Safety Sells Inc.
Safety Sells Inc was founded in 2007 to assist dietary supplement manufacturers in complying with the Dietary Supplement and Non-Prescription Drug Consumer Protection Act requiring that supplement manufacturers report Serious Adverse Events to FDA within 15 business days of receipt. Following this Act, the FDA Amendment Act was published and increased yet again the level of regulatory complexity that companies must navigate.
Safety Sells founders have significant experience with all aspects of Pharmacovigilance in the United States, Europe, and emerging countries. Their breadth of experience in PV, Regulatory Affairs, Pharmaceutical Product Development and promotion provide the basis for their unique approach to advising companies. Safety Sells' position is that as companies ensure safe use of their products, business will grow.
Safety Sells goal is to provide dietary supplement manufacturers as well as traditional pharmaceutical/biologic manufacturers with a range of services to ensure the development of a robust business from safe product use.
Safety Sells can provide advice on how to set up effective, efficient, and compliant internal safety operations as well as successful outsourced safety operations if this supports the business model. We can provide additional services, such as product information, signal detection, report writing, etc. to assist with whatever are the needs of the company.
Safety Sells is no longer offering standalone services at this time but its leadership team can be reached with any questions.
Leadership
Gregory J Fiore, MD - Founder and President
Dr. Fiore earned multiple academic awards during his undergraduate years and was elected to the Mortar Board Honor Society in recognition of both academic prowess and leadership ability. During medical school he earned several awards for academic performance, clinical ability, and leadership. He was elected to the Alpha Omega Alpha honor society in his third year of medical school and received a Trustee Merit Scholarship.
Dr. Fiore was the top student in his medical school class and joined the staff at Harvard University Medical School for internship and residency in Internal Medicine at Brigham and Women’s Hospital. He was promoted to the role of Fellow in Pulmonary and Critical Care Medicine at Harvard after only 2.5 years of residency, a full six months early. He completed clinical Fellow Ship in the Harvard combined pulmonary program. During both his residency and fellowship Dr. Fiore worked as an Internist at several Boston area hospitals.
Dr. Fiore was recruited from Harvard to join the world’s premiere management consultancy, McKinsey and Company, where he worked across industry segments. Projects included the creation of an “accelerator” to assist life sciences companies develop successful business strategies and obtain necessary resources. Dr. Fiore also worked with McKinsey client service teams to evaluate how Disease Management programs might add value to the portfolios of medical products companies. He also assisted with determination of options to expand pharmaceutical products into new markets.
From McKinsey and Company, Dr. Fiore was joined the Global Pharmacovigilance team at Abbott Laboratories in a role where he was charged with spearheading the integration of the pharmacovigilance departments of Abbott Laboratories and the recently acquired Knoll Pharmaceuticals. Dr. Fiore worked on this project for several months before turning it over to an external consultancy for additional resourcing.
Dr. Fiore was responsible for the safety of the billion dollar Cardiovascular and Metabolic drug portfolio. He was selected to participate in key initiatives in Drug Safety and was appointed by the Chief Scientific Officer to work on a special project. Dr. Fiore received an Employee Recognition Award for his work at Abbott.
Dr. Fiore was then recruited to head Drug Safety at a billion dollar specialty pharmaceutical company, The Medicines Company. This role required complete re-design of all drug safety activities to create a scalable function that could support the >50% compounded annual sales growth as well as clinical programs enrolling more than 20,000 patients. Specific activities included:
- Designing the Pharmacovigilance Organization, including authoring all written procedures
- Hiring and training the drug safety team
- Performing all signal detection activities
- Developing and executing an outsourcing plan
- Transitioning all safety data into the ARGUS safety database
- Authoring several responses to global regulatory authorities (including Risk Management Plans)
- Successfully leading the company through an inspection of Pharmacovigilance Systems
Also, while at The Medicines Company, Dr. Fiore took the leadership role for a Phase II clinical program, handling such activities as:
- Securing the rights to study the compound from the owning company
- Authoring Clinical Development Plan
- Pre-marketing Safety Plans
- Authoring the Phase II Protocol
- Authoring the Data Monitoring Committee Charter
- Sourcing a vendor to perform the trial, including training the vendor
- Developing an Executive Committee to advise the trial team
Dr. Fiore was then recruited from The Medicines Company to be the head of North American Pharmacovigilance for a $50 billion US pharmaceutical company. At this company, Dr. Fiore served as acting head for Latin America and Asia Pacific while in his role as North American Head. He was the business owner of the global safety database and helped establish the system to track and generate data outputs to support all health authority and internal data requests.
Dr. Fiore's team handled more than 35,000 safety reports per year and he developed the process by which volume and quality metrics were developed, captured, and used for performance management. He also oversaw the management of all safety data exchange agreements with partners as well as maintaining the partner safety relationships and compliance with agreements.
Dr. Fiore was responsible for outsourcing safety activities at the company and controlled a budget of ~$15mm along with a team of more than 100 Pharmacovigilance Professionals in multiple countries. Under his watch, the company successfully underwent several health authority inspections.
Dr. Fiore is a recognized expert and has lectured on the topics of setup of compliant PV operations in a small pharmaceutical company and successfully outsourcing PV activities.