S. Michael Imperiale Jr
Former Vice President
S. Michael Imperiale Jr M.D. | Rigid Standards
S. Michael Imperiale Jr M.D. is a Board member for ScripsAmerica, a provider of strong, low cost, broad based marketing, sales and distribution of generic and branded medicines.
ScripsAmerica markets its pharmaceuticals through mass merchants, supermarkets, chain and independent drug stores, HMOs, and other means. S. Michael Imperiale Jr M.D. says that it takes an average of about twelve years for an experimental medication to go from the laboratory to the American public, if it even makes it at all. That's because of the rigid standards put in place by the Food and Drug Administration, which is the government agency that regulates medications in the United States.
S. Michael Imperiale Jr M.D. says that only five of every five thousand drugs that go into preclinical testing ever go on to be tested on human subjects. And only one of those five that reach the stage of human clinical testing is approved by the FDA, which means that the chances of an experimental new drug being approved for market are really quite slim, only one in five thousand.
S. Michael Imperiale Jr M.D. served as the Vice President of Clinical Research Operations at Hana Biosciences in South San Francisco, California. He is also a former Senior Director at BioMarin, a pharmaceutical company based in Marin County in Northern California.
S. Michael Imperiale Jr M.D. - Family Time
S. Michael Imperiale Jr M.D. is a Director and Member of the Audit Committee at ScripsAmerica, the provider of a system of broad based national marketing and distribution of generic and branded pharmaceuticals. He is also a member of the company's Nominating Committee.
With his many work related duties, S. Michael Imperiale Jr M.D. leads a very busy life, but he knows the importance of making time for his family, and cherishes the hours he is able to spend with them. Marriage and families are probably the oldest and most resilient of human institutions, and he understands that families are crucial partners in promoting positive social skills. People group themselves into families in order to find emotional, physical, and communal support.
S. Michael Imperiale Jr M.D. understands that families are basic and foundational social units, and that this is true in human communities all over the world. They are intimate social environments and the places that most of us begin the vital processes of socialization, and learn how to survive and thrive in the world. Life in families can bring us great joy and be a never-ending resource for helping each of us endure the difficulties that life always brings with it. It is a source of great strength to S. Michael Imperiale Jr and one that he values above all others, because it contributes so much to his happiness and sense of well being.
S. Michael Imperiale Jr M.D. - Testing Pharmaceuticals
S. Michael Imperiale Jr M.D. is a Board member at ScripsAmerica, a provider of supply chain management for generic and branded pharmaceuticals.
As S. Michael Imperiale Jr M.D. knows, there is a strict process for getting new pharmaceuticals and medical supplies approved by the government. The agency responsible for approving new medications is the Food and Drug Administration (FDA). The FDA requires pharmaceutical companies to follow a specific sequence before they approve any new drug for sale to the public.
The first step is Preclinical testing, when the pharmaceutical company performs its own studies. This is done before the new medication is ever given to a human subject. The purpose is to demonstrate the effectiveness of the drug on the disease it is meant to treat. Next is an IND, or Investigational New Drug application. The company files this with the FDA in order to begin testing the new drug on humans. From there is Phase I Clinical Trials, when the first tests are done on healthy, human volunteers. Next are Phase II Clinical Trials, which are larger trials meant to determine minimum and maximum dosages. Then, in Phase III Clinical Trials, even larger testing is done, with the results submitted to the FDA. As S. Michael Imperiale Jr knows, Phase III subjects are examined for safety, efficacy and side effects.
From there, a New Drug Application is filed with the FDA, which can take up to two and a half years to approve. Finally, Phase IV studies collect additional data. As S. Michael Imperiale Jr M.D. knows, these are sometimes called post-marketing studies.
S. Michael Imperiale Jr - Hiking Tips
Hiking has never gone out of style, but it is enjoying a surge in popularity across the United States. Most experienced hikers have an entire regimen he observes when going on longer hikes. This includes wearing a pair of sturdy hiking shoes. He says that for shorter hikes, sneakers or running shoes are fine, but on more ambitious routes he suggests something a little hardier. For day hikes, you need to have a specific checklist of gear. Sun protection is high on the list, and he says to bring a hat, a pair of sunglasses, sunscreen, and lip balm with a 15 SPF. You should always take a jacket along, too, even on warm summer days. You should bring a compass and a big water bottle and some granola bars, too. All of your gear should be stored inside a backpack for easy transport. Then you are ready to hit the trail.
S. Michael Imperiale Jr., M.D. is a former Vice President of Clinical Research Operations at Talon Therapeutics, Inc., and a former Senior Director of Medical Sciences at Nuvelo, Inc., where he was the clinical lead and strategist of the oncology program, and managed the team of Medical Science Liaisons. He also loves to hike when he can.