We are thrilled to attend PMWC - Precision Medicine World Conference this week! Please join our founder and CEO, Sheila D. Walcoff, JD, for her panel on Wednesday and learn more about ‘Navigating Regulatory Hurdles and Reimbursement Pathways for Oncology Innovations’. The Goldbug Strategies LLC team will also be available to meet and collaborate – join us at Booth D1146 to learn more about how we can support your regulatory needs! Tal Behar #PMWC25 #FDA #Regulatory
关于我们
Goldbug Strategies is a regulatory consulting firm that works with select clients engaged in developing and marketing molecular therapies, in-vitro diagnostics, and innovative digital technologies. We provide strategic insight, planning and implementation to enable our clients to successfully drive the development, commercialization, and ongoing marketing of their new and modified products. We use the collective genius of our team to drive customer value by creating unprecedented solutions to regulatory barriers. Our expert consultants focus on a niche segment of the U.S. Food & Drug Administration (FDA) across different IVD technologies and platforms (NGS, PCR, Immunoassays, Flow Cytometry, etc.), therapeutic areas (oncology, infectious diseases, neurodegenerative disorders, etc.) and clinical use areas (single site IVD, distributed kits, direct to consumer (DTC), over the counter (OTC), laboratory developed tests (LDTs)). Our approach to client projects incorporates an entrepreneurial perspective with the necessary expertise to meet company’s consulting needs in an evolving marketplace and regulatory policy environment. Our expert consulting services create benefits that convert into tangible results for companies that have the desire to disturb the industry with innovations.
- 网站
-
www.goldbugstrategies.com
Goldbug Strategies LLC的外部链接
- 所属行业
- 商务咨询服务
- 规模
- 2-10 人
- 总部
- DC Metro Area
- 类型
- 私人持股
- 创立
- 2011
- 领域
- FDA Regulatory、Companion Diagnostics、Next Generation Sequencing、Genomics、Digital Health、In Vitro Diagnostics、Precision and Personalized Medicine、Lab Developed Tests、Clinical Trials、Quality Management Systems、Oncology Diagnostics、Investor Due Diligence和Clinical Decision Support Software/IT
地点
-
主要
获取路线
US，DC Metro Area
Goldbug Strategies LLC员工
动态
-
Excellent article written by Lizzy Lawrence at STAT on the political threat to FDA's regulation of lab-developed tests. This piece is an impressive approach to the issue with thorough attention paid to these nuanced details. https://lnkd.in/eR_JuP8K?
-
Goldbug Strategies LLC's Founding Principal and CEO, Sheila D. Walcoff, JD, will join Promise O. from NovoPath for a 6-month review of what’s changed since the FDA released the final rule on Laboratory Developed Tests (LDTs). Please join these expert speakers for an extended Q & A session and get answers on challenges and opportunities your lab faces. https://lnkd.in/gKBjHhk8
-
-
?? Join NovoPath's upcoming Expert Speaker Series as we offer an expanded Q & A on the FDA's Final Rule on LDTs. Six months into the new regulation. Where does your lab stand? Get feedback from expert Sheila D. Walcoff, JD, Founder and CEO of Goldbug Strategies LLC. NovoPath CEO Promise O. will host the event - join us! Spots are limited. Grab your seat here: https://lnkd.in/gKBjHhk8 #laboperations #ldts #diagnostics #fda
-
-
Join Goldbug Strategies LLC's Founding Principal & CEO, Sheila D. Walcoff, JD this Thursday, 9/12 @ 1pm (ET), along with Valerie Palmieri and Emily Johnson for The Dark Intelligence Group's webinar and learn all you need to know about FDA's LDT Rule, including essential actions every lab should take now to calculate the cost-benefit of LDT compliance. #LDT #FinalRule #LDTcompliance
NEW WEBINAR: Everything You Need to Know NOW about the FDA's LDT Rule! Join us for "How to Protect Your Lab’s Proprietary LDTs and Assess the Financial Impact of Compliance," on September 12, 2024 - 1pm ET. This is a 90 minute webinar with live Q&A hosted and offered by Dark Daily. You already know that the FDA’s final rule on Laboratory Developed Tests (LDTs) proposes a radical overhaul of the regulatory status quo that governed these tests for decades. What you don’t know yet are specific steps your lab must follow to bring your existing LDTs into compliance with the new rule so you can continue to offer these LDTs to your clients and produce revenue for your lab. The FDA’s LDT rule is a game-changer for your laboratory. But what you may not realize is how many actions your team must take in the eight short months before the May 6, 2025, compliance deadline arrives. The good news is we can give you a running start to ensure your lab’s most important LDTS are fully compliant by the deadline—thus protecting lab revenue from these LDTs while supporting patient care. You’ll be excited to see, hear, and interact with three nationally recognized experts with direct experience working with federal regulators, including the FDA. During this information-filled 90 minutes, you’ll be able to comment and ask questions directly to the three speakers. Register now to enjoy early-bird pricing! For more information and to register visit https://hubs.ly/Q02M3HBg0
-
-
Join Today's Clinical Lab and Sheila D. Walcoff, JD for a webinar this Thursday, September 5 at 1pm (EST) to learn about Oncology LDTs: How Cancer Labs Can Best Navigate the FDA's Final Rule. https://lnkd.in/gefhx-rV There is significant concern about the US Food and Drug Administration's (FDA) 2024 final rule to regulate laboratory-developed tests (#LDTs). Oncology labs that previously developed their own LDTs may now be unsure of how to proceed in terms of costs, filings, and data collection. During this free webinar, attendees will: - Learn how the final rule applies to oncology LDTs. - Find out what the FDA's action means for precision medicine efforts in cancer diagnosis and treatment. - Become familiar with upcoming timelines tied to the final rule.
-
Enjoyed speaking with Jondavid Klipp at Laboratory Economics regarding the potential impact of the Supreme Court decision overturning?Chevron?and the 3 things all U.S.?based clinical laboratories should be doing right now to comply with the new FDA rules. #Chevron #FDA #LDT #Labs
-
Enjoyed speaking with Jondavid Klipp at Laboratory Economics regarding the potential impact of the Supreme Court decision overturning?Chevron?and the 3 things all U.S.?based clinical laboratories should be doing right now to comply with the new FDA rules. #Chevron #FDA #LDT #Labs
-
Clinical labs and LDTs are at the forefront of innovation, especially in oncology. Without LDTs there would be no “precision medicine.” Aaron Tallent explores the advantages and disadvantages of regulating laboratory-developed tests (LDTs) following FDA’s final rule, sharing insights from several industry experts, including Sheila D. Walcoff, JD, in this article for Cancer Discovery News, American Association for Cancer Research. https://lnkd.in/e-M6PVTm
-
Amazing weekend in Chicago at DysConf2024 with an incredible group of clinicians, scientists, and patients working together to improve the lives of individuals suffering from POTS, HEDS, MCAS and other autonomic disorders. Tae Hwan Chung Dysautonomia International Russell Norris Shannon Koplitz
-