Biosimiliars

Biosimilars, Tuesday 19 September 2017

REALISING INDIA'S PHARMA VISION 2020

08:50

Organiser’s welcome remarks

Vikas Dandekar
08:55

Chairman’s opening remarks

Suja Chandy
09:00

Pharma Vision 2020, How close are we to the goal?

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?
Panel discussion
09:30

Boardroom panel: Creating a robust ecosystem for pharma in India

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?
10:30

Speed Networking

11:00

Networking Refreshments & Exhibition Visit

Rodrigo Blanco Zamora
11:30

LatAm: Investment, market access, and reimbursement issues in this key regional growth market

  • 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

Roundtable discussion

11:50

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

11:50

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

11:50

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

12:30

Networking Lunch & Exhibition Visit

Biosimilars Market Outlook

Pawan Kumar Singh
Biosimilars
14:00

The latest Biosimilar strategy to conduct clinical trials in India

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. 
Panel discussion
Biosimilars
14:25

Understanding post-market data and ADR reporting for biosimilars in India

  •     Emphasising the importance of identifying immunogenicity for biosimilars
  •     Understanding impact of delayed ADR in biosimilars
  •     Utilizing Benefits-risk analysis to ensure safety

Regulating India's Biosimilars Market

15:00

Networking Refreshments & Exhibition Visit

Panel discussion
Biosimilars
15:30

How can regulators and pharma work closer together to establish a robust regulation framework?

    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?

Commercialization & IP Protection

Panel discussion
Biosimilars
16:30

Overcoming challenges of bringing biosimilars to market

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?
17:10

Networking Drinks Reception

last published: 18/Sep/17 06:35