Phar-East 2018 Programme Agenda

 

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Singapore, 1 - 2 March 2018

Schedule

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Feb 2810:30
Conference pass

Building an entrepreneurial management team

Biotech workshop
Hardy Chan, Founder and Chairman, Allianz Pharmascience
Feb 2811:00
Conference pass

Effective digital strategy in biotech start-up business

Biotech workshop

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Mar 109:00
Conference pass

Venture capital funding for the biotech industry: A case study

Keynotes
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.
 
Mar 109:20
Conference pass

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

Keynotes
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?
 
Mar 109:40
Conference pass

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

Keynotes
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?
 
Mar 110:55
Conference pass

Thailand & Vietnam

Partnering & Licensing
Join us at this interactive roundtable session for an informal, one hour discussion with local pharma companies interested licensing their products. Ideal for pharma companies looking for local partners and distributors, and for distributors looking for new business opportunities.






 
Mar 111:00
Conference pass

Preparing for infectious viruses emerging from human-animal interface

Vaccines
From MERS to Ebola, Zika to bird flu, to yellow fever and more, human populations are experiencing a continuous onslaught of viral diseases emerging from nature. So how can we be prepared for the next epidemic episode?
 
Mar 111:00
Conference pass

Preparing for the blockbuster patent cliff 2020

Biosimilars
Following patent cliffs for Erbitux, Rituxan, Sandostatin, Vytorin and several big blockbusters, Herceptin, Avastin are now among the next biosimilar targets. This is creating huge potential for biosimilars, prompting innovators to shift their focus to target more emerging markets which remain untapped for many companies. What trends can we expect in 2018 and beyond?
 
Mar 111:00
Conference pass

Cancer precision medicine: From screening to drug selection and development

Immunotherapy
  • Personalised, affordable and high efficacy are the ideal criteria of a medicine. But the big question is how do we actually move towards providing highly personalised medicine to patients in need?
  • Investigate the pathway to the future of medicine, from drug discovery, development to reaching out to the patients.
Mar 111:00
Conference pass

Digital trends impacting clinical trials

Pharma 4.0
  • An overview on how data can transform pharma trials, from recruiting patients to real time drug performance evaluation
  • Using digital tools to optimise site selection, identification and engagement
  • Enhancing patient recruitment and compliance in trials conduction
Mar 111:00
Conference pass

Innovative access strategies for mature products in Asia

Market Access
Asia is home to generics, branded generics, non-branded generics and incremental modified drugs. How do established companies stay ahead in competition to better provide for patients? 
Mar 111:00
Conference pass

Investor Insights

Biotech Innovation
Mar 111:10
Conference pass

Biotech Showcase

Biotech Innovation
Mar 111:20
Conference pass

New vaccines for epidemic infectious diseases

Vaccines
  • Discovering rapid testing tools for infectious diseases prior to successful vaccine deployment
  • How do we speed up the development of effective vaccines in the case of epidemics?
Mar 111:20
Conference pass

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

Biosimilars
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?
 
Mar 111:20
Conference pass

Awakening the immune system against cancer - Moving into the clinic

Immunotherapy
Is cancer immunotherapy the beginning of the end of cancer? Discover cases where immunotherapy can be used to treat complicated cancer cases, including leukaemia, breast cancer and more.
 
Mar 111:20
Conference pass

The Internet of Medical Things (IoMT): Big data in electronic disease surveillance, modelling and beyond

Pharma 4.0
  • Generating and collecting electronic data and passive records from internet, mobile phones etc.
  • Designing participatory platforms and interactive digital infrastructure to allow better data collection
  • Combining e-health record (EHR), traditional and non-traditional digital data in disease surveillance, prediction and modelling
Mar 111:20
Conference pass

Indonesia

Partnering & Licensing
Join us at this interactive roundtable session for an informal, one hour discussion with local pharma companies interested licensing their products. Ideal for pharma companies looking for local partners and distributors, and for distributors looking for new business opportunities.






 
Mar 111:20
Conference pass

Panel discussion: To partner or to launch? Strategies for exploring Asia’s emerging markets

Market Access
  • Analysing commercial opportunities and in-country competition to formulate most the optimal access strategy
  • How do innovators compete with biosimilars to keep their market share of expiring biologics products? Is it about more than just price?
  • Case study
Mar 111:20
Conference pass

Biotech Showcase

Biotech Innovation
Mar 111:30
Conference pass

Biotech Showcase

Biotech Innovation
Mar 111:40
Conference pass

Next generation universal vaccines

Vaccines
  • Discovering novel antigens using reverse vaccinology
  • Too good to be true? What are the drawbacks and limitations?
  • A universal influenza vaccine: What have we learnt so far?
Mar 111:40
Conference pass

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

Biosimilars
  • 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
Mar 111:40
Conference pass

Enhancing regulation of advanced therapeutic products: How do we get there?

