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
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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?
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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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?
11:30
Conference pass

India’s vaccine R&D outlook: Advances & opportunities

Vaccines
  • 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?
11:30
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Are multipurpose manufacturing facilities the future of biologics manufacturing in India?

Biologics Manufacturing
  • Evaluating critical engineering aspects in designing of plant such as space and structural considerations
  • Equipment procurement and site planning considerations
  • Cost and benefit analysis of building a multipurpose facility: Do the numbers stack up for you?
11:30
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Show me the money! Support structures available for Biotechs to obtain funding

Therapeutic Innovation & Partnering
  • Identifying available funding and grants
  • Understand the role of the government in assisting Biotechs through incubators and accelerators
  • Exploring available resources for Biotechs to tap on (e.g office spaces, lab facilities and equipment)
  • How do you even get started?
11:50
Conference pass

Exploring ways to break into India’s private market

Vaccines
As one of the world’s most populous countries, India’s private market has huge potential for you to tap into. Many companies are looking at ways to get a share of the pie. This panel explores the challenges and strategies for entering India’s private market.
 
  • How should we navigate the fragmented reimbursement structure as well as the price ceiling in India?
  • What are the current demands on vaccines in India?
  • How should companies price their drugs to be competitive in this market?
11:50
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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?
11:50
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How and when should investors be involved in biotech funding?

Therapeutic Innovation & Partnering
Every new business needs some startup capital, for research, product development and production, permits and licensing and other overhead costs, in addition to what is needed to pay your staff, if you have any. Once you establish your needs based on the size of your company and what stage of development it is at, you have several options for obtaining funding to choose from. This panel explores how you can secure it.
 
  • When should you start seriously looking for funding?
  • Would angel investors or venture capital funding be more appropriate for you?
  • What are investors looking out for before they decide to fund a Biotech?
  • How should Biotechs position themselves better to be more attractive to investors?
  • Is it all about relationships, or do you just need a great idea?
12:10
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To copy or to create: Considerations for developing biobetters or novel biologics

Biosimilars
  • Should biobetters be a lucky byproduct of developing biosimilars or the other way around?
  • Understanding the difference in cost and time to market between developing biosimilars and novel biologics
  • Case Study 
12:10
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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
14:50
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USA’s move to attract more biosimilar investment: FDA’s new guidelines on interchangeability

Biosimilars
  • Proving a therapy as highly similar to a reference biologic and no meaningful differences in safety and efficacy: FDA’s abbreviated licensure pathway
  • Laying down the law on interchangeability
  • Understanding the ‘patent-dance’ requirements laid out in the Biologics Price Competition and Innovation Act (BPCIA)
  • Medicare and Medicaid biosimilar policy and the newly negotiated Biosimilar User Fee Act (BsUFA II)
14:50
Conference pass

Are neoantigen vaccines the future of cancer vaccines?

Vaccines
  • 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 Parker Institute and Cancer Research Institute and data presentation
14:50
Conference pass

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
15:10
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Leveraging Europe’s burgeoning biosimilars market

Biosimilars
  • 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
15:10
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Lessons to learn from Provenge: Is such a high cost of approval even worth it?

Vaccines
  • Understanding the cost of production and administration of Provenge
  • Evaluating the reimbursement to determine suitability for adoption
  • Personalization as the key to address heterogeneity
15:10
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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
15:30
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LatAm: Investment, market access, and reimbursement issues in this key regional growth market

Biosimilars
  • Taking advantage of Brazil, Mexico and Argentina's need for Adalimumab biosimilars for RA
  • Updates on the practical implementation of Mexico as a regional reference agency for other LatAm countries
  • What it takes to successfully launch biosimilars in LatAm and their various reimbursement infrastructure
15:30
Conference pass

Discovering the effectiveness of vaccines in combination therapy

Vaccines
  • Exploring the use of cancer vaccines with checkpoint inhibitor in combination treatments
  • Case study on BMS Opdivo and Bavarian Nordic CV301 cancer immunotherapy vaccines
15:30
Conference pass

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
16:30
Conference pass

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
Conference pass

Using therapeutic vaccines to cure HIV

Vaccines
  • Overview of progress in development of HIV vaccines
  • Preliminary data presentation and case study
16:30
Conference pass

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
16:50
Conference pass

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
Conference pass

Made in India: The world’s first Leprosy vaccine

Vaccines
  • Overview of true leprosy situation in India
  • Insights into the implementation of advanced field trials for Mycobacterium indicus pranii (MIP) vaccine in India
  • Data presentation and case study
16:50
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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
17:10
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India’s malaria vaccines: How far away are we?

Vaccines
  • Evaluating the challenges in developing malaria vaccines in India, including parasite complexity, protozoa, lack of funding & more
  • Updates of the development of malaria vaccines (20 candidates in Ph I/II)
  • Data presentation and case study (PfSPZ-CVac)
17:10
Conference pass

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

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
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?
 
