Predictive Oncology Inc. (NASDAQ:POAI) said it has further strengthened its offerings for pharmaceutical and biotech customers through several key developments.
The company said the first was its Good Manufacturing Practices (GMP) lab, which opens the opportunity to help clients move from pre-clinical drug development to the investigational new drug (IND) qualification, including Phase 1 clinical trials.
Predictive Oncology said the company has begun accepting orders.
READ: Predictive Oncology ends 2Q 2022 with strong balance sheet, solid cash position
Predictive Oncology CEO J Melville Engle said adding GMP production capabilities was a major accomplishment that had been underway over the past year and a half.
“This highly regulated designation, required by the Food and Drug Administration (FDA) in the manufacturing of pharmaceuticals, will generate opportunities for added business growth for us and provide a valuable resource to our customers,” he said.
“Keeping the development and production of our proprietary endotoxin removal process in-house saves our customers time and money, which is especially important at a time when drug development companies face increased pressure to get to clinical trials faster.”
Further, the company announced the addition of a strategic advisor with two decades of experience in drug development, President of Canopy Biopharma, Kamal Egodage.
Predictive Oncology said Egodage would lead formulation development and sales growth strategies for its drug formulation area of business.
“Dr. Egodage brings an in-depth knowledge of the biopharmaceutical regulatory and development process that makes him an ideal fit for the growth plans we have at Predictive Oncology,” said Larry DeLucas, senior vice president of operations at Predictive Oncology.
“He has the vision, passion and understanding to help expand our business growth in the area of formulation solutions,” DeLucas added.
CEO and chairman to retire
The company also announced that Engle will retire as its chief executive officer, chairman and a member of the company's board of directors.
The company said Engle will continue to serve in his role through October 31, 2022, to ensure a smooth transition of his responsibilities.
The governance committee of the company’s board of directors is working on a succession plan to replace Engle as CEO, it added.
"It has been a privilege to create and lead a team that embraces innovative ideas that will impact the future of oncology drug development," Engle commented.
"There is great wisdom, energy and inspirational work going on at Predictive Oncology by people who are dedicated to the fight against cancer. It is an honor to end my career here."
Engle, 72, has been with the company since 2016 when he joined the board of directors. He was appointed chairman of the board in January 2020 and was named chief executive officer in March 2021.
"We appreciate the vision that Mel has brought to the company and the impact he has made on our strategic positioning, which sets us up for the next stage of growth," said Bob Myers, Predictive Oncology’s chief financial officer.
Among his achievements at the company, Engle led the effort to acquire zPREDICTA, to broaden the company's offerings with the production of 3D tumor models in oncology drug development.
Predictive Oncology is a knowledge-driven company focused on applying artificial intelligence (AI) to develop optimal cancer therapies, which can lead to more effective treatments and improved patient outcomes.
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