Transcript 5 March | Pune, India

and
5 Reasons To Attend
Biosimilars World India 2015
Mingle with key players from both global and
Indian biosimilar industry at the same place,
at the same time.
Hear the current challenges & opportunities for
sustainable biosimilar manufacture from key
leaders in the regional biosimilar industries.
Discover cost-effective technologies, best
manufacturing practices and innovative
biosimilar developments in the region.
Engage in meaningful discussions with experts
in the regional biosimilar community to develop
business strategies and to guide the future of
the regional biosimilar industry.
Countless opportunities to build long term
business collaborations & partnerships.
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3 - 5 March | Pune, India
Biosimilars World India provides the FIRST and MOST FOCUSED platform
in 2015 for biosimilars industry leaders who will influence the future of
India’s biologics industry.
DISTINGUISHED PANEL OF SPEAKERS
Dr. Villoo
Morawala Pantell,
Chairman and
Managing Director,
Avesthagen,
India
Dr. Sanjay Singh,
CEO,
Genova
BioPharmaceuticals,
India
Dr. Syed Numan,
Associate Director,
Regulatory Affairs,
AbbVie,
US
Mr. Chetak
Buaria,
Director,
Partnerships and
Alliances,
Merck Serono,
Switzerland
Dr. Akhilesh
Sharma,
Chief Medical Officer,
Senior Vice President,
Global Head,
Medical Affairs,
Dr. Reddy’s
Laboratories,
India
Dr. Umesh
Shaligram,
Director, R&D,
Serum Institue of
India,
India
Mr. Murali
Neelakantan,
Global General
Counsel,
Cipla,
India
Dr. Ko Chung Lin,
CEO,
PharmaEssentia
Corp,
Taiwan
Mr. Rafael
Mendoza,
Senior Commercial
Director,
APAC Regional
Therapeutic Lead,
Pfizer,
Hong Kong
Dr. Rajendra Jani,
Senior Vice
President,
Clinical R&D,
Cadila
Pharmaceuticals,
India
Dr. S.D. Sinha,
Associate Vice
President,
Global Head,
Clinical Studies,
Hetero Drugs,
India
Dr. Alok Sharma,
Head, Analytical
Development,
Lupin Limited,
India
Mr. Anurag
Sharma,
Associate Vice
President,
Legal Affairs,
Biocon,
India
Mr. Arjun
Raguwanshi,
Manager, R&D,
Senior Scientist,
Gennova
BioPharmaceuticals,
India
Dr. Ashok Mishra,
Head of Downstream
Process,
Biotechnology
Division,
Lupin Pharma Ltd,
India
Mr. Chandru
Chawla,
Head, Cipla New
Ventures,
Cipla,
India
Dr. Hatim
Motiwala,
Principal Scientist,
Enzene
Biosciences,
India
Mr. S.R. Rao,
Advisor, DBT,
Government of
India,
India
Lunch Sponsor
Exhibitors
Mr. Ravishankar
Kasturi,
General Manager
and Head of Bio
Pharmaceuticals
Process
Development,
Reliance Life
Sciences, India
Dr. Subhash
Pande,
Senior Vice
President, QA,
Zydus Cadila,
India
Proudly created and produced by
W: http://www.imapac.com/business_conference/biosimilars-world-india-2015/ E: [email protected] C: +65 6493 2093
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BioSimilars World India 2015
3-5 March | Pune, India
Attendee Breakdown
Job Title
y
B
eography
G
By
3%
10% 2%
10%
10%
10%
5%
65%
10%
East Asia
Middle East
AustralAsia
10%
10%
30%
45%
10%
15%
15%
Indian
Subcontinent
USA
Europe
Industry
y
B
VPs & Directors of
Manufacturing
CEOs/CTOs/
CSOs/MDs
Vps and Directors
of R&D
15%
25%
VPs of CD and RA
Scientists & Engineers
Licensing & Business
Development
Others
Biosimilars
Manufacturers
Solution Providers
Regulatory Officials
Research
Institutes
Big Pharma/
MNCs
AGENDA AT A GLANCE
Main Conference Day 1
Main Conference Day 2
The Biosimilars Market Pathway
Speed to Market: Fast Track
Biosimilar Develoment I
Speed Networking & Morning Refreshment
Speed Networking & Morning Refreshment
IP and Regulations
Biosimilar Quality and Compliance
Speed to Market: Fast Track
Biosimilar Develoment II
Networking Lunch & Exhibition Visit
Networking Lunch & Exhibition Visit
Manufacturing Excellence
Innovations: The Next Generation Biologics
Afternoon Refreshments
Manufacturing Optimization and Best Practices
Afternoon Refreshments
Partnership and Business Models
For speaking opportunites or find out more on the programme, please contact:
Avik Sarkar
Conference Producer
+65 6493 1597
[email protected]
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BioSimilars World India 2015
3-5 March | Pune, India
Sponsorship Opportunities
PARTNER WITH US!
