Create your personal agenda –check the favourite icon
Create your personal agenda –check the favourite icon
-Overview of international cooperation frameworks for pandemic preparedness and response
-Assessing needs for further developments in global regulatory oversight
-Strategies for building flexible and resilient health systems
-Building global capacity to meet emerging demands; leveraging lessons from mpox to enhance preparedness
- Overview of global efforts to address inequities in distribution and access
- Local production, equitable distribution?
- Market shaping and health financing
- Impact of vaccination on infectious disease epidemiology
- How can we strategically align approaches with specific country requirements and adapt them to diverse disease landscapes for equitable outcomes?
- Is the global vaccine pipeline in development aligned with local and regional disease priorities to address immunization equity? How important is end to end R&D and manufacturing capacity in LMICs to achieve global immunization?
Join us in the exhibition hall for:1-2-1 partnering, refreshments
Join us in the exhibition hall for:1-2-1 partnering, refreshments, start-up pitches & poster sessions
12:20 Lovaltech: Beyond vaccination: exploiting the nasal route for optimal mucosal defense strategies - Serge Pampfer
12:25 Idevax: Resolving Skin Drug Delivery Challenges - Vanessa Vankerckhoven
12:30 bespark*bio: bespark*bio - the evolution of process development - Matthias Müllner
12:35 Meclinas: Meclinas, an Independant Clinical Trial Site - Ine Vercammen
12:40 Jurata Thin Film: Novel Formulations Eliminate Cold Chain and Enable Needle-Free Vaccine Administration - Megan Livingston
12:45 C-Cube: How to build a modular vaccine facility within 12 months – a case study - Thomas Hauser
12:50 KyooBe Tech: eFit - using low electron energy to make a difference Martina Hampel
12:55 Orlance MACH-1 Vaccines Deliver Optimal T-Cell and Mucosal Immunity – Kristyn Alto
13:00 Psyon Games: The future of health games – Olli Rundgren
13:05 VPUbio: Performance in Pseudotyping – Nigel Temperton
13:10: Cocoon Bioscience: CrisBio®: A novel, natural and scalable protein expression system – Maite Segurola
Deadline for poster abstract submission: Monday 7th October 2024
- Current landscape: overview of emerging alternative approaches, what programmes & strategies are being put in place to adopt alternative approaches to animal use?
- Strategies for integrating these approaches and assessing the reliability and validity of the data obtained; how is this data going to be used to understand disease at the level of R&D?
- Exploring the regulatory framework
- Collaborative efforts and knowledge sharing
- Challenges and future directions for accelerating the adoption of alternative methods
The use of high-performing raw materials is crucial for ensuring safe and efficient manufacturing of vaccines. Trypsin is a fundamental material in cell-based vaccine production facilitating virus expansion as well as playing an important role in activating specific virus particles including influenza. Despite rigorous testing of raw materials, the use of animal-derived trypsin carries the risk of introducing adventitious contaminants, and infection of cell cultures has potentially serious consequences for patients and production continuity. The new enzyme TrypsiNNex® addresses safety and consistency concerns. TrypsiNNex® is high-purity, recombinantly produced, animal-free trypsin, enabling a more robust production and reducing the risk for contamination.A controlled production process ensures TrypsiNNex® is being expressed and maintained in an inactive form until stabilization resulting in a high and consistent proportion of β-trypsin. This makes it ideal for virus-vaccine production. In this presentation, we will show how TrypsiNNex® can optimize the production of influenza vaccines.
- How are we considering the evidence of the value of vaccines against AMR in vaccine recommendations?
- What additional evidence is needed to inform policy and regulatory changes?
- The impact of viral vaccines on antibiotic usage and AMR incidence, how are we measuring this?
Immunoprofiling is essential for accelerating adjuvanted vaccine design by providing a detailed understanding of immune responses at the cellular and molecular levels, enabling more precise matching of vaccine formulations to target pathogens and populations. In this talk, we will present two key immunoprofiling approaches for vaccine development. First, we explore how exploratory clinical studies incorporating multiple tertiary immunoprofiling endpoints can guide vaccine formulation selection in early clinical phases. Second, we present data from an ex vivo human lymph node culture model that recapitulates key mechanisms of action of the AS01 adjuvant, demonstrating the potential of in vitro models to replicate vaccine effects observed in humans. Together, these findings underscore the opportunities to accelerate adjuvanted vaccine design through advanced immunoprofiling techniques
The emergence of scalable eukaryotic cell-free protein expression disrupts the current paradigm of protein production by removing cell engineering as a significant speed-limiting step. With ready-to-use cell-free lysates, protein expression from a gene of interest (via DNA template) to purified protein can now be achieved within 4-6 weeks, regardless of scale.
