The conference

Our 2017 agenda will be our biggest ever.

With 4 tracks covering Therapeutic Innovation & Partnering, Biologics Manufacturing, Biosimilars & Vaccines,
this is your one-stop shop for mapping out your place in India’s biopharma future.

 

Mumbai, India, 19 - 20 September 2017

Schedule

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Sep 1909:00
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Pharma Vision 2020, How close are we to the goal?

Keynotes
The Government of India unveiled 'Pharma Vision 2020' aimed at making India a global leader in end-to-end drug manufacturing. The Indian pharma market is expected to grow to US$ 55 billion by 2020. With the government implementing many new initiatives in its stride toward Pharma Vision 2020, how close are we to achieving it?
Suja Chandy, Vice President, Invest india
Sep 1909:30
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Boardroom panel: Creating a robust ecosystem for pharma in India

Keynotes
India is poised to become a top 5 global pharmaceutical hub by 2020. But in order to achieve this, there’s work to be done, to develop a successful ecosystem. Key stakeholders including the government, pharma, regulators and investors need to work closely together to build it. In this panel, we gather them to explore how, as we explore issues including:
 
  • How will the creation of new pharma clusters across India help enhance the ecosystem?
  • How is the Indian government playing an active role to help build up the ecosystem? (Building infrastructure, funding of incubators and accelerators, mission mode programmes)
  • Should a robust and sustainable ecosystem be centred around academic institutes to increase collaboration?
  • What are some existing models which India can emulate? (Boston,SF Bay area, Singapore, BioValley)
  • Is achieving that too idealistic? How far is India from achieving that?
Sep 1911:30
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LatAm: Investment, market access, and reimbursement issues in this key regional growth market

Keynotes
  • Highlighting the potential within the LatAm pharmaceutical markets
  • Regulatory reforms and deregulation in Mexico
  • Updates on the practical implementation of Mexico as a regional reference agency for other LatAm countries
  • Advantages for the registration of biologic drugs in LatAm
  • What it takes to successfully launch biologics in LatAm and their various reimbursement infrastructure
Rodrigo Blanco Zamora, Trade & Investment Commissioner, Pro Mexico
Sep 1911:50
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Table 3: Downstream innovation

Keynotes
Session led by: thermofisher-life-sciences-group
Sep 1911:50
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Table 1: Technology road mapping and industry collaboration in biologics manufacturing

Keynotes
Dhaval Tapiawala, Principal Scientist, Pfizer
Sep 1914:00
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How is the biosimilar market developing globally, and what does the future hold for biosimilars?

Biosimilars
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  •     Which biosimilars have recently been approved for sale in major markets and how did they do it? 
  •     Is there a Holy Grail and universal reference for biosimilars globally?
  •     How can India better establish itself in the global market?
Rebu Ninan, Senior Director Commercial, Biologics, Dr. Reddy's Laboratories Limited
Sep 1914:00
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Adult Vaccination in India: an untapped market potential?

World Vaccines Congress India
  •     Exploring strategies to create awareness for need of adult vaccinations
  •     How should we approach the education of the population?
  •     Case study: Success models from the developed world
Sarthak Vasudeva, V P and Head - International Business, Indian Immunological Limited
Sep 1914:00
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Automation to reduce human error in India’s biologics manufacturing

Biologics Manufacturing
  •     Identifying prevalent human errors in manufacturing processes
  •     Exploring possible automation solutions to eradicate
  •     Analysis on productivity improvements
  •     How does increased automation improve GMP compliance of the future of Biopharmaceuticals and how to achieve EU GMP compliance 
Sep 1914:20
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Sustainability of Vaccines Industry: Coping with pricing pressures

World Vaccines Congress India
India is supplying more than 60% of the vaccines procured by GAVI. Vaccines in the public market are older and mass manufactured. Due to the cost of production, new vaccines are not able to enter the market. Should local vaccine manufacturers focus on ensuring cheap production of old vaccines for the public market or should they develop new vaccines for their private market instead? This session will explore differences between public & private markets, together with strategies for navigating the public market.
  • Comparing the differences between public and private market in terms of development and production cost
  • Understanding the differences in demands for both markets
  • What are some challenges that are unique to the public market? (E.g. Price pressures from GAVI, WHO)
  • Explore strategies in overcoming these challenges to achieve a sustainable model
Mahesh Bhalgat, Chief Operating Officer, Shantha Biotechnics
Sep 1914:20
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A step towards continuous processing: Downstream perspective

