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Lan Le
(she/her) Principal Engineer at Bristol Myers Squibb
Professional Background
Lan Le is a dedicated scientist and engineering leader with extensive experience in manufacturing science and technology (MSAT), formulation/process development, and biologics. With a rich career trajectory that began at Genentech, one of the foremost biotechnology companies, Lan has consistently worked ardently to provide innovative medicines aimed at fulfilling unmet medical needs. His impactful journey through the biotech sector has been characterized by his specialization in bispecific antibodies, monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), and cell therapy.
His dedication to advancing the field of biotechnology was complemented by a transformative two-year sabbatical during which he traveled the world. This diverse experience not only enriched his personal growth but also invigorated his professional ambitions as he returned to the biotech landscape with renewed vigor at Aptevo Therapeutics. At this innovative Seattle-based start-up, Lan has actively contributed to the advancement of science in oncology and hematology sectors.
Currently, he is pivoting towards the exciting realm of autologous cell therapy, where he serves as a tech transfer lead to a contract manufacturing organization (CMO) in Japan. His current role encompasses navigating the intricate technical challenges posed by the one-lot-per-patient scale-out model. This structure is not only crucial for optimizing manufacturing processes but is pivotal for enhancing patient-centric solutions, thereby underscoring the critical importance of chemistry, manufacturing, and controls (CMC).
One of Lan's standout achievements includes leading the tech transfer of the Liso-cel manufacturing process to the CMO in Japan. His responsibilities have included developing tactical execution plans, implementing validation strategies for process performance qualification (PPQ), and conducting thorough root-cause analyses (RCA) to investigate low viabilities during tech transfers.
Roles Across Start-up
Lan's tenure at a start-up has granted him the unique opportunity to don many hats. Among his key responsibilities, he has engaged in formulation and ultra-filtration/diafiltration (UFDF) development, managed requests for quotes (RFQs) for CMOs, and led CMO selection processes. He has conducted batch record and deviation reviews while planning for clinical supply needs, overseeing GMP stability, and ensuring smooth tech transfers to CMOs.
Furthermore, Lan displayed his innovative leadership by developing new logistics strategies for transporting molecules from drug substance (DS) manufacturing to clinical site delivery, significantly influencing the operational efficiencies within the organization.
Lan's proficiency extends to creating low-high concentration formulations for both intravenous (IV) and subcutaneous (subcu) delivery methods. His hands-on leadership experience allows him to conduct comprehensive product development utilizing statistical design of experiments (DOE) to support GMP stability over extended periods. His ability to align various stakeholders, from director-level management to cross-functional teams, showcases his adept management capabilities.
Education and Achievements
Lan Le's academic background is rooted in prestigious institutions, having attained a Master’s of Science in Engineering (MSE) with a concentration in Mechanical Engineering from The Johns Hopkins University, where he also received his Bachelor’s degree in Biomedical Engineering. Further enhancing his professional skill set, Lan pursued a Certificate in Leadership and Management from the UC Berkeley extension.
His technical expertise has led to notable contributions to the field, including several published manuscripts, external presentations, and a couple of patents. His patent portfolio includes essential formulations to extend intellectual property rights, as well as noteworthy publications on the characterization of drug product (DP) mixtures. This work has been instrumental in demonstrating process control measures crucial for ensuring consistent product quality across multiple ADC molecules.
Contributions to Regulatory Filings
Lan's proficiency also extends to regulatory affairs, where he has actively participated in authoring the Chemistry, Manufacturing, and Controls (CMC) sections of Investigational New Drug (IND) and Clinical Trial Applications (CTA). His thorough understanding of regulatory requirements has been essential in crafting documents that detail facilities, molecule characterization, stability, drug delivery systems, and control systems for biologics. Lan is well-prepared for engagement with Health Authorities, reflecting his expertise and commitment to maintaining compliance and facilitating successful regulatory pathways.
Achievements
Lan Le's journey through the biotech realm exemplifies a commitment to scientific advancement, characterized by both leadership and collaboration. His in-depth understanding of product development, along with his focus on providing solutions for patients, has set a commendable precedent in his professional endeavors. Lan's strategic vision and ability to drive projects to successful completion have positioned him as a distinguished figure in the biologics and cell therapy sectors.
With a future-oriented mindset, Lan is excited to contribute to the growing field of autologous cell therapy, where patient-centered innovations are paramount. His current role presents an exciting opportunity to push boundaries in the biotechnology landscape, ultimately striving to deliver groundbreaking therapies that enhance patient outcomes and contribute meaningfully to public health.
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Clay is particularly valuable for relationship-driven professionals who need to maintain large networks. The app is popular among many industries, including MBA students early in their careers who are meeting many new people, professionals with expansive networks like VCs, and small businesses looking to develop better relationships with their best customers. Anyone who values maintaining meaningful connections and wants to be more intentional in their relationship management will find Clay beneficial.
Clay offers competitive pricing in the personal CRM market. Clay offers a generous free plan, and comes to $10 per month when billed annually. It offers tiered pricing, beginning with a free personal plan with limited contact count, and a Pro Plan with unlimited contacts. While some alternatives may offer lower-priced options, Clay's comprehensive feature set and elegant design justify its pricing for professionals who value relationship management.
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