Showcasing India’s biopharma future

3-4 November 2015The Westin Mumbai Garden City

Mumbai, India

www.terrapinn.com/biopharmaindia

Managing Director, Indian Immunologicals

GREAT EXPOSURE TO THE DEVELOPMENTS IN BIOPHARMA INDUSTRY - BOTH TECHNICAL AND COMMERCIAL ASPECTS.”

“

India’s biotech industry is forecast to reach US $11.6 billion in turnover by 2017. Such growth is unsurprising, given its low manufacturing costs, large patient population, impressive pharma expertise and improving regulatory environment.

But despite this huge potential, there are challenges for you to overcome, if you want to build a biopharma business in India. You need to be able to navigate India’s sometimes complex regulatory framework, protect your IP and ensure the integrity of in-country biomanufacturing processes, to name just a few.

That’s where we can help. Together with leading biotech entrepreneurs, biopharma organizations and associations, and big pharma players from both within and outside India, BioPharma India Convention 2015 will offer you a 360o overview of how India is innovating to lead the race to Asia’s biopharma future. Across two jam packed days, we will cover:

India is one of Asia’s hottest biopharma destinations

Endorsed by an advisory panel of outstanding biopharma leaders, this is an event created by the industry, for the industry.

This is not just a trade show. This is not just a conference. This is where you plot the course of your lucrative future in India’s biopharma industry.

If you are part of India’s biopharma ecosystem, or want to be, then you need to join us at the BioPharma India Convention 2015.

How India is supporting biotech entrepreneurs

How to find in-country partners and which partnership model is right for you

Therapeutic innovation in India, including biosimilars, NBEs and gene therapy

New developments in India’s biotherapeutic manufacturing processes

How to navigate India’s regulatory regime effectively

Director, Advent Worldwide

EXCELLENT OPPORTUNITY TO MEET TOP DECISION MAKERS, WHO ARE NORMALLY IN-ACCESSIBLE.”

“

Keynote Speakers Keynote Speakers

Dr Cyrus KarkariaWith stints at Celldex Therapeutics and CuraGen before joining Lupin Pharmaceuticals, Dr. Karkaria’s biotech pedigree is impressive. Having been part of teams that have developed multi-billion dollar blockbuster drugs in neurology, immunology and oncology and developed commercial processes all the way from the bench to manufacturing scale, he is well-placed to comment on how India is driving biopharma innovation and what more we need to do to drive growth.

Raj MehtaPresident of Cadila Biotech, Mr. Mehta brings 25 years’ experience in vaccines, biotech and pharmaceutical industry to this opening session. Building on his prior experience with global MNCs including Novartis and GSK, he has developed an innovative vision for sales, marketing and new business across US, South East Asia and India, giving a truly international perspective to our biopharma innovation panel.

Dr Renu SwarupWinner of the “BioSpectrum Person of the Year Award” in 2012, Dr. Swarup heads the National Bioresource Development Board at the Department of Biotechnology (DBT), where she is involved in developing, funding and monitoring programmes in Energy Biosciences, Bioresource Development & Utilisation and more. She is also Managing Director of the Biotechnology Industry Research Assistance Council (BIRAC), a government-incorporated company that nurtures and promotes innovation research in the biotech space, with special focus on Start‐ups and SMEs. Don’t miss her insights on encouraging biotech entrepreneurship during the closing session on day one.

Dr Sanjeev KumarIn his decade-long tenure as the Senior Vice President of Biotechnology and Head of Biologics at Zydus Cadila for more than ten years. Dr Kumar and his team started an end-to-end biosimilars program from clone development to product manufacturing. Prior to this, he garnered additional experience working with Expression Genetics and Valentis, and also with renowned professors from India’s National Institute of Immonologicals and Harvard. Learn from this experience as he offers insights into launching the world’s first Humira biosimilar in India.

K V BalasubramaniamA 25-year pharmaceutical industry veteran, Mr Balasubramaniam is a major player in India’s vaccine industry. During his tenure at Indian Immunologicals, he has been instrumental in reviving the fledgling unit of the National Dairy Development Board and making it a professionally managed, performance driven and result oriented vaccine player. His expertise developing commercial processes and scaling up production, combined with Indian Immunologicals’ mission of making biotechnology in healthcare affordable and accessible make him a great addition to our opening biopharma innovation panel.

