I partnered with Boudicca DX while at Prometheus Biosciences. Kelly provided great support and helped us navigate the regulatory journey on bringing the first diagnostic in Immunology. She was immensely knowledgeable in US and ex-US regulations and helped in ensuring we are on a seamless path to late stage development.
I partnered with Kelly in defining our regulatory strategy at startup Biological Dynamics, a maker of blood-based early cancer detection diagnostic tests. Like any startup we had grand visions of bringing a broad set of products to market, with little understanding of the process. Kelly stepped in and provided invaluable strategic direction for us by first understanding our products, then defining the possible landscapes in which we could operate. Her collaborative, personable, knowledgeable style made her a joy to work with and let to a greater understanding of the roadmap that lay ahead. This led to a workable set of projects and milestones and a clear understanding of the costs. I would look forward to partnering with Kelly going forward.
For the past two and a half years, Erasca has partnered with Kelly Gordon at Boudicca Dx to develop biomarker selection strategies for our Phase I through III clinical trials. Her deep understanding of the evolving diagnostics landscape—both in the U.S. and abroad—has been invaluable, particularly as we navigate collaborations with external diagnostic companies. Kelly consistently pinpoints core challenges and works alongside our team to craft effective solutions. Referred to us by a trusted contact at Illumina, we have since recommended her to others, who now also enthusiastically share our appreciation for her expertise and support.
I had the privilege of hiring Kelly as a consultant in 2019 when I was leading Regulatory Affairs at Guardant Health. Kelly supported us with early FDA regulatory interactions for our colon cancer early detection test. Kelly worked with the development team supporting analytical and clinical validation planning for the early cancer detection test and integrated the validation plans into key early FDA regulatory alignment submissions. Kelly communicates very effectively with product development teams and is very passionate about early cancer detection tests. I look forward to working with Kelly again in the future.
Collaborating with Kelly means a direct path to success. She brings extensive knowledge, responsiveness, efficiency, and a proactive approach, consistently staying ahead with the latest technologies and regulatory developments. Her professional expertise is further enhanced by her positive attitude, and outstanding interpersonal skills. In the dynamic and ever-evolving field of Companion Diagnostics, working with Kelly is an invaluable asset and a true privilege.
Kelly has helped us to advance with our precision medicine approach in septic shock. Her clear view and extensive knowledge on the field of companion diagnostics has been invaluable for us to navigate through FDA diagnostics division in coordination with the product division. This work has led to key agreements with the agency on our registration program for both the therapeutic product and its companion diagnostics. She has also been instrumental in the generation of intellectual property related to this program.
Boudicca Dx is our premier partner in the areas of biomarker strategy and companion diagnostic development. Their exceptional expertise and comprehensive services bridge the gap between bench and bedside, enabling us to transform our groundbreaking T cell receptor-based science into impactful clinical applications. Boudicca Dx’s ability to develop companion diagnostics from concept to commercial launch is unparalleled, ensuring we move quickly and purposefully at every stage from IND to POC. Boudicca Dx’s expertise in preparing and harmonizing molecular data for BLA and NDA therapy submissions exemplifies their ability to align scientific rigor with regulatory requirements. Boudicca Dx excels at leveraging cutting-edge bioinformatics tools, such as TCGA and GENIE (cBioPortal), to support indication selection and biomarker approaches. Their expertise in pharmacodynamic biomarker development for dose decision-making is invaluable, as is their ability to analyze biomarker data with precision using platforms like GraphPad PRISM. Additionally, Boudicca Dx helps select and manage our external partners, engaging KOLs for clinical validity and utility studies, preparing IRB submissions, and incorporating to their feedback. Boudicca Dx’s unwavering commitment to excellence, innovation, and regulatory compliance makes them a trusted and indispensable partner, and so I encourage you to reach out and consider partnering with them.
We have worked with Kelly for several years. She is extremely knowledgeable about CDx regulatory development, up to date on how FDA regulations evolve and change in real time, and is impressively strategic about how to approach filings and communications with FDA where she is well connected.
Kelly helped us navigate FDA communication in a swift and effective way. Highly recommend.
