ASIA 9 2 0

IBC
LIFE SCIENCES
ASIA
9TH
2 0
4 – 7 November 2014
Grand Copthorne Waterfront, Singapore
1
4
Asia’s Longest Running Generics Conference Unlocking
Innovation for Sustainable Growth
What’s NEW for 2014?
Reinventing the generics business and new areas
of growth
Dr. Shirish Kulkarni
Philip Cox
Senior Vice President, Formulation
Development,
President Director,
Sales force effectiveness and innovative channels
for generics distribution
PT Takeda, Indonesia
Establishing sustainable relationships with internal
and external stakeholders
Sun Pharmaceutical
Industries Ltd., India
Special focus on biosimilars and supergenerics
Successful Quality by Design (QbD) and Cost
Reduction strategies
Angelo Felix
Krishna Prasad
Country Manager,
Associate Director Regulatory Affairs,
Hovid, Philippines
Actavis, Singapore
Rajeev Raghuvanshi
Allan Marx Ancheta
Vice President, Differentiated
Formulations R&D,
Director Business Development and Strategy,
Commercial Innovation and Alliance,
Dr Reddy’s Laboratories, India
Merck, Philippines
WORKSHOPS
A Quality by Design (QbD) and Continuous Validation
B Innovation in Sales Force effectiveness Models
C Developing and Sustaining Profitable Market Entries in Asia
Produced by:
Media Partners:
Life
Sciences
International Marketing Partner:
www.generics-asia.com
CONFERENCE DAY ONE
5 November 2014 | Wednesday
Registration and Morning Coffee
14:20 Assessing Asia’s Growing Market and Challenges in
Marketing Generics in Domestic and International
Markets
9:00
Welcome from IBC Asia & Morning Ice Breaker
9:05
Chairman’s Welcome Remarks
Dr Siddharth Dutta, Industry Manager – Life Sciences
(Pharmaceuticals & Healthcare), Frost & Sullivan, Singapore
Regulatory Climate and Asia’s Market
Opportunities
9:10
Shift in the Global Generics Market: Trends and
Regulatory Climate
• Emerging trends, opportunities and prospects in the global
generics market
• Evaluating the accessibility and developing trends in Cambodia,
Laos, Myanmar and Vietnam
• What changes can be expected in the product and pricing
standards?
• Implications on ASEAN free trade agreement to locals and foreign
businesses
• How will the SEA free trade change the game play in Asia?
• How can generics companies maintain competitiveness in 2015
and beyond?
Krishna Prasad, Associate Director Regulatory Affairs,
Actavis, Singapore
9:50
How Local and Foreign Players Withstand the Intense
Competition and Cutting Edge Strategies in the
Philippines
• Growth forecast and what is expected in the market in the next
5 years
• Differences in Philippines generics market as compared to other
SEA countries
• Evolving business models and matching the market needs
• How local and foreign players win market share and will the
trend of market consolidation continue?
PANEL
DISCUSSION
8:00
• Overview of the pharmaceutical regulatory landscape in Asia in
relation to registration requirements, patent law and litigation,
pharmacovigilance and patent issues
• Clash of different standards over generic medicine production
between importer and exporter and lesson learnt
• Tailoring your marketing strategies according to customer and
payer characteristics and segmentation to gain maximum
exposure
• Tracking of recent M&A and partnerships, how the companies
modify and improve existing marketing strategies to entice
market demand
• Should generics companies focus on branding or penetrate
markets with the lowest possible price?
Panelists:
Mohd Fazli Shuib, Manager, Clinical Research,
Pharmacoeconomics and Clinical Assignments, Prince Court
Medical Centre, Malaysia
Allan Marx Ancheta, Director Business Development and
Strategy, Commercial Innovation and Alliance, Merck,
Philippines
Lynn Robles, Executive Director, Philippines Chamber of
Pharmaceutical Industry, Philippines
Krishna Prasad, Associate Director Regulatory Affairs, Actavis,
Singapore
Angelo Felix, Country Manager, Hovid, Philippines
Philip Cox, President Director, PT Takeda Indonesia,
Indonesia
Angelo Felix, Country Manager, Hovid, Philippines
15:20 Afternoon Networking & Refreshment Break
10.30 Morning Networking & Refreshment Break
11:00 Developing a Profitable Generics Portfolio under
Universal Healthcare Coverage in Indonesia
• Market trends and demand supply equilibrium
• Implications of the universal healthcare coverage policy on the
generics market
• Developing brand awareness amidst intense local competition
• Building partnerships and recent M&A trends
Sreeraj Roy, Business Director, Pfizer, Indonesia
11:40 The Patent Cliff and Future of Generics in Asia
• Market supply and demand in Asia and rest of the world – is the
market sustainable?
