Vaccines 2020 Virtual Conference

• The vaccine designed to contain only selected epitopes on the virus that are required for its direct infection of human cells
• In combination with the proper carrier protein, a peptide vaccine is highly immunogenic and is able to stimulate an immune response even in subjects suffering from immunosenescence
• Our peptide vaccine platform is a flexible and rapid and has low‐cost manufacturing process

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• How Australia’s progressive regulatory environment favours vaccine trials
• Nucleus Network: the largest Phase 1 vaccine trials specialist in the southern hemisphere
• 360biolabs: the virology and immunology experts delivering your vaccine efficacy data

• Implementing a national strategy to support multiple COVID19 vaccine trials simultaneously
• Ensuring cross sector collaboration and multi-agency collective response
• Coordinating site selection and set-up to maximise resources and expedite delivery
• Creating a public-health campaign to pre-consent vaccine trial participants

There will be a 10 minute open Q&A after presentation

• The Sky is NOT Falling: Executing a Vaccine Study during the Pandemic
• How Hybrid Study Design Approaches Decrease proof of Concept Timelines
• Adaptive Design Execution Experts: Rapid Start-up, Fast Track to Patients and Real-time Bioanalysis Data Feedback

• Highlighting the results of the vaccine design and preclinical results to date
• Analysing the vaccine vector platform and its applicability to the Coronavirus
• Looking at previous results observed in other infectious disease vaccines including HIV, Zika, Ebola, Marburg and Lassa fever

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• The story behind AAPM ACT: the first COVID-19 global taskforce: a worldwide network of over 200 experts.
• How AAPM ACT has developed, delivered, and disseminated strategies for COVID-19 specific prevention, diagnostics, therapeutics, supply chain logistics, AI-driven solutions, mental health, and other patient-centric precision medicine innovation techniques.
• Insight into building and deploying real-world solutions to fulfill the unmet COVID-19 patient care needs

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• Mucosal vs systemic immune responses
• Benefits of the oral tablet COVID-19 vaccine during a pandemic

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• Superior seroprotection rates (SPR) in adults >44 years of age immunized with the tri-antigenic hepB vaccine
• Higher SPR for tri-antigenic than mono-antigenic vaccinees in all comorbidities subgroups
• No safety signals identified

There will be a 10 minute open Q&A after presentation

• An overview of IRT
• Fusion’s IWRS module
• Advantages of managing randomization and reporting via a single log on
• How we do it in a turnaround period of 60 days

• Establishing your position with regulatory bodies to ensure you are keeping in line with the current practices
• Assessing current data collected to determine the current steps needed of your study
• Liaising with CRO’s to ensure they can fulfil their duty at hand
• Identifying alternative solutions if your current site is not in operation
• Patient safety first: Reviewing your candidates wellbeing to avoid any health risk

• Ensuring your site/practice is kept to a high standard to avoid any patients getting ill
• Forecasting is key: Ensure your patients have designated times to avoid contact and congestion Training local teams to be responsive to potential outbreak

M-001 is currently undergoing a pivotal, clinical efficacy, Phase 3 trial in about 12,400 participants. Results of the clinical trial are expected by the end of 2020. M-001 is designed to provide multi-season and multi-strain protection against all human influenza virus strains, both seasonal and pandemic. In 7 completed clinical trials the vaccine was shown to be safe, well tolerated and immunogenic to a broad range of flu strains.

