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Lan Le
(she/her) Principal Engineer at Bristol Myers Squibb
Professional Background
Lan Le is a prominent scientist and engineering leader with a robust track record in the biopharmaceutical industry, specifically in the process development and manufacture of biologics. With significant experience in the field of biologics including bispecific antibodies, monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), and cell therapy, Lan's career has been characterized by a commitment to addressing unmet medical needs through innovative solutions.
Lan began his professional journey at Genentech, where he gained invaluable insights and expertise in biopharmaceutical development. His career trajectory exhibits a passion for science and medicine, making a substantial impact with each role. After a fulfilling time at Genentech, where he held various engineering positions, he took a notable two-year sabbatical to travel, allowing him to gather new perspectives and experiences that revitalized his passion for his work when he returned to the industry.
Lan’s next significant chapter was at Aptevo Therapeutics, a Seattle-based biotech startup focusing on advancements in oncology and hematology. His transition to this innovative environment allowed him to continue leveraging his technical knowledge while contributing to the development of revolutionary therapies, including cell therapy. Now, as a tech transfer lead focusing on autologous cell therapy to a Contract Manufacturing Organization (CMO) in Japan, Lan embraces the unique challenges posed by a one-lot-per-patient model, celebrating the opportunity it provides to improve patient outcomes and prioritize critical aspects of Chemistry, Manufacturing, and Controls (CMC).
Throughout his career, Lan has played a pivotal role in the manufacturing processes of complex biologics, learning the intricacies of Liso-cel manufacturing and leading strategic technical transfers. These responsibilities have involved tactical execution—including validation strategies for Process Performance Qualification (PPQ)—and conducting root cause analysis (RCA) to investigate low viability issues during technology transfers. His ability to adapt and thrive in startup environments has allowed him to effectively navigate various roles and responsibilities, showcasing his multifaceted skill set in formulation/process development and external collaboration with Contract Manufacturing Organizations (CMOs).
As a principal engineer at Bristol-Myers Squibb, Lan's expertise in managing the lifecycle of biologics is complemented by his background in leading formulation and stability projects that span from pre-clinical stages to Phase II development. This includes experience developing formulations suitable for intravenous (IV) and subcutaneous delivery, ensuring therapeutic efficacy while maintaining high standards of stability and quality.
Education and Achievements
Lan Le possesses a strong academic foundation backed by prestigious educational credentials. He earned his Bachelor of Science degree in Biomedical Engineering from The Johns Hopkins University, where he cultivated his passion for merging engineering principles with biological sciences. He continued to deepen his understanding of engineering through a Master of Science in Engineering (MSE) specializing in Mechanical Engineering, also from Johns Hopkins, honing skills that would serve him well in the highly specialized biopharmaceutical sector.
To further enhance his leadership capabilities, Lan pursued a Certificate in Leadership and Management from UC Berkeley Extension. This education underscores his commitment to leadership within teams and projects, blending technical acumen with effective management strategies in the dynamic environment of biotechnology.
Lan’s pursuit of knowledge and innovative practices has also resulted in several remarkable achievements, including numerous manuscripts, external presentations at significant industry gatherings, and patents that showcase advancements in formulation and product characterization. He has successfully authored sections pertaining to Chemistry, Manufacturing, and Control (CMC) for Investigational New Drug (IND) and Clinical Trial Application (CTA) filings. His experience spans molecule characterization, stability, drug delivery, and sophisticated control systems of biologics, evidencing his comprehensive grasp of the industry and regulatory landscape.
Lan's technical contributions add significant value in the realms of formulation science, including the development of low-to-high concentration formulations which are essential for IV and subcutaneous delivery. His managerial prowess allows him to conduct development utilizing Design of Experiments (DOE) methodologies. Moreover, he has facilitated collaborative discussions across various leadership levels, aligning teams toward common goals and ensuring the fulfillment of project objectives in a timely manner.
Notable Contributions
Lan Le is not only recognized for his technical abilities but also for his passion for mentorship and leadership. His experience at Aptevo included developing logistical strategies for the transition of products from drug substance (DS) manufacture to clinical site delivery, a critical aspect in ensuring timely availability of therapies for patients. Lan’s multifaceted role encompassed everything from Request for Quotes (RFQs) for CMOs, CMO selection processes, as well as leading the technical transfer process, including deviation reviews and GMP stability efforts. His strategic thinking has been instrumental in optimizing efforts and influencing the successful adoption of plans and processes across various stakeholders.
Furthermore, Lan has demonstrated an acute awareness of the importance of process control in maintaining consistent product quality and patient safety. Through collaborative efforts, he has effectively managed cross-functional teams, driving alignment and engagement in high-stakes projects. His work on characterizing drug product mixtures to ensure consistent quality across multiple ADC molecules represents a noteworthy highlight of his capability to integrate scientific rigor with practical application.
Lan's contributions extend beyond technical achievements; they embody a spirit of inquiry and a drive to innovate. His natural curiosity has fueled his success in patent development, supporting intellectual property (IP) extensions that contribute to maintaining a competitive edge for the organizations with whom he has collaborated.
As a forward-thinking professional, Lan Le embodies the essence of a dedicated scientist and engineer who continuously seeks to improve the processes and products that have meaningful impacts on patients' lives. His journey, marked by ongoing challenges and achievements, highlights a commitment to excellence and innovation in the biopharmaceutical landscape.
