A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

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Dr Josephine Bautista

Director, Regulatory Affairs

Josie is well versed in regulatory and clinical laboratory sciences and management, with over 30 years of experience in both the private sector and the Federal Government.

While working at the Federal Drug Administration (FDA) that Josie rose through with career highlights including serving as Senior Advisor for In Vitro Diagnostic (IVD) Policy and Regulations and Chair of the Personalized Medicine Team, Office of Blood Research and Review (OBRR), Center for Biologics Evaluation and Research (CBER). In over three decades with the FDA she provided oversight and strategic planning for all compliance activities for new and emerging products, all pre- and post-market activities and training.

Other career highlights include work at Walter Reed Army Medical Center as Laboratory Manager for the Stat Lab and Hematology/Coagulation Division, Laboratory Manager for Maryland Medical Laboratories (now Quest Diagnostics), and Acting Director and Associate Director of the Hematology and Immunology Division in the Office of In Vitro Diagnostic Device Evaluation and Safety and the Associate Director of Compliance at the Center for Devices and Radiological Health (CDRH). Prior to joining Goldbug Strategies, Josie was Senior Staff for Regulatory Affairs in the Molecular Diagnostic Division of Beckman Coulter.

Just prior to joining Goldbug Strategies, Josephine was Senior Staff for Regulatory Affairs in the Molecular Diagnostic Division at Beckman Coulter where she had responsibility for all interactions and submissions to the FDA and international regulatory agencies.

Christine Bump, JD, MPH

Vice President, Strategy

Christine has expertise in decoding and driving the process of medical device regulation for our clients. With emphasis on laboratory developed tests, genetic tests, personalized medicine products, and wellness products at the intersection of FDA and CLIA regulatory policy.

Christine has the unique ability to create ways to market for products that do not have clearly defined regulatory pathways. Her commitment to risk minimization, includes the intersection.

Previous career highlights include working for the Center for Disease Control and Prevention, Hyman, Phelps & McNamara, PC, and Goodwin Procter LLP. Christine was recognized by SuperLawyers as a “Rising Star” in Food and Drug Law, and earned a B.A. with High Honors from Sweet Briar College. She earned a J.D. and M.P.H. from Emory University’s Schools of Law and Public Health, where she was Executive Managing Editor of the Emory International Law Review.

C

Joel Centeno

Vice President, RA/QA Portfolio

Joel has over 17 years experience in molecular diagnostics, medical devices and bio-implants.

His expertise focuses primarily in global regulatory approvals, quality systems, clinical trials, ISO accreditations and FDA inspections. Prior to joining Goldbug, Joel served as Vice President Regulatory Affairs, Quality Assurance, and Clinical Affairs at GenMark Diagnostics and Vice President Regulatory Affairs and Quality Assurance at Enigma Diagnostics and has been responsible for the successful FDA approval of multiple in-vitro diagnostic tests in the area of infectious disease. Joel’s professional career also includes leadership positions at Hologic, Inc., Boston Scientific and Tutogen Medical. Joel received his B.S. in Materials Engineering and Metallurgy from the University of Florida in 1999 and is currently completing a M.S. degree in Quality Assurance from the Southern Polytechnic State University.

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Chris Daly

Chief Operating Officer

Chris has served in leadership roles in healthcare, research, and government sectors as COO and CFO. He has expertise in building the organizational capacity of growing sustainable and profitable companies with special interest in driving new technology and innovation to market.

He has experience as a Founder and Board Chair of several businesses and non-profit community ventures. He has worked closely with several research universities and federal research institutions and served as an advisor and consultant of many successful start-up and early stage technology companies.

Chris attended Cornell University where he graduated with a BA with Distinction and Johns Hopkins University where he earned a Masters in Health Science (MHS) concentrating in Health Finance and Management.

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Rick Fletcher

Affiliated Consultant

Rick has 20 plus years of experience in medical devices, diagnostics, and software; and has specific interest and expertise in Quality System Implementation, ISO 13485, Supplier Auditing, Management Review, and CAPA.