The ALiCE® platform exemplifies how this breakthrough can be applied to a diverse range of targets,, including antigens, virus-like particles (VLPs), and proteins including metabolic labelling.
We present our vision of an end-to-end solution for epidemic and pandemic preparedness using the ALiCE® platform, a strategy we are currently exploring through a CEPI funded program. This approach has the potential to revolutionize rapid response capabilities for global health crises.
Join us in the exhibition hall for:1-2-1 partnering, refreshments,
Due to their quick development and ease of modifying the antigen, RNA vaccines play an important role in epidemic outbreaks. However, current RNA vaccine technologies can cause adverse events and may give short-lived protection, in addition to not being suitable for all types of pathogens. Changes to the delivery platform can potentially change the immune fingerprint of the vaccine through self-adjuvancy, improve the safety profile of the vaccine and increase the duration of protection. Specifically, this can be achieved through addition of immunostimulants to the formulation, through amended biodistribution and cell-targeting properties, and through optimizing stability and tissue distribution of the vehicle, respectively. At the talk, it will be presented how these concepts can be supported by the lipids offered by Avanti Research and Croda Pharma.
- Current landscape of antimicrobial use in animals
- What are our alternatives: Vaccines, Phages, etc.
- Can vaccination be a cost-effective solution?
- Financing models and incentives to develop and use alternatives to antimicrobials
- How to encourage the use of alternatives to antibiotics in livestock and aquaculture?
- COVID-19 vaccine landscape & public health impact
- Long COVID: definition, diagnosis & challenges
- Vaccine effectiveness & emerging COVID research
- Regulatory & funding challenges for COVID & Beyond
- Future Directions in COVID-19 research & policy
Technological advances have created exciting opportunities across various fields of synthetic biology. However, a key challenge and bottleneck in many areas is the availability of synthetic, high accuracy long DNA molecules of high sequence complexity. While established technologies effectively meet the demand of short oligonucleotides at scale, producing multi-kbp DNA molecules remain a challenge. Ribbon Bio addresses this limitation with its proprietary DNA synthesis platform, demonstrating the successful assembly of linear DNA molecules >10kbp in length, with high sequence accuracy and complexity, which conventional synthesis technologies cannot achieve. Examples and results for these challenging DNA assemblies, particularly in vaccine discovery research will be discussed.
- Closing the uptake gap between child and adult immunisation
- Current uptake issues: why is measles coming back and what can we do?
- The importance of RWE, data & management in immunisation programmes
- With 100+ vaccines in the pipeline; what are the realities for uptake and implementation?
- Case studies from countries with high uptake of seasonal vaccines
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- What are our most challenging and urgent vaccine targets?
- Which of our most stubborn targets with unmet R&D needs pose a great global threat?
- How do we prioritise development to balance the threat of viral diseases and antibiotic overconsumption with the urgency of addressing highly resistant bacterial infections?
- How can we best align these efforts with our global priorities and the pandemic accord?
- Priorities & considerations for developing vaccines: pandemic & endemic
Introducing the WHO Pandemic and Endemic pathogen lists, followed by panel:
- Surveillance of how climate change is driving changes in disease dynamics, distribution and spill over events.
- Highlighting the importance of a one-health approach
- Sustainable financing systems
- Policy and partnership strategies to strengthen our responses
- Exploring where we can adapt current vaccines to address climate-driven changes in pathogens and where novel vaccines will be needed to target emerging climate-sensitive diseases
Join us in the exhibition hall for:1-2-1 partnering, refreshments,
- Predicted the impact of novel vaccines on disease burden and AMR
- Including AMR surveillance during TB Vaccine trials
- Reaching communities most effect by TB, are we considering cost and delivery?
In the past century, vaccination has played a pivotal role in reducing mortality and morbidity caused by infectious diseases. Leveraging innovations from emerging technologies, vaccines are poised to meet evolving demands of a 21st-century society characterized by increased life expectancy, the emergency of new infections, and persistent poverty in low-income countries. Consequently, next-generation vaccines must be more effective, safer, and better tolerated across all ages, especially for children, the elderly, and other populations with compromised immune systems. Moreover, vaccine access and equality remain problematic in low- and middle-income countries (LMICs). Addressing this long-standing issue will require affordable vaccine supplies and local manufacturing capabilities. As a world-leading CRDMO, we will present how we get prepared and enable our clients, whether multinational corporations or biotech startups, to tackle these challenges. It includes comprehensive efforts to support structure-based immunogen design, accelerate novel vaccine development, enhance adjuvant accessibility and screening, and enable low-cost small-footprint manufacturing. Ultimately, the end-to-end platform aims to empower next-generation vaccine development, foster global collaboration, and support efforts in areas critical for epidemic and pandemic preparedness.
