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.

 

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09:00
Conference pass

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?
09:30
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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?
11:30
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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
11:50
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Leveraging Europe’s burgeoning biosimilars market

Keynotes
  • Updates on issues regarding regulatory harmonization, naming and labelling, innovative licensure norms and route to market
  • Blockbuster’ biologics expected to lose their EU patents before 2020, such as breast cancer, diabetes, multiple sclerosis and rheumatoid arthritis treatments
  • Replicating Truxima’s successful launch and approval for all indications
12:10
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Opportunities in the Middle East: Strategies to break into MENA region

Keynotes
  • Updates on reference pricing and GCC price unification for MENA region
  • Understanding the different financing models within MENA (Public financing of GCC vs Mixed financing of Near East and North Africa regions)
  • Strategies to overcoming slow and arduous regulatory processes in MENA
  • Growing interest of MENA countries in adopting HTA and pharma-economics for payer decision making
14:50
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How is the biosimilars market developing globally and what does the future hold for biosimilars?

Biosimilars
As the drive for cheaper medicines continues, many companies are developing biosimilars as a cheaper alternative to novel biologics.
This panel discuss will look at the current global market conditions and explore future biosimilars trends.
  • Which biosimilars have recently been approved for sale in major markets and how did they do it?
  • Exploring the latest developments in biosimilars: What does it take to achieve scale?
  • What lies ahead for biosimilars in terms of regulations and IP?
  • How can India better establish itself in the global market?
14:50
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Global Vaccines Action Plan (GVAP): What is India’s role in this?

World Vaccines Congress India
  • Updates for GVAP Review Process & Indicators
  • How does it affect the industry?
  • With India already being the leading manufacturers in vaccines for the world, how better can we contribute?
14:50
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Using 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 change the role of humans?
15:10
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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
15:10
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Continuous processing: How does it impact drug quality?

Biologics Manufacturing
  • Exploring ways to better spot and correct errors by eliminating breaks between process steps
  • Improving quality through better monitoring of process parameters (PAT)
  • How built in tracking can ensure quality
15:30
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Global scientific alignment of biogenerics 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
15:30
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Preparing the workforce for shift towards biologics manufacturing in India

Biologics Manufacturing
  • Understanding the skill and knowledge gaps in India’s current workforce
  • Exploring strategies for improvement of capability of India’s workforce
  • Case Study: Existing systems for continued training and education
16:30
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Exploring JAPAC’s biosimilars market

Biosimilars
  • Market impact of Australia's current controversy in empowering pharmacies to substitute an original for Inflectra without prescriber consultation
  • What does Japan's 30% biosimilar price reduction mean to the manufacturer? Is this a discount to the Japanese borne by the government? How will this increased biosimilar market share in Japan impact Japan's biosimilar market?
  • With Celltrion and Samsung Bioepis in South Korea, does the country have room for international biosimilar investment?
16:30
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India’s vaccine R&D outlook: Advances & opportunities

World Vaccines Congress India
  • Exploring how novel technologies can reduce the cost of vaccines production
  • Identifying key research areas for vaccines development in India (Eg. PCV, HPV)
  • Does the need for affordable medicines affect the R&D outlook?
16:30
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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: Bringing technology from US/EU to Asia
16:50
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Southeast Asia’s biosimilars market: Where do we go from here?

Biosimilars
Southeast Asia’s biosimilars market: Where do we go from here?
  • Understanding the ASEAN biosimilar regulation, the ACTR, ACTD and the ACCSQ
  • Leveraging Malaysia's growing biosimilars market and the demand for quality health in the country
  • Strategies around challenges in tech know-how and regulatory agencies different approaches and understanding of concepts
  • Crystal ball: What’s next on the horizon?
16:50
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Case Study: Novel platform technology for producing vaccines

World Vaccines Congress India
CPL’s recombinant nanoparticle platform technology
16:50
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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
17:10
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Case Study: Novel vectors and cell-line for vaccines production

World Vaccines Congress India
Sementis’ SCV vector and CHO Rescue cell-line technology
17:10
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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

Create your personal agenda –check the favourite icon

09:10
Conference pass

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?
09:35
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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?
 
10:00
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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.
 
11:20
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How can regulators and pharma work closer together to establish a robust regulation framework?

Biosimilars
Following 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?
11:20
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Case Study: Thermal Stability in Vaccines

World Vaccines Congress India
Serum’s thermal stable Rotavirus vaccine in Phase III
11:20
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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
11:40
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Case Study: mRNA Vaccines

World Vaccines Congress India
Moderna
CureVac
 
11:40
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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
12:00
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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
12:00
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Case Study: New class of synthetic Vaccines

World Vaccines Congress India
VBI Vaccines’ new eVLP platform
12:00
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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
14:10
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Overcome the 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?
14:10
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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
14:10
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Are neoantigen vaccines the future of cancer vaccines?

World Vaccines Congress India
  • What are some of the advances in personalized vaccines based on neoantigen?
  • Exploring collaborations between institutions and pharma to further neoantigen research
  • Case Study on ADXS-NEO
14:30
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Using therapeutic vaccines to cure HIV

World Vaccines Congress India
  • Overview of progress in development of HIV vaccines
  • Preliminary data presentation and case study
14:50
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Guidelines for Similar Biologics 2016: How do they help?

Biosimilars
  • Understanding the updates in the guidelines for biosimilar productions
  • How have the guidelines helped to reduce time to market over the past year?
  • Can we take it further? Exploring further improvements
14:50
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Case Study: Stem cell Vaccines

World Vaccines Congress India
Dendrit Biotech
J W CreaGene
14:50
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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.
15:10
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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
  • Case study: GSK
15:10
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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.
15:10
Conference pass

Best Practices for Analytical Method transfer: Lifecycle management perspective

Biologics Manufacturing
  • Emphasis on adequate method transfer as part of life cycle management
  • Understanding regulatory requirements for transfer
  • Continuous performance monitoring and management of analytical procedures following transfer
15:30
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Understanding requirements of local trials data for approval

World Vaccines Congress India
  • Case study: Sanofi’s Dengvaxia
  • Understanding the rationale for the rejection of waiver of phase III trials of Dengue vaccines in Indian population
  • Exploring the key considerations in using of global data to justify waiving of phase III studies in India
15:30
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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
15:30
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How would the National IPR Policy affect the future of biosimilars in India?

Biosimilars
  • Overview of the National IPR policy
  • What are the requirements for IP filing under this new policy?
  • Understanding how it affects biosimilars
15:50
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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?
15:50
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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
15:50
Conference pass

Biosimilars IP wars Overview 2016: Lessons to learn

Biosimilars
  • Understanding the requirements and restrictions in obtaining IP protection for biosimilars
  • Comparing the different IP regulations in different countries
  • Case study: Roche’s Erlotinib/ Avastin/ Herceptin/ Pfizer’s Prevenar

 

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