Mobile Agenda

 

 

Washington DC, 2 - 5 April 2018

Schedule

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Apr 308:40
Conference pass

Immunization across the lifespan – What will it take? A WHO perspective

Keynotes
  • Building routine influenza immunization programs in low-resource settings
  • Vaccinations in adulthood: An important role in public health and in reducing morbidity and mortality rates
  • Why are adults often behind in many vaccinations?
Apr 309:05
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Adjuvant technology and its impact on vaccine development

Keynotes
  • Analysis of the importance and role of innate immunity
  • Formulation of novel adjuvant combinations
Apr 309:30
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Designing and building the next generation of vaccine adjuvants

Keynotes
  • Discovery of adjuvants, their optimal delivery and how they advance into clinical evaluation and assessment of their performance
  • Creating robust and scalable formulations
  • Negotiating a path to potential approval
Apr 309:55
Conference pass

What it takes to get a vaccine from research to near elimination of H influenza type b (Hib) diseases globally: Saving 7 million lives by 2020

Keynotes
  • How the pivotal PRP-OMP conjugate vaccine efficacy trial was designed and conducted, leading to the licensure of the vaccine (Pedvax Hib)
  • Challenges and triumphs – lessons learned that can be applied to today’s vaccine research and trials for global access
Dr Mathuram Santosham, Professor, Johns Hopkins UniversityUnited States
Apr 311:21
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Aligning Sponsor/CRO/Laboratory Communication for Esoteric Laboratory Services

Keynotes
Apr 311:21
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Animal component free media: What’s critical?

Keynotes
Apr 311:21
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Applying next generation sequencing to assess immune-mediated drug hypersensitivity

Keynotes
Apr 311:21
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Are you ready for Phase II?

Keynotes
Apr 311:21
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Best practices for a Successful CRO/Pharma partnership for Vaccine Clinical Studies

Keynotes
Title TBC
Apr 311:21
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Better strategy to streamline collaboration between development teams (from process to analytical/formulation) and manufacture

Keynotes
Apr 311:21
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Clinical Development & trials: Conducting clinical trials in low resource settings

Keynotes
Apr 311:21
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Combating one health- Use of preventative vaccines to control food contamination

Keynotes
Apr 311:21
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Developing more effective vaccines for emerging/re-emerging pandemic threats

Keynotes
Senior representative, ClinicalRMTBC
Apr 311:21
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DNA, live vectors, adjuvanted vaccines. 30 years later, are they inter changeable or is there a specific use for each?

Keynotes
Apr 311:21
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How can we actually apply big data and AI into smarter vaccine design?

Keynotes
Apr 311:21
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How to measure and develop dual use vaccines?

Keynotes
Apr 311:21
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Managing your cold chain – Lessons learned from the Ebola clinical trials

Keynotes
Apr 311:21
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Non-clinical safety considerations when working with live virus and LNP based vaccines

Keynotes
Apr 311:21
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Sharing insights in taking novel adjuvants through the regulatory process: (Clinical) Trials and Tribulations

Keynotes
Apr 311:21
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Strategies to effectively identify and target neoantigens in solid tumors

Keynotes
Apr 311:21
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The human challenge testing paradigm

Keynotes
Apr 311:21
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The microbiome boom: Addressing intellectual property and regulatory pathways for microbiome based therapies

Keynotes
Apr 311:21
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The use of ePRO solutions and platforms in vaccine studies

Keynotes
Apr 311:21
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Treatment of veterinary cancers: Personalized cancer vaccines, cell & gene therapies for veterinary use

Keynotes
Apr 311:21
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Unexpected drivers of performance; doses per vaccine vial

Keynotes
Apr 311:21
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Vaccines, outbreaks, and pregnancy: How vaccine development and deployment can better meets the needs of pregnant women and their offspring

Keynotes
Apr 33:10
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Enabling guidance from the World Health Organization

Keynotes

- WHO’s target product profiles for outbreak vaccine development

- Data and sample sharing in emergencies and during the inter-emergency period

Apr 34:10
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Executive cancer panel: How will recent breakthroughs in immuno-oncology determine cancer vaccine and combinational treatments?

Keynotes
  • The significance of check point inhibitors, oncolytic viruses neoantigens, CAR T-cells and ACT on cancer immunotherapy progress
  • Supporting evidence from combinational studies
  • The role of cancer vaccines in the future of combinational approaches
Apr 34:55
Conference pass

The role of vaccines to combat antibiotic-resistant bacteria

Keynotes
  • Insights and recommendations from the national vaccine advisory committee and Chatham house
  • Use of vaccines to prevent the infections that could or have developed AMR to antibiotics, in adjunction to antibiotic stewardship
Apr 35:20
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Trispecific abs and novel platforms to prevent HIV and other viral infections

Keynotes
Apr 35:40
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Apr 409:00
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Chair’s opening remarks

Emerging & Re-emerging Diseases
Apr 409:00
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Chair’s opening remarks

Cancer & Immunotherapy
Apr 409:00
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Apr 409:00
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Apr 409:00
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Apr 409:00
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Apr 409:10
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Novel adjuvants: What’s needed and how to get them approved?

Clinical Trials
  • Future of adjuvants – what is needed?
  • The need for a better strategy for a rational design
  • Developing adjuvants to improve existing vaccines & reduce the amount of vaccine antigen needed
  • New mechanism of adjuvant; Inducible adjuvant mediated by multiple, but specific pathways
Apr 409:10
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Apr 409:10
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Vaccine supply chains in low resource environments: past, present and future perspectives

Vaccine Supply & Logistics
  • The most fully scrutinized public sector vaccine supply chain are in the least developed countries;
  • Supply chain strengths and weakness will be demonstrated - there are plenty of both;
  • Implications for the future for vaccine developers and manufactures will highlighted.
Apr 409:10
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VLA 1601, a jointly-developed vaccine candidate against Zika based on a well-proven technology platform

Emerging & Re-emerging Diseases

· Medical need and trends on Zika epidemiology

· Vaccine design and characterization

· Ongoing Phase I in the US and development outlook

Apr 409:10
Conference pass

What’s next after PD1? Next generation checkpoint inhibitors including anti-TGF-beta

Cancer & Immunotherapy
  • A deeper look at TGF-beta as a checkpoint inhibitor.
  • What are its effects on tumour growth and other cell types?
  • Synergy with vaccines and PD1 checkpoint inhibitors.
  • Brief look at other novel checkpoints, regulatory cells and cytokines; LAG3, Tim3
Apr 409:10
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The Human Vaccines Project: Harnessing recent technological advances in the biomedical and computational sciences to accelerate vaccine development

Immune Profiling
  • Deciphering the human immunome to facilitate diagnostic, vaccine, and therapeutic discovery
  • Interpreting immunogenicity to enable induction of specific and durable protective immune responses
  • Towards a universal influenza vaccine
Apr 409:10
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mRNA vaccines: A potentially disruptive modality

Bioprocess & Manufacture
Apr 409:10
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Areas of interest for big pharma: External collaborative research and partnering opportunities for vaccine development

Partnerships
More speakers from Merck, Pfizer, biotechs and academics to join
Apr 409:10
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Rational design of veterinary vaccines, is it less established than human vaccines?