• How innovators position themselves against generics – is there
a win-win situation for both?
• Where generics companies are heading to with reduction in offpatent products?
• Strategies to prolong product life and differentiating generics
products from competitors
Dr Siddharth Dutta, Industry Manager – Life Sciences
(Pharmaceuticals & Healthcare), Frost & Sullivan, Singapore
15:50 Managing Sales Force Effectiveness and Innovative
Channels for Generics Distribution
• What are the effective and efficient channels available to speed
up time to market?
• Equipping your sales force with essential product knowledge,
negotiation skills and creativity to increase product adoption
and awareness
• Educating physicians, payers and patients on product
differentiation and effectiveness through mobile communication
devices
• Common setbacks and how industry players tackle the issues
Marvin Biliwang, Commercial Effectiveness Director,
Takeda Pharmaceuticals Philippines, Inc., Philippines
16:30 How Can Pharmaceutical Companies Support Buyer
Decision Making?
12.20 Networking Lunch
Strategic Marketing Planning and
Branding
13:40 Building Brand Awareness and Managing New Generic
Product Launches
• Understanding how payers and patients perceive generics and
key purchasing considerations when selecting generics brands
• Raising brand awareness and identifying the key components
in driving consumer demands
• Delivering new products with cost effective strategies
• Equipping your sales force with essential product knowledge,
negotiation skills and creativity to increase product adoption
and awareness
• Case study of a successful branded generics strategy
Allan Marx Ancheta, Director Business Development and
Strategy, Commercial Innovation and Alliance, Merck,
Philippines
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Generics Distribution and
Buyer Behaviour
+65 6508 2401
• Expectations of stakeholders (buyers/physicians/pharmacists)
from both private and public institutions
• Product centricity versus customer service centricity?
• How can pharmaceutical companies help to speed up the buyer
decision making process?
• How do customers see sales reps - characteristics of sales reps
from buyers perspectives
Mohd Fazli Shuib, Manager, Clinical Research,
Pharmacoeconomics and Clinical Assignments, Prince Court
Medical Centre, Malaysia
17:10 Chairman’s Summary of the Day
17:15 End of Conference Day One
register@ibcasia.com.sg
www.generics-asia.com
CONFERENCE DAY TWO
6 November 2014 | Thursday
14:20 Biosimilar Development: Emerging Trends & Regulatory
Expectation
8.30
Morning Networking & Coffee
9.00
Chairman’s Opening Remarks
Himanshu Gadgil, Senior Vice President, R&D/Regulatory
Affairs Biotech Divison, Intas Biopharmaceuticals Ltd, India
• What to look for when establishing similarity in biosimilar drugs
• What are the regulatory compliant guidelines and how to ensure
safety of biosimilars?
• What are the successful partnership models that align capabilities
and business objectives in the biosimilar sector?
• Leading pricing strategies and risk reduction strategies
• What are the market access initiatives in ASEAN and which
country presents accessibility and acceptability of biosimilar
products?
