Hey Augster,
Globestar Therapeutics has been chatting with the FDA for some time in regards to the clinical trial process. Those posts are very old. We know Globestar, themselves, has a team containing individuals with specialties specific to biotech/pharma company growth.
The team,
1. James C. Katzaroff successfully negotiated with the holder of a patented treatment for Multiple Sclerosis for an exclusive perpetual license. Mr. Katzaroff is the founder of Advanced Medical Isotope Corp. (now known as Radiogel) and was the Chairman and Chief Executive Officer from 2007 through December 2016. Since December 2016 to present, Mr. Katzaroff is Senior Managing Director at KATMO, LLC.
Mr. Katzaroff is highly regarded internationally for his proven expertise in corporate organization as well as developing and implementing impactful senior-level corporate strategy. Mr. Katzaroff is passionate about fostering critical investment banking and private investor relationships as well as managing complex stakeholder relationships. Associates and clients continue to trust Mr. Katzaroff with their most critical business needs because of his passion, commitment and proven ability to be a solution provider and create win-win outcomes to the most complex issues that challenge all growth companies.
2. William “Bill” Farley to its Board of Directors. Farley’s experience in discovery and development, as well as his leadership roles at major health care organizations will bring additional resources and expertise to the AngioSoma team
3. Ms. Brooke Greenwald (not sure if she is still on the team) founded Cornerstone Communications, LTD over two decades ago. As an award-winning public relations, marketing and communications professional, Ms. Greenwald has written for hundreds of publications, created content for many of today’s most recognizable companies and their brands, managed full marketing campaigns, created and implemented major public relations and communications campaigns, and worked for some of the largest news organizations in existence today. She has focused her career on healthcare, technology, security, and communications. Greenwald is a former journalist and has worked inside most of the major news networks. Ms. Greenwald holds a master’s degree in Public Relations from the University of Maryland at College Park.
4. Steven F. Penderghast has spent the past three decades focused on clinical and product development, market development and commercialization of medical devices, capital equipment and biologics. His roles have included: clinical and regulatory affairs, product development, market development, sales management, national contracts, and corporate account management. Most recently, Steven served as Corporate Vice President, Health Systems & National Accounts with Becton Dickinson, Inc. He has marketed technologies in the areas of: Vascular and Oncology Drug Delivery, Tumor Ablation, Oncology Therapeutics, Cardiovascular Intervention, Imaging, Urology, General Surgery, and Diagnostics. Mr. Penderghast is a graduate of Pepperdine University, California.
5. Mr. David Croom is an executive management leader and entrepreneur and has broad experience with business processes. Leveraging 30+ years of experience in both large and small companies gives Croom a unique perspective with respect to the regulatory, financial, operational, and personnel-related issues faced by public companies. Mr. Croom is an effective networker and speaker who has consistently worked with everyone from Wall Street to Main Street.
6. Dr. Leonard Wisneski, MD, FACP is Clinical Professor of Medicine at George Washington University, Adjunct Faculty in the Department of Biochemistry and Molecular Biology at Georgetown University and also holds faculty positions in the Medicine and Nursing Departments at The University of Colorado. His medical practice in endocrinology and integrative medicine, spanning three decades, embodies the true meaning of integrative healthcare – an optimal combination of conventional and complementary medicine practiced with a whole-person approach delivered with reverence and humanism. Dr. Wisneski graduated from Thomas Jefferson Medical College and performed his postgraduate training in the field of Internal Medicine and Endocrinology in the George Washington University healthcare system, where he served as Chief Medical Resident in Internal Medicine.
Now, Globestar has a management team that should be able to spearhead development of the company and get Jim in the doors that he needs to try to be successful. Hospitals don't just say yes to everything, nor do they have the space at times to conduct trials, nor even answer you when you reach out.
The other management team normally comes from a specialized organization that can monitor the clinical trial process. Normally, companies would employ a Clinical Research Organization (CRO) to monitor quality control, ethical standards, and data privacy amongst other things. They are crucial to the success of FDA trials. Additionally, the company needs to put together documents, abstracts, data documents, marketing tools, and protocols that will be in place to safeguard humans during this trial so all ethical standards are being met. These documents have to be submitted to the International Review Board (IRB). The IRB is set up of scientists, non-scientists, specialists and alike that will look over all the paperwork to see if it meets ethical and regulated standards. Usually, the head of these documents is the Principal Investigator (PI) that will be taking on the FDA clinical trial at their hospital. I assume the PI is the clinical researcher who has agreed and signed a Clinical Research Agreement (CRA) with Globestar to conduct the trials. It's his/her/they name on the line as they are the one's taking control of the trial process from there on out.
So when he means another management team, this is what I mean. It's a separate team that monitors and conducts the clinical trial. Some of these steps can be ready to be sent but have to wait until a specific clinical researcher at a hospital signs off.
I'm slowly piecing together this entire process as well.
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