“Safety doesn’t live outside of you. It’s not a yellow ribbon that you wear in hospitals that says, ‘it’s patient safety week.’ It’s not a sign in your office that says, ‘this is patient safety month.’ It’s a consequence of how we approach our work on a day-to-day and hour to hour basis. And it’s by definition, therefore, an emergent property of who we are and how we engage with our work.” Dr. Jason Campagna
With great innovation comes great responsibility especially as it pertains to developing new and emerging therapeutics, devices and treatments–which is why we’re covering a new topic here on the show today. We’re focusing on cultivating a culture of safety.
In previous episodes of the Emerging Biotech Leader, we have talked about various types of responsibility. There’s the responsibility of managing the team. There’s the responsibility of navigating cross-functional stakeholder relationships. We’ve even touched on the responsibility of presenting to the board.
That said, today’s podcast topic of safety is just as pertinent. By textbook definition, safety is the condition of being protected from or unlikely to cause danger, risk, or injury.
To help us navigate this topic from the lens of the biotech sector, we have two new voices on the show: Amit Patel, Senior Vice President at SSI Strategy and Dr. Jason Campagna, Chief Medical Officer at Q32 Bio, Inc.
Q32 Bio is a biotechnology company developing therapeutics targeting powerful regulators of the innate and adaptive immune systems, with the goal of re-balancing the immune system in severe autoimmune and inflammatory diseases.
Our main co-host, Ramin Farhood, Sr. Vice President of Medical Affairs Practice at SSI, also lends his thoughts, voice and observations on this topic as well.
Back to our featured guest. When it comes to safety, Jason Campagna’s expertise is extensive and vast. He’s been a licensed physician leader who’s practiced in academic, clinical medicine and private practice. He’s held roles in hospital administration and he’s worked and served on boards in industry as well.
We’re thrilled to have Jason as a guest for many reasons including the opportunity to discuss how he prioritizes and strives to cultivate a culture of safety in any organization he leads. If the quote at the top of the page is any indication of his interview style, Jason holds no punches and offers insights that are clear, direct and compelling. On that note, here are a few key takeaways from this episode.
On The Importance of Safety In Biotech
Amit, Ramin and Jason all agree, building a culture of safety should be a top priority for both established, big pharma companies and smaller biotech startups as well. Afterall, patient safety is a universal concern, and even in the early stages of drug development, safety protocols should be firmly ingrained.
From a business and planning standpoint, this means prioritizing safety from day one–focusing on the preclinical and phase one stages. Yet for brand new companies navigating this with limited expertise or covering an entirely new patient population, this may not be as cut and dry. In fact, Jason cautions that all companies should exercise prudence when it comes to prioritizing safety very early on.
After some back and forth on this topic, Amit wanted more context. “It sounds like the output is patient safety but what are the inputs?”, he asked to help our listeners.
Jason’s answer was very eye opening.
“So, this is the eternal dilemma that we face. In the 1980s, there was a really interesting Yale psychologist named Scott Perrow. He wrote a book and it’s a widely influential book in the field of safety and risk called Normal Accidents. And he didn’t mean “normal” in terms of description of frequency. He meant normal in description of how they unfold. In any major safety event that occurs, it’s often the most banal and trivial things that lead to major safety events. It’s something very minor. For example, the patient didn’t exactly recall that they were supposed to stop their medication at this time. And when they called, the person who got them on the phone was a little rushed and they didn’t quite hear the full sentence. And the next thing you know, these banal and trivial events all add up to go, boom, major consequence.”
Listen in for another key learning from Perrow and a story on the Gus Grissom capsule.
As a pivotal takeaway, one of the inputs is to shift away from the view of “safety is a cost center”, to “it’s an ongoing, priceless, life saving priority.”
In terms of the economic arguments for investing in safety early and on a recurring basis, Jason does dive deeper into the topic around the 14:25 mark while Ramin also provides the invitation to move away from viewing safety as a “necessary evil.”
On Strategy and Collaboration in Biotech Particularly with PV
All the discussion around unified alignment and ownership of safety in biotech opened up the door for Ramin to glean Jason’s thoughts on collaboration and partnership especially with PV.
