Zogenix
Chief Executive Officer and President at Zogenix, Inc
Steadymed Therapeutics
Director
Zogenix
President
Aradigm Corporation 1995 - 2006
Senior Vice President and Chief Scientific Officer
Welsh School of Pharmacy Cardiff University 1986 - 1994
Senior Lecturer
Education:
University of Wales
Doctorates, Doctor of Philosophy, Philosophy
Skills:
Pharmaceutical Industry Biotechnology Medical Devices Clinical Development Life Sciences Clinical Trials Fda Neurology Gmp Oncology Clinical Research Regulatory Affairs Pharmaceutical Sales Product Launch R&D Biopharmaceuticals Cross Functional Team Leadership Strategic Planning Product Development Diabetes 21 Cfr Part 11 Lifesciences Analytical Chemistry Healthcare Urology Cardiology Quality System Gcp Quality Assurance Strategy Immunology Capa Infectious Diseases Hospitals Drug Development Cro Technology Transfer Change Control Neuroscience Iso 13485 Pain Management Regulatory Submissions Start Ups Dermatology V&V Validation Managed Care Sop
Igor Gonda - San Francisco CA Reid M. Rubsamen - Oakland CA Stephen J. Farr - Orinda CA
Assignee:
Aradigm Corporation - Hayward CA
International Classification:
A61M 1100
US Classification:
12820014, 12820022, 12820423
Abstract:
The need for the delivery of insulin by injection can be reduced or eliminated by delivering an aerosolized monomeric insulin formulation. Repeatability of dosing and more particularly the repeatability of the blood concentration versus time profile is improved relative to regular insulin. The blood concentration versus time profile is substantially unaffected by specific aspects of the patients breathing maneuver at delivery. Further, the rate at which blood glucose is lowered is increased by the use of monomeric insulin. Particles of insulin and in particular monomeric insulin delivered to the surface of lung tissue will be absorbed into the circulatory system. The monomeric insulin may be a dry powder but is preferably in a liquid formulation delivered to the patient from a hand-held, self-contained device which automatically releases an aerosolized burst of formulation. The device includes a sensor which is preferably electronic which measures inspiratory flow and volume which measurement can be used to control the point of drug release.
Method Of Use Of Monomeric Insulin As A Means For Improving The Reproducibility Of Inhaled Insulin
Igor Gonda - San Francisco CA Reid M Rubsamen - Oakland CA Stephen J. Farr - Orinda CA
Assignee:
Aradigm Corporation - Hayward CA
International Classification:
A61M 1100
US Classification:
12820014, 12820022, 12820423
Abstract:
The need for the delivery of insulin by injection can be reduced or eliminated by delivering an aerosolized monomeric insulin formulation. Repeatability of dosing and more particularly the repeatability of the blood concentration versus time profile is improved relative to regular insulin. The blood concentration versus time profile is substantially unaffected by specific aspects of the patients breathing maneuver at delivery. Further, the rate at which blood glucose is lowered is increased by the use of monomeric insulin. Particles of insulin and in particular monomeric insulin delivered to the surface of lung tissue will be absorbed into the circulatory system. The monomeric insulin may be a dry powder but is preferably in a liquid formulation delivered to the patient from a hand-held, self-contained device which automatically releases an aerosolized burst of formulation. The device includes a sensor which is preferably electronic which measures inspiratory flow and volume which measurement can be used to control the point of drug release.
Method Of Use Of Monomeric Insulin As A Means For Improving The Reproducibility Of Inhaled Insulin
Igor Gonda - San Francisco CA Reid M. Rubsamen - Oakland CA Stephen J. Farr - Orinda CA
Assignee:
Aradigm Corporation - Hayward CA
International Classification:
A61M 1100
US Classification:
12820014, 12820022, 12820423
Abstract:
The need for the delivery of insulin by injection can be reduced or eliminated by delivering an aerosolized monomeric insulin formulation. Repeatability of dosing and more particularly the repeatability of the blood concentration versus time profile is improved relative to regular insulin. The blood concentration versus time profile is substantially unaffected by specific aspects of the patients breathing maneuver at delivery. Further, the rate at which blood glucose is lowered is increased by the use of monomeric insulin. Particles of insulin and in particular monomeric insulin delivered to the surface of lung tissue will be absorbed into the circulatory system. The monomeric insulin may be a dry powder but is preferably in a liquid formulation delivered to the patient from a hand-held, self-contained device which automatically releases an aerosolized burst of formulation. The device includes a sensor which is preferably electronic which measures inspiratory flow and volume which measurement can be used to control the point of drug release.
