BioPharma Asia Convention 2017 Agenda

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09:00
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Option1: Biotech Bootcamp Part 1

Pre-conference activities
Financing a cure: Getting your business plan and pitch book right, for successful fundraising.
In part 1, we explore how to increase your chances of fundraising success, including: 
  • Setting up a biotech – A to Z
  • Valuing a company
  • Trends in licensing
  • Forecasting
Zhao Yi Yen, Finance and Business Development Analyst, ASLAN Pharmaceuticals
09:02
Conference pass

Option 2: Site tour to Agency of Science, Technology & Research (A*STAR)

Pre-conference activities

Witness drug discovery capabilities in Asia by joining us at a site tour to Experimental Therapeutics Center (ETC) and Genome Institute of Singapore (GIS),  members of Agency of Science, Technology & Research (A*STAR). 

About ETC: The Experimental Therapeutics Centre (ETC) was set up in 2006 as a centre of excellence to advance and accelerate drug discovery in Singapore. Its primary mission is to guide early stage scientific discoveries towards proof-of-concept in man and translate scientific discoveries into diagnostics and research tools in order to serve unmet medical needs. For more information, please visit https://www.a-star.edu.sg/etc/ 

About GIS: The Genome Institute of Singapore (GIS) is the national flagship programme for the genomic sciences in Singapore. It was established in June 2000, and initially known as the Singapore Genomics Programme. For more information, please visit: https://www.a-star.edu.sg/gis/About-Us/GIS-Story.aspx 

 

Agenda:

9.00am- Delegates gather at Suntec City 
9.30am- Delegates arrive at ETC for registration
9.45am- Corporate introduction and facility tour at ETC
10.45am- Corporate introduction and facility tour at GIS
11.45am- End of facility tour
12.15pm- Delegates arrive at Suntec City for lunch
 

09:03
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Option 3: Orphan Drug Congress Asia (Full day content)

Pre-conference activities
Join governments, regulators, patient groups and orphan drug manufacturers at the one-day Orphan Drug Congress Asia as we plot the pathway to ensuring rare disease patients get proper medical care in Asia. Key topics for discussion include:
  • ASEAN Harmonization: How can we get there?
  • If it’s good for them, it’s good for us: Reciprocal approval potential for orphan drugs in Asia
  • The price is right: Pricing & reimbursement strategies and their impact on government budgets
  • Trailblazers: Meet the countries who are supporting orphan drug access for their citizens and hear how they are doing it
  • Getting there early: Early diagnosis potential through newborn screening

Confirmed speakers include:
  • Carmencita Padilla, Chancellor, Department of Pediatrics, College of Medicine and Philippine General Hospital, University of the Philippines Manila 
  • Carolyn Anne Hall, Head of Patient Service, APAC, Shire 
  • Cath Jayasuriya, Executive Director, Coalition Duchenne
  • Cinzia Dorigo, Executive Director, Clinical Development, INC Research
  • Cynthia Magdaraog, President, Philippine Society of Orphan Disorders
  • Edmund Lim, Co-founder, We CARE Journey Malaysia
  • Hazel Gorham, Director, Biosimilars Development – Scientific Affairs, PRA
  • Hitesh Ghai, Area Medical Lead - Rare Diseases, Global Medical Affairs, Asia Pacific and China Region, GSK
  • John Lim, Executive Director at Duke-NUS CoRE & Deputy Director of Medical Services, Ministry of Health - ‎Singapore Clinical Research Institute
  • Kenneth Mah, Executive Director, Rare Disorders Society Singapore
  • Maria Melanie Liberty B.  Alcuasin, Director, New Born Screening Reference Center Philippines, NIH, UP Manila
  • Rajakanth Raman, Executive Director, Rainbow Across Borders
  • Ravdeep Singh Anand, Founder – President, Dystrophy Annihilation Research Trust
  • Teik Lee Yu, Senior Product Manager, JAPAC, Sanofi-Genzyme
Wong Chien Yeh, Chief Pharmacist/Director, Alliance PharmFor more information, please visit http://www.terrapinn.com/conference/world-orphan-drug-congress-asia/index.stm
14:00
Conference pass

Option 1: Biotech Bootcamp Part 2

Pre-conference activities
Primer in successful partnership management: Licensing, partnerships and strategic alliance management
 
In part 2, we talk partnerships and growth strategy:
 
  • Partnership and collaboration
  • Legal aspects of licensing and collaboration
  • Pitching
  • Case studies and group work
14:00
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Option 2: European Patent Office Workshop

Pre-conference activities
BioPharma Patenting at the European Patent Office, Principles and Practice – A Hands-On Experience
This Bring Your Own Device workshop for BioPharma professionals,  led by two experts from the European Patent Office will take you, step-by-step through
  • what is patentable and what is not
  • what is legal and what is not
  • patentable products and methods
  • genes, transgenic, microorganisms, cells
  • pharmaceuticals, second medical use
  • case law
We will bring in hands-on practical case studies to illustrate all of these issues, and you will have the opportunity to research, in real time, your own specialist subject areas.