Strategic Partnerships & Collaboration
9:10
Establishing Partnerships to Add Value and Build
Market Share
• Critical factors in forming partnerships and assessing different
partnership models to overcome barriers
• Comparing the pros and cons of different partnerships: Alliance
versus Outsourcing
• How to overcome the conflict of interests for partnering in the
region
• Case study on successful M&A and partnerships
Philip Cox, President Director, PT Takeda Indonesia,
Indonesia
9:50
Rahul R Nair, Research Scientist, Lupin Limited (Biotech
Division), India
15:00 Afternoon Networking and Refreshment Break
15:30 Overcoming Regulatory Barriers for Developing
Affordable Biosimilars in New and Emerging Markets
• Comprehensive fingerprint analysis to establish biosimilar
similarity through physicochemical characterization
• Critical Quality Attribute (CQA) based biosimilar strategy
• Implementing Quality by Design (QbD) approach for process
development
• Clinical trials strategies: choosing the correct indications to enable
extrapolation of indications
• Defining primary and secondary endpoints
• Immunogenicity assessment during clinical trials studies
Optimizing Strategic Relationships and Scientific Driven
Strategies in Branded Generics
• Establish and build strategic partnerships (government
hospitals/institutions, trade/retail segments, medical societies,
organized doctor groups) through brand “advocacies” and disease
awareness and brand awareness
• Practical scientific strategies to drive (brand/corporate)
differentiation through innovative continuing medical education
(CME), meaningful clinical trials and Medical Representative
engagement
Raymond Bernardo, Marketing Manager, Getz Pharma
(Pvt) Ltd., Philippines
10:30 Morning Networking & Refreshment Break
Himanshu Gadgil, Senior Vice President, R&D/Regulatory
Affairs Biotech Division, Intas Biopharmaceuticals Ltd, India
Streamlined Manufacturing, Cost
Reduction & Quality
16:10 Implementing Quality by Design (QbD) and Streamlining
Manufacturing
New Means of Growth
• QbD methodology
• Process Analytical Technology (PAT) to enable streamlined
manufacturing and quality assurance
• Benefits and examples of real time process monitoring and
control
• Achieving process robustness and highest product quality
• Cost reductions to ensure profitability
11:00 Innovation in Generic R&D for Prolonging Product Life
Cycles
Dr. Shirish Kulkarni, Senior Vice President, Formulation
Development, Sun Pharmaceutical Industries Ltd., India
11:40 Supergenerics: Achieving a Competitive Advantage in a
Crowded Market
• Regulatory requirements and development for supergenerics
• How supergenerics add value to your product portfolio
• Embracing innovation to retain margins and gain a competitive
edge
• Determining whether to develop product portfolios based on
new chemical entities or novel drug delivery systems
• Assessing the approval pathways and challenges for
supergenerics across Asia
Rajeev Raghuvanshi, Vice President, Differentiated
Formulations R&D, Dr Reddy’s Laboratories, India
16:50 International Quality Standards and Addressing
Counterfeiting Issues in Developing Countries
PANEL
DISCUSSION
• Current market scenario and how generics companies move up
the value chain from generics to branded generics to patented
drugs
• What are the incentives in investing in R&D in Asia and why
generics companies are spending more on it?
• Considerations and evaluating the cost and pricing pressure
under intensive competition
• Is R&D a model that generics companies should look at to prolong
product life cycles?
• Differences in quality standards in local and international markets
• New technology to streamline manufacturing
• What are the common setbacks and how international players
and regulators are addressing the issues?
• Are counterfeiting generics an issue in Asia deferring growth
and expanding in a global market?
• Case study on how companies fight counterfeit goods in the
market and align international standards
Panelists:
Dr. Shirish Kulkarni, Senior Vice President, Formulation
Development, Sun Pharmaceutical Industries Ltd., India
Himanshu Gadgil, Senior Vice President, R&D/Regulatory
Affairs Biotech Division, Intas Biopharmaceuticals Ltd, India
17:30 Chairman’s Summary of the Day & End of Conference
12:20 Networking Lunch
Biosimilars Development
• Current update on Biosimilars opportunities
• Competencies required for development and commercialization
of biosimilars
• Challenges and commercialization strategies
“The potential market for copies of biologic
drugs is enormous and this fact has not been
lost on drug companies in Asia”
Rahul Padhye, Senior Vice President, Reliance Life Sciences,
India
~ China Daily Asia, June 2014
13:40 Opportunities and Commercial Challenges of Biosimilars
REGISTER TODAY!
+65 6508 2401
register@ibcasia.com.sg
www.generics-asia.com
WORKSHOPS
PRE-CONFERENCE WORKSHOP A : 4 NOVEMBER 2014 • 9.00am – 5.00pm
Quality by Design (QbD) and Continuous Validation
Led by:
David Margetts, Managing Director and Co-Founder, Factorytalk Co., Ltd., Thailand
Bikash Chatterjee, President and CTO, Pharmatech Associates, US
Product quality issues have prompted regional players to look into operational
process and quality assurance to maximize cost efficiency, improve quality
and cut waste through Quality by Design (QbD).
This session will focus on the practical application of Manufacturing Execution
Systems (MES) to support Quality by Design (QbD) and continuous validation.
The session will include an overview on the principles covered and provide
real-life examples of how MES tools are integrating QbD data and functions
from early process design phases through to commercial batch production.
