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This profile was last updated on 2/10/14  and contains information from public web pages and contributions from the ZoomInfo community.

Dr. Cindy Dinella

Wrong Dr. Cindy Dinella?

President and Managing Partner

Email: c***@***.com
Local Address: New York City, New York, United States
Advyzom
221 Sherman Avenue
Berkeley Heights, New Jersey 07922
United States

Company Description: Advyzom is a leading boutique consulting company specializing in highly strategic regulatory and development advice and services for our partners in the...   more
Background

Employment History

Board Memberships and Affiliations

Education

  • Pharm.D.
  • R.Ph. Pharm.D.
15 Total References
Web References
Advyzom | People
www.advyzom.com, 25 Jan 2014 [cached]
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. Read full bio
Advyzom | News
www.advyzom.com, 18 Dec 2012 [cached]
Dr. Cynthia Dinella Selected to Facilitate MIT's Global Regulatory Innovation and Adaptive Licensing Program Session Dr. Cynthia Dinella Pharm.D., R.Ph, President and Managing Partner of Advyzom was selected to facilitate the September 10, 2012 meeting on Global Regulatory Innovation and Adaptive Licensing. The meeting was sponsored by Massachusetts Institute of Technology's (MIT) NEW Drug Development ParaDIGmS (NEWDIGS) program. The NEWDIGS program is a unique collaboration for transforming the global healthcare innovation system to deliver greater value to all stakeholders and to ensure its sustainability. For more information, click here.
July 24, 2012 Dr. Cynthia Dinella Provides a Collective Industry Perspective on Evaluation of Radiologic Review of PFS at Oncologic Drugs Advisory Committee Meeting Advyzom's President and Managing Partner, Dr. Cynthia Dinella, provided a collective industry perspective on evaluation of radiologic review of progression free survival at the Oncologic Drugs Advisory Committee (ODAC) meeting on July 24, 2012. The ODAC meeting was convened to discuss the evaluation of radiographic review in randomized clinical trials using progression free survival (PFS) as a primary endpoint in non-hematologic malignancies. The committee discussed the merits of an independent audit of investigator progression assessment in a pre-specified subgroup of patients instead of an independent review of all progression assessments. At the request of FDA, Dr. Dinella presented the industry's perspective on burden, cost and value of independent radiologic review in randomized PFS trials. A copy of the slides can be found here.
...
Advyzom's President and Managing Partner, Dr. Cindy Dinella to serve on ADVENTRX Pharmaceutical's Regulatory Advisory Board Advyzom is pleased to announce that Cindy Dinella, R.Ph, Pharm.D. will serve on the Regulatory Advisory Board of ADVENTRX Pharmaceuticals, INC (NYSE Amex: ANX).
Advyzom's President and ...
www.advyzom.com, 23 Mar 2012 [cached]
Advyzom's President and Managing Partner, Dr. Cindy Dinella to serve on ADVENTRX Pharmaceutical's Regulatory Advisory Board April 9, 2012 Advyzom is pleased to announce that Cindy Dinella, R.Ph, Pharm.D. will serve on the Regulatory Advisory Board of ADVENTRX Pharmaceuticals, INC (NYSE Amex: ANX).
Cindy Dinella , R.Ph. ...
www.adventrx.com, 9 April 2012 [cached]
Cindy Dinella , R.Ph. Pharm. D.
Dr. Dinella currently serves as Founder, President and Managing Partner at Advyzom, LLC , 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 Global Development and Member of the CEO's North American Operating Committee at Hoffman La Roche Inc. She brings more than 20 years of Regulatory and Drug Development experience.
Dr. Dinella has provided oversight and filed over one hundred IND filings across various therapeutic areas for both drugs and biologics. 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, 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.
Dr. Dinella has been recognized for her achievements in the industry; in 1990, she received both the
Regulatory Advisory Board - Mast Therapeutics
www.adventrx.com [cached]
Cindy Dinella, R.Ph. Pharm. D.
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