Yes, nice upgrades. The management team is becoming a strength.
Also I like, why we wait on combo to finish, the company going after as many p2 indications as possible at low cost.
CytoDyn Strengthens Management Team with Key Additions in Business Development and Quality Regulatory Compliance as it Advances Commercialization Plan for Leronlimab
https://www.cytodyn.com/media/press-releases/...ditions-in
VANCOUVER, Washington, May 14, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced the hiring of Brendan Rae, Ph.D., J.D., as Senior Vice President of Business Development and George Bitar as Executive Director - Head of Quality. The addition of these senior positions aligns with CytoDyn’s pursuit of strategic partnership agreements and efforts to attain its first FDA approval.
Dr. Rae will lead CytoDyn’s business development initiatives, including all potential partnering and licensing opportunities for leronlimab. Dr. Rae is an accomplished licensing and business development executive with a proven track record of deal-making. Dr. Rae comes to CytoDyn from Serina Therapeutics where he was Chief Business Officer, responsible for partnering, out licensing and overall company strategy. Previously, Dr. Rae was the Executive Director of NPS Pharmaceuticals and Head of GI and Endocrinology Business Development until the acquisition by Shire Pharmaceuticals for $5.2 billion in 2015. Prior to NPS, Dr. Rae held the role of Chief Business Officer at Arrowhead Research and Vivaldi Biosciences, as well as senior leadership roles at VIA Pharmaceuticals, Purdue Pharma and Hoffman-La Roche. Prior to entering the biopharmaceutical industry, Dr. Rae was an attorney specializing in biopharmaceutical intellectual property law and, earlier in his career was a research scientist focusing on metastasis and the molecular basis of cellular transformation. Dr. Rae holds a Juris Doctor degree from Seton Hall Law School and a Ph.D. in Virology from Glasgow University (Scotland) and completed a Postdoctoral Fellowship at the Roche Institute of Molecular Biology.
Mr. Bitar will be responsible for overseeing all facets of the company’s Quality Systems, Quality Assurance, and Compliance Operations to ensure that product is manufactured consistently to meet all FDA standards. As CytoDyn enters into a new era of manufacturing partnerships with contract manufacturing organizations (CMOs) in preparation for post-approval product launch of leronlimab, a knowledgeable Head of Quality is a critical component of the BLA approval and the commercialization process. Mr. Bitar brings to CytoDyn over 25 years in quality management, technical operations, pharmaceutical manufacturing and R&D, including most recently as the Global Head of Quality at Hitachi Chemical Advanced Therapeutics Solutions, a cellular and gene therapy contract development and manufacturing organization. Previously, Mr. Bitar led Pfizer’s generic oncology and biosimilars manufacturing through the approval process and was the Site Head of Quality for Pfizer’s specialty injectable and biologic drug products. Prior to Pfizer, Mr. Bitar was Vice President – Head of Quality at InnoPharma Inc., which was acquired by Pfizer. Mr. Bitar earned an M.S. in Pharmaceutical Chemistry with Honors from Seton Hall University and a B.Sc. in Chemical Biology (pre-med) with Honors from the Stevens Institute of Technology.
“We welcome Brendan and George to the CytoDyn team at this important point in our corporate trajectory,” stated Nader Pourhassan, Ph.D, CytoDyn’s President, CEO and director. “With our lead asset now in the final stages of our BLA submission and our agreement with Samsung BioLogics for future commercial manufacturing of leronlimab, the timing is ideal to have Brendan’s and George’s deep experience on the team, as we implement our commercialization plan and pursue new potential strategic agreements,” Dr. Pourhassan continued. “We remain highly encouraged by the potential commercialization of leronlimab as a combination therapy for HIV and its future prospects as a monotherapy, as well as the many other indications, including Phase 2 trials for metastatic triple-negative breast cancer and GvHD, to potentially create significant and enduring value for all shareholders,” concluded Dr. Pourhassan.
