WELCOME TO PHYSIS INTERNATIONAL
NEWS
07-01-2021
Physis submits final IP package to USPTO
06-30-2021
Physis passes final deadline for FDA submission.
About Us
Who We Are
Frederick O. Cope, Ph.D., M.S., F.A.C.N., C.N.S., CEO has served as Vice President and Senior Vice President and Chief Scientific Officer of Pharmaceutical Research and Clinical Development at Navidea from February, 2009 until October, 2018. Prior to serving at Navidea, Dr. Cope served as the Assistant Director for Research and Head of Program Research Development for The Ohio State University Comprehensive Cancer Center, The James Cancer Hospital and The Richard J. Solove Research Institute. Dr. Cope also served as head of the Cancer and AIDS product development and commercialization program for the ROSS/Abbott Laboratories division, and head of human and veterinary vaccine production and improvement group for Wyeth Laboratories. Dr. Cope served internships at Baylor University, Vanderbilt University, and the NIH/NCI (pathology) and as a fellow in oncology at the McArdle Laboratory for Cancer Research at the University of Wisconsin-Madison and was the honored scientist in residence at the National Cancer Center Research Institute in Tokyo; he is the recipient of the Ernst W. Volwiler Award and nominee for the EROTC Marie Curie award. Dr. Cope is also active in a number of professional and scientific organizations such as serving as an editorial reviewer for several professional journals. Dr. Cope received his B.Sc. from the Delaware Valley College of Science and Agriculture, his M.S. from Millersville University of Pennsylvania and his Ph.D. from the University of Connecticut.
Michael S. Blue, M.D., F.A.C.E.M., CMO, has served as Chief Medical Officer and medical advisor to numerous corporations including Hy-Gene Biomedical, Cardinal Health, and Navidea Biopharmaceuticals Inc., as well as technical medical consultant to investment groups. Dr. Blue has extensive clinical trials and regulatory experience in tissue engineering, medical imaging, and emergency and critical care. Dr. Blue has also served as Medical Director of Emergency Services for Mount Carmel-St Ann's Healthcare Systems. Dr. Blue received B.S. degree from Miami of Ohio University and his M.D. degree from The Ohio State University College of Medicine.
Simon A. Blackburn, B.A., CCRA, CCO, has more than 25 years experience in clinical trials, and drug and device development. Mr. Blackburn has served as project lead and head of clinical operations for numerous companies, including Cardiox Corporation, Neoprobe Corporation. Mr. Blackburn has also spearheaded Blackburn International, an international CRO in partnership with StatKing Clinical Services data management organization. Mr. Blackburn received his B.A. degree from Denison University.
LATEST NEWS & OPPORTUNITIES FOR PHYSIS
TOP NEWS
(01 July 2021) Physis submits final IP package to USPTO for an anti-Covid agent. Physis submits a final patent documents (CT-RX-I/I-001TL) to the USPTO for use in treating Covid 19 disease. This patent is based on Physis' data derived from cadaver tissue assessments. Physis intends to now publish these data for general review.
(30 June 2021) Physis passes final submission deadline for FDA submission. Physis passed the deadline (19 June 2021) for submission of materials to FDA for review of PI-OC-T/G-0001PF. Physis is happy to announce that it exceeded this deadline for primary materials by more than 2 months. Supplemental materials were also submitted more than a month prior to the deadline. Physis anticipates its meeting with the Agency in the coming months.
(13 May 2021) Dr. Brigitte Boldyreff is appointed as key advisor to Physis. Physis is happy to announce the appointment of Dr. Brigitte Boldyreff as an advisor to Physis. Dr. Boldyreff brings years of experience in biotechnology, company development and product commercialization as an aide to Physis. Her biosketch is listed below for review.
(12 May 2021) Dr. Michael McGrath, advisor ,takes over new company: Dr. Michael McGrath, a long-time advisor to Physis, will be leaving the Board and advisory position with Physis. He will now assume the role of a C-officer in a biotechnology company in California. Dr. McGrath has been an superlative aide to Physis during his tenure and we wish him the best. He will remain as friend and ally to Physis.
(07 May 2021) Physis submits additional information to FDA in advance of review: Physis has submitted supplemental information to FDA as of 7 May 2021. This additional information relates to the review and assessment of claims for the PI-OC-T/G-0001PF agent. This additional information is intended to aid the Agency in its assessments.
(30 March 2021) Physis submits second package to FDA in advance of meeting: Physis has submitted a comprehensive package to FDA in anticipation of FDA's review of Physis' PI-OC-T/G-0001PF agent. Physis is working with FDA on possible early assessment.
