During the early 1990s, increasing regulatory complexity, combined with decreasing clinical relevance in the clinical research process of new anticancer agents, led Professor Esteban Cvitkovic to take a step towards counteracting this frustrating trend. Together with a group of partners, including medical oncologists, he founded a development consultancy, Cvitkovic & Associés Consultants (CAC).

Its focus was to provide selected clinical operations and regulatory support services in the field of clinical oncology research. Three widely used anticancer agents – oxaliplatin, docetaxel and irinotecan – immediately benefited from major input from this structure.

Ten years later, thanks to the recruitment of senior pharmaceutical industry personnel, the consultancy has developed into an experienced full-service CRO. With corporate headquarters in France, it now has over 100 personnel and a physical CRO presence covering North and South America as well as Western, Eastern and Central Europe.

The medical focus of CAC was precisely the fit that AAIPharma, an international CRO in the process of expanding its therapeutic capabilities, was looking for. In October 2006, AAIPharma acquired CAC, which became AAIOncology. The group has maintained its status as a global unit dedicated to oncology drug development and clinical trial management. It also serves as an important model for the development of further therapeutic-specific clinical units at AAIPharma.

In-house expertise

Driving AAIOncology’s success is the philosophy of ‘medicalisation’ and specific know-how in oncology clinical research, thanks to the presence of several in-house medical oncologists and onco-haematologists bringing experience as investigators in the hospital setting, preclinical research and industry.

Complementing this medical know-how is the solid integration of therapeutic specialisation throughout all areas of trial management, notably regulatory support, project management, monitoring, statistics and medical writing. With a high percentage of personnel with advanced degrees, the company is dedicated to ongoing oncology-focused and study-specific training.

AAIOncology’s in-house depth of knowledge is supported by a network of external consultants. Cvitkovic remains active, overseeing all scientific and medical oncology consulting. Experts in regulatory affairs, pharmacokinetics, preclinical research and oncology in the US and Europe are also routinely consulted.

Extensive services

AAIOncology has significant expertise in all phases of cancer drug development, various tumour types and haematological diseases. It also offers wide-ranging therapies, including cytotoxics, cytostatics, monoclonal antibodies, vaccines and hormonal therapies.

Its experience is derived from a diverse range of settings, providing AAIOncology with specialised know-how in oncology product development and registration strategies, lead assessment, clinical and preclinical optimisation of novel compounds, prognostic and regulatory-driven development of phase 1 single agent and combination chemotherapy regimens. These include first-in-man molecules, recommendation and execution of exploratory phase 2 trials and large international phase 3 studies for registration purposes, and exploration of treatments for targeted populations with unmet needs.

AAIOncology’s medical and scientific input ensures study feasibility with targeted protocol design. Also essential to its approach are medically driven statistical analyses and clinical report writing to ensure accurate and complete data interpretation.

Its experience in the oncology field has led the unit to develop various niche services, including on-site medical source review by oncologists, database cleaning for registration trials and oncology training. Its wide scope of services has the added benefit of providing access to and hands-on knowledge of a global network of experienced investigators.

AAIOncology’s clients range from small to medium-sized biotech through to large pharma companies, the determining criteria being the merits of the product. In the current competitive environment, the importance of medical needs is often pushed to its limits. AAIOncology has refocused on medicine and science, providing the means to bring medical content-rich innovative services to clients in the oncology field.

Company profile

AAIPharma Inc. is a global provider of product development and support services to the pharmaceutical, biotechnology and medical device industries.