36th EPF Annual Conference
Illusions - Illusions - Illusionen
22nd-26th March 2023 – Cannes, France
Registration early bird deadline: 1st February 2023
Venue and hotel
Palais des Festivals et des Congrès
1 Boulevard de la Croisette
06400 Cannes
France
Your arrival:
- Plane: Nice Côte d’Azur Airport (NCE) or Cannes-Mandelieu Airport (CEQ)
- Car: A8 motorway “La Provençale”, exit 42 “La Bocca” or exit 40 “Cannes”
- Train: “Cannes” train station
Host:
European Psychoanalytical Federation
Rue Gérard 35, 1040 Etterbeek (Belgium),
epf-conference@csihamburg.de
Unless otherwise stated in the programme, all sessions will be held in English.
Important note on Covid Regulations in France
Find COVID information regarding traveling to France on Coronavirus – Advice for Foreign Nationals in France – Ministry for Europe and Foreign Affairs (diplomatie.gouv.fr). Please always check the latest updates yourself.
Programme
The main conference at a glance (PDF)
You will receive a full printed programme on site at the conference.
Day 1: Monday 13 March 2023
Minimal non-clinical safety package to support the first dose in human
09:00 – 09:15
Coordinator: Henri Caplain, Clinical Pharmacologist, Senior Advisor in Early Clinical Development, Translational Pharmacology, and Drug Safety Risk Management, President AFPT-Le Club Phase 1
09:15 – 11:15
Learning objectives: To provide an understanding/knowledge of general and reproductive toxicology evaluation supporting the first dose in human.
Key concepts: Design of general and reproductive toxicology studies; Dose and species selection; Safety ratio/safety margin; No Observed Effect Level/No Observed Adverse Event Level (NOAEL); Lowest Observed Adverse Effect Level (LOAEL); Maximal Tolerated Dose (MTD); Maximum Feasible Dose (MFD); Limit doses/exposures in repeated -dose toxicity studies; Target organs; Relevance of animal models, including target expression, pharmacodynamics, metabolism and PK aspects, and off-target binding activities and receptor/ligand occupancy and kinetics; Micro-dosing and sub-therapeutic dose concepts and limitations; Juvenile animal testing; Duration of studies to support clinical trials and marketing approval.
Speaker: Philippe Detilleux, Global Head, Preclinical safety, Sanofi R&D
11:15 – 11:30
Coffee Break
11:30 – 13:00
Learning objectives: To provide an understanding/knowledge of pharmacodynamic and safety pharmacology evaluation supporting the first dose in human.
Key concepts: Primary pharmacodynamic studies (in vitro and/or in vivo); Design of safety pharmacology studies; Core battery systems; Assessment of effects on cardiovascular, respiratory and central nervous systems (CNS); Supplemental and follow-up safety pharmacology studies; Secondary organ systems of interest; Use of in silico, animal- and cell-based models of disease mechanisms to study the pharmacology of a new drug.
Speaker: Stephanie Plassman, Specialist in Veterinary Pharmacology and Toxicology, AGAH Regent
13:00 – 14:00
Lunch
14:00 – 16:00
Learning objectives: To provide an understanding/knowledge of nonclinical pharmacology and pharmacokinetic evaluation supporting the first dose in human and PK/PD modelling to bridge nonclinical and safety endpoints.
Key concepts: Assessment of the mode of action/effects of candidate compound on the target; Absorption/distribution/ metabolism and excretion (ADME) assessment; Toxicokinetic evaluation; Half-life, Cmax, systemic exposure (AUC), in vitro metabolic and plasma protein binding for animals and humans, clearance, volume of distribution, intrinsic and extrinsic factors which affect the PK; PK linearity/non-linearity/ Dose-proportionality; Steady-state; Accumulation factors; Metabolites assessment (animals and nonclinical characterization for humans); Pharmacogenetics/polymorphisms/ Pharmacometrics/PK/PD modelling.