There will be a 10 minute open Q&A after presentation

• The need to address the known theoretical risk that vaccines against COVID-19 enhance the disease prior to starting firstin-human clinical trials.
• Pre-clinical data required to support proceeding to first-in-human clinical trials with investigational medicinal products
• Highlighting regulatory differences between global bodies to ensure your study complies with it

There will be a 10 minute open Q&A after presentation

• Pre-market evaluation: What is working and what is not?
• Change to address zoonosis, food safety, and antimicrobial resistance
• How can vaccines advance sustainability objectives?
• Legislative and regulatory developments to enable the next generation of vaccines

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• Harmonising common standards throughout vaccine development
• Successful partnerships have provided support and accelerated, vaccine innovation, clinical trials and registration
• Strong partnerships, based on experience and trust, help leverage opportunities and are critically important to advancing the shared goal of providing quality vaccines for all people

QS-21 is a natural product isolated from the Chilean soapbark tree. It has developed a plant cell culture approach to establish a sustainable and scalable approach to the production of this compound.

There will be a 10 minute open Q&A after presentation

• What are the obstacles in data collection during vaccine trials?
• How can technology accelerate trial start up?
• How can I incorporate subject preferences to enhance subject engagement and compliance?

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• The advantages of Australia’s clinical trial landscape
• Understanding GMO regulations, approval processes, classifications and the role of an IBC
• Solutions from Australia’s most experienced GMO clinical trials group

• Using machine learning techniques for better understanding the vaccine mode of action
• Developing bioinformatics tools to predict the immune response to a number of infectious diseases
• Developing systems to enhance vaccination responses
• Exploring profiling platforms to accelerate and de-risk vaccine development

There will be a 10 minute open Q&A after presentation

• Identification of neoantigen candidates
• Improving selection of immunogenic candidates
• Monitoring T cell responses

There will be a 10 minute open Q&A after presentation

• Using machine learning techniques for better understanding the vaccine mode of action
• Developing bioinformatics tools to predict the immune response to a number of infectious diseases
• Developing systems to enhance vaccination responses
• Exploring profiling platforms to accelerate and de-risk vaccine development

• Technology impact on scalability and manufacturing lead times
• Evaluating technical feasibility and regulatory acceptability of technology transfers to localize production
• Assessing demand to right-size supply and adjust delivery schedule
• Managing affordability for buyers and corporate profitability objectives through pricing and advanced commitments

There will be a 10 minute open Q&A after presentation

Join us for our pre-recorded Q&A with our expert, who shall be tackling those post marketing questions regarding safety, regulatory considerations and general health

There will be a 10 minute open Q&A after presentation

• Do your homework: Study similar trial cases to prevent any early obstacles
• How to manage progress with insufficient data from previous trials?
• Having a medical directory is essential for to determine the right patient

• What are the obstacles for manufacturing vaccines?
• How much contract manufacturing capacity exists for vaccines?
• What COVID-19 vaccines are in development?
• What are the contract manufacturing agreements for COVID-19 vaccines?
• Who is investing in COVID-19 vaccine manufacturing?

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• How one technology can ensure consistent results from R&D all the way to cGMP manufacturing
• What to think about when going from the lab to production scale
• Why Microfluidizer technology gets superior results in vaccine adjuvant production
• Invest in one technology for multiple applications

• Understanding the role of blockchain as a single source of truth in a complex world
• Analyzing and prioritizing distribution and verification processes that could be streamlined with a real-time blockchain implementation
• Evaluating the financial impact of enhanced business intelligence and reduced labor costs
• Identifying the optimal methods to deploy an internal blockchain pilot within your organization

There will be a 10 minute open Q&A after presentation

Join us for our pre-recorded Q&A with our expert, who shall be tackling those post marketing questions regarding transport capability, regulatory considerations and identifying the long term challenges.

• Traditional versus virtual decentralized clinical trial model.
• Blockchain as the Database building blocks for machine learning and Artificial intelligence.
• incorporating hybrid decentralized virtual trial with conventional centralized trial protocols.
• Future of the clinical trials catalyzed by pandemic

There will be a 10 minute open Q&A after presentation

• Traditional versus virtual decentralized clinical trial model.
• Blockchain as the Database building blocks for machine learning and Artificial intelligence.
• incorporating hybrid decentralized virtual trial with conventional centralized trial protocols.

There will be a 10 minute open Q&A after presentation