About
Claudia Lin, Ph.D
I am a global biotech veteran with over 30 yrs of experience in leading biotech MNCs in the US, and an entrepreneur in China during its first decade (2015-2024). My career has progressed from R&D to translational research, then to CMC, quality and regulatory compliance with a strong focus on all biologics and CGT. My business in China contributed to many of the China-Firsts in biologics product launches in China, which with my support, gained approvals in the US and Europe.
Having had first-hand participation and a current network of leading hospitals with PIs for each disease area, local biotech leaders, CDMOs and GXP service groups, my knowledge about working with China is uniquely deep and current. This puts me and my partners in a unique position to serve as a bridge between waves of East/West innovation and integration. The waves combining forces, evident from a $120B total BD deals for 2025 that has become a proven business model with global MNCs such as Astra Zeneca, J&J, Eli Lilly, Novartis sourcing their early stage - late-stage clinical assets from Chinese biotech. So, the question is no longer IF (you should leverage China), but HOW?
How do we utilize the strength from China to maximize the speed and value of our product development programs, while avoiding traps with unforeseen risks? HOW do we advance my program with the limited funding and get to a higher value inflection point? HOW a Chinese innovative asset without Western-facing BD capabilities gets IND approval in the West?
I would suggest, as much as the Western players would like to follow a certain path with prior success, it is impossible to approach working with China as a PLATFORM. China is infinitely more complex than most of Westerners could understand, and navigate, not just the rapidly changing regulatory and IP landscape, business development vs. technical capabilities, one must understand the cultural differences that permeate into all aspects of your journey to the East. The most important aspect of the Chinese culture is "Relationship". It is the hidden cost in doing business with Chinese, which maybe deleterious when ignored.
My passion of seeing more science and technological innovation turn into life-changing medicine in the world makes me highly motivated to work with clients/partners in these exciting times of East/West biotech synergy.
Empower
Growth ACROSS the east/west
Western Companies in Need of a China Strategy
Very few people in western biotech nowadays would debate about the necessity of leveraging Chinese biotech R&D and early stage clinical development capabilities as part of their drug development strategy. However, how does one find the right path that gives your innovative asset the best chance of advancement, without costing you more at this stage? How do you use your early seed funding most efficiently so that you can secure your next round of funding to take your drug candidate further? The answer is a complex one, of course. What it is not, however, is attempting to follow a "proven" path; for example, Wuxi, a small town in the Jiangsu Province of China, is now a widely known global player in drug development and manufacturing. Western companies looking to work with Wuxi due to their proven success. Although this is likely a low risk path, it is not the smartest way to work with China as Wuxi is no longer the economic option, and that the technical team that will take on your project may not be the best for a small unknown biotech, so you are paying the premium price for the quality of work that is likely average and when problems arise, as they always do, you will not get the attention your project deserves. So, what is the key?
Chinese Companies Looking to File IND/IMPD in the West (出海）
If you are a Chinese biotech startup with a world-class innovative drug candidate. You have taken them through in vitro and in vivo validation to demonstrate the proof of therapeutic concept. You have conducted preclinical studies and demonstrated safety and even some efficacy and perhaps even in initial human studies. While moving forward in China, you would like to start your journey to take your asset to the global stage. Instead of investing in a new western facing BD team and a technical team capable of interacting with the western counterpart, you would benefit from a partner who can do that for you. This is what we are going to be for you.
Services
China IIT Planning and Execution
This service provides detailed analysis of your current program and identify the most cost-effective and risk-mitigated approaches to leveraging China local resources. It includes, but not limited to identifying leading PIs in reputable hospitals for the disease indication you are interested in, decisions on additional preclinical studies in China before clinical, GCP and GLP audits, and clinical protocol submission to the IRB, data review / monitoring infrastructures, intellectual property etc.
Clinical Ready CMC Package
Offering specific guidance on client's current CMC packages in their readiness for supporting first-in-human, with sharp focus on ensuring product safety, through critical controls including quality controls and process scalability. Mitigate quality risks. Provide hands-on assistance in technology transfer, material sourcing, and cross-boarding import/export. This service helps optimize, and navigate Eastern-Western product development dynamics effectively.
China Asset Going West
We will take a high quality pre-clinical or early-stage clinical asset to the next stages by finding funding, filing IND/IMPD or amendments to advance the development in the West.
BD/Investment Opportunities
The innovative therapy assets that we manage will be available at certain defined stages (i.g. first-patient dose, US IND approval etc.) for licensing, co-development, or VC funding.