, R.Ph. Pharm.
Dr. Dinella currently serves as Founder, President and Managing Partner at
, a leading boutique consulting company specializing in highly strategic regulatory and development advice and services for the pharmaceutical and healthcare industry.
Dr. Dinella was formerly the Vice President of Drug Regulatory Affairs, the Nutley Site Head for
and Member of the CEO's North American Operating Committee at
Hoffman La Roche Inc.
brings more than 20 years of Regulatory and Drug Development experience.
has provided oversight and filed over one hundred IND filings across various therapeutic areas for both drugs and biologics.
has filed and received approval for over thirty-five New Molecular Entities (NMES) and major efficacy supplements.
She has developed and managed thirteen Risk Evaluation Mitigation Strategies (REMS) with Medguides, Communication Plans, and Elements to Assure Safe Use (ETASU).
has led numerous milestone and critical issue
meetings across Divisions, Centers and with FDA
has led, presented, and managed oversight for thirteen FDA
Public Advisory Committees for NME approvals, safety issues, and Risk Management.
is experienced with Special Protocol Assessments (SPAs), Orphan Drug Designation, Fast Track Designation, Accelerated Approval and Pediatric Plans (PREA, PIPs, Exclusivity).
She has led the corporate
Global Regulatory Forum
to define, discuss, and align global strategic regulatory plans at key milestones in development, manage critical issues, define product risk assessment, and set direction for regulatory policy and external influencing.
has been recognized for her
achievements in the industry; in 1990, she
received both the