Leena MenghaneyAs the South-Asia Head for MSF’s new Access Campaign, Ms. Menghaney specialises in public health, innovation and intellectual property. A keen advocate for affordable generic drugs, she worked extensively on the people’s campaign for the inclusion of public health safeguards in the Patent (Amendment) Bill 2005, as its provisions seriously affected their production. Ms. Menghaney will be sharing her experiences in striving for affordable healthcare initiatives in India, and directing the discussion at the start of day two.

2015 Speakers include:

ADVISOR

Dr. Ajith V. Kamath Head, External R&D Innovation, IndiaWorldwide Research & DevelopmentPfizer Inc., India

ADVISOR

Swapnil Ballal Senior Director, Quality Assurance, Biocon, India

Gouri Shankar Drug Inspector, CDSCO, India

Milind Ponde Global Head, Submission Publishing and Site Head Drug Regulatory Affairs, Novartis Healthcare, India

ADVISOR

Dr. Manjunath Ramarao Director and Head, Disease Sciences and Technology, Bristol-Myers Squibb, IndiaGovernment of India

Renu Swarup Senior Advisor, Department of Biotechnology, Ministry of Science and Technology, Government of India

Nipom Deka Regional Pharmacovigilance Manager - Asia, Africa & Middle East Global Pharmacovigilance (EPD), Abbott, India

Gaurav Gupta Head, Virology and biotechnology, Vaccine Technology Center, Zydus Cadila, India

ADVISOR

Dr. Mahalaxmi Andheria Vice President Intellectual Property Rights, Panacea Biotec, India

ADVISOR

Dr Craig Smith Vice President Development and R&D, Bioproduction Division, Thermo Fisher Scientific, USA

Shubhadeep Sinha Associate VP and Head, Clinical Affairs, Medical Affairs and Pharmacovigilance, Global Operations, Hetero Group, India

Sridhar Kottakota Principal Scientist, Lupin, India

B.N. Manohar Managing Director, Stempeutics Research Pvt Ltd, India

ADVISOR

Dr. Sandhya Kumaraswamy Associate Director, Quality Assurance, Dr Reddy’s Laboratories, India

Cyrus Krakaria President, Biotechnology Division, Lupin Limited

Narasimha Rao Nedunuri Managing Director & CEO, Clonz Biotech Pvt. Ltd., India

ADVISOR

Sanjay Desai Director, Supply Chain Asia, Thermo Fisher Scientific, Singapore

Ashwani Pandita Deputy General Manager and Head, Clinical Quality Management & Training ,Global Clinical Research Operations, Glenmark Research Centre, India

Shraddha Tawade General Manager, Quality and Training, Global Clinical Research, Wockhardt Ltd, India

Jyoti Iyer Principal Scientific Manager, Process Development, Monoclonal Antibodies, Biocon, India

Chandrakant Kathote Plant Head, Biotechnology Division, Lupin, India

Kaushik Deb Managing Director & CEO, Merisis Therapeutics, DiponEd Biointelligence, India

Anurag Rathore Professor, Department of Chemical Engineering, Indian Institute of Technology Delhi, India

Dilip Bandyopadhyay Head, Novel Biological Entity, Zydus Cadila

Nandan Pendsey Partner and Head of IP, AZB & Partners, India

Prasad Koka Chief Scientific Officer and Scientific Director, Merisis Therapeutics, DiponEd Biointelligence, India

Dulal PandaProfessor, Chair, BioSciences and BioEngineering, Indian Institute of Technology Bombay, India

Sunita K. SreedharanFounder and CEO, SKS Law Associates, India

Atul Kumar Senior Principal Scientist, Academy of Scientific and Innovative Research, Central Drug Research Institute (CDRI), India

Anup KarnikBusiness Solution Lead, COE, Life sciences and Healthcare, Capgemini, India

Sunny Kataria Senior Research Fellow, Institute for Stem Cells and Regenerative Medicine, India

Amulya Panda Staff Scientist VII (Scientist G), National Institute of Immunology, India

Murali NeelakantanFounder and Principal, Amicus, India

Arnaud LefevreManaging Director, UCB India, India

Takashi Shimada Manager, R&D, Life Science Research Center, SHIMADZU Corporation, Japan

Varun GuptaManager, Market Access, Novartis, India

Devi KalyanAssociate Director, Dr Reddy’s Laboratories, India

Gazala Khan-Koticha, Associate Director, Manufacturing technical services, Dr Reddy’s Laboratories, India

Raman GovindarajanHead, External Science and Partnering, Sanofi-Aventis, India

Monalisa Chatterji, Associate Director, Biocon, India

Clive FernandesPrincipal Consultant, Joint Commission International and Group Clinical Director, Wockhardt Group Hospital, India

Sheikh Raisuddin Professor, Head, Centre for Translational and Clinical Research, Jamia Hamdard, India

Organiser’s opening remarks

Chair’s opening remarks

Opening keynote session

Speed Networking

Networking refreshment break

Keynote Opening Panel: – How is India driving biopharma innovation?