(19 January 2021 & 12 December 2020) Physis receives response on proposed "B" meeting with FDA: Physis has received notices from FDA with acceptance for a meeting regarding PI-OC-T/G-0001PF. Physis is providing a second package to FDA for the upcoming meeting now scheduled for August 2021.
(15 December 2020 & 12 January 2021) Physis receives positive test results affecting the potential development of its Covid-19 therapeutic agent CT-RX-I/I-001TL. Physis has received data evaluations from human tissue samples from Covid-19+ that further suggest that its agent would provide significant benefit to SARs-Cov-2-infection. These data cover pulmonary, liver and GI assessments. Physis is pursuing the IP and development of this product set.
(30 October 2020) Physis files review package with FDA: Physis, today, filed a review package with FDA regarding its PI-OC-T/G-0001PF product line. Physis anticipates discussions with FDA in the coming weeks.
(15 October 2020) Physis receives IND assignment for its drug line PI-OC-T/G-0001PF: Physis has received from FDA an IND assignment for its line of topical drug products. Physis is completing arrangements with FDA for review.
(9 October 2020) Physis received a follow-up data assessment regarding the potential therapeutic efficacy of Covid-19 therapeutic agent CT-RX-I/I-0001TL: Physis has received a second prospective data set evaluating the potential of its anti-Covid-19 agent in Covid-19-infected human tissues derived from deceased infected patients. The data further indicate that 0001TL has a strong potential to provide significant relief from Covid-19 -induced symptoms even in later stages of the infection. The data, again, suggest that cell types other than those expressing ACE2-r may be involved in infection and/or disease progression. Physis is completing a third round of evaluations in a large patient population tissue sample.
OTHER NEWS:
(6 August 2020) Physis received the first data assessment regarding the potential therapeutic efficacy of Covid-19 therapeutic agent CT-RX-I/I-0001TL: Physis has received the first prospective data evaluating the potential of its anti-Covid-19 agent in Covid-19-infected human tissues derived from deceased infected patients. The data indicate that 0001TL has a strong potential to provide significant relief from Covid-19 -induced symptoms even in later stages of the infection. Additionally, the data suggest that cell types other than those expressing ACE2-r may be involved in infection and/or disease progression. Physis is seeking additional information and evaluations of 0001TL.
(2 July 2020) Physis files patent for new anti-Covid-19 therapeutic agent CT-RX-I/I-0001TL: Physis has filed a patent with the USPTO for a new therapeutic agent for the control of Covid-19 (Sars-2-Covid), corona viruses, and other virus species. This agent is focused on mitigation of even late-stage symptomology of Covid-19 infection. More information will become available as further testing progresses.
(28 June 2020) Physis completes CMC arrangements for manufacture of Six PI/OC-T/C products and product line: Phys has completed manufacturing arrangements its entire PI/OC-T/C product line comprised of 6 key products. Physis anticipates completion of product 0001 by EOY.
(30 May 2020) Physis completes first testing of it new anti-Covid-19 therapeutic agent CT-RX-I/I-0001TL: Physis has completed the first testing from human samples of Covid-19 with much better than expected results. Physis provide updates as further testing progresses.
(24 February 2020) Physis completes regulatory assessment and final strategy four-product drug line: Physis has expanded it product line and has completed the regulatory strategy and data evaluations for these products. Physis is now planning on completing the regulatory assessment and review.
(12 November 2019) Physis announces agreement with FDA advisory group in Washington, D.C.: Physis recently signed an agreement with Olsson Frank Weeda Terman & Matz PC of Washington, D.C. Special counsel will be provided to Physis for the approval of its first product PI-OC-T/G-0001PF.
(11 August 2019) Physis adds Dr. Gerald M. Haase to advisory group: As of this day, Physis has added Dr. Gerald Haase to its group of distinguished advisors. Dr. Haase is well skilled in technology development and commercialization of medical products. We are pleased that he has offered his counsel to Physis.
(11 July 2019) Physis adds Dr. Olaf-Georg Issinger to advisory group: As of this day, Physis has added Dr. Olaf Georg Issinger to its advisory panel of distinguished advisors. Dr. Issinger is well skilled in drug action and commercialization of biological products. We are pleased that he has offered his counsel to Physis.
(09 July 2019) Physis will add two new advisors to its distinguished advisory panel: Physis has identified two additional authorities that will be added to its panel of distinguished advisors.
These two additional persons will provide further medical and mechanistic expertise as well as business experience in product development and disposition. Look for the postings in the near future.
Directors and Advisors Group
Brigitte Boldyreff, Dr.rer.nat.habil, B.Sc.