WHY SPONSOR BIOSIMILARS WORLD INDIA 2015?
BioSimilars World India 2015 provides the first and only platform focus on India’s biosimilars industry.
Leverage on this year’s best marketing and sales opportunity to access the fastest growing
biosimilars markets in India and the world!
Are you a biosimilars service and/ or technology provider looking to stay abreast of developments in Indian
market, continuously build new leads, brand yourself as a solution provider and grow your market share?
If yes, Biosimilars World India 2015 is for you.
PRAISE FOR PAST BIOLOGICS EVENTS
BIOLOGICS WORLD KOREA 2014
Thank you very much for the super
organization of this event! It was very
insightful and a good way to connect!
Christian Groeger
President & CEO
Eppendorf Korea Ltd
Thank you all so much for your
help and promoting us so well at
the conference. They are much
appreciated.
Gary Wright
Senior Account Director
Bioproduction Group,
To find out more on the programme, please contact:
Natasha Jiandani
Business Development Manager
+65 6493 1881
[email protected]
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BioSimilars World India 2015
3-5 March | Pune, India
Floorplan
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BioSimilars World India 2015
CONFERENCE DAY 1
3-5 March | Pune, India
4 MARCH 2015
8:00
Registration Commences
8:45
IMAPAC’s Welcome Remarks
8:50
Chairman’s Opening Remarks
Dr. S. R. Rao, Advisor, DBT, Government of India, India
The Biosimilars Market Pathway: Keynote Session
9:00
Leadership Panel: Indian Biosimilars Success Strategy: Today and Tomorrow
Biosimilars market opportunities: trends and challenges in India vs. global markets
Understanding different challenges and opportunities in unregulated, semi-regulated, tightly-regulated global markets and
identifying a prioritization strategy
Ensuring profit margin, preventing hostile rivalry: how do Indian biopharmas work together?
Will or should India move up the value chain from biosimilars to biobetters to NBEs?
Global partnership as a success strategy: what partners does India need?
Confirmed Panelists:
Dr. Villoo Morawala Patell, Chairman & Managing Director, Avesthagen, India
Dr. Sanjay Singh, CEO, Gennova Biopharmaceuticals, India
Case Study
9:45
10:10
Case Study: India as Global Biosimilar Launch Pad
Prioritizing the “right” biologics to establish competitive advantage on global counterparts and to respond to health challenges
Importance of partnerships for a sustainable biosimilar industry
Opportunities and challenges for pharmacovigilance (Phase IV) – entry into regulated markets through the Indian/ other
semi-regulated biosimilar markets – India and Latin America
Confirmed Panellists:
Mr. Chandru Chawla, Head, Cipla New Ventures, India
Morning Refreshments and Speed Networking
IP and Regulations
10:35
Understanding Regulatory Pathway in India from Manufacture to Market for Biosimilars
Updates in the clinical trial regulatory pathway for biosimilars in India
Monographing to US/EU standards in regulation to speed up global approval
Regulatory protocol overview for establishing complete bioequivalence
Dr. S. R. Rao, Advisor, DBT, Government of India, India
11:00
The USFDA Regulatory Updates: MAb Biosimilar Guidelines
11:25
Navigating the IP Minefield of Biosimilars
Challenges with clinical trials and pharmacovigilance for Mab biosimilar approval by US
Clinical trial strategies for breaking through into regulated markets for Asian Companies from semi-regulated or unregulated market
Dr. Vijay Tammara, Senior Vice President, Global Regulatory Affairs, Wockhardt Inc., India
Understanding the Legal Issues and Challenges to Biosimilars Development
Strategies for navigating patent strategies for cell line cloning methodologies
Analysis of IP policies and freedom to operate in India
Case study of legal precedents
Mr. Murali Neelakantan, Global General Counsel, Cipla, India
11:50
Tackling IP and Regulation Challenges in Indian Biosimilars Pathway
Dr. Anurag Sharma, Associate Vice President, Head of Legal Affairs, Biocon, India
Biosimilar Quality and Compliance
12:15
Cost By Design: Need for Global Harmonization for Development of Biosimilars:
