Download Advyzom BIO Cindy Dinella Final

Cynthia Dinella, R.Ph. Pharm.D.
President and Managing Partner
Dr. Cindy Dinella is a founding partner and holds the position of President and Managing
Partner of Advyzom, located in New Jersey and Washington, DC. Advyzom is a leading
boutique consulting company specializing in highly strategic regulatory and development
advice and services for our partners in the pharmaceutical and healthcare industry. She is
committed to providing experienced, scientific and proven successful leaders to advise and
deliver on regulatory strategy, medical writing and regulatory intelligence.
Dr. Dinella specializes in leading, guiding, and assisting biopharmaceutical companies with
global and US drug development programs to meet and influence health authority
requirements in order to successfully deliver the best outcome for each patient and company.
She has strong leadership, strategic thinking, influence management and cross-functional
teamwork skills, gained over many years of experience working within global drug
development across therapeutic areas, throughout phases of development, internally with
Senior Corporate Management and Boards, and externally with the Food & Drug
Administrations (FDA) . Dr. Dinella managed and mentored hundreds of employees over her
tenure and believes in people with talent and core values as a critical asset to success. Based
on her experience, skills and passion for her work, Dr. Dinella has been partnering with clients
to advise on developing products, resolve critical regulatory issues, proactively influence health
authorities, develop people and increase confidence with Boards and Investors with their
programs and plans.
At Advyzom, Dr. Dinella works with a diverse set of clients both locally and internationally
ranging from start-ups, small to mid-sized and large Pharma/biotech companies. She provides
guidance across therapeutic areas and phases of development for biologics, drugs, drugdevice combinations, bioterrorism products, 505(b)(2)’s, accelerated approval and global
regulatory pathways. She has been advising CEO’s, Heads of Development, global product
teams and presents to Boards of Directors, Senior Management forums and FDA meetings.
Before co-founding Advyzom, Dr. Dinella worked at Hoffmann-La Roche Inc. in Nutley, New
Jersey (1992-2011). Hoffmann-La Roche Inc. is a large, research-focus healthcare company
that discovers, develops, and provides new biopharmaceuticals and diagnostics within core
disease areas. As Vice President of Drug Regulatory Affairs (2001-2011), Dr. Dinella was
responsible for managing a regulatory department including strategic U.S. and global
regulatory program management; mature products; FDA policy and regulatory intelligence;
advertising and promotion; medical writing; labeling; submissions and archiving. Dr. Dinella
also served as Site Head in New Jersey for Global Development from 2007 to 2011 where she
provided oversight cross-functionally for over 1000 employee and contractors. She was a
member of the CEO’s North American Operating Committee from 2002 to 2009 which was
responsible for meeting the North America business objectives and charged with operating the
Nutley site, including the three thousand marketing, R&D, and support service professionals. .
Prior to Hoffmann-La Roche, Dr. Dinella spent time working as a post-Doctoral fellow, Clinical
Research & Drug Regulatory Affairs (1990-1992). During this time, she trained and worked as
a clinical research associate for Phase I and II development.
Dr. Dinella has provided oversight and filed over one hundred IND filings across various
therapeutic areas. She 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). Dr. Dinella has led numerous milestone and critical
issue FDA meetings across Divisions, Centers and with FDA Senior Management. She has
led, presented, and managed oversight for thirteen FDA Public Advisory Committees for NME
approvals, safety issues, and Risk Management. She is experienced with Special Protocol
Assessments (SPAs), Orphan Drug Designation, Fast Track Designation, Pediatric Research
Equity Acts of 2003 (PREA), Pediatric Investigation Plan (PIPs), and Pediatric Exclusivity. She
led the 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. Dr. Dinella has lectured at Rutgers
University College of Pharmacy and acted as a teaching assistant at St. Johns University
(1988-1990). She was a research scientist (1988) with Ciba-Geigy Pharmaceuticals in Summit,
NJ, an International Drug Registration Intern (1987-1988), and a Pharmacology Assistant
(1987).
As a result of her determination and skill, Dr. Dinella has been recognized for her diligence and
achievements. In 1990, she received both the Upjohn Pharmacy Research Award for
Excellence in Clinical Research and the Sandoz Pharmacy Award for Superior Academic
Achievement & Contribution to Health Care. Since then, Dr. Dinella was accepted and
graduated in 2000 from the Leadership New Jersey program designed to take proven
professional leaders and make them Leaders of State issues within health care,
environmental, social services, education, politics, and racism. In 2001 received the Tribute to
Women in Industry (TWIN) Award (2001) in recognition of her significant contributions to her
company as a professional woman.
Dr. Dinella earned her Bachelor of Science in Pharmacy from Rutgers University in
Piscataway, NJ (1988). She then earned a Doctor of Pharmacy from St. Johns University in
Jamaica, NY (1990). She loves spending time with her family and friends entertaining and
traveling.