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09:05
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Chairman’s opening remarks

Keynotes
09:10
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The future of medicine and how it impacts patients, pharma, physicians and regulators.

Keynotes
In the digital age, with technology changing so rapidly, how can we make sure that we are prepared for the future? This exciting opening address for BioPharma Asia 2017 will explore the most exciting trends, ideas and technologies driving the future of our industry, including practical advice on how you can brace your business for the times ahead.
 
09:40
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Blockchain meets Biopharma: How to prepare for the global data evolution

Keynotes
When you hear blockchain, you don’t necessarily think biopharmaceuticals. But the applications of blockchain can do so much more than digital currency. For example, it can help to increase the efficiency of the drug development process, by providing better security and transparency. It allows you to indelibly record medicinal and genomic data to combat counterfeit pharmaceutical production and protect intellectual property. That’s just a few applications. Join us as we uncover more and also consider some of the potential challenges that could be created, for example, around compliance and privacy. 
10:10
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Redesigning healthcare system with genomics, technology driven drug discovery

Keynotes
Advances in next generation sequencing (NGS) technologies over the last decade are beginning to have an impact on the amount and depth of sequencing data available to researchers in the pharmaceutical industry. In target identification and validation, the availability of human genetic data to link the target to the disease, can mean the difference between success and failure in phase II clinical trials. In this presentation, various techniques and drug discovery platforms will be discussed to help companies in improving efficiency of drug delivery products to drive the pharma industry towards the goal of personalized medicine.
10:30
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Latest developments for BioPharma Patenting at the European Patent Office (EPO)

Seminar
The EPO is the patent office for Europe, but its patent search examination, publication and information roles have international effects. In this presentation we highlight the most significant initiatives supporting BioPharma organisations wanting to file patent applications at the EPO, and the patent information services which are accessible to BioPharma professionals, researchers and entrepreneurs alike.
11:29
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Chair's opening remarks

Asia Pharma Leadership Track
11:29
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Chair's opening remarks

Biotech innovation
11:29
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Chair's opening remarks

Clinical trials
Mr Sebastian Bather, President APAC and Japan, InVentiv Health
11:30
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Catalysing global opportunities for life science innovation

Asia Pharma Leadership Track
A great idea can come from anywhere, but innovators often face many hurdles when it comes to bringing that great idea from concept and ideation to commercialization.  Where do you start? How do you make vital industry connections for funding and partnerships? Who can you look to for guidance?  Melinda Richter, Head of Johnson & Johnson Innovation, JLABS has been at the helm of JLABS since its inception starting in San Diego, California in 2012 and growing to 9 locations with over 150 residents.  Ms. Richter will reveal what happens when an entrepreneurial mentality, innovative design, corporate capabilities and infrastructure collide to create the optimal environment to empower entrepreneurs to bring the next generation of life-saving, life-enhancing solutions to people around the world.  
11:30
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Company presentation

Biotech innovation
Eliminating gastric cancer in Asia with B cell peptide immunotherapy – clinical update
 
11:30
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Asia’s market access landscape

Market Access
•    Exploring strategies to satisfy healthcare needs by working closely with stakeholders
•    Understanding key considerations and priorities needed when planning for market access strategies
•    Formulating an efficient communication channel for building a sustainable healthcare environment
11:30
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Key considerations in designing clinical trials protocols for pan-Asia clinical studies

Clinical trials
  • Where are the next clinical trial hotspots in Asia?
  • Exploring external R&D partnerships to accelerate new drugs to market
  • Discovering key preferred countries in conducting trials from pre-clinical, early phase to patient safety and consent
  • Strategies for navigating Asia’s fragmented regulatory landscape
Dr Josemund Menezes, Medical Affairs Director – Hospital and External Relations, Tessa Therapeutics
11:30
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Keeping up with the production demands of an evolving portfolio in Asia

Manufacturing
  • Understanding the challenges associated with the biomanufacturing of an evolving portfolio
  • Balancing flexibility, scalability and cost of manufacturing of emerging biological products
  • Case study on manufacturing of immuno-oncology products
11:30
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Innovating your drug product to gain competitive advantage

Seminar
•    Leveraging advancement in delivery technologies
•    Addressing complex molecule challenges through bioavailabity and stability
11:40
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Company presentation

Biotech innovation
11:50
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Improving accessibility of drugs and immunisation in developing countries

Asia Pharma Leadership Track
Sometimes vaccines are available, but not accessible to those who need them in less developed countries. There can be many barriers. NGOs are working to try to overcome these barriers, by addressing things like cold chain, policies, capacity of health staff and community concerns. Discuss how NGOs play a role of bridging public and private sector interests, while addressing the needs of communities, utilizing new approaches to increase access to vaccines.
 