Veterinary
  • Strategy when conventional vaccines don’t work
  • Can vaccines alone eradicate? The need to combine treatments outside of vaccines with alternative approaches
Apr 409:40
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Achieving an effective balance of attenuation and immunogenicity for RSV live attenuated vaccines (LAV)

Influenza & Respiratory

· Engineering RSV LAV strains with enhanced immunogenicity using a multi-faceted, rational mutagenesis approach

· Enhancing expression of the pre-fusion conformation of the RSV fusion (F) protein

· Using genetic mapping to identify residues that correlate with pre-fusion antigen maintenance and thermal stability of infectivity into LAV candidates

· Candidatesexhibiting elevated pre-fusion antigen levels, thermal stability, immunogenicity, and efficacy

Apr 409:40
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MVA-VLP as a Plug and Play platform for development of safe and effective single dose vaccines for emerging infectious diseases, preclinical data for Zika, Ebola and Lassa as examples

Emerging & Re-emerging Diseases
Apr 409:40
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Panel Discussion: challenges to enhancing the therapeutic effectiveness of immune checkpoint antagonists with checkpoint agonists and inhibitors of immuno-metabolic pathways

Cancer & Immunotherapy
  • Activating the antitumor immune T cell response through agonistic targets such as CD137 and OX40
  • Understanding the pathways used to create immune suppression and techniques to slow down immune suppression
  • What makes t-cell agonists so hard to work with vs checkpoint inhibitors?
Apr 409:40
Conference pass

Success Factors for managing a scalable global clinical supply chain system

Vaccine Supply & Logistics
  • Managing vaccine supply chains at a global level; setting the right inventory levels, avoiding stock outs, managing supply and demand
  • Challenges associated specifically with vaccine supply;
    • Long lead times
    • Heavy focus on Quality Assurance
    • Complying with global regulation
  • Keeping up with constant improvements in the manufacturing process
Apr 409:40
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Immune profiling in the context of TB and Malaria vaccination

Immune Profiling
Apr 409:40
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Practical solutions enabling rapid production of viral based therapies

Bioprocess & Manufacture
Apr 409:40
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Technology showcase 1

Partnerships
Vesicular stomatitis virus vectors – A promising vaccine platform
Apr 409:40
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Vectored herpesvirus vaccines and novel approaches, for their attenuation and continued efficacy

Veterinary
Apr 409:55
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Technology showcase 2

Partnerships
Chimpanzee adenovirus vector vaccine technology
Apr 410:10
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A Plug-and-Play Technology Platform to Expedite the Production of Vaccines for Biodefense and Emerging Infectious Diseases

Emerging & Re-emerging Diseases

· The potency and functionality of our platform with data from studies with highly pathological avian influenza (HPAI) and MERS-CoV vaccines

Apr 410:10
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Have we made enough progress in overcoming the unique challenges in conducting vaccine clinical trials in Asia?

Clinical Trials
  • Use of surrogate endpoints, differential efficacy / safety in diverse populations, accuratemeasures of exposure
Apr 410:10
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Optimizing supply chains to meet the demands of an increasingly large and costly portfolio of vaccines

Vaccine Supply & Logistics
Apr 410:10
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Panel: Pfizer’s RSV vaccine program

Influenza & Respiratory

· Research background

· Pre-clinical results and clinical plan

Dr Beate Schmoele-Thoma, Senior Director Vaccine Clinical Research and Development, Clinical Lead, RSV, PfizerUnited States
Apr 410:10
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Using the Sentinel program to assess vaccine safety

Vaccine Safety & Pharmacovigilance
  • Protocol-based studies, e.g. intussusception risk after rotavirus vaccination
  • Data-mining studies, e.g. evaluating the safety of HPV4 vaccine
Apr 410:10
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Latest advancements in production process intensification to support demand for affordable vaccines

Bioprocess & Manufacture
  • Use of fixed-bed bioreactors
  • Development of microfacilities
Apr 410:10
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Technology showcase 3

Partnerships
Nanodisc technology for personalized cancer vaccination
Apr 410:25
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A single-dose live-attenuated Zika vaccine

Emerging & Re-emerging Diseases

· 3’UTR 10-nucleotide deletion

· Prevents infection in rhesus macaques & utero transmission in pregnant mice

· Protects testis and sperm count damage in mice

· Protective immunity within two weeks in rhesus macaques

· Durable immunity with potential life-time protection

· Excellent safety profile in mice and non-human primates

Apr 410:25
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Long range production platform for pharmaceuticals: Application to CRM197

Bioprocess & Manufacture
Apr 410:25
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Technology showcase 4

Partnerships
ImplaVaxTM – Unique needle free solid dose vaccine platform delivering enhanced immunogenicity with ultimate convenience and no cold chain
Apr 411:40
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Driving the immunization supply chain with data

Vaccine Supply & Logistics
  • Digital solutions and other innovations for improving data visibility, including case study examples
  • How to build a culture of data use
  • Future directions in improving the visibility and use of data
Apr 411:40
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Apr 411:40
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Apr 411:40
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PD-1 antibodies are transforming cancer therapy both as monotherapies and in combination

Cancer & Immunotherapy
  • PD-1 antibody monotherapy indications continue to expand
  • PD-1 antibody has shown potential important activity when combined with:
    • Standard therapies e.g. chemotherapy
    • Targeted therapies e.g. with TKIs
    • Other immune modifying therapies e.g. IDO-1 inhibitors
    • Oncolytic viruses e.g. TVEC
  • Precision medicine will be increasingly important in patient selection
Apr 411:40
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The RSV F Nanoparticle Vaccine for Infants via Maternal Immunization in Phase 3: Rationale and Update