Finding the right treatment for the right patient is what we also strive to do but biomarker-driven patient selection in early development can often be more hype than reality. That is, unless you have a thought partner like Kelly Gordon from Boudicca Dx. Kelly is steeped in hands-on experience and real-world practicality. She is both a thinker and a doer when it comes to diagnostic strategy development and driving interactions with health authorities on diagnostic approaches for a patient enrichment. I cannot say enough positive things about Kelly as a solution focused leader in the diagnostics space and would highly recommend her to anyone.
Kelly and her team at Boudicca Dx are the rare force multiplier that allows emerging companies to compete with the larger established players in the complex field of diagnostics. Kelly is expertly at home with the complexity of the underlying science, the various phases of test development and the clinical validation strategy required to enter the market. Kelly brings all this to bear in her regulatory action plans, communicates very effectively, and brings a rare passion to her work. We look forward to much continued success with Kelly and Boudicca!
Boudicca Dx has been advising Hawkeye on the regulatory strategy for Hawkeye’s biosensor technology. The Hawkeye biosensors are a novel technology that can detect the activity of enzymes involved in chronic inflammatory diseases such as cancer and autoimmunity; all compatible with non-invasive samples such as blood, saliva and exhaled breath. Hawkeye has focused initially on developing a blood test for the early detection of lung cancer. Boudicca Dx has provided instrumental, confident and assured regulatory guidance, refining the intended use and providing prompt and clear feedback as questions arose. Indeed Boudicca Dx deep scientific background has been very helpful in also providing analytical validation guidance based on their experience with other cancer detection assays. The team has too many strengths.
I’ve had the privilege of working with Kelly on multiple biomarker projects across multiple companies, all seeking various levels of regulatory approval. I always recommend seeking Kelly out due to her thoroughness, knowledge, and quality of work. Through her and her network of experts at Boudicca Dx, we outlined strategies for data generation and analysis that have led to approvals as well as projects where it was helpful to realize we needed to focus our intended use and dataset to more favorably compete in a complicated space. In all cases, the result was a stronger clinical, regulatory and commercial strategy in diagnostic biomarkers. Given the rapid pace, the fluctuating attitudes of the regulatory agencies, the costs involved and the analyses necessary, it’s invaluable to have a partner as reliable and competent as Kelly and Boudicca Dx.
I’ve had the privilege of collaborating with Kelly on numerous projects, preparing the biomarker plan for the clinical programs. Her extensive expertise in the biomarker and diagnostic landscape is unparalleled. Kelly’s ability to foster valuable introductions, orchestrate apple-to-apple comparisons, getting the right match of the technique to the question and facilitate collaborations is instrumental in advancing products to patients. Her focus on the most effective development path that provides the right tools for the question at hand is unparalleled.
Beyond her technical skills, Kelly is a pleasure to work with. Her exceptional responsiveness and ability to navigate the complexities with ease make her an invaluable partner. I wholeheartedly recommend Kelly to anyone seeking to accelerate their biomarker and diagnostic strategies.
I had the great pleasure working with Kelly on our lead program at Artizan Biosciences. We had developed a laboratory assay but needed to take it to the next level to ready it for clinical trials. Kelly recommended several excellent CROs to help us through the process, and then supported us as we interviewed them and gathered quotes. We ended up with a great partner and a robust assay. In addition, Kelly guided us through our assay validation strategy development and helped us create a blueprint and budget for late stage development and commercialization, even though we were a few years away from that. She was a great member of our team and a delight to work with, and we all learned from her expertise. I would recommend her to any team looking to develop a strong diagnostic strategy!
Alentis is leveraging Boudicca Dx’s broad expertise in companion diagnostics to help guide the development of a new diagnostic test to detect and quantify CLDN1 in human tumor tissues. During this collaboration, they have shown to be an experienced partner that knows the regulatory environment very well and provides excellent advice. The support for our IND submission was very helpful.
