About Goldbug

In   2011, Sheila D. Walcoff, CEO and Founder, established a boutique consulting firm to advise innovative molecular science and digital health technology companies on their business and regulatory strategies. The name Goldbug Strategies was inspired by the children’s book “Cars and Trucks and Things That Go” by Richard Scarry. The illustrations depict a journey of the main character, Goldbug, through the moving vehicles and organized chaos of the busy streets, striking a parallel to our modern regulatory environment.

Similar to the story in the book, our modern regulatory environment is a “busy, busy world!” with its dynamic nature and complex landscape needed to adapt and keep up with the rapid technological innovations. Navigating the intricate web of the regulatory requirements can be overwhelming and, at times, elusive for diagnostic companies, thus Goldbug Strategies develops solutions and provides guidance needed to achieve desired results.

We are driven by our passion to advance patient care by facilitating the rapid availability of innovative diagnostic products. Goldbug works with a select group of clients who work to revolutionize healthcare services and improve public health. Groundbreaking initiatives, such as expanding genetic testing directly to consumers, advancing detection of cancer at earlier stages, enabling diagnostics for more targeted therapeutics, and providing cost effective testing for infectious diseases to lower socioeconomic populations are at the core of our consulting services. We have a proven record of helping our clients overcome regulatory barriers and advancing their first-of-kind products to market.

Meet The Team

The Goldbug team is a unique group of professionals with multifaceted expertise focused on creating strategic pathways for innovative products and services within the  precision medicine industry. The variety of skillsets and diverse experiences integrated across our team are the foundation upon which we deliver trusted, recognized, and proven value to our clients. Our team is our greatest asset.

Sheila D. Walcoff, J.D.

Founding Principal

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.

Ulyana Kanitska


Ulyana Kanitska serves as a Principal and Chief Operating Officer at Goldbug Strategies LLC. Since joining the firm in 2016, Ulyana has developed an expertise in consulting for IVD medical devices and LDT. Her deep knowledge spans the total product life cycle compliance, with a particular focus on regulatory strategies, FDA submissions and quality management systems.

In her dual role, Ulyana oversees Goldbug’s strategic initiatives and operational execution, ensuring the delivery of high-impact consulting services that meet the complex needs of different clients, ranging from innovative biotech startups to established healthcare corporations. Ulyana’s career is distinguished by her ability to integrate financial acumen with technical and regulatory knowledge. Her strategic vision and operational prowess have significantly contributed to the firm’s growth and reputation for excellence.

Before Goldbug, Ulyana spent over a decade working in different financial roles, including acquisition due diligence, financial audits, and management consulting. She earned her Bachelor of Science in Accounting and Finance from Temple University. She also holds an honors diploma from the National Academy of Finance in Ukraine, in Finance and Tax Regulation.

Outside of her professional work, Ulyana is passionate about helping kids in need. She manages a small non-profit organization dedicated to supporting children with difficult living conditions. Ulyana also enjoys traveling and exploring the world.

Stu Lawson

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 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.

Ariane Guerreiro

Chief of Staff

As Chief of Staff, Ari uses her strong organizational and problem-solving skills to assist with the daily operations of the organization. In addition to collaborating with executive team members to determine and prioritize business strategies, she works closely with the company’s CEO and Founder to provide insight on company operations and tactical support to implement ideas. Ari also plays an integral role in managing the daily operations of the business, including human resources, accounting, and office administration.

Ari’s prior experience includes over 15 years as a client development and marketing professional with the international law firms of Reed Smith LLP and Debevoise & Plimpton LLP, as well as a communications professional with media companies including WorldNow, ABC Primetime Casting and Berman Talent Group (NY subsidiary of United Talent Agency). Ari kicked off her career as an intern for the acclaimed daytime talk show, The Rosie O’Donnell Show.

Ari graduated from the University of Michigan with a Bachelor of Arts in Communication Studies.

Ari enjoys spending time with her husband, two sons and their Golden Retriever, Pringle, a rescue dog from Turkey! When life isn’t keeping her busy, she enjoys the company of family and friends, listening to podcasts, sharing great meals, and laughing as much as possible.

Adam Odeh, Ph.D

SME – Regulatory & Digital Health

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)

Homero Rey, Ph.D

SME – Regulatory & Assay Development

Dr. Homero Rey is an assay deployment expert with over 20 years of experience in the field of molecular diagnostics. He has a strong foundation in the Life Sciences with a B.S. in Biology from M.I.T. and a Ph.D. in Molecular and Cell Biology from U.C. Berkeley.

Dr. Rey started his carrier with some of the leading scientific instrumentation companies, such as Applied Biosystems, Affymetrix, and Pacific Biosciences, where he worked on developing innovative molecular assays and platform applying different technologies, including qPCR, Microarrays, and Next-gen sequencing.  Later in his career, Homero worked on moving molecular diagnostic assays into CLIA and CAP compliant clinical laboratories, building and leading effective technical teams to develop RUO, LDT, IVD and Companion Diagnostics assays for the industry pioneers such as Genomic Health, Complete Genomics, Asuragen, and Thermo Fisher Scientific.

Homero has a proven record of successful regulatory submissions, including a de novo 510(k) for the gold-standard AmplideX® Fragile X Dx & Carrier Screen Kit (Assurgent) and EUA clearance for the ground-breaking AmplitudeTM Solution platform for high-throughput Covid-19 testing at Thermo Fisher Scientific. Dr. Rey has also developed an extensive experience with GxP principles, typically operating under ISO 13485 and utilizing various Quality Management Systems and design control frameworks.

Our Commitment

Goldbug consulting services are defined by our vision, mission, and values. Many companies in the precision medicine industry face compliance regulations that may seem unfamiliar and even ill-suited for advancing their innovative technologies. This uncertainty often makes the path forward appear nonexistent. Our commitment is to guide our clients through the complex regulatory and legislative environment to achieve their business goals. Goldbug Strategies pulls from its extensive experience and earned credibility with policymakers to realize possibilities and forge new pathways to overcome potentially costly regulatory roadblocks. Goldbug consulting services are defined by our vision, mission and values:

Our Vision

Patient care reimagined through innovative diagnostics and targeted, more individualized therapeutics.

Our Mission

Facilitate advancement of personalized medicine by closing the gap between industry innovators and regulatory bodies and creating pathways for novel products and services.

Our Values

  • Discerning Client Service: Being committed to our clients and encouraging resourcefulness to deliver the highest quality work product developed with integrity and purpose.
  • Unique Culture: Cultivating a casual, flexible, and enthusiastic work environment that offers interesting and challenging work where we rely on professionalism to drive accountability in achieving goal-oriented success.
  • Expertise-Driven Confidence: Continuously developing our extensive knowledge within our niche to decipher the shadows and illuminate strategic pathways enabling our clients to maximize the commercial value of their innovative products and services.
  • Collective Genius: Embracing a collaborative approach and utilizing our multifaceted expertise to perceive the typically imperceptible.