Biologics Manufacturing
  •     Integrating continuous cell culture and purification 
  •     A case of multi-column chromatography for capture and polishing steps
  •     Current view of challenges for implementation
Sep 1914:20
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Viral safety testing and clearance in biopharma industry

Biosimilars
Sep 1914:40
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Global scientific alignment of biosimilars drug development

Biosimilars
  • Scientific alignment versus harmonization – relevancy & complexities?
  • Emphasis on need for comprehensive data studies to demonstrate similarity
  • Addressing global regulatory key challenges in clinical development
Akhilesh Sharma, Senior Vice President and Global Head of Global Medical Affairs, Dr.reddy's Pharmaceutical Company
Sep 1914:40
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Highly accelerated platforms for mAb and next generation mAb development

Biologics Manufacturing
  •     Key elements of a mAb platform enabling gene to GMP in 9 months
  •     High throughput process development tools for developing next generation mAbs
  •     Challenges encountered with these novel types of molecules
  •     Rapid and streamlined process characterization and validation studies to enable BLA/MAA filings for breakthrough therapies and biosimilars 
Sep 1915:00
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How can regulators and pharma work closer together to establish a robust regulation framework?

Biosimilars
    wing India’s efforts to strengthen its regulatory landscape, there have been several updates and revisions of requirements and regulations. This constant changing in regulations has posed many challenges to pharma companies. This panel discussion explores how pharma and regulators can collaborate to establish a robust yet understandable regulatory framework. 
  •     What are some of the recent updates in regulations?
  •     How effective are the subject expert committee, therapeutic committee and apex committee in actioning change in policies?
  •     How can regulators and pharma work more closely together?
Shubhadeep Sinha, Head Global and Vice-President, Clinical Development and Medical Affairs (CD and MA), Hetero Drugs Ltd
Sonika Shah, Head Regulatory Affairs, Amgen India
Sep 1915:00
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Best practices in scale up and technology transfer

Biologics Manufacturing
  •     Creating the considerations for smooth scale up and technology transfer
  •     Analysing the new technologies available
  •     Case Study: Practical challenges in scaling up a Biosimilar process 
Sep 1915:00
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Single-window clearance for vaccines approval in India

World Vaccines Congress India
  •     Updates of discussions with regulators for single-window clearance
  •     How can companies work better together with regulators to streamline process? 
Arani Chatterjee, Senior Vice President, Clinical Research, Aurobindo Pharma
Sep 1915:20
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Novel platform technologies for development and production of Vaccines

World Vaccines Congress India
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  •     Overview of the traditional vaccine technology
  •     Exploring new vaccine platforms in development, including recombinant, DNA, VLP, Live virus vectors and cancer vaccine
  •     Case study in CPL Biological
Nirav Desai, Vice President, CPL Biologicals
Sep 1915:20
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Monoclonal antibody characterization: routine and advanced workflows

Biologics Manufacturing
  •     Simpler and faster solutions for Routine mAb characterization 
  •     Exploiting SWATH, the data independent strategy for the identification of low abundance critical quality attributes (CQAs)
  •     Charge variant analysis; utilizing the separation power of capillary electrophoresis with mass spectrometry.
  •     Exploring MS based strategy as an orthogonal means of HCP analysis.
Sep 1915:40
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Understanding post-market data and ADR reporting for biosimilars in India

Biosimilars
  •     Emphasising the importance of identifying immunogenicity for biosimilars
  •     Understanding impact of delayed ADR in biosimilars
  •     Utilizing Benefits-risk analysis to ensure safety
Sep 1915:40
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Case Study: Novel platform vector and CHO cell substrate technology

World Vaccines Congress India
Sementis’ SCV-vectored vaccines for Chikungunya, Zika and Peanut Allergy
Sep 1915:40
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Determining optimum conditions for scaling down models in downstream processing

Biologics Manufacturing
  •     Making sure scaled down hardware is able to control and calibrate perimeters precisely and accurately
  •     Ensuring operational equivalence with all operational perimeters run at center of optimum range using large scale
  •     Understanding the importance of model qualification to pre determine acceptance criteria for scale down
Sep 1916:30
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Overcoming challenges of bringing biosimilars to market

