Leadership
Albert Li, MBA – Chief Executive Officer
Albert was named Chief Executive Officer of HTL Bio in January 2019. Initially, he joined HTL Bio as a research scientist where he led formulation and stability studies for protein and peptide projects.His decade-long commitment to the biotech industry has been underscored by significant contributions to the development of over 30 different protein/peptide therapeutics. This hands-on experience not only fortified his scientific expertise but also ignited a passion for leading innovation in the biotech sector. He holds a MBA from Pepperdine University and a Bachelor of Science in chemical engineering from the University of California Santa Barbara.
Cynthia Li, MS – Chief Operating Officer
Before joining HTL in 2019 Cynthia spent almost 23 years at Amgen. During the 23 years at Amgen, she managed and executed numerous bioanalytical testing projects for molecule assessment of therapeutic protein candidates, protein high-order structure characterization, product comparability and similarity assessments. She has extensive hands-on experiences with Fourier-transform infrared spectroscopy (FTIR), Raman spectroscopy (Raman), Differential scanning calorimetry (DSC), Circular dichroism (CD), fluorescence spectroscopies (FL), Dynamic light scattering (DLS), Capillary electrophoresis (CE), Amino Acid analysis (AAA) and HPLC. She is familiar with CMC filing and authored various sections of filing documents for several biosimilar programs.
Prior to working at Amgen, Cynthia was a research scientist at Genemedicine Inc designing and constructing gene delivery formulations, characterizing DNA-formulation and DNA-protein complexes by DLS, ITC, DSC, electron microscopy, FTIR, CD, UV-VIS and fluorescence spectroscopies. She received her M.S. in Chemistry in 1987 from Peking University and M.S. in Biochemistry in 1992 from University of Missouri-Kansas City.
Cynthia has authored 27 scientific publications, including 25 directly related to biotechnology and pharmaceutical applications.
Dave Brems, PhD – Chief Scientific Officer
David is an esteemed expert in protein stability, formulation, structure, and folding, with over 30 years of leadership experience in the Biopharma development industry. He has contributed significantly to the success of various marketed products, including Humalog, Neulasta, Aranesp, Nplate, Prolia, Vectibix, and Xgeva. With a strong background in solving pharmaceutical development challenges and optimizing formulation strategies, Dr. Brems has authored over 80 publications in reputable journals and holds 10 issued patents. As a consultant, he has been invited to speak at international scientific meetings, universities, and FDA workshops. Dr. Brems has also served as an Adjunct Professor at Texas A&M University and the University of Colorado, mentoring students and participating in scientific initiatives. Notably, he has received prestigious awards such as the Eli Lilly Presidents Award and the Ebert Prize from the American Pharmacists Association. Dr. Brems obtained his PhD from the University of Utah and conducted postdoctoral research at the University of Iowa and Stanford. Throughout his career, he has excelled as both a laboratory scientist and an executive leader, overseeing teams of all sizes.
Scientific Advisory Board
Linda Narhi, PhD
Linda recently retired as a Scientific Executive Director in Process Development at Amgen after more than 30 years with the company. She has been involved in the process and product development and characterization of protein therapeutics throughout her career. At Amgen this included leading the biophysics group which provided higher order structure analyses for all phases of protein development, developing the early candidate selection strategy (including reformulation studies), and co-leading the team engineering universal Fc scaffoldings. She is currently a member of the USP Dosage Form expert committee, and the expert panels for visible inspection, devices, and the USP stakeholders Forum, and leads the expert panel on subvisible particle analysis. She has led several industry efforts including those to understand the potential immunogenicity of protein aggregates, the population of submicron particles present in product, and the challenges of silicon oil in DP. She has published more than 130 articles in peer reviewed journals, authored multiple book chapters, and edited 2 books, on the subjects of protein folding, stability, formulation, and aggregation, potential immunogenicity of protein aggregates, and biotherapeutic development. She holds a Bachelor of Science in Chemistry and in Cell and Molecular biology from the University of Michigan, and her PhD in Biological Chemistry from UCLA.
Tom Boone
Tom Boone has more than 28 years of accomplishments in the discovery and development of protein therapeutics. His career at Amgen began in 1981 with the isolation and cDNA cloning of novel cytokines and growth factors including G-CSF. Tom Boone’s responsibilities grew from Scientist to Director and he developed proprietary processes used to produce recombinant G-CSF and other therapeutic candidates for clinical applications. Tom Boone was the first Vice President of Amgen Protein Science and his teams were responsible for the majority of the current Amgen product portfolio and late stage clinical programs. Tom was the inventor and a lead scientist in the development of Nplate®, a treatment of thrombocytopenia. His critical role in the discovery and process development of G-CSF (Neupogen) is widely recognized. Tom Boone’s expertise in protein engineering, production, purification and process development are in high demand. In addition to his role at HTL, he serves as a consultant or scientific advisor to more than 10 different companies and investment groups.
Jan Fang, PhD
Jan Fang is a veteran of the biopharmaceutical industry with more than 20 years of experience, including her most recent position of Research Scientist at Amgen. She possesses extensive knowledge of and experience in multi-modality drug product development from the earliest stages through global marketing applications and has successfully led global cross-functional teams in drug product development. Additionally, Dr. Fang has experience in cGXP and regulatory compliance and filings, and she has successfully removed multiple clinical holds for her clients. She has a great track record of supporting multiple new drug applications (NDAs), investigational new drug applications (INDs), pre-approval (PAI) inspections, and post-marketing product improvement. Her experience includes stints at Amgen and Pfizer. Dr. Fang earned her Ph.D. in Chemistry from Rutgers University.
Zaiqing Wen, PhD
With an illustrious career spanning over 30 years in the biopharmaceutical industry, Zaiqing Wen brings unparalleled expertise to the field. Over his 24+ years at Amgen, he has played a pivotal role in the development of more than 40 therapeutic proteins and peptides. Zaiqing's expertise extends to novel analytical method development and biophysical characterization for Drug Substance (DS), Drug Product (DP), and combination DP in process and formulation development. Notably, he is a seasoned investigator in customer complaints, as well as clinical and commercial product non-conformance issues. Beyond the lab, Zaiqing is a prolific scholar with over 70 peer-reviewed journal papers and more than 50 presentations as an invited speaker at prestigious national and international conferences, including AAPS, AAPS-Bio, ACS, Biophysics Society, PDA, PDA Europe, FACSS (Scix), and the International Raman Conference. His remarkable achievements underscore not only his technical proficiency but also his strategic vision and leadership impact in advancing the frontiers of biopharmaceutical science.