Influenza & Respiratory
Apr 411:40
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Biomarkers of vaccine safety

Immune Profiling
  • The need for specific trial design
  • Systemic vs local markers
  • The experience of Biovacsafe
Apr 411:40
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What can we learn from mAB bioprocessing to vaccines to make more vaccines? From R&D to full scale manufacturing and worldwide distribution

Bioprocess & Manufacture
  • The transition from lab to manufacturing and large-scale production of low cost vaccines globally
Apr 411:40
Conference pass

Technology showcase 5

Partnerships
Novel nanoparticle formulations for delivery of protein or RNA vaccines
Apr 411:40
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Immunomodulators: Rationale for targeting the innate immune response when vaccines aren’t effective

Veterinary
  • Role of innate immunity
  • Immunostimulants as preventative and therapeutic agents
  • Recent developments in veterinary immunomodulators
Apr 411:55
Conference pass

Technology showcase 6: Salipro nano-membrane particles - A platform for antigen stabilization and vaccine development

Partnerships
Dr Robin Löving, CSO, Salipro Biotech ABSweden
Apr 412:10
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A comprehensive analysis of combination studies in immuno-oncology

Cancer & Immunotherapy
  • Summary of all IO agents, targets and companies
  • Overview of ongoing PD-1 combination studies
  • Trends and areas to enhance efficiencies
  • Role of Philanthropy in IO
Apr 412:10
Conference pass

Building further on Viroclinics Ferret model with novel insights: Transmission of HRSV in Immunocompromised ferrets

Influenza & Respiratory

· Demonstration of efficient transmission of human respiratory syncytial virus (HRSV) from immunocompromised ferrets to both immunocompromised and immunocompetent ferrets

· Research findings were collected by applying several assays including Sequencing, PCR, Virus Culture/Titration. Furthermore, histo pathological changes of respiratory tissues from donor and contact ferrets were demonstrated by standard and immunohistochemistry

· A high transmission rate of HRSV was found and more …

Apr 412:10
Conference pass

Overcoming challenges in seasonal vaccine studies, including maternal immunization

Clinical Trials
Marty Anderson, Executive Director, Clinical Development - GenMed, Syneos HealthUnited States
Apr 412:10
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Redesigning immunization supply chains in low and middle-income countries: a case study

Vaccine Supply & Logistics
  • What is the current scope of the problem
  • What level of change is needed
  • Promising examples of change in sub-Saharan Africa
Apr 412:10
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Principles of broad and potent antiviral human antibodies: Insights for vaccine design

Immune Profiling
  • Isolating and studying human antiviral mAbs and the basis for their activity
  • Understanding of the chemical and physical basis for molecular recognition of viral surface proteins
  • Building predictive molecular models that can be used for vaccine design
Apr 412:10
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Bridging the Global Health Gap – Viral and bacterial vaccine development at Intravacc

Bioprocess & Manufacture
Apr 412:10
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Technology showcase 7: Lentiviral vectors as a novel platform for T-cells vaccines

Partnerships
Apr 412:10
Conference pass
Apr 412:25
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ExpreS2 – an insect cell based vaccine production system suitable for difficult-to-express proteins

Bioprocess & Manufacture
Apr 412:25
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Investor panel: Hear from different VCs to better understand what they are looking for before they invest

Partnerships
More VCs to be announced shortly
Stephen Nagler, Executive Director, MedPro Investors LLCUnited States
Apr 412:40
Conference pass

A CMV vaccine based on non-replicating lymphocytic choriomeningitis virus vectors expressing gB and pp65

Clinical Trials
  • 12 months Phase I data supporting a Phase 2 randomized, placebo-controlled trial in CMV-negative recipient patients awaiting kidney transplantation from CMV-positive donors
Apr 412:40
Conference pass

Landscape analysis of RSV vaccine development and future implications

Influenza & Respiratory
Apr 412:40
Conference pass

Rapid and efficient development of combination therapies through a novel cancer immunotherapy platform.

Cancer & Immunotherapy
  • Introduction to Morpheus; a novel cancer immunotherapy platform
  • How to go about selecting a combination study
  • Potential for use across several indications
Apr 412:40
Conference pass
Apr 412:40
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Analytical characterization of aluminum adsorbed vaccines: Stability indicating methods for product release

Bioprocess & Manufacture
  • What general guidance is there on release and stability test methods for aluminum adsorbed vaccines?
  • Understanding of the antigen stability following adsorption
  • Reviewing potential release tests and proposing a panel of stability indicating tests for aluminum adsorbed vaccines
Apr 412:55
Conference pass

A systematic review and meta-analysis on the safety of newly adjuvanted vaccines among the elderly

Vaccine Safety & Pharmacovigilance
  • We searched the literature for clinical trials (CTs) including new adjuvant systems (AS01, AS02, AS03, or MF59), used in people of 50 years and older, published between January 1995 and September 2017.
  • 12 CTs were retained on AS01/AS02, AS03 and MF59 adjuvants, respectively, covering 92,123 subjects
  • This systematic literature review showed no overall increase in SAEs, fatalities, or unsolicited AEs following newly adjuvanted vaccines.
  • Higher rates for local or general AEs were observed for all newly adjuvanted vaccines, but AEs were mostly mild and transient.
Apr 412:55
Conference pass

Comparisons between QIV and Vaxart’s oral vaccine for protection against influenza challenge in humans

Influenza & Respiratory
Apr 412:55
Conference pass

QS-21 Adjuvant: Validated, Efficacious and Available

Clinical Trials
Dr Leandro Padilla, R & D Director, Natural ResponseUnited States
Apr 42:40
Conference pass

Characterization of the immune response induced by plant-made influenza vaccines

Influenza & Respiratory

Immunogenicity of a plant-derived quadrivalent VLP vaccine in adults and the elderly

· Phase 2 clinical results on QIV seasonal VLPs in healthy adults and elderly

· Comparison of humoral and cell-mediated immune responses induced by VLPs

Apr 42:40
Conference pass

Considerations and challenges in pre-clinical safety assessment of vaccines and passive immunization strategies