11:50
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Company presentation

Biotech innovation
11:50
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Balancing costs and benefits when partnering with academic CRO

Clinical trials
  • Exploring various partnership models available in conducting clinical trials in Asia
  • Discovering key considerations when selecting CROs- what should be expected and why?
  • Case study: Working with academic and commercial CRO for immuno-oncology clinical research in Asia
11:50
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Transforming Biopharmaceutical Manufacturing Industry with technology roadmapping

Manufacturing
•    Non-competitive collaborative effort of Biotech Industry to align innovation efforts in biomanufacturing
•    Building a shared vision of the future in all areas of biomanufacturing responding to market trends and patient needs
•    Discussing key enabling technologies of in-line monitoring & real-time release, process technology, automation, modular & mobile, knowledge management and supplier partnerships 
12:00
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Company presentation

Biotech innovation
12:00
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Experiences and case studies from 30 Years of structural analysis of biopharmaceuticals

Seminar
12:10
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Company presentation

Biotech innovation
12:10
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Will performance-based reimbursement be the future scheme in Asia?

Market Access
  • Discovering benefits of performance-based patient access schemes, as an alternative to current reimbursement plans in countries across Asia
  • Understanding the challenges in implementing risk sharing schemes in Asia
  • Identifying key practices required for long term viability of performance based drug reimbursement
  • Is a strategy like this even possible when multiple country regulators are involved?
12:10
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Benefit risk assessment for biologics product lifecycle

Clinical trials
-    Overview of current regulatory landscape in pharma development
-    Streamlining product lifecycle management with appropriate risk assessment strategies
-    Case study: Risk assessment strategies in biological development
12:10
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Manufacturing recombinant protein: What works best in Asia?

Manufacturing
•    Building internal manufacturing capability vs using an established CMO
•    Using single use bioreactors versus stainless steel bioreactors.
•    Exploring the usage of technical innovations and new strategies to reduce development and manufacturing timelines.
12:10
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Licensing as an alternative model to establish presence in Asia

Asia Pharma Leadership Track
A great alternative to access the complicated Asia market, licensing is a preferred option with its unique set of challenges. In this session, we investigate the key concerns in building successful licensing models in Asia-international settings, while take away some key tips to build a mutually beneficial working relationship in Asia.
12:20
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Company presentation

Biotech innovation
12:30
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12:30
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Company presentation

Biotech innovation
12:30
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Country-specific market access strategies: Case study in India

Market Access
  • Besides pricing and reimbursement, what are the other factors in consideration when accessing a new market in India?
  • Understanding the role of patient groups and the importance of patient-centric approaches in defining your access strategy
  • Overcoming regulatory hurdles: How can we handle the fragmented regulatory structures?
  • Licensing by reciprocity in India: Is it even possible?
12:30
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Drawing parallels between EU and Chinese safety regulations

Clinical trials
  • Understanding safety requirements in clinical Phase 1 to 4 trials
  • Developing cross functional teams to streamline safety operations
  • Ensuring compliance and adherence to relevant regulations in EU and Asia
12:30
Conference pass

T-ETM pharmaceutical molecules with both targeting and effector functions for improved efficacy and safety

Seminar
Immunwork develops T-ETM molecules containing both targeting (T) and effector (E) moieties for applications in cancer, autoimmune, infectious, and CNS diseases. The T and E modules, which are based on multi-arm linker units, are constructed separately and then joined together by click chemistry. Our T-ETM platform can produce ADCs with improved DAR, homogeneity, and manufacturing processes, and also bispecific and multi-specific antibodies with optimal valency of T and E elements.
12:40
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13:00
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ADC Development: Keys to Rapid IND Submission and Approval

Seminar
13:30
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T Pre-clinical candidate in treating Autism Spectrum Disorder

Seminar
14:00
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RetroMAD1 – broad spectrum orally-delivered antiviral protein therapeutic

Seminar
RetroMAD1 is made using recombinant E.coli and easy to upscale. It has very good safety characteristics and it can withstand digestive enzymes for 2 hours. It is absorbed into the blood within 30 minutes and has a 39% bioavailability in non-human primates.  It has also been tested on a variety of RNA and DNA viruses in selected in vitro and in vivo models in shrimp, fish, cats, dogs and monkeys. Among the potential human viruses of interest where testing has been carried out are Ebola, Dengue and Zika.
 
14:15
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14:20
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PANEL: Key considerations when considering IPO vs Acquisitions

Asia Pharma Leadership Track
It may be overly simplistic, but generally speaking, there are 2 ways in which biotech companies grow their business. Going public helps to gain more capital and investments for further developments, while keeping more control of the direction of growth of the company. On the other hand, acquisition by one an industry stalwart can also be a very attractive option, as it opens up access to resources and additional expertise. We explore what’s right for your business.
 
