Albert Li, MBA – Chief Executive Officer
Albert was named Chief Executive Officer of HTL Bio in January 2021. Previously, he joined HTL Bio as a research scientist for over 7 years where he led formulation and stability studies for protein and peptide projects. 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 APL in 2018 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, listed here, including 25 directly related to biotechnology and pharmaceutical applications.
Dave Brems, PhD – Chief Scientific Officer
David is a recognized expert in the field of protein stability, formulation, structure, and folding. He has been a leader in the Biopharma development industry for over 30 years working for Amgen, Eli Lilly, and Upjohn. He has made critical contributions to the development of the following marketed products; Humalog, Neulasta, Aranesp, Nplate, Prolia, Vectibix, and Xgeva. He has extensive experience in solving and preventing pharmaceutical development challenges, protein formulation automation technology, and optimum formulation resource strategies. Dr, Brems has authored over 80 publications in top tier journals, has 10 issued patents, and currently is a consultant. He has been an invited speaker at numerous international scientific meetings, universities, and FDA workshops. He has been an Adjunct Professor in the Dept. of Molecular and Cellular Medicine at Texas A&M University and the Dept. of Pharmaceutical Sciences at the University of Colorado and has served as a member of dissertation committees for several students. He has organized numerous sessions for international scientific societies and has served on executive advisory councils for various multicenter scientific initiatives. He is the recipient of the Eli Lilly Presidents Award and Ebert Prize by the American Pharmacists Association.
Dr. Brems received his PhD from the Dept. of Biochemistry at the University of Utah and was a postdoctoral fellow at the University of Iowa and Stanford. He has been a successful laboratory scientist and executive leader over small and large groups.
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 has more than 28 years of accomplishments in the discovery and development of protein therapeutics. Prior to helping found REMD Biotherapeutics, Tom worked at Amgen and served in positions of increasing responsibility in growing Amgen Protein Sciences to an organization of over 300 researchers across five different sites while maintaining a long tradition of industry excellence. 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. His continuing success led to leadership of all research protein technologies, and the evolution of Protein Sciences as an independent organization. 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 responsibilities at REMD, he serves as a consultant or scientific advisor to more than 10 different companies and investment group.
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.