ABOUT US
OUR STORY
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Committed To Your Success
Jill Herendeen founded Rubicon Consulting with the objective of bridging the intersection between innovation in drug discovery and development with the complexities of the regulatory environment, ensuring your product meets the stringent safety, efficacy and quality standards set by regulatory authorities.
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Rubicon focuses on supporting companies, particularly start-ups with limited in-house resources, to navigate today's dynamic regulatory ecosystem. We provide strategic support rooted in experience, enabling you to focus on driving innovation to advance your product pipeline. Rubicon's primary goal is to increase patient access to innovative products addressing unmet need, while maintaining an uncompromising commitment to safety, efficacy and quality.
Our Founder
Recognizing that many small or mid-size biopharmaceutical companies often do not have in-house regulatory expertise, Dr. Jill Herendeen, PharmD, founded Rubicon Consulting to provide regulatory solutions and services customized for companies' specific needs. With over two decades of clinical and regulatory experience across large (Amgen, BMS, Abbvie), mid-size (Pharmacyclics), and small biopharmaceutical companies (Silverback Therapeutics, Orca Bio), Jill has an established record of developing and commercializing novel therapeutics designed to address unmet need, specifically in oncology and autoimmune disease.
Rubicon supports all stages of product development, from early-stage candidate selection and first-in-human trials to mid-stage clinical proof of concept and registration-enabling studies, as well as late-stage marketing authorization filings and lifecycle management. Jill has successfully filed global marketing applications in the US, Canada, Australia, Europe, Latin America, and Japan for Vectibix® and Imbruvica®.
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In today’s complex life sciences landscape, where innovation and regulation intersect, Rubicon provides a trusted, customized end-to-end approach, allowing your team to focus on innovation while Rubicon handles the regulatory path to success.
Crossing the Rubicon
The term "Rubicon" represents a point of no return, symbolizing a decisive commitment to action. In drug development and commercialization, crossing the Rubicon marks the critical moment when a company must invest its capital and limited resources to navigate today’s complex regulatory landscape. Our team provides expert regulatory guidance throughout the product lifecycle, ensuring a focus on quality, safety, and efficacy at every stage of development. Our shared goal is to expedite the development timeline and achieve marketing authorization, empowering you to confidently cross the Rubicon and accelerate patient access to innovative therapies.