14:20
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Company presentation

Biotech innovation
14:20
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Overcoming registration and submission challenges in pan-Asia clinical studies

Clinical trials
  • What has changed since last year’s meeting?
  • How can RA representatives be more effective in navigating through the fragmented SEA market?
  • Exploring the possibility of using an adaptive regulatory submission system, customised from established markets
  • Established vs. emerging markets in Asia
14:30
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Company presentation

Biotech innovation
14:30
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Analytical methods for therapeutic antibody characterization, comparability, release, and stability

Seminar
•    Review of typical analytical methods employed for therapeutic antibodies.
•    Development, qualification, and validation of analytical methods.
•    Application of methods in characterization, comparability, release and stability of therapeutic mAb’s
14:40
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14:40
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Process development preparation for effective technology transfer and operation

Manufacturing
•    From R&D to manufacturing operations, what are the considerations required to ensure smooth transfer?
•    Evaluating critical aspects to evaluate to ensure event free manufacturing
•    Discovering the importance of cross function communication to promote successful routine bioproduction
14:50
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15:00
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15:00
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Promoting regulatory innovation in Asia: Case study in Taiwan

Clinical trials
  • Understanding the need for creating a  simplified, innovative regulatory framework to support the exponentially-growing number of trials in Asia
  • Strategies for improving regulatory expertise and cross-nation support for promoting regulatory policy innovation
  • Discussing methods to remove or reduce regulatory complexity, and minimise the impact of regulatory diversity, to ensure timely access to safe, high quality therapeutic products
15:00
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Implementing successful CMC strategy for Biosimilars: recent trends

Manufacturing
  • Discovering CMC technologies suitable for advanced biosimilar markets.
  • Designing approaches to enhance quality through compound characterization, process development, analytical testing.
  • Case Study: Biosimilars production
15:00
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DASGIP: the parallel cultivation platform for re-usable and disposable bioreactors in fermentation and cell cultivation and the efficient tool for QbD

Seminar
15:20
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India’s latest biosimilars guidelines: Opportunities and threats

Clinical trials
•    Understanding key concerns and considerations when working on biosimilars products in India 
•    Specific differences between the former and the current biosimilar guidelines and its impact on the industry
•    How should companies leverage on India’s regulatory landscape to launch biosimilars products? 
15:30
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Supply chain development and strategy in nascent markets (bioTech, NanoTech and ICT)

Seminar
This presentation covers both demand and supply issues of dealing with nascent market where the companies confront with ambiguous environment which is distinct from uncertainty in established markets. Some of the best practices from international companies will be discussed and the findings of a field research project conducted at MIT Global SCALE Network will be shared with participants. A key emphasis would be upon how nascent firms leveraging high techs (like biotech, nanotech and ICT) facing with ambiguous environment should think and invest in their demand and supply parts of their business. 
16:00
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Innovative research created by collaboration between academia, industry and society

Seminar
Interdisciplinary collaboration may be a key to lead cooperation for producing new items and the coproduction system may bring a breakthrough to the research frontline. Collaboration between academia and industry is a key issue to create innovative works in a wide variety of research fields, particularly in oncology area. Recent experiences will be introduced and discussed.
16:20
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Table 1 Country-specific strategies in overcoming challenging green field regulatory landscapes

Keynotes
16:20
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16:20
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Table 5 Hybrid delivery models: Understanding the continuum of clinical collaboration

Keynotes
As biopharma companies in Asia evaluate strategies to advance their products to market, they are increasingly doing so with new options on partnership.  CRO or Vendor partners are invited to solve challenges of capacity, quality, expertise, and infrastructure - but not necessarily all at the same time.  Effective solutions are therefore about taking the BEST approach (Blended Efficient Sustainable Team) that may integrate different partners as well as different models of delivery from resource augmentation, through project-based outsourcing to high accountability joint-investment partnerships.
Key points to discuss:
-    Defining the challenge correctly to ensure value
-    Understanding the continuum of solutions
-    Best practices for efficient partner management that balance cost, quality and oversight
16:20
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Table 6 Strategies to overcome production challenges when starting new manufacturing project in Asia

Keynotes
16:20
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Table 7 Transforming Discussing the role of Asia biopharma and technology companies in enabling biomanufacturing innovation

Keynotes
16:20
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Table 8 Key considerations and strategies in R&D outsourcing

Keynotes
Ms Jessica Thongcharen, Associate Director, Pharmacovigilance, Takeda
16:21
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16:21
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Table 9 Building sustainable innovation ecosystem in Asia

Keynotes
16:21
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Table 4 Fully automated QC process in Asia- how do we get there?

Keynotes
17:00
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Singapore QuickFire Challenge – Metabolic Disease Innovation

Keynotes
17:00                  
Healthcare Innovation in Biotech
•             Opportunities and challenges in nurturing healthcare innovation in today’s biotech ecosystem
•             Johnson & Johnson Innovation’s global approach to open innovation, including Innovation Centers, JLABS, and  QuickFire Challenges
Melinda Richter, Head of Johnson & Johnson Innovation, JLABS
 
17:10                    
Panel Discussion:  Collaboration by industry, government and academia in developing innovative solutions for diabetes and other metabolic diseases
•             What is the current state of innovation in addressing metabolic diseases in the Asia Pacific in light of the growing burden of disease in places like China and India?
•             How do we leverage and nurture the ecosystem to address metabolic diseases?
•             What are the current bottlenecks and opportunities for collaboration in Singapore and beyond
•             Case studies involving engagement with governments, academics, entrepreneurs, start-ups, and other early-stage innovators in consumer healthcare, pharmaceuticals, and medical devices
 
