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Endocrine - Metabolic

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Advocacy Alert

US Medical Device Regulations and Regulatory Landscape Mike Winegar
Vice President Regulatory Affairs, Medpace Medical Device

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QT Evaluation in Early Clinical Development Thomas Todaro, MD, JD, FACC
Medpace Vice President, Medical Affairs

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The incidence of diabetes and obesity are increasing on a global scale and Medpace and our partners are focused on developing new therapies to treat these types of chronic metabolic disorders. Led by an international team of medical and regulatory experts who have helped pioneer many preventative metabolic compounds, Medpace has extensive experience in trial design, drug classes, and disease endpoints for Phase I-IV research. In fact, our years of experience conducting diabetes trials around the world is unmatched by any other Clinical Research Organization (CRO).

Medical and Regulatory Expertise

Key opinion leader and frequent industry speaker, David G. Orloff, MD, is the Medpace Executive Director of Regulatory Affairs. An endocrinologist and a past Director of the Division of Metabolism and Endocrinology Products at the FDA, Dr. Orloff has extensive experience as a medical reviewer and team leader in lipid-lowering, diabetes, and obesity drugs. He has been interviewed as an industry expert on the recent FDA guidance on diabetes drug development and the role played in cardiovascular health, which has been a hot topic for a number of recent industry presentations.

Therapeutic Expertise

90 diabetes trials (Ph I-IV)
  • 50% of trials have been multinational
  • Strong experience in emerging regions
  • Experience in difficult to recruit populations
    • narrow HbA1c criteria
    • concomitant diseases (obesity, hypertension, metabolic disorders)
    • metformin-only patients
  • Ability to leverage populations through global site experience
  • Written and advised on numerous diabetic development programs

Compound Experience (Diabetes, Dyslipidemia, Obesity)

  • Injectable insulins
  • Exenatide
  • Hyaluronidase
  • Metformin
  • Saxagliptin
  • Rivoglitazone
  • Colesevelam
  • A thiazolidinedione
  • Amlodipine besylate
  • Dry powder inhalers
  • Netoglitazone
  • Halofenate
  • Oxo pioglitazone
  • Rebaudioside A
  • Insulin glargine
  • Sulodexide
  • Pyridoxamine dihydrochloride
  • Quinapril
  • Fenofibrate
  • Ethyl EPA
  • Lovastatin
  • Rosuvastatin
  • Cerivastatin
  • Colstarlan
  • Pitavastatin
  • Atorvastatin
  • Cholesta Gel Capsules
  • Mipomersen
  • Fluvastatin
  • Simvastatin

>> Click here to learn more about Medpace's capabilities and therapeutic focus on endrocrine and metabolic disorders.