YOUR GOLDBUG EXPERTS
Sheila D. Walcoff, J.D.
CEO and Founder
As a health and science attorney with over 20 years of experience in Washington, D.C., Sheila understands the complexities of the health and science industry, as well as the intricacies of the legal and regulatory system.
After graduating from Georgetown University Law Center in Washington, D.C. in 1993, she became a health and FDA law partner in the international law firm of McDermott Will & Emery LLP. Her senior executive government service includes Counselor for Science and Public Health Policy to U.S. Department of Health and Human Services (HHS) Secretary Michael O. Leavitt and Associate Commissioner for External Affairs at the Food and Drug Administration (FDA).
Sheila is a life-long entrepreneur and has started, built, and sold several businesses in addition to Goldbug Strategies.
Chief of Staff
Ari is the right hand for Goldbug’s Founder & CEO and helps keep things running smoothly. Her experience includes over 15 years as a marketing and communications professional with Reed Smith LLP, Debevoise & Plimpton LLP, WorldNow, ABC Primetime Casting, Berman Talent Group (NY subsidiary of United Talent Agency), and as an intern for the Rosie O’Donnell Show. Ari graduated from the University of Michigan with a Bachelor of Arts in Communication Studies.
Director of Operations
Ulyana is Goldbug Strategies’ Controller and is responsible for the accounting operation and financial information of the company. As a part of the team, Ulyana contributes to the wide range of decision-making processes and provides financial analysis of various outcomes.
Prior to Goldbug, Ulyana worked Alaco Consulting, a boutique accounting consulting firm, acting as a Controller for multiple small to mid-size clients, operating in various industries. While at Alaco Consulting, she developed an expertise in project base accounting and reporting. Ulyana’s previous experience also include Clondalkin Group, a large international manufacturing company, where Ulyana worked as an Assistant Controller and was responsible for the internal audits and financial reporting. Ulyana has a Bachelor of Science in Accounting and Finance from Temple University and a Bachelor of Science in Finance and Tax Regulation from the National Academy of Finance in Lviv, Ukraine.
Director, Regulatory Affairs
Katie Chowdhury joins the Goldbug team with over thirteen years of US Food and Drug Administration (FDA) experience. During her tenure at the Agency Katie held multiple roles as a senior reviewer and regulatory health scientist in FDA’s Center for Devices and Radiological Health (CDRH). In her most recent role on the Partnerships to Advance Innovation and Regulatory Science (PAIRS) team Katie served as the primarily liaison between the Center and their largest public-private partnership, the Medical Device Innovation Consortium (MDIC) where she supported regulatory science projects in clinical diagnostics, case for quality, early feasibility studies, computational modeling and simulation, science of patient input, cybersecurity and the National Evaluation System for health Technology coordinating center (NESTcc). She also managed research and regulatory science activities internally for the Center. Before her position in PAIRS Katie spent four years in the Office of Orphan Products Development (OOPD) where she was a grants officer for the rare disease clinical trials grants program as well as the pediatric device consortium grant program. Katie was also the lead reviewer of Humanitarian Use Device (HUD) applications and supported the drug designation program. Prior to her OODP experience Katie was a senior scientific reviewer in the Intervention Cardiology Devices Branch (ICDB) for nine years where she successfully led the review of premarket submissions such as premarket notifications, premarket applications, investigational device exemptions, company q-sub requests, and contributed to guidance documents and special projects for therapeutic medical devices such as drug eluting stents (combination product), bare metal stents, guidewires and balloon angioplasty catheters. Katie also successfully completed the Leadership Readiness Program in 2013 and acted as Branch Chief of ICDB. Prior to FDA Katie held a clinical and ventricular assist device (VAD) engineer position at the University of Maryland Medical Center where she supported the biomedical technician team and trained staff in the clinical care units. Katie holds her bachelor’s degree in Bioengineering from the University of Pittsburgh (Cum Laude) in 2004 and her Master of Science in Healthcare Technology Management from Marquette University in 2005
Andrew L’Huillier, PhD
Director, Regulatory Affairs
With over a decade of experience in research and product development, Andrew has a wide range of experience from immuno-oncology therapeutics through diagnostics. Through his career Andrew has increasingly moved from product to regulatory. Andrew has developed diagnostics still used today, lead development of companion diagnostics for clinical trials, and overseen product launch from concept through regulatory approvals. Andrew received his PhD from Rutgers University and has worked extensively in the Biotech and Cell & Gene Therapy industries including Enzo Life Sciences, Advaxis Immunotherapies, and Americord Registry. Andrew loves to see his experience help high impact products make it to market where they can benefit patients.
Chief Financial Officer
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 turn-around 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.
Kelli Tanzella, Ph.D.
An experienced Regulatory Affairs professional with complex project management skills, Kelli has detailed expertise in post-market quality audits, FDA inspections and regulatory submissions and approvals (including premarket approvals). Kelli also has done high-level work with international agencies.
Jessica Roth, M.P.H.
Jessica is a reimbursement policy expert who has served as director of health policy in different settings including law firms, pharmaceutical companies, and non-profit organizations. She has experience working closely with the Centers for Medicare & Medicaid Services in developing and implementing health care pay-for-performance and value-based purchasing objectives.
Jessica has a Bachelor’s degree from Colgate University and a Master’s degree in Health Policy & Management from Yale University.
next. generation. advisors.
Goldbug Strategies LLC
510 Diamondback Drive, Suite 570
Gaithersburg, Maryland 20878
+1 (301) 355-2660