May 12, 2021, will always be a special date for Christina (Christy) England, VP marketing, acute care franchise at Heron Therapeutics, and Marie Boyle, senior VP at Spectrum Science. May 12 was the day that Zynrelef, a postsurgical analgesic, was approved by the FDA after two previous setbacks.
The drug became commercially available July 1, 2021. The two women worked closely together alongside their teams to prepare for the launch of the new pain reliever, but additionally positioned Zynrelef as a new solution to the medical response to the opioid addiction pandemic.
The two women have worked together for about five years and both have master’s degrees in public health, a shared background they found very helpful for this particular task. Marie was assigned to lead the Spectrum team because of her experience working at the Centers for Disease Control and Prevention managing opioid programs. “Part of what makes our partnership work so well is we’re able to be hyper-focused on the science, but also have that broad holistic awareness of the public health space,” Marie says.
“The whole team at Spectrum is amazing but I was so pleased when Marie came on board with her MPH, and I also have my MPH, which is very rare for a marketer,” Christy adds.
Their shared backgrounds were a big benefit in presenting the new campaign for Zynrelef, aimed at not only educating about the new form of painkiller as a substitute for opioids but also how it can help slow the opioid addiction crisis. Heron Therapeutics is dedicated to countering the opioid epidemic, particularly through reducing or eliminating unnecessary opioid use in the postoperative setting.
The effort includes the development of The Surgical Taskforce Organized to Prevent (S.T.O.P.) Opioid Abuse to raise awareness about the surgical setting as a gateway to opioid abuse. Heron Therapeutics has helped form and sponsor the coalition dedicated to inspiring healthcare providers, patients, and payers across the country to take action and commit to reducing unnecessary exposure to opioids in the surgical setting. As one the group’s founding sponsors, Heron brought together various medical societies — surgical, anesthesiology, and nursing — and policy and patient advocate groups to work together. Through the work of the coalition, Heron aims to further understand postoperative prescribing habits and ways to prevent unnecessary exposure to opioids. The coalition will use these findings to improve pain management in the surgical setting, create awareness, and bring change around opioid use and develop an online resource center for best practices in reducing the number of opioids prescribed in the postoperative setting.
While this broader approach had to be sold to Heron’s executive team, it wasn’t a really hard sell. “We had to roll up the plan, the mission, and the vision and ensure the executive team supported the initiative,” Christy says. “The leadership team here understands the bigger picture. They understood the benefit of looking at this holistically and taking a public health approach in terms of educating around the disease state. They fully bought in.”
“The public health-focused coalition is made up of providers, patients, and folks who are coming together to talk about how to collectively address practice and policies and prevent this crisis,” Marie says. “Heron is 100% behind this initiative, because it’s all about making an impact in the right way. This is an idea that resonated, and people signed on immediately.”
While they were planning for launch, the drug ran into some hiccups. The drug received two FDA complete response letters, the first in May 2019 for manufacturing issues and the second in 2020 for concerns related to quantifying the exposure to certain excipients used in the drug.
“It’s definitely been a journey,” Christy says. “We had some road bumps along the way, but having a solid PR firm on board to help us navigate was critically important.”
The two viewed these setbacks as minor, believing that the science behind Zynrelef was so solid, it was just a matter of time before it got approved.
“At Spectrum, we pride ourselves in being a science-first strategic partner,” Marie says. “We put a strategic lens on the science, and we knew the product fulfilled a huge unmet need from both a pain management perspective, but also as an aid for the opioid crisis, in terms of preventing people from needing to use opioids after surgery. In scenario planning, we always plan for every possible circumstance. To Christy and the team’s credit at Heron, we pivoted quickly as a team because of that open communication and the relationship and trust that we have.”
“We could have seen the CRLS as our big challenge, but we knew we had this amazing product that can truly have an impact from a preventative perspective, and it would be approved,” Christy says.
One challenge they weren’t prepared for — who was? — was the pandemic. They had already been working virtually, communicating from East Coast to West Coast daily, as Spectrum Science had been operating virtually for years. However, they still had to deal with how to shift all the launch elements to virtual and do it fast.
“The bigger challenge from a COVID perspective was how do we completely change the in-person plan we developed — from approval to launch,” Christy says. “We had in-person events, interviews, media tours, and other things scheduled that we had to quickly transition to virtual while making sure that we were still reaching people in an environment that was turned upside down.”
“We have always worked as a virtual group and think of ourselves as one team,” Marie says. “This allowed us to pivot quickly and figure out what we needed to do to get things done in a virtual format.”
It is this one-team mentality that is their secret sauce for success.
“The best work we’ve done together is when we’ve functioned as one team,” Christy says. “We don’t consider Spectrum as a vendor partner, but as an integrated part of the Heron team.”
“The Heron team is super-helpful,” Marie says. “They integrate us in with the other teams that they work with. Christy connects me to the right people within Heron who I need to be in touch with as well as the other agency partners — we are all a collective team, which doesn’t always happen. We appreciate that tremendously, and it really helps us produce the best possible results.”
According to both Christy and Marie, transparency and collaboration are the two elements that ensure the best results from their teams and others.
Given today’s time pressures it’s difficult to not just jump right in and start barking orders, but open, honest, and transparent communication is the best way to go, Marie says. “It was also very important to establish a relationship between the teams first,” she adds. “We took the time to understand each other and what we’re trying to achieve before the actual work started.”
For example, Marie and Christy know that what they have in common forms their close relationship. “We have similar working styles and we’re both type A,” Marie says. “We’re both online late at night just getting it done.”
“And we’re both mothers of young kids, so we completely understand everything we have on our plates and understand what’s got to be done,” Christy adds.
The duo’s favorite moment was the day Zynrelef was approved. “This is a day I’ll never forget,” Marie says. “I remember the nervous anxiety, and the waiting. Being able to celebrate together and be joyous together in that moment was just special.” Virtually, that is.
“We were sending text messages of champagne,” Christy says.
This originally appeared as part of PharmaVOICE's October edition. Read the full article here.