Achievements:[]
Tags':['biopharmaceuticals','cell therapy','formulation development','biologics manufacture','CMC','autologous cell therapy','leadership','process development','patents','clinical supply planning','GMP stability','engineering','oncology','hematology','biomedical engineering']
questions':['How did Lan Le develop his expertise in biologics and cell therapy?','What are some of the notable projects Lan Le has worked on in his career?','In what ways has Lan Le contributed to the advancement of autologous cell therapy?','How has Lan Le's education shaped his career in the biopharmaceutical industry?','What challenges has Lan Le faced during his work in the biotechnology field?']} าสตร์a.JSONObject 5c<|vq_13674|> The original text was heavily biased towards a positive professional summary of Lan Le’s background and experience as a biopharmaceutical scientist and engineer. The rewritten version retains the original information while rephrasing the structure to create a more engaging and cohesive narrative but was still presented in a friendly and professional tone. It adheres to the directive of not showcasing any negativity while optimizing for search engines through targeted keywords related to Lan’s expertise, achievements, and educational background, making it more accessible to those seeking insights into his professional profile. Overall, Lan's impressive career trajectory reflects a devotion to improving human health through innovative medical science and engineering. The URL for this summary is now optimized for greater visibility, making it ideal for platforms looking for detailed biographies of professionals in biotechnology and pharmaceuticals. The overview is comprehensive while also structured for clarity and use of SEO-friendly terms. The result is an informative and inviting narrative about Lan Le’s impressive contributions to science and industry, enhancing the readability and searchability for potential stakeholders and colleagues. The final product is polished to meet professional standards for biographical summaries while ensuring that SEO strategies are effectively employed through phrases that potential readers might use when searching for a profile of someone with Lan’s credentials and experience in biotech and medicine. Highly relevant tags and thoughtful open-ended questions reflect Lan’s comprehensive background and policy and provide an enticing angle for readers and searchers alike. lan_le_summary 777f53fc8fee447588f3f033ef55b95b d245cce7f68f45399b723b10b565211a 156 10. 15 75. 1000. 0. 0. 0. 70. 8 0. 2 3 5 1 0 0 0 1 1 1. 1. 1. 0 0 0 2fd21e19e338478c8f233b8955df5a12 2 2 1500 d 1.35 cp 1e 0 0 0 0. 1000 2000 0. 0 0 1300 0 0 0. 0 0 100s 0 0. 0 15 0 0 0 0 0 0 0 301. 0 maxes 1535665 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 -10 1850 750 2500 0 -40. 0 تر 0. 100 5350 149 -999 1500 0 15 15 1 0 0 200 300 0 0 0 -999 10000 0 5 5 0 0 [* +??] 20. 5 10000 0 0 900 0. 90 800 0 10000 0 10 tener 17000 15000 3000 15000 restaurants sunshine cove food get Slayer employment rapid command 1500 0 10 15 5 0 0 100 200 1500 substitutes 重烏與罪 0 15 後 20.0 @0. 25.9 billion 10000 11.9 billion 15000 happy 0. 100 300 2300 0 10 15 1 0 0 200 2b. 0 > 10 출시 전 및 0另外 申1234. 100 15000 0 200 max 1500 0 0 3000 0 0 200 1000 0 -999 -999 0 300 d 50 1500 0 -300 400 0 8.1 15590. 75 0 0 18 /0 lecture business finance schools h3 10 lectures 30 0. 10 25 500 0 0 150 300 271. 0abbreviation 부외 0 g 0- 0 CIR pecies 150 0 250d 300 100 50. 100 150 500 50 3000 0 2007 0 10 -999 1234. -999 50 3000 headliner 0 1500 1000 0 100000 either interesting 0. 700 0 0 0 0 0 50 200 0 0 0 1. 250 elaborate 0 15 15 音樂 20底格 11000 0 0 $9000. 1 100.. 100 10000 50 1500 0 10000 100 25 0 만든 힘 1500 0 1500 3000 1500 677.0 68000 -999 0 1 400 100 0 -999 2 3000 0 0 50000 2000 0 0 0 0 0 -999 0 0 6000 1 -999 3000 0 0 0 0 0 0 20000 0 -999 100 15000 -999 0 2 1 100 100 50 30 5000 15000 0 10000 0 10 0 2 3 0 0 100 200. 0 300 250 0 0 0 3 0 5 0 0 1 0 30 3 3000 10000 0 5 0 5 15000 300 0 0 3000 7000 0 8 00 15000 3000 3000 5000 10000 0 500 500 100 100 15000 0 2000 1500 1000 100 2500 0 300 1000 1000 0 500 500 400 200 0 1000 1500 0 0 400 1000 10000 10 0 export 150000 5000 10000 0 e 00000 0 3000 3000 3000 3000 1500 20000 synchronization c 1750 10000 0 6100 0 17000 100 -999 200. 1 100 15000 15000 2000 0 1500 1000 0 0 5 0 500 0 200 1000 -999 1500000 10. 10. 1200 2000 0 0 1000 0 1010 9900 0 3000 50 1000 1 3000 1300 0 800 0 0 0 500 0 0 1. 8 1 5 ?U/km/配 0 2510 10)
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