About
My name is Claudia Lin
I am a biotech veteran with over 30 yrs of experience in leading biotech MNCs in the US, EU, and also an entrepreneur in China biotech during its first decade. I offer a unique combination of knowledge and experiences on business strategy, technical consulting for biotech portfolios that seek to take advantage of the evolving synergy between the West and East to achieve best chance of success at each stage of the product development leading to ultimate commercial success and return of investment. My in-depth technical experience covers post-R&D translational research, pre-clinical development, CMC for clinical development all the way to commercial manufacturing with strong emphasis on Quality by Design， QA， QC and global regulatory compliance. My product knowledge covers all traditional biologics as well as advanced therapeutics including cell and gene therapy.
ABOUT ME
I'm a unique blend and therefore, I can help with your unique and complex needs: I grew up in Shanghai China. After attending university there, I went to the US for post-graduate education and got my Ph.D from UC Berkeley and post-doc in UC LA in cell and molecular biology of cancer and neurobiology. I spent the next 24 yrs building my career in biotech in the US working for some of the leading biotech/pharma companies including Genentech, ROCHE, Exelixis and Bayer. After post-doctoral training, my early career focused on R&D and clinical product development including translational research. For the next 18 yrs to follow, my career pivoted towards product development and manufacturing and quality. I worked my way up in various parts of the global supply chain supporting 30+ IND and 5 BLAs and more in between; my responsibilities covered all areas of quality and regulatory compliance throughout product life cycle, with head of QC, QA and Head of Quality under my belt, during a time when pharmaceutical quality system was being redefined as a science and risk based systematic approach.
Over time, I became a strategic leader in the West for early adoption of the new quality system approach for the biotech industry, including implementation of Quality by Design for biologics from pre-IND to post-approval monitoring programs. I authored some of the first draft guidelines and BLA sections using these new concepts. The new quality and regulatory framework and tools paved the road for the rapid expansion of biologics product platforms in the past 20 years, including the accelerated approval pathways for the new advanced therapy products including cell and gene therapy products, and RNA based therapies in the recent years.
In 2015, I moved to China and worked there for the next 9 years. I had the great opportunity to witness the most dramatic changes in the biologics industry in China, from a nascent state to an industry that's now catching the attention of the developed markets in the US and EU. After first working as an executive for one of the leading Chinese biopharmaceutical companies, I founded a startup company based on China that provided comprehensive consulting and QC testing services for pan-biologics products.
My company were involved in all the milestone events for Chinese biotech industry including the first IND submissions for monoclonal antibodies, the first commercial launch of biosimilar and anti-PD-1 products, the first IND for CAR-T, the first commercial launch of CAR-T, the first IND for TIL and iPSC etc.
Our unique focus on pan-biologics including ATPs, and specialty in global submissions that cover the regulatory requirements for US, EU and China simultaneously, have gained the recognition of not only our Chinese and global clients, but also a global giant CXO who formed a strategic partnership with us.
With the above combination of East-West on-the-ground leadership experiences, I am starting a new chapter now to provide consulting services for clients who are interested in optimizing their product development, commercialization and supply chain planning in an ever-evolving global environment. I look forward to providing unique solutions to YOUR unique requirements and challenges using not only my own background and experiences, but also my extensive global network of experts in all areas related to biologics product development and supply chains.