PRINCIPAL CONSULTANT, PHARMA PROGRAMS
Suttons Creek

My specialty is device development engineering and program management for combination products. With over 10 years of experience in the pharmaceutical industry, I have practical,  hands on experience in various types of drug delivery systems and global combination product collaboration through participation on various international standards committees and other industry forums. 

DIRECTOR, TECHNICAL SERVICES
Suttons Creek

My expertise lies in developing and executing technical, regulatory, and business strategies to deliver drug delivery technologies to patients in need. With extensive industry experience and a background as a former leader within the FDA, I am uniquely qualified to empower teams to devise practical solutions for the most complex challenges.

PRINCIPAL CONSULTANT
Suttons Creek

My specialty is complex combination product regulatory strategy and the support of global medical device and combination product programs and process improvement initiatives. With 10 years of experience in medical device and drug delivery development and regulation, including over 4 years at the FDA as a Reviewer and Team Leader of injection device combination products, I have used my hands-on knowledge to contribute to policy development of connected “smart” drug delivery devices, on-body delivery systems, emergency-use injectors and implantable infusion pumps.

SENIOR PRINCIPAL CONSULTANT & ASSOCIATE DIRECTOR OF TECHNICAL LEARNING AND DEVELOPMENT
Suttons Creek

I specialize in creating and implementing adaptable technical and regulatory strategies for drug delivery systems to benefit patients. With experience in medical device engineering, early research, and as a Lead Reviewer at the FDA, I am well-equipped to guide, advise, and lead teams to develop practical solutions and tackle complex challenges.

SENIOR CONSULTANT, SYSTEMS ENGINEERING
Suttons Creek

My specialty is in medical and combination product device development, project management, and lifecycle management.  With over 8 years of experience in all stages of development, I have practical, hands-on experience developing prefilled syringes, pen injectors, co-packs/convenience kits, lyophilized product systems, infusion devices, and implantables.

SENIOR PROJECT MANAGEMENT CONSULTANT
Suttons Creek

My specialty is in project management for device development and new product introductions. With over 13 years in the medical device industry, my experience collaborating with cross-functional teams and stakeholders has equipped me with the ability to proactively navigate complex projects, adapt to changing priorities and foster productive working relationships in dynamic environments.

SENIOR PRINCIPAL REGULATORY CONSULTANT
Suttons Creek

My specialty is in developing and executing global regulatory strategies and submissions for medical devices, drug-device combination products, drugs and biologics in a variety of fields including Oncology, Immunology, Neurosciences, Infectious Diseases, Metabolic Disorders, Cardiology, Ophthalmology, Gene Therapy and Orphan drugs. With over 20 years of pharmaceutical, biotech, and medical device industry experience, I have led numerous, successful international Health Authority interactions and developed specialized skills in bridging studies, Human Factors validation, and drug delivery device clinical studies.