I have had the privilege to work with Kelly for about 5 years. If I had to choose one word that describes her it would be AWESOME! Kelly is bright, innovative, solution oriented and just a great person to work with overall. I refer and work with Kelly on a number of clients in the drug/diagnostics space and she is my number one person to pull in when my clients are seeking the best advice on companion diagnostic development and working with CDRH. Kelly not only can advise the client, work with FDA on their behalf but also work with diagnostic companies to bridge discussions between the Company and the Diagnostic partner. Kelly develops diagnostic strategy and delivers successful outcomes. She is highly respected by FDA and can influence them thru communications including briefing packages, INDs, NDA/BLAs and meetings. Kelly is a Strategic Partner to Advyzom and I can totally trust and high respect for her to deliver for our clients.
Kelly and Boudicca Dx provided us with crucial input on our patient selection approach for a rare genetic target in oncology. Not only was her guidance key to our clinical diagnostic development strategy, but also she proactively managed a number of our vendors to help identify patients in real-time for the clinical trial. Kelly goes deep into the science, while at the same time bringing a mastery of how to navigate the increasingly complex diagnostic development & regulatory landscape and knowledge of the most up-to-date changes in the requirements. She integrated fully as a member of the team and was a pleasure to work with! We would definitely consider Kelly and the Boudicca Dx team for our future translational and diagnostic development needs.
It has been a pleasure working with Kelly for our regulatory needs. Kelly’s professionalism, insight, and rapid responsiveness were just what we needed. Integral Molecular’s Membrane Proteome Array (MPA) is the first technology accepted for the FDA’s pilot ISTAND program. Being the first to submit to a new regulatory space comes with a lot of uncertainty. Kelly’s knowledge and guidance was a major contributor to the strength of our Qualification Plan submission and provided us with confidence as we moved through the program. Our team will continue to use BoudiccaDx for this and other regulatory consulting needs.
Kelly was engaged by Context Therapeutics to develop a custom IVD for patient enrichment to support a first in human clinical trial. Kelly is an absolute star who is a pleasure to work with and someone Context looks forward to working with for many years to come. Highly, highly recommend!
I recommend (without reservation) Kelly Gordon and the Boudicca Dx., LLC team! I’ve worked with Kelly for more than 3 years on everything from biomarker discovery, CDx planning and lab developed tests. Most recently we have worked on using MRD in liquid tumors to improve outcomes in our patients. This is a complex area with no real standardization across multiple platforms and Kelly’s advice has been extremely valuable.
Kelly is an extraordinarily adept regulatory consultant who is worth her weight in gold. She helped us plan from the most nascent stages of regulatory readiness aspirations through execution. She brings an exceptional degree of clarity and simplicity to what otherwise can feel like an overwhelmingly complex process and “just gets it done”. Not only did she make everyone on our team feel comfortable with a strategic plan and the concrete steps involved in carrying this out, as an advisor who would regularly join calls and in-person meetings with large pharma customers, her ability to ask the right questions and be able to respond confidently to those of customers, markedly helped bring multiple of key deals/contracts across the line.
I consider Kelly a key thought partner and part of a team of experts I rely on in my consulting practice as I span multiple engagements across many companies. Unsolicited feedback about Kelly and what she provides for many early stage companies is unanimous and consistent. “Incredibly valuable advice” “Practical and fit-for-purpose companion diagnostic development plans” “is there anyone in the field that Kelly does not know?” Kelly has also been a partner and colleague with me at many US FDA interactions and her writing and oration style are bar none. She is and will always be my “go to” for any precision medicine approach for any company I work with.
Kelly is the best. If a companion diagnostic may be part of the development or a company needs to select vendors for biomarkers and pharmacodynamics, Kelly is the person.
Kelly knows her stuff! She has deep knowledge in IVD development. I have learned a lot from her from partner selection, contract set up, FDA interactions to validation. Regardless of technical, regulatory and logistics, she knows it all. In addition, she is highly efficient and fun to work with. I highly recommend her to whoever needs consultation for companion diagnostic development.