Inhaled Insulin Dosage Control Delivery Enhanced By Controlling Total Inhaled Volume
Igor Gonda - San Francisco CA Reid M. Rubsamen - Alamo CA Stephen J. Farr - Orinda CA
Assignee:
Aradigm Corporation - Hayward CA
International Classification:
A61M 1100
US Classification:
12820014, 12820022, 12820312, 12820423
Abstract:
Dosages of inhaled insulin are controlled within a narrow range by controlling the total volume of air inhaled by a patient. By repeatedly delivering aerosolized insulin with the same total inhaled volume of air, the amount of insulin delivered to the patient each time is consistent. A device for delivering insulin by inhalation is disclosed which device comprises a means for measuring inhaled volume and for halting inhalation at a pre-determined point. The device also comprises an adjustable means for applying various amounts of force to a container of formulation to expel different amounts of drug from the container based on the force applied.
A system is disclosed which makes it possible for a patient to be delivered gradually reduced amounts of nicotine over time thereby allowing the patient to be gradually weaned off of dependence on nicotine and quit smoking. The system is comprised of a means for aerosolizing a formulation and containers of formulation. The formulation is comprised of nicotine in a pharmaceutically acceptable carrier. Preferably, a plurality of containers are produced wherein the concentration of nicotine in the different containers or different groups of containers is reduced. The patient uses containers with the highest concentration initially and gradually moves towards using containers with lower and lower concentrations of nicotine until the patients dependence on nicotine is eliminated.
A system is disclosed which makes it possible for a patient to be delivered gradually reduced amounts of nicotine over time thereby allowing the patient to be gradually weaned off of dependence on nicotine and quit smoking. The system is comprised of a means for aerosolizing a formulation and containers of formulation. The formulation is comprised of nicotine in a pharmaceutically acceptable carrier. Preferably, a plurality of containers are produced wherein the concentration of nicotine in the different containers or different groups of containers is reduced. The patient uses containers with the highest concentration initially and gradually moves towards using containers with lower and lower concentrations of nicotine until the patient's dependence on nicotine is eliminated.
Method Of Use Of Monomeric Insulin As A Means For Improving The Reproducibility Of Inhaled Insulin
Igor Gonda - Melbourne, AU Reid M. Rubsamen - Alamo CA, US Stephen J. Farr - Orinda CA, US
Assignee:
Aradigm Corporation - Hayward CA
International Classification:
A61M 11/00
US Classification:
12820014, 12820312, 12820423
Abstract:
The need for the delivery of insulin by injection can be reduced or eliminated by delivering an aerosolized monomeric insulin formulation. Repeatability of dosing and more particularly the repeatability of the blood concentration versus time profile is improved relative to regular insulin. The blood concentration versus time profile is substantially unaffected by specific aspects of the patient's breathing maneuver at delivery. Further, the rate at which blood glucose is lowered is increased by the use of monomeric insulin. Particles of insulin and in particular monomeric insulin delivered to the surface of lung tissue will be absorbed into the circulatory system. The monomeric insulin may be a dry powder but is preferably in a liquid formulation delivered to the patient from a hand-held, self-contained device which automatically releases an aerosolized burst of formulation. The device includes a sensor which is preferably electronic which measures inspiratory flow and volume which measurement can be used to control the point of drug release.