10:00
Conference pass

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
Conference pass

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
Conference pass

Development of Chikungunya vaccines in India

Vaccines
  • Understanding the chikungunya situation in India
  • Updates of the development of chikungunya vaccines
  • Data presentation and case study (Eilat/chikungunya vaccine)
11:20
Conference pass

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
11:20
Conference pass

Affordability of drugs for India’s mass market

Commercialisation
  • Understanding the impact of the price ceiling & average pricing in managing drug prices in India
  • Exploring strategies for pharma to work together with the government to keep drugs affordable
  • Future outlook of drug pricing environment in India
11:40
Conference pass

Understanding requirements of local trials data for approval

Vaccines
  • 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
11:40
Conference pass

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
11:40
Conference pass

Affordability vs Innovation: Striking a balance

Commercialisation
Innovation has been a much discussed topic in India as the pharma industry shifts away from generics, towards biosimilars and novel biologics manufacturing. With the focus of the generics market aimed at making drugs as cheap as possible, many local companies want to innovate but face the issue of lack of capital for innovation.
 
  • How can government help pharma in terms of funding for innovation?
  • Would open innovation help in the reducing the cost of innovation for pharma?
  • How can pharma still innovate while focusing on affordability?
12:00
Conference pass

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
Conference pass

Leishmaniasis vaccines development: Status of potential vaccines candidate in trials

Vaccines
  • Understanding the Leishmaniasis situation in India
  • Updates of the development of leishmaniasis vaccines
  • Data presentation and case study (LEISH-F3 vaccine)
12:00
Conference pass

Practical approaches to Quality by Design (QbD) implementation

Biologics Manufacturing
  • Exploring ways to design robust processes using statistical design of experiments (DoE)
  • Selecting the right process analytical technology (PAT) tools
  • Process validation in the QbD paradigm
14:10
Conference pass

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
Conference pass

Overcoming challenges in bringing new vaccines into India

Vaccines
  • Working together with BIPP, BIG, BIRAC & more to overcome lack of government support and funding
  • Exploring incentive structures to overcome misconstrued inclusion of vaccines into NLEM which demotivates industry
  • Improving communication channels with regulators to overcome regulatory challenges and redundancies
14:10
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
14:10
Conference pass

Pay for Performance Drugs: Case Study on Novartis’ Entresto/ Eli Lilly’s. Trulicity/ Amgen’s Repatha

Commercialisation
  • Understanding the considerations behind implementing a pay for performance reimbursement model
  • Understanding the requirements and data necessary for implementing such a model
  • Case Study
14:30
Conference pass

Lower price for more Access: How do we determine the sweet spot?

Vaccines
  • Understanding the demand and potential of the private market in India
  • Explore strategies in maximizing profitability through pricing vs volume analysis
  • Case study: GSK
14:30
Conference pass

Would a performance based pricing model work for India?

Commercialisation
As the demand for quality, cheaper healthcare increases around the world, many companies are turning towards a performance based reimbursement model for drug reimbursement. This panel will explore its applicability in India.
 
  • Is there a focus on quality over cost in India?
  • Will states willing to pay for better quality?
  • As India’s market is still developing, would there be enough demand for high quality drugs for this model to work?
  • How can you reconcile a performance-based pricing model with the need for affordable healthcare?
14:50
Conference pass

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
Conference pass

PCV Vaccine competition in India: Is $5 per dose possible?

Vaccines
  • Identifying current players in PCV vaccine manufacturing
  • Exploring pricing strategies for PCV vaccine in India
  • Ensuring stability and quality of vaccine
14:50
Conference pass

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
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.
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
15:10
Conference pass

The US reimbursement model: A case study

Commercialisation
  • Understanding the reimbursement model in the US (Very little out of the pocket expenses)
  • Pros and Cons analysis of the US model
  • Comparing the applicability of such a model in India
  • Are there other models that might suit India better?
15:10
Conference pass

Considerations for vaccines market access: Public or Private?

Vaccines
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?
  • Explore strategies in overcoming these challenges
15:30
Conference pass

Optimizing analytical methods used for stability testing

Biologics Manufacturing
  • Identifying stability attributes and necessary tests for measurement
  • Exploring analytical methods indicative of stability
  • Understanding the validation necessary for the different phases of development
15:30
Conference pass

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
15:30
Conference pass

Future of India’s pricing and reimbursement

Commercialisation
India currently has different reimbursement structures for each of their states. This results in a very fragmented structure. This panel will explore how the different states can work closer together to establish a better reimbursement framework.
  • How can states collaborate to regulate payment of drugs to prevent over or underpayment?
  • How should the reimbursement structure be determined? What drugs should be reimbursed?
  • Should the drugs be reimbursed based on price alone or should quality be considered as well?
15:50
Conference pass

WHO Prequalification updates

Vaccines
  • Taking a look at recent updates for WHO prequalification
  • Analysis of WHO Public Inspection Reports to identify potential pitfalls
  • Strategies for overcoming challenges in meeting standards
15:50
Conference pass

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
15:50
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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contact Pinky Fadullon at pinky.fadullon@terrapinn.com or +65 6322 2738