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 1908:55
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Chairman’s opening remarks

Keynotes
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
Conference pass

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
Conference pass

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
Sep 1911:50
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Table 2: Single-Use Technology - qualification testing for the films used in flexible bags (BioProcess Containers)

Keynotes
Sep 1911:50
Conference pass

Table 1: Technology road mapping and industry collaboration in biologics manufacturing

Keynotes
Sep 1911:50
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Table 3: Innovative market access, RWE and HEOR strategies for emerging and mature products in India

Keynotes
Sep 1913:50
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Chair’s opening remarks

Biologics Manufacturing
Sep 1913:50
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Sep 1914:00
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The latest Biosimilar strategy to conduct clinical trials in India

Biosimilars
Regulation was previously a big issue in India but the country is making a comeback as a biosimilars trial destination. Join this session to learn more about the latest regulations and key requirements for conducting biosimilar trials in India. Topics include quality compliance in running biosimilar trials in India. 
Sep 1914:00
Conference pass

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
Sep 1914:00
Conference pass

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
Sep 1914:20
Conference pass

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 1914:25
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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 1914:40
Conference pass

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 1915:25
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Sep 1915:25
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Sep 1915:30
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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?
Sep 1915:30
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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 1915:30
Conference pass

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? 
Sep 1915:50
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Case Study: Novel platform vector and CHO cell substrate technology

World Vaccines Congress India
  •     Development of a novel vaccine delivery vehicle derived from vaccinia virus called SCV
  •     The cell substrate for the production of SCV is a genetically engineered CHO suspension cell line
  •     SCV has been used to develop protective vaccines for chikungunya and zika virus infection
Sep 1915:50
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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 1916:10
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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 1916:10
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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
Conference pass

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?
Sep 1916:30
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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 1916:30
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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
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 1916:50
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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

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Sep 2009:10
Conference pass

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?
 
Sep 2009:35
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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 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.
 
Sep 2011:15
Conference pass

Chair’s opening remarks

Biologics Manufacturing
Sep 2011:15
Conference pass
Sep 2011:20
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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 2011:20
Conference pass
Sep 2011:30
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Biotech showcase

Biotech Innovation
Sep 2011:40
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Biotech showcase

Biotech Innovation
Sep 2011:45
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Viral safety testing and clearance in biopharma industry

Biologics Manufacturing
  •     Overview of viral contamination events in the Biologics Industry
  •     Consequences of the viral contamination in Biologics drugs
  •     Importance of viral risk mitigations in ensuring safety of drugs
  •     Regulatory expectations for viral safety in Biologics
  •     Syngene’s  support towards meeting viral safety requirements of the Biologics manufacturers
Sep 2011:50
Conference pass
Sep 2013:30
Conference pass

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
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
Sep 2014:10
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Scaling up Vaccine Production: Process Validation

Biologics Manufacturing
  • Demystifying process validation
  • Process validation deliverables
  • Application in vaccine industry: Post Approval change
  • Application in Pharma industry: Warning letter
Sep 2014:30
Conference pass

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
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
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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
last published: 18/Sep/17 05:35 GMT

 

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contact Pinky Fadullon at pinky.fadullon@terrapinn.com or +65 6322 2738