Meet Our Expert
Denise Morris, PhD
Pharmaceutical Expert, Clinical Pharmacology and Model Informed Drug Development
With over 15 years of experience in drug development, I bring a strong combination of scientific expertise and operational leadership. My work spans early discovery through clinical research, with direct contributions to hundreds of preclinical and clinical studies and several successful drug approvals. I’ve supported a broad range of treatment modalities and therapeutic areas across biotech, large pharma and CRO environments.
In addition to my technical background in modeling and simulation, I have over a decade of experience leading complex, cross-functional projects spanning business development, project management, and learning and development. I’m skilled at translating high-level objectives into clear project plans, navigating shifting or competing priorities, and managing deliverables in highly dynamic environments. This combination of scientific and operational expertise allows me to effectively support critical components of the drug development and submission process, particularly where coordination, technical rigor, and strategic oversight are required.
Testimonials
Why Clients Rely on Us
Denise was pulled in to support the analysis and interpretation of the PK/PD outcomes for one of our studies. She immersed herself in the data and embraced the team dynamics. Throughout this multi-stakeholder collaboration, she was able to help us prioritize the key PK/PD responses, determine the most effective method to display the differences across treatment groups, and provide the text to ensure the messaging was clear. As a bonus, despite supporting multiple clients she was readily available for calls and never missed a deadline.
Vice President
Denise is a thorough professional with a grand vision for her function, her team, and the broader organization. She’s perhaps one of the most organized and articulate people you will ever meet. She’s highly knowledgeable on all things modeling & simulation from all facets, including Pharma, CRO, and Regulatory – which allows her to have tremendous empathy towards whomever she’s engaged with. She has always offered me great advice on improving things, creating processes around them, and more. I enjoyed every moment of working with her.
Senior Director
We hired Denise to evaluate a population PK model that was done by another vendor and rejected by the FDA without much context. She dug into the model and provided an unbiased assessment of its gaps from a regulatory and technical perspective to help us understand its deficiencies. We were so impressed with her work that we asked her to lead our popPK and PK/PD strategy to support Phase 2b dose selection. She helped us select an appropriate vendor, proposed a strategy that was within budget and phase-appropriate, and provided rigorous oversight of model development and execution while ensuring our team’s feedback was incorporated. She managed multiple pivots and worked closely with the vendor to deliver high quality work in record time. We would not have achieved success without her support!
Executive Director
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