PROGRAM LEADER
Dr Lina Benajiba, associate Professor, ATIP-Avenir & ERC-Stg team leader, Université Paris Cité, INSERM U1342, Saint-Louis Research Institute – Paris, Clinical Investigations Center (CIC #1427), Saint-Louis Hospital – Paris.
As part of the French national MD-PhD program, Lina conducted her PhD training at the Dana Farber Cancer Institute in Boston, focusing on the identification and characterization of new therapeutic targets in acute myeloid leukemia (AML). Lina also trained as a physician and obtained her MD from the Paris Cité University with a specialization in both hematology and clinical pharmacology. Lina developed an expertise in drug development as a visiting scientist to the Investigational Drug Branch of the Cancer Therapy Evaluation Program of the NCI-NIH. Her clinical efforts are currently focused on early drug development in myeloproliferative neoplasms (MPN) and AML.
In 2020, Lina started her own research group in Saint-Louis Research Institute in Paris, as part of the “CCA-INSERM-Bettencourt” physician-scientist program. Lina’s team obtained the ATIP-Avenir label in 2023 and an ERC-Starting grant in 2024. Her team develops large-scale descriptive and functional translational approaches to better understand myeloid leukemogenesis and decipher innovative therapeutic strategies, with a particular focus on the niche-leukemic crosstalk and environment driven oncogenic signals. Her team also develops complex preclinical models, including in vivo organoids, to improve the efficiency of the drug discovery and development journey. The team is affiliated to the IHU “Leukemia Institute Paris Saint-Louis” and the SIRIC “InSitu”.
Lina has authored more than forty scientific articles in international journals and several chapters of medical and scientific books. Her work was recognized by a number of national and international awards including a French Academy of Medicine award. She is an elected member of the steering committee of the French national clinical research cooperative group for MPN, « France Intergroupe des syndromes Myéloprolifératifs (FIM)”. She is also an active member of several charity and institutional scientific and organizational committees, and an expert for the EUnetHTA (European Network for Health Technology Assessment). Lina is also in charge of several educational programs in pharmacology and hematology.
HEALTHCARE EXECUTIVE
Corinne Marechal
STRENGTHS IN THE FOLLOWING AREAS
Cancer Care
The Cancer Institute includes two Clinical Investigation Centers (CIC): CIC Saint Louis Hospital and CIC Bichat Hospital.
The ARS (Agence Régionale de Santé) “Place of Research Involving the Human Person” (LRIPH) authorization enable us to receive patients included in early phase clinical trials (first administration in humans, phases I and II), which requires a specialized and approved environment. Our CIC has been operating as a week hospital, which is able to receive patients or healthy volunteers 24 hours a day from Monday to Friday, since November 2015.
Patient pathways and experience:
Mastering the patient pathway is a major quality goal for us, which contributes to ensuring the proper conduct of clinical trials.
We have developed patient pathways in order to better inform the volunteers about the typical progress of a clinical trial. It is also intended for health professionals, students and other people interested in clinical investigation. They cover the chronological follow-up of the patient pathway, including the information visit, the official recruitment and the progress until the end of the trial. You will find examples of patient pathways concerning the CIC Saint Louis Hospital by clicking the following link: https://cic-paris-saint-louis.com/parcours-patient/
Patient satisfaction surveys:
CIC-1427 – Saint-Louis Hospital: in order to improve our services and the experience of the patients, we carried out a satisfaction survey in 2018 about the patient’s medical care and the management of the clinical trials by our teams.
Patients included in clinical trials, CIC workers (investigators, clinical research associates-CRA, biological analysis laboratory, etc.) and sponsors (institutional + industry) participated to the survey.
Survey results: https://doi.org/10.1016/j.therap.2020.02.001
This feedback enabled us to establish a plan of action and to determine the improvement priorities in order to meet their expectations.
Quality:
CLIP²
The CIC-P of Saint-Louis Hospital is one of the 16 CLIP² or « Centres Labellisés INCa Phases Précoces » created by the National Cancer Institute (INCa) throughout France since 2010. This accreditation was renewed in 2015 and 2019. Its main objectives are:
- To facilitate the availability of new drugs for patients
- To strengthen the visibility and attractiveness of the French clinical research
- To improve the quality of early phases trials
- To promote academic research by evaluating drugs in rare indications
Certification ISO 9001
Since 2017, the CIC-1427 (Saint Louis Hospital), is committed to the ISO9001_V2015 certification process, by:
- Providing training in quality management for two members of his team at AFNOR (Association Française de Normalisation), with the support of INSERM (Institut National de la Santé et de la Recherche Médicale).
- Developing a quality unit which aimed at:
- Fostering the mindset of continuous improvement of the team
- Moving from a “curative” management mode to a preventive one
- Process monitoring and follow-up through risk management
- Implementing analysis tools:
- Performance dashboards
- SWOT Analysis (Strengths, Weaknesses, Opportunities and Threats) for planning
- FMECA methodology (Failure Modes, Effects and Criticality Analysis), which is used to chart the probability of failure modes against the severity of their consequences.
- Deming cycle (PDCA: plan-do-check-act), for driving Projects forward, with SMART objectives and precise indicators
All these tools have enabled us to continuously improve our processes and organization.
The CIC of Bichat Hospital will soon also obtain the ISO9001 certification. The accreditation process is ongoing.
Research
PHRC, PRTK, PLBIO, PRIME, ANR, CLIIP, AAP ARC, ligue contre le cancer, FRM, GEFLUC, PAIR :
- 5 PHRC (KADIG 01, ACTIW, UCPVax, UCPVax-Cohorte Glioblastome, PICASSO)
- 1 CLIP (METIMGAST)
FHU, SIRIC, RHU, IHU: IHU Thema (Hematology)
Basic science:
- U830 INSERM, Bichat
- UMRS1131 Inserm, Saint-Louis, IRSL
Education
- Pr. JJ. Kiladjian is the coordinator of a first year of Master’s degree named « Preclinical and clinical pharmacology » at Université Paris Cité.
- Dr. Z. Ghrieb is responsible for pharmacy students (in the 5th year, Université Paris IV), as part of their industry research internship (with a dissertation in the end). She is also in charge of trainees during 6 months to validate their CRA (Clinical Research Associates) training (Meddiaxe, Clinact, Université De Vinci, DUFARC, etc.), and of work-study students “Alternants” of the Master 2 “Coordinateurs d’études dans le domaine de la santé”, during a year.
- Pr. X.M. Duval is in charge of a DIU (Diplôme Inter-Universitaire) dedicated to the training of CRAs (Clinical Research Associates) and nurses working in clinical research.
- Pr. G. Zalcman is professor in the national training “INVEST” for clinical research investigators in thoracic oncology (of the IFCT – Intergroupe Francophone de Cancérologie Thoracique) and in the national training “ARTEC” for Clinical Research Associates of Cooperating groups in oncology (GCO – Groupes Coopérateurs en Cancérologie).
- Dr. V. Gounant coordinates the national training “INVEST”. In the context of the Université Paris Cité, she is in charge of the training of the residents (consent process) and general practitioners in clinical research.
- Dr. I. Madelaine is in charge of training oncology pharmacists in clinical research.Find out more about training at CIC 1427 – Saint Louis Hospital: https://www.youtube.com/watch?v=P7SY3iw7sGA