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.