BioPharma Asia Convention 2017 Agenda

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09:00
Conference pass

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
Conference pass

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
Conference pass

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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09:10
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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
Conference pass

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.
11:00
Conference pass

Treating Tubercolosis infected patients in Asia

Seminar
Professor Pui Lai, Rachel Ee, Assoc Professor, National University of Singapore
11:29
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Chair's opening remarks

Biotech innovation
Dr Siew Hwa Ong, Director, BioSingapore
11:29
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Chair's opening remarks

Clinical trials
Mr Sebastian Bather, Regional Managing Director, InVentiv Health
11:30
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Moving from generics production to investing in innovative products: Is this the right approach in developing countries?

Asia Pharma Leadership Track
While IP laws are essential in promoting creativity and innovation, generics drugs are crucial to meet affordable healthcare demands in developing countries. While more countries are spending heavily to encourage the building of R&D centres, does it make sense for existing generics companies to shift towards producing innovative drugs? Join this case study to find out more.
 
11:30
Conference pass

Company presentation-Imugene

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: Understanding the perspectives of payers, healthcare policy makers, pharma and patients

Market Access
  • Exploring strategies to satisfy healthcare needs by working closely with pharma, policy makers and payers
  • Understanding key considerations and priorities from the payers’ perspective
  • Formulating an efficient communication channel for building a sustainable healthcare environment
11:30
Conference pass

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
Conference pass

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
Hung Fai Poon, Chief Scientific Officer, Zhejiang Hisun Pharmaceuticals. Ltd
11:30
Conference pass

Establishing coherent supply chain practices in Asia

Supply Chain
  • Promoting free trade movement to encourage trade and economic growth – where are we now and what’s next?
  • Encouraging the alignment of regulations and standards to ensure hassle free movement of goods and people
  • Overcoming IP, trade secret and safety regulation while opening borders
  • Investigating the possibility of achieving coherency in border regulation and movement of goods with the Trans-Pacific Partnership Agreement.
11:30
Conference pass

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-Novogen

Biotech innovation
11:50
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Supporting R&D in developing markets: A private equity perspective

Asia Pharma Leadership Track
With a strong preference for cheaper healthcare alternatives, it’s not uncommon for them to select generic drugs as the treatment of choice. When a country’s priority lies in providing basic needs, it is only natural for there to be a much lesser focus on R&D from a financial perspective. In such a developing landscape, how can private equity play a role in promoting innovation and R&D? How do fund managers justify the risk and make their investment worthwhile? How can pharma and biotechs work more effectively with them to foster innovation?
 
Dr Judith Li, Partner, Lilly Asia Ventures
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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Integrating hybrid options in biomanufacturing: Economic and operational implications

Manufacturing
  • Discovering the best strategy for integrating disposable solutions in existing facilities
  • Realising the need for flexibility and scalability of hybrid manufacturing system in producing emerging therapeutic products
  • Practical advice for integrating hybrid systems in your manufacturing operations
12:00
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Company presentation

Biotech innovation
Jeng Her, Chief Executive Officer, Ap Biosciences Inc
12:00
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Characterization of biologics products

Seminar
12:10
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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.
 
12:10
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Company presentation

Biotech innovation
12:10
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Pricing strategies and key considerations for bringing drugs from red to blue ocean markets in Asia

Market Access
  • Risk assessment and management in post market drugs
  • Discover strategies for accessing this market, and navigating the fragmented regulatory framework in Asia
  • Opportunities for working with country regulators to harmonise general, locally-adaptable guidelines improving drug access for patients
12:10
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Meeting the needs of patients: Practical advice for clinical developers planning pan-Asia trials

Clinical trials
  • Ensuring patient centricity of your clinical practices, through close communication with CROs, trial sites and partners
  • Building the optimal communication methods with patients, for example, setting up apps or dedicated call centres
  • Working with patient advocacy groups to better understand patient needs
12:10
Conference pass

Next generation processes: What model works the best in Asia?

