CEO and Founder of JADE Biomedical Claudia Lin, PhD
Biologics
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Regina Kelder

JADE Biomedical Builds a Unique Niche in China’s Cell and Gene Therapy Market

Founder and CEO Claudia Lin on how her company is helping drug makers navigate the regulatory channels

When Claudia Lin began her PhD studies at UC-Berkeley in the 1990s, she never envisioned that one day she would create and run her own company. What she did know was that she wanted to work in the cancer field. Survival rates for patients were grim and like many aspiring scientists, Dr. Lin hoped to contribute to new drugs that would extend lives and improve treatment options.

After obtaining a degree in cell and molecular biology from UC Berkeley, the Shanghai native began working for various California-based pharmaceutical companies, eventually finding her way to Genentech, the founder of the biotechnology industry and a recognized leader in oncology drug development. Dr. Lin arrived at the company as it was pioneering new approaches to treating cancer by molecularly targeting signals that make cancer cells grow, metastasize or self-destruct. These so-called targeted therapies, when delivered with biologically derived drugs, biopharmaceuticals, had much improved long-term safety and efficacy profiles, which made Genentech the birthplace of biopharmaceuticals, but also the world’s premiere oncology drug company even to this day.

Dr. Lin joined Genentech, after a 10-year career in cancer R&D, starting her focus on clinical drug development, CMC and GMP quality management. At Genentech, Dr. Lin worked on more than 10 blockbuster biologics—including Avastin, Perjeta, Herceptin, Rituxan, Actemra, Kadcyla and Tecentriq during both clinical development as well as product commercial launch and post-marketing product quality management. Her career in biopharmaceutical product development and commercialization GMP quality management were further extended at the Bayer Healthcare North American site where she served as Head of Quality for all products from pre-IND to first commercial launch. There, Dr Lin played a critical role in modernizing GMP Quality systems for Bayer Biologics, as well as supporting the new commercial launches for Kovaltry, Jivi, Eylea, and Bayer biologics development pipeline.

She might have remained with these global companies a lot longer, but when her parents becameChina, C&GT market, Claudia Lin profile seriously ill, Dr. Lin returned to China to care for them. She became the Head of Quality and Compliance for leading biopharmaceutical companies in China in 2015, where the biologics market was relatively new but developing fast. She was instrumental in bridging the GMP quality gaps between the China company and its US strategic partners, by establishing a state of the art biologics Quality systems and teams and operations in the Chinese company. But when she realized the severe shortage of biologics Quality experts/leadership in China for the growing industry, she decided to strike out on her own and launch JADE Biomedical, a small niche firm with a big mission: providing technical services, and regulatory and quality services to the growing biopharmaceutical industry in China.

With the cell and gene therapy market heating up, JADE Biomedical began focusing its energies almost exclusively on this industry, providing expert guidance to clients on quality assurance, quality systems, and quality control. “It’s exciting, it’s intriguing, it’s challenging and there is a huge market in China,” said Dr. Lin.

JADE Biomedical also recently signed a strategic partnership with Charles River Laboratories as its first and only partner in China for Biologics Testing Solutions.

Eureka recently connected with Dr. Lin for a wide-ranging conversation about her experiences running a company in China, and how its role is integral to the success of cell and gene therapy clients. She also had some advice for girls and young women with an eye toward the corner office.

Eureka: What is the regulatory climate in China like right now in terms of cell and gene therapies?

Dr. Lin: China’s version of the FDA, the National Medical Products Agency (NMPA)-- has done an amazing job of transforming the regulatory process and standards to catch up with the more advanced markets. The once somewhat a protectionist policy that kept foreign new drugs out of China for 10 years or so to preserve the market for Chinese drug companies proved to be limiting not only for fair competition, but also for the most innovative life-saving medicines for the Chinese people. The Chinese government realized this was an issue and about five years ago, NMPA started to revolutionize how they regulated drugs. Most remarkably, China joined the ICH in 2018, which gave them voting rights, while committing China to the same rules and regulations as other ICH member countries. So that really propelled a lot of positive changes within the Chinese regulatory agency, including the way it prioritizes its resources and allows a more open environment for global competition.

Cell and gene therapy (CGT) development has gone through a zigzagged pathway in China, justClaudia Lin C&GT therapy profile like it has in the US and EU. There was a lot of CGT clinical research being conducted by clinical research laboratories as medical technologies, which were not under the jurisdiction of drug regulatory agencies in China since the late 2000s. Such an unregulated industry came to a squelching halt in 2016 when some well publicized cases of patient deaths were reported. Since then, the US and EU have approved the marketing of several CAR-T therapies, reactivating the CGT sector of the biopharmaceutical industry in China in 2019. While the regulations are becoming more harmonized with US and Europe, the reality is that the therapy developers, regulators, and the service providers, i.e., the entire ecosystem for CGT is not as mature in China as in the US. That being said, China celebrated the launch of its first CAR-T product this year, June 23 rd, to be exact. I remember the day so clearly because it was the day before Jade Biomedical held its four-year anniversary/opening of our new Biologics Testing Laboratory; as the GMP Quality strategic partner to the developer of China’s first commercial CGT product [FosunKite Biopharmaceutical], we had a signing ceremony the day after its official drug approval. Currently, there are many hundreds of CGT in clinical development stages from Chinese companies, as well as non-Chinese companies aiming for the China market. More and more of these leading companies are already or becoming JADE clients. Looking back, I think my strategic decision as of two to three years to get [JADE Biomedical] ready as a leading comprehensive quality service provider in the CGT space has worked out so far.

Eureka: What kinds of services does JADE Biomedical provide for clients?

