Putting Medical Science Back into Clinical Research

In the early nineties, 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 trend. Together with a group of collaborators including medical oncologists, he founded a development consultancy, Cvitkovic & Associés Consultants (CAC). Their focus was to provide selected clinical operations and regulatory support services in the field of clinical oncology research. Three currently widely used anticancer agents (oxaliplatin, docetaxel, and irinotecan) benefited from major input of this young structure. Ten years later, thanks to the recruitment of senior pharmaceutical industry personnel, the consultancy had developed into an experienced full-service CRO with over a hundred personnel, the corporate headquarters being in France 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 AAI Pharma, an international CRO in the process of expanding its therapeutic capabilities, was looking for. In October 2006 AAI Pharma 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 AAI Pharma.

In-house Oncologists

Driving AAIOncology’s success is the philosophy of “medicalization” and specific know-how in oncology clinical research. This is founded on 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 specialization 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, one of the ground rules is ongoing oncology-focused and study-specific training.

AAIOncology’s in-house depth of knowledge is reinforced via a network of external consultants. CAC’s founder, Prof. Cvitkovic remains active, overseeing all scientific and medical oncology consulting. Experts in US and European regulatory affairs, pharmacokinetics, preclinical research and oncology specialists are also routinely consulted.

Oncology Services

AAIOncology has significant expertise in all phases of cancer drug development, with various tumour types and haematological diseases, and with wide-ranging therapies (cytotoxics, cytostatics, monoclonal antibodies, vaccines, hormonal therapies, etc). Its experience is derived from a diverse range of settings, providing AAIOncology with specialized know-how in oncology product development and registration strategies, lead assessment, clinical and preclinical optimization of novel compounds, prognostic and regulatory-driven development of Phase I single agent and combination chemotherapy regimens, notably for first-in-man molecules, recommendation and execution of exploratory Phase II trials and large international Phase III 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.

AAIOncology’s 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 mid-sized biotech companies through large Pharma, 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 AAI Pharma with the means to bring medical content-rich innovative services to clients in the oncology field.