Day Two - 4 April



DC Co-conference Day 2 April 4

Vaccine Supply & Logistics

Chair’s opening remarks

Beyond Checkpoint Inhibitors

Global Immunization Supply Chains

Improving Immune Responses and Clinical Efficacy

International Vaccine Safety

Rapid Response Vaccines & Vaccine Safety

RSV Vaccines & Maternal Immunization

Industry Insights & Biotech Showcases

One Health

Rational Vaccine Designs Against Infection and Disease – What Do We know?

Vaccine Bioprocessing

Clinical Trials

Novel adjuvants: What’s needed and how to get them approved?

  • 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
Vaccine Supply & Logistics

Vaccine supply chains in low resource environments: past, present and future perspectives

  • 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.
Emerging & Re-emerging Diseases

VLA 1601, a jointly-developed vaccine candidate against Zika based on a well-proven technology platform

·         Medical need and trends on Zika epidemiology

·         Vaccine design and characterization

·         Ongoing Phase I in the US and development outlook

Cancer & Immunotherapy

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

  • 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

One health zoonotic disease prioritization

  • Overview of recent efforts to prioritize zoonotic diseases
  •  Rationalising the need for vaccines, and identifying the vaccine profiles required
Immune Profiling

The Human Vaccines Project: Harnessing recent technological advances in the biomedical and computational sciences to accelerate vaccine development

  • 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

New technology from the most promising biotechs and institutions

Viral Vectors & Novel Platforms

Influenza & Respiratory

Achieving an effective balance of attenuation and immunogenicity for RSV live attenuated vaccines (LAV)

·         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

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

Vaccine Supply & Logistics

Success Factors for managing a scalable global clinical supply chain system

  • 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
Emerging & Re-emerging Diseases

A Plug-and-Play Technology Platform to Expedite the Production of Vaccines for Biodefense and Emerging Infectious Diseases

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

Vaccine Supply & Logistics

Improving end-to-end supply chain management, optimizing global cold chain distribution and working with external stakeholders

Dr Talitha Hampton, Lead, Supply Chain Packaging and Product Security, AstraZeneca LP
Vaccine Safety & Pharmacovigilance

Using the Sentinel program to assess vaccine safety

  • Protocol-based studies, e.g. intussusception risk after rotavirus vaccination
  • Data-mining studies, e.g. evaluating the safety of HPV4 vaccine
Emerging & Re-emerging Diseases

A single-dose live-attenuated Zika vaccine

·         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


Technology showcase 4

ImplaVaxTM – Unique needle free solid dose vaccine platform delivering enhanced immunogenicity with ultimate convenience and no cold chain

Networking coffee break

Combination Therapy

Supply Chain System Design

Immune Enhancers & Vaccine Technology

Cancer & Immunotherapy

PD-1 antibodies are transforming cancer therapy both as monotherapies and in combination

  • 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
Vaccine Supply & Logistics

Redesigning immunization supply chains in low and middle-income countries: a case study

  • What is the current scope of the problem
  • What level of change is needed
  • Promising examples of change in sub-Saharan Africa

Technology showcase 5

Novel nanoparticle formulations for delivery of protein or RNA vaccines

Immunomodulators: Rationale for targeting the innate immune response when vaccines aren’t effective

  • Role of innate immunity
  • Immunostimulants as preventative and therapeutic agents
  • Recent developments in veterinary immunomodulators
Immune Profiling

Biomarkers of vaccine safety

  • The need for specific trial design
  • Systemic vs local markers
  • The experience of Biovacsafe
Cancer & Immunotherapy

A comprehensive analysis of combination studies in immuno-oncology

  • 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
Influenza & Respiratory

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

·         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 …

Vaccine Supply & Logistics

Driving the immunization supply chain with data

  • 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
Immune Profiling

Principles of broad and potent antiviral human antibodies: Insights for vaccine design

  • 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

Vaccine Production and Delivery Systems

Methods In Pharmacovigilance

Clinical Trials

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

  • 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
Cancer & Immunotherapy

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

  • Introduction to Morpheus; a novel cancer immunotherapy platform
  • How to go about selecting a combination study
  • Potential for use across several indications
Bioprocess & Manufacture

Analytical characterization of aluminum adsorbed vaccines: Stability indicating methods for product release

  • 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

Universal and Pandemic Influenza Vaccines

Vaccine Safety & Pharmacovigilance

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

  • 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.

