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August 30, 2015 8:38 AM ET

Healthcare Providers and Services

Company Overview of RRD International, LLC

Company Overview

RRD International, LLC, a product development company, provides strategic and operational support services for product development, evaluation, and identification programs for the biotechnology, pharmaceutical, and medical device companies. It offers product development services, such as creating and managing domestic and global product development programs, such as scientific, medical, clinical, regulatory, toxicology, manufacturing, patent review, and market assessment for biotech, pharmaceutical, and medical device products; product development support services, including strategic planning, protocol design, project management, clinical trial management, regulatory affairs support, prepar...

7361 Calhoun Place

Suite 325

Rockville, MD 20855

United States

Founded in 2002

Phone:

301-762-6100

Fax:

301-762-6154

Key Executives for RRD International, LLC

Co-Founder, Chief Executive Officer and Managing Director
Co-Founder, Chairman, Managing Director and Chief Scientific Officer
Chief Financial Officer and Senior Vice President
Vice President of Operations
Compensation as of Fiscal Year 2015.

RRD International, LLC Key Developments

RRD International Announces the Appointment of Katie Laessig as Senior Vice President of Regulatory Affairs and Medical Safety

RRD International announced the appointment of Dr. Katie Laessig as senior vice president of regulatory affairs and medical safety. Laessig, a 16-year Food and Drug Administration (FDA) veteran, has served as deputy director of the Division of Anti-Infective Products (DAIP) since 2007 and been responsible for review of antimicrobial drug and biologic products for the treatment as well as prevention of infectious diseases. Prior to joining DAIP, she held several positions of increasing responsibility within the Division of Anti-Viral Products (DAVP). In her new role, Laessig will serve as an expert advisor to RRD's product development teams and partner companies for specific products and indications. She will also work with the senior management team to develop and implement new business initiatives in the anti-infectives area.

RRD International Announces Management Changes

RRD International announced the addition of Brian R. Gallagher, CMA, to the executive team. Gallagher joins RRD as senior vice president and chief financial officer, bringing more than 20 years of finance experience from the biopharma industry, with both multi-national corporations and commercial-stage public biotechnology companies. Robert L. Smith, Jr., CPA, the current senior vice president of finance and administration, will be retiring at the end of the calendar year. Brian Gallagher's previous experience includes positions at Merck & Company and Adolor Corporation. Most recently, Gallagher was vice president of finance for Optimer Pharmaceuticals.

Dipexium Pharmaceuticals, Inc. Enters into Amendment to Its Product Development Agreement with RRD International, LLC

On May 22, 2014, Dipexium Pharmaceuticals Inc. entered into an amendment to its Product Development Agreement, dated January 1, 2014, with RRD International, LLC. Pursuant the Amendment, the parties agreed upon a new scope of services and budget to commence preparation of a New Drug Application to be submitted to the FDA for Pexiganan Cream 0.8% (Pexiganan) if and to the extent the company successfully completes its pivotal Phase 3 clinical studies and otherwise successfully completes the Pexiganan drug development program. The Amendment also addresses, among other things, certain medical monitoring (and related) activities, the addition of a new Phase 1 Site Monitor, and the addition of additional fees and pass-through expenses to the development budget.

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