“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.” 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 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...