• Is India innovative or falling behind innovation?

• Realising the potential of India as a global innovative biopharmaceutical hub

• Encouraging infrastructure investment and building capacity in administration to encourage India to innovate

• Exploring current Modi’s policies and initiatives in encouraging FDI in India’s biopharma market

• Building a biotechnology hub in India by utilising the strength of India’s market in availability of affordable, English speaking talent

• Establishing supportive policies to encourage innovation in India

Panellists include:Cyrus Karkaria, President, Biotechnology Division, LupinRaj Mehta, President, Cadila Pharma BiotechnologyK V Balasubramaniam, Managing Director, Indian Immunologicals Ltd

09:00

09:05

10:00

10:15

10:50

11:10

10:45

09:15

Therapeutic & research innovations Partnering & regulatory modelsBiotherapeutic manufacturing

Biosimilars & biobetters development

New Biological Entities (NBE) & New Chemical Entities (NCE)

Launching the first Humira biosimilar: A case studySanjeev Kumar, Senior Vice President, Biotechnology, Head, Biologics, Zydus Cadila, India

Pharmacovigilance and drug safety in biosimilars and biobetters development

• Pharmacovigilance and studies in ensuring biosimilars product safety

• Understanding and overcoming the commonly encountered safety related risks with the development of biosimilars and biobetters

• Overcoming drug safety risk with proper Developmental risk management plan

Nipom Deka, Regional Pharmacovigilance Manager - Asia, Africa & Middle EastGlobal Pharmacovigilance (EPD), Abbott, India

Chair’s openingDr Craig Smith, Vice President Development and R&D, BioProduction Division, Thermo Fisher Scientific, USA

Improvising bulk biologic manufacturing with OPEX initiativesChandrakant Kathote, Plant Head, Biotechnology Division, Lupin, India

Designing a flexible antibody manufacturing processJyoti Iyer, Principal Scientific Manager, Process Development, Monoclonal Antibodies, Biocon, India

Chair’s openingAnurag Rathore, Professor, Department of Chemical Engineering, Indian Institute of Technology Delhi, India

Regulatory requirements for marketing of Biosimilars and Biobetters in India

• Applicable regulations, guidelines and competent authority in marketing of biosimilars

• Preclinical studies, clinical trial application and post-market data requirement for biosimilars and biobetters approval

• Understanding data required for market authorization application.

Gouri Shankar, Drug Inspector, CDSCO, India

Protecting human rights and clinical ethics in trialsSanjeev Hegde, Head, Clinical Development, Reliance Life Sciences, India

11:30

11:50

12:10

12:30

12:50

Developing CLONZAb, a biosimilar MAb to treat Non Hodgkins Lymphoma

• Early challenges in the development of CLOZAb.

• Establishing the analytical methods to test for biosimilarity

• Process innovation in creating an affordable therapy for Non Hodgkins Lymphoma

Narasimha Rao Nedunuri, Managing Director & CEO, Clonz Biotech Pvt. Ltd., India

Coping with osteoporosis with CDRI 99/373 (Centhank)

• Strategies in discovering new chemical entities

• Designing target-specific drugs in treating osteoporosis

• Performing ADME and toxicity studies for CDRI 99/373

Atul Kumar, Senior Principal Scientist, Academy of Scientific and Innovative Research, Central Drug Research Institute (CDRI), India

Design, synthesize and evaluate potent microtubule-targeted anticancer agents

• Recognising microtubules as successful anticancer drug targets

• Strategies in delivering of microtubule targeted drugs

• Highlighting the progress and challenges for developing microtubule targeted anticancer drugs

Dulal Panda, Professor, Chair, BioSciences and BioEngineering, Indian Institute of Technology Bombay, India

High throughput, sensitivity, and resolution in glycan analysis for characterisation & comparability studiesDr Craig Smith, Vice President Development and R&D, BioProduction Division, Thermo Fisher Scientific, USA

Protein recovery from inclusion bodies using mild solubilisation processes

• Nature of protein affect its solubility and aggregation process

• Develop novel solubilization method by understanding the dominant force that cause aggregation of protein into inclusion bodies

• Protecting the native-like protein structure during solubilisation as the key for high throughput recovery of bio active protein from inclusion bodies