“I’ve seen in organizations, with my own experience, where PV and drug safety were really a strategic partner cross-functionally and being more proactive,” Ramin said.
“They were not just sitting in the office and for a drug, you know, addressing events that happened and doing their investigations and the forms and the reporting as requested: they were actually being more proactive. They were trying to look for signals. And making sure that the product continues to sing in the market, because with those signals, there are certain actions you can take. You can focus on education. You can focus on papers, posters, manuscripts that you can have to make sure that the conditions are appropriately knowledgeable and have the education to make the right decisions. So Jason, what is your view about PV and safety as a strategic partner?”
Jason’s answer included a specific mentor, Clive. “I think Clive was the model for me on how safety and PV is, by definition, a strategic asset to a company. That being said, I think it’s an anomaly, unfortunately. I think what you just outlined, teams that are consistently able to do that over long periods of time in a cross-functional manner, I think that’s rare.”
For more on the importance of working cross-functionally in biotech, tune into Episode 13 of the Emerging Biotech Leader.
To become a team that does collaborate with PV cross-functionally on a consistent basis, listen to Jason’s thoughts around HRO’s: high reliability organizations as well as how PV alignment can also help with sales.
One additional perspective Jason shares especially as it pertains to strategy and collaboration is preparing for the worst…even in the absence of it. “In a world in which there’s the absence of an event, how much do you practice? How much do you rehearse? How much do you plan? What would happen if?”
These are all notable things to consider and discuss with your team when cultivating a culture of safety.
On Adapting To Challenges In Biotech
While covering the topic of adversity and navigating the unknown, Amit jumped back in by guiding the conversation to other challenges…from top-down leadership challenges to budgetary challenges as well.
“You’re going to need the right people, the right team, and the right systems in place to do a lot of that monitoring. Right? So how do you approach the questions such as the optimal balance of staffing an organization to meet that culture and come out on the other end with that culture of safety?” he probed Jason.
His candid reply was inspirational. Jason describes his approach as a little unorthodox.
“I always ask and I open with the team: ‘what do you believe we need to ensure and maximize subject protection in our clinical programs?’ It’s a very basic question, but it’s a human question. It often amazes me every time I ask it. The answer I get is that everyone is worried about this. Everyone. They all have an answer to that question and it often has nothing to do with medical monitoring or reviewing safety labs or signal evaluation and risk management. It comes down to some degree of ‘well, who is the person doing the medical monitoring? Do I trust them? Can I believe them? Have we met the investigator and the people or the CRA that are reviewing the data? Notice they’re not asking for a CRA. Or for an investigator, they simply want to know who they are. There’s a humanity to all of this. And do we trust those people to tell us that everything’s okay or everything’s not okay?”
From here, Jason then shared that he also applies a human-centric approach to aligning with his vendors as well.
“We’re not just trying to enroll numbers in a clinical trial here. We’re asking, ‘Hey, Amit, in the case of when we’ve worked together for many years now, who are the people that are in front of our trials? What is the nature of their training? How reliable are
they? Can we meet with them? Can we talk to them? Can they meet the teams? Do the investigators like them? I know those are “soft”, and often people would say, ‘who cares? If they have a degree and they’re able to do the work and they’re not very expensive?’ That’s wonderful. But my approach is the exact opposite from that.
As if that answer wasn’t heartfelt enough, Jason does go on to offer advice and encouragement for those who are new to all of this, especially those sitting in the CMO seat for the very first time.
“The higher up you go on the leadership ladder, I think the more important it is to be willing to raise your hand and say, ‘This is important to me personally, and I also believe it’s the right thing to do for this company.’ And if you’re willing to do that, often my view is that wonderful things are given back to the organization when people take that position. This is very different than the traditional advice of, you know, “study hard, work hard, run clinical trials lean, save people money.”
Jason’s generous wisdom didn’t stop there. While we’d love to give you even more of a play-by-play recap on Jason’s other advice, the best way to hear his answers–and those from Amit and Ramin as well–is by tuning into episode 24 and hearing the bonus takeaways for yourself.
As we close this recap out, we appreciate you being here and invite you to join us each month for more conversations with biotech leaders. Also, if you’d ever like help navigating the complexities of biotech, reach out to our team at SSIStrategy.com.