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Innovation, superiority and best practice proof-of-concept in CNS clinical development
22 November 2011
Innovation, superiority and best practice proof-of-concept in CNS clinical development

 

 

 

In association with

 

                 

 

PharmaNeuroBoost (PNB) creates NCE’s out of existing therapeutics combined with the company’s proprietary boosting technology. PNB has granted CoM and use patent coverage in different countries around the world for the individual compounds in its pipeline. Over its first five years of life, PharmaNeuroBoost has proved its innovative fixed-dose combination concepts in preclinical and clinical proof of concept trials, and has shown support from the FDA for a pivotal trial that uses a new endpoint demonstrating superior efficacy over standard of care. During 2011, the company will initiate phase III trials for PNB01 and phase IIa trials for PNB02, respectively in the treatment of major depression and schizophrenia. www.pharmaneuroboost.com/

 

 

Who should attend this event?

Chief Executives, Vice Presidents, Heads, Directors, Chief Scientists and Project Leaders of

  • POC
  • PNB
  • Antidepressant development
  • CNS Clinical Discovery
  • Clinical Trial Management and Operation
  • Neurology/Neuroscience
  • Medical Directors
  • Clinical Pharmacology

 

What is this workshop about?

This session shall provide unique insight into establishing best practise in POC trials, innovation in CNS discovery and PNB boosting, by utilising a data driven case study in to antidepressant therapy and our host’s vast expertise in mid to late phase CNS development.

 

Scroll down for full workshop agenda.

 

Who is leading it?

 

Erik Buntinx CEO – Managing Director PharmaNeuroBoost  

 

Erik Buntinx, MD, CEO, founded the Belgian CNS specialty company PharmaNeuroBoost (PNB) in December 2006 and has raised up till date EUR 25 M. PNB’s platform technology is based on Buntinx’s discovery of the boosting capabilities of highly-selective serotonin 2A and dopamine 4 receptor antagonists. Buntinx is a qualified psychiatrist, and previously founded the Anima Center, an outpatient psychiatric clinic and integrated clinical research unit. He obtained his MD degree from the Catholic University of Leuven (KUL), Belgium and completed his psychiatric residency at the KUL and the University of Maastricht, The Netherlands.

 

Workshop agenda

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12:30

Registration & Coffee

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13:00

Welcome and Introductions

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13:10

Innovative CNS Drugs: To Be Superior of Not to Be!

  • Unmet Medical Needs and New Clinical Paradigms
  • Regulatory Requests
  • Designing ‘superior’ clinical trials
  • New End Points
  • clock

    13:45

    The PNB Boosting Concept: Demonstrating Superiority

  • Pharmacological Considerations
  • Clinical Goals
  • IP Matters
  • Pipeline
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    14:45

    Afternoon Tea

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    15:15

    15:00 The PNB01 Clinical Development Program – A Novel Boosting Antidepressant Therapy

  • Objectives
  • Phase II Proof of Concept Data showing beneficial effects
  • The New Pivotal End Point: Early and Sustained Response Rate (ESR)
  • The Phase III Study: Outline
  • clock

    16:25

    Discussion Session

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    17:30

    Close of Workshop

    Marriott Regents Park

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    Marriott Regents Park

    This 4 star north London hotel in zone 2 is the perfect destination for the astute business traveler as well as the leisure guest that knows how convenient north London hotels are, as a base from which to explore the city .Bond Street is just 3 stops from Swiss Cottage underground station on the Jubilee Line, so you can be shopping, exploring the sights and taking in one of London’s world-renowned West End shows in less than 15 minutes when you stay at this hotel near central London. At the same time, the hive of activity that is Camden Town, the chic shops, cafes and restaurants of Primrose Hill and ZSL’s London Zoo in Regents Park are all just a short walk from this hotel in north London.

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