He has implemented and improved quality systems from design control to product transfer and operations. Rick has built a strong reputation as a strategic leader with a broad range of knowledge in the functional areas of regulated companies, including development, quality control, quality assurance and operations.

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Ariane Guerreiro
Office Manager, Client Relations

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 United Talent Agency, ABC Primetime Casting, WorldNow, Debevoise & Plimpton LLP, Reed Smith LLP, 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.

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Ulyana Kanitska

Controller

Ulyana is Goldbug Strategies’ Controller responsible for 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, manufacturing packaging product, where Ulyana worked as an Assistant Controller and was responsible for the internal audits 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.

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Stuart Lawson

Chief Financial Officer

Stuart has more than 30 years’ 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.

Stuart spent the first 10 years of his career with Arthur Andersen, LLP, providing financial services, hospitality, government contracting, transportation, technology and healthcare clients standard audit and advisory services 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, Internet, government contracting, energy and professional services firms, including the world’s largest solar-thermal power provider.

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Jessica Roth, MPH

Affiliated Consultant

Jessica is a reimbursement policy expert who has served as director of health policy in different settings including a law firms, Pharma companies, and non-profits.

She has experience working closely with CMS 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.

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Wendy Sauber

Affiliated Consultant

Wendy is a regulatory affairs leader with over 20 years diverse experience in Medical Devices, In Vitro Diagnostics, Prescription Drugs, Electrotechnical Devices, and Over-the-Counter Medicines.

She is passionate regarding culture and capability-building and is committed to mentoring for individual and team growth. Prior to working with industry leaders such as Life Technologies and Proctor & Gamble, Wendy worked as a healthcare professional including serving as the Leader of Heart Transplant Surgical Unit. Wendy has a BSN from the University of Cincinnati.

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Kelli Tanzella, PhD

Affiliated Consultant

An experienced Regulatory Affairs professional with complex project management skills, Kelli has detailed expertise in related post-market quality audits, FDA inspections, regulatory submissions and approvals (including PMAs). Kelli also has done high level work with international agencies.

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Sheila D Walcoff, J.D.

CEO and Founder

As a health and science attorney with over 20 years of experience in Washington, DC, 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, DC 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 US 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.

Judy Wilber

Affiliated Consultant

Judy has a long and distinguished career as an executive and consultant in Clinical Sciences and Laboratory Operations.

She has worked with large corporations, start-ups, and government agencies including an early career stint as the Chief of Virology for the San Francisco Public Health Department. Her expertise covers fields of Biotechnology, Virology, Clinical Research, Infectious Diseases, Molecular Biology, Life Sciences, Laboratory Medicine, Lifesciences, and Genomics. Judy earned her Ph.D in Microbiology & Biochemistry from Rutgers University.

Michael Williamson

Senior Associate

Michael has deep knowledge of the FDA and CMS Regulatory issues as he has previously worked as a Bloomberg BNA reporter covering medical devices and Medicare Part A. His articles have appeared in Bloomberg BNA’s Health Care Daily Report, Medicare Report and the Medical Devices Law & Industry Report.

Michael regularly covered congressional hearings, conferences, and regulatory affairs and is experienced in interacting with C-level executives, high-ranking governmental officials, and other industry leaders. Michael earned his bachelor of Arts in History from St Olaf College and a Master of Arts in International Commerce and Policy from George Mason University.

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Justyna Zwolak, Ph. D

Scientist-Associate

In addition to her doctorate in Physics from the Nicolaus Copernicus University in Poland, Dr Zwolak has a Master of Science degree in Mathematics and has developed her own software for statistical calculations and verifying statistical methodology for scientific trials.

Her academic work includes studying learning networks and the most effective techniques to communicate and teach complex content in science and math. Prior to joining Goldbug, Justyna completed post-doctoral appointments at Oregon State University and Florida International University, was an instructor at the Johns Hopkins Center for Talented Youth, and has worked as a visiting researcher at Ulm University in Germany, Los Alamos National Laboratory, and the Centre of Quantum Technologies in Singapore.

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(301) 355-2662

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