Safety Pharmacology Society Webinar: An FDA and EMA Perspective: Combined

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
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Introduction
Relevant results from an Industry Survey
Upcoming SPS Events
Expert panel presentations
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EMEA’s perspective: Beatriz Silva Lima
FDA’s perspective: Donald N. Jensen
Open discussions
Closing remarks
Introduction
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Safety Pharmacology in Toxicology Studies: A Long Debate Topic…
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Luft J, Bode G. Integration of safety pharmacology endpoints into
toxicology studies. Fundam Clin Pharmacol. 2002,16(2):91-103.
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Japanese Safety Pharmacology Society 2010
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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
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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