Pharmaceutical Development
Early Clinical Development
Clinical Development
About AAIPharma
Media Press Center

Press Releases

AAIPharma cited in Success of SCOLR Pharma's Phase III Trial of 12 Hour Ibuprofen

AAIPharma Strengthens Global Clinical Development Services Unit with the Addition of Andreas Dreps Ph.D. and Ralf Wolter Ph.D.

DATELINE (November 10, 2008) – AAIPharma, a global provider of drug development services, today announced the appointment of Andreas Dreps, Ph.D., as Senior Vice President, Global Clinical Development Services.  In addition, the company also announced that Ralf Wolter, Ph.D., has joined as Vice President Clinical Operations – Europe reporting to Dr. Dreps.

Dr. Ronald Kershner To Discuss Data Monitoring Committees at SoCRA Annual Conference

September 17, 2008

 

Ron Kershner, Ph.D., vice president of biostatistics and data management at AAIPharma, will present “The Role of the Data Monitoring Committee (DMC)” during the Society of Clinical Research Associates Annual Conference in Vancouver, BC.

 

AAIPharma announces the appointment of Scott Neilson to the position of Chief Operating Officer.

AAIPharma announces the appointment of Scott Neilson to the position of Chief Operating Officer.  Mr. Neilson will be responsible for AAIPharma's global drug development services operations reporting to Dr. Ludo Reynders, Chief Executive Officer and President. 

 

 

Ronald Kershner Appointed to Lead AAIPharma’s N. American Biostatistics and Data Management Services

Ronald Kershner joins AAIPharma to lead the Company’s North American Biostatistics and Data Management Services groups. Ronald brings over 25 years of industry experience at various large pharmaceutical, biotechnology and Contract Research companies. In previous roles with inVentiv, Inveresk and Omnicare, Ronald was responsible for the oversight of biostatistics and data management across a variety of therapeutic areas. Ronald brings significant experience with regulatory submissions and FDA interactions and has been involved in over 20 NDA submissions.

AAIPharma received certification that the company’s operations are in compliance with EU Good Manufacturing Practice regulations

AAIPharma has received its second certification from a European Union (EU) regulatory body that the company’s operations are in compliance with EU Good Manufacturing Practice (GMP) regulations. Following an audit of AAIPharma’s manufacturing, testing and stability operations located in Wilmington, North Carolina, USA, Sweden’s Medical Products Agency (MPA) notified the company that tablet, capsule and other solid dose drug manufacturing and testing operations can be certified as meeting EU GMPs.

AAIPharma achieves 9,000,000 work hours without a lost workday case.

AAIPharma achieves 9,000,000 work hours without a lost workday case. The period of time covered for this achievement was from August 4, 1999 through February 21, 2008. The North Carolina Department of Labor presented AAIPharma, Inc. with an achievement award for reaching this significant milestone. Gold annual recipient awards, representing 17 years of safety excellence, were also presented to AAIPharma's two main analytical laboratories.

 

Ronald Norton Appointed to Lead AAIPharma's Expanded North American Exploratory Development Services

Wilmington, N.C., February 5, 2008 -- Ronald Norton joins AAIPharma to lead the Company's expanded North American Exploratory Development Services group which includes phase I-IIA clinical pharmacology, bioequivalence and bioanalytical services. Ronald brings over 20 years of industry experience at both Pharmaceutical and Contract Research companies. In previous roles with Glaxo Wellcome and MDS Pharma Services, Ronald was responsible for the oversight of both phase I and late phase clinical trials across a variety of therapeutic areas.

AAIPharma Expands Central and Eastern European Operations

Wilmington, N.C., November 6, 2007 -- AAIPharma Inc. announced today that it is further expanding its operations in Central and Eastern Europe with the addition of an experienced team in Hungary. The new office is in Budapest and will initially consist of seven staff. AAIPharma already has two other offices in Central and Eastern Europe with established operations in Croatia and Russia. With the recent addition of an office in South Africa, AAIPharma now has operations in 14 countries worldwide.

