Generics Asia 2014

www.generics-asia.com

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LifeSciences

IBCLIFE SCIENCES

2 0 1 4ASIA9TH

4 – 7 November 2014Grand Copthorne Waterfront, Singapore

Asia’s Longest Running Generics Conference UnlockingInnovation for Sustainable Growth

What’s NEW for 2014?Reinventing the generics business and new areasof growth

Sales force effectiveness and innovative channelsfor generics distribution

Establishing sustainable relationships with internaland external stakeholders

Special focus on biosimilars and supergenerics

Successful Quality by Design (QbD) and CostReduction strategies

Dr. Shirish KulkarniSenior Vice President, FormulationDevelopment,Sun PharmaceuticalIndustries Ltd., India

Krishna PrasadAssociate Director Regulatory Affairs,Actavis, Singapore

Angelo FelixCountry Manager,Hovid, Philippines

Philip CoxPresident Director,PT Takeda, Indonesia

Rajeev RaghuvanshiVice President, DifferentiatedFormulations R&D,Dr Reddy’s Laboratories, India

Allan Marx AnchetaDirector Business Development and Strategy,Commercial Innovation and Alliance,Merck, Philippines

WORKSHOPS

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Quality by Design (QbD) and Continuous ValidationInnovation in Sales Force effectiveness ModelsDeveloping and Sustaining Profitable Market Entries in Asia

REGISTER TODAY! +65 6508 2401 [email protected] www.generics-asia.com

CONFERENCE DAY ONE5 November 2014 | Wednesday

8:00 Registration and Morning Coffee

9:00 Welcome from IBC Asia & Morning Ice Breaker

9:05 Chairman’s Welcome RemarksDr Siddharth Dutta, Industry Manager – Life Sciences(Pharmaceuticals & Healthcare), Frost & Sullivan, Singapore

Regulatory Climate and Asia’s MarketOpportunities9:10 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 IntenseCompetition and Cutting Edge Strategies in thePhilippines• 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?Angelo Felix, Country Manager, Hovid, Philippines

10.30 Morning Networking & Refreshment Break

11:00 Developing a Profitable Generics Portfolio underUniversal 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 trendsSreeraj 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 off-

patent products?• Strategies to prolong product life and differentiating generics

products from competitorsDr Siddharth Dutta, Industry Manager – Life Sciences(Pharmaceuticals & Healthcare), Frost & Sullivan, Singapore

12.20 Networking Lunch

Strategic Marketing Planning andBranding

13:40 Building Brand Awareness and Managing New GenericProduct 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 adoptionand awareness

• Case study of a successful branded generics strategyAllan Marx Ancheta, Director Business Development andStrategy, Commercial Innovation and Alliance, Merck,Philippines

14:20 Assessing Asia’s Growing Market and Challenges in

Marketing Generics in Domestic and International

Markets• 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 productionbetween importer and exporter and lesson learnt

• Tailoring your marketing strategies according to customer andpayer characteristics and segmentation to gain maximumexposure

• Tracking of recent M&A and partnerships, how the companiesmodify and improve existing marketing strategies to enticemarket demand

• Should generics companies focus on branding or penetratemarkets with the lowest possible price?

Panelists:Mohd Fazli Shuib, Manager, Clinical Research,Pharmacoeconomics and Clinical Assignments, Prince Court

Medical Centre, MalaysiaAllan Marx Ancheta, Director Business Development andStrategy, Commercial Innovation and Alliance, Merck,PhilippinesLynn Robles, Executive Director, Philippines Chamber of

Pharmaceutical Industry, PhilippinesKrishna Prasad, Associate Director Regulatory Affairs, Actavis,SingaporeAngelo Felix, Country Manager, Hovid, PhilippinesPhilip Cox, President Director, PT Takeda Indonesia,Indonesia

15:20 Afternoon Networking & Refreshment Break

Generics Distribution andBuyer Behaviour

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 adoptionand awareness

• Educating physicians, payers and patients on productdifferentiation and effectiveness through mobile communicationdevices

