Who We Are

As a health and science attorney with 30 years of legislative and regulatory experience in Washington, D.C., Sheila understands the complexities and intricacies of the legal and regulatory system within the health and science industry. While working with government agencies, Sheila closely collaborated with key stakeholders to establish a regulatory framework for in vitro diagnostics (IVD) as a medical device, gained insights to the policy development process and acquired deep regulatory expertise for laboratory developed tests (LDTs), IVD products, companion diagnostics and digital health. Her extensive industry experience and outside the box thinking cultivates novel, first-of-a-kind strategies for innovative products.

Before founding Goldbug Strategies, Sheila was a health and FDA law partner at the industry leading firm, McDermott Will & Emery LLP. In her role as a partner, Sheila was responsible for developing regulatory strategies for clients and forming productive relationships with FDA. During this time, she was deeply involved in shaping FDA’s regulations for LDTs and developing legislative alternatives. Sheila also worked as Senior Associate of Governmental Affairs at Mayer Brown LLP.

Throughout her career, Sheila has held multiple senior positions within different government agencies, such as Principal Counselor to Secretary Michael O. Leavitt for Science and Public Health Policy at the U.S. Department of Health and Human Services (HHS), Associate Commissioner for External Affairs at FDA, Principal Advisor on the health policy platform at the White House, and Counselor for the Armed Services Committee at the U.S. House of Representatives. While working in the U.S. government, Sheila led various initiatives related to personalized medicine and worked closely with key stakeholders to resolve complex policy issues.

Sheila earned her Juris Doctor (JD) from Georgetown University Law Center in Washington, D.C., and her Bachelor of Arts in Business Administration and History from Minot State University in North Dakota.

Sheila is a life-long entrepreneur and is passionate about starting and building businesses. She loves dogs and is co-owner of a state of the art veterinary hospital, located in Clarksburg, MD.

Stu has more than 30 years of financial and operations expertise, including numerous capital raises, M&A transactions and two IPOs. He has extensive experience resolving complex accounting issues, structuring transactions, and streamlining back office operations for companies ranging from start-ups to mature organizations.

He has worked with numerous organizations to improve back office operations and identify related cost savings. He most recently completed a three-year assignment as SVP-CFO of a $50 million government contractor, which involved a complex turnaround of the business and culminated in the sale of the company in June 2015. Stu spent the first 10 years of his career with Arthur Andersen, LLP, providing financial services and standard audit and advisory services to hospitality, government contracting, transportation, technology, and healthcare clients while also working on numerous M&A and capital raising transactions. He subsequently served as CFO or VP, Finance for several publicly traded and privately held high-tech, government contracting, energy and professional services firms, including the world’s largest solar-thermal power provider.

Dr. Adam Odeh is a seasoned regulatory expert, specializing in novel IVDs and medical devices with machine learning and AI-based algorithms. With over a decade of the industry experience, Adam has led multiple FDA submissions for novel products that achieved clearance for the U.S. market and served as a regulatory liaison for product reviews in Canada, Australia, UK, and EU.  Dr. Oden also has extensive experience with designing and implementing FDA-complain quality management system. He has built quality systems for AI-based products that are certified under ISO 13485.

Throughout his career Adam worked with multiple small to midsize companies with AI/ML based-technologies, as well as large personal genomics company. While at 23&Me Dr. Odeh led a pre-market submission for the direct-to-consumer diagnostic test that achieved first ever FDA authorization. He also accomplished multiple FDA clearances for AI/LM powered software products intended for analyzing medical images (Overjet).

Dr. Odeh earned his Ph.D. in Microbiology and Immunology from the University of North Texas, a bachelor’s degree from Cornell University. He holds a Regulatory Affairs Certification (RAC) and is an ISO 13485: 2016 Lead Auditor (British Standard Institution)