Networking Lunch & Poster Session

Cancer Vaccines

Cold Chain, Technology & Data

Vector Control & Trial Design

Funding Your Research & Expanding Your Range of Partnerships

Delivery and Manufacturing

Biomarkers and New Technologies to Decode the Immune System

Influenza & Respiratory

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

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

Vaccine Safety & Pharmacovigilance

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

  • 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
Clinical Trials

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

  • Current status of Zika Vaccine candidates in Clinical Development
  • Geographical Considerations: Epidemiology v Trial Locations
  • Considerations for Zika Vaccine Clinical Development Strategy
Emerging & Re-emerging Diseases

How to achieve executional success in emerging/re-emerging disease studies with real world examples – The success formula

·         Considerations when conducting vaccine clinical research including:

·         Picking the right geographic mix, networks, sites and vendor relationships in place

·         Understanding the patient landscape and cultural patterns - Mapping the ecosystem for success

·         How to trace the lines of accountability in your study ecosystem which is different from simply assigning responsibility within that eco-system

·         Learn about our on-the-ground experiences: Common pitfalls vs. proven recipe for success

Vaccine Supply & Logistics

Overcoming Key Supply Chain Challenges for Vaccine Shipments

  • 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
Cancer & Immunotherapy

State of the art and novel approaches to T Cell Vaccines

  • How have recent advances in immunotherapy provided a path forward for T-Cell Vaccines?
  • Biomarkers for T-cell strategies
Dr Michael Kalos, Vice President, Immuno-Oncology and Cell Therapies, Janssen

The formation of new companies developing infectious disease vaccines

  • The impact of the current vaccine industry ecosystem on funding for vaccine start-ups
  • Looking beyond venture capital for early stage funding
Bioprocess & Manufacture

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

  • 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
Emerging & Re-emerging Diseases

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

·         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

Vaccine Supply & Logistics

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

  • 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.
Vaccine Safety & Pharmacovigilance

Safety assessment during the clinical development phase of a vaccine

  • Capturing of data
  • Relevance of causality assessment
  • When to build a benefit/risk assessment
  • Different populations vs different approaches
Cancer & Immunotherapy

Synergy of DNA Vaccines with checkpoint inhibitors

  • Selection of appropriate vaccine antigens for prostate cancer
  • Updates from ongoing translational trials of DNA vaccines in prostate cancer
Immune Profiling

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

  • 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.
Bioprocess & Manufacture

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

  • 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

Clinical need and justification for developing chronic infectious disease vaccines

Vaccine Supply & Logistics

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

  • 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
Cancer & Immunotherapy

Hollow microneedles for use in delivery of cancer vaccines

  • 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.
Vaccine Safety & Pharmacovigilance

Vaccine pharmacovigilance: the once and future challenges

  • 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.

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

  • 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
Bioprocess & Manufacture

Accelerating vaccine production using a non-viral enabling technology for cell engineering

  • Discuss Phase I, fully-scalable technology that allows efficient, cost-effective evaluation of vaccine candidates
  • Learn about the role media has on antigen folding, expression and glycosylation for transfection
  • Review customized purification techniques and characterization assays to overcome variability
Influenza & Respiratory

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

  • The promise of prevention: A novel universal vaccine virus Protection from drifted or mismatched flu strains
  • Breadth of protection in multiple age groups
Cancer & Immunotherapy

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

  • 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.

Networking coffee break

Recent progress in vaccines and outbreak management of emerging virus infections

Involvement of the Microbiome and Cross Talk with Immune Cells

Bioprocess needs for the developed & developing world

Vaccine Safety & Pharmacovigilance

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

  • 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.
Cancer & Immunotherapy

Targeting cancer through SurVaxM, a new peptide immunotherapeutic vaccine

  • 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
Vaccine Supply & Logistics

UNICEF's contribution in building the next generation of immunization supply chains: availability, potency and efficiency

  • 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

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

  • 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

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

  • 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?
Bioprocess & Manufacture

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

  • Understanding in securing strains, safety,  regulatory hurdles and manufacturing hurdles
  • Considering the logistics of distribution

Interactive Discussion – Mandating Vaccination

Supply Chain Preparedness

Vaccine Supply & Logistics

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

  • 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
Cancer & Immunotherapy

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

  • 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
Vaccine Supply & Logistics

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

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  •              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
Influenza & Respiratory

Rapid protection & immunization against the next airborne pandemic

  • 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

Nobivac® canine flu bivalent vaccine

  • 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
Bioprocess & Manufacture

Continuous Process for Vaccine Manufacturing: Challenges and opportunities

  • 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

Chair’s closing remarks and close of congress day 2


Networking Drinks & Party

last published: 23/Mar/18 16:45 GMT

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