CMC Analytics and PAT for Biosimilars Manufacture
Effective CMC strategies for non-clinical studies as predictors of safety and efficacy
Statistical Process Monitoring and Continuous Process Improvement with steps to identify Critical Quality Attributes of the
Biosimilar product
Effectively utilizing CMC analysis protocols in different stages of biosimilar development for head to head comparison
Dr. Himanshu Gadgil, Senior Vice President, R&D, Biologics, Intas Pharmaceuticals, India
12:40
Tackling Challenges in PAT for Development of MAb Biosimilars in Comparison to Recombinant
Protein Based Biosimilars
Structural and conformational complexities of Mab Biosimilars compared to recombinant protein - Stability studies
Use of analytical technologies in biosimilar antibody engineering
Features vs. Limitations of current technology and future technological advances
1:05
Networking Luncheon
Manufacturing Excellence
2:05
Preventing Chromatographic Loss During Biosimilar Manufacture
Mr. Ashok Mishra, Head of Downstream Process, Biotechnology Division, Lupin, India
2:30
RESERVED
Integration and Retrofitting Single-Use Platform into Manufacturing Operations for Biosimilars
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BioSimilars World India 2015
3-5 March | Pune, India
2:55
Optimization Platform Technologies for Faster Upstream Development of MAb Biosimilars
3:20
Achieving Consistent Titer Downstream, Maneuvering Challenges in Protein Formulation and Purification
3:45
Afternoon Refreshments
Current upstream manufacture challenges for MAb biosimilars
Utilizing platform technologies for optimized antibody producing cell lines to shorten time in upstream manufacture
Meeting demands of market through platform technology
Mr. Ravishankar Kasturi, GM & Head - Biopharmaceutical Process Development, Reliance Life Sciences, India
Challenges in tackling protein aggregation and its effect on biosimilar clinical quality
Strategies for obtaining good titer and quality for biosimilar to demonstrate similarity
Overcoming challenges in biosimilar product formulation and analysis of current purification technologies
Mr. Ashok Mishra, Head of Downstream Process, Biotechnology Division, Lupin, India
Manufacturing Optimization and Best Practices
Fed-Batch Cell Culture Using a Novel Nutrient Additive
4:15
RESERVED
4:40
Continuous Processing and Process Intensification: Path Forward for Biosimilar Manufacturing
5:05
Effectively Utilizing Post Translational Modification Analysis to Fast Track Process Development for biosimilars
5:30
Achieving Optimum Protein Expression and Desired Protein Purity for Head to Head Comparison
5:55
Chairman’s Closing Remarks
6:00
Conference Day 1 Closes and Welcome Cocktail
Cost of Goods (COGS) for process development and design for manufacturing
New technologies for meeting the current needs and future direction, particularly in the areas of downstream operations
Mr. Arjun Raghuwanshi, Manager R&D, Senior Scientist, Gennova Biopharmaceuticals, India
Highlighting need for PTM analysis before scale up to maintain optimum titer and protein purity for commercialization
Glycosylation profile as a critical criteria for similarity to originator in terms of efficacy and safety
Glycosylation analytical challenges for head to head comparison and overcoming them in order to speed up manufacture process
Dr. Sanjeev Gupta, Deputy General Manager, Biotech R&D, IPCA Laboratories, India
Effective leader peptide tags with vector-promoter systems for optimum protein expression and purity
Utilizing effective expression vectors for enhancing desired peptide expression
Reducing heterogeneity of cloned cell proteins through novel methods
Dr. Hatim Motiwala, Principal Scientist, Enzene Biosciences, India
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BioSimilars World India 2015
CONFERENCE DAY 2
3-5 March | Pune, India
5 MARCH 2015
8:00
Registration Commences
8:50
Chairman’s Opening Remarks
Dr. S. R. Rao, Advisor, DBT, Government of India, India
Speed to Market: Fast Track Biosimilar Development I
Global Clinical Trials Management for Global Biosimilars Development- A Reality?
