The Ins and Outs of Running a Biopharma Startup

Fireside Chat with Dr. Kate Rochlin (Ph.D. ’14) Kicks Off Accelerating BioVenture Innovation

Dr. Kate Rochlin (Ph.D. ’14) was finishing up her degree at Weill Cornell Graduate School of Medical Sciences while contemplating her next career move. She could accept a job offer at a well-known Boston-based consulting firm or perhaps pursue a postdoctoral fellowship. Instead, she chose to build an allergy diagnostics startup at a time when entrepreneurship wasn’t widely available as a career option for early-career scientists.

A blonde woman wearing a long black dress

Dr. Kate Rochlin

“Congratulations; you just picked the riskiest of those three options,” Dr. Rochlin recalled her father saying as she excitedly shared her choice. Years later, Dr. Rochlin, who is now president and chief operating officer of IN8bio, a clinical-stage cell therapy and T cell engager company, never regretted that decision and still loves what she does day to day. She shared her journey and practical advice candidly on Sept. 8 in Uris Auditorium with an audience consisting of Accelerating BioVenture Innovation participants and faculty and students from the Tri-Institutional community.

Academia’s embrace of technology commercialization and entrepreneurship has changed drastically in the past decade. Dr. Rochlin said she was delighted to see that BioVenture eLab offers entrepreneurial programs and resources to interested students, with some of her Weill Cornell Medicine mentors teaching these classes.

When she was working on her first company, Dr. Rochlin learned to draft a formal licensing agreement, develop milestones and pitch to investors while sitting on the floor of an old, retired developmental biology lab at Weill Cornell. Her allergy diagnostics startup got off the ground with a lead investor, lab space and technology targeted as a companion diagnostic for novel peanut allergy therapeutics. That experience paved the way for more biotech company formations with an international reach.

In 2020, Dr. Rochlin landed at IN8bio, which is developing gamma-delta T cell therapies for cancers such as glioblastoma and leukemia, and autoimmune diseases using gamma-delta T cell engagers. Although gamma-delta T cells can seek out and kill tumor cells as well as recruit other immune cells to help, they are a very rare subset of immune cells that are difficult to mass-produce. Dr. Rochlin helped advance these clinical programs and was involved in developing an innovative solution to cellular therapy manufacturing challenges.  Rather than outsourcing to costly contract development and manufacturing organizations (CDMOs) or building a manufacturing facility, she leased third-party academic GMP space, which allowed the company to manufacture for Phase 1 trials at a reasonable cost, while generating data and de-risking the technology in early clinical programs. IN8bio manufacturers and scientists could control the manufacturing process and quality of the cell therapy for their clinical trial at a fraction of the outsourced cost. IN8bio not only saved money, Dr. Rochlin said, but the company also gained a better understanding of its cell therapy production, which allowed for process improvements and streamlining. “Think about what you can do creatively,” she said. “Your Ph.D. research is about being creative and figuring out how to solve questions that don't have obvious answers. You can certainly think out of the box about how you would build a company and put different options together.”

Realistic and strategic thinking is equally important in startup operations. Dr. Rochlin advised her audience to look backwards and forwards in their business development timeline to ensure milestones are meaningful and achievable. She challenged them to think through what asset to fund, identify inflection points and not underestimate the financing that is required. Investors are not impressed with unrealistic finance plans, she said. Dr. Rochlin also cautioned against trying to accomplish too much in an era where companies need to be focused and ensure they are advancing assets meaningfully. Specifically, she highlighted the need to think through potential indications and pick the best lead, rather than proposing bringing assets to IND stage in multiple indications, which is often not feasible with limited resources. Investors prefer a focused path that creates meaningful value, she noted. Contrary to a scientist’s instinct, she added, decision makers of a biotech startup may have to reprioritize programs when the market and investors lack interest, even though the science is interesting.

Additionally, Dr. Rochlin emphasized biotech entrepreneurs should learn to communicate with different stakeholders effectively. She described how discussions with clinical trial groups and physicians might be much more granular into mechanism and patient journey. IN8bio also tailors presentations to investors that may consider their scientific backgrounds or experience investing in a specific sector with the hope of boosting funding success.

Biotech leaders benefit from being open-minded to disparate opinions and criticism. IN8bio spoke to various KOLs and based on suggestions by a neurooncologist specializing in glioblastoma, approached the FDA and asked to conduct their Phase 1 trial in newly diagnosed patients. This is different from the relapsed or late line settings where most companies initiate trials in novel cellular therapies. It allowed IN8bio to try to help patients at disease diagnosis when the tumor is the most vulnerable and not in relapsed and refractory disease where the patients may be too sick to complete the duration of treatment. The FDA permitted the trial to utilize the gamma-delta T cell therapy on top of standard of care in frontline – a potentially much more beneficial setting where patients are healthier and adding additional time in remission is most meaningful. 

Dr. Rochlin told the audience she had to acquire operational knowledge from spending years working with mentors, asking questions and tackling each challenge head-on, learning what is needed to develop and lead a company. At the end of the day, she found it rewarding. “When I was finishing my Ph.D., I wasn't seeing how science got out of the lab and to patients. So I really wanted to be that translator,” said Dr. Rochlin. She encouraged the audience to follow their gut instincts if they feel passionate about something, whether it is entrepreneurship or another career path.