• Common setbacks and how industry players tackle the issuesMarvin Biliwang, Commercial Effectiveness Director,Takeda Pharmaceuticals Philippines, Inc., Philippines

16:30 How Can Pharmaceutical Companies Support Buyer

Decision Making?• 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 perspectivesMohd 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

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CONFERENCE DAY TWO6 November 2014 | Thursday

8.30 Morning Networking & Coffee

9.00 Chairman’s Opening RemarksHimanshu Gadgil, Senior Vice President, R&D/RegulatoryAffairs Biotech Divison, Intas Biopharmaceuticals Ltd, India

Strategic Partnerships & Collaboration

9:10 Establishing Partnerships to Add Value and BuildMarket 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 partnershipsPhilip Cox, President Director, PT Takeda Indonesia,Indonesia

9:50 Optimizing Strategic Relationships and Scientific DrivenStrategies in Branded Generics• Establish and build strategic partnerships (government

hospitals/institutions, trade/retail segments, medical societies,organized doctor groups) through brand “advocacies” and diseaseawareness and brand awareness

• Practical scientific strategies to drive (brand/corporate)differentiation through innovative continuing medical education(CME), meaningful clinical trials and Medical Representativeengagement

Raymond Bernardo, Marketing Manager, Getz Pharma(Pvt) Ltd., Philippines

10:30 Morning Networking & Refreshment Break

New Means of Growth

11:00 Innovation in Generic R&D for Prolonging Product LifeCycles• Current market scenario and how generics companies move up

the value chain from generics to branded generics to patenteddrugs

• What are the incentives in investing in R&D in Asia and whygenerics companies are spending more on it?

• Considerations and evaluating the cost and pricing pressureunder intensive competition

• Is R&D a model that generics companies should look at to prolongproduct life cycles?

Dr. Shirish Kulkarni, Senior Vice President, FormulationDevelopment, Sun Pharmaceutical Industries Ltd., India

11:40 Supergenerics: Achieving a Competitive Advantage in aCrowded 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 AsiaRajeev Raghuvanshi, Vice President, DifferentiatedFormulations R&D, Dr Reddy’s Laboratories, India

12:20 Networking Lunch

Biosimilars Development

13:40 Opportunities and Commercial Challenges of Biosimilars• Current update on Biosimilars opportunities• Competencies required for development and commercialization

of biosimilars• Challenges and commercialization strategiesRahul Padhye, Senior Vice President, Reliance Life Sciences,India

14:20 Biosimilar Development: Emerging Trends & RegulatoryExpectation• 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 biosimilarproducts?

Rahul R Nair, Research Scientist, Lupin Limited (BiotechDivision), India

15:00 Afternoon Networking and Refreshment Break

15:30 Overcoming Regulatory Barriers for DevelopingAffordable 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 studiesHimanshu Gadgil, Senior Vice President, R&D/RegulatoryAffairs Biotech Division, Intas Biopharmaceuticals Ltd, India

Streamlined Manufacturing, CostReduction & Quality

16:10 Implementing Quality by Design (QbD) and StreamliningManufacturing• 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

16:50 International Quality Standards and AddressingCounterfeiting Issues in Developing Countries• 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, FormulationDevelopment, Sun Pharmaceutical Industries Ltd., IndiaHimanshu Gadgil, Senior Vice President, R&D/RegulatoryAffairs Biotech Division, Intas Biopharmaceuticals Ltd, India

17:30 Chairman’s Summary of the Day & End of Conference

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“The potential market for copies of biologicdrugs is enormous and this fact has not beenlost on drug companies in Asia”~ China Daily Asia, June 2014


WORKSHOPSPRE-CONFERENCE WORKSHOP : 4 NOVEMBER 2014 • 9.00am – 5.00pm

Quality by Design (QbD) and Continuous ValidationLed 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 operationalprocess and quality assurance to maximize cost efficiency, improve qualityand cut waste through Quality by Design (QbD).