Moderated by: Melinda Richter, Head of Johnson & Johnson Innovation, JLABS
 
 
17:45
Launch Ceremony for the QuickFire Challenge
Ms Sue-Anne Toh, Senior Consultant, Division of Endocrinology, National University Health System
Latt Mansor, Director, Business Development, Holmusk
Monica Mohan, Head of Partnership Propositions and Business Development, Allianz
18:00
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BioPharma Industry Awards Presentation

Keynotes
Innovation. Commercialisation. Access.
These key attributes are what Asia’s leading minds possess and what we are looking for in this year’s BioPharma Industry Awards. The 7th awards will be a celebration that will recognize seven organizations for their significant contributions and achievements in Asia’s burgeoning biotech industry as well as for their passion to better shape the global value chain.


Award categories:
Best CRO in Asia
Best CMO in Asia
Clinical Supply Chain Excellence in Asia
Most Innovative Asian Biotech
BioSingapore Innovative Biomedical Company Award
 

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09:10
Conference pass

From ideas to international success: A real breakthrough story brought to you by an Asian biotech company

Keynotes
Starting from nothing to million dollar success, hear from true blue biotech company in Asia on their success story in building the reach of their companies from domestic to international market
09:30
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Keynote Panel: Big pharma perspective in driving Asia biopharma innovation

Keynotes
With the highest amount of resources which can be invested into operation, big pharma companies are in the best position to lead the industry direction. When making a key decision, it is important to understand the impact in organisation and industry wide. How can big pharma avoid being “too-big-to-fail” and lead the industry to be more innovative? 
 
10:30
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Microvalve Bioprinting of Therapeutic Cells

Seminar
Three Dimensional (3D) printers are being used for driving major innovations in various areas such as manufacturing, engineering, education and medicine. Advances in this technology have enabled cells and biocompatible materials to be incorporated into the printing process. 3D bio printing can be potentially useful in dispensing therapeutic cells by increasing the overall efficiency and by decreasing the time and labour involved. This presentation showcases the use of 3D bioprinter, microvalves and Human Colorectal Carcinoma Cells (HCT116) to test its feasibility.
11:10
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Considerations to be made while choosing primary container for Bio drugs

Seminar
In today’s time of fast changing regulations, with the need to be ahead of the curve with product differentiation and yet choosing what’s the right container for the Bio drug is very critical. 
We look at some of the unmet needs in the packaging / container domain – protein aggregation, Silicon oil residues, Tungsten…… and share the offerings we as a leader in Medtech space bring to the Pharmaceutical (Biotech)  industry which are ready to be adopted. 
11:10
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Chair's opening remarks

Asia Pharma Leadership Track
11:10
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11:10
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Chair's opening remarks

Manufacturing
11:10
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Chair's opening remarks

Medical Affairs
11:15
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Company presentation

Biotech innovation
Dr Tse Wen Chang, Chairman and Founder, Immunwork Inc.
11:15
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Medical led stakeholder engagement: How can drug providers better interact with patients and healthcare professionals in Asia?

Medical Affairs
  • How can pharma providers better engage patients and investigators by setting aside investigator led funding, education grant and trial grant bonds for quality studies?
  • Discovering strategies in making patients the priority in medical communication
  • Exploring options to provide support, sponsorship and resources to patient groups and care givers
11:15
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Driving clinical innovations: A big pharma perspective

Clinical trials
  • Discovering the adoption of emerging technology to improve clinical quality and efficiency.
  • Redefining SOP in clinical operations to integrate technology and encourage innovative practices without compromising trials quality
  • Discovering strategic plans to train staff in instilling innovation and moving towards digitalised practices
11:15
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Chemical stability of protein drugs - Degradation mechanisms and strategies to improve product stability in biomanufacturing

Manufacturing
  • Developing high stability indicating assays
  • Coping with the latest configurations, reagents and alternatives in method validation and performance
  • Exploring automation as a method for streamlining QC processes and maintaining uniformity of analytical processes
11:15
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Autologous haematopoietic stem cell gene therapy- where are we now?

Asia Pharma Leadership Track
Autologous hematopoietic stem cells gene therapy has emerged as an exciting alternative to allogeneic bone marrow transplant to treat severe inherited disorders over the past 20 years. Now, second generation lentivirus-based gene therapy carry the promise of safer and more effective treatments, and the potential to tackle devastating metabolic & neurodegenerative diseases.
11:25
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Company presentation- PharmAbcine

Biotech innovation
11:35
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Immuno-Oncology, the new paradigm in cancer treatment

Asia Pharma Leadership Track
Unlike conventional cancer treatments, immuno-oncology boosts the body’s own immune system to recognize and kill cancer. Recently, this field has moved into the mainstream for the treatment of many cancers. This presentation will provide an overview of current progress, lessons learned, and future prospects for immuno-oncology approaches to cancer.
11:35
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11:35
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The patient advocate perspective: Working better with pharma and key stakeholders to provide better patient care