Amulya Panda, Staff Scientist VII (Scientist G), National Institute of Immunology, India

Enabling continuous processing of biotech therapeutics: Case studies

• Elucidating the concept of continuous processing with case studies

• Creating novel experimental setup for continuous refolding of granulocyte colony stimulating factor (GCSF)

• Using of a novel, two-stage chromatographic purification process consisting of ion-exchange and hydrophobic interaction modes for effective and efficient control of aggregates for a mAb therapeutic

Anurag Rathore, Professor, Department of Chemical Engineering, Indian Institute of Technology Delhi, India

Best aseptic transfer techniques for preventing contamination

• Drafting SOPs in sterile manufacturing

• Crafting the best training for aseptic fill and finish process

• Critical steps and procedures in preventing contamination

Exploring the potential of disposable and automated downstream processingReserved for sponsor

Strategies for achieving favourable clinical trial inspection outcomes in India

• Overview of clinical trials market and FDA inspections within APAC region

• Comparing inspection outcomes of India with other members of APAC

• Strategies in achieving favourable inspection outcomes for successful clinical development

Ashwani Pandita, Deputy General Manager and Head, Clinical Quality Management & Training , Global Clinical Research Operations, Glenmark Research Centre, India

Biosimilar clinical development- Regulatory and clinical strategies in emerging markets

• Regulatory considerations in conducting biosimilar trials in India

• Strategies in overcoming challenges to obtain approval for biosimilar trials in India

• Biosimilar regulatory strategies in global developing markets, such as India, LATAM, ASEAN and middle east

Shubhadeep Sinha, Associate VP and Head, Clinical Affairs, Medical Affairs and Pharmacovigilance, Global Operations, Hetero Group, India

IND submission and filling for orphan drug biosimilars in India

• Regulatory requirements for research & production of orphan drugs in India\

• Procedures for IND submission and filing in India’s current regulatory framework

• Exploring the potential of orphan drug biosimilars for treating rare diseases in India

Protecting regulatory data and confidential submissions

• Comparison between India, Europe and USA: What can India learn from the west?

• Navigating through regulatory framework in India

• Strategies in ensuring confidentiality of documents submitted

Milind Ponde, Global Head, Submission Publishing and Site Head Drug Regulatory Affairs, Novartis Healthcare, India

Chair’s openingMahalaxmi Andheria, Vice President Intellectual Property Rights, Panacea Biotec

Obtaining central regulatory approval for vaccine products Reserved for sponsor

Case study: Single use technology in downstream processingReserved for sponsor

Efficient data management in NBE discoveryReserved for sponsor

IND & clinical approvalProcess development

Manufacturing technology showcase

DAY ONE Tuesday, 3rd November, 2015 1 of 4 DAY ONE Tuesday, 3rd November, 2015 2 of 4

Networking Luncheon

Roundtable Discussions

13:10 Afternoon Refreshments16:10

14:10

14:30

14:50

Cell & gene therapy

Overcoming challenges in treating peripheral arterial disease (PAD) with stem cellsB.N. Manohar, Managing Director, Stempeutics Research Pvt Ltd, India

Intervening in chronic disease development: A novel pathway for myofibroblast recruitment in fibrotic tissue

• Mediating epithelial to mesenchymal interaction in a mouse model of fibrosis

• Stimulating dermal fibroblasts migration and myofibroblast differentiation

• Facilitating fibroblast migration through Src family of kinases

Sunny Kataria, Senior Research Fellow, Institute for Stem Cells and Regenerative Medicine, India

Immunotherapies and immunomodulation using stem cells

• Alleviation of haematological disorders with stem cells

• Gene expression and profiling with immunohistology and flow cytometry

• Using humanised immunodeficient mouse models for investigating applications of stem cells in treating cancer

Prasad Koka, Chief Scientific Officer and Scientific Director, Merisis Therapeutics, DiponEd Biointelligence, India

Upstream process characterisation and validation with QbD Subhra Ranjan Chakrabarti, Associate Vice President, Shantha Biotechnics- a Sanofi Company, India

Managing the quality of high expression E.coli & CHO cell lines in vaccine production

• Mastering the art of managing cell lines of mammalian and bacteria cell cultures in biologic production

• Comparing methodologies for growing cell cultures with fed batch, continuous or batch processes

• Maximising yield with E.coli and CHO Cell lines

Case study: Overcoming challenges in expressing recombinant protein with Pichia pastoris systems

• Overcoming the inherent properties of recombinant proteins which challenges for its expression from typical bacterial cell lines

• Adopting yeast expressing system to mass produce recombinant complex mammalian protein

