Welcome to Partnology’s Biotech Leader Spotlight Series, where we highlight the remarkable accomplishments and visionary leadership of biotech industry pioneers. This series is about showcasing the groundbreaking strides made by exceptional leaders who have transformed scientific possibilities into tangible realities. Through insightful interviews, we invite you to join us in following the inspiring journeys of these executives who continue to shape the landscape of the biotech industry. This week we are recognizing Nicole White, PhD.
Nicole White, PhD, serves as the Chief Manufacturing Officer of Assembly Bio. Nicole joined Assembly in 2020 and previously served as the Company’s Senior Vice President, Pharmaceutical Development and Manufacturing. Prior to joining Assembly, she headed up Process Chemistry at Gossamer Bio and led Chemistry, Manufacturing, and Controls (CMC) for multiple early and late-stage programs in development. Prior to that she held progressive leadership roles at Gilead Sciences to advance multiple programs from Phase 1 through commercial launch and helped guide the drug substance manufacturing and global outsourcing strategy. While at Gilead she contributed to the development and commercial launch of multiple antiviral programs including Harvoni®, Vemlidy® and Vosevi®. Nicole earned a PhD in Organic Chemistry from the University of California, Irvine, and a Bachelor of Science degree from the University of California, San Diego.
Walk me through your career journey: what have been some of the most pivotal moments or projects in your career and what inspired you to focus on CMC in the biotech space?
My career journey was driven by a fascination with science and a deep desire to contribute to society and help others. Initially, in college at the University of California, San Diego, I was set on attending medical school, having taken the MCAT and prepared accordingly. However, an organic chemistry class taught by Professor Jay Siegel changed my path. I found the subject fascinating, like learning an entirely new language, and quickly fell in love with the science.
Through that class, I connected with fellow students and secured an internship at Agouron Pharmaceuticals, which later became part of Pfizer. There, I experienced life as an organic chemist, and really enjoyed working in the lab. I decided to defer medical school to pursue organic chemistry full-time. My first job out of college was with Neurocrine Biosciences, where I worked as a medicinal chemist—a role I thoroughly enjoyed.
Eager to deepen my understanding of chemistry, I returned to graduate school at the University of California, Irvine, joining Professor Larry Overman’s group. Larry was an inspiring mentor, passionate about science and committed to high standards and scientific rigor, making my time there formative. After graduate school, I joined Gilead Sciences as a process chemist. This role differed from my previous work, but it offered new challenges and opportunities. At Gilead, I was fortunate to work as part of an incredible team on programs for hepatitis C and hepatitis B, including a groundbreaking hepatitis C cure. Seeing the real-world impact of these therapies on patients’ lives was incredibly motivating.
Following my years at Gilead, I transitioned to the smaller biotech space to broaden my experience across CMC, eventually, joining Gossamer Bio in its early, pre-IPO days. I thrived in this dynamic environment, where I could wear multiple hats, expanding my experience in drug product development and gaining broader expertise in Chemistry, Manufacturing, and Controls (CMC). Eventually, I moved on to lead CMC at Assembly Bio, where I not only oversee an incredible CMC team but also serve as an officer of the company, working closely with the executive team on overall strategy.
Throughout my career, I’ve been fortunate to work with and learn from a variety of mentors, including bosses, colleagues, and consultants from every company I’ve joined. These relationships have been invaluable, and I still reach out to many of these mentors for advice and support. Building and maintaining these connections across different stages of my career has been one of the most rewarding aspects of my journey.
Tell me more about the work you’re doing at Assembly Bio – what are your top priorities to ensure long-term success and scalability?
Assembly Bio is focused on developing novel antivirals to treat serious viral diseases, particularly those associated with herpesviruses and viral hepatitis. Recently, we initiated a Phase 1b trial for ABI-5366 as part of a combined 1a/b study for recurrent genital herpes, along with a separate 1b trial in hepatitis B using our capsid assembly modulator, ABI-4334. We’re also planning to advance two additional compounds into the clinic before year-end 2024, making this an active year for us.
On the manufacturing side, our focus has been on ensuring an uninterrupted supply for both clinical and non-clinical studies. The CMC team plays a unique role in the organization by bridging the research, non-clinical, and clinical departments. We’re consistently working to support clinical supply needs while partnering with the research team to advance new compounds toward development candidates. This alignment of efforts across teams has been our main focus this year, keeping us quite busy.
Developing antiviral therapies poses unique challenges in CMC. Could you share some of the critical hurdles you’ve encountered and how you’ve navigated them?
