Clinical Trials



As new technologies and personalized vaccines become the norm, the dynamic of clinical trials has to evolve. This focused clinical development conference will allow you to showcase your services to those who are looking to run new trial models, need support in choosing and gaining approval for different clinical endpoints and want to understand how to get the best out of the information collected.






Clinical Trials, Wednesday 4 April 2018

Improving Immune Responses and Clinical Efficacy

Panel discussion
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
Lynlee Burton
Clinical Trials

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

  • Use of surrogate endpoints, differential efficacy / safety in diverse populations, accurate measures of exposure

Networking coffee break

Dr Steven Black
Clinical Trials

Limitations of randomized controlled clinical trials in vaccine development

Marty Anderson
Clinical Trials

Overcoming challenges in seasonal vaccine studies, including maternal immunization

Camille Kotton
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
Dr Leandro Padilla
Clinical Trials

QS-21 Adjuvant: Validated, Efficacious and Available


Networking Lunch & Poster Session

Dr Grace Chen
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

Clinical need and justification for developing chronic infectious disease vaccines

Thomas Lingelbach
Clinical Trials

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

  • Background and medical need
  • Vaccine design including preclinical data for VLA15        
  • Phase I results and development outlook

Networking coffee break

Dr David E. Anderson
Clinical Trials

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

Dr David Subich
Clinical Trials

Infectious disease vaccines: Questions and a view from the trenches


Chair’s closing remarks and close of congress day 2


Networking Drinks & Party

last published: 02/Apr/18 21:25

Clinical Trials, Thursday 5 April 2018

Preventing Nosocomial Infections & Hard to Develop Vaccine

Dr Alan Cross
Clinical Trials

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

  • 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?
Dr Annaliesa Anderson
Clinical Trials

Update on Group B streptococcal maternal immunization program

Dr Adrian Wildfire
Clinical Trials

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

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

Networking coffee break

Dr Raphael Simon
Clinical Trials

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

Dr Bill Thomas
Clinical Trials

Cost effective development of multivalent conjugate vaccines

Dr Bill Thomas, CTO, Paragon Bioservices Inc

Networking Lunch & Poster Session


Dr Angela Shen

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

  • 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
Dr Jeffrey Stoddard

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

  • 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 Walter A Orenstein

With polio eradication succeeding, should measles eradication come next?

  • 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
Dr Paul Offit

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

  • Challenges to communicating science through the opaque prism of the media
  • How certain cultural biases can influence the perception of science 

3:40 Chair closing remarks and end of congress

last published: 02/Apr/18 21:25


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