Biosimilars
As the pharma market in India shifts from generics to biosimilars production, more and more players are entering the biosimilars market and competition is becoming stiff. In order to overcome the competition, Pharma has to ensure that they produce the products cheaper and faster. How can they do that?
  • How can Pharma reduce the cost of production?
  • What are some cutting edge technologies presently available to help manage the cost?
  • Are there capital and infrastructure investments that can be made to save cost in the long run?
Dinesh Kundu, GM, Business strategy & development, Intas Pharmaceuticals Ltd. – Biopharma Division
Radhika Bhalla, AVP Commercial Ops/Strategy, Business Analytics, Emerging Markets, Mylan Laboratories,India Ltd
Sep 1916:30
Conference pass

Synthetic conjugate vaccines: An overview

World Vaccines Congress India
  •     Understanding the difference between traditional conjugate vaccines vs synthetic conjugate vaccines
  •     How do synthetic conjugates help in increasing product quality and reducing cost?
  •     Review of existing synthetic conjugate vaccines and ongoing research
  •     Presentation of preliminary data from MSD Wellcome Trust Hilleman Laboratories
Sep 1916:30
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Extractables and leachables testing using a Quality Risk Management approach

Biologics Manufacturing
  • Understanding extractables and leachables for better adoption of single use systems
  • Ensuring safety of drug through determining the level of leachables throughout product life cycle
  • Case Study of implementation of standardized testing protocol
Dhaval Tapiawala, Principal Scientist, Pfizer
Sep 1916:50
Conference pass

Prokarium’s oral and thermostable Vaxonella platform to deliver a combination typhoid-paratyphoid vaccine

World Vaccines Congress India
  •     Combination typhoid-paratyphoid vaccine
  •     Oral and thermostable
  •     Platform widely applicable to other indications
Sep 1916:50
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Ensuring quality and stability in cell-line development

Biologics Manufacturing
  • Avoiding animal-origin material contact through use of a serum free medium
  • Exploring ways to address the translation, secretion and cell trafficking issues
  • Evaluating glycosylation and charge heterogeneity for consistency
Kaumil Bhavsar, Senior Scientist of Cell Culture, Intas Pharmaceuticals Ltd
Sep 1917:10
Conference pass

Compulsory Licensing in India: Is it here to stay?

Biosimilars
  • Understanding the impact compulsory licensing has on local pharma companies
  • Does compulsory licensing impede innovation in India?
  • Exploring solutions for big pharma to overcome this
Kedar Suvarnapathaki, Head of Regulatory Affairs and IP, Boehringer Ingelheim India Pvt. Ltd.
Sep 1917:10
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Lower price for more Access: How do we determine the sweet spot?

World Vaccines Congress India
  •     Understanding the demand and potential of the private market in India
  •     Explore strategies in maximizing profitability through pricing vs volume analysis  
Sep 1917:10
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Utilizing Alternating Tangential Flow (ATF) for perfusion cell culture

Biologics Manufacturing
  • Comparing the difference between ATF and TFF in filtration
  • Cost-benefit analysis of ATF and TFF
  • Case Study

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Sep 2009:10
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Is the future of medicine personalised?

Keynotes
With the recent advancements in the study of genomics, much progress has been made creating medicines tailored specifically to an individual’s conditions and symptoms. Are we entering a new era of medicine with personalized medicine? To what extent are payers, providers, systems, physicians and patients ready for the change? How will digital technologies and solutions play into the vision of personalised medicine? What are the remaining challenges in making the vision of personalised medicine a reality?
Sep 2009:35
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An organised approach to promoting nation-wide innovation

Keynotes
When it comes to encouraging innovation centers in India, the government has a more decentralised approach where states have the flexibility and funds to build individual programs and innovation centers to promote the growth of biotech hubs. However, sometimes too many cooks may end up spoiling the broth. So how do different government units truly measure the real return of investment of these expenditures, and how do stakeholders work together in organising a more united approach to instilling real innovation within India?
 
Taslimarif Saiyed, Director & CEO, Centre for Cellular and Molecular Platforms (C-CAMP)
Sep 2010:00
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Creating the workforce of the future: A case study on Biocon Academy

Keynotes
Biotechnology is a relatively young field in India, and it can sometimes be challenging to source for helpful manpower as real talented young individuals often get allured by overseas opportunities. This case study will share Biocon’s success story in building an academy with financial support and assistance to help young graduates to explore more options in their career, whilst growing essential talents to support the local ecosystem in India.
 