Brigitte Boldyreff, Dr.rer.nat.habil, B.Sc.
Brigitte Boldyreff, Dr.rer.nat.habil, B.Sc.
Adel A. Mikhail, Ph.D.
Brigitte Boldyreff, Dr.rer.nat.habil, B.Sc.
Brigitte Boldyreff, Dr.rer.nat.habil, B.Sc.
Kenneth C. Williams, Ph.D.
Brigitte Boldyreff, Dr.rer.nat.habil, B.Sc.
George Q. Mills, M.D., M.B.A.
George Q. Mills, M.D., M.B.A.
Olaf-Georg Issinger, Dr. rer. nat. habil.
George Q. Mills, M.D., M.B.A.
Olaf-Georg Issinger, Dr. rer. nat. habil.
Olaf-Georg Issinger, Dr. rer. nat. habil.
Olaf-Georg Issinger, Dr. rer. nat. habil.
Gerald M. Haase, M.D.
Olaf-Georg Issinger, Dr. rer. nat. habil.
Olaf-Georg Issinger, Dr. rer. nat. habil.
Directors and Advisors Group
Brigitte Boldyreff, Dr.rer.nat.habil, B.Sc.
Brigitte Boldyreff, Dr.rer.nat.habil, B.Sc ., Has more than 20 years experience in biotechnology commercialization. She is founder of Kinase Logistics ApS, a solo company which now currently serves as European Agent for the Japanese company Carna Biosciences Inc. She holds a PhD degree in Molecular Biology from the University of Lübeck, Germany and a Bachelor degree in Human Nutrition and Health from the University College Haderslev, Denmark. She had been working as Executive Director at Kinase Logistics ApS, as CSO at KinaseDetect ApS and had been Associate Professor at the Institute of Biochemistry and Molecular Biology, University of Southern Denmark. She has a strong interest in receptor and signal transduction mechanisms as these related to mechanisms of action and efficacy, especially the physiological role of protein kinases and their involvement in diseases, as well as impact of nutrition on health. In addition, She has contributed > 60 peer reviewed publications in numerous areas including oncology, vascular disease, and bone diseases, among others.
Adel A. Mikhail, Ph.D.
Adel A. Mikhail, Ph.D., is the founder and CEO of Phylogeny Inc., a company that specializes in tissue analyses and molecular pathology. Most recently, Dr. Mikhail has merged his company with two other organizations to form Discovery Life Sciences (Phylogeny, Conversant Bio, and Folio Bio). Dr. Mikhail has more than 25 years in bio-corporate development, investment, and biotechnology applications to new and repurposed drugs and drug development.
Kenneth C. Williams, Ph.D.
Kenneth C. Williams, Ph.D., is Full Professor in the Department of Molecular Biology at Boston College. Dr. Williams work has centered on inflammation and normal and diseased states. This work includes: a) studies to define subpopulations of macrophages in the CNS and their precursors in blood and bone marrow, b) the role of the cellular immune system especially CD8 T cells controlling monocyte/macrophage activation and CNS pathogenesis, and c) developing drugs that target HIV and SIV infected/activated macrophages resulting in cell death or deactivation. In addition, we are exploring an exciting field of emergent populations of monocytes and dendritic cells that are expanded with disease. This work uses a monkey model of rapid, consistent AIDS and neuroAIDS, CD8 T lymphocyte depletion, MR spectroscopy, monocyte/macrophage biology and immunology. Dr. Williams has more than18 years of experience in the field of inflammation and disease.
George Q. Mills, M.D., M.B.A.
George Q. Mills, M.D., M.B.A. has held several senior roles at the FDA, including as a Division Director in the Center for Drugs (CDER), Branch Chief and designated Acting Deputy Division Director of the Biologics Oncology Division at the Center for Biologics Evaluation and Research (CBER). In these roles, he provided expertise in medical diagnostic imaging and therapeutic radiopharmaceutical oncologic biologics and drugs. He also served as the CBER/CDER expert in conjunction with the review of radiographic imaging submissions in support of multiple licensure submissions. Dr. Mills also served as Vice President of Medical Imaging for Perceptive Informatics, a PAREXEL Company. Dr. Mills has spoken at numerous industry conferences and has published articles in scientific journals and industry publications on imaging and regulatory topics, including the FDA Critical Path Initiative. Dr. Mills has been certified by the American Board of Nuclear Medicine and the American Board of Pathology, Anatomic and Clinical Pathology. Dr. Mills holds a M.D. Degree from Creighton University in Omaha, Nebraska, a M.B.A. degree from Pepperdine University, and a B.A. degree from the University of Nebraska.