Speaker: Jeremy Perrier, PBPK scientist, PhinC Development
16:00 – 16:15
Coffee Break
16:15 – 18:15
Learning objectives: To provide an understanding/knowledge of on- and off-target evaluation before the first use in human.
Key concepts: On- and off-target binding affinities; Receptor/ligand occupancy and kinetics.
Speaker: Friedemann Schmidt, Computational / Systems Toxicologist, Sanofi R&D and Technical University Darmstadt
18:15
Adjourn
Day 2: Tuesday 14 March 2023
Minimal non-clinical safety package to support the first dose in human and principles of risk assessment from non-clinical safety package
09:00 – 10:30
Learning objectives: To provide an understanding/knowledge of evaluation of potential immunotoxicity.
Key concepts: Standard toxicity studies; Study design to assess drug-induced immunotoxicity; Selection of assays; Potential immunotoxicity linked to the pharmacological properties, intended patient population, structural similarity, disposition of the drug.
Speaker: Pr. Marc Pallardy, Dean Faculty of Pharmacy and Director of Interdisciplinary Action “Health and Therapeutic Innovation” Paris-Saclay University
10:30 – 10:45
Coffee Break
10:45 – 12:15
Learning objectives: To provide an understanding/knowledge of nonclinical package require before the first use in human of gene therapy medicinal product.
Key concepts: Pharmacodynamic “proof of concept” in nonclinical model(s); Biodistribution; Studies to establish dose; Toxicity studies for the whole gene therapy medicinal product (virus or other micro-organism or vector particle and/or delivery system + expression vector including cassette + transgene; Integration studies; Germline transmission; Target tissue selectivity; Immunogenicity and immunotoxicity; Delivery devices and excipients; Environmental risk/shedding.
Speaker: Philippe Detilleux, Global Head, Preclinical safety, Sanofi R&D
12:15 – 13:15
Lunch
13:15 – 14:15
Learning objectives: To provide an understanding/knowledge of genotoxicity evaluation supporting the first dose in human and potential genotoxic impurities.
Key concepts: Design of genotoxicity assessment; In vitro and in vivo testing; Genotoxic impurities and threshold of toxicological concern (TTC).
Speaker: Guy Bouvier, Toxicology and Product Safety Director, Pierre-Fabre Laboratories
14:15 – 15:15
Learning objectives: To provide an understanding/knowledge of photosafety testing before the first use in human.
Key concepts: Phototoxicity; Photoallergy; Photogenotoxicity; Photocarcinogenicity; Need for photosafety testing before first in human study; Phototoxicity testing.
Speaker: Béatrice Gauthier, Veterinary Pathologist Expert, Sanofi R&D
15:15 – 16:15
Learning objectives: To provide an understanding/knowledge of nonclinical local tolerance evaluation.
Key concepts: Design and need of local tolerance studies; Sensitizing potential; Oral, ocular, cutaneous tolerance testing; Transdermal systems; parenteral tolerance testing; Rectal and vaginal tolerance testing.
Speaker: Béatrice Gauthier, Veterinary Pathologist Expert, Sanofi R&D
16:15 – 16:30
Coffee Break
16:30 – 18:30
Learning objectives: To provide the principles behind the principal of risk assessment from nonclinical studies.
Key concepts: Importance of toxicokinetic; Risk factors/Safety factor; PK linearity/nonlinearity/dose proportionality/accumulation; Variable bioavailability; Steep dose response curve; Severe toxicities; Non-monitorable toxicities; Reversible/Irreversible toxicities; Toxicities without premonitory signs; Long-lasting binding and effects; Nature of the target and novel therapeutic targets; Differences and similarities between the pharmacology and toxicology of compounds and their metabolites in animals, humans, and cell preparations that provide qualitative and quantitative assessment: genotoxicity, general toxicity, toxicokinetics, pharmacokinetics, drug metabolism, safety pharmacology, immunotoxicity, reproductive toxicity, carcinogenicity; Relevance of nonclinical findings in various organ systems (liver, CNS, endocrine, eye, kidney, reproductive and gastrointestinal tract); Extrapolation of animal findings to human; Differences in nonclinical safety and toxicity packages between small molecules, biological medicines, advanced therapies.