• Exploring alternative cell lines to express recombinant protein

Overcoming the impact of IP on access to vaccine technologies in India

• Overcoming challenges of IP for India’s companies in accessing vaccine technologies

• Case study: Gaining access to vaccine technology via licensing

• Strategies in preventing infringement of IPR

Mahalaxmi Andheria, Vice President Intellectual Property Rights, Panacea Biotec, India

IP protection in cross nation out-licensing

• Anticipating legal challenges in out-licensing technologies

• Strategies in overcoming IP and contractual challenges

• Case study on cross nation out- licensing stories

Sunita K. Sreedharan, Founder and CEO, SKS Law Associates, India

IP beyond patent: What’s next for India?

• Gaining competitive advantage with brand names, trademarks, copy right, trade secret and data exclusivity

• Future of competition law analysis in India healthcare market

• Crafting the next business model: Venturing into a brand new market resulting from compulsory and other licensing method in India

Murali Neelakantan, Founder and Principal, Amicus, India

Licensing & IP ProtectionManaging fermentation and upstream

processes

DAY ONE Tuesday, 3rd November, 2015 3 of 4 DAY ONE Tuesday, 3rd November, 2015 4 of 4

15:10

15:30

Branding your technology for out-licensing Reserved for sponsor

Best cell banking methods for high expression upstream bioproductionReserved for sponsor

Exploring gene delivery strategies as vaccination toolsReserved for sponsor

Therapeutic table A:

Biosimilar and biobetter developmentSenior Representative, Thermo Fisher Scientific

Regulatory table A:

Searching for the right tech transfer partnerAnup Karnik, Business Solution Lead, COE, Life sciences and Healthcare, Capgemini, India

Manufacturing table A:

Process optimisation in biomanufacturingAnurag Rathore, Professor, Department of Chemical Engineering, Indian Institute of Technology Delhi, India

Therapeutic table B:

Commercialising NBEs

Regulatory table B:

Necessary regulation amendments of required to enforcing IPR protectionNandan Pendsey, Partner and Head of IP, AZB & Partners, India

Manufacturing table B:

Raw material testing for quality production

Closing keynote session: Starting a biotech in India

Keynote - Competing in India’s biotech market: Evolution, needs and challenges

• Protecting invention with proper IPR enforcement

• Realising the full potential of India’s biotech market by overcoming regulatory hurdles

• In-licensing useful technologies to heads up R&D effort

Closing panel – Encouraging biotech entrepreneurship in India

• Growing India’s biotech business via strategic partnerships in Asia Pacific

• Funds, regulatory approvals and infrastructure equipment requirements for building an accessible, affordable and high-quality healthcare system in India

• Empowering emerging biotech enterprise to encourage R&D efforts in coping with increasing needs of therapeutic products.Moderator:Renu Swarup, Senior Advisor, Department of Biotechnology, Ministry of Science and Technology, Government of India

Panellists:Narasimha Rao Nedunuri, Managing Director & CEO, Clonz Biotech Pvt. Ltd., IndiaB.N. Manohar, Managing Director, Stempeutics Research Pvt Ltd, IndiaKaushik Deb, Managing Director & CEO, Merisis Therapeutics, DiponEd Biointelligence, India

16:40

17:00

Chair’s closing remarks

End of Conference Day 1

17:40

17:50

Do you provide solutions to India’s biopharma market?

We have limited speaking opportunities available for first-class solution providers.

Contact Soo Min Lee for more information on soomin.lee@terrapinn.com

nSMOL: Limited proteolysis on the Fab & accelerating mAb bioanalysis using LC/MS/MS

• Limitation of ELISA and conventional proteolysis for mAb quantitation using LC/MS/MS

• Novel and simple protocol for Fab-selective proteolysis

• Bioanalytical application for several different mAbs like Trastuzumab, Bevacizumab etc.

Takashi Shimada, Manager, R&D, Life Science Research Center, SHIMADZU Corporation, Japan

DAY TWO Wednesday, 4th November, 2015 1 of 3 DAY TWO Wednesday, 4th November, 2015 2 of 3

Organiser’s opening remarks

Chair’s opening remarks

Keynote session

Quality and affordability: Jan Aushadhi initiatives

• Why is Jan Aushandhi needed for India’s healthcare system?• Strategies for ensuring quality generics drug provided to the public • Influencing pricing of generics drug and their regulation in India Shri Kuldeep Chopra, Director of Operations, Jan Aushadhi, Bureau of Pharma PSUs of India (BPPI), Government of India

Keynote Panel: Developing affordable and quality healthcare access in India

• Promoting product quality, efficacy and safety

• Balancing market demand, patent protection, affordability with profit margins

• How can branded generics manufacturers differentiate themselves in India’s highly competitive market?