Vaccine Safety & Pharmacovigilance
  • Respiratory Syncytial Virus Infection in Adults and Pediatric populations
  • Demonstration of disease exacerbation in an animal model
  • Species selection
  • Monoclonal antibodies with half-life extension mutations
Apr 42:40
Conference pass

Design and implementation of clinical trials in an emerging epidemic: Flavivirus Case Study

Clinical Trials
  • Current status of Zika Vaccine candidates in Clinical Development
  • Geographical Considerations: Epidemiology v Trial Locations
  • Considerations for Zika Vaccine Clinical Development Strategy
Apr 42:40
Conference pass

Overcoming Key Supply Chain Challenges for Vaccine Shipments

Vaccine Supply & Logistics
  • Establishing a strong global network increases the strength of your supply chain
  • Explore the latest technological advances in packaging and tracking for complete end to end visibility
  • Learn how performing a detailed risk assessment, including lane verification, helps to ensure a smoother and less risk-sensitive shipment process
Apr 42:40
Conference pass

Session title TBC

Emerging & Re-emerging Diseases

Senior representative, Pharm-Olam International

Apr 42:40
Conference pass

State of the art and novel approaches to T Cell Vaccines

Cancer & Immunotherapy
  • How have recent advances in immunotherapy provided a path forward for T-Cell Vaccines?
  • Biomarkers for T-cell strategies
Apr 42:40
Conference pass

Integrated Immune Monitoring Solutions for Preclinical and Clinical Development of Immunotherapeutics

Immune Profiling
Session led by: caprion-biosciences
Apr 42:40
Conference pass

Review of the current alternative vaccine delivery methods and how their effectiveness is assessed

Bioprocess & Manufacture
  • The advantages and progression of up taking alternative delivery systems and packaging
  • The logistical challenges to consider for developing countries
  • How to make new technologies applicable and build a stronger business case to be used
  • Total system effectiveness: Cost modelling of delivery systems
Apr 42:40
Conference pass

The formation of new companies developing infectious disease vaccines

Partnerships
  • The impact of the current vaccine industry ecosystem on funding for vaccine start-ups
  • Looking beyond venture capital for early stage funding
Apr 42:55
Conference pass

FluoroSpot in vaccine research: Investigating polyfunctional T cell responses and B cell cross-reactivity

Immune Profiling
Session led by: mabtech
Apr 42:55
Conference pass

High-resolution profiling of antibody responses to arrays of peptides

Immune Profiling
Applications in vaccines, oncology, autoimmune disorders, antibody discovery
Apr 43:10
Conference pass

How can vaccines and vector control be integrated and used synergistically in a control program

Emerging & Re-emerging Diseases

· Clinical development challenges associated with the design and conduct of emerging epidemic trials

· Current status of Zika Vaccine candidates in Clinical Development

· Geographical Considerations: Epidemiology v Trial Locations

· Considerations for Zika Vaccine Clinical Development Strategy

Apr 43:10
Conference pass

Innovations in cold chain equipment – preventing freezing in the vaccine cold chain using wireless remote temperature monitoring

Vaccine Supply & Logistics
  • Many newer, more expensive vaccines are freeze / heat sensitive – so monitoring and maintenance of cold chain equipment is critical.
  • High-income as well as low- and middle-income countries suffer when cold chain equipment fails and tempertatures damage or destroy vaccines.
  • Real-time temperature monitoring allows for quick detection of problems, rapid response to save vaccines, intelligent maintenance, and more.
  • At a high level, the data collected enables evidence-based budgeting, procurement, equipment placement, and effective planning.
Apr 43:10
Conference pass

Safety assessment during the clinical development phase of a vaccine

Vaccine Safety & Pharmacovigilance
  • Capturing of data
  • Relevance of causality assessment
  • When to build a benefit/risk assessment
  • Different populations vs different approaches
Apr 43:10
Conference pass

Synergy of DNA Vaccines with checkpoint inhibitors

Cancer & Immunotherapy
  • Selection of appropriate vaccine antigens for prostate cancer
  • Updates from ongoing translational trials of DNA vaccines in prostate cancer
Apr 43:10
Conference pass

Utilization of eDiaries in Vaccine Studies: Where are we now?

Clinical Trials
Wilhelm (Willie) Muehlhausen, VP eCOA & Innovation, ICONUnited States
Apr 43:10
Conference pass

Utilizing human challenge studies to accelerate the development of respiratory vaccines

Influenza & Respiratory

Session title TBC

Apr 43:10
Conference pass

Neoantigens versus tumour associated antigens: What are their relative roles as targets for cancer immunity?

Immune Profiling
  • While there is clear evidence that mutation associated neoantigens provide relevant targets, the role of tumor associated antigens remains to be validated.
  • Tumor viruses allow us to have our cake and eat it- they are tumor specific, yet shared.
  • New platforms for sensitive and specific assessment of t cell responses to cancer open the door to a broader range of immunotherapies.
Apr 43:10
Conference pass

Creating the next generation of vaccines and immunotherapies by mimicking an infection to enhance the immune response

Bioprocess & Manufacture
  • Illustrating how the delivery of sustained release vaccine depots via microneedle patch improves immunogenicity
  • Logistical conquest in easy administration, shelf life stability and only minutes of wear time
  • Current progress with an in-house influenza vaccine and partnered programs to advance formulation for optimal patient uptake
Apr 43:10
Conference pass

Innovative mechanisms in funding vaccine technology: A PPP model for international partnerships that bring Japanese innovation, investment and leadership

Partnerships
  • How will current investments plan contribute to IDs, NTDs and vaccine development?
  • The importance of cross collaborations
B.T. Slingsby, Chief Executive Officer and Executive Director, Global Health Innovative Technology FundChina
Apr 43:10
Conference pass

Bench to Market: Challenges and opportunities in the commercialization of academic vaccine candidates to the marketplace

Veterinary
Apr 43:25
Conference pass

A patch and a laser = vaccination without a cold chain?

Bioprocess & Manufacture
Apr 43:40
Conference pass

Development of a novel prophylactic vaccine for the prevention of Lyme disease: Phase I results of Valneva’s Lyme vaccine candidate VLA15 and development outlook

Clinical Trials
  • Background and medical need
  • Vaccine design including preclinical data for VLA15
  • Phase I results and development outlook
Apr 43:40
Conference pass

Engaging private sector innovators to create sustainable change at scale in low resource environments.