Medical Affairs
  • Exploring various working strategies to understand patients’ needs and promote disease awareness
  • Working with patient groups to deliver better treatment outcomes
  • Understanding potential collaboration and partnership opportunities between pharma, patient advocacy groups and government units
11:35
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Developing clinical trial infrastructure

Clinical trials
•    Discussing key considerations with developing clinical trial capabilities, i.e. gene therapy.
•    Developing infrastructure for the leadership and oversight of clinical development program, including building in-house capabilities
•    Deciding which aspect to outsource and keep in house
•    Selecting providers and managing relationships and project 
 
11:35
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Enhancing purification and analytical techniques in bispecific biologics production

Manufacturing
  • Discussing the potential application of using 2D liquid chromatography to characterise therapeutic proteins
  • Developing critical attributes for deciding on the analytical techniques to be used in bioproduction
  • Case study: Bispecific antibody production
11:45
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Company presentation

Biotech innovation
11:50
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Advanced Microscopy for the Biomedical Sciences

Seminar
In this presentation, key examples of research projects that the IMB Microscopy Unit (IMU) is facilitating will be presented. IMU is a core platform of A*STAR's Institute of Medical Biology providing the expertise together with advanced microscopy instrumentation and image analysis tools to enable research in the biomedical sciences. The unit houses >20 high-end microscopes, including superresolution, multiphoton and electron microscopy. IMU contributed to many collaborative research projects with both the academic and industrial research community of Singapore and from overseas.
11:55
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Oncology in Asia: Developing immuno-oncology for Asia-specific diseases

Asia Pharma Leadership Track
The shift of focus to develop drugs for Asia specific indications is prompted by the establishment of healthcare industry within the region. What’s happening right now and what’s next to be expected in Asia oncology industry?
 
11:55
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Company presentation

Biotech innovation
11:55
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From pre- to post- launch: Improving the role of medical affairs in product life cycle management

Medical Affairs
  • Understanding the different roles of medical affairs personnel in reimbursed market
  • Exploring how medical affairs personnel help in pharma marketing
  • From design, execution and supporting investigator initiated studies, how can medical affairs better utilise the available clinical outcomes to convince stakeholders in reimbursement decisions? 
11:55
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Leverage Real World Data to Make Better Decisions

Clinical trials
  • Evidence-based approaches for protocol validation, study feasibility and patient access
  • Enhancing global accrual rates for clinical trials
  • Mining public and private databases to create a proprietary methodology for patient and site access
11:55
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Host cell protein (HCP) characterisation and mass spectrometry strategies

Manufacturing
  • Adding mass spectrometry as part of the host cell protein workflow
  • Analytical strategies in HCP identification and purification process
  • Developing quantitative MS/MS methods to determine HCP levels
12:15
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Overcoming challenges in treating Tuberculosis in Asia

Asia Pharma Leadership Track
The largest number of new TB cases occurred in Asia. According to WHO, 60% of the TB cases happen at India, Indonesia, China, Pakistan, Nigeria and South Africa. What are the strategies to help this large amount of patients in Asia, and how to make these treatments more affordable? 
12:15
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12:15
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Innovation in action: Using remote sensing and IoT for stroke patient monitoring

Clinical trials
  • Using IoT for real time patient monitoring
  • Discussing infrastructure limitation and potential solutions in overcoming these challenges
  • Sharing case studies on using remote sensing for patient monitoring off-sites
12:30
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The therapeutic potential of IL-20 antibody in liver fibrosis and breast cancer-induced osteolysis

Seminar
13:10
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Potential therapeutic effect of nigella sativa oral rinse for oral and dental diseases

Seminar
Nigella sativa extract were reported as an anti-inflammation and antibacteria. The beneficial effects of nigella sativa extract were shown to be related to a reduction of the inhibition of inducible nitric oxide synthase and interleukin (IL)–1β expression.  The rationale of the study is based on our previous studies demonstrating the beneficial antioxidant effect of nigela sativa extract 3 % in vitro. These findings suggest that nigella sativa extract properties, including the anti-inflammatory, anti-oxidant and increase modulation of host. Additionally, nigella sativa oral rinse a good alternative for oral immune diseases, as well as its antioxidant and its antineoplastic activities.
13:45
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Chair's opening remarks

Asia Pharma Leadership Track
13:45
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Chair's opening remarks

Medical Affairs
13:45
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13:50
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Changing landscape in First-in-Human studies, in the era targeted drugs and immunotherapy

Asia Pharma Leadership Track
The existing cancer therapy methods are often harmful and detrimental to the health of patients. While targeted therapy is becoming the hot discussion topic within the industry, research process is still too expensive and lengthy to quickly bring drugs from bench to beside. In this presentation, changing landscape of therapy methods will be explored along with the prediction of next generation drugs and its study methods to help speeding up the drug discovery process.
 
