3-4 November 2015

The Westin Mumbai Garden City

Mumbai, India

Showcasing India’s
biopharma future

www.terrapinn.com/biopharmaindia
“GREAT EXPOSURE TO THE
DEVELOPMENTS IN BIOPHARMA
INDUSTRY - BOTH TECHNICAL AND
COMMERCIAL ASPECTS.”
Managing Director, Indian Immunologicals
India is one of Asia’s hottest
biopharma destinations
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:
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
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.
“EXCELLENT OPPORTUNITY TO MEET
TOP DECISION MAKERS, WHO ARE
NORMALLY IN-ACCESSIBLE.”

Director, Advent Worldwide

Keynote Speakers
Dr Cyrus Karkaria
With 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.
K V Balasubramaniam
A 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.
Dr Renu Swarup
Winner 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.
Keynote Speakers
Raj Mehta
President 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.
Leena Menghaney
As 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.
Dr Sanjeev Kumar
In 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.
2015 Speakers include:

ADVISOR ADVISOR ADVISOR ADVISOR ADVISOR ADVISOR ADVISOR Renu Swarup Cyrus Krakaria Gouri Shankar Shubhadeep
Dr. Ajith V. Dr. Mahalaxmi Dr. Manjunath Dr. Sandhya Sanjay Desai Swapnil Ballal Dr Craig Smith Senior Advisor, President, Drug Inspector, Sinha
Kamath Andheria Ramarao Kumaraswamy Director, Supply Chain Senior Director, Quality Vice President Department of Biotechnology Division, CDSCO, India Associate VP and
Asia, Thermo Fisher Assurance, Biocon, Development and R&D, Biotechnology, Lupin Limited Head, Clinical Affairs,
Head, External R&D Vice President Director and Head, Associate Director, Ministry of Science
Intellectual Property Disease Sciences and Quality Assurance, Scientific, Singapore India Bioproduction Division, Medical Affairs and
Innovation, India and Technology,
Rights, Panacea Technology, Bristol- Dr Reddy’s Thermo Fisher Pharmacovigilance,
Worldwide Research & Government of India
Biotec, India Myers Squibb, Laboratories, India Scientific, USA Global Operations,
Development
IndiaGovernment of Hetero Group, India
Pfizer Inc., India
India

Nipom Deka Narasimha Rao Ashwani Milind Ponde B.N. Manohar Sridhar Gaurav Gupta Shraddha Anurag Rathore Chandrakant Jyoti Iyer
Regional Nedunuri Pandita Global Head, Managing Director, Kottakota Head, Virology and Tawade Professor, Department Kathote Principal Scientific
Pharmacovigilance Managing Director & Submission Publishing Stempeutics Principal Scientist, biotechnology, Vaccine General Manager, of Chemical Plant Head, Manager, Process
Deputy General
Manager - Asia, Africa CEO, Clonz Biotech and Site Head Drug Research Pvt Ltd, Lupin, India Technology Center, Quality and Training, Engineering, Biotechnology Division, Development,
Manager and Head,
& Middle East Global Pvt. Ltd., India Regulatory Affairs, India Zydus Cadila, India Global Clinical Indian Institute of Lupin, India Monoclonal Antibodies,
Clinical Quality
Pharmacovigilance Novartis Healthcare, Research, Wockhardt Technology Delhi, Biocon, India
Management &
(EPD), Abbott, India India Ltd, India India
Training ,Global Clinical
Research Operations,
Glenmark Research
Centre, India

Dilip Amulya Panda Atul Kumar Dulal Panda Sunny Kataria Sunita K. Prasad Koka Murali Anup Karnik Nandan Kaushik Deb
Bandyopadhyay Staff Scientist Senior Principal Professor, Chair, Senior Research Sreedharan Chief Scientific Neelakantan Business Solution Pendsey Managing Director
Head, Novel Biological VII (Scientist G), Scientist, Academy BioSciences and Fellow, Institute Founder and CEO, Officer and Scientific Founder and Principal, Lead, COE, Partner and Head of & CEO, Merisis
Entity, Zydus Cadila National Institute of of Scientific and BioEngineering, for Stem Cells SKS Law Associates, Director, Merisis Amicus, India Life sciences IP, AZB & Partners, Therapeutics,
Immunology, India Innovative Research, Indian Institute of and Regenerative India Therapeutics, and Healthcare, India DiponEd
Central Drug Technology Bombay, Medicine, India DiponEd Capgemini, India Biointelligence, India
Research Institute India Biointelligence, India
(CDRI), India

