Amy Kong is Chief Executive Officer and Co-Founder of Bionova Scientific, where she has led the company through rapid growth and expansion from its early days as a start-up CRO to its current state as a full-service CDMO.
Prior to co-founding Bionova in 2014, Amy held several scientific roles at leading biopharmaceutical firms including Boehringer Ingelheim, Amgen and Abgenix. At Boehringer Ingelheim, Inc. and Amgen, Amy spent several years as a Senior Research Scientist where her responsibilities included managing the Upstream Process Development group, leading media development activities, process development and process characterization (including characterizing the production bioreactor unit operation for a commercial process), process transfer and process improvements. In these roles, Amy prepared cell culture filings for the FDA QbD pilot program. She also evaluated the impact of critical raw materials on the productivity and product quality for a commercial process, resulting in 30% improvement in titer and improved process consistency.
In a prior role at Abgenix, Amy specialized in commercial cell line development and vector performance improvement. She successfully developed high producing cell lines for production and an IND filing using a DHFR-amplified system and also worked intensively with several CHO host cell lines, including CHO-DG44, DUXB-11, and CHO-K1. At Abgenix, Amy also developed protein expression vectors and evaluated them through small scale cell culture. She successfully improved vector performance by optimizing the promoter, introns and other vector enhancing elements.
She started her career as a molecular biologist at Scios, Inc., where she focused on vector constructs, gene expression and cloning.
Amy has published several peer-reviewed scientific articles and is the inventor of record for a U.S. patent involving mediators of signal transduction.
Amy earned her M.S. in Chemistry at the University of Minnesota and her B.S. in Biology at Fudan University, Shanghai, China.
Chung Chun is Chief Operating Officer and Co-Founder of Bionova Scientific.
Prior to co-founding Bionova in 2014, Chung spent nearly 20 years in the biopharmaceutical industry, establishing an impressive track-record of delivering technical results and achieving business goals. Much of her pre-Bionova career was at Abgenix, Amgen and Boehringer Ingelheim.
Most recently, Chung was a Senior Manager at Boehringer Ingelheim overseeing process development, tech transfer, and GMP campaigns for BI’s CDMO operations.
During her prior tenure at Abgenix (and later as part of Amgen), she was instrumental in the development and production of Vectibix®. For 10 years, she shepherded the product from the R&D stage, through IND and BLA filings, and into commercial GMP production.
Chung’s technical experience and expertise focuses on clinical and commercial upstream process development, process characterization; cGMP facility design and buildout including stainless steel and single-use technologies; manufacturing operations including Tox, Phase I, II, III and commercial; clinical and regulatory affairs including IND & BLA filings; and commercial product audits including FDA, EMEA, KFDA, ANVISA, PMDA & CFIA.
Chung earned her B.A. in Molecular and Cell Biology at the University of California, Berkeley.
Richard Vaillant has over 30 years of experience in the pharmaceutical and medical device sectors in the life sciences industry.
Prior to joining Bionova Scientific as Chief Financial Officer, Rich served as Director of Portfolio Company Financial Operations of Great Point Partners. Prior to Joining Great Point Partners he served as Chief Financial Officer of Vitalink Research, a Clinical Trial Services site management organization a former GPP II portfolio company.
Prior to Vitalink Research Mr. Vaillant served as the Chief Financial Officer of Cytovance Biologics (CDMO), a former GPP I portfolio company (7.4x return on invested capital). During his tenure at Cytovance (2011 -2016), revenues grew at a 45% CAGR. In prior roles, Rich served as Chief Financial Officer of Histogenics Corporation a tissue regeneration company and as Corporate Operations Controller of American Cystoscope Makers, Inc., a Urology, Endoscopy and Gynecology medical device manufacturing company. Previously, he spent over a decade at Boston Scientific Corporation, a multi-billion-dollar medical device manufacturer as Division Controller for two divisions (Meditech and Meadox).
Rich earned a B.S. in Accounting from Merrimack College and an M.S. in Accounting from Suffolk University.
Bruce Frazier is Vice President of Business Development and Sales at Bionova Scientific.