Speaker: Nigel Roome, Toxicology and Toxicologic Pathology Senior Consultant
18:30
Adjourn
Day 3: Wednesday 15 March 2023
Safety in human pharmacology trials
09:00 – 10:30
Learning objectives: To provide an understanding/knowledge of how to perform a safe first-in-human study.
Key concepts: How to read and understand the safety concerns in the first Investigators Brochure (IBs) and its maintenance; General principles of first-in-human studies, including overall design; Estimating the first safe dose in a first-in-human trial, including the concepts of Human Equivalent Dose (HED), Maximum Recommended Starting Dose (MRSD), NOAEL-based approach, Minimal Anticipated Biological Effect (MABEL), Minimum Effective Dose (MED), Pharmacological Active Dose (PAD); Allometric scaling; Sequence and interval between dosing of subjects within the same cohort, concept of sentinel subjects; Safe dose escalation scheme and last dose, including the Anticipated Therapeutic Dose Range (ATD); Minimal clinical evaluations and evaluations depending on the nonclinical findings, including the intensity and duration of monitoring; Safety biomarkers; Stopping rules; How to proceed from single ascending dose to multiple ascending dose – assessment evaluation of SAD safety and PK data, integrated protocols versus consecutive trials (pros, cons and operations); Maximum duration of treatment; Decision making group or safety review committee; Identification of protocol violations and deviations; Safety data: tables and graphs for the evaluation of adverse events, laboratory data and other data related to safety; PD data: tables and graphs for the evaluation of pharmacodynamic.
Speaker: Yves Donazzolo, Principal Investigator Optimed/Eurofins, AFPT-Le Club Phase 1, Past-President EUFEMED
10:30 – 10:45
Coffee Break
10:45 – 11:45
Learning objectives: To provide an understanding/knowledge of how to perform a safe first-in-human study.
Key concepts: How to read and understand the safety concerns in the first Investigators Brochure (IBs) and its maintenance; General principles of first-in-human studies, including overall design; Estimating the first safe dose in a first-in-human trial, including the concepts of Human Equivalent Dose (HED), Maximum Recommended Starting Dose (MRSD), NOAEL-based approach, Minimal Anticipated Biological Effect (MABEL), Minimum Effective Dose (MED), Pharmacological Active Dose (PAD); Allometric scaling; Sequence and interval between dosing of subjects within the same cohort, concept of sentinel subjects; Safe dose escalation scheme and last dose, including the Anticipated Therapeutic Dose Range (ATD); Minimal clinical evaluations and evaluations depending on the nonclinical findings, including the intensity and duration of monitoring; Safety biomarkers; Stopping rules; How to proceed from single ascending dose to multiple ascending dose – assessment evaluation of SAD safety and PK data, integrated protocols versus consecutive trials (pros, cons and operations); Maximum duration of treatment; Decision making group or safety review committee; Identification of protocol violations and deviations; Safety data: tables and graphs for the evaluation of adverse events, laboratory data and other data related to safety; PD data: tables and graphs for the evaluation of pharmacodynamic data.
Speaker: Yves Donazzolo, Principal Investigator Optimed/Eurofins, AFPT-Le Club Phase 1, Past-President EUFEMED
11:45 – 12:30
Learning objectives: To provide the principles of the management of medical emergencies in human pharmacology trials.
Key concepts: Pre-trial interviews and screening procedures; Up-to-date resuscitation procedures and guidelines; Diagnosis and management of anaphylaxis and other severe allergic phenomena, cardiac arrhythmias, respiratory emergencies, syncope, convulsions and other neurotoxicity.
Speaker: Yves Donazzolo, Practitioner Emergency Department, Grenoble University Hospital, AFPT-Le Club Phase 1, Past-President EUFEMED
12:30 – 13:30
Lunch
13:30 – 14:30
Learning objectives: To provide an understanding/knowledge of choice of study population for the first-in-human trial.