Bindu Ajit, Program Director, Biocon Academy
Sep 2011:20
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Process chromatography selection for downstream processing

Biologics Manufacturing
  • What are some of the new chromatography options available and how do they stack against existing ones?
  • Understanding key considerations such as biologics stability, buffer compatibility and ease of scale up
Sep 2011:20
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Biotech showcase

Biotech Innovation
Caroline Mathen, CEO, Co-Founder, OCT THERAPIES AND RESEARCH PVT LTD
Sep 2011:30
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Biotech showcase

Biotech Innovation
Pradip Sinha, Co-Founder, InvivoD Solutions
Sep 2011:40
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Exploring the implementation of single use in downstream processing

Biologics Manufacturing
  •     Identifying the benefits of single use in downstream processing: Cost savings, reduced turnaround time, lower capital outlay & more
  •     Understanding the limitations of utilizing single use in downstream processing: Increased inventory, insufficient data on leachables & extractables, scalability
  •     Case Study of fully single use downstream processing
Manish Sharma, Sr. Manager, Head of Downstream Processing, IPCA
Sep 2011:40
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Biotech showcase

Biotech Innovation
Sep 2011:50
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Sep 2012:00
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Strategies for overcoming the downstream bottleneck for Cell and Gene Therapy (CGT)

Biologics Manufacturing
  •     Identifying the key areas of bottleneck in downstream processing (harvesting, washing, cell concentration, formulation, final fill/finish, and preservation)
  •     Balancing between high specificity and high throughput of downstream platforms for maximum efficiency
  •     Exploring ultra scale-down tools to better predict large scale downstream processing steps 
Sep 2012:00
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Biotech showcase

Biotech Innovation
Parul Ganju, Executive Director, Ahammune Biosciences
Sep 2013:30
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Ensuring uniformity of GMP inspections in biologics manufacturing

Biologics Manufacturing
Countries across the globe are concerned about the safety and efficacy of the drugs supplied. As India expands its biologics supply globally, there is an increased emphasis in ensuring uniformity in inspection requirements for drugs manufactured in India. This panel discusses how global regulators such as US FDA, EMA can work closer together with CDSCO in ensuring uniformity in GMP inspections.
  • Overview of India’s inspection landscape and updates
  • Understanding the differences and overlaps in current standards
  • Exploring ways for various regulators to work closer together, including more combined inspections for newly recruited CDSCO inspectors
Mayur Parmar, Senior Drug Inspector, Gujarat FDA
K Bangarurajan, Deputy Drugs Controller West Zone, CDSCO
Sep 2013:30
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Biotech showcase

Biotech Innovation
Rohan Kamat, Co-founder, Viravecs Labs
Sep 2013:40
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Sep 2013:50
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Sep 2014:00
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Biotech showcase

Biotech Innovation
Arun Chandru, Co-founder, Pandorum Technologies
Sep 2014:10
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Resolving the regulatory compliance issues in India

Biologics Manufacturing
  • Exploring solutions for data integrity issues in manufacturing plants
  • Ensuring proper recording of data for improved data quality
  • Emphasis on long term quality culture as compared to quick fix solutions.
Dr Akshay Goel, Senior Vice President - R&D, Biological E Ltd
Sep 2014:10
Conference pass
Sep 2014:30
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Analytical Development of novel immuno-oncology (IO) drugs

Biologics Manufacturing
  •     Exploiting various modes of biological IO treatments
  •     Efficacy assays and predictive toxicology for target validation
  •     Analytical process development and CMC strategies for novel I-O drugs
Sep 2014:30
Conference pass

Biotech showcase

Biotech Innovation
Anand M Joshi, Product development executive, OmniBRx Biotechnologies Pvt ltd.
Sep 2014:40
Conference pass
Sep 2014:50
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Practical considerations for establishing analytical similiarity in biosimilars

Biologics Manufacturing
  • Assessment of critical quality attributes (CQA) and evaluation of tiers
  • Using risk management principles to supplement statistical approaches for assessment of analytical similarity for CQAs
  • Ranking of quality attributes based on potential impact on activity, PK/PD and immunogenicity
Sep 2014:50
Conference pass

Biotech showcase

Biotech Innovation
Chaitanya Saxena, Chief Executive Officer, Shantani Proteome Analytics Pvt Ltd
Sep 2015:00
Conference pass
Sep 2015:10
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Development of liquid chromatography-Mass spectrometry (LC-MS/MS) based methods for pharmacokinetic and toxicokinetics study of biologics

Biologics Manufacturing
  • Advantages of LC-MS/MS based methods over ELISA methods
  • Parameters to be considered while developing LC-MS based methods for pK/tK  study
  • Challenges during method development and validation: requirement of stable isotope labeled internal standards
Dipak Thakur, General Manager, Genomics and Biotechnology, Wockhardt Ltd
last published: 18/Aug/17 06:15 GMT

 

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