Prior to joining Bionova, Bruce spent more than 20 years in the biopharmaceutical industry, including more than a decade in CDMO/CRO business development and sales roles and several years in technical and scientific roles.
Bruce spent nine years in various business development roles at Boehringer Ingelheim (BI) in Fremont, California. Most recently, he was Director of Business and Contracts, with responsibility for leading the Fremont Business & Contracts team, growing BI’s portfolio of late-stage products and supporting key accounts. Bruce also held previous business development positions with Laureate BioPharma and Charles River Labs. Earlier in his career, he was a Research Associate in assay development at Peregrine Pharmaceuticals. At Peregrine, he transitioned to leading the QC/EM function at the company’s subsidiary Avid Bioservices, which was launching its CMO business.
Bruce holds his B.S. in Biology from the University of New Mexico.
Eric Fulmer is Vice President of Quality & Compliance at Bionova Scientific, with responsibility for all quality and compliance programs and systems.
Prior to joining Bionova, Eric held several Quality leadership roles at Samsung Biologics. In his most recent role at Samsung, Eric was Director/Team Leader for Drug Substance Quality Assurance for Samsung’s Commercial and Clinical Manufacturing plants. His responsibilities included Manufacturing Oversight, Batch Review, Warehouse Operations, Raw Material Receipt and Dispensing, Quality Control Laboratories, Investigations, CAPA, Change Control, Product Change Over and more.
Prior to Samsung, Eric held various Quality Assurance roles at Amgen, providing oversight to Cell Banking, Biosafety Laboratories, Analytical Development, Quality Control Testing, Device Design, Drug Substance Manufacturing, Drug Product Manufacturing, Combination Device Assembly, and Packaging / Labeling / Distribution. At Amgen, Eric also managed a manufacturing team performing mammalian cell culture and microbial fermentation to supply clinical studies. Earlier in his career, he worked in manufacturing and pilot-scale process development at Pyramid Biological Corporation, a maker of devices made from human-sourced materials.
Eric holds a B.S. in Chemistry from the University of Utah.
Hung Huynh is Vice President of Project Management at Bionova Scientific.
Hung joined Bionova Scientific 2015 as Director of Operations and was instrumental in building our Research and Process Development teams. In his current role as Vice President of Project Management, Hung leads the team that manages all client projects and communication and ensures that client programs are on-track. He also supports project management for internal projects, including the build-out of Bionova’s commercial ready cGMP manufacturing facility.
Prior to joining Bionova, Hung was Manufacturing Supervisor at Boehringer Ingelheim where he managed a GMP Upstream Manufacturing team and performed more than 10 successful GMP campaigns. He previously held several roles at Amgen, primarily in upstream process development. His work included equipment and process validation for commercialization of Vectibix® and he executed the PC studies and QbD studies for filings.
At Amgen, he was also involved in GMP facility design and led facility fit analysis for upstream tech transfer projects including 15 kL scale GMP production campaigns. He also worked on upstream process development at lab scale in 3L bioreactors and Pilot plant up to 100L tech transfers, and supported troubleshooting on GMP runs including Panitumumab (Vectibix®), Etanercept (Enbrel®), and Denosumab (Prolia®). Hung started his career in cell line development and research material generation projects at Abgenix.
Ling-Ling Kang is Vice President of Protein Sciences (Downstream, Formulation & Analytical Sciences) at Bionova Scientific and oversees the technical sectors in Bionova’s analytical, downstream and formulation groups.
Ling-Ling is an accomplished protein scientist with over 30 years of experience in the biotechnology industry. She brings an extensive chemistry-based understanding to the development of protein therapeutics, protein purification processes, product quality assessment, and formulation stabilization strategies.
Prior to joining Bionova, Ling-Ling held technical positions at Applied Viromics, DURECT Corporation, iMEDD, Inc., Alza Corporation, and Scios, Inc.
Her areas of research have included elucidation of protein structure and biological function relation, peptide synthesis, E. Coli protein expression, and multi-discipline protein reactions and analyses.
Lingling earned her M.S. in Organic Chemistry at the University of Massachusetts at Amherst and her B.S. in Chemistry at National Chung-Hsin University in Taiwan.