13:50
Conference pass

Encouraging investigator-led studies in Asia

Medical Affairs

·         Understanding how investigator led studies encourage drug access and reduce drug price in countries

·         Providing easier access to drugs to encourage investigator led studies

·         Establishing better reporting system by taking account of patient’s opinions

13:50
Conference pass

Cost and considerations in selecting CRO for end-to-end operations and supply

Clinical trials
  • Exploring the availability of high quality, cost effective CRO services in Asia
  • Working with CROs to implement best practices in clinical supply
  • Discovering strategies to innovate clinical supply practices
13:50
Conference pass

QbD and beyond- where are we now in Asia?

Manufacturing
  • In some countries, QbD has been listed as one of the requirements in the submission for approval. What is the status in Asia and how can manufacturers continuously innovate to improve production cost and quality?
  • Identifying critical process parameters and critical quality attributes to ensure robust technology transfer
13:50
Conference pass

Image descriptors for cardiothoracic imaging biomarkers extraction

Seminar
Cardiothoracic imaging focuses on acquiring, characterizing, and interpreting images of pulmonary, cardiac, and vascular regions for diagnosis of cardiothoracic diseases. Along with imaging modalities advancements, these images may provide richer information than just diagnostic purposes. Imaging biomarkers, important parameters extracted from clinical and preclinical imaging, may also represent tissue specific properties that indicate therapeutic and rehabilitative outcomes. However, these parameters need further processes to extract biological, functional or structural organization of the cardiothoracic tissues. Image processing can be effectively used to standardize, process, extract, and analyze the parameters in multidimensional and multispectral domains. Image descriptors, as parts of image processing techniques, are used to quantify morphological, spatial, and structural features, and correlate the features with clinical parameters to generate quantitative imaging biomarkers. With these techniques, the knowledge of the biological basis of the disease can be revealed, resulting in more accurate cardiothoracic treatment decisions.
14:10
Conference pass

Innovation and implementation of precision medicine

Asia Pharma Leadership Track
Precision medicine is the next step forward towards personalised medicine in the future. With the help of biomarkers and emerging technologies, it is very possible that one will soon be able to diagnose patients and cater to their healthcare needs with minimum risk at an affordable rate. But that’s easy to plan and hard to implement. Hear how precision medicine companies aim to be the future of medicine and the impact of precision medicine on the human population.
 
14:10
Conference pass

Company presentation

Biotech innovation
14:10
Conference pass

Adopting HEOR to balance short-term goals and long-term market access goals

Medical Affairs
  • Using HEOR to convince healthcare authorities on drug functions and value
  • Key strategies for presenting collected medical research data and demonstrate drugs value
  • Discover the importance of HEOR in countries without a reimbursement framework
14:10
Conference pass

Driving patient centricity to optimize clinical supply

Clinical trials
  • Understanding the evolution of the clinical supply model
  • Need a new approach: internal pressures to drive efficiency, quality and value while reducing risk
  • Case Study:  a fundamentally different approach to other clinical supply models
14:10
Conference pass

Ensuring excellent production quality of emerging therapeutic products

Manufacturing
  • Discover GMP and cGMP guidelines in manufacturing of novel biologics, i.e. biosimilars, in Asia
  • Strategies for analytical development and quality control platform implementation 
  • China case study
14:20
Conference pass

Company presentation

Biotech innovation
14:30
Conference pass

Strategy of sequencing the whole genome and its impact of next generation medicine

Asia Pharma Leadership Track
Targeted therapy is an essential part of immuno-oncology. With the help of biomarkers, immuno-oncology helps better targeting of drugs to minimise toxicity and improve efficacy. What’s the key strategy in sequencing whole genome from a clinical perspective and how does it help to bring closer to the future of personalised medicine?
 
Jurgen Eils, Group Leader, German Cancer Research Center (DKFZ)
14:30
Conference pass

Company presentation

Biotech innovation
14:30
Conference pass

Innovative supply chain strategies to improve agility and efficiency

Clinical trials
  • Formulating strategies to ensure optimal process flow
  • Exploring various options to satisfy segmentation requirements with variable volumes and packaging needs
  • Using late stage customisation to overcome country specific regulations and requirements 
  • Overcoming existing infrastructure limitations to fully utilise the potential of 2D barcoding in track and trace
14:30
Conference pass

Ensuring quality and safety in biologics production using glyco-analytical platforms

Manufacturing
  • Understanding the importance in glycosylation in biologics in efficacy, function, safety and thus compliance
  • Exploring analytical platform technology used to address needs to characterise glycosylation
  • Application of such technologies during biologic/biosimilar development to ensure the best product
14:30
Conference pass

Antibiofilm of extract Propolis against biofilm Enterococcus faecalis as herbal medicine potential in root canal treatment

Seminar
Some microorganisms, including E. Faecalis in pulp necrosis were able to form biofilm to enhance pathogen virulence. This presentation shows the usage of Propolis, which contains Antibiofilm with antibacterial properties to inhibit the growth and development of bacterial biofilm, potentially treating root canal problems.
Mrs Dian A Wahjuningrum, Senior Researcher and Lecturer, Airlangga University
14:40
Conference pass

