Home  |  About Us  |  Services Drug Development Boot Camp Biosimilars Jobs   |  Latest Regulatory Updates  |  Diabetes Webinars  | 
Speid & Associates Webinars  |  Contact Us
Free Audio Launch File  |  Keep Up To Date
   
The Diabetes Series 2008

       

       

To receive updates on diabetes therapeutics provide your email address.

       

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.

We look forward to your participation.

Click on any date for more information

       


       

 

 

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.

Stay Informed. Don't miss this opportunity!

       

Click Here >>
   

       

To receive updates on diabetes therapeutics provide your email address.

       

 

CALL DR. SPEID NOW!

Contact Dr. Speid at 858 793 1295 or at lspeid@sndtm.com

 
All rights reserved by Speid & Associates, Inc.
"));