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Academic Training on Drug Development

A podcast presented by the Foundation For Rare Diseases with the participation and support of Sanofi Genzyme. Discover the TAmDeM podcast on all platforms

Are you a researcher or doctor, do you represent a research promotion organization or are you simply curious about the progress of science? Throughout the episodes, you will follow the development of a drug, from its creation in an academic laboratory to its marketing by an industrial company.

Interviewer: Dr. Christine Fetro
Dr. in Pharmacy, responsible for the valorization of research and industrial partnerships at the Foundation

Voice-over: Hervé Haubold
Podcast producer, STEREOLAB


Target validation and choice of indications

Link to the episode: https: //www.podcastics.com/podcast/episode/validation-des-cibles-et-choix-des-indications-116922/

Speaker: Dr. Souad Naimi
Global Head of the Center of Excellence for Molecular & Digital Histopathology at Sanofi's R&D Translational Sciences Unit.

Dr. Souâd NAIMI is the Global Head of the Center of Excellence for Molecular & Digital Histopathology at the Translational Sciences Unit of Sanofi R&D. Souâd NAIMI received her PhD from the University of Paris VII. Before joining the industry, she was an associate scientist at the Neuroplasticity and Therapy laboratory (INSERM U421 - Paris).


Target validation and choice of indications

The organelles (or organelles) are the elements contained in the cytoplasm of the cell. Lysosomes and mitochondria are two examples of organelles.

A cytoplasm is the internal part of the cell that contains the nucleus and other organelles.

The infusions are an anglicism for treatments delivered by infusion, such as enzyme replacement therapies indicated for certain rare diseases.

The substrate is the substance on which an enzyme acts to activate a biochemical reaction.

A biomarkerA biomarker is something that can be precisely measured in the human body to provide accurate information about the existence of a disease or the effectiveness of a drug. Accordingly, a translational biomarker refers to a newly identified biomarker in a patient from which researchers will try to develop a new therapy.

Proteomics is the science that studies all the proteins of an organism, a biological fluid, a tissue or a cell.

Cardiomyopathies refers to diseases of the heart muscle.

The Sanofi Innovation AwardsThe Sanofi Innovation Awards program, or Sanofi iAwards Europe, aims to promote scientific discoveries that could represent a major scientific breakthrough through the exchange of knowledge between Sanofi teams and the best academic scientific teams. It provides funding and support for one year for selected projects, potentially leading to new collaborations. The goal is to accelerate the research and development process and respond more quickly to patient needs. These efforts combine the new knowledge of academic institutions on disease biology with Sanofi's discovery and development capabilities. For more information: https: //www.sanofi.fr/fr/science-et-innovation/notre-recherche-et-developpement/les-sanofi-iawards-un-tremplin-pour-la-recherche

A neo-antigen is an antigen that is not normally expressed in the body; an example is tumor-induced antigen

Risk assessment and anticipation

Link to the episode: https: //www.podcastics.com/podcast/episode/lenjeu-de-la-toxicologie-dans-le-developpement-clinique-dun-medicament-121937/

Speaker : Dr Philippe Detilleux

Global Head, Preclinical Safety, Sanofi R&Ds

Dr. Detilleux graduated in Veterinary Medicine from the University of Liège in Belgium and obtained a Master's and a PhD in Veterinary Pathology from Iowa State University, Ames, Iowa, USA. He has more than 30 years of experience in the pharmaceutical industry, first as a Toxicological Pathologist and then as head of departments in charge of preclinical drug safety evaluation. He is currently responsible for the worldwide Preclinical Safety department of Sanofi R&D. Philippe Detilleux is a Diplomate of the American College of Veterinary Pathologists (ACVP), an active member of various professional associations in Toxicology and Toxicological Pathology and participates in various courses in preclinical development of health products. Within the framework of the European public/private partnership IMI (Innovative Medicine Initiative), he chairs the Strategic Governance Group (SGG) within EFPIA, which is responsible for promoting projects in the field of Translational Safety.


Risk assessment and anticipation

Toxicology is the step in the development of a drug candidate that aims to identify the potential target organs and the toxic doses for the organism of the future drug.

