BIOSIMILARS

Biosimilars, Thursday 1 March 2018

08:45

Organiser's Welcome Remarks

08:50

Chair's Opening Remarks

Asia's Biotech Landscape:Innovation & Funding

Carolyn Ng
09:00

Venture capital funding for the biotech industry: A case study

It takes millions of dollars to transform an innovative idea to a commercially viable pharma product. Especially in developing countries where the government has other more important priorities than to invest in early stage companies, the role of the VC becomes even more crucial and necessary for success. Investigate how VC helps biotech to take flight in the competitive generics and biosimilar-focused Asia market.
 
John Connolly
09:20

Fostering biotech and bio-entrepreneurship in Asia: How do we build the next biotech unicorn in Southeast Asia?

Southeast Asia is extremely diverse. It is a home to near 620 million people across 11 countries, each with different languages and religions. Among the countries many are still in the developing stage where R&D is not as much a priority than providing necessity to minimise the income gap between the rich and the needy. Yet thriving biotech landscape offering innovative solutions is starting to be seen. What needs to be done to help these promising companies to fully realise their potential? How can ASEAN come together in supporting the biotech industry in the region, as well as building the next possible biotech unicorn in SEA?
 
Panel discussion
09:40

The Macro View: What will it take for Asia’s biotech industry to really flourish?

Everyone knows it is too generic to classify all Asian countries in a single category. With the exception of China and India, the remaining part of Asia is complicated, fragmented and diversified. With growing GDPs and middle class populations, the potential of Asia’s biotech industry is undeniable in the eye of global leaders. The main question is, how can government and related stakeholders assist the biotech industry to flourish to provide more affordable, personalised medicine for its populations? How do countries move away from a “me-too” to “me-first” mentality, especially when it comes to pharma R&D?
 
10:20

Speed Networking

10:30

Exhibition Visit & Networking Refreshments

Biosimilars in Asia

Biosimilars
10:55

Chair's Opening Remarks

Joe Zhou
Biosimilars
11:00

mAb Industry in China: Biosimilars vs. Innovative Biologics

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  •     Landscape changes of mAb therapeutics
  •     New targets and process/manufacturing innovation
  •     Key consideration of mAb industry in China  
Forrest Hu
Biosimilars
11:20

Invention vs innovation: How Asian pharma companies remain competitive in the biosimilar space

Asian companies have seen more success in the generics and biosimilars space compared to their peers in developed markets. With the success of Celltrion, Samsung, Dr Reddy’s, Biocon and more Asian pharma companies, should Asian companies focus on core expertise to improvise originator drugs, or on inventing new drugs for Asia-specific diseases?
 
Kaustubh Berde
Biosimilars
11:40

Cost vs quality: What’s the best strategies for Asia biosimilars market?

  • Exploring strategies in addressing differences in biosimilar regulation
  • Case study: Regulated vs unregulated biosimilars market in Asia
  • Overcoming challenges in tech know-how and different approaches and understanding of concepts by regulatory agencies
Kaustubh Berde, Vice President for International Business : Emerging Markets, Wockhardt Limited
12:00

Roundtable Discussion Session

Now's your chance to get really interactive. Simply pick a table and join the debate. 

Table 1: Upcoming vaccines in Asia and how to prepare for it

Table 2: Sustainable vaccines strategies in global health, high-income and private sector

Table 3: Sustainable biosimilar models in Asia

Table 4: Key strategies to overcome challenges in biosimilar development and manufacturing processes

Table 5: What can we learn fromCAR-T, PDL1, Cancer Vaccines successes, and what’s next in Asia?

Table 6: CRISPR & Precision medicine

Table 7: AI& Big data in drug discovery

Table 8: IoT and blockchain in clinical studies

Table 9: Pricing & Reimbursement strategies in Asia

Table 10: What can we do to reconcile our diversified pharma regulations in Asia?

Table 11: Bringing it together: Roles of Patient, Pharma, Hospital and Government in Drug Development

12:50

Exhibition Visit & Networking Lunch

Biosimilar Regulation

Biosimilars
14:10

Chair's Opening Remarks

Biosimilars
14:20

Operating in countries with developing biosimilar guidelines

  • Displaying product’s similarity in clinical performance, quality, and potency
  • Convincing authorities that the designed manufacturing process is well understood and robust
  • Marketing products at a lower price as compared to originator 
Biosimilars
14:40

Could adoption of biosimilars be slowed due to government rebates on biologics?

Biosimilars may be priced lower but government pre-existence rebates on originator products may possibly slow down uptake. If that’s the case, should companies expand to untapped emerging economies instead of focusing on developed countries?
Biosimilars
15:00

Regulatory and quality requirements for biosimilar filing- An overview

We know South Korea, China and India are big players in biosimilars, but what about South East Asia? With over 5% GDP growth per year, countries such as Vietnam, Cambodia, Indonesia, and Malaysia have an increasingly high demand for affordable treatments. This presentation investigates the regulatory aspects in filling for approval in to access the SEA pharma industry.
 
15:20

Exhibition Visit & Networking Refreshments

Biosimilars Development

Biosimilars
16:00

Choosing the right Asian country for your biosimilar trials

  • Exploring solutions for overcoming the unique challenges in running clinical trials for biosimilars in Asia
  • Overcoming knowledge gaps among investigators when it comes to handling biosimilars
  • Crafting education and awareness campaigns to promote trial participation interest
Dinesh Kundu
Biosimilars
16:20

India’s Biosimilar clinical trials landscape: What do you need to know?

