Judy Gordon’s Legacy: Helping Firms Navigate a Path to FDA Approval of Transformative Technology

Judy Gordon, DVM, is not a job-hopper. When Laguna Beach, Calif.-based ClinReg Consulting Services, a company she founded in 1998, announced her retirement in March, Dr. Gordon had held exactly two previous jobs going back to 1983—with Chiron Vision (1986 to 1997); and with Newport Pharmaceuticals (1983 to 1986)—according to her LinkedIn profile.

This 38-year stretch apparently was enough to enable her to become a transformative person in ophthalmology, with a hand in major innovations and a ringside seat to the relentless improvement in clinical ophthalmic care over the past 3+ decades. And she did this, according to colleagues, clients, and friends, with a quiet competence.

In pharmaceutical parlance, the lasting effect of a treatment is called its durability. ClinReg Consulting Services will live on in a new organization, Regulatory Pathways Group, led by several of her former ClinReg colleagues, including Lee Kramm, MD, MSE, Debe Deck and Maureen Johnson, RN.

Vitrasert: A Breakthrough Intravitreal Implant

One significant achievement in Dr. Gordon’s career was her role at Chiron Vision in obtaining Food and Drug Administration approval, in 1996, of Vitrasert, an intravitreal ganciclovir implant to treat cytomegalovirus (CMV) retinitis in people with AIDS. At the time, roughly 40% of patients with AIDs suffered from CMV retinitis, often resulting in blindness. In 1997, Bausch + Lomb acquired both Chiron Vision and Storz Instrument Company within days of each other and merged the two companies in early 1998.

The Vitrasert approval was one of Dr. Gordon’s proudest moments. “I helped shepherd the device through the FDA,” she told OIS Weekly, “and through the process developed an incredible set of relationships with HIV/AIDS activists who had become increasingly engaged in ensuring treatments were developed with their input. To this day, it is one of the devices I am most proud to have helped bring to market.”

For the founder of Chiron Vision, William J. Link, PhD, (now managing partner of Flying L Partners) Dr. Gordon was a clinical and regulatory “go-to” person not only at Chiron Vision during the 1990s, but also for many of the companies in Dr. Link’s portfolio at the venture-capital firms he co-founded, Versant Ventures and now Flying L Partners. “With her expertise and communications skills, she added immense value,” Dr. Link wrote in an email. “She is a fine person and a good friend.”

ClinReg: A Values-Driven Company

The creation in 1998 of ClinReg Consulting Services is another milestone Dr. Gordon considers an achievement. A company inevitably reflects the character of its leader. As a young woman, Dr. Gordon earned a doctorate in veterinary medicine from the University of Bologna in Italy. In 1998 she said she was ready to form a team with kindness as a core value.

“ClinReg in its early years was a female-led group,” Dr. Gordon said. “I was able to bring in the best talent in the field and create an organization that was equal parts strategic, rigorous, compassionate and kind. We created a supportive environment where our staff could balance their family and work lives, grow into increasingly complex projects, and get the support they needed to deliver great work.

“I absolutely loved our team and loved the work we did,” she said. “Launching and building ClinReg was one of the great privileges of my life, and I was able to do it alongside a set of talented individuals, all of whom I consider my dearest friends.”

The Spirit Behind Many Innovations

Trudy Larkins, executive director of the American-European Congress of Ophthalmic Surgery (AECOS), held senior marketing positions at Alcon Laboratories—now just Alcon since its spinoff from Novartis—LenSxLasers and Advanced Medical Optics from 2000 through 2012. “From the introduction of the Hansatome, which really was the gateway to LASIK acceptance in the United States, to the IntraLase laser, which would ultimately replace mechanical microkeratomes with the precision of a laser, and then also the LenSx laser, which would change cataract surgery forever—Judy was instrumental to the approval of these devices.”

Following Alcon’s acquisition of LenSx in 2011, Larkins started her own briefly lived consultancy. She went to Dr. Gordon for advice. “To my surprise, she not only told me this was a great idea, but she also encouraged me to start a company that would attract known talent, especially young women, [who] could benefit from what we had learned,” Larkins said. “She also instructed her business manager to share everything she had established with me—open the doors—from how to start, how to set up billing/accounting systems, consulting agreement forms, everything. I was completely shocked and, of course, grateful beyond words.”

At AECOS, Larkins often invited Dr. Gordon to serve as a featured speaker or panelist. “Judy was a true partner to innovators and visionaries—always a keen strategist, forever modest, and perhaps most importantly, the most generous person one could ever have the pleasure to meet.” Larkins added.

Regulatory Challenges Ahead

As Dr. Gordon looks at the regulatory terrain ahead, she noted the importance for startup companies to develop clear lines of communication—and negotiation—with the FDA. She listed several challenges facing companies, including:
• Harmonizing development plans to satisfy regulatory bodies in multiple geographies.
• Understanding the new medical device regulation framework for CE Mark certification.
• Anticipating what’s needed for market access and reimbursement.

“The innovation cycle for medical devices, especially those which are software driven, is often very short and incompatible with the review cycles involved with regulatory efforts, “ Dr. Gordon said. “It is challenging for many companies to reconcile the design changes for a particular device, the associated verification and validation testing plans, and the regulatory framework.

“With enough planning, anticipation, and negotiation,” she added, “these challenges can be overcome—but they are real challenges nonetheless.”

After a 40-year career helping bring new drugs and devices to those in need, Dr. Gordon said she looks forward to spending more time with family and friends, and following her former colleagues now at Regulatory Pathways Group. “I couldn’t be more confident that they will continue to provide exceptional services and deliver impact,” Dr. Gordon said.