Arnaud Lefevre Clive Fernandes Gazala Khan- Varun Gupta Monalisa Devi Kalyan Takashi Sheikh Raman
Managing Director, Principal Consultant, Koticha, Manager, Market Chatterji, Associate Director, Shimada Raisuddin Govindarajan
UCB India, India Joint Commission Associate Director, Access, Novartis, Associate Director, Dr Reddy’s Manager, R&D, Life Professor, Head, Head, External Science
International and Manufacturing India Biocon, India Laboratories, India Science Research Centre for Translational and Partnering,
Group Clinical Director, technical services, Center, SHIMADZU and Clinical Research, Sanofi-Aventis, India
Wockhardt Group Dr Reddy’s Corporation, Japan Jamia Hamdard,
Hospital, India Laboratories, India India
DAY ONE Tuesday, 3rd November, 2015
09:00 Organiser’s opening remarks
09:05 Chair’s opening remarks
09:15
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, Lupin
Raj Mehta, President, Cadila Pharma Biotechnology
K V Balasubramaniam, Managing Director, Indian Immunologicals Ltd
10:00 Speed Networking
10:15 Networking refreshment break
Therapeutic & research innovations
Biosimilars & biobetters development
10:45 Chair’s opening
Dr Craig Smith, Vice President Development
and R&D, BioProduction Division, Thermo Fisher
Scientific, USA
10:50 Launching the first Humira biosimilar: A
case study
Sanjeev Kumar, Senior Vice President,
Biotechnology, Head, Biologics, Zydus Cadila,
India
11:10 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 East
Global Pharmacovigilance (EPD), Abbott, India
Opening keynote session
Biotherapeutic manufacturing
Process development
Chair’s opening
Anurag Rathore, Professor, Department of
Chemical Engineering, Indian Institute of
Technology Delhi, India
Improvising bulk biologic
manufacturing with OPEX initiatives
Chandrakant Kathote, Plant Head, Biotechnology
Division, Lupin, India
Designing a flexible antibody
manufacturing process
Jyoti Iyer, Principal Scientific Manager, Process
Development, Monoclonal Antibodies, Biocon,
India
1 of 4
Partnering & regulatory models
IND & clinical approval
Chair’s opening
Mahalaxmi Andheria, Vice President Intellectual
Property Rights, Panacea Biotec
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 trials
Sanjeev Hegde, Head, Clinical Development,
Reliance Life Sciences, India
DAY ONE Tuesday, 3rd November, 2015
11:30 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
11:50 High throughput, sensitivity, and
resolution in glycan analysis for
characterisation & comparability
studies
Dr Craig Smith, Vice President Development
and R&D, BioProduction Division, Thermo Fisher
Scientific, USA
New Biological Entities (NBE) & New
Chemical Entities (NCE)
12:10 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
12:30 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
12:50 Efficient data management in NBE
discovery
Reserved for sponsor
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
Exploring the potential of disposable
and automated downstream processing
Reserved for sponsor
Manufacturing technology showcase
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
Case study: Single use technology in
downstream processing
Reserved for sponsor
2 of 4
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
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
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
Obtaining central regulatory approval
for vaccine products
Reserved for sponsor
DAY ONE Tuesday, 3rd November, 2015
13:10 Networking Luncheon
Cell & gene therapy