One of the key challenges in manufacturing is that, when a compound is initially nominated as a development candidate, the clinical plan is often still in flux. There’s uncertainty around the study design, target countries, and other evolving details. Due to manufacturing lead times, we often have to start production “at risk,” so strategic planning is crucial to ensure we have materials in place to support a variety of potential clinical scenarios. We need to be prepared to support whatever plan is developed, including any number of countries and sites, but also manage costs carefully. Balancing these two objectives requires significant experience.
Our approach generally involves starting with certain commodity chemicals, especially those with longer lead times. We may begin by purchasing larger quantities of these materials, allowing us flexibility. As demand projections become clearer, we can either hold back material to control costs or proceed with a full production campaign, depending on requirements. This way, we ensure adequate stock of hard-to-procure items, while also adjusting production as the clinical scenario becomes more defined.
Another ongoing challenge is geopolitical uncertainty, which necessitates constant risk assessment. We hold monthly reviews to evaluate supply chain risks, assigning a rank to each based on probability, severity, and potential impact. For high-risk items (labeled “red”), we proactively implement risk mitigation strategies to avoid supply disruptions. If a risk is deemed low in both probability and impact, we’re less likely to address it immediately. This regular reassessment helps us stay ahead of potential issues and maintain a secure supply chain.
Lastly, early-stage projects present dose-related challenges, as the efficacious dose is often unknown. Formulation development, which depends on understanding the target dose, can be particularly challenging. For Phase 1 studies, we usually develop formulations capable of supporting a broad dose range, as Phase 1 studies typically evaluate a wide range. As the program advances, we adjust formulations to maintain a manageable tablet size and efficient production. Our goal is to create an adaptable formulation early on that we can fine-tune as needed, without delaying the start of Phase 1.
How do you collaborate with the R&D team to ensure that manufacturing considerations are integrated early in the therapeutic development process?
This is an area that’s incredibly important for early-stage companies. In an early-stage company, the timeline from development candidate (DC) nomination to the clinic is crucial, and the goal is to get there as quickly as possible. At Assembly, we start preparing about six months before the DC nomination. A CMC team member, begins sitting in on research meetings to provide guidance on scalability and PK formulations. We may even take initial chemistry efforts in-house, contracting out process development to start building familiarity with the compound before it’s formally nominated.
This early involvement helps us establish a scalable process so that, once the compound is nominated, we can begin producing larger quantities—multi-kilogram batches, as opposed to the milligram-to-gram scales typically produced in medicinal chemistry. Additionally, we support the medicinal chemistry team early on by creating stockpiles of key materials, which accelerates timelines by providing ample material for their research activities. This early integration is crucial and allows us to accelerate our timelines moving from DC nomination to the clinic. For most programs at Assembly, we’ve achieved this transition in less than a year, a significant advantage for a small pharma company.
The biotech industry is evolving rapidly. What exciting trends or innovations in manufacturing do you think will reshape the CMC landscape in the next few years?
One of the trends I’m particularly interested in is the advancement of long-acting formulations, both oral and injectable. This area has seen significant progress and has truly revolutionized the treatment of serious diseases. Not only has it improved efficacy, but it has also reduced the burden on patients by enabling less frequent dosing. We’ve seen this transformation most notably in the HIV space, which has been incredible to watch. At Assembly, we are very focused on this area, especially with our ABI-5366 program for recurrent genital herpes, which is a long-acting therapy aimed at potentially weekly to monthly oral dosing. The progress in this field has been exciting and continues to advance rapidly.
Another area of interest for me, rooted in my background in organic chemistry, is flow chemistry. This technology has opened the door to scaling chemistry that was once thought impossible. Some reactions that were previously considered too hazardous can now be safely managed in a flow setup. This advancement has enabled the scaling of highly elaborate processes with a much lower environmental impact, thanks to the smaller footprint required. Even with non-hazardous reactions, flow chemistry has made it possible to produce hundreds of kilograms of material in a compact space, which is a great evolution in manufacturing.
What advice do you have for emerging leaders in biotech, particularly those working in manufacturing or operational roles, as they navigate the complexities of the industry?
One of my main pieces of advice is that communication is key. A company can have incredible science, but equally important is the ability to effectively communicate and discuss it, both internally and externally. Internally, it’s crucial to provide teams and contract manufacturing organization (CMO) partners with context for the activities they’re driving. It’s important that everyone understands why they’re doing what they’re doing and how their work contributes to the company’s larger goals.
Additionally, I believe in actively soliciting feedback from others and encouraging out-of-the-box thinking, especially from those who may not be subject matter experts. Sometimes, they offer the most innovative ideas. Tailoring your presentations to suit the audience is also important—fine-tuning your approach as questions arise and allowing it to evolve naturally.
Fostering an environment of clear communication, both internally and externally, really drives innovation and accelerates drug development. Ultimately, I think most of us are in this field because we want to bring novel therapies to patients in need. That’s what motivates me every day, and it’s why I love this job.
