Inhalation Toxicology

Utilizing the respiratory route of delivery gets more drug to the site of disease than parenteral administration while limiting potential systemic side effects. Alternatively, systemic delivery of drugs through the respiratory tract has been shown to effectively control metabolic disease (e.g., diabetes), to provide needle-free delivery for drugs and vaccines, to avoid “first pass” liver metabolism, and to provide a faster onset of action (e.g., naloxone) than parenteral delivery. To support respiratory drug development and inhalation toxicology, multiple clinical and nonclinical liquid (nebulizer, nasal spray), dry powder, and metered dose inhaler (MDI) aerosol generators are used to produce atmospheres of drug that are delivered to nonclinical species through unique aerosol delivery systems

Challenges in Inhalation Toxicology

Because our team has been in the industry for so long, we understand that inhalation toxicology programs have many challenges. The following roadblocks are frequently encountered during the non-clinical development of inhaled medications:

Regulatory agencies require targeted nonclinical nasal or lung delivery to support clinical dose administration
Physicochemical properties of the molecules (such as particle size and shape, charge, and susceptibility to shear forces) may impede the generation of a suitable aerosol.
Inhalation toxicology requires large amounts of the drug product.
Pulmonary pharmacokinetic processes can be complex
Experienced technicians are required
The appropriate use of an inhaler is critical in the clinic and for commercialization.

We are Here to Help Your Inhalation Program Succeed

With over 50 years of combined hands-on experience in troubleshooting technical issues with inhalation systems, we are here to help:

KreaMedica has in-depth knowledge of the different inhalation systems
Early evaluation of aerosol generation to ensure that technical issues are addressed promptly.
Two experienced inhalation toxicologists in our team to support your development needs.
Experts support different product formulations (e.g., carriers, lubricants, micronization) or changing the structure of the particles using modified supercritical anti-solvent technologies.
A network of prequalified CROs with inhalation capabilities and experienced study directors and technicians.

Team Member Highlight

Meet a Couple of Our Toxicology Experts

Matthew Reed, PhD, DABT, ATS Fellow

Matt is a pharmacologist, board certified toxicologist and Fellow of the Academy of Toxicological Sciences. He has over 23+ years of experience in inhaled and intranasal drug development having supported formulation and device feasibility, in vitro-animal-human dose translation, pharmacology/ animal models of respiratory disease, ADME/PK/PD, regulatory toxicology, domestic and international regulatory filings, and early-phase clinical trials. Dr. Reed has supported technologies ranging from small molecules, peptides, proteins, oligonucleotides, lipid nanoparticle gene delivery, and antibodies to conjugate-based platforms, etc.

Dr. Reed was formerly Vice President of Applied Toxicology and Nonclinical Development, Director of Preclinical Drug Development, and a Senior Scientist at Lovelace Biomedical. In additional to general respiratory consulting, Matt currently serves as CSO of Nob Hill Therapeutics and in senior management (consulting) roles at Rage Biotherapeutics and Kinnear Pharmaceuticals.

Dominic Poulin

KreaMedica’s Senior Preclinical Toxicologist.

With over 20 years of experience in the preclinical CRO industry, from hands-on technician to study director, his first years were solely devoted to inhalation, later increasing his portfolio to include all general routes of administration, in vivo pharmacology animal models, and client management. His experience in inhalation troubleshooting and knowledge of CRO and regulatory expectations will be a great asset to your team.

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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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