• Strategies in decreasing manufacturing cost in healthcare access

Moderator:Leena Menghaney, Regional Head, South Asia, Médecins Sans Frontières (MSF)Access Campaign, Doctors without Borders, India

Confirmed Panellists:Arnaud Lefevre, Managing Director, UCB India, IndiaClive Fernandes, Principal Consultant, Joint Commission International and Group Clinical Director, Wockhardt Group Hospital, India

09:00

09:05

09:10

09:30

Morning Refreshments

Networking Luncheon

10:10

13:10

10:40

10:50

11:10

Therapeutic & research innovations Partnering & regulatory modelsBiotherapeutic manufacturing

Chair’s openingDr. Manjunath Ramarao, Director and Head, Disease Sciences and Technology, Bristol-Myers Squibb

Therapeutic vaccines for oncology studyGaurav Gupta, Head, Virology and biotechnology, Vaccine Technology Center, Zydus Cadila, India

The role of bioinformatics in speeding drug development

• Speeding the search for leads in vaccine development

• Accurately predicting the structure-activity relationship between lead and targeted receptor to create high potency drug

• Predicting the pharmacodynamics and pharmacokinetic properties with bioinformatics before pre-clinical trials

Chair’s openingSenior Representative, Thermo Fisher Scientific

Overcoming challenges in upscaling the production of Exemptia, the first Humira biosimilarVibhor Saraswat, Vice President and Head of Manufacturing, Zydus Biologics, India

Upscaling and technology transfer in antibody manufacturing

• Exploring current trends in upscaling and technology transfer in India

• Overcoming challenges and mitigation of upscaling and technology transfer

• Case study: Strategies in upscaling of antibody manufacturing

Gazala Khan-Koticha, Associate Director, Manufacturing technical services, Dr Reddy’s Laboratories, India

Chair’s opening

Overcoming price control challenges on MNCs

• Understanding pricing challenges in India

• Exploring commonly used tactics by MNC to cope with pricing challenges

• Winning the game by overcoming limitations of the most optimal strategies

Rahul Chauhan, Associate Director, Regulatory Affairs and Pharmacovigilance, Eli Lilly, India

Improving healthcare access without increasing costs

• Periodic portfolio optimization during drug development to minimize cost burden

• Early Integration & alignment of commercial strategies to maximize reach

• Proactive partnering with stakeholders to enhance access and affordability

Varun Gupta, Manager, Market Access, Novartis, India

Vaccines

Antibody

Drug delivery & translational research

Pricing

Generics

Outsourcing relationship management

Upscaling production and flexible manufacturing

Bioassay validation

GMP Compliance and Quality assurance

11:50

11:30

12:30

12:10

14:10

12:50

Resolving ethical issues with pricing policies Reserved for sponsor

Driving generics drug selection with proper pricingD M Tripathi, Managing Director, Medicare Remedies Private Limited, India

Pharmacodynamic and clinical equivalence requirements for complex generic products

• Understanding current complex generics regulations for proper filling procedures

• Determining the right parameters for measuring the clinical equivalence of generic products

• Using pharmacodynamics and pharmacokinetics studies to qualify drug as complex generics

ANDA filing for generic peptides in India’s biopharma market

• Exploring the potential of global Peptide Therapeutics market

• Understanding ANDA as a simplified marketing authorization process for generic peptides launch.

• Discussing scientific considerations of ANDA filing for generic peptides.

Devi Kalyan, Associate Director, Dr Reddy’s Laboratories, India

The checklist of to-do, not-to-do, and why it should be done when working with CRO, RI and academic institutionsAjith Kamath, Senior Director, Head, External R&D Innovation, India, Worldwide Research & Development, Pfizer India

Accelerating approvals with drug pharmacokinetics studies Reserved for sponsor

Sustainable disposable and single use technology in upscaling biomanufacturing Senior Representative, Thermo Fisher Scientific

Scaling up biosimilars production: Processes and challenges Sridhar Kottakota, Principal Scientist, Lupin, India

Effect of matrix composition in influencing bioproductivity

Standardizing criteria for bioanalytical assay development and pre-validation

• Overview of the expectation from the guideline for an bioanalytical assay

• Taking ELISA for HCP as an example – discuss development process and challenges

