Safety Pharmacology Society Webinar: Simon Authier, DVM, MBA, PhD Director - Safety Pharmacology and Veterinary Science CIToxLAB North America
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1 Safety Pharmacology Society Webinar: Simon Authier, DVM, MBA, PhD Director - Safety Pharmacology and Veterinary Science CIToxLAB North America
2 Agenda Introduction GI presentation rescheduled Upcoming SPS Event DSPS Accreditation Program Expert presentation: Thomas J Hudzik, Ph.D. Real-time survey Open discussions Closing remarks
3 Introduction FDA Draft Guidance for Industry Assessment of Abuse Potential of Drugs UCM pdf (Published January 27, 2010)
4 Introduction Drug abuse is the non-medical use of a prescription drug most of the time for positive subjective effects Clinically relevant dose levels are not applicable Drug dependence is the need to continue taking a drug to avoid withdrawal effects (e.g. SSRI)
5 Introduction Drug development industry aims to identify abuse potential as early as possible Commercial impact of drug scheduling (limited prescription) Drug abuse may apply to small molecules/chemicals or biotherapeutics When should an «abuse package» be submitted? If the drug affects the CNS, is chemically or pharmacologically similar to other drugs with known abuse potential, or produces psychoactive effects such as sedation, euphoria, and mood changes.(fda Guidance document)
6 Introduction Drug abuse liability studies are usually recognized for relatively high predictivity to the human response compared to other non-clinical models but there remains several challenges in the field A variety of pharmacological, regulatory and medical considerations need to be evaluated and the approach should be tailored to each drug candidate All drug candidates with CNS effect (intentional or not), will need to be evaluated for drug abuse potential
7 Introduction Several source of non-clinical abuse data: Chemical analysis and structural similarities In vitro assays (e.g. receptor ligand and functional endpoints) PKPD profile in animal species (brain:plasma ratio) Animal behavioral and physiological evaluations (including toxicology studies) Non-clinical Abuse Potential Studies: Self-administration Drug discrimination Physical dependence and withdrawal
8 Introduction Safety pharmacology endpoints may increased sensitivity in detecting withdrawal signs with technologies such as telemetry that enables continuous monitoring of parameters such as: Heart rate Arterial pressures Respiratory rate Body temperature Activity level
9 A Glance at an Interesting Scientific Program Reducing Safety Related Attrition - Increasing Likelihood of Success: - Target Related Safety - Chemistry (molecule) & Off-target (selectivity) Related Safety - Novel Approaches to Safety Screening Expanding the Frontiers of Safety Pharmacology: - Support to Late Stage Drug Development (Phase II onwards) - Safety Assessment Evaluation of Nonconventional Therapeutic Modalities - Safety Pharmacology beyond Small Molecules -Best Practice Comparing Safety Pharmacology as stand alone to SP-endpoint inclusion in Toxicology Pharma, Regulators and Academia
10 Diplomate of Safety Pharmacology Society Various Accreditations are available in Toxicology (DABT and ERT) The Safety Pharmacology Society will launch a Certification specific to our field: Diplomate of Safety Pharmacology Society: DSPS First Accreditation Examination on September 15th, 2013 at the SPS Annual Meeting 2013 in Rotterdam Information on the DSPS program will be on the SPS website on May 30, Scope of the Accreditation (scientific areas and literature references) - Process to take and maintain the DSPS Accreditation
11 Diplomate of Safety Pharmacology Society Regulatory guidelines (10%) Cardiovascular safety pharmacology Electrophysiology (20%) Hemodynamy and contractility (10%) Neurological safety pharmacology General neurological evaluations (15%) Drug abuse potential (2%) Seizure liabilities (3%) Respiratory safety pharmacology (15%) Renal safety pharmacology (5%) Gastrointestinal safety pharmacology (5%) Other systems and models (5%) Cross discipline knowledge (10%) Physiology Pharmacokinetics Toxicology Dosing formulation and Analytical methods Immunology
12 Slides of expert panel members
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