MANAGING PRINCIPAL, CO-FOUNDER
Clintrex

As co-founder/President and now Managing Principal Clintrex, my specialty, is helping pharma and biotech companies create their clinical development plan using efficient clinical trial designs, and solving complex regulatory issues at all stages of development. I also help companies with their partnering strategies, including the identification and communication with potential partners, whether strategic or fiscal. I have nearly 40 years of CNS clinical trials experience, in all phases, including as a site Investigator, chair of DSMBs, and global coordinating investigator. I also served as the Chair of the FDA Peripheral and Central Nervous System Advisory Committee.

MANAGING PRINCIPAL
Clintrex

My specialty is to provide pharmaceutical companies with clinical development and regulatory affairs strategic support. I am a neurologist with fellowship training in movement disorders and vascular neurology. I have over 20 years of experience as an Investigator and in the pharmaceutical industry, mostly as a chief medical officer. I can help you design and execute efficient clinical trials and provide strategic regulatory guidance throughout all stages of development.

VICE PRESIDENT, PEDIATRIC & RARE DISEASES
Clintrex

My specialty is providing pharmaceutical companies with regulatory and scientific support in pediatric and rare disease development. I am a pediatrician and child neurologist with fellowship training in neuroimmunology. In my 7 years at the FDA, I held numerous leadership positions, including as the Deputy Director of the Office of Neuroscience and the Director of the Division of Neurology 2. I have also been an investigator at the NIH and was a reviewer for the Undiagnosed Diseases Program in the NIH’s National Human Genome Research Institute. I am excited to leverage my clinical and regulatory expertise along with my basic scientific knowledge to help you at every stage of your development programs, providing essential assistance with the unique challenges inherent to investigations in children and rare diseases.

VICE PRESIDENT, REGULATORY STRATEGY
Clintrex

My specialty is helping pharmaceutical companies navigate challenging drug development issues in a rapidly changing regulatory environment.  I have over 13 years of leadership experience at FDA, including as the Director of the Division of Neurology 2, and also have spent time as a senior executive in biotech.  I am eager to leverage that experience to maximize the chances of regulatory success for your development programs.

SENIOR REGULATORY ADVISOR
Clintrex

I have 40+ years of regulatory expertise having been the Director of the FDA Division of Neurological products until my retirement in 2013.  My specialty, since joining Clintrex, is helping pharma and biotech companies solve complex regulatory issues, whether it is developing the initial regulatory strategy, to helping companies come off of partial or full clinical hold, plan for pIND, IND, EOP2, pNDA or NDA meetings.

VICE PRESIDENT OPERATIONS
Clintrex

My specialty is to provide CNS clinical trial operational excellence to our clients from the planning and implementation phases, though to analysis, regulatory submission, and publication. I have 30+ years of CNS clinical trial experience in all aspects of clinical trial operations including: study design, project management, data management, recruitment/retention, regulatory strategy, ethical considerations, drug/device supply logistics from cradle to grave, CSR creation, regulatory submissions, and manuscript writing, having been involved in the conduct of more than 300 multi-center clinical trials from First in human through phase IV. My goal is to ensure our clients clinical trials are conducted with scientific and operational rigor, and completed on time and within budget.