Revolutionary Public-Private Partnership for Early Phase Trials Established in France
The Centre Hospitalier Universitaire (CHU) de Caen, a university teaching hospital and the largest hospital in the West of France, and Therapharm, a large, private contract research organization founded in 1980, have joined forces to form the first public-private partnership to conduct early phase clinical research in France. The clinical research center is called Centre de Recherche Clinique-Basse Normandie (CRC-BN). The center conducts phase I and II clinical trials that are industry-sponsored, investigator-initiated and government-sponsored.
Antoine Cournot, who is president of Therapharm and spearheaded the partnership, said, “The objective of the clinical research center is to be able to perform early phases, phase I and II, with a high level of international quality but with a professional approach.”
The impetus for the unique partnership was to attract more industry-sponsored clinical research to France. Creating a public-private partnership clinical research center in a large hospital has been a dream of Cournot’s for 20 years, when he first attempted to establish one in Paris, where Therapharm’s headquarters are. Ten years ago, when Therapharm moved its phase I unit from Paris to Caen—in close proximity to CHU de Caen—Cournot approached the hospital about his idea.
But, it wasn’t until 18 months ago that the hospital and Therapharm met for a serious discussion about plans for building CRC-BN...
Each organization brings important assets and expertise to the partnership. CHU de Caen has 1500 beds, 80,000 patient visits per year, a catchment area of 2.4 million people, a technology platform and experienced physician investigators. Therapharm offers decades of clinical pharmacology expertise and administrative support, and standard operating procedures that the new department has adopted. Therapharm has 80 employees in France alone.
The company is also a 20% shareholder in a pan-European CRO, called Imitis, which has 180 employees, 35 of whom are in France, and offices that, in addition to France, include locations in Sofia, Bulgaria; Nuremberg, Germany; Bucharest, Romania; and Barcelona, Spain.
CRC-Basse Normandie is on the 18th floor of the hospital. The center is a completely renovated and refurbished space with a reception area, 10-bed clinical pharmacology unit, a surgery and administrative offices. CRC-BN has all new equipment and 15 full-time dedicated employees coming in nearly equal numbers from both the hospital and Therapharm.
“That’s really an original model. It’s totally unusual to do that in France. It’s like a dream to have a public-private clinical research center in a large hospital,” said Cournot.
The center will focus on oncology, neurology, infectious disease (including HIV), and cardiology, but, Cournot said, “the door is open for the rest.”
The CHU de Caen and Therapharm each invested 75,000 euros in the new center. Cournot estimated that it will take three years for the center’s revenues to pay back each organization’s investment. But, creating CRC-BN is just the first step toward Cournot’s goals for clinical research in France. After revenues pay back the investment, Cournot would like to expand the center by adding more beds and employees. Then he would like to make the center available to general practitioners [GPs] working in the area of the hospital.
“The idea is to say to the GPs, ‘When you are doing a study, if you need some help, if you need material, if you need a secretary or CRAs or nurses, you can perform the study with your patient in our unit.’ It’s a second step. It will certainly be more difficult to convince the GPs to come in our unit, but why not? We are really innovating a new method,” said Cournot.
Cournot would like to persuade other large French hospitals to enter public-private partnerships. He is giving presentations about the center to these other hospitals in hopes that they will use CRC-Basse Normandie as a model. But, Therapharm does not have to be the private clinical research organization that participates in all the public-private partnerships across France. Cournot’s ultimate objective is to have a large clinical research network that industry can tap into.
“If Therapharm can invest in other hospitals, I shall be very happy. But I don’t want to have a monopoly on that. The idea that when I’m visiting the U.S. biotechs, I could say that five, six or seven big French hospitals have good clinical research centers, would be very nice, with or without Therapharm. The goal is really to convince people to come in France,” said Cournot.
Several different parties in France are working toward the goal of making France more attractive for clinical research, and Cournot’s efforts are part of the larger effort of various organizations.
“We have a very good relationship between the French drug agency, AFSSAPS [Agence Française de Sécurité Sanitaire des Produits de Santé], and with LEEM [Les enterprises de medicament, equivalent of PhRMA in the U.S.] and with the French association of CROs, AFCROs. For five years, we have been working together very hard in order to increase and to promote French clinical research,” said Cournot.
In addition to making presentations at other large French hospitals to promote the CRC-BN public-private model, Cournot is giving presentations to colleagues at private clinical research organizations.
“I did my first presentation in front of my colleagues from the French Association of CROs [AFCROs]. I said, ‘May I show you what I did in Caen? Maybe some of you can copy it and try to do the same thing in all the hospitals.’ I also gave this presentation to my European colleagues,” said Cournot.
When asked if he would like CRC Basse-Normandie to become a national model for France, he replied, “It’s ambitious, but why not?”