9:25
Effective Biosimilars Clinical Research Study Designs for India
Panel
Discussion
9:00
Designing effective clinical strategies - global study designs, appropriate clinical end-points and clinical methodology
Targeting right patient profile, optimizing patient recruitment and global study execution
Right site selections, early decision on site redundancies
Targeting global regulations and integrating sites to achieve multi-country regulatory approval
Dr. Akhilesh Sharma, Chief Medical Officer, Senior Vice President, Global Head, Medical Affairs, Dr. Reddy’s Laboratories, India
Understanding challenges in GCP implementation
Designing an effective clinical study strategy
Confirmed Panelists:
Dr. Rajendra Jani, Senior Vice President, Clinical R&D, Cadila Pharmaceuticals, India
Dr. Jaideep Gogtay, Chief Medical Officer, Cipla, India
Dr. S.D. Sinha, Associate Vice President & Head, Global Operations, Clinical Development, Medical Affairs & Pharmacovigilance,
Hetero Drugs, India
10:10
Overcoming patient recruitment challenges in global clinical trials for biosimilars
10:35
Morning Refreshments and Speed Networking
RESERVED
Patient recruitment requirements by EMA ad FDA
Need to select te most sensitive indication with the highest effect size and a homogeneous population with limited comordibities has
reduced the options for patient recuitment
Choice of indications for biosimilar programs based on FDA and EMA requirements
Speed to Market: Fast Track Biosimilar Development II
11:00
Biosimilar Quality: Biosimilarity and Bioequivalence Comparability Studies
11:25
Biosimilar Safety: Pharmacovigilance and Risk Management
11:50
Analyzing Toxicity and Pharmacokinetics for MAb Biosimilars
12:15
Bioanalytical Assay Development and Analytical Method Validation of Biosimilars
Drug substance and drug product quality assessment
EMA Regulatory updates
Dr. Subhash Pande, Senior Vice President, QA, Zydus Cadila, India
PK/PD comparability optimization for biosimilars and efficacy-safety relationship with originator in terms of dosage
Addressing critical safety concerns of biosimilars through immunogenicity studies
Understanding the importance of and challenges in pre-clinical studies for toxicology
Considering effective patient safety and trial design with effective risk management
Highlighting best practices in pharmacovigilance and models for immunogenicity studies
Post marketing safety and critical concerns
Dr. Syed Numan, Associate Director, Regulatory Affairs, AbbVie, India
Comparison of EMA guidelines to Indian guidelines
Single dose, repeat dose toxicology analysis
VED
RESER
Analyzing mutagenicity and carcinogencity
Dr. Alok Sharma, Head, Analytical Development, Lupin, India
12:40
Panel Discussion
Integrating and Optimizing Analytics to Speed Up Biosimilar Development
Confirmed Panelists:
Dr. Alok Sharma, Head, Analytical Development, Lupin, India
1:05
Lunch Networking Session + Technical Seminars
Innovations: The Next Generation Biologics
2:00
Panel Discussion
Getting Ahead in the Game: Biosimilars or Biobetters?
Gearing up for the future through biobetter pipleline
Comparison and contrast between biosimilars and biobetters in the Indian context
Analyzing the current Indian Scenario and evaluating cost vs benefits of biobetters
Confirmed Chair:
Dr. S. R. Rao, Advisor, Minister of Science & Technology, Department of Biotechnology, India
Confirmed Panelist:
Dr. Umesh Shaligram, Director, R&D, Serum Institute of India, India
Dr. Steven Lee, CEO, Singapore Operations, Technical Operations, Global Head, Dr. Reddy’s Laboratories, India
2:45
Biobetters Through Novel Site-Specific PEGylation Platforms
Dr. Lin Ko Chung, CEO, PharmaEssentia, Taiwan
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BioSimilars World India 2015
3:10
3-5 March | Pune, India
Monoclonal Antibodies and Biobetters - Innovations and Overcoming Challenges
- Development at Serum Institute
Dr. Umesh Shaligram, Director, R&D, Serum Institute of India, India
3:35
Case Study
Developing Herceptin Biosimilar Through Alternative Expression Systems
Challenges in current protein expression systems
Novel expression systems for biosimilar and biobetter development
Advantages over the current expression systems
4:00
Afternoon Refreshments
Partnership and Business Models
4:15
The Big Pharma Perspective: Partnership Models and Needs
Mr. Rafael Mendoza, Senior Commercial Director, APAC Regional Therapeutic Lead, Pfizer, Hong Kong
4:40
Case Study
Successful Biosimilar Development and Distribution Partnership Model
Highlighting the benefits of the strategic partnership model
Mr. Chetak Buaria, Director, Partnerships and Alliances, Merck Serono, Switzerland
5:05
Panel Discussion
The Right Partner, the Right Model, the Right Outcome
Understanding your partnership needs and selecting the right partners
Strengthening portfolio through licensing
Win-win partnering model: considerations and case studies
Managing the partnership to realize the mutual benefits: When, what and how?
Confirmed Panelist:
Mr. Chetak Buaria, Director, Partnerships and Alliances, Merck Serono, Switzerland
Mr. Chandru Chawla, Head, New Business Ventures, Cipla, India
Mr. Rafael Mendoza, Senior Commercial Director, APAC Regional Therapeutic Lead, Pfizer, Hong Kong
5:50
Chairman’s Closing Remarks
6:00
Conference Day 2 Closes
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