Inhaled Insulin Dosage Control Delivery Enhanced By Controlling Total Inhaled Volume
Igor Gonda - San Francisco CA, US Reid M. Rubsamen - Oakland CA, US Stephen J. Farr - Orinda CA, US
Assignee:
Aradigm Corporation - Hayward CA
International Classification:
A61M 11/00
US Classification:
12820014, 12820022, 12820312, 12820423
Abstract:
Dosages of inhaled insulin are controlled within a narrow range by controlling the total volume of air inhaled by a patient. By repeatedly delivering aerosolized insulin with the same total inhaled volume of air, the amount of insulin delivered to the patient each time is consistent. A device for delivering insulin by inhalation is disclosed which device comprises a means for measuring inhaled volume and for halting inhalation at a pre-determined point. The device also comprises an adjustable means for applying various amounts of force to a container of formulation to expel different amounts of drug from the container based on the force applied.
Stephen Farr, PhD, president of Zogenix, said although the company is pleased with the outcomes from our safe use initiatives, implemented with the introduction of Zohydro ER last year, we believe moving forward with this formulation change at the earliest possible time is a responsible actio
Date: Feb 02, 2015
Category: Health
Source: Google
FDA Gives 'Priority Review' to New Hydrocodone Painkiller
We believe we have two strong technology options to deter misuse and abuse without affecting the established safety and efficacy profile of Zohydro ER, and look forward to submitting our data to the FDA with the goal of bringing these new options to patients, said Stephen Farr, President of Zogeni
Date: Jul 08, 2014
Category: Health
Source: Google
Fearing 'wave of addiction,' Hal Rogers hopes to overturn FDA approval of ...
"Zogenix recognizes and appreciates that prescription opioid misuse and abuse is a critical issue," company head Stephen Farr said in a statement posted on its website in December 2012. "However, it is also important to remember that there is a documented patient need for an extended-release hydroco
Date: Mar 16, 2014
Category: Health
Source: Google
Retirement Plans, Milan Probe, EU Cartel Fines: Compliance
indsay Fortado in London; Elisa Martinuzzi and Sonia Sirletti in Milan; Heather Smith in Paris; Karin Matussek in Berlin; Margaret Collins and Elizabeth Ody in New York; Jim Brunsden in Brussels; and Silla Brush, Ian Katz and Cheyenne Hopkins and Nicholas Johnston in Washington. Editor: Stephen Farr
Sandler and David Glovin in New York; Shinhye Kang and Jun Yang in Seoul; Jef Feeley and Steven Church in Wilmington, Delaware; Erik Larson in London; Tom Schoenberg in Washington; David Voreacos in Newark, New Jersey; Margaret Cronin Fisk in Detroit; and Naomi Kresge in Berlin. Editor: Stephen Farr
Date: Jan 06, 2012
Category: U.S.
Source: Google
MF Global Files Bankruptcy as Broker-Dealer Unit Liquidates
teven Church and Phil Milford in Wilmington, Delaware, Joe Schneider, Victoria Batchelor, Rebecca Evans and Tim Smith in Sydney, Andrew Harris in Chicago, Joel Rosenblatt in San Francisco, Anthony Aarons and Christopher Scinta in London, and Silla Brush in Washington. Editors: Stephen Farr, Andrew Dunn
Date: Nov 01, 2011
Category: Business
Source: Google
MF Global Files for Bankruptcy After Bad Bets on European Debt
awn Kopecki in New York, Dawn McCarty, Steven Church and Phil Milford in Wilmington, Delaware, Joe Schneider, Victoria Batchelor and Tim Smith in Sydney, Andrew Harris in Chicago, Joel Rosenblatt in San Francisco and Anthony Aarons and Christopher Scinta in London. Editors: Stephen Farr, Andrew Dunn
Glovin in New York; Margaret Cronin Fisk in Southfield, Michigan; Andrew Harris in Chicago; Heather Smith in Paris; Jef Feeley and Phil Milford in Wilmington, Delaware; Carter Dougherty in Washington; Oliver Suess in Munich; and Nicholas Comfort and Aaron Kirchfeld in Frankfurt. Editor: Stephen Farr