This session will focus on the practical application of Manufacturing ExecutionSystems (MES) to support Quality by Design (QbD) and continuous validation.The session will include an overview on the principles covered and providereal-life examples of how MES tools are integrating QbD data and functionsfrom early process design phases through to commercial batch production.

Key Topics Include:A system and data perspective on QbD and continuous validationContinuous ValidationPractical QbD implementation: from Process Design through to CommercialProductionProcess development and the definition of Certificate of Pharmaceutical(CPP) and Corporate Quality Assurance (CQA)Introducing MES to capture and control the design spaceReal life examples: Leveraging MES to support QbD and ContinuousValidation

About the Workshop Leaders:David Margetts is the Managing Director and Co-Founder of Factorytalkand acts as a trusted advisor and consultant to the Pharmaceutical andBiotech industries. He oversees a widely experienced and rapidly growingbusiness and team of experts who apply compliance, technology andoperational improvement solutions into practice across Asia, US andEurope. Margetts previously worked in engineering and validation roles

for Industrial Technology Systems Ltd and AstraZeneca PLC and is an ISPE certifiedtrainer for Computer Validation (GAMP5).

Bikash Chatterjee has more than 30 years’ experience in the pharmaceutical,biosciences, medical device/ diagnostic and nutraceutical/dietarysupplement industries. He has held senior management positions inoperating companies for more than a decade and has successfully broughtmultiple drug and product platforms through the FDA regulateddevelopment process to market. Throughout his career he has been

responsible for product development including Quality by Design, technology and processtransfer and technology, process validation and established global supply chain processesin over 40 different countries around the world and been responsible for thecommercialization of over a dozen products.

POST-CONFERENCE WORKSHOP : 7 NOVEMBER 2014 • 9.00am – 12.30pm

Innovations in Sale Force Effectiveness ModelsLed by: Allan Marx Ancheta, Director Business Development and Strategy, Commercial Innovation and Alliance, Merck, Philippines

Key Topics Include:Innovations in the Sales Force Effectiveness models and assessing differentsales models to fit your organization’s business strategyDeploying and structuring size of sales teams and aligning territoryaccording to target customer and coverageDeveloping the right set of KPIs to effectively monitor and improve salesperformanceDeveloping a sales training plan and setting frequency of training programsStreamlining marketing, communication and IT processes to support salesforce performanceRecruiting and retaining sales talent by understanding motivation in anAsian sales culture to develop effective incentives and rewards

The nature of sales in the generics industry is rapidly changing. With intensivecompetition, players are developing innovative Sales Force Effectiveness(SFE) models to separate themselves from other competitors and squeezingout competition by expanding their sales force. Hence, it is vital for genericscompanies to execute sales force optimization and growth throughout thefocused strategy. This workshop provides you with insights on how to developan innovative SFE model, implement the right set of measurements andmonitoring framework that fits the size and operational requirements ofyour organization.

About the Workshop Leader:At Merck / MSD Philippines, Allan Ancheta is the Director for Business Development, Corporate Strategy, Commercial Innovation and Alliance Management. He leadsthe planning, analysis, evaluation, organization, & recommendation of commercial opportunities, strategic partnerships, innovative marketing approaches & prospectiveaccounts with the objective of expanding the business of the company and access to its products. Portfolio management includes new products planning, marketresearch and pricing. He also leads in innovation for go-to-market, customer centricity and multichannel marketing. Prior to Merck he was a consulting principal forIMS 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 thePharmaceutical and Healthcare Industry (MEPI) in the Philippines

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POST-CONFERENCE WORKSHOP : 7 NOVEMBER 2014 • 1.30pm – 5.00pm