Kelly is a global leader in diagnostic technical and regulatory research and development. I have employed Kelly’s consulting expertise across multiple companies, targets and types of assays including NGS and IHC. Kelly is able to get up to speed quickly, has strong relationships with diagnostic companies and has built a high degree of credibility with the FDA and other global regulatory agencies. She is always aware and incorporating the latest technical and regulatory guidance to make sure her advice is optimized for current and future practice.
Kelly is a fantastic resource who is very knowledgeable and experienced in companion diagnostic development and related oncology test development. She helped us file an FDA breakthrough device application on Biocept’s CNSide in early 2021 that was ultimately denied by the agency, but helped establish our route to a more robust assay validation and clinical development plan. This included an expanded analytical validation for quantitative analysis of CSF tumor cells including additional tumor types and a multi-institutional prospective clinical study to establish the clinical performance and utility of the assay compared to standard of care work-up for suspected leptomeningeal metastasis in patients with advanced solid tumors. She was also a terrific educational resource spending several days with our team in San Diego in 2022 to advance our understanding of pharmaceutical clinical trial requirements and related topics, particularly as related to CLIA laboratory developed tests for niche markets such as CSF testing for CNS metastasis.
I have known Kelly for a long time. I worked with her when she was at Kura Oncology and have kept in touch with her. I have been impressed with her breadth of knowledge in the diagnostic field. She is a diagnostic expert with experience and knowledge not only about diagnostic/companion diagnostic development but also about diagnostic instruments and methodologies…be it IHC or RT-PCR or NGS or FISH etc. for nucleic acid protein detection. She has kept abreast of the latest development in the field and I am always looking forward to her posts on LinkedIn.
I would add that her greatest strength is in providing guidance on regulatory strategy and submissions to FDA. I wish her the best and hope she continues to share her knowledge and help the diagnostic community.
Dr. Gordon and I collaborated together on an IVD development project. Her knowledge of the product development process is strong and multilayered. Dr. Gordon had the exceptional ability to take complicated processes and information and translate it to basic laymen’s terms for my staff to understand. The accuracy and clarity of her analytical and clinical validation reports were thorough and impressive, not to mention on time and underbudget. She is accessible, responsive and very efficient. Furthermore, Dr. Gordon has a robust understanding and comprehension of the LDTs in the clinical laboratory. Dr. Gordon has the unique ability to function in both a research/development and clinical laboratory space. I hope to work with her again soon.
Kelly is a great consultant. I have known and worked with Kelly for the past 6 years. She is extremely knowledgeable about molecular diagnostic development (e.g., NGS, PCR, IHC, or FISH). In addition to product development, she can drive regulatory and quality strategy and planning (e.g., FDA, CLIA, CAP, NYSOH, IVDD/IVDR). She understands business partnering well if development and/or manufacturing is being outsourced and can help an organization or a team succeed with any molecular diagnostic development needs. Kelly is easy to work and communicate with. She brings creative ideas and out-of-the-box thinking to the projects. Her management skills are astounding, she always goes above and beyond the task with her advice because she brings such a broad skill sets on the table. It is an honor to work with someone of her caliber. She is deliberate with her development and regulatory tactics and implements with great attention to every detail. For me, one of her most important skill sets is her ability to self-manage and keep deliverables moving with such a high level of agility, speed, and quality. No worries once you have agreed on a strategy and a course of action. Additionally, Kelly puts her passion into her work. She gives everything she’s got when she gets involved in a program and really cares about delivery to stakeholders including the ultimate customer, the patient. I am humbled to work with someone of such high integrity and so committed to develop and deliver outstanding and innovative molecular diagnostic solutions to cancer patients. A truly great business partner. I highly recommend Kelly’s consulting services.
Dr. Kelly Gordon and I have worked together on several diagnostic development projects over the past 5 years, and her scientific, regulatory and strategic experience provided the guidance necessary for the success of the biostatistical support that I provided. She is smart, forward-thinking and understands the landscape. Her ability to communicate with her clients and her team members is outstanding. She is dedicated, attentive to details and is vested in the work she undertakes. I look forward to many future collaborations with Kelly.
