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About The Diabetes Series
Many companies are involved in the development of therapeutics and
diagnostics for diabetes and its complications. There are an
innumerable number of possible targets between Type I / Type II
diabetes, and the complications of diabetes. As companies grapple with
the various scientific issues, a smooth pathway to registration must be
navigated. What are the pitfalls in moving very early diabetes
compounds through the IND process? What are some of the issues that
must be considered in designing clinical trials for the different
possible indications? What are the considerations for
registering compounds for the different diabetes therapeutic
indications? These are only some of the questions to be discussed
during The Diabetes Series.
This webinar series is aimed at senior executives as well as scientists
and management level staff involved in the research and development of
therapeutics intended for diabetes and the complications of diabetes.
The seminars have the goal of allowing companies to get up to speed with
the latest developments in diabetes drug development. The sessions will
be very interactive and allow you to ask questions of the experts.
Considerations for the Development of Diabetic Therapeutics
5th March
2008 7:30 am PST to 9:00 am PST [10:30 am Eastern Time to 12:00 Noon
Eastern Time] Dr. Alexander Fleming, Ex-FDA, Kinexum
Dr.
Alexander Fleming will provide an overview of diabetes (Type
I and Type II), and related illnesses, and complications.
Obesity, cardiovascular and vascular complications will
be discussed. Possible targets and implications of studying
these will be considered.
Nonclinical Models for Diabetic Indications
14 March 2008 - 7:30 am PST to 9:00 am PST [10:30 am Eastern Time to 12:00 Noon Eastern Time] *Dr. Diane Hargrove, Amylin*
Dr. Bill Hodnick, Ricerca Biosciences
*Dr. Gregory Janis, Medtox
Considerations for study designs for different diabetic indications will
be presented. Considerations for development of bioanalytical methods
and validation of these will be presented.
Toxicological Evaluation of Diabetic Therapeutics
31st March 2008 7:30 am PST to 9:00 am PST [10:30 am Eastern Time to 12:00 Noon Eastern Time] *Dr. Scott Boley, MPI*
*Dr. Bill Hodnick, Ricerca*
*Dr. Gregory Janis, Medtox
An overview of the GLP toxicological studies that must be conducted for
Investigational new Drug Applications and New Drug Applications /
Marketing Authorization Applications will be presented. Combination
products and diagnostic / device products will also be considered.
Clinical Research for Diabetic Therapeutics
3 April 2008 - 7:30 am PST to 9:00 am PST [10:30 am Eastern Time to 12:00 Noon Eastern Time] Professor John Baxter, UCSF
Dr. Alexander Fleming, Ex-FDA, Kinexum
Dr.John K. Whisnant, Kinexum
The metabolic syndrome is a constellation of diseases that includes
obesity, insulin resistance and Type II diabetes, high blood pressure
and alterations in cholesterol and fat metabolism. This syndrome (also
known as Syndrome X) represents one of the largest health threats to the
western world today. Treatments for individual components of the
syndrome will be very useful in their own right, but also have the
potential to influence other facets of this inter-related disease. For
example, treatments that reduce obesity should also reduce the risk of
developing Type II diabetes.
Professor Baxter will use the development of thyroid hormone analogues
to illustrate issues and approaches with the development of novel
therapeutics for the treatment of the metabolic syndrome.
Clinical Development of Diabetic Therapeutics
23 April 2008 - 7:30am PST to 9:00 am PST [10:30 am Eastern Time to 12:00 Noon Eastern Time] Dr. Alexander Fleming, Ex-FDA, Kinexum*
Dr. John K. Whisnant, Kinexum
*Mr. Gregory Janis
Clinical development considerations for diabetes and the complications
of diabetes will be presented. This webinar will include protocol
designs for novel therapeutic approaches including transplantation
approaches.
Registration Strategies for Diabetic Therapeutics and the Complications of Diabetes
30 April 2008 7:30 am PST to 9:00 am PST [10:30 am Eastern Time to 12:00 Noon Eastern Time] *Dr. Alexander Fleming - Ex-FDA, Kinexum
Dr. Ray Lipicky - Ex FDA*
*Dr. Lorna Speid, Speid & Associates, Inc.
Registration strategies, registration endpoints,
considerations for building registration dossiers will be
covered for various types of diabetic therapeutics. There
will be opportunities for asking specific questions for
currently encountered issues in an anonymous format.
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Contact Dr. Speid at 858 793 1295 or at lspeid@sndtm.com