14:10 Overcoming challenges in treating
peripheral arterial disease (PAD) with
stem cells
B.N. Manohar, Managing Director, Stempeutics
Research Pvt Ltd, India
14:30
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
14:50 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
15:10 Exploring gene delivery strategies as
vaccination tools
Reserved for sponsor
15:30
Therapeutic table A:
Biosimilar and biobetter development
Senior Representative, Thermo Fisher Scientific
Therapeutic table B:
Commercialising NBEs
Managing fermentation and upstream
processes
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
Best cell banking methods for high
expression upstream bioproduction
Reserved for sponsor
Roundtable Discussions
Manufacturing table A:
Process optimisation in
biomanufacturing
Anurag Rathore, Professor, Department of
Chemical Engineering, Indian Institute of
Technology Delhi, India
Manufacturing table B:
Raw material testing for quality
production
3 of 4 DAY ONE Tuesday, 3rd November, 2015 4 of 4
16:10 Afternoon Refreshments
Closing keynote session: Starting a biotech in India
Licensing & IP Protection
16:40 Keynote - Competing in India’s biotech market: Evolution, needs and challenges
Overcoming the impact of IP on access
to vaccine technologies in India • Protecting invention with proper IPR enforcement
• Overcoming challenges of IP for India’s • Realising the full potential of India’s biotech market by overcoming regulatory hurdles
companies in accessing vaccine • In-licensing useful technologies to heads up R&D effort
technologies
• Case study: Gaining access to vaccine
17:00 Closing panel – Encouraging biotech entrepreneurship in India
technology via licensing
• Strategies in preventing infringement of • Growing India’s biotech business via strategic partnerships in Asia Pacific
IPR • Funds, regulatory approvals and infrastructure equipment requirements for building an accessible, affordable and high-quality healthcare
Mahalaxmi Andheria, Vice President Intellectual system in India
Property Rights, Panacea Biotec, 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
IP protection in cross nation out-
licensing Panellists:
Narasimha Rao Nedunuri, Managing Director & CEO, Clonz Biotech Pvt. Ltd., India
• Anticipating legal challenges in out- B.N. Manohar, Managing Director, Stempeutics Research Pvt Ltd, India
licensing technologies Kaushik Deb, Managing Director & CEO, Merisis Therapeutics, DiponEd Biointelligence, India
• Strategies in overcoming IP and
contractual challenges
• Case study on cross nation out- licensing 17:40 Chair’s closing remarks
stories
Sunita K. Sreedharan, Founder and CEO, SKS 17:50 End of Conference Day 1
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 Do you provide solutions to India’s biopharma market?
resulting from compulsory and other
licensing method in India
We have limited speaking opportunities available for first-class solution providers.
Murali Neelakantan, Founder and Principal,
Amicus, India Contact Soo Min Lee for more information on soomin.lee@terrapinn.com
Branding your technology for out-
licensing
Reserved for sponsor
Regulatory table A:
Searching for the right tech transfer
partner
Anup Karnik, Business Solution Lead, COE, Life
sciences and Healthcare, Capgemini, India
Regulatory table B:
Necessary regulation amendments of
required to enforcing IPR protection
Nandan Pendsey, Partner and Head of IP, AZB &
Partners, India
DAY TWO Wednesday, 4 th
November, 2015 1 of 3 DAY TWO Wednesday, 4 th
November, 2015 2 of 3

