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Richard J Malcolmson

from San Carlos, CA
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Also known as:
Richard Joseph Malcolmson
Related to:
Richard Malcomson, 59Sabrina Malcolmson, 58
Connected to:
Aaron Y Malcolm, 68Alex N Malcolm, 29Alfred H Malcolm, 70Annie R Malcolm, 37Apryl S Malcolm, 30Bill Malcolm, 42Bradford D Malcolm, 53Brendan K Malcolm, 58Brittney Malcolm, 28Cassandra R Malcolm, 28

Richard Malcolmson Phones & Addresses

  • San Carlos, CA
  • 54 Bayport Ct, San Carlos, CA 94070 (650) 341-3401

Work

Company: Novartis Jan 2009 to Mar 2016 Position: Product development

Education

Degree: High school graduate or higher

Skills

20 Years of Inhalation Aerosol Product D... • Led Cmc Development of Inhaled Amphoteri... • Broad Experience of Written and F2F Fda ... • Broad Experience In Pai Readiness and In... • Novartis Cmc Expert at Tobi Podhaler Fda... • Expertise Across All Phases of Inhalatio... • Specialization In Late Phase Inhalation ... • Understanding of Both Device/Drug Develo... • Contributor and Lead Author For Numerous... • Led Cmc Multi Dose Dpi Development For C... • Drug Development • Product Development • Gmp • Fda • Validation • Biotechnology • Biopharmaceuticals • R&D • Medical Devices • Clinical Development • Life Sciences • Regulatory Affairs • Sop • Technology Transfer • Regulatory Submissions • U.s. Food and Drug Administration

Languages

English

Interests

Exercise • Electronics • Reading • Music • Movies

Industries

Pharmaceuticals

Resumes

Resumes

Richard Malcolmson Photo 1

Head, Pharmaceutical Development

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Location:
54 Bayport Ct, San Carlos, CA 94070
Industry:
Pharmaceuticals
Work:
Novartis Jan 2009 - Mar 2016
Product Development
Aerogen Pharma Corp Jan 2009 - Mar 2016
Head, Pharmaceutical Development
Nektar Therapeutics 2004 - 2008
Associate Director, Pharmaceutical Development
Inhale Therapeutic Systems 1999 - 2003
Associate Director, Pharmaceutical Development
Skills:
20 Years of Inhalation Aerosol Product Development
Led Cmc Development of Inhaled Amphotericin B
Broad Experience of Written and F2F Fda and Other Ha Interactions
Broad Experience In Pai Readiness and Inspection Participation
Novartis Cmc Expert at Tobi Podhaler Fda Advisory Committee
Expertise Across All Phases of Inhalation Product Development
Specialization In Late Phase Inhalation Product Development
Understanding of Both Device/Drug Development Processes
Contributor and Lead Author For Numerous Ind/Cta and Nda/Maa Submissions
Led Cmc Multi Dose Dpi Development For Copd Products
Drug Development
Product Development
Gmp
Fda
Validation
Biotechnology
Biopharmaceuticals
R&D
Medical Devices
Clinical Development
Life Sciences
Regulatory Affairs
Sop
Technology Transfer
Regulatory Submissions
U.s. Food and Drug Administration
Interests:
Exercise
Electronics
Reading
Music
Movies
Languages:
English

Publications

Us Patents

Compositions Comprising Amphotericin B, Mehods And Systems

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US Patent:
8513204, Aug 20, 2013
Filed:
Sep 20, 2006
Appl. No.:
11/523978
Inventors:
Richard Malcolmson - San Mateo CA, US
Alan Kugler - Montara CA, US
Theresa D. Sweeney - El Granada CA, US
Keith Washco - Fremont CA, US
Danforth Miller - San Carlos CA, US
Assignee:
Novartis AG - Basel
International Classification:
A61K 31/70
US Classification:
514 31, 536 65
Abstract:
The present invention comprises compositions and formulations comprising amphotericin B, compositions and formulations comprising amphotericin B with one or more excipients, methods of making amphotericin B compositions and formulations, as well as systems for using amphotericin B compositions and formulations. Also provided are pharmaceutical compositions comprising the formulation, methods of administering the pharmaceutical compositions and methods of treating patients with the pharmaceutical compositions.

Compositions Comprising Amphotericin B

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US Patent:
20120128728, May 24, 2012
Filed:
Dec 21, 2006
Appl. No.:
12/087142
Inventors:
Richard J. Malcolmson - San Carlos CA, US
Theresa D. Sweeney - El Granada, CA
Danforth P. Miller - San Carlos CA, US
Alan R. Kugler - Montana CA, US
Keith Washco - Fremont CA, US
David Han - Pacifica CA, US
Ramakrishna Gadiraju - Foster City CA, US
Farzaneh Nakhjiri - Belmont CA, US
Assignee:
NOVARTIS PHARMA AG - Basel
International Classification:
A61K 9/14
B32B 5/16
A61P 31/10
A61K 31/7048
C07H 17/08
US Classification:
424400, 514 31, 536 65, 428402
Abstract:
The present invention comprises compositions and formulations comprising amphotericin B comprising less than 10% degradants, compositions and formulations comprising amphotericin B with one or more excipients, methods of making amphotericin B compositions and formulations, as well as systems for using amphotericin B compositions and formulations. Also provided are pharmaceutical compositions comprising the formulation, methods of administering the pharmaceutical compositions and methods of treating patients with the pharmaceutical compositions.

Compositions Comprising Amphotericin B, Methods, And Systems

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US Patent:
7326691, Feb 5, 2008
Filed:
Jun 21, 2005
Appl. No.:
11/158332
Inventors:
Sarma Duddu - Redwood City CA, US
Srinivas Palakodaty - Foster City CA, US
Danforth Miller - San Carlos CA, US
Alan R. Kugler - Montara CA, US
Christopher Frantz - Sunnyvale CA, US
Trixie Tan - Daly City CA, US
Richard Malcolmson - San Mateo CA, US
Keith Washco - Fremont CA, US
Theresa Sweeney - El Granada CA, US
Thomas E. Tarara - Burlingame CA, US
Sarvajna Dwivedi - Redwood City CA, US
Michael A. Eldon - Redwood City CA, US
Assignee:
Nektar Therapeutics - San Carlos CA
International Classification:
A61K 9/14
A61K 31/70
US Classification:
514 31, 536 65, 424489
Abstract:
A composition includes particles including at least about 95 wt % of amphotericin B, wherein the particles have a mass median diameter ranging from about 1. 1 μm to about 1. 9 μm. Another composition also includes particles including at least about 95 wt % of amphotericin B, wherein at least about 80 wt % of the particles have a geometric diameter ranging from about 1. 1 μm to about 1. 9 μm. Yet another composition includes particles including amphotericin B, wherein the particles have a mass median diameter less than about 1. 9 μm, and wherein the amphotericin B has a crystallinity level of at least about 20%. Unit dosage forms, delivery systems, and methods may involve similar compositions.
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Richard J Malcolmson from San Carlos, CA Get Report