Manufacturing
  • Compare and contrast the available full scale processing technologies, and discover what works the best for manufacturing next generation therapeutic products in Asia.
12:10
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Handling challenges raised from parallel imports

Supply Chain
  • Understanding impact of grey market imports in drug pricing and motivation to innovate in Asia
  • Exploring various pricing strategies to overcome parallel import of genuine products
  • Exploring repackaging requirements for none authorised distributor prevent patient misinformation
12:20
Conference pass

Company presentation

Biotech innovation
12:30
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Company presentation

Biotech innovation
12:30
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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?
12:30
Conference pass

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

In-house manufacturing vs outsourcing: How to balance benefits and costs when selecting CMO in Asia?

Manufacturing
Hear first-hand on key considerations when selecting CMOs for bioproduction in Asia
12:30
Conference pass

Emerging compliance supply chain requirements in Asia

Supply Chain
  • Establishing collaborative, enterprise wide process for communicating compliance requirements with suppliers
  • Ensuring clear assignment of compliance execution ownership for compliance adherence to local regulations
  • Using constant engagement and linkage of individuals throughout an organization to prevent delay and potential loss of sales and product obsolescence
12:30
Conference pass

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.
12:30
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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Company presentation

Biotech innovation
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.
 
Mr Eng Huan Ung, Chief Technology Officer, BioValence Sdn Bhd
14:20
Conference pass

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
Conference pass

Company presentation

Biotech innovation
Hui (David) Shao, Chief Financial Officer, Yisheng Biopharma
14:20
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Exploring country-specific market access strategies

Market Access
  • Besides pricing and reimbursement, what are the other factors in consideration when accessing a new market in Asia?
  • 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 Asia: Is it even possible?
Mr Rachid Janta, Head of Market Access, Baxter
Bo Kyung Kim, Director, Market Access and Policy APAC, UCB
14:20
Conference pass

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
14:20
Conference pass

From clone to pilot plant scale up: Case study of developing a CHO cell culture platform for antibody production from OPEX perspective

Manufacturing
This presentation will explore steps in upscaling antibody production from clone to manufacturing scale, including process development, tech transfer and quality measurements
14:20
Conference pass

Panel: Innovative supply chain solutions to improve agility and efficiency

Supply Chain
  • 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
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Company presentation

Biotech innovation
14:30
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Topic to be announced

Seminar
Session led by: terumo
14:40
Conference pass

Company presentation

Biotech innovation
Mr Eng Huan Ung, Chief Technology Officer, BioValence Sdn Bhd
14:40
Conference pass

Identifying matrices to improve human performance in Asia biopharmaceutical plant

Manufacturing
  • Identification and prevention of true human error events in manufacturing plants
  • Improving human performance through operational excellence
  • Case study in Singapore
Mr Christian D. Cater, Associate Director, Business Excellence,, Roche
14:50
Conference pass
15:00
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Promoting regulatory innovation in Taiwan and the rest of Asia

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
Conference pass

Adopting the Kaizen model for achieving Operation Excellence in Asia

Manufacturing
  • Dicovering current challenges in adopting Kaizen model
  • Exploring potential solutions to streamline production and minimize waste
  • Case Study: Emerging markets in Asia
15:00
Conference pass

Innovate cargo monitoring and tracking for pharmaceutical products with IoT

Supply Chain
  • Understanding the infrastructure requirements for using IoT for supply chain in Asia
  • Balancing cost and benefits in using IoT to ensure quality of products delivered
  • Case study in Asia: Strides
15:00
Conference pass

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
Conference pass
15:20
Conference pass

India’s latest biosimilars guidelines: Opportunities and threats to generics and innovation driven pharma

Clinical trials
  • Understanding key concerns and considerations when working on biosimilars products in India
  • How do pharma companies leverage on India’s regulatory landscape to launch biosimilars products?
  • Should biosimilar industry be worried over AbbVie’s IPR success case vs Amgen in the US and most recently India’s latest biosimilars guidelines?
15:20
Conference pass

Implementing CMC strategies for scale-up operations in biologics manufacturing

Manufacturing
  • Discovering innovative CMC technologies and strategies for operational excellence.
  • Designing approaches to enhance quality through compound characterization, process development, analytical testing.
  • Case Study: Biosimilars production
15:20
Conference pass

Streamlining supply chain with Big Data

Supply Chain
  • Discover how big data can help you handle your supply chain more easily in Asia
  • Understanding the benefits of using cloud, data and analytics to drive operational efficiencies
  • Overcoming challenges in real time transmission of data into cloud storage
15:30
Conference pass

