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Pharma Biotech Consultants

 OUR PARTNERS

CHAD

The Center For Health Technology Assessment and Drug Research

Coimbra University, Portugual

We partner with CHAD, from AIBILI, Coimbra University,Portugual. The longstanding experience of CHAD allied with the clinical and industrial experience of Pharma Biotech Consultants will provide customers with a unique set of strategic pharmaco-economic evaluation services The Centre for Health Technology Assessment and Drug Research (CHAD) focus is on evaluation of medicines and other medicinal products for market access purposes, as it relates to financing and reimbursement, as well as pharmacovigilance . Together we will provide consultancy services to pharmaceutical companies for Health Technology Assessment, pricing and reimbursement (medicines and medical devices): a. Early advice, starting at Phase I, to develop a value strategy for market access. b. Supporting strategic value enhancements through expert panels and advisory boards. c. Identification of unmet medical needs for modelling clinical development and economic studies. d. Core value dossier elaboration. e. Core value dossier adaptation for different EU marketplaces. f. HTA, pricing and reimbursement submissions. For more information on CHAD, please visit http://www.aibili.pt/chad_about.php

Quinten

A company specialized in the analysis and valuation of data

Paris,  France

We partner with Quinten, a company specialized in the analysis and valuation of data. The partnership allows Pharma Biotech Consultants to support customers in making sound science-based business decisions The partnership with Quinten enables Pharma Biotech Consultants to generate new information from analyzing large databases (internal or external data). It permits to turn raw data into useful information and discover hidden patterns or relationships. The use of data mining techniques is one of the most exciting new areas in health care ! Examples of data mining Phase II to Phase III transition: through extensive analysis of available data, identify potential high-risk patients subgroups for specific monitoring, prognostic, predictive markers to allow patient enrichment/patient stratification strategies, etc... Drug rescue strategies: identify winning strategies for product filing or repurposing after trial failure or unconvincing results Optimization of the trial design identification of high vs low risk groups using simulation tools One of the most powerful features of data mining lies in building predictive models that can lead to relevant strategies and actionable decisions. For more information on Quinten, please visit www.quinten-france.com

Elistat

A company specialized in Statistics

Paris,  France

We partner with Elistat, a company specialized in Statistics. Lucile Awad is the head of Elistat. Lucile is a known statistician in the oncology community. She has tremendous experience in drug development covering various therapeutic areas. She has also numerous worldwide submissions under her belt with a lot of interactions with regulatory agencies. As responsible for a Biometrics department at RPR/Aventis/Sanofi, she has worked in Oncology, Cardiovascular, CNS, and Anti-Infective therapeutic areas. Her experience in oncology spans from phase I to phase III. She contributed to several oncology dossiers including CPT-11 metastatic colorectal cancer 1st line (FDA 2000) metastatic colorectal cancer 1st line (EMEA March 1999), metastatic colorectal 2nd line (FDA -1998), metastatic colorectal 2nd line (EMEA-1996) colorectal 2nd line (France, 1995), and Taxotere Breast cancer 2nd line (1993). CPT-11 FDA dossiers were prepared in collaboration with Pharmacia Upjohn. She has also led the development and registration of Enoxaparine (Lovenox) and of the anti- infective Oroken.
 Lucile has also performed statistical research on new developments of Patient–Related Outcomes, especially quality of life measurements applied to oncology. Lucile started as a researcher at INSERM (Unit 170, Villejuif-France) where she specialized in theory statistics on rare events and on epidemiology of asbestos and other toxic compounds such as lead and nitrates.