27-28 September, 2018

Boston, USA

Day One
Thursday, 27 September, 2018

Day Two
Friday, 28 September, 2018

08.00
Registration & Breakfast

08.50
Chair’s Opening Remarks

Non-Addictive Opioid Based Therapeutics as a Catalyst for Better Pain R&D

09.00
Case Study:Opioid Crisis at a Glance from the R&D Perspective

  • Craig Hartrick President of World Institute of Pain; President & CSO , Caventure Drug Discovery, Inc.

Synopsis

  • The opioid crisis in the US and the global response
  • Pathophysiologic underpinnings contributing to the opioid crisis and chronic pain
  • Exploiting chronic pain pathophysiology in the development of non-addictive opioids

09.30
Case Study:Allosteric Modulators of Opioid Receptors: A Novel Approach to Safer Pain Therapeutics

  • Andrew Alt Director, Center for Chemical Genomics , University of Michigan

Synopsis

  • Positive Allosteric Modulators (PAMs) of opioid receptors block pain by amplifying the activity of endogenous opioid agonists which are naturally released in pain states
  • Opioid PAMs do not directly activate opioid receptors, and have no effect in tissues where agonists are not present
  • Therefore, opioid PAMs may exhibit significantly improved side effect and abuse liability profiles compared to current opioid medications
  • The current preclinical data supporting a rationale for developing opioid receptor PAMs as novel pain medications will be presented

10.00
Case Study:Targeting Imidazoline-2 Receptors In the Development of New Non-Opioid Analgesics and as a Safe, Non-Addictive Combination with Low-Dose Opioids

Synopsis

  • Case study of Imidazoline-2 receptor (I2R) ligands as potent, non-opioid analgesics
  • CR4056 is a first-in-class I2R ligand endowed with strong analgesic activity in animal
    models of inflammatory, neurogenic, neuropathic, post-surgical, fibromyalgia-like and
    osteoarthritis pain
  • A first proof-of-concept was obtained in human knee osteoarthritis pain and CR4056
    is currently in phase II clinical trials in different other pain indications
  • A strong non-clinical package shows that low-dose CR4056 combined with lowdose
    opioids provide full analgesia, with no opioid-addictive properties, absence of
    tolerance and without relevant side effects

10.30
Case Study:Beyond Mu: Novel Opioid Development

  • Craig Hartrick President of World Institute of Pain; President & CSO , Caventure Drug Discovery, Inc.

Synopsis

  • Opioid receptors in analgesia and addiction
  • Alternatives to mu-opioid agonists
  • Novel molecular entities designed to address alterations in pain pathways associated
    with chronic pain states

11.00
Speed Networking & Morning Refreshments

Highlighting Novel Pre-Clinical Approaches to Non-Opioid Pain Drug Developmentt

11.30
Case Study:Developing a first-in-class Peripheral Kappa Opioid Receptor Agonist for Pain and PONV

Synopsis

  • This presentation will discuss the novel mechanism and pharmacology of difelikefalin
  • Human Abuse Liability and Respiratory safety data will be discussed
  • Recent Phase 2/3 acute post-op pain/PONV data will be presented

12.00
Case Study:The Cannabinoid System as a Therapeutic Target for Pain

  • Alexandros Makriyannis Chemistry & Chemical Biology Director, The Center for Drug Discovery Northeastern University

Synopsis

  • Analgesic effects by CB1 activation
  • Neuropathic pain through CB2 activation
  • Analgesia by indirectly engaging the cannabinoid system

12.30
Case Study:Highly Selective A3AR Agonists as Novel Non-Narcotic Analgesics

  • Daniela Salvemini Professor of Pharmacological and Physiological Science , Saint Louis University

Synopsis

  • A3 adenosine receptor (A3AR) agonists as potent non-narcotic analgesics
  • A3AR agonists as adjunct to opioids to mitigate opioid-induced adverse effects
  • Mechanistic insights from the above

13.00
Networking Lunch

14.00
Case Study:Development of functional antibodies against human Nav1.7 to modulate pain

Synopsis

  • Mutation in the SCN9A gene which causes loss of function in the Nav1.7 channel causes
    Channelopathy Insensitive to Pain (CIP); consequently blocking the Nav1.7 channel
    represents a very strong target for drug development
  • Opioid tolerance and opioid induced hyperalgesia were substantially reversed after
    mesenchymal stem cell transplantation in animals
  • Strategies to develop functional monoclonal/single domain antibodies against human
    Nav1.7
  • Exploited CIP to develop antibodies against human Nav1.7 as novel analgesics

 

 

14.30
Case Study:ANAVEX®1066, a Sigma-1 Receptor Antagonist, as a Therapeutic Candidate for Pain

  • Daniel Klamer VP, Business Development & Scientific Strategy , Anavex Life Sciences Corp.

Synopsis

  • Strong scientific rational for the use of Sigma-1 Receptor antagonists in pain
  • ANAVEX®1066 have demonstrated efficacy in several different pain models
  • ANAVEX®1066 is safe in doses exceeding the observed efficacious ranges

15.00
Case Study:Selective Targeting of Sodium Channel Blockers into Nociceptors to Produce Analgesia

Synopsis

  • Broad spectrum Na channel blockers are effective analgesic agents but produce
    nonselective sensory, motor and autonomic block
  • Broad spectrum Na channel blockers also have limited duration of action limiting their
    use
  • Selective targeting of Na Channel blockers into specific sets of axons via activation
    of differentially expressed large-pore channels provides an opportunity to produce
    prolonged local analgesia

15.30
Afternoon Refreshments & Networking

Highlighting & Discussing Key Areas to Drive Successful Non-Opioid Pain Drug R&D

16.00
Case Study:CT-044: A Reactive Species Decomposition Accelerant (RSDAx) for the Treatment of Acute Incisional Pain and Chronic Diabetic Neuropathy

Synopsis

  • Reactive Species such as peroxynitrite and peroxide are formed as a consequence of
    injury (e.g., tissue damage) or disease (e.g., diabetes)
  • Downstream effects of peroxynitrite include hyper-excitation of sensory ion channels
    leading to pain
  • CT-044 removes peroxynitrite thus thwarting the ensuing path to hyperalgesia and
    allodynia
  • CT-044 is active in a host of preclinical ‘pain’ models; CT-044 is also safe and well-tolerated
  • CT-044 is completing IND-enablement and CerSci Therapeutics will advance CT-044
    into Phase 1 clinical trials later this year

 

16.30
Panel Discussion:Challenges in Design and Interpretation of Pain Clinical Trials and How to Overcome Them?

  • Silviu Itescu CEO & Executive Director, Mesoblast Ltd.
  • Craig Hartrick President of World Institute of Pain; President & CSO , Caventure Drug Discovery, Inc.

Synopsis

  • How to overcome failure to demonstrate efficacy in early clinical development phases?
  • With no objective end points and pain to be a matter of personal opinion and patient
    reported, how to overcome current challenges associate with pain clinical trial designs?
  • How to effectively blind the studies when study drug has particular adverse events?

17.00
Roundtable Discussion

Synopsis

Our breakout roundtables will allow you to have more intimate discussions with AI and pharma leaders around some of the hottest topics in the field. Discover multiple perspectives on these key issues, so that you can learn from your fellow experts in the audience. Drive your own learning, crowd-source ideas and get inspired. Immerse yourself in the following discussions:

17.30
Chair’s Closing Remarks & End of Day One