Also I like, why we wait on combo to finish, the company going after as many p2 indications as possible at low cost.
CytoDyn Strengthens Management Team with Key Additions in Business Development and Quality Regulatory Compliance as it Advances Commercialization Plan for Leronlimab
https://www.cytodyn.com/media/press-releases/...ditions-in
VANCOUVER, Washington, May 14, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced the hiring of Brendan Rae, Ph.D., J.D., as Senior Vice President of Business Development and George Bitar as Executive Director - Head of Quality. The addition of these senior positions aligns with CytoDyn’s pursuit of strategic partnership agreements and efforts to attain its first FDA approval.
Dr. Rae will lead CytoDyn’s business development initiatives, including all potential partnering and licensing opportunities for leronlimab. Dr. Rae is an accomplished licensing and business development executive with a proven track record of deal-making. Dr. Rae comes to CytoDyn from Serina Therapeutics where he was Chief Business Officer, responsible for partnering, out licensing and overall company strategy. Previously, Dr. Rae was the Executive Director of NPS Pharmaceuticals and Head of GI and Endocrinology Business Development until the acquisition by Shire Pharmaceuticals for $5.2 billion in 2015. Prior to NPS, Dr. Rae held the role of Chief Business Officer at Arrowhead Research and Vivaldi Biosciences, as well as senior leadership roles at VIA Pharmaceuticals, Purdue Pharma and Hoffman-La Roche. Prior to entering the biopharmaceutical industry, Dr. Rae was an attorney specializing in biopharmaceutical intellectual property law and, earlier in his career was a research scientist focusing on metastasis and the molecular basis of cellular transformation. Dr. Rae holds a Juris Doctor degree from Seton Hall Law School and a Ph.D. in Virology from Glasgow University (Scotland) and completed a Postdoctoral Fellowship at the Roche Institute of Molecular Biology.
Mr. Bitar will be responsible for overseeing all facets of the company’s Quality Systems, Quality Assurance, and Compliance Operations to ensure that product is manufactured consistently to meet all FDA standards. As CytoDyn enters into a new era of manufacturing partnerships with contract manufacturing organizations (CMOs) in preparation for post-approval product launch of leronlimab, a knowledgeable Head of Quality is a critical component of the BLA approval and the commercialization process. Mr. Bitar brings to CytoDyn over 25 years in quality management, technical operations, pharmaceutical manufacturing and R&D, including most recently as the Global Head of Quality at Hitachi Chemical Advanced Therapeutics Solutions, a cellular and gene therapy contract development and manufacturing organization. Previously, Mr. Bitar led Pfizer’s generic oncology and biosimilars manufacturing through the approval process and was the Site Head of Quality for Pfizer’s specialty injectable and biologic drug products. Prior to Pfizer, Mr. Bitar was Vice President – Head of Quality at InnoPharma Inc., which was acquired by Pfizer. Mr. Bitar earned an M.S. in Pharmaceutical Chemistry with Honors from Seton Hall University and a B.Sc. in Chemical Biology (pre-med) with Honors from the Stevens Institute of Technology.
“We welcome Brendan and George to the CytoDyn team at this important point in our corporate trajectory,” stated Nader Pourhassan, Ph.D, CytoDyn’s President, CEO and director. “With our lead asset now in the final stages of our BLA submission and our agreement with Samsung BioLogics for future commercial manufacturing of leronlimab, the timing is ideal to have Brendan’s and George’s deep experience on the team, as we implement our commercialization plan and pursue new potential strategic agreements,” Dr. Pourhassan continued. “We remain highly encouraged by the potential commercialization of leronlimab as a combination therapy for HIV and its future prospects as a monotherapy, as well as the many other indications, including Phase 2 trials for metastatic triple-negative breast cancer and GvHD, to potentially create significant and enduring value for all shareholders,” concluded Dr. Pourhassan.