Thrombosis is the formation of a blood clot (thrombus) within the venous network (venous thrombosis) or the arterial network (arterial thrombosis).

Prostaglandins are substances derived from a fatty acid. They are present in many tissues of the body and are involved in many biological processes (contraction of the uterus, inflammation, blood coagulation, etc.).

The Off Target applies to all unintended effects of a drug candidate.

The DNA is the acronym for DNA.

A mutagen is a drug candidate that has the effect of modifying the genome.

Monoclonal antibodies are antibodies that are artificially produced by a cell clone (a group of identical cells derived from a single mother cell) and used for therapeutic or diagnostic purposes.

Clinical trials

Link to the episode: https: //www.podcastics.com/podcast/episode/les-essais-cliniques-124785/

Speaker : Dr Véronique Schneider
Medical Director France of Sanofi Genzyme

Dr. Véronique Schneider is a physician who has spent her entire career in the pharmaceutical industry; she has been working on rare diseases for the past 10 years.


Clinical trials

Pharmacokinetics: it traces the path of the active substance of a drug in the body, namely Absorption, Distribution, Metabolism and Excretion (ADME).

Real-life data: these describe the use of a drug in the patient's daily life and not in a controlled environment as in clinical trials.

MA: "Marketing Authorization", this authorization is issued by a competent European or national authority (Agence Nationale de Sécurité du Médicament et des Produits de Santé -ANSM, European Medicines Agency - EMA) and must be obtained for each drug or each new use of an existing drug before it is marketed. Its issuance is based on the results of phase 1, 2 and 3 clinical trials conducted by the pharmaceutical company. It should be noted that for an orphan drug (i.e., one intended for the treatment of a rare disease), the MA is centralized, which means that it is valid for the entire European Union.

Early access file: this is a specific system that allows patients with a therapeutic impasse, such as those suffering from rare diseases, to benefit, on an exceptional and temporary basis, from drugs that do not yet have marketing authorization.

Pharmacovigilance: its purpose is to monitor drugs and prevent any risk of adverse effects resulting from their use (whether this risk is proven or potential). The monitoring of drugs is guaranteed throughout the life of the drug.

Access to the market

Link to the episode: https: //www.podcastics.com/podcast/tamdem/

Speaker : Martine Bruyninckx
Director of market access for rare diseases and multiple sclerosis, Sanofi Aventis France

- Doctor of Pharmacy, holder of a DESS in Health Law and a certificate in Health Economics of Pharmaceuticals (Sophia Antipolis)

- In the pharmaceutical industry since 1985 - international laboratories (Roche, Pharmacia, Genzyme and Sanofi) - where I have spent my entire career in various fields:

  • analytical and pharmacokinetic development ( 4 years)
  • regulatory affairs (19 years), including 10 years as Head Pharmacist
  • access to the market ( 21 years old)

Real-life data

Link to the episode: https: //www.podcastics.com/podcast/tamdem/

Speaker : Thomas Séjourné
Data Expansion lead - Global Digital RWE

Passionate about health data, I have dedicated my expertise for more than 10 years to developing a better understanding of the pathways of patients suffering from rare diseases in order to provide them with better support in understanding their pathologies, faster access to an appropriate diagnosis and better management in collaboration with health professionals.


Real-life data

PMSI (Programme de Médicalisation des Systèmes d'Information): collects data on all hospitalizations in France for the purpose of financing health care institutions and organizing the health care system.

SNIIRAM (Système national d'information inter-régimes de l'Assurance maladie): an anonymous French database containing information from reimbursements made by all health insurance schemes for care in the private sector.

CNIL (Commission Nationale de l'Informatique et des Libertés): responsible for ensuring the protection of personal data contained in computer files and processing or paper, both public and private.

Health Data Hub: also known as the Health Data Platform (HDP), a platform designed to facilitate the sharing of health data from a wide variety of sources to support research.

Podcast produced with STEREOLAB
Web : https://www.stereolab.fr
Mail : hello@stereolab.fr