Company presentation

Biotech innovation
14:50
Conference pass

Company presentation

Biotech innovation
14:50
Conference pass

Justifying the investment in HEOR and the value it brings

Medical Affairs
•             Exploring the growing need for companies to invest in HEOR
•             Understanding the value in using HEOR across the product lifecycle
•             Measuring the returns of investment for use of HEOR
14:50
Conference pass

Optimising cell-line engineering and upstream process parameters with Design of Experiment (DoE)

Manufacturing
  • Recent advancement in Cell engineering for improved titer and quality (Case study)
  • Use of modern gene editing tool for metabolic engineering of production cells
  • HTP devices and work flow for clone and upstream process development
  • Using DoE as a compliment to QbD for upstream process optimization (Case Study)
  • Developing critical quality attributes in process monitoring and validation
14:50
Conference pass

Tissue chips for drug development and disease modeling

Asia Pharma Leadership Track
Approximately 30% of drugs have failed in human clinical trials due to adverse reactions despite promising pre-clinical studies, and another 60% fail due to lack of efficacy. To address this challenge in drug development, the NIH Tissue Chips program is developing alternative approaches for more reliable readouts of toxicity or efficacy. These microfabricated devices are useful for modeling human diseases, and for studies in precision medicine and environment exposures.
15:00
Conference pass

Company presentation

Biotech innovation
15:10
Conference pass

Gynura procumbens: Fertility herb for diabetic

Seminar
Diabetes mellitus is a chronic metabolic disease related to the disorders of carbohydrate metabolism and characterised by the inability to produce or secrete insulin that results in hyperglycemia. This non-communicable disease associated with male reproductive health problems such as infertility, impotence and libido complications. Medicinal plants or herbs are given a great focus by the government to serve as therapeutic alternatives and safer choices of treatment. Interestingly some plants such as Gynura procumbens (GP) have beneficial effects in curing diabetes as well as infertility and libido problem. This study was designed to determine the effect of GP on blood glucose level, fertility and libido in diabetic male. 
15:40
Conference pass

Establishing the medical affairs role as a cornerstone to build trust in pharmaceutical industry

Medical Affairs
  • Discovering strategies to ensure medical compliance within institution
  • Exploring ways in building strong, multi-faceted medical affairs organisation to navigate global healthcare landscape
  • Case study
Dwaipayan Patnaik, Medical Director- Oncology, Medical Affairs, Asia-Oceania, Astellas Pharma
15:40
Conference pass

Investigations in Healthy Volunteers (HVs) : Opportunities and issues

Clinical trials
  • Understanding opportunities in global clinical development considering HVs in different geographical regions
  • Overcoming challenges in HV definition, identification and assessment
  • Case studies on overcoming operational challenges in investigations in HV in Asia
15:50
Conference pass

Ontology population from Malaysia medicinal herb textual documents

Seminar
Knowledge representations that consist of relevant terms in medicinal herbs domain are crucial in the development of medicinal herbs TBox domain ontology and ontology population. Ontology development is not only a complex process that requires the involvement of domain experts but also has to rely on accurate sources of information. Textual documents are among the resources that can be used to develop ontology. To structure the text for ontology development and population is challenging task because most of the terms are embedded in unstructured documents, have less semantic meaning and ambiguity. This research showed that the ontology population rules effectively extracting instances from textual document sources from specific domains.
16:00
Conference pass

Cultivating patient centricity in the evolving role of medical affairs

Medical Affairs
  • Strategies for implementing patient centricity frameworks within India pharma companies
  • Crafting patient education and engagement programs in South Asia
  • Emphasizing data, quality and sincerity as integral core values in medical practices
16:00
Conference pass

Conducting quality clinical trials in China, a case study

Clinical trials
The Chinese government has recently reformed its healthcare structure to improve quality of clinical trials and manufacturing. Find out more about the status quo of clinical operations in China and how global companies can help in ensuring quality operation by strictly enforcing GCP and other SOP in their respective team.
16:20
Conference pass

Emphasizing patient centricity in biologics pharmacovigilance

Medical Affairs
  • Exploring strategies to overcome delayed ADR effects
  • Investigating the effectiveness in shifting from pure safety analysis to a benefits-risk evaluation
  • Case Study: Discovering how patient centricity can improve the quality of pharmacovigilance analysis
16:20
Conference pass

How can big pharma lead GCP implementation to promote quality clinical research in India?

Clinical trials
Clinical trials in India have been plagued with scandals due to lack of compliance and ambiguous guidelines. While the CDSCO is renewing its policy to promote quality trials in the country, local companies need to learn from their overseas counterparts to regain international confidence in the market. Find out how big pharma in India can help in leading GCP within the country.
16:40
Conference pass

The art and science of patient recruitment – Strategies for emerging markets

Clinical trials
•    Demonstrate how industry is expanding their engagement of the public, healthcare providers, and industry partners in order to increase patient recruitment. 
•    Highlight the need for patient recruitment specialist roles and identify avenues to broaden current educational knowledge in this space.
•    Share lessons learned from current established markets in order for emerging markets to mitigate future challenges.  
16:40
Conference pass

Q&A session

Medical Affairs
This Q&A panel allows interaction between audiences and the 3 speakers in the session.​