AVX 0.00% 2.5¢ avexa limited

I have been quietly excited about what the recent arrangement...

  1. 142 Posts.
    I have been quietly excited about what the recent arrangement with Tibotec/Johnson and Johnson may lead to.

    Came across this profile of one Addy Alsumde which states he has been a past "Director, Clinical Development and Drug Safety" at both ALZA Corp/Johnson and Johnson and Avexa!!!

    I can't find any record of an American "Avexa Pharmaceutical company", and I can't find any record of Addy Alsumde in regard to our Avexa.

    I would love to find there is a link!

    Can anyone throw any light on this?

    JRH

    http://www.linkedin.com/pub/addy-alsumde/5/128/9a6

    Addy AlsumdeDirector, Clinical Development at Elan Pharmaceuticles

    San Francisco Bay Area
    Contact Addy Alsumde
    Add Addy Alsumde to your network

    Current Director, Clinical Development at Elan Pharmaceuticles
    Director, Clinical Development at Johnson and Johnson, Alza
    Past Senior Director, Drug Safety and Clinical Development at Avexa
    Director, Clinical Development and Drug Safety at ALZA Corporation / Johnson & Johnson
    Drug Safety at Bayer HealthCare
    Director of Clinical Development and Clinical Safety at Curn, Inc.
    see less...

    1 more...
    Education University of Liverpool
    Connections 31 connections Industry Pharmaceuticals
    --------------------------------------------------------------------------------

    Addy Alsumde’s Summary
    Physician with extensive expertise in the biotech and pharmaceutical industry. Experienced in a broad range of therapeutic and functional areas including Drug Safety, Clinical Development, and Medical Affairs. Experienced in Phase I-IV.
    Strengths include:

    - Narrative writing
    - Aggregation of safety data and early signal assessment
    - ADRs analysis
    - Benefit risk management
    - Comprehensive knowledge of drug development processes


    --------------------------------------------------------------------------------

    Addy Alsumde’s Experience
    Director, Clinical Development
    Elan Pharmaceuticles
    (Public Company; ELN; Pharmaceuticals industry)

    January 2009 — Present (5 months)


    Director, Clinical Development
    Johnson and Johnson, Alza
    (Public Company; JNJ; Pharmaceuticals industry)

    April 2005 — Present (4 years 2 months)

    - Designing templates for SAEs, and AEs narratives of special interest, to facilitate and consistently reporting them to the authorities.
    - Providing responses to general medical and safety-related inquiries from a variety of internal and external departments and ad hoc ensuring that evidence-based messages supporting harmonized risk communication strategies
    - Developing risk management plan by providing strategic input
    - Identifying and evaluating safety issues engaging multi-disciplinary team members communicating and implementing risk management strategies
    - Working on composition of evidence-based messages regarding benefit/risk balance for complex medical analyses in support of risk communication strategies and label justification
    - Maintaining medical licensure and current knowledge as a pharmaceutical physician related to general medicine, clinical pharmacology and toxicology, relevant therapeutic areas, and global regulations regarding product safety
    - Developing ADRs

    Senior Director, Drug Safety and Clinical Development
    Avexa
    (Pharmaceuticals industry)

    2008 — 2009 (1 year)

    Director, Clinical Development and Drug Safety
    ALZA Corporation / Johnson & Johnson
    (Pharmaceuticals industry)

    2005 — 2008 (3 years)

    Drug Safety
    Bayer HealthCare
    (Public Company; Pharmaceuticals industry)

    2007 — 2008 (1 year)

    Director of Clinical Development and Clinical Safety
    Curn, Inc.
    (Public Company; 51-200 employees; Pharmaceuticals industry)

    February 2001 — November 2002 (1 year 10 months)

    - Designed templates for SAEs and AEs of special interest narratives
    - Responded to general medical and safety-related inquiries from internal and external departments
    - Wrote FDA applications NDA and IND for lower and upper gastrointestinal tract device (Secca and Stretta), which was then received approval from the FDA.
    - Assisted PIs in writing scientific papers and abstracts that led to 2 published scientific papers and acceptance of 17 presentations in National and International medical and scientific meetings
    - Sales increased 40% percent after working with PIs to publish clinical data during medical and scientific meetings including the DDW where the PIs presented 11 abstract resulting in increase sales
    - Designed and implemented a registry study involving 590 principle investigators resulting in 2 publications and 5 presentations
    - Identified and trained proper PIs resulted in increased patients enrollments
    - Contributed to the evaluation of new commercial opportunities

 
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