Immunotherapy
  • The importance of cross education and working closely with government representatives to ensure fair competition, whilst keeping patients’ interests front-of-mind
  • What is pharma’s role in influencing regulation crafting in Asia developing countries?
Mar 111:40
Conference pass

Big data & AI in digital rare disease patient recruitment

Pharma 4.0
  • Using supercomputer and AI in matching patients to trials
  • Aligning your strategy & planning with R&D objectives
  • Evaluating and improvising planned digital clinical trial strategy
Oscar Luo, Research Scientist, Australian E-Health Research Centre, CSIRO Australian Animal Health Laboratory
Mar 111:40
Conference pass

Biotech Showcase

Biotech Innovation
Mar 112:00
Conference pass

Roundtable Discussion Session

Keynotes
Now's your chance to get really interactive. Simply pick a table and join the debate. 
Mar 112:01
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Table 7: AI& Big data in drug discovery

Keynotes
Mar 112:01
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Table 11: Bringing it together: Roles of Patient, Pharma, Hospital and Government in Drug Development

Keynotes
Mar 114:10
Conference pass

Malaysia

Partnering & Licensing
Join us at this interactive roundtable session for an informal, one hour discussion with local pharma companies interested licensing their products. Ideal for pharma companies looking for local partners and distributors, and for distributors looking for new business opportunities.






 
Mar 114:20
Conference pass

Overcoming the complexities of conjugate vaccine production

Vaccines
Topic to be finalised
Mar 114:20
Conference pass

Operating in countries with developing biosimilar guidelines

Biosimilars
  • 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 
Mar 114:20
Conference pass

Breast cancer vaccines: What have we learnt so far?

Immunotherapy
  • Addressing the importance of breast cancer vaccines in Asia
  • Exploring unique challenges in Asia and strategies for developing cancer vaccines
  • Case study on OBI pharma
Cristina Chang, Vice President of Global Medical and Clinical Development, OBI Pharma
Mar 114:20
Conference pass

Fast-tracking drug discovery with supercomputers and artificial Intelligence (AI)

Pharma 4.0
  • Using supercomputers and AI to automate virtual drug screening
  • Machine learning and pattern analysis in developing therapeutic treatments
  • Discussing the potential limitations of AI in drug discovery, and how we can overcome them
Mar 114:20
Conference pass

Shifting from volume to value: How value based pricing will impact the Asian market

Market Access
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  •     Tackling pricing trends from free market to structured pricing mechanisms
  •     Which pricing model works best in Asia?
  •     Compare and contrast patient access schemes, performance based pricing etc. to decide on the best pricing strategies
Mar 114:20
Conference pass

Investor Insights

Biotech Innovation
Mar 114:30
Conference pass

Biotech Showcase

Biotech Innovation
Robin Low, CEO, Areteon Pte Ltd.
Mar 114:40
Conference pass

Effective vaccine tech transfer (TT) for sustainable, quality local accessibility

Vaccines
  • Ensuring equity between partners and equitable TT meets both parties’ expectations
  • Freedom to operate once the recipient receive the TT to ensure production sustainability
  • Building regulatory capacity for quality monitoring and approval
Mar 114:40
Conference pass

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

Biosimilars
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?
Mar 114:40
Conference pass

Anti-viral immunotherapy: A case study

Immunotherapy
Topic to be finalised
Mar 114:40
Conference pass

Moving towards personalised medicine: Using big data to predict and customise treatment

Pharma 4.0
  • Using digital to deliver better patient outcomes
  • Embracing digital reporting for stronger performance across key R&D capabilities
  • Addressing the potential compliance and cybersecurity risks in R&D digitalisation
Mar 114:40
Conference pass

Reimbursement for high value drugs

Market Access
  • Exploring reimbursement policies for high value drugs and treatments in developed Asian markets.
  • Using evidence for pricing and reimbursement negotiation
  • Case study: I-O drug, i.e. PD-L1 inhibitor
Mar 114:40
Conference pass

China

Partnering & Licensing
Join us at this interactive roundtable session for an informal, one hour discussion with local pharma companies interested licensing their products. Ideal for pharma companies looking for local partners and distributors, and for distributors looking for new business opportunities.
 
