"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."
Sherri Borman, Ph.D., HLCD, NYCoQ (Oncology & Tumor Cell Markers)
Laboratory Director in a CLIA/CAP/ NY CLEP Accredited Laboratory
Sherri Borman, Ph.D., HLCD, NYCoQ (Oncology & Tumor Cell Markers)
Laboratory Director in a CLIA/CAP/ NY CLEP Accredited Laboratory
"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."
Yassine Labiad, M.S., RAC
Director, Company Diagnostics Regulatory Affairs & Regulatory Project Manager, Loxo Oncology
"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."
Laura B. Gillis, PhD
Independent Statistical Consultant
"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!"
Julie Engel, PhD, RAC
Sr. Director, Molecular Diagnostics
Cyteir Therapeutics
"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."
Ronald A. Blum, Ph.D.
Chief Executive Officer
Blum & Associates Consulting, LLC
"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"
Anonymous
San Francisco Private Equity Firm
Anonymous
San Francisco Private Equity Firm
"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."
Gregory J. Opiteck, PhD.
Executive Director
Precision Medicine
Gossamer Bio, Inc.
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."
Gregory J. Opiteck, PhD.
Executive Director
Precision Medicine
Gossamer Bio, Inc.
"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!"
Jennifer Wiley
VP, Regulatory Affairs
Alpine Immune Sciences
Jennifer Wiley
VP, Regulatory Affairs
Alpine Immune Sciences
"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.”
Chief Executive Officer
Diag-Nose Medical Pty Ltd (Australia)
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.”
Chief Executive Officer
Diag-Nose Medical Pty Ltd (Australia)
Nasdaq Bell Ringing Ceremony with Client Elevation Oncology, September 2021