A Path To Biotech For Young Women
By Louis Garguilo, Chief Editor, Outsourced Pharma
“I’m one of the original founders at Aristea Therapeutics, a start-up company here in San Diego.”
One of the founders?
Sara McCutchan takes the room by surprise with her self-introduction at a recent Outsourced Pharma San Diego conference.
By now, we should be inured to how thoroughly younger generations are contributing to our biopharma industry. We are in the midst of our own youth movement.
Within that, we’re also witnessing more women involved in drug development and manufacturing outsourcing.
McCutchan, as well as helping found Aristea Therapeutics, is accountable for regulatory and quality, and plays a major role in CMC outsourcing. Subsequent to the conference, she spoke to me in detail about her career and experiences.
She expounded on key concepts and best practices for drug development and manufacturing outsourcing, and working effectively with CDMOs. Those I’ll detail for readers in a following editorial.
For now, through documenting her career, McCutchan points out paths forward for other young – particularly female – students and professionals thinking through job opportunities and industries.
And she’ll inspire some thinking by all Outsourced Pharma readers.
In fact, her experience reminds us of another professional we recently featured, Tara Caiano, Virtual Plant Manager, Biogen. Similarities run from participating in sports, signing up for internships, openness to taking on different assignments – and ending up managing CDMOs.
Aristea is a clinical-stage immunology biotech of a handful of employees, focused on developing novel therapies to treat serious inflammatory diseases. Its lead therapeutic candidate, RIST4721, was licensed in 2018, and is currently under investigation for the treatment of Palmoplantar Pustulosis (PPP).
Aristea – and McCutchan – are actually spinouts of a bigger biotech, Ardea Biosciences.
And so, not long out of college, McCutchan was exiting one biopharma and starting up another.
But not quite so directly.
A Path Forward
While contacts and licensing agreements were in process, and because “you never really know how things are going to fall into place,” in the interim of the establishment of Aristea, McCutchan spent a few months helping out at nearby Arena Pharmaceuticals.
“I got good experience there,” she recalls. “I was in program management, but specialized in clinical and regulatory affairs. It was a different angle to the disciplines I was familiar with, and provided a new perspective.”
Once at Aristea, McCutchan says she quickly learned: “As a startup, we all wear many hats.”
“I have input into the clinical and non-clinical CMC pieces. I’ve learned a lot in terms of how to utilize resources, and how to be creative with things like tech transfer – maintaining a high level of quality throughout a transition, and working closely with CDMOs. ”
Similar to Biogen’s Caiano, McCutchan’s background was not directly biosciences-related, but it was an internship opportunity that brought her into the biotech fold.
“Out of the blue, I took an internship at Ardea,” she continues. “I was a junior at UC San Diego. The company advertised on my school's electronic job board. It was a summer internship. I was playing volleyball competitively and studying cognitive science. I was interested in science and medicine, but didn't want to pursue a medical career. I thought I’d give the internship a try.”
McCutchan was assigned to an analytical lab. She ended up continuing with Ardea even when the school year re-started.
Subsequently, the post-graduation job that opened up for her at Ardea was in quality assurance.
“It sounded good coming out of college – not necessarily what I wanted to do long term, but it would give me visibility into what everybody else at a biotech does.
“In QA, you're interacting with everybody, whether those people like it or not. I worked in quality systems, the training program, the world of SOPs and auditing. We had a couple of FDA inspections because we were in the NDA process. I gained valuable insight, and even more importantly, built solid relationships with colleagues and mentors during my time in QA.”
McCutchan next saw regulatory affairs as an appealing place for her, and found her way into that space.
“I touched several areas at Ardea that gave me insight into what I am doing now, handling quality and regulatory affairs. And I am involved in CMC, which goes all the way back to when I started my career in analytical sciences. (Again, more on this in part two).
“It all pieced together,” she says serenely. “I feel lucky to have had opportunities to try all those fields before settling where I am … And who knows what I'll wander into in the future.”
The Millennial Minefield
I ask: Do you get backlash from fellow millennials for working in this industry?
“I do occasionally hear negative commentary from peers,” McCutchan replies, after a moment to collect her thoughts. “People will sometimes refer to pharma as the ‘dark side,’ or complain that drug prices are out of control.”
“I try not to get involved in those conversations, and stop at mentioning how much work goes into getting a drug to market, how much people in the drug industry care about patients, and about the quality of the whole process.”
No further evangelizing?
“I like to stick with what I know is true for myself and my company. We care very deeply.”
Outsourced Pharma readers know I’ve been looking for signs of a “changing of the guard,” from older generations of biopharma workers to newer ones. Are we in fact finding and training the next generation of workers? Are they helping the older generation do better?
I ask McCutchan as much. “Those are good questions,” she responds slowly.
“Right now, I definitely feel there's more of a synergy between the two or three generations in our workforce. Especially as the millennials get older and become more embedded. I think it’s a positive synergy.
“I don't think there necessarily needs to be a changing of the guard, but more of a deeper sharing of the wealth of experience. There's still so much to learn from where I’m sitting.”
And then this:
“I do feel sometimes millennials need to take more ownership, more commitment. I try to be cognizant of that. I think that might be a shortcoming of the millennial generation.”
And what of the following generations?
McCutchan says she’s been involved in alumni athletic-mentoring programs through her college.
“It's interesting to talk to alumni and current student athletes, to simply share where we are in life now. I love our biotech industry. I think it's a great space for graduates out of college. There’re certainly jobs here in San Diego. Whenever young women ask me about it, I speak very highly of our industry.
“Encouraging students – listening to their concerns – is eye-opening. It doesn't feel that long ago I was playing volleyball and studying for finals.”
Or starting up biotechs, we might add.
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We’ll get into the sage-beyond-the-years advice on the specifics of working with CDMOs and outsourcing, when we continue our discussion with Sara McCutchan of Aristea Therapeutics.
If readers are interested in participating in Outsourced Pharma Conferences, feel free to contact me at Louis.Garguilo@LifeScienceConnect.com.