re: Generation

December 16, 2020

Our quality culture enables pioneering science


Quality is a mindset that enables our science at Generation Bio.

It’s all about rigor. Responsibility. Integrity. And a commitment not just to do great work but to document that science so it can be understood, replicated, and built upon for years to come.

At Generation Bio we’re pursuing a bold goal: developing a new class of non-viral gene therapy to treat millions of people living with rare and prevalent diseases. We can’t get there without an ambitious focus on quality. So, from the start, we have worked to build a culture that enables and empowers every one of us to own quality. In my experience, it’s rare for a company at the pre-IND stage to formally establish a Quality function. At Generation Bio, we’ve done that, and we’ve made quality a priority across the entire company.

A primary area of focus has been data integrity. This means setting up processes to meticulously plan our science and capture ensuing data. Importantly, we’re training everyone on the team to document not just their successes — but also the experiments that fail. We learn valuable lessons from every bit of research, no matter the outcome, and preserving that knowledge will serve us well down the road. After all, insights gleaned from a failed experiment today might spur a groundbreaking discovery tomorrow.

We tell our team members that they should expect to spend about 20 percent of their time capturing and reviewing their work. Candidly, achieving that goal can require quite a mind-shift. People often perceive documentation as a boring bureaucratic exercise. We work hard to make it clear that, on the contrary, it’s a vital component of doing good science.

We can’t achieve our ultimate goal — delivering safe and effective gene therapies — unless we build quality into every step of our work, and that includes rigorous documentation of our science.

I’ve seen our team embrace this quality-focused mindset. To make the process as smooth as possible, we’re using electronic lab notebooks and working with our fantastic IT team, who are helping us build a state-of-the-art system that makes it easy to both input and retrieve experimental data.

Another key area of focus: establishing a culture of continuous learning. At Generation Bio we aim to create an environment that values continuous improvement. People should feel comfortable raising their hand or calling attention to something that isn’t quite right — with the understanding that we’ll all learn, grow and find a way to improve next time.

To enable this culture, our Quality group hosts educational seminars — open to the entire company — so everyone understands the quality and technical elements involved in developing our technologies and how those elements connect to the regulatory requirements. Our educational offerings give a line of sight into the future, when we hope our medicines will potentially be in the clinic, so that we can prepare for what is to come. For instance, we recently held a workshop to explain how regulators assess quality when they’re reviewing clinical trial applications. We want everyone on the team to be working now to establish the good quality practices that the Food and Drug Administration, European Medicines Agency and other global regulatory agencies will want to see down the road.

Our aim is for everyone at the company to not only understand quality but also feel ownership of quality in their work, no matter their role. Each one of us owns and is accountable for quality every day.

 I joined Generation Bio because I recognized in our team a strategic and action-oriented commitment to building a culture of quality. We’re working at the cutting edge of biology, developing redosable, titratable, non-viral gene therapies with the potential to transform the lives of millions of patients worldwide. I believe in that mission. And I believe we will achieve it — enabled by a rigorous culture dedicated to quality.


Safe Harbor Statement: Any statements in this press release about future expectations, plans and prospects for the company, including statements about our strategic plans or objectives, our technology platforms, our research and clinical development plans, the expected timing of the submission of IND applications and preclinical data, our manufacturing plans, our expectations regarding our new facility and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the conduct of research activities, the initiation and completion of preclinical studies and clinical trials and clinical development of the company’s product candidates; uncertainties as to the availability and timing of results from preclinical studies and clinical trials; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; uncertainties regarding the timing and ability to complete the build-out of the Company’s manufacturing facility and regarding the new manufacturing process; expectations regarding the timing of submission of IND applications; expectations for regulatory approvals to conduct trials or to market products; challenges in the manufacture of genetic medicine products; whether the Company’s cash resources are sufficient to fund the company’s operating expenses and capital expenditure requirements for the period anticipated, including the funding of the new manufacturing facility; the impact of the COVID-19 pandemic on the company’s business and operations; as well as the other risks and uncertainties set forth in the “Risk Factors” section of our most recent annual report on Form 10-K and quarterly report on Form 10-Q, which are on file with the Securities and Exchange Commission, and in subsequent filings the company may make with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof. The company anticipates that subsequent events and developments will cause the company’s views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date on which they were made.

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