Vaccine Development

Empowering Immunity: Enabling Breakthroughs in Vaccine Development for a Healthier Future

From traditional vaccines to an era of novel approaches to preventive and therapeutic vaccine-like products, coupled with new adjuvants and delivery systems, knowing the right approach to demonstrate nonclinical proof-of-concept and safety is essential. Our team of expert immunologists, toxicologists, and program managers will help you develop a tailored nonclinical program for your vaccine candidate.

Challenges Within Vaccine Development

Because our team has been in the industry for so long, we understand that vaccine development programs have many challenges. The following roadblocks are frequently encountered during the development:

Different vaccine types follow different regulatory pathways and require customized nonclinical programs.
Developing a suitable in vitro potency assay is challenging.
Toxicology programs for vaccines are often streamlined vs. other modalities but always require ‘case-by-case’ thinking and relevant endpoints based on the vaccine type.
Selecting the appropriate species depends on the vaccine candidate’s immunological mechanisms and the species’ permissiveness or relevance.
While vaccines are generally well tolerated locally and systemically, theoretical and actual risks require consideration and assessment depending upon the mechanism(s) of action.
Efficacy models are neither standardized nor validated and may produce conflicting results.
Immunogenicity models are of limited informative power for humans.
Surrogate markers of efficacy are to be identified to ensure the feasibility of pivotal clinical trials.

Solutions

Infectious Diseases or Cancer Vaccines, Strengthen Your Application Path With KreaMedica’s Solutions

Our experts understand the regulatory requirements for nonclinical and clinical development of your candidates.
We assist you in selecting the appropriate model(s) for your program based on the composition, mechanism, and indication of your vaccine candidate by integrating relevant immunological and safety endpoints to enable key decision-making.
Our team of experts will help you design your preclinical and clinical studies for efficient vaccine development up to NDA/MAA.
Our scientific project managers align potential multisite activities, foresee challenges, and align solutions collaboratively with relevant stakeholders.

Truth in Numbers

110+

Development Programs

70+

Sponsors Who Trust Us

73+

Years Combined
Industry Experience

Testimonials

Don’t take our word for it.

James L. Ellis, Ph.D.
Nocion Therapeutics, Inc., Chief Scientific Officer

They provided valuable insights and recommendations while seamlessly integrating into our team.

I have had the pleasure of working with KreaMedica on several programs. They proactively identified and addressed issues and provided regular updates to ensure everyone was on the same page. Their attention to detail and willingness to take ownership of the project’s success makes them invaluable partners. They are great to work with, and I would highly recommend them to anyone looking for a drug development partner.

Brian Jones
Respirion Pharmaceuticals, Chief Operating Officer

KreaMedica was an essential complement to our virtual team.

They supplemented and filled in gaps in our internal network and worked well with our advisors. They truly wanted to contribute to and be part of the project’s success. I highly recommend Claude, Poulomee, and Rudi as reliable partners for planning and executing toxicological and bioanalytical projects.

Ron Wolff
RK Wolff Safety Consulting Inc., Principal

The combination of all their perspectives made a tremendous difference.

I have worked with KreaMedica for many years, and I must credit them for the team’s talent, professionalism, and chemistry. That doesn’t happen by accident. As a consultant, I rely on them as the first line to monitor studies and provide proactive solutions when required.

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