Key Topics Include:
A system and data perspective on QbD and continuous validation
Continuous Validation
Practical QbD implementation: from Process Design through to Commercial
Production
Process development and the definition of Certificate of Pharmaceutical
(CPP) and Corporate Quality Assurance (CQA)
Introducing MES to capture and control the design space
Real life examples: Leveraging MES to support QbD and Continuous
Validation
About the Workshop Leaders:
David Margetts is the Managing Director and Co-Founder of Factorytalk
and acts as a trusted advisor and consultant to the Pharmaceutical and
Biotech industries. He oversees a widely experienced and rapidly growing
business and team of experts who apply compliance, technology and
operational improvement solutions into practice across Asia, US and
Europe. Margetts previously worked in engineering and validation roles
for Industrial Technology Systems Ltd and AstraZeneca PLC and is an ISPE certified
trainer for Computer Validation (GAMP5).
Bikash Chatterjee has more than 30 years’ experience in the pharmaceutical,
biosciences, medical device/ diagnostic and nutraceutical/dietary
supplement industries. He has held senior management positions in
operating companies for more than a decade and has successfully brought
multiple drug and product platforms through the FDA regulated
development process to market. Throughout his career he has been
responsible for product development including Quality by Design, technology and process
transfer and technology, process validation and established global supply chain processes
in over 40 different countries around the world and been responsible for the
commercialization of over a dozen products.
POST-CONFERENCE WORKSHOP B : 7 NOVEMBER 2014 • 9.00am – 12.30pm
Innovations in Sale Force Effectiveness Models
Led by: Allan Marx Ancheta, Director Business Development and Strategy, Commercial Innovation and Alliance, Merck, Philippines
The nature of sales in the generics industry is rapidly changing. With intensive
competition, players are developing innovative Sales Force Effectiveness
(SFE) models to separate themselves from other competitors and squeezing
out competition by expanding their sales force. Hence, it is vital for generics
companies to execute sales force optimization and growth throughout the
focused strategy. This workshop provides you with insights on how to develop
an innovative SFE model, implement the right set of measurements and
monitoring framework that fits the size and operational requirements of
your organization.
About the Workshop Leader:
Key Topics Include:
Innovations in the Sales Force Effectiveness models and assessing different
sales models to fit your organization’s business strategy
Deploying and structuring size of sales teams and aligning territory
according to target customer and coverage
Developing the right set of KPIs to effectively monitor and improve sales
performance
Developing a sales training plan and setting frequency of training programs
Streamlining marketing, communication and IT processes to support sales
force performance
Recruiting and retaining sales talent by understanding motivation in an
Asian sales culture to develop effective incentives and rewards
At Merck / MSD Philippines, Allan Ancheta is the Director for Business Development, Corporate Strategy, Commercial Innovation and Alliance Management. He leads
the planning, analysis, evaluation, organization, & recommendation of commercial opportunities, strategic partnerships, innovative marketing approaches & prospective
accounts with the objective of expanding the business of the company and access to its products. Portfolio management includes new products planning, market
research and pricing. He also leads in innovation for go-to-market, customer centricity and multichannel marketing. Prior to Merck he was a consulting principal for
IMS in the ASEAN Area (Philippines, Malaysia, Singapore, Indonesia, Thailand, Vietnam and Pakistan). He has also worked in Johnson & Johnson, AstraZeneca and Unilab.
He also worked as academic in the University of the Philippines and University of Asia and the Pacific. Allan is a past president of the Marketing Executives of the
Pharmaceutical and Healthcare Industry (MEPI) in the Philippines
POST-CONFERENCE WORKSHOP C : 7 NOVEMBER 2014 • 1.30pm – 5.00pm
Developing and Sustaining Profitable Market Entries in Asia
Led by: Salman Bokhari, Founder & Managing Director, Sidrapex Pte Ltd, Singapore
With the growth focus having clearly shifted to Asia, international companies
want to increase their share of the Asian pharmaceutical market, using limited
resources but are also expected to deliver their corporate share of profits.
Given this background, the ability to use third-party resources and deliver
a balanced risk growth model will increasingly determine future market
success.
There will be a continuing upwards pressure on costs and a downwards
pressure on selling prices. Market access, pricing, reimbursement, listing in
tenders, and life-cycle management are some of the areas which will also
increasingly feature in the corporate focus of priorities as an increasing
number of countries take steps to introduce some form of universal health
care.
