“I had the pleasure of meeting Debra in 2010 when we embarked on a challenging clinical development program spanning 17 countries. Initially deemed impossible to execute, Debra’s collaborative and focused approach transformed it into a highly successful study that exceeded recruitment targets ahead of schedule.
Debra’s patient-centric approach was instrumental in addressing the concerns of disappointed investigators and patients. She worked seamlessly with the team and regulators to find solutions that were acceptable to all parties involved. This experience laid the foundation for a professional relationship that has flourished over the past 15 years across multiple programs.
Debra is truly an all-round compassionate fixer in the rare disease space. Her expertise covers the entire spectrum of clinical trial setup, execution, approval, and post-approval support. I highly recommend her for any role that requires dedication, skill, and a patient-first mindset.”
“Debra is a dedicated, experienced, and creative clinical scientist who is also absolutely a joy to work with. Debra’s sustained and detailed efforts were critical to the execution and success of the pegvaliase clinical trials in which I was privileged to participate. Over the entire span of Phase I, II, and III trials, with significant tribulations along the way due to drug-related adverse events, she was a rock. Her advice and counsel were key to event management and crucial to the ultimate success of gaining regulatory approval for the drug. I highly endorse her consultative services for any stage of clinical trial development and execution.
“I worked with Debra for over 10 years, during which time she was responsible for overseeing clinical trials at Biomarin and I was a PI on a number of these studies in rare disease. I found her to be extremely competent, detail-oriented and professional while also maintaining excellent relationships with study investigators. I worked with her to address some regulatory issues during on specific trial and found that she was very knowledgeable with regard to regulatory issues and very skilled in her dealing with regulators. I have worked with many different individuals in a number of different companies in conducting clinical trials and I have to say that Debra is one of the best.”
“I have worked with Debra for over 10 years. She is without reservation the finest clinical trialist I have collaborated with. We have worked together on proof of concept, pivotal and label expansion studies in a broad variety of therapeutic areas across the span of treatment modalities. In that time, Debra’s commitment to patient safety, data quality and protocol execution is exemplary. She has a clear understanding of study objectives, a wealth of experience, and she is accessible and collaborative working with sites, investigators, patient advocacy and sponsors to achieve and frequently exceed expectations. Debra’s consistent application of quality, completeness and execution supports strategic pipeline decision-making, and her career has many notable successes. Debra is perceptive, insightful and diligent; she has been a highly valued team member and a mentor and role model for inexperienced clinical trialists. I am hugely supportive of Debra in this venture of her career; she is a major value-add to any team and development program.”
“I have worked with Debra for over 10 years and she sets a high standard for clinical development plans and execution, including collaboration and attentiveness to clinical study needs. Her high engagement with site PIs assures quick trial recruitment of the appropriate participants, with high uniformity and completeness of data acquisition.
For a pivotal trial in MPS IVa disease, Debra’s care in training and monitoring sites on the implementation of a primary (functional) endpoint assessment, performed in replicate for increased precision, was essential to the approval of the first and only MPS IVa treatment. This quality trial and drug approval enabled the company to take on the next level of growth.”