Vaccine Supply & Logistics
  • Bringing business acumen and innovation to bear to save lives and create sustainable health systems
  • What are the biggest supply chain related obstacles to reaching all children with life-saving vaccines
  • How can partnerships be created that provide a win-win for both the public and private sectors
Apr 43:40
Conference pass

Hollow microneedles for use in delivery of cancer vaccines

Cancer & Immunotherapy
  • Delivery to appropriate target tissue is critical to control the safety and effectiveness of vaccines
  • We have used a new product developed by 3M to consistently for intradermal delivery of a cellular vaccine
  • The unit is easy to load and deliver the product
  • Our autologous DC vaccine using this product has shown evidence of efficacy for newly diagnosed glioblastoma patients.
Apr 43:40
Conference pass

Influenza vaccines immunological assessment

Influenza & Respiratory
Apr 43:40
Conference pass

Vaccine pharmacovigilance: the once and future challenges

Vaccine Safety & Pharmacovigilance
  • Data sources for vaccine safety are advancing; the introduction of more sophisticated data sources and methods may help address some of the shortcomings of the most established pharmacovigilance tools.
  • The introduction of novel vaccines into an increasingly globalized health market creates an increasing demand for robust and timely vaccine safety monitoring systems.
  • The introduction and impact of successful vaccines and public health implementation programs have been paralleled by advances in communication technologies which have coalesced to raise societal expectations for vaccine safety.
Apr 43:40
Conference pass
Apr 43:40
Conference pass

Accelerating vaccine development & biomanufacturing using a universal, non-viral delivery platform for engineering of relevant cell types

Bioprocess & Manufacture
  • Rapidly express mg to gram quantities of MAbs, recombinant proteins, viral vectors, and VLPs
  • Bench to bedside scalability in cells relevant to bioproduction (CHO, HEK, Vero, MDCK, BHK21, insect cells, etc.)
  • Synergize and streamline migration from transient expression to stable cell line generation
Senior representative, Maxcyte
Apr 43:40
Conference pass

The role of emerging markets in the global supply and demand for vaccines: Perspectives from Brazil

Partnerships
  • Paving the way for a Dengue vaccine in Brazil
  • Soliciting support for sound scientific endeavors
  • Developing the framework for their realization, and reaching out for international partners
Dr Jorge Kalil, Former director of Butantan Institute, Professor and Head Clinical Immunology, School of Medicine, University Of Sao PauloBrazil
Apr 43:40
Conference pass

The role of veterinary vaccines in the emergency management of a foreign animal disease outbreak

Veterinary
Apr 43:55
Conference pass

Results of a PhIa study of a universal influenza vaccine in healthy adults

Influenza & Respiratory
  • The promise of prevention: A novel universal vaccine virus Protection from drifted or mismatched flu strains
  • Breadth of protection in multiple age groups
Apr 43:55
Conference pass

The AAVLP platform for prophylactic and therapeutic vaccines with special focus on HPV-L2

Cancer & Immunotherapy
  • Adeno Associated Virus Like Particles as a vaccine platform.
  • Broad coverage HPV vaccine without adjuvant, targeting the L2 minor capsid protein.
  • Prophylactic and therapeutic AAVLP-HER2/Neu vaccine.
Apr 44:40
Conference pass

CDC’s post-licensure vaccine safety monitoring systems – addressing 21st century public health needs

Vaccine Safety & Pharmacovigilance
  • The Centers for Disease Control and Prevention (CDC) conducts post-licensure vaccine safety monitoring of licensed vaccines in U.S. children, adolescents and adults.
  • The three CDC post-licensure monitoring systems are the Vaccine Adverse Event Reporting System (VAERS), Vaccine Safety Datalink (VSD), and the Clinical Immunization Safety Assessment (CISA) Project. The functions of these systems complement each other and include passive surveillance (VAERS), active surveillance (VSD), clinical and epidemiologic research (VSD and CISA), and individual patient-level clinical case vaccine safety evaluations (CISA).
  • Overview of CDC’s post-licensure vaccine monitoring systems and describe some examples of how the systems have worked together to advance our understanding of vaccine safety.
Apr 44:40
Conference pass

Improved potency & immunogenicity of Sci-B-Vac in support of phase III evaluation in adult populations

Clinical Trials
Apr 44:40
Conference pass

Operational considerations for global respiratory studies – Using seasonality to guide study execution

Influenza & Respiratory
Apr 44:40
Conference pass

Overview Phase 2 progress with a measles vectored Chikungunya vaccine candidate, and implications for the development of this vector platform

Emerging & Re-emerging Diseases
Apr 44:40
Conference pass

Rolling out cold chain innovations on a larger scale

Vaccine Supply & Logistics
  • Experience gained from implementing the greatest revitalization of the cold chain in decades
  • Spreading innovation:
    • What does it take to roll out on a large scale?
    • What are the challenges in reaching so many countries
  • How the roll out is managed between partner organizations
Apr 44:40
Conference pass

Targeting cancer through SurVaxM, a new peptide immunotherapeutic vaccine

Cancer & Immunotherapy
  • SurVaxM is a synthetic long peptide (SLP) vaccine with incorporated peptide mimic technology
  • Engineered to trigger a stronger immune response than wild type peptide, through better MHC binding
  • Completed Phase 1 clinical trial in recurrent glioblastoma
  • Interim phase 2 data and designing a phase 3 trial
  • Exploring other indications and combination therapies
Apr 44:40
Conference pass

A rationally designed therapeutic consortium reshapes the gut microbiota and induces peripheral immune tolerance to protect from allergic asthma

Immune Profiling
Apr 44:40
Conference pass

Vaccine self-sufficiency and responding to pandemic outbreaks from small to large scale

Bioprocess & Manufacture
  • Understanding in securing strains, safety, regulatory hurdles and manufacturing hurdles
  • Considering the logistics of distribution
Peter Khoury, CEO, Ology BioservicesUnited States
Apr 44:40
Conference pass

Partnerships for global health: Redefining areas of the vaccine business that don’t attract commercial interest and revenue

Partnerships
  • How new international partnerships in different markets can help you find new alternative investments
  • Going beyond science: Moving to where the people are to redefine the vaccine business model
Apr 44:40
Conference pass

The need for a Nipah virus (NiV) vaccine - What are the challenges and why now?