• Reviewing criteria assessed during pre-validation

Monalisa Chatterji, Associate Director, Biocon, India

Implementing QbD in India’s manufacturing plants

• Adopting QbD principles to increase manufacturing efficiencies

• Post approval change minimization with QbD approaches

• Higher early stage efforts Vs changes in filed and approved processes

• Designing manufacturing plants to achieve “Regulatory flexibility”

Swapnil Ballal, Senior Director, Quality Assurance, Biocon, India

Designing cell lines for low cost, high quality vaccines productionReserved for sponsor

Cutting edge technology in vaccines production

Minimised targeted cancer treatment toxicity with ADCs

• Novel combinations of antibodies with anticancer drugs for targeted treatment

• Investigating novel linkers for successful delivery of drug to the correct targets

• Increasing the specificity of ADC by adopting EGFR targeted antibodies

Discovery platform for developing novel therapeutic antibody

• Discovery of novel human antibody from naïve human phage display library

• Humanization of monoclonal antibody

• Development of antibody drug conjugates

Dilip Bandyopadhyay, Head, New Chemical Entity, Zydus Cadila, India

Overcoming side effects of cancer treatment with innovative immunotherapeutic methodsManjunath Ramarao, Director and Head, Disease Sciences and Technology, Bristol-Myers Squibb, India

Crafting manufacturable, low immunogenicity risk ADCsReserved for sponsor

DAY TWO Wednesday, 4th November, 2015 3 of 3

14:30

14:50

Understanding the role of natural products in preventing anti-cancer drug toxicity

• Learning the toxic effect of anticancer drugs on the host’s defence system to onslaught of other chemicals and immunological defence to infections.

• Exploring conventional approaches of reducing the toxic side effects of anticancer drugs are not very effective.

• Adopting natural products to enhance host’s defence to toxic onslaught and infection challenge while treating cancer

Sheikh Raisuddin, Professor, Head, Centre for Translational and Clinical Research, Jamia Hamdard, India

Improving efficacy of biopharmaceutical substances with nanotechnology drug delivery platformRinti Banerjee, Madhuri Sinha Chair Professor, Department of Biosciences and Bioengineering, Indian Institute of Technology Bombay, India

Data integrity essentials in biomanufacturing

• Learning the importance and necessity of data integrity in quality assurance

• Understanding changes in the regulatory environment around data integrity and what the increased surveillance entails for the industry

• Discuss and obtain key learning points from case studies

Sandhya Kumaraswamy, Associate Director, Quality Assurance, Dr Reddy’s Laboratories, India

Achieving quality manufacturing with proper metrics evaluation

• Strategizing a more quantitative and objective measure of quality at the product, site and systems level.

• Promoting positive firm behaviour and a corporate culture of responsibility for improving product quality.

• Applying continuous improvement process to achieve high quality product, systems and control on site in achieving competitiveness.

Narendira Kumar, Senior Manager, Quality Assurance, Formulations, Orchid Healthcare, India

Crafting good working relationship with strategic partners

• Defining internal need, capabilities and the need for external partners

• Choosing the right partner and building the right relationship with them.

• Overcoming potential partnership failures and introducing mid-course correction measurements

Raman Govindarajan, Head, External Science and Partnering, Sanofi-Aventis, India

Managing the quality of clinical data

• Implementing QbD in clinical trials

• Quality risk management in clinical research studies

• Exploring the importance of vendor oversight in quality management in successful trials

Shraddha Tawade, General Manager, Quality and Training, Global Clinical Research, Wockhardt Ltd, India

15:10 Ensuring product integrity when using 3PLs Reserved for sponsor

End-to-end validation in sterile operation Reserved for sponsor

Case study: Image guided drug deliveryReserved for sponsor

Roundtable Discussions 15:30

Therapeutic table A:

Designing affordable vaccines for mass production

Regulatory table A:

Generics pricing schemes

Manufacturing table A:

Strategies for upscaling biosimilar productionSenior Representative, Thermo Fisher Scientific

Therapeutic table B:

Increasing the specificity of antibody-drug conjugates

Regulatory table B:

Managing strategic partners

Manufacturing table B:

Quality assurance and control of biologic products

Close of BioPharma India Convention 201516:10

WHO ATTENDS?

AcademicsBioprocess solution providers

Governments

MNC BiopharmasAnalytical instrument manufacturers

Consultants

CROs/CMOsCold Chain Packaging & Cargo

Clinical trial supply chain providers

Biotechs & Startups Lab consumablesLegal Counsels

WHERE FROM?

JOB TITLES

Who attends?

