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Dr. Lee is a highly accomplished pharmaceutical industry expert with over 38 years of in regulatory affairs and clinical development. 

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Dr. Lee has held leadership positions at several pharmaceutical companies, including Cornerstone Pharmaceuticals, Acorda Therapeutics, ATON Pharma (acquired by Merck), VION Pharmaceuticals, IBEX Technologies, and Sterling-Winthrop.  His expertise has been instrumental in securing FDA approvals for multiple successful products, including ZOLINZA™ (vorinostat) for leukemia, Primacor (milirinone) for congestive heart failure, Omniscan™ (gadodiamide) as an MRI contrast agent, and various in vitro diagnostic (IVD) medical devices for hematologic testing.

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Dr. Lee's extensive experience spans both large pharmaceutical companies and startups, where he has demonstrated expertise in regulatory strategy development, clinical and nonclinical study design, and direct interaction with regulatory agencies worldwide, including the FDA, EMEA, and Health Canada. ​​