Steve is the Owner and Principal Consultant of Up-n-Up Solutions, a healthcare compliance & ethics consulting firm. Steve has over 20 years experience as a biopharmaceutical compliance and legal operations executive counseling start-ups to large, publicly traded companies on corporate compliance programs, quality systems, corporate finance, mergers & acquisitions, and licensing, with an expertise in FDA’s regulation of drug/device sales and marketing. Steve is a former general counsel and compliance officer for Salix Pharmaceuticals (2001-2006) as well as the former chief compliance officer for Mayne Pharmaceuticals US (2015-2018) and Inspire Pharmaceuticals (2007-2011).
Steve's specialty is providing biopharma, medical device, and diagnostics organizations with business focused advice and solutions for issues related to legal and regulatory compliance, quality systems, and risk management. And while he is very comfortable operating in the trenches on these issues with line staff, he is equally at ease advising C-Suite and Board level clients on high level compliance strategy, assessment, planning, and government enforcement issues.
Steve has enjoyed working with companies in an ever expanding list of therapeutic areas, including: respiratory (asthma/COPD/cystic fibrosis/allergy/smoking cessation); anesthesia (neuromuscular blockers, amnesics, analgesics); cardiovascular (congestive heart failure, atrial fibrillation); neurology (anti-epileptic, mood disorders); gastroenterology (IBD, IBS, and purgatives); ophthalmology (ocular surface infections, dry eye, diagnostics); dermatology (acne); women's health (estrogen therapies); immunology (HAE, immunodeficiency); and subcutaneous injection devices (hydration, surgical adjuncts, diabetes).
In his spare time, Steve enjoys listening to and performing music--a LOT. In fact, since the early 2000s he has been moonlighting as lead vocalist and now manager of an acoustic Americana group known as The Gravy Boys.
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