Dr. Lin: JADE is a one-stop shop for GMP quality and regulatory affair services. The two major lines of services are: Biologics Contract Quality Organization (Bio-CQOR), and as a Contract Testing Laboratory (CTL). The Contract Testing Laboratory or CTL is the part of our business that partners most closely with Charles River. We provide contract testing for pharmaceutical products, mainly biologics, which are undergoing GMP manufacturing, whether it is for the purpose of regulatory submission and routine operations or clinical trials and commercial manufacturing. BIO-CQO is a brand-new concept focused on GMP quality and the delivery of quality related services. We do not do process development, or manufacturing for clients. What we do is to provide technical and regulatory compliance support around the quality requirements that apply in designing a quality system. This includes supervising clients to make sure they are capturing the key quality controls at the right stages during the product development life cycle. We also write regulatory submission documents from IND to BLA with focus on CMC.

Eureka: Does GMP mean something different in China than in Europe or the U.S, or is their harmony among the different regulatory bodies?

China, C&GT market Claudia Lin ProfileDr. Lin: Even the US and Europe are not perfectly harmonized, and they have been working together for the past 50 years. The US is definitely the world leader in drug regulation. Other regions have followed but have also developed their own preferences and their own emphasis. China being a new player has many regulations that are historically very different from the US and EU. In China, traditional ways of pharmaceutical regulations, policies and procedures came from traditional Chinese medicine, or chemical drug API regulations, and hence needed significant changes/adaptations for the more modern pharmaceutical products, especially biopharmaceuticals. For example, some of the compendial testing in China can be very different than that in the US or Europe. There are also many factors that make certain aspects of the Chinese regulations much more stringent, for example, the compendia testing for Tween 80. Part of JADE’s expertise is to be able to look at what the client’s needs are and guide them; to make sure that they are fulfilling the right requirements at the right time for their unique product.

Eureka: Given how critical quality is to the final product, it kind of sounds like your company is the last line of defense between the client and the regulator, that you play a rather unique role.

Dr. Lin: I would have to think that is true. Many clients are early-stage researchers moving to drug development and therefore need rather broad assistance from us. Given that our services are comprehensive, yet personalized to the client, we have enjoyed the trust of plenty of clients (40+), including many of China’s leading biopharmaceutical companies, and it’s also a booming market, but it’s also a little bit, how should I say, overheated. In order to fulfill the biggest impact to the blooming industry, for the purpose of enabling Quality modern medicine, we need to be able to discern, to a certain level, if a potential client has development programs that have a real potential for delivering clinical differentiation of therapeutic benefit. We face so many different types of clients developing different products, many on the cutting edges of biopharmaceutical development so it makes our jobs exciting. It’s like that in the US as well, but in China, the entire field is more primitive, and therefore more challenging to serve.

Eureka: How did you initially connect with Charles River and how does the partnership work?

Dr. Lin: I was contacted last August by Charles River’s Director of Biologics for Asia Pacific through LinkedIn. Just as she contacted me, one of her direct reports in China also found me through LinkedIn. They said they were searching for good partners for their Biologics Testing Solutions business in China. One thing led to another and on Dec. 24. 2020, we signed the partnership agreement, so things happened rather fast. I think it is because both of us felt good about the fit between what Charles River was looking for and what Jade Biomedical was looking for for the next stages of business development.

Eureka: So, who is the direct point of contact with the client – Charles River or JADE Biomedical?

Dr. Lin: Both of us have sales and marketing teams in China and we both refer clients to eachClaudia Lin profile, Chinese biotech market other. One remarkable thing that is making the collaboration even more efficient and exciting though is this process called mutual qualification from quality and GMP compliance perspectives. We started this in-depth evaluation by Charles River’s quality and regulatory teams and JADE’s quality team, strictly against US FDA and Eudralex GMP requirements. Some issues were discovered by the process, and we worked hard and fast to remediate these gaps. Within a few months, we were able to claim a satisfactory conclusion on mutual qualification of each other as a subcontractor testing laboratory, which means Charles River can basically send its global testing overflow to JADE's laboratory and vice versa.

Eureka: Are most of JADE’s clients in China?

Dr. Lin: We do have US clients trying to bring their products to China or who are licensing products pre-developed by Chinese companies. But 80% of our clients are Chinese companies and most of them have a global market as their drug development target.

Eureka: In the science fields, where it can be hard for women to move up the career ladder, can you talk a bit about your journey to the highest ranks for management.

Dr. Lin: I did not plan to become a woman CEO for a startup in China, but it became necessary. I really wanted to do GMP quality services for complex biologics medicines, but at the time, no one else really believed in me, so I had to do it on my own. Biopharmaceutical industry in China is still very much a man’s world in China, especially when you get to the Chairman of the board or C level positions. When I go to domestic conferences, most of the keynoters are men, although I am delighted to see an increase in women leaders in the past few years.

I just knew that to really fulfill my vision of an impactful business using my own background and passion, I would have to create it myself, be able to pull the shots, and make my own decisions for this new type of business. That meant I had to be in charge, at least at the beginning. I have gone through a lot during the last four years creating and running JADE Biomedical and gaining trust and reputation of our valued customers, one at a time. It helps that I really feel passionate about what we do, the value we bring, and the importance of staying in the forefront of pharmaceutical industry regarding science, technology, and regulations. I always come back to remembering that patients need companies like us to make sure drug companies put out medicines that are safe, efficacious and have reliable product quality. I think I speak for my entire team that we feel very proud every day doing what we do. All the struggles, stress, other challenges, at the end of the day, it's been well worth it.