About the Workshop Leader:
In this workshop, the following areas will be covered:
Suggested ways to analyze and prioritize market potential without relying
only on IMS data. This may be especially the case with generics and the
institutional sector sales
Selected risk minimization approaches with creative entry strategies.
Strategies to effectively manage unforeseen change
Strategic decisions in launching a new product
Workshop Programme
Creating a Market Attractiveness Grid
Allocating resources – short case study
Launching a new brand – (pre-reading)
Increasing sales and also profitability
Some real-life examples, building and restructuring businesses
Meeting and managing expectations
SALMAN BOKHARI has more than 35 years of successful international business and management experience with an extensive background in Asian and Middle
Eastern contexts. He has an established record of delivering competitive advantage and market share gains for internationally-driven companies in startup, turnaround,
and growth environments. He has a proven expertise in formulating lean operations and executing market-winning strategies. Salman is an entrepreneurial leader
who drives above-average growth and profitability by repositioning businesses, establishing strategic alliances and licensing agreements, building high performance
teams, and reorganizing distribution channels. Currently, Salman is based in Singapore and is a partner in a boutique life sciences consulting firm. During the last three
years he has been involved in helping set up the regional and global operations of niche generic and specialty pharmaceutical companies. He also contributes regularly
with write-ups to SCRIP Asia 100 and is a speaker at regional conferences.
REGISTER TODAY!
+65 6508 2401
register@ibcasia.com.sg
www.generics-asia.com
IBC
LIFE SCIENCES
ASIA
9TH
2 0
4 – 7 November 2014
Grand Copthorne Waterfront, Singapore
1
4
“The world market for generics drugs will reach almost $200 billion in 2014, driven by increasing demand both in developed
and emerging economies as a result of populations ageing and cost-cutting pressures on healthcare systems”
~ Pharma Asia, Feb 2014
IBC’s Generics 2014 is into its 9th year with a new agenda
to unlock key concerns through interactive sessions. The
conference is a perfect opportunity to gain critical insights
on market access, strategic partnerships, marketing planning,
investment opportunities, supergenerics and biosimilars and
best practices for MNCs and regional generics companies.
GEOGRAPHY
How can effective strategic partnerships and sustainable
relationships be developed?
Assess different partnership models and gain insights from the
successful case studies from Takeda and Getz Pharma
What is needed to develop branded generics and new products?
Understand how to deliver new products with cost effective
strategies from Merck
Who You Will Meet at
The Conference:
INDUSTRY
What are the hurdles when accessing new markets and how can
product registration be accelerated?
Get the latest assessment on regulations and learn from Hovid,
Pfizer and Actavis on how they entered Asia’s markets and
captured market share
■ Government/Regulators 5%
■ Generic & Biosimilars Companies
35%
■ Innovator Pharma Companies
20%
■ Contract Research Organizations/
Contract Manufacturing
Organizations 15%
■ Active Pharmaceutical Ingredients
5%
■ Distribution and Logistics 5%
■ Marketing, Advertising and PR
Firms/ Consultants 5%
■ Manufacturing Equipment/
Service Providers/Process
Analytical Technologies and IT
Solutions Providers 5%
■ Finance/Investors/VCs 5%
What are some innovative models and new means of growth to
sustain the generics business?
Hear from Sun Pharmaceutical on how generics companies
are moving up the value chain and investing in R&D
What are the competencies required for the development and
commercialization of supergenerics and biosimilars?
Evaluate the latest developments of affordable supergenerics
and biosimilars in new emerging markets by Dr Reddy’s, Lupin,
Reliance Life Sciences and Intas Biopharmaceuticals
■ North Asia (China, Japan, Korea,
Hong Kong, Taiwan) 15%
■ South Asia (India, Pakistan) 15%
■ South East Asia (Singapore, Thailand,
Malaysia, Indonesia, Philippines,
Vietnam) 50%
■ Australia & New Zealand 5%
■ US and Europe 5%
■ Rest of the World 10%
Register
3 Delegates &
the 4th Attends
for Free!
Sponsorship Opportunities Available!
Position your company as a market leader at this event with our
customized Sponsorship & Exhibition package which offers prime
exposure to key decision-makers and exceptional branding in the
generics industry. To explore speaking, branding and marketing
opportunities, please contact: Ms. Yvonne Leong at
Tel: + 65 6508 2489 | Email: Yvonne.Leong@ibcasia.com.sg
REGISTER TODAY!
+65 6508 2401
register@ibcasia.com.sg
www.generics-asia.com