Country update: Thailand

Market Access
Mr Rachid Janta, Head of Market Access, Baxter
16:20
Conference pass

Table 1 Countries specific strategies in overcoming challenging green field regulatory landscape

Keynotes
16:20
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16:20
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Table 4 Talent management and communication strategies in pharma landscape

Keynotes
Maggie Sy, Director - Asia Sourcing And Procurement, Mead Johnson & Company
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
Mark Scullion, Senior VP, Global Alliance Management, Strategic Resourcing, Inventiv Health
16:20
Conference pass

Table 6 Strategies to overcome production challenges when starting new manufacturing project in Asia

Keynotes
16:20
Conference pass

Table 8 Key considerations and strategies in R&D outsourcing

Keynotes
Ms Jessica Thongcharen, Associate Director, Pharmacovigilance, Takeda
16:21
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Table 11 Finding licensing and supply chain partner in Asia developing economy

Keynotes
16:21
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16:21
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Table 10 Building sustainable innovation ecosystem in Asia

Keynotes
17:00
Conference pass

Overcoming metabolic diseases incidences in APAC

Keynotes
And how JLABS QuickFire Challenge can help
Details to be announced.

 
Session led by: j&j-innovation-centre

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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, this biotech company currently employs thousands to benefit the healthcare industry. Hear from true blue biotech company in Asia on their success story in building the reach of their companies from domestic to international market
 
Interviewer: Ed Lane, Senior Editor, Fierce Pharma Asia
09:30
Conference pass

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? 
 
10:10
Conference pass

Strategies in providing affordable healthcare in developing countries

Keynotes
Developing countries are facing enormous challenges when it comes to dedicating natural funds and resources. In the dilemma between investing on more economy boasting industries, and providing better healthcare infrastructure and facilities for the people, the former often get more attention to promote overall growth of the country. In Asia, many countries depend on out-of-pocket to fund healthcare policies, the big question is, how can stakeholders work together in providing accessible and affordable healthcare in limited funding by the government and people to afford these services?
 
Dr Francesco Berlanda Scorza, Scientific Director of Influenza Vaccine Project, P.A.T.H.
10:30
Conference pass

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.
Dr Suchitra Derebail, Lecturer, Republic Polytechnic
11:00
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Platform technology showcase- Imaging technology

Seminar
11:15
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Company presentation-Immunwork

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
Conference pass

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
Conference pass

Understanding regulatory restrictions in implementing new biomanufacturing processes

Manufacturing
  • Understanding the regulatory requirements for modifying bioproduction processes in their respective countries
  • Discussing strategies for speeding up approval procedures to upgrade bioprocesses
  • Is it worth the time and resources to upgrade existing manufacturing processing to continuous systems?
11:15
Conference pass

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
11:30
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Integrated antibody-nanotechnology for targeted cancer therapy

Seminar
11:35
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Big data: Is it a hype or a hope for upcoming reality?

Asia Pharma Leadership Track
Everyone in the world is excited about big data. With super computer power to analyse, capture, search, share and store information, its huge potential can be translated into drug discovery, clinical development, patient recruitment, and even post clinical marketing and sales processes of pharma companies. The big question remains: Is this just a hype by idealistic techies and too good to be true, or is this really happening in the industry?
 
11:35
Conference pass
11:35
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Payer, policy maker and provider engagement

Medical Affairs
  • Exploring key relationship building strategy in working with payers and policy makers
  • Understanding the concerns and priorities of stakeholders when building relationships with the national guideline committees
  • Country case studies: How to successfully engage stakeholders for medical studies and drug reimbursement conversations
Manish Garg, Medical Director, MSD Pharmaceuticals
11:35
Conference pass

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
Conference pass

Process validation for breakthrough and accelerated approval drugs

Manufacturing
  • Discover difference in process design for breakthrough vs regular drugs
  • Ensuring quality reproducibility at production commercial scale
  • Developing a framework for process monitoring to ensure product safety
11:45
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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
Conference pass

Company presentation

Biotech innovation
11:55
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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
Rajakanth R, Executive Director, Rainbow Across Borders Limited
11:55
Conference pass

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
Conference pass

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
12:00
Conference pass

The therapeutic potential of IL-20 antibody in liver fibrosis and breast cancer-induced osteolysis

Seminar
12:05
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Company presentation

