monitor the conduct and progress of their clinical
investigations, but do not prescribe specific steps to
follow in order to comply.
• Understand FDA Guidance on Risk-Based Monitoring
and its impact on Asian trials
• Challenges and efforts of quality system in GCP
• Quality standards, continuous improvements and
auditing
• Differences in Chinese GCP and International ICH
GCP
Amer Alghabban, Director GCP Quality Assurance and
Audit Management, Merck Serono
15:45 Ensuring Successful
Early Phase Studies
As the world of Phase I
providers and client needs
grow increasingly complex, it
is vital to engage with trusted
experts to ensure timely,
high-quality results.
• Review problem areas in
early phase studies in the
region
• Discuss how to select the
right CRO partner for
early phase studies in
Asia
Christa Maurer, Regional
Quality Lead- Asia Pacific,
Bristol Myers Squibb
PHARMA STRATEGIC SOURCING & OUTSOURCING ASIA
16.15 Asia’s Evolving Role in Pharmaceutical Clinical Trials and its Impact
on External Partnerships
• Changing motives (business and scientific) for clinical trials in Asia
• The shift in partnering frameworks from global to regional and local
• Key considerations and challenges while meeting regional clinical
outsourcing needs
• Suitable partnering options and models that work for the region and
address regional business constraints
Vinayak Krishna, Regional Sourcing Manager (Clinical) – Asia Pacific, Global
Pharma R&D Sourcing (GPS), Janssen, Singapore
16.50
Closing Remarks from the Chair and Conference Concludes
PARTNERSHIPS IN CLINICAL TRIALS ASIA
16:15 Closing Visionary Panel: Determining Your Clinical Development Strategy in
Asia
• What are the future trends and growth opportunities in clinical research?
• How will partnering models change how clinical development is done in Asia?
• Where should we place our bets for the next big investment?
Moderator:
Patrice Hugo, Senior Global Director, Scientific Affairs, LabCorp Clinical Trials
Panelists:
Vincenzo Teneggi, Senior Director, Head Early Development and Clinical Pharmacology,
R&D China, GlaxoSmithKline
Yuko Kojima, Director, Asia-Pacific Medical Communications Development Center of
Excellence (Asia-Pacific), Lilly Suzhou Pharmaceutical
Hua Mu, Executive Vice President & Chief Medical Officer, Hutchison Medipharma
17.05
Closing Remarks from the Chair and Conference Concludes