DAY TWO 4 APRIL

DC Co-conference Day 2 April 4

Vaccine Supply & Logistics
09:00

Chair’s opening remarks

Cancer & Immunotherapy
09:00

Chair’s opening remarks

Clinical Trials
09:00

Chair’s opening remarks

Partnerships
09:00

Chair’s opening remarks

Immune Profiling
09:00

Chair’s opening remarks

Bioprocess & Manufacture
09:00

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
09:10

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
Emerging & Re-emerging Diseases
09:10

Protecting against mosquito-borne viral infection Chikungunya with a potential single immunization

·         Rising incidence and further geographic spread of the disease

·         VLA 1553 pre-clinical data, PhI trial design and market potential

Vaccine Supply & Logistics
09:10

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.
Cancer & Immunotherapy
09:10

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
Veterinary
09:10

Rational design of veterinary vaccines, is it less established than human vaccines?

  • Strategy when conventional vaccines don’t work
  • Can vaccines alone eradicate? The need to combine treatments outside of vaccines with alternative approaches
Immune Profiling
09:10

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
09:40

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
09:40

Mitigating the impact of natural disasters on vaccine supply chains

  • Impacts on power and communication infrastructure
  • Impacts on airports
  • Impacts on seaports
Cancer & Immunotherapy
09:40

Panel Discussion: challenges to enhancing the therapeutic effectiveness of immune checkpoint antagonists with checkpoint agonists and inhibitors of immuno-metabolic pathways

  • 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?
Emerging & Re-emerging Diseases
09:40

Working with government and industry partners to tackle biodefence diseases and our efforts in developing a vaccine against Zika

Bioprocess & Manufacture
09:55

Overview of cell culture & new expression systems improving vaccine bioprocessing

Emerging & Re-emerging Diseases
10:10

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

Clinical Trials
10:10

Early and late phase clinical trial design conundrums

  • Use of surrogate endpoints, differential efficacy / safety in diverse populations, accurate measures of exposure
Vaccine Supply & Logistics
10:10

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
Vaccine Safety & Pharmacovigilance
10:10

What will the impact of EudraVigilance be on launching new vaccine products in Europe from 2018 onwards?

Veterinary
10:10

Controlling zoonotic diseases in the developing world

Immune Profiling
10:10

Creating a detailed understanding of how the immune responds to foreign pathogens or self-antigens and developing tools for prediction

Bioprocess & Manufacture
10:10

New approaches for analytical characterization: Can in vitro potency approaches be used to replace animal models?

Emerging & Re-emerging Diseases
10:25

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

Partnerships
10:25

Technology showcase 4

ImplaVaxTM – Unique needle free solid dose vaccine platform delivering enhanced immunogenicity with ultimate convenience and no cold chain
 
10:40

Networking coffee break

Combination Therapy

Supply Chain System Design

Immune Enhancers & Vaccine Technology

Vaccine Supply & Logistics
11:40

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
Cancer & Immunotherapy
11:40

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
Partnerships
11:40

Technology showcase 5

Novel nanoparticle formulations for delivery of protein or RNA vaccines
 
Veterinary
11:40

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
11:40

Biomarkers of vaccine safety

  • The need for specific trial design
  • Systemic vs local markers
  • The experience of Biovacsafe
Partnerships
11:55

Technology showcase 6

Cancer & Immunotherapy
12:10

Progress of combination studies using vaccines & checkpoint inhibitors in combination with other agents for the treatment of cancer

Vaccine Supply & Logistics
12:10

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
Clinical Trials
12:10

The problem with powering clinical trials PhII to PhIII, quo vadis?