70%

India

15%

Rest of Asia

10%

US & UK

5%

ROW

Directors30%

Managerial Level 23%

Heads of Department 22%

Executive Level 8% Top Management (Managing Directors, Presidents, VPs, CEOs)

17%

Some of our previous attendeesAbbott Healthcare Pvt. Ltd. Astrazeneca Pharma India Ltd Bayer

Healthcare Bharat Serums And Vaccines Ltd Biocon Research

Limited Biological E Ltd Boehringer Ingelheim Pharma G.M.B.H.

and Company K.G. Bristol-Myers Squibb Cadila Pharmaceuticals

Ltd Central Drugs Standard Control Organization (West Zone)

Centre for Cellular and Molecular Platforms Cipla Ltd Clonz Biotech

Pvt Ltd DGHS , Dhaka , Bngladesh Dr. Reddys Laboratories Limited

Eisai Pharmaceuticals India Pte Ltd Eli Lilly And Company India

Ltd Glenmark Pharmaceuticals Ltd Haffkine Bio-Pharma Corp Ltd

Hospira Indian Immunologicals Limited Intas Pharmaceuticals Ltd

Abbott Healthcare Pvt. Ltd. Astrazeneca Pharma India Ltd Bayer

Healthcare Bharat Serums And Vaccines Ltd Biocon Research

Limited Biological E Ltd Boehringer Ingelheim Pharma G.M.B.H.

and Company K.G. Bristol-Myers Squibb Cadila Pharmaceuticals

Ltd Central Drugs Standard Control Organization (West Zone)

Centre for Cellular and Molecular Platforms Cipla Ltd Clonz Biotech

Pvt Ltd DGHS , Dhaka , Bngladesh Dr. Reddys Laboratories Limited

Eisai Pharmaceuticals India Pte Ltd Eli Lilly And Company India

Ltd Glenmark Pharmaceuticals Ltd Haffkine Bio-Pharma Corp Ltd

Hospira Indian Immunologicals Limited Intas Pharmaceuticals Ltd

Floorplan

Current sponsors & exhibitors:

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Partner with us: The BioPharma India Opportunity

You’ve got goals? We can help you achieve them. We can work with you to achieve your targets in 2015 by positioning your brand in front of the Asia Pacific biopharmaceutical industry. Join us as a sponsor to:

Meet, interact and network with senior level decision makers from India’s biopharma industry

Generate qualified and targeted leads for your sales team

Showcase your solutions to an audience keen to explore new technology

Extend your marketing footprint within India’s biopharma space

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Booth Organisation

1 Finesse Solutions

2 CPC Worldwide

3 Malvern Instruments

4 Thermo Fisher Scientific

5 BioClinica

6 RESERVED

7 RESERVED

8 AVAILABLE

9 AVAILABLE

10 AVAILABLE

11 RESERVED

12 AVAILABLE

13 AVAILABLE

Pod-stands

A AVAILABLE G AVAILABLE

B AVAILABLE H RESERVED

C AVAILABLE I RESERVED

D Kaneka J AVAILABLE

E Shimadzu K AVAILABLE

F AVAILABLE L RESERVED

SOLD RESERVED AVAILABLE

Benefits Platinum Gold Silver Roundtable Exhibitor Pod-stands

Chairperson 1 1

Keynote Presentation Day One Day Two

Conference Presentation 1 1 1

Roundtable discussion host 4 2 1 1

Pre-arranged onsite meetings

10 5

Lead Generation via Content E-Book

1 1

Lead Generation via Total Biopharma

3 2 1

Exhibition BoothTable-top

BoothTable-top

BoothTable-top

BoothTable-top

BoothTable-top

BoothPod-stand

Conference Passes 7 5 4 2 1 1

Access to networking app Unlimited Unlimited Unlimited Unlimited Unlimited Unlimited

Your Marketing Footprint

Backed by esteemed industry associations and scientific publications, Terrapinn Life Sciences gets its additional boost in outreach through a sound network of supporting partners.

300+Industry Stakeholders

70+Speakers

200+Meetings

20+Networking hours

100+Companies

Supporting association:

Media Partners

Awarded the “Best Marketing Team - 2014” in the annual Conference Awards, this speaks volumes of how aggressive we are with what we do best. To top it off, Terrapinn Life Sciences run the TotalBioPharma community as well as a weekly newsletter that reaches out to more than 110,000 industry professionals in the world.

North America

38%Asia

29%Europe

21%Australia

7%

Sou

th A

merica/Caribbean2%Middle East

2%

36,500 20,000 110,000

Newsletter recipientsVisitorsPage views

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