Mar 115:00
Conference pass

Halal certified vaccine manufacturing: Coping with complex challenges in regional social requirements

Vaccines
  • With middle east investment in South East Asia and Malaysia’s pledge to operate the world’s first halal vaccine plant, there’s a rising trend in creating religion-friendly, high quality vaccine products
  • Defining halal standards requirements in manufacturing tools, materials and processes
  • Coping with the logistics requirements of transporting halal vaccinations separately to non-halal products
Mar 115:00
Conference pass

Regulatory and quality requirements for biosimilar filing- An overview

Biosimilars
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.
 
Mar 115:00
Conference pass

Dendritic cell vaccines in Asia: The first CDSCO approved Indian dendritic cell cancer immunotherapy

Immunotherapy
Discover the success story behind dendritic cell therapy for treatment of cancer, first of its kind in India
Bandana Sharan, Director, Research, APAC Biotech
Mar 115:00
Conference pass

Genome data mining and analysis for new drug discovery

Pharma 4.0
  •     Identifying key gaps between current clinical trial methods with personalised treatment  
  •     Exploring key methods in genomics data mining and matching with patients to identify personalised treatment 
  •     Case study from Samsung Genomic Institute on the pathway towards personalised treatment
Mar 115:00
Conference pass

Managing pharma leakage and off-label promotions

Market Access
  • Pricing off-label drugs right for reimbursement
  • Exploring the win-win pricing structure where payers, pharma and patients will be best benefitted
  • Discussing application of volume-based pricing to control unspecific drug usage
Mar 116:00
Conference pass

Reaching everyone, everywhere with lifesaving vaccines: A Global Vaccine Action Plan (GVAP) update

Vaccines
Established in 2012, GVAP aims to prevent millions of deaths by 2020, by providing more equitable access to existing vaccines for people from developing countries. With just 2 more years to go, what are the latest updates and how can pharma play a greater part in achieving the GVAP pledge?
Mar 116:00
Conference pass

Choosing the right Asian country for your biosimilar trials

Biosimilars
  • 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
Mar 116:00
Conference pass

Expansions of trials for with Avastin refractory recurrent GBM patients and combination of Tanibirumab + anti-PD1 antibody for refractory cancer patients

Immunotherapy
  • Insights learnt from Tanibirumab recurrent GBM phase IIa open labelled three arms multi centre trial in Australia 
  • Expansions of trails for with Avastin refractory recurrent GBM patients and combination of Tanibirumab + anti-PD1 antibody for refractory tumours
Mar 116:00
Conference pass

IoT in Pharma manufacturing: What have we learnt so far?

Pharma 4.0
  • Using IoT and emerging tech for predictive maintenance
  • Optimising real time monitoring to improve pharma manufacturing
  • Case study: Lessons learnt from implementing IoT in pharma manufacturing
Mar 116:00
Conference pass
Mar 116:00
Conference pass

Practicing HEOR activities in Asia

Market Access
  • Identifying challenges and opportunities using Real world evidence in reimbursement propositions
  • Cross-country analysis in better planning for HEOR execution
  • Setting digital platforms to connect patients to cloud for more accurate information gathering
Mar 116:00
Conference pass

India

Partnering & Licensing
Join us at this interactive roundtable session for an informal, one hour discussion with local pharma companies interested licensing their products. Ideal for pharma companies looking for local partners and distributors, and for distributors looking for new business opportunities.
 
Mar 116:10
Conference pass
Mar 116:20
Conference pass

Updating vaccine supply and distribution frameworks for more efficient global immunization programs

Vaccines
  • Improving cold chain structures in developing countries
  • Minimising supply network redundancy to reduce waste
  • Upskilling and retraining supply chain personnel including airport & cargo staff for vaccine handling
Mar 116:20
Conference pass

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

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.
Mar 116:20
Conference pass

Using genetic information to predict the effectiveness of combination immunotherapy

Immunotherapy
  • Using molecular analytics in creating effective combinations
  • Disease modelling and prediction with big data and analytics
  • Case study sharing
Mar 116:20
Conference pass

Better decision making with big data analytics

Pharma 4.0
  • Making sense of huge data volumes when using data analytics
  • Building real-time analysis capabilities for useful information collected from variable sources
  • Using big data in production lines to increase maintenance efficiency, improve availability and optimise maintenance costs
Mar 116:20
Conference pass