  • Identifying contributing factors to late phase failure and to provide some insights into models for future Phase II trials to better evidence efficacy in the field
Influenza & Respiratory
12:10

Virospot MN Assay methodology and research findings

Immune Profiling
12:10

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
Bioprocess & Manufacture
12:10

New VLP production techniques: Challenges and opportunities

Vaccine Production and Delivery Systems

Methods In Pharmacovigilance

Clinical Trials
12:40

Immunosenescence: A growing population & an increasing unmet problem

Vaccine Supply & Logistics
12:40

Industry perspective: Improving your supply chain strategy and system design

Cancer & Immunotherapy
12:40

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
Vaccine Safety & Pharmacovigilance
12:40

Tools for clinical data visualization that improve efficacy and accuracy of safety assessment and allow firms to keep up with changing regulatory requirements

Veterinary
12:40

ELISpot and FluoroSpot in veterinary vaccine research

  • T-cell ELISpot assays and B-cell ELISpot assays in veterinary vaccine research
  • Novel potential of T and B-cell FluoroSpot assays in veterinary vaccine research
  • Why FluoroSpot and not intracellular cytokine staining and Flow cytometry?
Session led by: mabtech
Bioprocess & Manufacture
12:40

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

1:10

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
2:40

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

Emerging & Re-emerging Diseases
2:40

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

·         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 Safety & Pharmacovigilance
2:40

New techniques to overcome challenges in pre-clinical safety assessment of vaccines

Vaccine Supply & Logistics
2:40

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
2:40

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
Partnerships
2:40

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
Veterinary
2:40

The need to mass inoculate: What delivery systems have we developed that can cater for the different animal groups?

Immune Profiling
2:40

High-resolution profiling of antibody responses to arrays of peptides

Bioprocess & Manufacture
2:40

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
3:10

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
3:10

New and alternative delivery systems and routes for vaccine supply

Vaccine Safety & Pharmacovigilance
3:10

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
3:10

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
Influenza & Respiratory
3:10

Utilizing human challenge studies to accelerate the development of respiratory vaccines

Session title TBC

Andrew Catchpole, Scientific and Operations Director, hVIVO
Immune Profiling
3:10

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
3:10

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
3:40

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
3:40

Novel oncolytic virus-based therapeutic cancer vaccines

Partnerships
3:40

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
Veterinary
3:40

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

Bioprocess & Manufacture
3:40

Dry powder vaccine stabilization and delivery by spray drying

  • Methods and considerations for Spray dried macromolecules
  • Different Delivery Routes and their application to spray drying
  • Enteric Capsules for oral delivery and rapid pre-clinical development
  • Case Studies
Influenza & Respiratory
3:55

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
4:10

Networking coffee break

Vaccines against forgotten and underfunded diseases

Involvement of the Microbiome and Cross Talk with Immune Cells

Bioreactor needs for the developed & developing world

Influenza & Respiratory
4:40

100 Years since 1918: Are we ready for the next pandemic?

Vaccine Safety & Pharmacovigilance
4:40

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.
Clinical Trials
4:40

PhIII HBV vaccine results

Vaccine Supply & Logistics
4:40

Rolling out cold chain innovations on a larger scale

  • 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
Cancer & Immunotherapy
4:40

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
Partnerships
4:40

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
Veterinary
4:40

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?
Immune Profiling
4:40

The significant role of the microbiome in disease prevention, treatment and therapeutic development

Bioprocess & Manufacture
4:40

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
5:10

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
Emerging & Re-emerging Diseases
5:10

Lassa fever vaccine developments

Cancer & Immunotherapy
5:10

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
Clinical Trials
5:10

Strategies for global eradication – Do we need a prophylactic Hep C vaccine?

Veterinary
5:10

Mucosal PRRSV vaccine for swine

Bioprocess & Manufacture
5:10

A platform approach for viral vaccine manufacturing

  • Our platform approach for the manufacturing of viral vaccines
  • How technological developments help to set-up a robust and scalable process using single use technologies
Clinical Trials
5:40

Encouraging results from clinical studies for a HIV vaccine

Influenza & Respiratory
5:40

Maternal immunization on respiratory infections: Benefits to mother and child

Vaccine Supply & Logistics
5:40

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
Partnerships
5:40

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

  • How to position yourself to the different pharma companies and investors to gain maximal funding and options
  • Deal structure and alliance management
Veterinary
5:40

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
Immune Profiling
5:40

Panel: Manipulating the immune response with microbiome derived immunotherapies

Panellists to be announced shortly
Bioprocess & Manufacture
5:40

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
6:10

Chair’s closing remarks and close of congress day 2

6:15

Networking Drinks & Party

last published: 10/Nov/17 15:15 GMT