Veterinary
  • Current platform review of soluble glycoprotein vaccines and virus vector platforms
  • Exact correlates of protection against NiV have not been completely defined
  • Sporadic nature of NiV outbreaks makes large scale Phase III clinical trials difficult to plan - how will we overcome this?
Apr 45:10
Conference pass

Clinical data from our pandemic influenza mRNA vaccines (H7N9 and H10N8)

Influenza & Respiratory
Apr 45:10
Conference pass

Discussion: Linking supply chains to immunization registries at home and abroad

Vaccine Supply & Logistics
  • In the USA:
    • The U.S. Vaccines for Children program move to centralized distribution and the need to automate the ordering process
    • How IIS are used to monitor vaccine usage, project vaccine needs, budget for future needs and monitor storage environments
  • In LMIC:
    • The need to have systems that provide routine program data as well as supply chain data
    • The integration, interoperability & data sharing of these systems with examples in Tanzania and Zambia
    • How has the linkage of systems allowed the tracking of stock levels and projection of accurate usage rates for more efficient ordering and distribution
Apr 45:10
Conference pass

Infectious disease vaccines: Questions and a view from the trenches

Clinical Trials
Apr 45:10
Conference pass
Apr 45:10
Conference pass

Panel Discussion: Tumor neoantigEn SeLection Alliance (TESLA) – discovering the keys to developing personalized cancer vaccines

Cancer & Immunotherapy
  • Accurately identifying neo-epitopes
    • What is the diversity of neo-epitope predictions from different groups?
    • How well did these predictions perform in terms of patient sample analysis?
    • Can we identify key parameters that improve the ability to predict neo-epitopes?
  • How do we convert this data into the creation of personalized cancer vaccines?
    • Merits of different vaccines platforms
Apr 45:10
Conference pass

Stockpiling heat stable oral vaccines to combat emerging disease

Emerging & Re-emerging Diseases
Apr 45:10
Conference pass

A new paradigm for vaccine process development: solving challenges through supplier-manufacturer collaborations

Bioprocess & Manufacture
Reserved for Millipore Sigma
Ranjeet Patil, Global Segment Marketing Manager, MilliporeSigmaUnited States
Apr 45:10
Conference pass

A double perspective from both sides: How to foster vaccine partnerships

Partnerships
  • Lesson learned in global access agreements
  • Catalytic funding
Partner to be announced
Apr 45:40
Conference pass
Apr 45:40
Conference pass

Preparing for a pandemic: successful planning and distribution of large quantities of vaccine within a limited time frame

Vaccine Supply & Logistics
  • Long term relationships with potential pandemic countermeasure suppliers
  • Regular planning and response communication with contractual partners and stakeholders.
  • Advanced development work focusing on potential threats
  • Vetted and approved response, modeling, capability and capacity plans
Apr 45:40
Conference pass

Rapid protection & immunization against the next airborne pandemic

Influenza & Respiratory
  • Infectious diseases emerge and mutate with high frequency
  • Conventional vaccination strategies take too long to positively affect the outcome of pandemics
  • We present an innovative technology to address the required rapidity and avoid selection of protective antigens
  • The device has been tested with both bacterial and viral pathogens and data from a study with influenza will be presented
Nigel Silman, Senior Business Development Manager, Public Health EnglandUnited Kingdom
Apr 45:40
Conference pass
Apr 45:40
Conference pass

Panel: Manipulating the immune response with microbiome derived immunotherapies

Immune Profiling
Panellists to be announced shortly
Apr 45:40
Conference pass

Continuous Process for Vaccine Manufacturing: Challenges and opportunities

Bioprocess & Manufacture
  • Experiences & lessons learned from the industry on continuous processing
  • Disposable technology & continuous technology: a powerful combination
  • Rapid technology advancement for key enablers to support continuous processing
  • FDA Fully on Board with the Concept of continuous processing
Apr 45:40
Conference pass

How to fund and develop vaccines for overlooked diseases? Insights on how a biotech should approach big organisations for a partnership deal

Partnerships
  • How to position yourself to the different pharma companies and investors to gain maximal funding and options
  • Deal structure and alliance management
Nima Farzan, Chief Executive Officer, PaxVax IncUnited States
Apr 45:40
Conference pass

Nobivac® canine flu bivalent vaccine

Veterinary
  • Merck Animal Health’s response to CIV H3N2 outbreak in Chicago
  • CIV H3N2 infection in dogs
  • First vaccine to aid in the control of disease associated with both canine influenza virus (CIV) H3N2 and canine influenza virus H3N8
  • Efficacy study results
  • Next steps
Apr 45:55
Conference pass

Phase 2 influenza vaccine shows broad cross-protection and superiority in nonclinical heterologous challenge

Influenza & Respiratory

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Apr 509:00
Conference pass

Chair’s opening remarks

Influenza & Respiratory
Dr George Siber, CSO of ClearPath Vaccines & Scientific Advisory Board of Genocea, ClearPath VaccinesUnited States
Apr 509:00
Conference pass

Chair’s opening remarks

Cancer & Immunotherapy
Apr 509:00
Conference pass
Apr 509:00
Conference pass

Chair’s opening remarks

Bioprocess & Manufacture
Dr Bo Arve, Executive Director, PfizerUnited States
Apr 509:00
Conference pass
Apr 509:10
Conference pass

DNA vaccines for cancer immunotherapy

Cancer & Immunotherapy
  • Introduction to DNA plasmid and electroporation delivery technology
  • Updates in proof of concept studies from various trials
  • Head and neck cancer, bladder cancer, prostate cancer
  • Examples of potential combination partners
  • The regulatory landscape for DNA Vaccines
Apr 509:10
Conference pass

Ensuring safety during outbreaks; the EBOLA experience

Vaccine Safety & Pharmacovigilance
  • Challenges in vaccine clinical trials during public health emergencies
  • Ebola case study
Apr 509:10
Conference pass

Results on developing a new pertussis vaccine – Opportunities for maternal

Influenza & Respiratory

· The need for a new pertussis vaccine with longer lasting immunity

· Challenges in making an effective pertussis vaccines: Cyclical by nature, waning immunity, asymptomatic carriers

Apr 509:10
Conference pass

The importance of supply chain security – counterfeiting, product theft and vaccine-specific concerns

Vaccine Supply & Logistics
  • The big picture: why is supply chain security so important?
  • Specific security concerns in vaccine supply for developing countries
    • Alternative distribution infrastructure
    • The ease of obtaining counterfeit vaccines
  • Strategies to prevent counterfeiting
Apr 509:10
Conference pass

Using a core endotoxin vaccine (J5) to fight the increasing spread of multidrug-resistant (MDR) gram-negative bacterial (GNB) infections

Clinical Trials
  • Directing a vaccine against the conserved LPS core (lipooligosaccharide, LOS) region of GNBs as a highly effective and protective target
  • Two Ph1 trials showing how well-tolerated and non-reactogenic the vaccine was as well as high immunogenic levels when administered with CPG 7909 adjuvant
  • Future applications to generate antibodies for the treatment of a broad range of MDR GNB infections
  • How could the vaccine affect the microbiome?
Apr 509:10
Conference pass

Will a new 2018 global leadership commit to NTDs?