Key concepts: Healthy participants versus patients; Inclusion of special population including women, children, elderly, ethnicity, genotype(s), cultural differences, possible interaction with subject’s lifestyle, e.g. smoking, use of alcohol or drugs; Use of other medications with the possibility for adverse reactions and/or difficulties in the interpretation of results; Safety criteria of inclusion and exclusion; How to exclude participants with drug abuse and drug dependence; Protection of research participants; Sponsor and investigator responsibilities in context of trial participants, in particular, to avoid conflicts of interest.
Speaker: Lionel Hovsepian, Clinical Pharmacologist, Early development expert, AFPT-Le Club Phase 1
14:30 – 14:45
Coffee Break
14:45 – 16:30
Learning objectives: To provide an understanding/knowledge of first-in-human oncology trials.
Key concepts: Trials design, including traditional 3+3 design, Continual Reassessment Method (CRM), Dose Escalation with Overdose Control (EWOC) and other Bayesian approaches; Phase I trials of Agent Combinations; First dose; Dose escalation; Stopping rules; Grading of adverse events including the ‘Common Terminology Criteria for Adverse Events’ (CTCAE) descriptive terminology; Maximal Tolerated Dose (MTD; Dose limiting toxicities (DLTs); Data safety monitoring board (DSMB).
Speaker: Pr. Christophe Massard, Medical Oncologist, Centre Eugene Marquis Rennes
16:30 – 18:30
Learning objectives: To provide an understanding about the timing and safety implications of other Phase I trials, how to assess safety findings and individual exposure and an understanding/knowledge of the integrated cardiac safety.
Key concepts: Safe food effect trial; Bioequivalence study; Drug-drug interactions to be performed in Phase I of clinical development; Patients with renal or hepatic impairment; Design and timing of TQT study; Integrated cardiac safety concept.
Speaker: Denis Gossen, Clinical Pharmacologist, AFPT-Le Club Phase 1
18:30
Adjourn
Day 4: Thursday 16 March 2023
Pharmacovigilance in human pharmacology trials
09:00 – 10:30
Learning objectives: To provide an understanding/knowledge of AEs/ADRs evaluation and reporting.
Key concepts: Role of the pharmaceutical professional in drug safety and pharmacovigilance; Methodology for collection in clinical trials, including reporting; Mechanisms of AEs/ADRs/safety risks; Assessment and classification of adverse events (AEs), adverse drug reactions (ADRs), serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), adverse events of special interests (AESIs);.MedDRA coding and classification; Medical aspects of AEs/ADRs, including principles of event attribution, evidence for association and causality, expectedness and seriousness assessments; The extent of variation in normality.
Speaker: Hervé Bester, VP Global Patient Safety – Rare Diseases Therapeutic Area Head, Ipsen
10:30 – 10:45
Coffee Break
10:45 – 12:15
Learning objectives: To provide an understanding/knowledge of.AEs/ADRs evaluation and reporting.
Key concepts: Role of the pharmaceutical professional in drug safety and pharmacovigilance; Methodology for collection in clinical trials, including reporting; Mechanisms of AEs/ADRs/safety risks; Assessment and classification of adverse events (AEs), adverse drug reactions (ADRs), serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), adverse events of special interests (AESIs);.Medical aspects of AEs/ADRs, including principles of event attribution, evidence for association and causality, expectedness and seriousness assessments; The extent of variation in normality.
Speaker: Hervé Bester, VP Global Patient Safety – Rare Diseases Therapeutic Area Head, Ipsen
12:15 – 13:15
Lunch
13:15 – 14:45
Learning objectives: To illustrate the potential safety impact of AEs/ADRs.