- The impact of vaccination on managing disease outbreaks - what have we learnt from French programs?
- The economic impact of vaccination on trade
- Matching our vaccines to the circulating strains
- Monitoring disease epidemiology and spill over to mammals, will this be the next human pandemic?
- Does livestock vaccination protect human health?
Staphylococcus aureus is one of the most common causes of death due to bacterial infections. In the current environment of increasing antimicrobial resistance, preventative strategies are urgently needed. No successful S. aureus vaccine has been developed to date, probably due to lack of inclusion of staphylococcal immune evasion virulence factors in vaccine formulations and the use of poorly representative mouse models. To assess new S. aureus vaccine candidates, we developed a Staphylococcal minipig surgical site model based on the close homogeny between the immune systems and the skin of humans and pigs. Our candidate vaccine targets two immune evasion mechanisms of S. aureus combined with an adjuvant. The candidate vaccine significantly reduced the bacterial load in minipig surgical site infection model. Our study presents a new strategy to develop a S. aureus vaccine by way of including critical immune evasion factors, the addition of a potent adjuvant, and by using a minipig challenge model.
Flaviviruses, such as dengue, Zika, West Nile or Yellow Fever viruses, are vector-borne pathogens of increasing global importance. Due to their structural similarity, vaccination against or infection with one flavivirus may induce immune responses that cross-react with responses to a heterologous flavivirus. As a consequence, disease enhancement of secondary flavivirus infections has been reported, a significant challenge for the development of flavivirus vaccines. The presentation will introduce the problem of antibody-enhancement in secondary flavivirus infections and will present strategies to mitigate the risk of vaccine-induced disease enhancement by designing novel antigens for safe and efficient flavivirus vaccines.
Join us in the exhibition hall for:1-2-1 partnering, refreshments, start-up pitches & poster sessions
Identifying challenges and opportunities in planning for RWE generation during vaccine development
Deadline for submission: Monday 7th October 2024
The pharmaceutical industry relies heavily on advanced analytical techniques to streamline drug discovery and manufacturing processes. The careful selection and planning of these techniques are crucial for product development, regulatory compliance, and overall efficiency.
In this scenario, ADVAXIA Biologics, a cGMP Contract Development and Manufacturing Organization (CDMO), exemplifies how analytical methods optimization can significantly enhance and accelerate drug development from preclinical to clinical phases.
This case study will explore the pivotal role of developing and applying advanced analytical methods in pharmaceutical manufacturing, focusing on ADVAXIA Biologics' practices in GMP-enabling activities for a viral-based vaccine.
By developing, validating, and applying these methods, ADVAXIA Biologics has enhanced its production process understanding, improved product quality, ensured regulatory compliance, and increased operational efficiency.
This comprehensive approach highlights the critical role that analytical advancements play in the success of biopharmaceutical manufacturing and the overall drug development process.
- Diseases (e.g. Ebola, Malaria, Dengue) that are associated with outbreaks and are not established as endemically with vaccines that have/are being developed
- How should the global health community consider evaluation of these vaccines outside of clinical trials leading to EUA?
Introduction
Messenger RNA vaccines have demonstrated efficacy in protection against COVID-19. The speed and flexibility of the platform lends itself well to influenza, where the virus is constantly evolving and there remains an unmet need for better influenza vaccines. Pfizer has developed a quadrivalent mRNA vaccine targeting influenza, qIRV.
Methods
Pfizer conducted a Phase 3, randomized, observer-blinded study to evaluate the safety, tolerability, immunogenicity, and efficacy of qIRV compared to a licensed influenza vaccine (QIV) against laboratory-confirmed (RT-PCR) influenza (LCI) in healthy adults 18 years and older (stratified by age: 18 through 64 and ≥65 years). Participants 18–64-years were enrolled during the 2022–2023 northern hemisphere influenza season. Immunogenicity was evaluated by hemagglutination inhibition (HAI) assay and quantification of hemagglutinin-specific CD4+ and CD8+ T cells. Reactogenicity was collected by eDiary in a subset population and other adverse events were collected from all participants.