Emerging & Re-emerging Diseases

· How will the shift in global governance from 2017 (in the UN, WHO, US president and UK prime minister) affect the global support for NTDs?

· What does our community of NTD scientists, public health experts, and health care providers want this new global leadership to know about our diseases?

· What should they prioritize?

Apr 509:10
Conference pass

Panel: Engineering CAR-T & TCR cells for cancer therapy

Immune Profiling
  • How can you additionally modify T-cells beyond the T cell receptor/ the CAR to behave in a more controlled and/or potent fashion?
  • The challenge of keeping the manufacturing process simple, whilst maintaining the effectiveness of the product
  • The use of molecular imaging to track CAR T cells: Where do they go in the body? Do they accumulate in the tumor?
  • Mitigating side effects: controlling neurotoxicity etc.
  • Biomarkers – Identifying patients that will respond to treatment
  • Combination strategies
Apr 509:10
Conference pass

Understanding how vaccines elicit immune responses

Bioprocess & Manufacture
Apr 509:10
Conference pass

Role of vaccines in preventing further AMR - The big push

Veterinary
  • What are the incentives for industry?
  • Proposed diseases where development or improvement of vaccines would have a high impact on antibiotic use
  • Creating global vaccine research networks to pull resources and expertise to address gaps for priority diseases
Apr 509:40
Conference pass

Archaeal lipid adjuvants and adenovirus vector delivery systems for cancer vaccine delivery Sulfated semi-synthetic archaeal lipids are potent modulators of vaccine immunity

Cancer & Immunotherapy
  • A single lipid formulation can effectively deliver cancer antigens and provide protection in cancer models
  • Therapeutic benefit can be extended through combination vaccines with adenoviral vector antigen delivery and check-point inhibitor blockade
Apr 509:40
Conference pass

Bioconjugate Shigella vaccine in clinical development

Emerging & Re-emerging Diseases

· The development plan for a Shigella vaccine demonstrated in PhI and a PhIIB human challenge study

· A regulatory tool for licensing

Apr 509:40
Conference pass

Immune profiling techniques to help develop a more effective pertussis vaccine

Influenza & Respiratory
Apr 509:40
Conference pass

Supply disruptions – how to limit impact of supply disruptions on country vaccination programs

Vaccine Supply & Logistics
  • A closer look at the causes of the recent hepatitis vaccine shortage
  • Measures taken to avoid disruptions in supply
  • Potential solutions to avoid disruption from future shortages
    • Should other countries be stock piling?
    • How practical is this?
Apr 509:40
Conference pass

The science of causality assessment

Vaccine Safety & Pharmacovigilance
  • The science of causality assessment is poorly understood by healthcare providers and the general public
  • Temporal relationships and hypotheses regarding mechanisms are not sufficient to establish causality
  • Journals should establish standard criteria for publishing case reports of alleged causal relationships
  • Decisions to compensate for alleged vaccine injuries should be based on science
  • Safety profiles may vary in different populations
  • All countries should have formal vaccine safety programs
Apr 509:40
Conference pass

Update on Group B streptococcal maternal immunization program

Clinical Trials
Apr 509:40
Conference pass

Enabling translation of vaccine discovery into clinical candidates in academia

Bioprocess & Manufacture
Apr 509:40
Conference pass

Advancements made in bacterial vaccines

Veterinary
  • Technologies for identification of antigens
  • Novel vaccine formulations
Apr 51:40
Conference pass

Report on U.S. vaccine development and innovation including the current landscape, existing challenges, and drivers and levers to incentivize development

Keynotes
  • A combined effort from HHS, NIH, CDC, FDA, BARDA to promote innovation in the development of vaccines that minimize the burden of infectious disease
  • What is the optimal process to determine which vaccines would be beneficial to public health and how information on such vaccines is disseminated to key stakeholders
  • Identifying whether obstacles exist that inhibit the development of beneficial vaccines
  • Recommendations on how best to promote and incentivize vaccine innovation and development
Apr 510:10
Conference pass

Densigen, a versatile immunotherapeutic platform to promote broad and robust T cell immunity against viral infections and cancer

Cancer & Immunotherapy
  • Densigens are rationally designed, CD4+/CD8+ T cell epitope-containing peptides modified by a fluorocarbon moiety providing self-adjuvanting properties
  • Densigen-based immunotherapeutics promote robust T cell responses in humans while achieving broad population coverage
  • Densigens simultaneously target multiple antigenic determinants to prevent immune escape
  • Prime-boost immunizations with Densigens can act synergistically to promote better T cell responses
Dr Scot Roberts, Chief Scientific Officer, AltimmuneUnited States
Apr 510:10
Conference pass

How could needle free vaccines change the way vaccines can be distributed and perceived in response to an emerging disease?

Emerging & Re-emerging Diseases
Apr 510:10
Conference pass

Unplanned parainfluenza virus infection on an isolation ward – A case study

Clinical Trials
In this presentation a case of unplanned Parainfluenza Virus (PIV) is discussed with possible routes of acquisition and its effects on study data. Also the potential limitations of early diagnosis in preventing commonly circulating, community diseases infecting those entering or already housed in containment facilities
Apr 510:10
Conference pass

Update on next-generation pneumococcal vaccines

Influenza & Respiratory
Dr George Siber, CSO of ClearPath Vaccines & Scientific Advisory Board of Genocea, ClearPath VaccinesUnited States
Apr 510:10
Conference pass

What can vaccines learn from neglected diseases on effectively engaging the private sector?

