Safety Pharmacology Society Webinar: An FDA and EMA Perspective: Combined Safety Pharmacology and Toxicology Studies Simon Authier, DVM, MBA, PhD Director - Safety Pharmacology and Veterinary Science CIToxLAB North America Agenda     Introduction Relevant results from an Industry Survey Upcoming SPS Events Expert panel presentations – –   EMEA’s perspective: Beatriz Silva Lima FDA’s perspective: Donald N. Jensen Open discussions Closing remarks Introduction  Safety Pharmacology in Toxicology Studies: A Long Debate Topic… – Luft J, Bode G. Integration of safety pharmacology endpoints into toxicology studies. Fundam Clin Pharmacol. 2002,16(2):91-103. – Japanese Safety Pharmacology Society 2010 – 3 SPS webinars (Respiratory, CNS and Cardiovascular) in 2012 Industry Survey Results Total of 361 participants… and 118 participants with no prior experience at including Safety Pharmacology into Toxicology studies Have you had experience in designing, performing or interpreting the safety pharmacology component of a study when performed as part of a toxicology study? 32.8% Yes 67.2% No Industry Survey Results The majority of participants had never submitted Safety Pharmacology data obtained in Toxicology studies to Regulatory Agencies Have you submitted data to a regulatory agency where your S7 studies have been performed as part of a toxicology study rather than stand alone? 42.0% 58.0% Yes No Safety pharmacology in toxicology represents a risk during regulatory submission as it is not an industry standard 140 Sensitivity of safety pharmacology in toxicology is insufficient to provide an acceptable assessment in most programs 160 Assignment of safety pharmacology expert technical staff to conduct investigations in toxicology studies is problematic 200 Safety pharmacology investigations in toxicology studies could have significant interferences on toxicology endpoints and parameters. 180 Interferences on functional safety pharmacology endpoints by toxicology related activities in the room are unavoidable Based on your experience, which of the following do you consider a meaningful disadvantage of adding S7 safety pharmacology endpoints onto regulatory toxicology studies: Industry Survey Results Total of 361 participants… and 118 participants with no experience including Safety Pharmacology into Toxicology studies 120 100 80 Very important disadvantage 60 Important disadvantage 40 Modest disadvantage 20 0 Not a disadvantage 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 A Safety Pharmacology Accreditation Program Various Accreditations are available in Toxicology (DABT and ERT) The Safety Pharmacology Society will launch a Certification specific to our field: The Diplomate of Safety Pharmacology Society: DSPS First Accreditation Examination at the SPS Annual Meeting 2013 in Rotterdam Information on the DSPS Accreditation program will be available on the SPS website Scope of the Accreditation Process to take and maintain the DSPS accreditation 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 at the SPS Annual Meeting 2013 in Rotterdam Information on the DSPS program will be on the SPS website in Spring 2013 - Scope of the Accreditation (scientific areas and literature references) - Process to take and maintain the DSPS Accreditation Diplomate of Safety Pharmacology Society        Regulatory guidelines (10%) Cardiovascular safety pharmacology  Electrophysiology (20%)  Hemodynamy and contractility (10%) Neurological safety pharmacology  General neurological evaluations (15%)  Cross discipline knowledge (10%)  Drug abuse potential (2%) – Physiology  Seizure liabilities (3%) – Pharmacokinetics Respiratory safety pharmacology (15%) – Toxicology Renal safety pharmacology (5%) – Dosing formulation and Gastrointestinal safety pharmacology (5%) – Analytical methods Other systems and models (5%) – Immunology Meeting Announcement The 28th Annual Scientific Meeting of the British Society of Toxicological Pathology (BSTP) is being held in partnership with the Safety Pharmacology Society (SPS). The theme is: Theme: “Integrated cardiovascular risk assessment from functional and pathological data” November 14th and 15th 2013 Alderley Park Conference Centre, Cheshire, UK Refer to BSTP website: http://www.bstp.org.uk/content/bstp-28th-annual-scientific-meetingincluding-annual-general-meeting (More details to follow in due course.) Slides of expert panel members