HTA in Taiwan: An update

Market Access
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  •     Introduction of ahealthcare framework in Taiwan, including the role of CDE and National Health Insurance (NHI) in reimbursement decision
  •     Understanding the role of HTA in Taiwan reimbursement evaluation process
  •     Best practices to ensure neutrality in evaluation process, including roles of drug providers and patients in evaluation processes  
Chung-Lin Yang, Team Leader, Division of Health Technology Assessment, Center For Drug Evaluation
Mar 116:30
Conference pass

Philippines

Partnering & Licensing
Join us at this interactive roundtable session for an informal, one hour discussion with local pharma companies interested licensing their products. Ideal for pharma companies looking for local partners and distributors, and for distributors looking for new business opportunities.
 
Mar 116:40
Conference pass

Thermostable vaccines: Where are we now?

Vaccines
Thermostable vaccines are an alternative solution to overcome vaccine distribution limitations in developing countries. What’s the update on progress after several years of R&D and discussion? Case studies will also be discussed during this presentation.
Mar 116:40
Conference pass

Biocomparability and stability studies in biosimilar production

Biosimilars
  • Key characterisation techniques to ensure biosimilar functionality
  • Discussing strategies to maintain product quality in upscaling biosimilars
  • Exploring key assays techniques and development for biosimilars testing
Mar 116:40
Conference pass

Creating immune modulator synergy in cancer management

Immunotherapy
  • Understanding why promising cancer vaccine trials fail
  • Exploring the roles of drug combination in favourably formulating positive immune responses in low dosages
  • Theoretical reasoning vs. reality: How do we maximise drug potential and minimise failure rates?
Mar 116:40
Conference pass

Asset management and fleet tracking with IoT

Pharma 4.0
  • Achieving greater visibility of products with multiple sensors on packages, trailers, warehouses and more
  • Enabling real time monitoring from pick up to delivery
  • Real-time track and trace to maximise product integrity
Mar 116:40
Conference pass

Technology assessment for new oncology drug

Market Access
    style="font-size: 10.0pt;">The development of targeted therapies and personalised cancer drugs offers opportunities, but also increases the complexity of the assessment. In this session, we will examine :
  •     Strategies for the assessment of new treatments, including possible join assessment
  •     Best practice for translating trial efficacy into effective clinical practice

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Mar 209:10
Conference pass

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

Keynotes
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.
 
Mar 209:30
Conference pass

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

Keynotes
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?
 
Mar 209:50
Conference pass

Working with increasingly informed and empowered patients in the digital age

Keynotes
Patients are becoming gradually empowered and educated on the treatment which they wish to or are about to receive. While this can be beneficial in many ways, the need for professional advice will still be essential to provide patients with the right information for them to make the most informed decision. What needs to be considered when dealing with digital-empowered patients, from clinical trials to understanding their needs to design what’s best for them? What are the guidelines updates required to protect them in this new age?
 
Ivor Lim, Founding Director & Group Chief Medical Officer, Cellresearch Corporation
Mar 211:10
Conference pass

Preventing infectious diseases with nucleic acid based vaccines

Vaccines
  • Cost effective synthesis of DNA vaccines to prevent infectious diseases
  • Using naked DNA and plasmid to induce protective immune response
  • Delivery of gene encoding vaccine antigens to stimulate infectious disease prevention
  • Vaccine design in providing rapid response time to emerging pandemics
Mar 211:10
Conference pass

Platform tech development for biosimilar upscaling

Biosimilars
  • 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
  • Exploring the possibility of using single use, high throughput bioreactors in the upscaling process
Mar 211:10
Conference pass

Using CRISPR to remove HIV genes

Cell & Gene Therapy
  • Scientists at Temple University were able to cut out HIV genes from animal models with a 50% success rate.
  • What’s next?
  • What are the concerns and consequences if applied on human subjects?
Mar 211:10
Conference pass

Multi regional clinical trial (MRCT) harmonisation: An overview

Regulatory Affairs
This one hour session includes an overview presentation on MRCT in Asia, with quick 10-minute updates from Japan, Taiwan, Malaysia, Singapore and a combined 20 minutes panel session to discuss regulatory challenges from both regulator and pharma perspectives, successes so far and what can be expected in the year of 2020
 
11:00 Overview of MRCT in Asia
James Cai, VP Global Regulatory Affairs, Access & Policy, Amgen, China
 
11:10 Japan’s latest MRCT ICH guidelines
 
11:20 Taiwan
I-Ning Tang, Senior Senior Reviewer, Center For Drug Evaluation, Taiwan
 
