Conference Day One: 7 December 2010, Tuesday

Conference Day One: 7 December 2010, Tuesday »

Conference Day Two: 8 December 2010, Wednesday »

last modified: 27 August '10

8am

Registration and refreshment

9am

Organiser’s welcome remarks: Terrapinn Asia

9.05am

Chairman’s opening remarks

LEADERSHIP ROUNDTABLE-INNOVATIONS AND STRATEGIC PARTNERSHIPS

9.15am

India’s Visionary Leaders Panel: Propelling India’s growing pharmaceutical industry through innovations and strategic partnerships

The promises and challenges for India’s pharmaceutical players in an era of globalization
Developing India’s emerging innovations and analyzing its impact in the country’s pharmaceutical industry
Looking into the global business opportunities that will drive global expansion and growth for Indian pharmaceuticals
Finding the right business model and strategies for Indian pharmaceuticals to achieve success in the global pharmaceutical arena

Confirmed Panelists:
Murtaza Khorakiwala, Managing Director, Wockhardt, India
K.V. Subramaniam, President and Chief Executive Officer, Reliance Life Sciences, India
Somesh Sharma, Chief Executive Officer, Piramal Life Sciences, India
Shrikumar Suryanarayan, Chief Executive Officer, Translational Research Institute, Bioscience Cluster Delhi and Honorary Director-General, Association of Biotechnology Led Enterprises (ABLE), India
A.S. Mohanty, Executive Director and Member of the Board, Glenmark Pharma, India

Confirmed Moderator:
KS Shadshidhar, Business Head, Science Park, MARG Limited, India

10.15am

Morning refreshment

BIOSIMILARS TRENDS AND DEVELOPMENTS

11.15am

Opportunities and challenges in developing and manufacturing biosimilars

Commercial opportunities for biosimilar MAbs
Structural aspects of MAbs and their relevance for biosimilar MAb developments
Clinical and regulatory considerations in the context of biosimilar MAbs

Thomas Schreitmuller, Head, Technical Regulatory Policy & Strategy Biologics EU and RoW, F. Hoffmann-La Roche, Switzerland

11.35am

Thought Leadership Panel: Understanding and overcoming the regulatory and comparability issues of biosimilars

Discussing the biosimilars market landscape and updates
Looking into biosimilars development concepts
Critically analyzing design specification and comparability of biosimilars

Panelists:
Anand Iyer, Vice President, Corporate Development, Divisional Head, Ranbaxy Biologics Division, Ranbaxy Laboratories, India
Thomas Schreitmuller, Head, Technical Regulatory Policy & Strategy Biologics EU and RoW, F. Hoffmann-La Roche, Switzerland
K. Anand Kumar, Assistant Vice President, Quality, Wockhardt, India
Anurag Rathore, Faculty, Department of Chemical Engineering, Indian Institute of Technology, Consultant, Biotech CMC Issues, India

12.20pm

Critically analysing design specification and comparability of biosimilars

Definition and systematic evaluation of critical product quality attributes using multivariate analytical design specifications combined in QbD concepts.
Overview of biosimilar guidelines and rationale for biosimilar benchmarking. Qualification, validation and method comparability.
Current demands and future challenges facing the industry to meet global regulatory requirements.

Geetha Sodhan, Head, Downstream Process, Biopharmaceuticals, Avesthagen, India

12.40pm

Networking luncheon

CELL CULTURE AND UPSTREAM PROCESSING

2.30pm

Platform choice determines biosimilar development success

How integrated platforms enable universality for manufacturing
IP considerations when choosing a platform
How platform choice affects product equivalency

Laurie Donahue-Hjelle, Business Director, Cell Culture Product Development, Life Technologies, USA

2.50pm

Strategies for media optimization to support cell culture production and performances

To achieve high expression in cell line a combination of host cell engineering and media development is important.
Metabolic pathway design™ to optimize media for better performance.
Improving process yields through development of optimized feeding strategies

Sonjoy Mukerjee, Associate Director, Technical BPP, BID, APAC, Thermo Fisher Scientific, India

3.10pm

Animal free supplementation of chemically defined and complex media for optimized performance

Hydrolysates
Recombinant proteins
Chemically Defined supplements

Jagdish Kuchibhatla, Director, Cell Nutrition, Business Development & Technical Sales, APAC, Sheffield Bio-Science, Singapore

3.30pm

Networking break and exhibition visit

DOWNSTREAM PROCESSING

4pm

High productivity purification technologies and approaches to enable QbD based process development

Key challenges in QbD based downstream processing
Technologies that can significantly de-bottleneck downstream purification
Approaches that together with these technologies can enable QbD implementation within time and resource constraints

Anurag Rathore, Faculty, Department of Chemical Engineering, Indian Institute of Technology, Consultant, Biotech CMC Issues, India

4.20pm

Mab industry: flexibility and future manufacturing

High titer cell culture leading to smaller facility
Smart design of facility with great flexibility for high efficiency
Integrated bioprocessing required for high productivity at low cost

Joe Zhou, Chief Executive Officer, Genor BioPharma, China

4.40pm

Integrated process development and its impact on economics of manufacturing

Assessing the impact of integrated process development strategies on the biomanufacturing efficiency and facility through put
Comparing traditional bioprocesses with advanced technologies and their effect on manufacturing cost of goods
Discussing integrated process design to generate effective regulatory strategies for antibody manufacturing

Vikram Paradkar, Vice President, Process Development, Reliance Biopharmaceuticals, India

5pm

Panel Discussion: Rapid development, scale-up, and validation of downstream purification processes with fewer resources

Development objectives in early process development (speed and quality)
Application of platform technologies and rapid screening tools for process development
Interface upstream and downstream development
Process optimization for late stage development

Satish Ravetkar, Senior Director, Serum Institute of India
Joe Zhou, Chief Executive Officer, Genor BioPharma, China
Vikram Paradkar, Vice President, Process Development, Reliance Biopharmaceuticals, India
Geetha Sodhan, Head, Downstream Process, Biopharmaceuticals, Avesthagen, India

5.40pm