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GlycoMimetics Appoints Deepak Tiwari, Ph.D., as new Vice President, Technical Operations
Rhea-AI Impact
(Low)
Rhea-AI Sentiment
(Neutral)
Tags
management
Rhea-AI Summary
GlycoMimetics, Inc. (Nasdaq: GLYC) has appointed Dr. Deepak Tiwari as Vice President of Technical Operations. With over 25 years of experience, Dr. Tiwari's expertise includes over 30 regulatory submissions and 15 product launches. He previously held leadership roles at Rafael Pharmaceuticals and ZyVersa Therapeutics. The company continues to advance its investigational drug, uproleselan, for acute myeloid leukemia (AML), which has received Breakthrough Therapy designation. Dr. Tiwari's leadership is expected to enhance GlycoMimetics' operational capabilities.
Positive
Dr. Tiwari brings over 25 years of experience in CMC operations, which may strengthen leadership.
His expertise includes more than 30 regulatory submissions and 15 commercial product launches, enhancing operational success.
Uproleselan is progressing in a Phase 3 trial and has received Breakthrough Therapy designation from the FDA for AML.
Negative
Concerns about potential continuity and experience gaps in technical operations after Dr. Tiwari's transition.
ROCKVILLE, Md.--(BUSINESS WIRE)--
GlycoMimetics, Inc. (Nasdaq: GLYC) announced today that Dr. Deepak Tiwari has joined the Company as Vice President, Technical Operations.
“Dr. Tiwari brings over 25 years of diverse CMC experience. He has contributed to more than 30 regulatory submissions and 15 commercial product launches throughout his career. As we continue to move uproleselan forward, Deepak’s breadth of experience and leadership is a valuable addition to GlycoMimetics,” commented Harout Semerjian, GlycoMimetics’ Chief Executive Officer.
Dr. Tiwari joins the Company from Rafael Pharmaceuticals where he was Vice President and Head of CMC Operations working on development of devimistat in multiple indications including patients with relapsed or refractory Acute Myeloid Leukemia (AML). Prior to that, he worked at ZyVersa Therapeutics (previously Variant Pharmaceuticals), where he held the position of Assistant Vice President, CMC Operations and Product Development. He has extensive experience in both large and small molecules, including pre-formulation, formulation development, analytical characterization, process development, scale-up, technology transfer and process validation. He is the author of many peer-reviewed journal articles and the recipient of numerous awards for technical achievements. Dr. Tiwari holds a Ph.D. and an M.S. in Pharmaceutical Sciences, both from St. John's University, N.Y., and a B.S. in Pharmacy from the University of Delhi in India.
About Uproleselan (GMI-1271)
Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed or refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better-than-expected remission rates and overall survival compared to historical controls, which have been derived from results from third-party clinical trials evaluating standard chemotherapy, as well as lower-than-expected induction-related mortality rates. Treatment in these patient populations was generally well-tolerated, with fewer than expected adverse effects.
About GlycoMimetics, Inc.
GlycoMimetics is a clinical-stage biotechnology company focused on the discovery and development of novel glycomimetic drugs to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role. GlycoMimetics’ wholly owned drug candidate, uproleselan, an E-selectin antagonist, was evaluated in a Phase 1/2 clinical trial as a potential treatment for AML and is being evaluated across a range of patient populations including a Company-sponsored Phase 3 trial in relapsed/refractory AML. GlycoMimetics has also completed a Phase 1 clinical trial with another wholly-owned drug candidate, GMI-1359, a combined CXCR4 and E-selectin antagonist. GlycoMimetics is located in Rockville, MD in the BioHealth Capital Region. Learn more at www.glycomimetics.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding the planned or potential development, and the potential benefits and impact, of the Company’s drug candidates. Actual results may differ materially from those in these forward-looking statements. For a further description of the risks associated with these statements, as well as other risks facing GlycoMimetics, please see the risk factors described in the Company’s annual report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 2, 2021, and other filings GlycoMimetics makes with the SEC from time to time. Forward-looking statements speak only as of the date of this release, and GlycoMimetics undertakes no obligation to update or revise these statements, except as may be required by law.