Results
The primary analysis of relative vaccine efficacy (RVE) of qIRV versus QIV in participants 18 through 64 years of age was performed based on 144 total LCI cases as of 17 Mar 2023. RVE in the evaluable efficacy population was 34.5% (95% CI 7.4-53.9) which met both non-inferiority (NI) and superiority criteria. The LCI cases included A/H3N2 and A/H1N1 strains. NI of HAI antibody responses was shown for influenza A strains but not influenza B. IFNγ+ CD4+ T-cell and CD8+ T-cell GMFRs were higher in the qIRV group for all 4 strains. Primarily mild or moderate reactogenicity was observed in both vaccine groups but reported more frequently among qIRV recipients. AE profile was similar between both vaccine groups.
Conclusions
qIRV is the first mRNA vaccine to demonstrate efficacy in prevention of influenza. Lack of influenza B cases limits confirmation of efficacy against both influenza A and B strains. qIRV has an acceptable safety profile.
Join us in the exhibition hall for:1-2-1 partnering, refreshments
- The evolving landscape of what constitutes a vaccine; exploring therapeutic vaccines and the distinction between prophylactic and therapeutic approaches
- How well do we understand the immune system to be able to manipulate it for therapeutic uses?
- Updates on therapeutic vaccine development
- Future prospects for therapeutic vaccines & immune modulation
Senior Representative, BioNTech - TBC
Join us in the Exhibition Hall for networking drinks
Create your personal agenda –check the favourite icon
Join us in the exhibition hall for 1-2-1 partnering
Learn how mobile sites adhere to the same rules and regulations as B&M sites.
Addressing Misconceptions about Mobile Sites: Mobile research sites are not limited in scope; they offer the same high-quality care and research capabilities as traditional sites, expanding access to underrepresented populations.
Clinical Trial Performance: Mobile sites enhance clinical trial performance by reaching diverse patient populations, improving recruitment and retention rates, and accelerating study timelines without compromising data integrity.
Centralized Infrastructure: A robust centralized infrastructure supports mobile sites by ensuring seamless coordination, consistent data management, and adherence to regulatory standards across all locations, boosting trial efficiency.
Join us in the exhibition hall for:
1-2-1 partnering & poster sessions
§ Overview of emerging trends in vaccine development.
§ The role of vaccine innovation in addressing a wide range of health challenges, such as health emergencies, antimicrobial resistance, or dangers posed by climate change and demographic changes.
In this session, we will explore opportunities of reliance for vaccines supporting regulatory authorities’ decision-making based on information submitted and approved by high surveillance agencies. The collaboration among regulators reduces duplication of efforts at agency and industry level accelerating patients access to medicines, particularly, vaccines. Practices on post-approval and pre-approval space will be shared with focus on a recent pilot with the African Medicines Agency (AMA), which aims to establish a harmonized regulatory framework for medicines in Africa.
- What global efforts are being made to integrate and ensure global manufacturing capacity?
- Will the EU follow suit and implement similar policies?
- Current strategies for developing the next-generation malaria vaccines
- What exciting prospects do novel technologies present for advancing malaria vaccine development, especially multistage vaccines?
- Accelerating malaria vaccine development through public-private partnerships
In the "post pandemic" world, access has become an "all country" issue as both high- and low-income settings still find themselves challenged by vaccine delivery for outbreaks like Mpox and routine vaccination. ApiJect is looking to address these challenges with innovative approaches to delivery that finally solve last mile challenges and open up markets in an environmentally sustainable way. This presentation will summarize the key elements to some of those approaches and device programs.
- What type of manufacturing capabilities need to be established to take ownership of vaccine production and distribution within the region?
- Adopting and innovating new tech to enhance self-reliance and reduce dependency on global supply chains
- The importance of strategic regional partnerships; addressing challenges in knowledge transfer, and building sustainable local expertise in vaccine production
- Strategies for creating a sustainable and resilient vaccine manufacturing ecosystem
- Examination of the regulatory frameworks governing vaccine manufacturing in LATAM; Challenges in harmonizing regulations across the region to streamline manufacturing processes
- Advances in thermostability and alternative delivery to reduce the need for cold chain; inequities of cold chain infrastructure and vaccine distribution
- What strategies are being employed to secure vaccine supply chains and technologies?
- Managing supply chains and manufacturing processes in the current global landscape.
- Policy changes & implications on vaccine distribution and supply chain security
Join us in the exhibition hall for:
1-2-1 partnering