AAIPharma adds Experienced South African Clinical Operations Team

Wilmington, N.C., November 1, 2007 -- AAIPharma Inc. announced today that it has added an experienced clinical research team based in South Africa to its growing worldwide clinical research capabilities. The new office in Johannesburg will house ten employees initially and will provide a base for the expansion of services in this region.

AAIPharma Chooses SAS’ Clinical Trials Solution to Support Rapid Growth

Wilmington, N.C., September 10, 2007 -- SAS, the leader in business intelligence, today announced that AAIPharma will help fuel its ongoing global expansion efforts by using SAS® Drug Development, SAS's powerful data management, collaborative reporting and analysis solution for pharmaceutical, medical device and biotechnology firms.

AAIPharma Announces Vice President of Clinical Business Development, Europe

Wilmington, N.C., September 3, 2007 -- AAIPharma Inc. announced today the appointment of Dr. Ralf Wulkow M.D. to the position of Vice President of Clinical Business Development, Europe. With over eighteen years of experience in the pharmaceutical industry, Dr Wulkow will be responsible for all clinical business development activities in Europe.

Phase Forward, AAIPharma Enter Alliance Agreement

Wilmington, N.C., August 29, 2007 -- Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced a multi-year alliance agreement with AAIPharma, Inc., a leading global contract research organization (CRO).

AAIPharma Strengthens South American Operations through Acquisition of Instituto de Pesquisa Clinica de São Paulo, Ltd.

Wilmington, N.C., May 17, 2007 -- AAIPharma Inc. announced today that it has completed the acquisition of Instituto de Pesquisa Clinica de So Paulo, Ltd. (IPCSP), a contract research organization providing clinical development services in Brazil. The acquisition of IPCSP combined with AAIPharma's existing operations in Argentina and Peru provides the Company critical mass in South America and a platform for continued growth in this region.

AAIPharma Grows and Strengthens Parenteral Manufacturing and Sterile Product Release Capabilities

Wilmington, N.C., April 3, 2007 -- AAIPharma Inc. announced today the completion of over $2.0 million in upgrades to its parenteral manufacturing facility in Charleston, South Carolina and its sterile product release operation in Wilmington, North Carolina. Improvements were made to increase capacity and to ensure compliance with European Union (EU) aseptic processing and testing guidelines, positioning the facilities to be approved for aseptic filling and release of products exported to the EU.

AAIPharma and Mallinckrodt Form Pharmaceutical Outsourcing Alliance

Alliance to deliver one-stop drug development and commercial manufacturing solution for the pharmaceutical and biotechnology industries

AAIPharma Expands Clinical and Non-Clinical Operations with Strategic Hires

Wilmington, N.C., August 23, 2006 -- AAIPharma Inc. announced today two new additions to its management team. Lee Karras joins the Company as senior vice president, Non-Clinical Services, and Anne Wiles joins AAIPharma as senior vice president, Data Systems and Processes.

AAIPharma Announces Appointment of Vice President of European Business Development

Wilmington, N.C., June 1, 2006 -- AAIPharma Inc. announced today the appointment of Ms. Victoria Winters to the position of Vice President of European Business Development. With over sixteen years of experience in the pharmaceutical industry, Ms. Winters will be responsible for all business development activities in Europe.

AAIPharma Announces Executive Appointment

Wilmington, N.C., May 2, 2006 -- AAIPharma Inc. announced today the appointment of John M. Hall, Ph.D. to the position of President of European Operations. With over thirty years of global experience in the pharmaceutical, chemical and consulting industries, Dr. Hall possesses a broad range of knowledge in research and development operations management, change management, strategic planning, facility design and construction, marketing and global pharmaceutical product development. Most recently, Dr.

AAIPharma Completes Financial Reorganization

Wilmington, N.C., March 7, 2006 -- AAIPharma Inc. announced today that it has emerged from chapter 11, and the Company's Joint Chapter 11 Plan has become effective. As previously announced, AAIPharma and its domestic subsidiaries filed for chapter 11 bankruptcy protection with the United States Bankruptcy Court for the District of Delaware on May 10, 2005, and the Company's Joint Chapter 11 Plan was confirmed by the Court on January 20, 2006.