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.
Sujay Singh
Biosimilars
16:40

Moving from generic antibody supplier to biosimilars developers: Key insights learnt from development to biosimilars productions

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  •     Sharing of company background and insights learnt moving from antibodies supplier to biosimilars developer 
  •     Discussing strategies to maintain product quality in upscaling biosimilars
  •     Exploring key assays techniques and development for biosimilars testing
Sujay Singh, Chief Executive Officer, Imgenex India Pvt. Ltd
17:00

Networking Cocktail & Phar-East Industry Awards Presentation

last published: 20/Nov/17 06:25

Biosimilars, Friday 2 March 2018

09:00

Organiser's Welcome Remarks

09:05

Chair's Opening Remarks

Disruption & Digitalisation

09:10

Pharma 4.0: How digitisation & disruption are creating a need for agility and entrepreneurship in pharma

Digitisation is changing the way pharma interacts with payers, doctors and patients, leading pharma to seek out different skills and personality traits in employees. The challenge is selecting the right disruptor to foster a forward-thinking organisation, and identifying the suitable digital strategy whilst also complying with local regulations and continuing to invest in core R&D capabilities. Hear from big pharma on how they are moving forward and embracing the digital disruption.
 
09:30

CAR-T therapy, the next miracle drug in the making

Recently raised to fame as the new miracle method to treat even the most stubborn cancer cases, CAR-T trials have proven to save patients who have failed all known treatment. However, the rapid advances still stir fears about the safety of the drug after failed cases and deaths on some pharma sponsored trials. With more companies putting their CAR-T pipeline to test in the market, how can regulators ensure patient safety? And from a pharma perspective, what methods can they adopt to produce these highly personalised, customised treatments at scale? Even if it becomes fully approved for commercial deployment, what needs to be done to help patients afford the sky high cost of immunotherapy?
 
Ivor Lim
09:50

Working with increasingly informed and empowered patients in the digital ageEducated guesses, lofty aspirations, hard realities

Ideas are free and to be able to catch one by the wings and bring it back to ground is a wonderful feeling indeed. For doctors, the next step is to bring this good idea into the wards for the patient’s benefit. The transition of bench research to bedside application seems very straightforward at first glance, but it is not until the first steps are taken that one realises the numerous hurdles that have to be surmounted in order to achieve this. In the best interests of the patient, this translational sequence is prescriptive and tedious, and yet it pays no heed to other essentials crucial for the translational effort to be truly successful. This presentation also shares the journey of CellResearch Corporation which 13 years to see the light at the end of the tunnel.
10:10

Exhibition Visit & Networking Refreshments

Manufacturing: Upscaling

Biosimilars
11:00

Chair's Opening Remarks

Hung Fai Poon
Biosimilars
11:10

Platform tech development for biosimilar upscaling

  • Discover strategies to move candidate molecules through development
  • Building consistent, straightforward processes with low variability
  • Exploring the possibility of using single use, high throughput bioreactors in the upscaling process
Solomon Alva
Biosimilars
11:30

Continuous processing in biosimilars development and production

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  •     Key strategies in developing quality, novel biosimilars
  •     Getting familiar with the regulatory processes to establish alignment with stakeholders 
  •     Exploring options to either invest in advanced production processes with the help of single use technology, or choosing a reliable external outsourcing partner
Biosimilars
11:50

Outsourcing biosimilar manufacturing as an alternative to successful upscaling processes

  • What are the deciding factors in choosing a partner for biosimilar manufacturing?
  • Cost vs quality: Deciding between a more affordable local partner and a costlier but more trustworthy international one
  • Case study in Asia
12:10

Exhibition Visit & Networking Lunch

Marketing & post authorisation

Biosimilars
13:40

Chair's Opening Remarks

Biosimilars
13:45

Adoption of biosimilars-issues and challenges

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  •     Getting marketing authorisation is not enough, how do biosimilar companies convince providers to switch to more affordable yet less established biosimilar alternatives?
  •     Exploring alternative strategies in developing vs developed markets
  •     Establishing awareness campaigns for patients and prescribers 
Biosimilars
14:05

Exploration and construction of physician training in handling biosimilar drugs

  •     Strategies for implementing frameworks to promote biosimilar awareness 
  •     Crafting patient education and engagement programs in Asia 
  •     Exploring strategies to overcome delayed ADR effects
Biosimilars
14:25

Understanding post market data and Adverse Drug Response reporting for biosimilars

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  •     Using post market data to identify immunogenicity of biosimilar drugs
  •     Performing benefit-risk analysis to ensure drug safety
  •     Collecting ADR in developing countries: How do we do it?
14:45

Exhibition Visit & Networking Refreshments

Pharmacovigilance

Stewart Geary
Biosimilars
15:15

Good Pharmacovigilance Practice (GVP): What can Asia learn from the EMA?

The EMA has recently set up a new chapter in its guidelines dedicated to good pharmacovigilance practices.  This is a measurement designed to ensure a robust system for safety monitoring, to protect patients’ interests. What are the similar guidelines in Asia and what can we learn from GVP when running biosimilar trials in Asia? Should GVP be a compulsory practice in Asia?
Biosimilars
15:35

GMP & Pharmacovigilance

  •     Incorporating medical expertise, clinical assessment of potential safety issues with product performance and quality systems
  •     Establishing Critical Quality Attributes (CQA) for safety and filling issues
  •     Good risk control strategies to minimise medical patient risk
Biosimilars
15:55

Challenges and opportunities for pharmacovigilance in resource constrained settings

  •     Discovering strategies to promote adverse drug reporting (ADR) in emerging economies 
  •     Promoting awareness and monitoring of ADR with limited resources

Close of Phar-East 2018

last published: 20/Nov/17 06:25