Olaf-Georg Issinger, Dr. rer. nat. habil.
Olaf-Georg Issinger, Dr. rer. nat. habil., is Professor emeritus at the Department for Biochemistry and Molecular Biology at the University of Southern Denmark – Odense, DK. Dr. Issinger is founder of KinaseDetect ApS, a privately held company involved in production and sale of protein kinases, substrates and antibodies for pharmaceutical industries. Dr. Issinger’s interest in protein kinase research began as a postdoctoral fellow at the Univ. of Calif. Davis. He continued his career as Assistant professor at the Univ. of Stuttgart and Associate professor at the Medical Faculty of Saarland University – Homburg/Saar, Germany. He worked as a guest scientist at the National Cancer Center in Tokyo (1986/87) and at the St. Vincent’s Institute, Melbourne, Australia (2009). He received several special awards and serves as reviewer on various boards and international Journals. Dr. Issinger received his M.S. from the Free University in Berlin and his Ph.D. from Freiburg University, Germany. Dr. Issinger has authored over 180 scientific articles in the fields of protein kinases, signal transduction and cancer.
Gerald M. Haase, M.D.
Gerald M. Haase, MD, is Clinical Professor of Surgery at the University of Colorado, School of Medicine and principal of Rocky Mountain Medical Research. He co-founded of a nutritional science research and development entity that was acquired by a public company, New Age Corporation, of which he became Chief Medical Officer. He was the co-founder of CURE, a non-profit foundation assisting China in management of cancer in children. Dr. Haase has been actively involved in medical research and clinical trials for 35 years including the design of central venous access devices, applications for intra-operative radiation therapy in pediatric solid tumors, technical surgical innovations in adult and childhood cancer, and development of novel strategies for antioxidant micronutrient therapy for war fighter protection, adverse clinical conditions, against hazardous exposures. Dr. Haase also served as chairman of the Board of Scientific Counselors of the Cancer Treatment Research Foundation and as a senior member of the Commission on Cancer of the American College of Surgeons. He was appointed to the Board of Trustees of the National Childhood Cancer Foundation and served on its Medical and Scientific Advisory Board. He has published/ presented more than 200 scientific papers, is the inventor/co-inventor of ten issued U.S. patents for micronutrient and phytonutrient therapy with five pending patents and been the recipient of clinical research grants and contracts funded at a several million-dollar cumulative level. Dr. Haase participated with the International Office of the National Cancer Institute and has been an examiner in pediatric surgery for the American Board of Surgery. He is a member of more than 25 professional societies including the American Association for Cancer Research, International College of Surgeons, American Academy of Pediatrics, New York Academy of Sciences, American College of Physician Executives, and is a charter member of the International Society of Pediatric Surgical Oncology. In addition, he served on the Board of Directors of the Pacific Association of Pediatric Surgeons. Dr. Haase received his undergraduate degree from the Johns Hopkins University and M.D. degree from Tufts University School of Medicine with graduate honors in research. His surgical training was at the University of Colorado, Health Sciences Center and he specialized in pediatric surgery and oncology at Children’s Hospital Medical Center, Boston, and Nationwide Children’s Hospital, Columbus, Ohio.
Key Efforts
Focus on Innovation and Opportunity
Our company understands the role of medicine in health care, and the clinical and regulatory processes for providing therapeutic agents to those in need. Our team of experienced professionals stays current about the latest drug trends and development.
Drug Development and Testing
Our team is constantly keeping up with medical trends and technology and strives to find better ways to improve the health of patients in an
ever-changing industry.
Regulatory Assessment and Trials
Other drug developers work with us to support clinical trials. We maintain the highest level safety when it comes to testing, manufacturing and transferring of products.
US
Culture
· Develop relationships that make a positive difference patients’ lives.
· Deliver life-improving value to patients.
· Uphold the highest research and clinical study standards always.
· Work together, across boundaries, to meet the needs of patients.
· Respect for People - value our people, encourage development and reward performance.
· We are good citizens and stewards in the global communities in which we work.
· Exhibit a strong will to win in the marketplace and in every aspect of our business.
· We are responsible for our own success and the delivery of life-improving products.
Committment
Physis is proceeding aggressively to become a leader in new, specialty, and off-patent medicines. Physis is formed as a global operation in support of a strategy and vision where Physis delivers an enduring health impact across its ethical product line of medicines. Physis intends to act as a trusted and respected associate in the healthcare sphere. Physis seeks to provide reasonable cost healthcare in areas of health crisis and to all economic environs, with a goal of making healthcare available to all in need.