Vaccine Supply & Logistics
  • Introduction to NTDs and shared components with immunization – how are the programs components are similar?
  • Development of global partnership: Uniting to Combat NTDs
    • Relationship with pharma is critical
  • Examples of success stories:
    • supply chain and logistics coordination
Apr 510:10
Conference pass

Combinatorial immunotherapy: expanding the horizons with bispecific DART® molecules

Immune Profiling
Apr 510:10
Conference pass

Designing vaccines focusing on critical quality attributes and analytical strategies

Bioprocess & Manufacture
Apr 510:10
Conference pass

How early stage vaccine application aids decrease in the use of antibiotics, either for preventive or curative purposes in poultry

Veterinary
  • Benefits of early control in immunosuppressive poultry diseases
  • Application of vaccines at early stages of development, for example day 18 of age embryos for in ovo, or day old at hatch
Apr 510:25
Conference pass

HiA; A vaccine solution to address an urgent public health need

Emerging & Re-emerging Diseases
Dr Andrew Cox, Senior Research Officer, National Research CouncilCanada
Apr 511:30
Conference pass

Development of a Combined Shigella-ETEC Live Vaccine

Emerging & Re-emerging Diseases
Apr 511:30
Conference pass

Novel multivalent vaccine for gram-negative bacterial pathogens, including multiple antibiotic-resistant strains

Clinical Trials
Apr 511:30
Conference pass

Panel: Innovation, emerging technology and digitalization in vaccine supply chains

Vaccine Supply & Logistics
Panellists to be announced shortly
Apr 511:30
Conference pass

Recent progress in clinical TB vaccine development

Influenza & Respiratory
Apr 511:30
Conference pass

Safety assessment, communication of risk and interventions around acceptance in maternal immunization

Vaccine Safety & Pharmacovigilance
  • Safety of TDaP and IIV vaccine
  • Emerging issues around 1st trimester vaccination, adverse outcomes and how this has informed acceptance
Apr 511:30
Conference pass

Translational Studies Informing the Design and Feasibility of a vaccine against Epstein Barr Virus

Cancer & Immunotherapy
  • Opportunities for the development of a vaccine against EBV
  • Understanding the medical necessity, market potential and public health use of EBV Vaccine.
  • The science behind the 3 vaccine candidates that currently exist:
    • Pre-clinical safety data
    • Updates on progress of phase 1 trials.
Apr 511:30
Conference pass

Synthetic biology: Enabling the next wave of adoptive cellular therapies

Immune Profiling
Apr 511:30
Conference pass

Developing vaccines for developing countries – A case study on Typhoid conjugate vaccine

Bioprocess & Manufacture
Dr Viliam Pavliak, Head of Vaccine Development, International Vaccine InstituteRepublic Of Korea
Apr 511:30
Conference pass

Panel:Alternatives to Antibiotics: Issues and opportunities from funders’ perspective

Veterinary
  • How to incentivise vet pharma companies to produce new veterinary products to reduce AMR resistance
  • Marketing the science and the costs associated with this
  • Statement of societal goals that the funding entity would like to accomplish
  • Political feasibility of incentive mechanisms (e.g., is a program that gives money to large pharma companies likely to be accepted by legislators?)
  • Economics of incentive mechanisms (e.g., which incentive ‘lever’ can be pushed for maximal effect? What would unintended consequences of such incentives be?)
Apr 512:00
Conference pass

Advances in the development of a replication-deficient human cytomegalovirus vaccine for the prevention of congenital infection

Cancer & Immunotherapy
  • The Burden of Disease caused by maternal/fetal/infant CMV infection
  • Natural History of maternal/fetal/infant CMV infection
  • Merck’s CMV vaccine candidate
  • Strategies to demonstrate the efficacy and safety profiles of CMV vaccines targeted to prevent congenital CMV infection
Apr 512:00
Conference pass

Cost effective development of multivalent conjugate vaccines

Clinical Trials
Apr 512:00
Conference pass

H1N1 Pandemic flu vaccine, lessons in safety and communication learned from the 2009-10 vaccine program and lessons for future surveillance

Vaccine Safety & Pharmacovigilance
  • What are the unique challenges in maintaining public confidence during a pandemic?
  • What safety monitoring system was used during the 2009-10 pandemic?
  • What lessons can be learned from the handling of this pandemic that can be applied to future outbreaks?
Apr 512:00
Conference pass

Presenting early stage development of a vaccine to prevent the bacterial infections that exacerbate Chronic Obstructive Pulmonary Disease (COPD)

Influenza & Respiratory

· COPD is a very common, chronic, progressive, respiratory illness of adults, which can be triggered by bacterial infections

· A vaccine to prevent these respiratory infections could modify the clinical progression of COPD, and improve quality of life

Apr 512:00
Conference pass

Strategies for developing vaccines against Paratyphoid A fever

Emerging & Re-emerging Diseases
Dr Sushant Sahastrabuddhe, Director, Enteric Fever, International Vaccine InstituteRepublic Of Korea
Apr 512:00
Conference pass

Development of off-the-shelf immunotherapy from pluripotent cells

Immune Profiling
  • Pluripotent Cell Derived T and NK cells: Cornerstone Approach for Off-the-Shelf Cancer Immunotherapy
  • Use of small molecules and biologics, ex vivo, to optimize the biological properties and therapeutic function of hematopoietic cells
Apr 512:00
Conference pass

From development to commercialization of vaccines – a case study

Bioprocess & Manufacture
Apr 52:10
Conference pass

Zoster vaccine recombinant, adjuvanted: A journey from research to approval

Keynotes
  • Non-live, recombinant vaccine to help prevent herpes zoster (shingles), combining glycoprotein E with an adjuvant system, AS01
  • Sharing positive results from Phase III revaccination study
Dr Jeffrey Stoddard, US Medical Affairs Lead for Zoster Vaccine, GSK VaccinesUnited States
Apr 52:40
Conference pass

With polio eradication succeeding, should measles eradication come next?

Keynotes
  • Changing the perception from polio: Focusing on measles elimination to build our overall immunization program
  • Using a “diagonal” approach when dealing with highly contagious preventable diseases like measles
  • Surveillance - a weakness in our system?
  • Cost of controlling outbreaks and the consequences
Apr 53:10
Conference pass

Vaccine hesitancy: How to respond to the media to advance better health

Keynotes
  • Challenges tocommunicating sciencethrough the opaque prism ofthemedia
  • How certain cultural biases can influence the perception of science
last published: 23/Feb/18 09:35 GMT

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