Biotech innovation
12:15
Conference pass

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
Conference pass

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? 
Dr Pranab Kalita, Medical Director - Medical Affairs - Lundbeck SEA Cluster, Lundbeck Singapore
12:15
Conference pass

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
12:15
Conference pass

Using QbD as the core design principle in continuous processing

Manufacturing
  • Overcoming regulatory uncertainties in using continuous processing
  • Does continuous manufacturing really help to reduce drug development and commercialisation costs?
  • Navigating regulatory guidelines to ensure compliance
12:25
Conference pass
13:50
Conference pass

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

Using evidence-based discussions to build pharma reputation and brand recognition

Medical Affairs
  • Discovering strategies to further develop and translate worldwide evidence base for local applications
  • Improving uniformity and consistency in local investigator led studies
  • Navigating policy intervention in scientific, evidence based decision making processes
Dr Viraj Rajadhyaksha, Medical Director for Malaysia, Singapore and Brunei, AstraZeneca
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
14:00
Conference pass

Company presentation

Biotech innovation
Sathyabalan Murugesan, Head, Analytical Development & Quality Control, Zumutor Biologics Inc
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

Clinical safety studies and key considerations in biosimilars drugs

Medical Affairs
  • Discovering key parameters to be considered when studying safety of biosimilars in clinical phase
  • Originator vs biosimilars: what needs to be considered in pharmacovigilance studies
  • Understanding how data collected helps in supporting market access mission of medical affairs when working with biosimilars drug
S.D Sinha, Associate Vice President & Head (Global)-Clinical Development, Medical Affairs & Pharmacovigilance, Hetero Drugs Ltd
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
  • Vendor selection and management: How do we measure the quality success of our vendors?
  • China case study
Amy Que, VP, QC, Innovent Biologics Co., Ltd.
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

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
Mr Dominique Milea, Director Health Economics & Epidemiology, Lundbeck
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
Patrik Jonasson, Director, Public Policy Asia Pacific, G.S.1 Malaysia
14:30
Conference pass

Quality assurance and control requirements for cell therapy products

Manufacturing
  • From facilities to equipment and material, how do manufacturers make sure that cell therapy products are manufactured in well-controlled manner?
  • Exploring how a risk-based approach helps in biomanufacturing QA measurements
  • Deriving quality measurements to ensure compliance in upscaling from clinical stage
14:40
Conference pass

Company presentation

Biotech innovation
14:50
Conference pass

Key performance indicators in measuring the success of HEOR

Medical Affairs
  • How can companies prioritise HEOR spending to best impact payers’ pricing decisions?
  • Balancing financial and manpower investments to maximise the output of resources invested
  • Promoting proper data analysis throughout the drug development process to ensure accurate communication with stakeholders
14:50
Conference pass

Optimising product and process parameters with Design of Experiment (DoE)

Manufacturing
  • Using DoE as a compliment to QbD
  • Developing critical quality attributes in process monitoring and validation
  • Modelling approaches to gain full benefit of DoE in satisfying quality design and development activities
15:00
Conference pass

Company presentation

Biotech innovation
Ying-Wannarak Siraarparsate, Business and Commercial Manager, Siam Bioscience Co. Ltd
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
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
15:40
Conference pass

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
Min Li, Vice President, Analytical Operations, Zhejiang Huahai Pharmaceutical Co Ltd
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.
16:00
Conference pass

Biocomparability and stability studies in biosimilar production

Manufacturing
  • Key characterisation techniques to ensure biosimilar functionality
  • Discussing strategies to maintain product quality in upscaling biosimilar
  • Exploring key assays techniques and development for biosimilar testing
Venkata Ramireddy Yeturu, Director, Biologics QC, Dr Reddys Laboratories
16:20
Conference pass

Competency and compliance training of medical staff

Medical Affairs
  • Establishing guidelines and structures to promote cross functional team working and communication
  • Ensuring staff to adhere to required SOPs and comply with regulations
  • Strategies in training medical affairs staff to adhere to consistent, high quality standards
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.
16:20
Conference pass

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
Sathyabalan Murugesan, Head, Analytical Development & Quality Control, Zumutor Biologics Inc
16:40
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

Dr Abhi Bhagat, Medical Director, Asia, Abbvie Ptd Ltd
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

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