11:30 Malaysia
 
11:40 Singapore
 
11:50 Panel: What successes have we achieved so far and how can we build a better synergy model to promote cross-country drug development?
I-Ning Tang, Senior Senior Reviewer, Center For Drug Evaluation, Taiwan
James Cai, VP, Global Regulatory Affairs for JAPAC, Amgen
Mar 211:10
Conference pass

Investor Insights

Biotech Innovation
John Zhu, Partner, Wuxi Hi-Tech Venture Capital Co. Ltd.
Mar 211:20
Conference pass

Biotech Showcase

Biotech Innovation
Mar 211:30
Conference pass

Potential safety concerns for nucleic acid based vaccines

Vaccines
DNA/RNA vaccines are potential gene therapy tools which can integrate very well in plasmid and other delivery tools. However, it can also be potentially tumorigenic due to its nucleic acid nature. How do you take safety into consideration to maximise the potential of nucleic acid vaccines?
Mar 211:30
Conference pass

Single use tech in biosimilars upscaling

Biosimilars
  • Exploring options to either invest in advanced production processes with the help of single use technology, or choosing a reliable external outsourcing partner
  • Getting familiar with the regulatory processes to establish alignment with stakeholders
  • Case study
Mar 211:30
Conference pass

Safety considerations in using CRISPR in human cancer treatment

Cell & Gene Therapy
The US NIH recently approved the first in human project to modify the immune cells of 18 different cancer patients. The main focus of this test is to decide on the safety of CRISPR technology on human subjects. Before we discuss on using CRISPR in cancer treatment, how safe is the technology on human? What have we learnt so far from these studies?
Mar 211:30
Conference pass

Biotech Showcase

Biotech Innovation
Mar 211:40
Conference pass

Biotech Showcase

Biotech Innovation
Mar 211:50
Conference pass

Bioinformatics in reverse vaccinology (RV)

Vaccines
  • Using RV in identifying prospective antigens and possible vaccine candidates
  • Case study: RV in infectious diseases R&D
Mar 211:50
Conference pass

Outsourcing biosimilar manufacturing as an alternative to successful upscaling processes

Biosimilars
  • 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
Mar 211:50
Conference pass

CRISPR trial in lung cancer treatment

Cell & Gene Therapy
A high stakes, first in human trial using CRISPR to treat lung cancer was kick-started in China. There are also some researchers claiming gene-editing alternatives to CRISPR-edit DNA in human embryos. What were the results and how can we learn from them as we work to drive CRISPR forward?
 
Mar 211:50
Conference pass

Biotech Showcase

Biotech Innovation
Mar 212:00
Conference pass

Biotech Showcase

Biotech Innovation
Mar 213:45
Conference pass

VLP as efficient vaccines: Case study on infectious diseases

Vaccines
  • Overview of VLP vaccines and development so far
  • Duplicating success in Hepatitis B VLP in creating new generation of effective vaccines
  • Case study: Duplicating VLP success in Zika prevention
Mar 213:45
Conference pass

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

Biosimilars
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?
 
Mar 213:45
Conference pass

Coping with manufacturing variability in producing personalised medicine

Cell & Gene Therapy
  • Defining critical process parameters and critical attributes of emerging therapeutics 
  • Discussing current challenges in manufacturing and logistics of personalised medicine
  • How can emerging technologies including IoT, AI and more help in potentially overcoming these challenges?
Mar 213:45
Conference pass

Evidence Based Medicine (EBM) in Asia: Latest update

Regulatory Affairs
  • Learning from established framework to implement RWE-supported regulatory structures in Asia
  • Exploring the increasing importance of real world evidence in seeking drug approval
  • Preserving evidence quality with the increasing volume of clinical research
  • Developing, disseminating, and implementing better evidence for better healthcare
Mar 213:45
Conference pass

Investor Insights

Biotech Innovation
Mar 213:55
Conference pass

Biotech Showcase

Biotech Innovation
Karen Tseng, Bio Preventive Medicine
Mar 214:05
Conference pass

Construction of VLP expression systems and purification methods

Vaccines
  • Exploring different host for VLP expression
  • Using transient expression method in rapid VLP production
  • Overview of key options for purification of VLPs expressed in different host-types
Mar 214:05
Conference pass

GMP & Pharmacovigilance

Biosimilars
  • 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
Mar 214:05
Conference pass

