Who We Are
Reliable source of regulatory expertise for your commercialization and compliance goals
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
Sheila D. Walcoff, J.D.
CEO and Founder
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.
Vice President, Regulatory & Operations
Ulyana joined Goldbug in 2016 as a financial controller, but quickly grew to be a leader within the organization and became a member of the executive team. In her current role as Vice President, Ulyana oversees client services and operations of the business. During her time at Goldbug, Ulyana acquired substantial knowledge of regulatory science for diagnostic devices and gained substantive experience in the health and science industry. Ulyana plays a key role in Goldbug’s consulting services, which includes developing regulatory strategies, creating FDA submissions, assessing validation strategies and performance data. She is also responsible for managing company’s day-to-day operations and advancing Goldbug’s mission and vision.
Prior to joining Goldbug, Ulyana spent 15 years in corporate accounting and financial reporting, including cash management, business performance evaluation and internal audits. The last 2 years before joining Goldbug, Ulyana worked as a financial consultant where she gained critical skills in managing client relationships and delivering value-add services.
Ulyana earned her degree from Temple University, where she received a diploma of Bachelor of Science in Accounting and Finance with honors. She also holds an honors diploma from the National Academy of Finance in Ukraine, Bachelor of Finance and Tax Regulation.
Ulyana loves visiting countries around the world and also enjoys exploring famous landmarks in the United States while traveling with her family in an RV. She is passionate about helping kids in need and runs a small non-profit dedicated to supporting children who lost their parents and/or have difficult living conditions.
Haydar Celik, Ph.D.
Senior Director, Clinical and Regulatory
Dr. Haydar Celik is a clinical and device development expert who brings a unique combination of extensive laboratory experience and a strong knowledge of FDA policies and internal procedures. Haydar is a regulatory strategist and a diagnostic expert with in-depth experience in IVD development and commercialization, analytical validation, and clinical evidence generation within regulated environments under design control.
Prior to Goldbug, Haydar served as an FDA senior level reviewer of scientific and clinical data for different submission types including PMA, 510(k), De Novo classification, IDE, Q-submissions, Breakthrough Device Designation requests, Product Development Protocols (PDPs), Annual Reports, and Post-Approval studies. While working at FDA, Haydar provided service as an expert primarily for molecular diagnostics including tissue and liquid biopsy based NGS and PCR tests for CDx use and tumor-gene profiling, multi cancer early detection (MCED) and minimal residual disease (MRD) tests. Also, as FDA’s primary liaison, Haydar worked closely with Clinical and Laboratory Standards Institute (CLSI) on the development of standards for molecular diagnostic tests, and currently continues his role as a committee member for CLSI.
After his work at FDA, Haydar held a management position at a molecular diagnostics company where he gained valuable hands-on industry experience. The company specialized in developing tissue and liquid NGS-based oncology IVDs for CDx, MRD testing and MCED uses. As the Director of Regulatory Affairs, Haydar led cross-functional efforts to guide technology development with requirements for global regulatory approvals, including U.S. FDA and EU (IVDD and IVDR). He also played a pivotal role in building the Quality Management System (QMS) for the diagnostic laboratory in compliance with 21 CFR 820 and ISO 13485.
Haydar has extensive academic and laboratory research experience and is a published author of scientific research conducted in both his native country Turkey, as well as in the United States. He was invited by Georgetown University Medical Center to conduct his post-doctoral studies within the drug discovery and development field for molecularly targeted therapies of pediatric cancers. After completing his post-doctoral research, Haydar continued working in the same University as the Assistant Professor of Molecular Oncology. Later, he joined the laboratory of myeloid malignancies at NIH/NHLBI, where he studied translational human immunology to find ways to detect, prevent and treat AML relapse. Haydar has published 21 peer-reviewed papers with 11 papers as the first or corresponding author.
Haydar earned his Ph.D. and M.S. in Biochemistry from METU in Turkey, where he also worked as a faculty member and currently holds an Associate Professor degree.
In his free time, Haydar enjoys gardening, traveling, and hiking with his wife, two kids and their Labrador Retriever, Pasha. He and his family enjoy spending time with friends, going to the beach, and state/national parks. Haydar is passionate about exploring novel information related to astronomy, space, and reading about the meaning of human existence.
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.
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.
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:
Patient care reimagined through innovative diagnostics and targeted, more individualized therapeutics.
Facilitate advancement of personalized medicine by closing the gap between industry innovators and regulatory bodies and creating pathways for novel products and services.
- 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.