Developing and Sustaining Profitable Market Entries in Asia

In this workshop, the following areas will be covered:Suggested ways to analyze and prioritize market potential without relyingonly on IMS data. This may be especially the case with generics and theinstitutional sector salesSelected risk minimization approaches with creative entry strategies.Strategies to effectively manage unforeseen changeStrategic decisions in launching a new product

Workshop ProgrammeCreating a Market Attractiveness GridAllocating resources – short case studyLaunching a new brand – (pre-reading)Increasing sales and also profitabilitySome real-life examples, building and restructuring businessesMeeting and managing expectations

With the growth focus having clearly shifted to Asia, international companieswant to increase their share of the Asian pharmaceutical market, using limitedresources but are also expected to deliver their corporate share of profits.Given this background, the ability to use third-party resources and delivera balanced risk growth model will increasingly determine future marketsuccess.

There will be a continuing upwards pressure on costs and a downwardspressure on selling prices. Market access, pricing, reimbursement, listing intenders, and life-cycle management are some of the areas which will alsoincreasingly feature in the corporate focus of priorities as an increasingnumber of countries take steps to introduce some form of universal healthcare.

About the Workshop Leader:SALMAN BOKHARI has more than 35 years of successful international business and management experience with an extensive background in Asian and MiddleEastern 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 leaderwho drives above-average growth and profitability by repositioning businesses, establishing strategic alliances and licensing agreements, building high performanceteams, and reorganizing distribution channels. Currently, Salman is based in Singapore and is a partner in a boutique life sciences consulting firm. During the last threeyears he has been involved in helping set up the regional and global operations of niche generic and specialty pharmaceutical companies. He also contributes regularlywith write-ups to SCRIP Asia 100 and is a speaker at regional conferences.

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Led by: Salman Bokhari, Founder & Managing Director, Sidrapex Pte Ltd, Singapore


IBCLIFE SCIENCES

2 0 1 4ASIA9TH

4 – 7 November 2014Grand Copthorne Waterfront, Singapore

■ 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%

“The world market for generics drugs will reach almost $200 billion in 2014, driven by increasing demand both in developedand 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 agendato unlock key concerns through interactive sessions. Theconference is a perfect opportunity to gain critical insightson market access, strategic partnerships, marketing planning,investment opportunities, supergenerics and biosimilars andbest practices for MNCs and regional generics companies.

What are the hurdles when accessing new markets and how canproduct registration be accelerated?

Get the latest assessment on regulations and learn from Hovid,Pfizer and Actavis on how they entered Asia’s markets andcaptured market share

How can effective strategic partnerships and sustainablerelationships be developed?

Assess different partnership models and gain insights from thesuccessful 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 effectivestrategies from Merck

What are some innovative models and new means of growth tosustain the generics business?

Hear from Sun Pharmaceutical on how generics companiesare moving up the value chain and investing in R&D

What are the competencies required for the development andcommercialization of supergenerics and biosimilars?

Evaluate the latest developments of affordable supergenericsand biosimilars in new emerging markets by Dr Reddy’s, Lupin,Reliance Life Sciences and Intas Biopharmaceuticals

Sponsorship Opportunities Available!Position your company as a market leader at this event with ourcustomized Sponsorship & Exhibition package which offers primeexposure to key decision-makers and exceptional branding in thegenerics industry. To explore speaking, branding and marketingopportunities, please contact: Ms. Yvonne Leong atTel: + 65 6508 2489 | Email: [email protected]

Who You Will Meet atThe Conference:

■ Government/Regulators 5%

■ Generic & Biosimilars Companies35%

■ Innovator Pharma Companies20%

■ Contract Research Organizations/Contract ManufacturingOrganizations 15%

■ Active Pharmaceutical Ingredients5%

■ Distribution and Logistics 5%

■ Marketing, Advertising and PRFirms/ Consultants 5%

■ Manufacturing Equipment/Service Providers/ProcessAnalytical Technologies and ITSolutions Providers 5%

■ Finance/Investors/VCs 5%

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Generics Asia 2014

Health & Medicine

Transcript of Generics Asia 2014