Key concepts: General tolerability; Tolerance; Liver/renal toxicity, including drug-induced liver injury (DILI); CNS toxicity; Cardiac toxicity, including pro-arrhythmogenic risk; Immune toxicity, including cytokine release syndrome (CRS); Other system or local toxicities of concern; Monitoring of vital signs; What happens in case of pregnancy during a trial; Predisposing factors and the impact of pre-existing disease on the susceptibility for and severity of adverse events.
Speaker: Henri Caplain, Clinical Pharmacologist, Senior Adviser in Early Clinical Development, Translational Pharmacology, and Drug Safety Risk Management, President AFPT-Le Club Phase 1
14:45 – 15:00
Coffee Break
15:00 – 16:30
Learning objectives: To provide an understanding/knowledge of how read and fill a development safety update report after the first Phase I clinical trials.
Key concepts: Rational for writing DSURs; ICH E2F and CIOMS V; Assessment process; DSUR outcomes; Compliance; Benefit/risk balance assessment concept.
Case study(ies)
Speaker: Henri Caplain, Clinical Pharmacologist, Senior Adviser in Early Clinical Development, Translational Pharmacology, and Drug Safety Risk Management, President AFPT-Le Club Phase 1
16:30 – 18:30
Learning objectives: To provide the principles of the risk management plan in early drug development.
Key concepts: Risk concept; Crisis management; Impact of AE on drug development and further trials; Risk management plan and planning; Risk evaluation and mitigation strategy; Safety specifications; Important identified and potential risks, missing information; Risk assessment; Risk minimization activities; Risk communication; Effectiveness of risk minimization; DRMP/DSUR progression during drug development; How to fill a risk management plan prior to the CTA/IND.
Case study(ies)
Speaker: Henri Caplain, Clinical Pharmacology, Senior Adviser in Early Clinical Development, Translational Pharmacology, and Drug Safety Risk Management, President AFPT-Le Club Phase 1
18:30
Adjourn
Day 5: Friday 17 March 2023
Management of medical emergencies in human pharmacology trials and exam
09:00 – 10:30
Work by sub-group on a case study
Facilitator: Henri Caplain, Clinical Pharmacology, Senior Adviser in Early Clinical Development, Translational Pharmacology, and Drug Safety Risk Management, President AFPT-Le Club Phase 1
10:30 – 10:45
Coffee Break
10:45 – 12:30
End and reporting
Facilitator: Henri Caplain, Clinical Pharmacology, Senior Adviser in Early Clinical Development, Translational Pharmacology, and Drug Safety Risk Management, President AFPT-Le Club Phase 1
12-30 – 13:00
- Facilitator: Henri Caplain, Clinical Pharmacology, Senior Adviser in Early Clinical Development, Translational Pharmacology, and Drug Safety Risk Management, President AFPT-Le Club Phase 1
13:00 – 14:00
Lunch
14:00 – 16:00
- Selection of multiple-choice questions (1 hour): 60 % of questions must be correctly answered to pass test and receive a certificate.
- Short questions (4 of 15 minutes each): 10/20 must be obtained to pass test and receive a certificate
16:00
End of the training
16:30 – 18:30
Learning objectives: To provide an understanding about the timing and safety implications of other Phase I trials, how to assess safety findings and individual exposure and an understanding/knowledge of the integrated cardiac safety.
Key concepts: Safe food effect trial; Bioequivalence study; Drug-drug interactions to be performed in Phase I of clinical development; Patients with renal or hepatic impairment; Design and timing of TQT study; Integrated cardiac safety concept.
Speaker: Denis Gossen, Clinical Pharmacologist, AFPT-Le Club Phase 1
Attendance fees
395,00 €*
Member of an EPF-Society / IPA member
100,00 €
475,00 €*
195,00 €*
50,00 €
50,00 €
Students
* ‘Early bird‘ discount, available until 1st February 2023
Contact and further information
Organiser and responsible for the programme
European Psychoanalytical Federation
Rue Gérard
351040 Etterbeek
Belgium
PCO – Professional Conference Organiser
CSi Hamburg GmbH Goernestraße 30 20249 Hamburg Germany