Panel: Selecting the right model for GMP of cell therapy products

Cell & Gene Therapy
  • Balancing cost and quality of centralised vs decentralise manufacturing of CAR-T products
  • Flexible strategies in optimising speed and cost to deliver multi modal product portfolio
  • Key preparations required in keeping up with emerging therapeutic portfolio
  • Case study on fully single use, real time monitoring production facility in Asia
  • Comparing in-house manufacturing vs outsourcing in Asia C
  • Is licensing a good alternative in manufacturing cell therapy products?
Mar 214:05
Conference pass

Panel discussion: Using Real World Evidence (RWE) to support the rational use of medicine in Asia

Regulatory Affairs
  • Practicality issues in using RWE in Asia
  • Challenges and opportunities of regulatory innovation for SME pharma companies
  • RWE on emerging therapeutics: Key challenges and opportunities
Mar 214:05
Conference pass
Mar 214:25
Conference pass

Artificial VLPs as adjuvants

Vaccines
  • Using biomimetic antigenic nanoparticles to elicit a positive immune response to influenza
  • Drawbacks and safety concerns
Mar 214:25
Conference pass

Challenges and opportunities for pharmacovigilance in resource constrained settings

Biosimilars
  • Discovering strategies to promote adverse drug reporting (ADR) in emerging economies
  • Promoting awareness and monitoring of ADR with limited resources
Mar 215:15
Conference pass

Nanoparticle-aided antigen presenting cells (APC) in targeted vaccine delivery

Vaccines
Using antigen presenting cells and nanotechnology as delivery platform to improve vaccine efficacy.
Mar 215:15
Conference pass

Creating the incentive to switch from originator drugs to biosimilars substitutes

Biosimilars
  • 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
Mar 215:15
Conference pass

What’s next after CAR-T in Leukaemia treatment?

Cell & Gene Therapy
CAR-T cell therapy is a combination of cell, gene and immunotherapy and it is finally here, to serve as an alternative cancer treatment. Starting with Leukaemia, CAR-T has been tested on solid tumours, genetic diseases and more. What’s Asia role in the CAR-T I-O field and how do we keep up with global trends? 
Mar 215:15
Conference pass

Change and risk management in Asian manufacturing settings

Regulatory Affairs
  • Building a harmonised pharma quality system with emphasis on product life cycle, with design space planning, quality risk management and manufacturing science
  • Understanding opportunities and challenges associated with incorporating risk management principles in quality management systems
  • Case study in Asia
Mar 215:15
Conference pass

Investor Insights

Biotech Innovation
Ahmad Redzuan Sidek, Chief Investment Officer, ABio Sdn Bhd
Mar 215:35
Conference pass

mRNA vaccine delivery with lipid nanoparticles

Vaccines
This is a case study where mRNA, a nucleic base vaccine can potentially be coupled with lipid nanoparticles in therapeutic vaccine discovery
 
Mar 215:35
Conference pass

Exploration and construction of physician training in handling biosimilar drugs

Biosimilars
  • Strategies for implementing frameworks to promote biosimilar awareness
  • Crafting patient education and engagement programs in Asia
  • Exploring strategies to overcome delayed ADR effects
Mar 215:35
Conference pass

CAR-T Therapy: Keeping pace with severe adverse effects

Cell & Gene Therapy
  • Understanding the underlying mechanism of CAR-T therapy
  • Discovering alternative preclinical models for toxicity studies
  • Strategies to further refine our approach and therapy mechanism
Mar 215:35
Conference pass

Ensuring data integrity in manufacturing process

Regulatory Affairs
  • Current data integrity issue in industry and how to overcome them
  • Strategies to prevent data integrity issues from impacting global supply chain activities
  • Data integrity from regulator’s perspective
Mar 215:55
Conference pass

Viral vs non-viral vectors for gene therapy delivery

Vaccines
Exploring options, compare and contrast different viral and non-viral systems in the best gene therapy performance.
 
Mar 215:55
Conference pass

Understanding post market data and Adverse Drug Response reporting for biosimilars

Biosimilars
  • 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?
Mar 215:55
Conference pass

Case study: What it takes to achieve commercial success for cell & gene therapy products

Cell & Gene Therapy
The uphill path towards commercial success of cell & gene therapy is costly and time extensive. So how do we get there?
Mar 215:55
Conference pass

Regulatory perspectives in enabling life cycle quality improvement

Regulatory Affairs
  • Understanding the influence of organisation culture in production quality and performance
  • Building metrics to measure quality culture
  • Exploring strategies to build strong organisational quality culture
last published: 01/Oct/17 15:25 GMT