Conference on Analgesic Trials
The cost for APS CAT is $100. Preregistration is required.
As a follow up to 2016’s first annual APS Conference on Analgesic Trials (APS-CAT), APS will present the second annual APS-CAT on May 17, 2017. This event will be chaired and moderated by Neil Singla, MD, APS Clinical Trials special interest group chair and chief scientific officer of Lotus Clinical Research.
APS-CAT is a full-day conference focused on optimizing the design and conduct of analgesic clinical trials. APS-CAT 2016 had 200 pain research professionals in attendance and featured expert presentations as well as Q & A with an eight-member panel. Audience feedback was overwhelmingly positive.
APS-CAT 2017 presenters include:
Lars Arendt-Nielsen, MD PhD
Center for Sensory-Motor Interaction (SMI)
Department of Health Science and Technology, School of Medicine, Aalborg University
Translational, Quantitative, Healthy Volunteer Pain Models of Pain and Sensitization
Early proof-of-concept studies utilizing human experimental pain bio-markers may help profiling new analgesic or anti-inflammatory compounds and determine adequate doses. The challenge is to translate the animal experimental data on analgesic efficacy into a meaningful clinical context. The translation of animal data into humans and further into patients is problematic but a set of experimental human pain bio-markers have been developed helping this transition. The application of experimental pain stimuli to healthy volunteers can be performed under normal conditions, but also under semi-pathophysiological conditions where peripheral or central sensitization can been imposed experimentally. This area of human experimental pain research has advanced significantly over the last 20 years and is now a valuable tool in early drug development.
Human volunteer models may act as proxies for clinical conditions/symptoms and hence be used as surrogate models help predicting which patient population or pain mechanism will respond to the compound. Experimental pain bio-markers can tease out mechanistically which pain pathways and mechanisms are modulated by a given compound. Predictive human volunteer pain models and adequate derived bio-markers mimicking different conditions (e.g. inflammatory, neuropathic, musculoskeletal, visceral) and symptoms (e.g. hyperalgesia, allodynia, after-sensation) may optimize drug development and make Phase II and III studies much more cost effective.
The bio-markers derived from experimental models can be psychophysical, electrophysiological, imaging or bio-chemical. The psychophysical markers can be e.g. pain thresholds, threshold tracking, or stimulus response functions. Selected bio-markers can then be used to probe the effect a given compounds on particular mechanisms such as temporal summation, generalized hyperalgesia, long term potentiation, spread of pain, referred pain, or descending conditioning pain modulation (CPM).
The multi-modal, multi-tissue pain assessment paradigm for profile compounds can predict which patient population e.g. visceral pain should be selected for later clinical trials. More and more studies indicated the advantage of including experimental pain bio-markers in clinical phase I, II and III studies as they often are more sensitive than simple clinical pain measures and provide a valuable mechanistic understanding of the drug action.
Sharon Hertz, MD
Director, FDA Division of Anesthesia, Analgesia, and Addiction Products
Laurie Burke, MD
Founder, LORA Group
Former Director, FDA Study Endpoints and Labeling Development (SEALD) Team
Getting the Claims You Want: Optimizing Your Study Endpoints and Labeling
Nathaniel Katz, MD
President, Analgesic Solutions
What Can Be Done About the Placebo Response in Clinical Trials: A Review of the Evidence
- A review of interventions designed to reduce the placebo response and their results
- A review of accuracy of pain reporting and its relationship to interoceptive accuracy and the placebo response
- Recommendations on addressing the placebo response in clinical trials
Bob Rappaport, MD
Founder, Analgesic Concepts
Former Director, FDA Division of Anesthesia, Analgesia, and Addiction Products
Getting the Indication You Want: Selecting an Appropriate Analgesic Model
Dr. Rappaport will discuss the data that are needed to support the currently accepted indications for analgesic and anesthetic drug products, and comment on the challenges associated with understanding what data are necessary to support broad vs. narrow indications in some analgesic/anesthetic settings. Potential ways to better define appropriate standards will also be discussed.
Lee Simon, MD
Principal, SDG, LLC
Former Director, FDA Division of Analgesic, Anti-Inflammatory and Ophthalmologic Drug Products
Clinical Trial Design Considerations for Studies in Osteoarthritis
Osteoarthritis is one of the most common problems confronting most Western Societies and consumes a significant portion of the medical budgets of most countries around the world. Both progressive symptomatic and structural disease leads to both increased disability as well as increased mortality due either to therapy associated adverse events or to increased sedentary lives. The development of drugs to alter progression of the progressive disease is in the distant future; thus, the development of therapies to improve pain and function continue to be the mainstay of therapy. However, the studied patient populations are heterogeneous, the drugs are impressive only being adequate in alleviating pain, and it is unclear how short terms studies help to understand the chronic effects both in terms of durable efficacy as well as in terms of safety.
Neil Singla, MD
Chief Scientific Officer, Lotus Clinical Research
Opioid Sparing Endpoints: Trial Design, Clinical Relevance and Label Claims
APS-CAT features a panel format, with each presenter speaking for 30 minutes followed by 30 minutes of audience/panel Q & A.
The goals of this conference are:
- Gather world-renowned experts in clinical trials to convey and analyze current best practices.
- Disseminate the latest scientific and regulatory developments in topics of interest to the analgesic research industry.
- Discuss experimental methods that increase analgesic trial assay sensitivity.
- Involve audience members in dialogue with thought leaders in the field from regulatory bodies, industry, and academia.
- Convene at a familiar venue before the APS Annual Scientific Meeting to facilitate networking and future collaboration.
For questions or comments, please contact Clinical Trials SIG Chair Neil Singla, MD.