Nonclinical Safety and Toxicology Consulting

make your breakthrough a reality

Transforming Scientific Expertise into Breakthrough Medicines

From discovery to the clinic, Toxistrategy delivers tailored nonclinical safety solutions to meet your program's unique challenges. Whether navigating toxicology strategy, IND-enabling packages or regulatory authoring, we provide unmatched
expertise to ensure your therapeutic reaches its full potential.

SERVICES

Nonclinical
Strategy

Nonclinical development of assets from discovery to clinic, including overall strategy, timeline management, budget planning and investor relations.

Study
Execution

End-to-end nonclinical study execution including CRO management, protocol development, study monitoring, and report authoring.

Regulatory
Submission

Authoring and coordination of nonclinical regulatory documents including INDs, CTAs, IBs, BBs, as well as SEND dataset oversight.

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WHO WE ARE

Dessi McEntee, MS, DABT

Owner & Consultant

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Rate: $300/hr

Dessi is a board-certified toxicologist with a rare blend of expertise that places her among the leading nonclinical safety professionals in the industry. With 15+ years of hands-on experience in exploratory and GLP sciences across the pharmaceutical sector, she has successfully led nonclinical toxicology strategies across a wide range of therapeutics (small molecules, biologics, nanoparticles, radiopharma) and indications (oncology, immunology, pain, rare disease). Her leadership has been instrumental in advancing numerous critical medicines to the clinic, and her track record in regulatory submissions is flawless.

Toxistrategy is not a big consulting firm—it’s a one-woman powerhouse. When you work with Dessi, you get direct access to a dedicated expert who delivers a tailored, high-touch service designed to drive your program forward. No bloated teams, no wasted hours—just smart, strategic guidance to turn your breakthrough into reality.

TESTIMONIALS

"I have worked closely with Dessi for many years, both at small molecule and protein biologics companies. What has impressed me the most about her skill sets and experiences is that she is very diligent in not only designing the studies, executing them to the highest standards but she also makes a concerted effort to understand the science behind the programs she has been involved with.

In an area that seems to be changing in the requirements for nonclinical safety and drug development, Dessi is extremely up-to-date on this morphing landscape. This has been comforting for me and my teams in that we know that she will ensure compliance with the changing times.

Even after our times together at the same organizations I continue to reach out and recommend Dessi as my go-to nonclinical colleague. Besides her immense knowledge base in the areas of safety and nonclinical drug development, Dessi is one of the kindest, hard-working individuals I know and would be a benefit to any organization/team. I have worked with Dessi for years and look forward to continuing any opportunity where we can work together again."

Principal Consultant, TranslationalBio LLC

"Dessi is an excellent toxicologist who provides useful and practical guidance related to the development of both large and small molecules. Her extensive knowledge base of compound characteristics, study design and in vivo observations allows her to provide perspective on both how to design toxicology studies and how to interpret the results.

I particularly appreciate her ability to separate “signals” from “noise” allowing companies to determine whether the findings will impact development, whether additional studies are warranted and what a path forward might look like. Her pragmatism is invaluable in executing a successful toxicology program. I highly recommend Dessi to any company needing toxicology input."

Biotech CEO

"Ringing endorsement right here! Dessi has brought clarity, strong project management, and adherence to timeline, with a clear set of deliverables expectations. But what sets her apart is early and highly contextualized understanding of the program, the study, and the analysis."

VP, Strategic Programs

"We have had the pleasure of collaborating with Dessi on several projects spanning multiple therapeutic indications, and her contributions have been consistently outstanding. As a toxicologist, Dessi delivers thorough, well-reasoned insights that not only answer our questions but also provide a clear scientific rationale behind each recommendation.

Her ability to respond quickly and comprehensively has been invaluable to our work, enabling informed decision-making across a diverse portfolio of early drug discovery programs. Dessi’s expertise and professionalism make her an exceptional partner, and we deeply appreciate the clarity and depth she brings to every engagement.

As an Academic Drug Discovery Accelerator supporting projects globally, we rely on collaborators who combine scientific rigor with responsiveness — and Dessi exemplifies exactly that.”

Director, Drug Discovery and Development

"I was fortunate to work with Dessi while she consulted for a couple of pre-clinical, small molecule programs. She was able to succinctly summarize recommendations for studies that aligned with company budget and R&D needs to progress the programs. She was also able to adjust studies, plans and work with vendors to make immediate adjustments if plans changed, which is critical for start-ups. She interfaced with other consultants and CROs to ensure a seamless execution of planned studies, and was always a pleasure to work with."

Director, Business Development

"It was a pleasure to work with Dessi both as a colleague and manager. Dessi is among the most innovative scientists I’ve known, with broad expertise in molecular techniques, drug discovery, toxicology, SEND datasets, and mechanisms of drug toxicity. She consistently delivered high-quality, well-reviewed data and was instrumental in interpreting results to advance projects.

Dessi’s collaborative approach, reliability, and exceptional time management truly set her apart. She’s an excellent communicator, a quick learner, and a thoughtful leader, blending technical, scientific, business, and interpersonal skills seamlessly. As a manager, she is supportive, fair, and a strong mentor. I highly recommend Dessi as an invaluable leader for any organization."

make your breakthrough a reality

Transforming Scientific Expertise into Breakthrough Medicines