09:00 Organiser’s opening remarks 11:30 Cutting edge technology in vaccines Scaling up biosimilars production: Driving generics drug selection with
production Processes and challenges proper pricing
Keynote session Sridhar Kottakota, Principal Scientist, Lupin, India D M Tripathi, Managing Director, Medicare
Remedies Private Limited, India

09:05 Chair’s opening remarks

11:50 Designing cell lines for low cost, high Sustainable disposable and single Resolving ethical issues with pricing
09:10 Quality and affordability: Jan Aushadhi initiatives quality vaccines production use technology in upscaling policies
• Why is Jan Aushandhi needed for India’s healthcare system? Reserved for sponsor biomanufacturing Reserved for sponsor
• Strategies for ensuring quality generics drug provided to the public Senior Representative, Thermo Fisher Scientific

• 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
Antibody Bioassay validation Generics

09:30
12:10 Discovery platform for developing novel nSMOL: Limited proteolysis on the Fab ANDA filing for generic peptides in
Keynote Panel: Developing affordable and quality healthcare access in India
therapeutic antibody & accelerating mAb bioanalysis using India’s biopharma market
• Promoting product quality, efficacy and safety LC/MS/MS
• Discovery of novel human antibody from • Exploring the potential of global Peptide
• Balancing market demand, patent protection, affordability with profit margins naïve human phage display library • Limitation of ELISA and conventional Therapeutics market
• How can branded generics manufacturers differentiate themselves in India’s highly competitive market? • Humanization of monoclonal antibody proteolysis for mAb quantitation using • Understanding ANDA as a simplified
• Strategies in decreasing manufacturing cost in healthcare access LC/MS/MS marketing authorization process for
• Development of antibody drug
Moderator: conjugates • Novel and simple protocol for Fab- generic peptides launch.
Leena Menghaney, Regional Head, South Asia, Médecins Sans Frontières (MSF)Access Campaign, Doctors without Borders, India selective proteolysis • Discussing scientific considerations of
Dilip Bandyopadhyay, Head, New Chemical
Confirmed Panellists: Entity, Zydus Cadila, India • Bioanalytical application for several ANDA filing for generic peptides.
Arnaud Lefevre, Managing Director, UCB India, India different mAbs like Trastuzumab, Devi Kalyan, Associate Director, Dr Reddy’s
Clive Fernandes, Principal Consultant, Joint Commission International and Group Clinical Director, Wockhardt Group Hospital, India Bevacizumab etc. Laboratories, India
Takashi Shimada, Manager, R&D, Life Science
Research Center, SHIMADZU Corporation, Japan

10:10 Morning Refreshments

12:30 Minimised targeted cancer treatment Standardizing criteria for bioanalytical Pharmacodynamic and clinical
Therapeutic & research innovations Biotherapeutic manufacturing Partnering & regulatory models toxicity with ADCs assay development and pre-validation equivalence requirements for complex
• Novel combinations of antibodies with • Overview of the expectation from the generic products
Upscaling production and flexible anticancer drugs for targeted treatment guideline for an bioanalytical assay • Understanding current complex generics
Vaccines Pricing regulations for proper filling procedures
manufacturing • Investigating novel linkers for successful • Taking ELISA for HCP as an example
delivery of drug to the correct targets – discuss development process and • Determining the right parameters for
10:40 Chair’s opening Chair’s opening Chair’s opening • Increasing the specificity of ADC by challenges measuring the clinical equivalence of
adopting EGFR targeted antibodies • Reviewing criteria assessed during pre- generic products
Dr. Manjunath Ramarao, Director and Head, Senior Representative, Thermo Fisher Scientific
Disease Sciences and Technology, Bristol-Myers validation • Using pharmacodynamics and
Squibb Monalisa Chatterji, Associate Director, Biocon, pharmacokinetics studies to qualify drug
India as complex generics
10:50 Therapeutic vaccines for oncology Overcoming challenges in upscaling Overcoming price control challenges
study the production of Exemptia, the first on MNCs 12:50 Crafting manufacturable, low Effect of matrix composition in Accelerating approvals with drug
Gaurav Gupta, Head, Virology and biotechnology, Humira biosimilar • Understanding pricing challenges in immunogenicity risk ADCs influencing bioproductivity pharmacokinetics studies
Vaccine Technology Center, Zydus Cadila, India Vibhor Saraswat, Vice President and Head of India Reserved for sponsor Reserved for sponsor
Manufacturing, Zydus Biologics, India
• Exploring commonly used tactics by
MNC to cope with pricing challenges
• Winning the game by overcoming 13:10 Networking Luncheon
limitations of the most optimal
strategies
Rahul Chauhan, Associate Director, Regulatory Drug delivery & translational research GMP Compliance and Quality assurance Outsourcing relationship management
Affairs and Pharmacovigilance, Eli Lilly, India

11:10 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
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
14:10
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
Overcoming side effects of
cancer treatment with innovative
immunotherapeutic methods
Manjunath Ramarao, Director and Head, Disease
Sciences and Technology, Bristol-Myers Squibb,
India
Implementing QbD in India’s The checklist of to-do, not-to-do, and
manufacturing plants why it should be done when working
• Adopting QbD principles to increase with CRO, RI and academic institutions
manufacturing efficiencies Ajith Kamath, Senior Director, Head, External
R&D Innovation, India, Worldwide Research &
• Post approval change minimization with Development, Pfizer India
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
DAY TWO Wednesday, 4
14:30 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
14:50 Improving efficacy of
biopharmaceutical substances with
nanotechnology drug delivery platform
Rinti Banerjee, Madhuri Sinha Chair Professor,
Department of Biosciences and Bioengineering,
Indian Institute of Technology Bombay, India
15:10 Case study: Image guided drug delivery
Reserved for sponsor
15:30
Therapeutic table A:
Designing affordable vaccines for mass
production
Therapeutic table B:
Increasing the specificity of antibody-
drug conjugates
16:10 Close of BioPharma India Convention 2015
th
November, 2015
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
End-to-end validation in sterile
operation
Reserved for sponsor
Roundtable Discussions
Manufacturing table A:
Strategies for upscaling biosimilar
production
Senior Representative, Thermo Fisher Scientific
Manufacturing table B:
Quality assurance and control of
biologic products
3 of 3
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
Ensuring product integrity when using
3PLs
Reserved for sponsor
Regulatory table A:
Generics pricing schemes
Regulatory table B:
Managing strategic partners
Who attends? Some of our
WHO ATTENDS?

