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Press Releases

• Kinexum CEO Discusses Challenges of Diabetes Product Development and the FDA - Part of the Problem or Part of the Solution to the Diabetes Epidemic: Dr. Alexander Fleming Joins Kelly Close on CNBC Broadcast to Discuss the Issues
  September 16, 2011
  
  
• dLife examines how potential drugs and medical devices are reviewed by the FDA
  September 16, 2011
  
  
• Seoul, South Korea
  Kinexum and RHI (Regulatory Harmonization Institute) collaborate with KHIDI (Korea Health Industry Development Institute)
  Kinexum and RHI (Regulatory Harmonization Institute) collaborate with KHIDI (Korea Health Industry Development Institute) - Translated
  August 22, 2011

• CNN’s Inside Business video about Kinexum support for Exsulin.

Newsletters

• November 2010

Presentations (PowerPoint, PDF)

• Seoul, South Korea Project Columbus - Nonclinical and Clinical Development of Health Products: Opportunities and Challenges
  Alexander Fleming, M.D., Chris Yun - June 2011
• Seoul, South Korea Basics of FDA Regulation of Medical Devices
  Ronda Balham, O.D. - June 2011
• Bio 2011 Washington DC,
  Regulatory policy and recommendations: Getting Treatments and Preventions Approved for T1DM-Progress Made and Challenges Remaining
  G. Alexander Fleming, MD - June 29th, 2011
• ADA 2011 San Diego, CA
  Where do we stand - unraveling the FDA regulatory pathway for diabetes and obesity drug
  G. Alexander Fleming, MD - June 24th, 2011
• Understanding the FDA Advisory Committee Process
  G. Alexander Fleming, MD - March 1, 2011
• Re-Engineering Insulin: Can We Improve on Mother Nature?
  G. Alexander Fleming, MD - November 13, 2010
• Implementing the Large Simple Trial and Appropriate Technologies to Efficiently Evaluate Cardiovascular Safety of Chronic Therapies
  G. Alexander Fleming, MD - October 6, 2010
• Challenges and Opportunities for FDA Approval of Traditional Chinese Medicines, G. Alexander Fleming, MD

Selected Papers, Documents, Articles

• Fleming A. Regulatory and policy issues for T1D immunotherapy. Human Vaccines. 2011 Jan 7:1, 1-6.
• Fleming GA, Klonoff DC. Glutamic Acid decarboxylase therapy for recent-onset type 1 diabetes: are we at the end or the beginning of finding a cure? J Diabetes Sci Technol. 2009 Mar 1;3(2):215-8.
• Cernea S, Raz I, Herold KC, Hirshberg B, Roep BO, Schatz DA, Fleming GA, Pozzilli P, Little R, Schloot NC, Leslie RD, Skyler JS, Palmer JP; D-Cure Workshop. Challenges in developing endpoints for type 1 diabetes intervention studies. Diabetes Metab Res Rev. 2009 Nov;25(8):694-704. Review.
• Fleming A. What will it take to get therapies approved for type 1 diabetes? Ann N Y Acad Sci. 2008 Dec; 1150:25-31.
• Fleming A, Rosenberg L. Prospects and challenges for islet regeneration as a treatment for diabetes: a review of islet neogenesis associated protein. J Diabetes Sci Technol. 2007 Mar;1(2):231-44.
• Palmer JP, Fleming GA, Greenbaum CJ, Herold KC, Jansa LD, Kolb H, Lachin JM, Polonsky KS, Pozzilli P, Skyler JS, Steffes MW. C-peptide is the appropriate outcome measure for type 1 diabetes clinical trials to preserve beta-cell function: report of an ADA workshop, 21-22 October 2001. Diabetes. 2004 Jan;53(1):250-64. Erratum in: Diabetes. 2004 Jul;53(7):1934.

Books

• Optimizing Therapeutic Development in Diabetes, G. Alexander Fleming, MD, et al, Greenwich Medical Media, 1999
• Fleming GA, Regulatory Considerations in the Development of Therapies for Diabetic Nephropathy and Related Conditions In The Kidney and Hypertension in Diabetes Mellitus, CE Morgensen Editor Kluwer Academic Publishers, Boston, 2000

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