I have known Dr. Gordon for about 5 years. We worked together at Ventana where it became clear that Dr. Gordon’s knowledge and expertise in assay development were very strong. Dr. Gordon not only has a strong regulatory and scientific background, but she has the ability to develop assays for a variety of purposes including regulatory approval, CE marking, pharmacodynamics/target engagement, etc. As a consultant, Dr. Gordon is instrumental in helping us with assay development and regulatory strategy for our current program in development. On a personal level, Dr. Gordon is straight-forward and easy to work with – I highly recommend her!
It’s a real privilege to write this recommendation for Kelly Gordon. Kelly has the extremely rare qualities of not only being exceptionally bright, knowledgeable, experienced and creative in her thinking and problem solving, but is a true pleasure to work with. I had the good fortune to work with Kelly on an in vitro diagnostic (IVD) commercialization plan for a new oncology biomarker.
The project required providing a regulatory strategic plan for bringing the biomarker to market as an IVD in the U.S. Kelly did a masterful job in presenting all the various regulatory pathway options available for submitting through the FDA, and anticipating what the agency would likely challenge or require, as well as ways to potentially expedite the process. She was instrumental in outlining the various clinical studies that would be needed to pursue each regulatory path and the timelines and risks associated with each option. Kelly was extremely good at problem solving, especially in today’s increasing complex and ever changing regulatory climate.
On a personal level, Kelly is an incredibly warm, thoughtful team player with a great sense of humor and a true joy to work with. She is a welcome and vital part of any team.
Kelly worked with our team on two separate projects – a diligence for a life science services provider and a teach-in session on liquid biopsy. Her knowledge of the space and ability to synthesize / process information into digestible content was highly valued. Her ability to put together presentations (e.g., via PPT) and accessibility for follow-up questions was also highly appreciated. Our team definitely will be using Kelly again in the future
Boudicca Dx (Kelly Gordon) and I had the pleasure of working together at Gossamer Bio since 2018. Kelly is not only a person of integrity, she is an outstanding scientist and consultant. During our time working together, I could always depend on Kelly to show up on time, prepared, with a wealth of knowledge and experience. She is energetic, happy, fair, dependable, and mostly importantly, possesses a wonderful sense of humor.
I recall a time we were trying to sort out a particular assay to be run to screen patients for a Phase 2 clinical study. Kelly thought about the problem outside of the box, and offered up a number of different options that we could pursue, depending on how much risk we wanted to take, how much money we wanted to spend, and how fast we wanted to do. That is exactly the sort of work product my company and I need, as we try to fearlessly transform the practice of medicine together. Kelly then went the extra mile, beyond the strategy, to help implement the plan, and put all the pieces together.
I would hire Kelly as a full-time employee in a minute, but it’s clear that she enjoys being a consultant, and is clearly very good at doing so. Boudicca Dx (Kelly Gordon) would contribute to, and thrive in, your organization, and I’m sure you’ll be happy working with her.
Kelly has worked with my team for the last several years on a diagnostic development project. Kelly has been a huge asset to the team with her scientific and regulatory strategic acumen. She is always well prepared, focused, and delivers high quality work products. Team members really enjoy interacting with her and are quick to say “let’s get Kelly’s input”; a sign that Kelly is a great consultant and a valued member of the team. Diagnostic development can be challenging but Kelly makes it seem easy!
We engaged BoudiccaDx to conduct a review of our current technical, scientific and clinical progress as an early stage startup and to advise on our strategy for bringing our product to market.
Kelly has an incredible gift for making the complex technical diagnostic concepts appear simple while still capturing the complexity of the problem. She is a pleasure to work with and always delivers to an exceptionally high standard. She consults impeccably to understand organisational needs and then brings innovative business relevant ideas and solutions to the table.
She helped us conduct an independent technical review of our scientific and clinical evidence prior to providing us with alternative perspectives on how to approach our proof of concept clinical studies and also the future development of our in-vitro diagnostic product.
She also provided insights about potential regulatory pathways, highlighting her experience with applications for FDA breakthrough designation when we considered moving forward some of our pipeline applications.
Our team will definitely be using BoudiccaDx’s services again in the near future.