Bioprocess solution
previous attendees
Academics Governments
providers

CROs/CMOs
Clinical trial supply Cold Chain Abbott Healthcare Pvt. Ltd. Astrazeneca Pharma India Ltd Bayer
chain providers Packaging & Cargo
Healthcare Bharat Serums And Vaccines Ltd Biocon Research
Analytical instrument
MNC Biopharmas Consultants
manufacturers
Limited Biological E Ltd Boehringer Ingelheim Pharma G.M.B.H.
Biotechs & Startups Legal Counsels Lab consumables and Company K.G. Bristol-Myers Squibb Cadila Pharmaceuticals
Ltd Central Drugs Standard Control Organization (West Zone)
WHERE FROM? Centre for Cellular and Molecular Platforms Cipla Ltd Clonz Biotech
Pvt Ltd DGHS , Dhaka , Bngladesh Dr. Reddys Laboratories Limited
70% 15% 10% 5%
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
India Rest of Asia US & UK ROW
Abbott Healthcare Pvt. Ltd. Astrazeneca Pharma India Ltd Bayer
Healthcare Bharat Serums And Vaccines Ltd Biocon Research
JOB TITLES Limited Biological E Ltd Boehringer Ingelheim Pharma G.M.B.H.
and Company K.G. Bristol-Myers Squibb Cadila Pharmaceuticals
Executive Level 8% Top Management
17% (Managing Directors, Ltd Central Drugs Standard Control Organization (West Zone)
Presidents, VPs, CEOs)
Centre for Cellular and Molecular Platforms Cipla Ltd Clonz Biotech
Managerial Level 23% Pvt Ltd DGHS , Dhaka , Bngladesh Dr. Reddys Laboratories Limited
Eisai Pharmaceuticals India Pte Ltd Eli Lilly And Company India
30% Directors
Ltd Glenmark Pharmaceuticals Ltd Haffkine Bio-Pharma Corp Ltd
Hospira Indian Immunologicals Limited Intas Pharmaceuticals Ltd
Heads of Department 22%
Partner with us:
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achieve your targets in 2015 by positioning your brand in front of the Asia Booth Organisation
Pacific biopharmaceutical industry. Join us as a sponsor to: 1 Finesse Solutions
7 13 2 CPC Worldwide
L
3 Malvern Instruments
Meet, interact and network with senior level decision makers from India’s biopharma
industry 6 K 12 4 Thermo Fisher Scientific

5 BioClinica

6 RESERVED
Generate qualified and targeted leads for your sales team J
5 11 7 RESERVED

I 8 AVAILABLE

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H 13 AVAILABLE

Pod-stands
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4
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Chairperson 1 1 F
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D Kaneka J AVAILABLE
Keynote Presentation Day One Day Two E
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Conference Presentation 1 1 1 F AVAILABLE L RESERVED

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Pre-arranged onsite
10 5
meetings

Lead Generation via Current sponsors & exhibitors:

1 1
Content E-Book
3 D
Lead Generation via Total
3 2 1
Biopharma
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Access to networking app Unlimited Unlimited Unlimited Unlimited Unlimited Unlimited
300+
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70+
Speakers
Your Marketing Footprint
Awarded the “Best Marketing Team - 2014” in the annual Conference Awards, this speaks
200+ 20+ 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
Meetings Networking hours
than 110,000 industry professionals in the world.

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100+ or ic Asia
Companies Europe

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gets its additional boost in outreach through a sound network of supporting partners.

Supporting association:

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To sponsor / exhibit:
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To speak:
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To attend:
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