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MEI Pharma Strengthens Clinical and Quality Expertise with New Key Executive Appointments
Rhea-AI Impact
(Neutral)
Rhea-AI Sentiment
(Very Positive)
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Rhea-AI Summary
MEI Pharma, Inc. (NASDAQ: MEIP) has announced the expansion of its management team with the appointments of Alejandro Ricart, M.D., as Senior Vice President of Clinical Development, and Yomara Gomez-Naiden as Senior Vice President of Quality. Both executives bring over 20 years of experience to the company. Dr. Ricart previously worked at TG Therapeutics and Novartis, while Ms. Gomez-Naiden has a strong background in quality assurance from AGC Biologics and Merck. The company aims to advance its cancer therapies, including zandelisib, toward regulatory approval.
Positive
Appointment of Alejandro Ricart, M.D. as Senior Vice President of Clinical Development, enhancing clinical capabilities.
Yomara Gomez-Naiden appointed as Senior Vice President of Quality, strengthening quality assurance efforts.
Overall reinforcement of management team to support growth and development of zandelisib.
Negative
None.
SAN DIEGO--(BUSINESS WIRE)--
MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today announced the expansion of its management team with the addition of two experienced industry executives. Alejandro Ricart, M.D., joins MEI as senior vice president, clinical development, a role that will report to Richard Ghalie, M.D., chief medical officer, and Yomara Gomez-Naiden joins as senior vice president, quality, reporting to Daniel P. Gold, Ph.D., chief executive officer. Both appointments are effective immediately.
Dr. Ricart has more than 20 years of drug development experience, including a background in registration-enabling clinical trials. Most recently, he was vice president of clinical development at TG Therapeutics. Prior to TG Therapeutics, Dr. Ricart was executive medical director at Novartis. Previously, he was a senior director at Merck Oncology, where he played a key role in the Pembrolizumab (KEYTRUDA®) Breakthrough Therapy Designation and in the Supplemental Biologics License Application (sBLA) for Hodgkin lymphoma. Dr. Ricart’s experience also includes clinical development roles at Pfizer Inc. and Roche. Dr. Ricart is board certified in internal medicine and medical oncology, and was previously a practicing medical oncologist. He holds a medical degree from the Universidad de Buenos Aires and has published more than 100 journal articles, abstracts, reviews and book chapters.
“MEI Pharma has made significant strides in its progress toward becoming a commercial stage company,” said Dr. Ricart. “I look forward to bringing my experience leading registration-enabling clinical trials and clinical development to support the Company’s continued growth and mission to provide improved outcomes to patients with cancer.”
Ms. Gomez-Naiden joins MEI with over 25 years of experience in both biotechnology and pharmaceutical industries, and her expertise spans quality assurance operations, quality systems, integrations, regulatory compliance and quality management. She has also contributed to the successful approval of drugs and biologics in multiple therapeutic areas. Previously, Ms. Gomez-Naiden served as vice president of corporate quality at AGC Biologics, where she led the establishment of the company's first Global Quality Management System and Corporate Quality Program. Prior to that, Ms. Gomez-Naiden held positions of increasing responsibilities at Acerta Pharma, GE Life Sciences, Merck, Schering-Plough, PF Laboratories and Warner Lambert (now Pfizer). She received a bachelor's degree in Chemistry from the University of Puerto Rico and an MBA in Pharmaceutical Chemistry from Fairleigh Dickinson University.
“I’m excited to join MEI and I am eager to work closely with such a dedicated and patient-focused team. I’m looking forward to contributing to MEI by leveraging the clinical success accomplished to date and helping lead the team towards a successful Pre-Approval Inspection and commercialization of our medicines to make a meaningful impact in patients’ lives,” said Ms. Gomez-Naiden.
Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma, commented, "We are very excited by the recent appointments of Dr. Ricart and Ms. Gomez-Naiden, strengthening our clinical and quality functions. Their experience and leadership are a great fit for MEI as we move forward with preparations for the potential marketing authorization of zandelisib, including the buildout of the infrastructure needed to support our growing development program and planned commercialization. We welcome Dr. Ricart and Ms. Gomez-Naiden and look forward to working with them as we progress zandelisib as a potential differentiated therapeutic for patients with hematologic cancers."
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a late-stage pharmaceutical company focused on developing potential new therapies for cancer. MEI Pharma's portfolio of drug candidates contains multiple clinical-stage assets, including zandelisib, currently in ongoing clinical trials which may support marketing approvals with the U.S. Food and Drug Administration and other regulatory authorities globally. Each of MEI Pharma's pipeline candidates leverages a different mechanism of action with the objective of developing therapeutic options that are: (1) differentiated, (2) address unmet medical needs and (3) deliver improved benefit to patients either as standalone treatments or in combination with other therapeutic options. For more information, please visit www.meipharma.com. Follow us on Twitter @MEI_Pharma and on LinkedIn.
Forward-Looking Statements
Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical studies and approved by the FDA as being safe and effective for the intended use. Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results; the impact of the COVID-19 pandemic on our industry and individual companies, including on our counterparties, the supply chain, the execution of our clinical development programs, our access to financing and the allocation of government resources; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
What recent management changes have occurred at MEI Pharma?
MEI Pharma announced the appointments of Alejandro Ricart as Senior Vice President of Clinical Development and Yomara Gomez-Naiden as Senior Vice President of Quality.
What is the role of Alejandro Ricart at MEI Pharma?
Alejandro Ricart will serve as Senior Vice President of Clinical Development, focusing on the company's clinical programs.
What experience does Yomara Gomez-Naiden bring to MEI Pharma?
Yomara Gomez-Naiden has over 25 years of experience in quality assurance and regulatory compliance in the pharmaceutical industry.
How do these appointments impact MEI Pharma's pipeline?
The appointments are expected to strengthen MEI Pharma's efforts in advancing its cancer therapies, particularly zandelisib, towards commercialization.
What regulatory approvals is MEI Pharma seeking for zandelisib?
MEI Pharma is preparing for potential marketing authorization of zandelisib from the U.S. Food and Drug Administration.