BAW March Interview with Joan Shen
Summary and Review
On March 8th, 2022, we were very honored to have our guest, Dr. Joan Shen join our March Interview “Female Leader in Global Biotech Industry and Cross Region Development Collaboration”. Joan was selected by Endpoints News as one of the top 20 women in Biopharma R&D honorees 2021 and was listed as Forbes top 50 Women in Tech in China 2021.
Interview Highlights include:
Dr. Joan Shen’s career evolution from Eli Lilly to Wyeth to Pfizer’s China Clinical Lead to Hengrui’s CMO to Janssen’s China Development Head to I-Mabs’ CEO to NeuShen Founder & CEO
Joan’s Experience conducting clinical trials in China in the early days, while at Pfizer
Going global with clinical trials in US and China at I-Mab with Abbvie
FDA Communication is Key on global clinical trial design and protocols
Global Standard for clinical trials
Global aspirations for China biopharma
Her passion for Neuroscience, and inspiration for her newest endeavor
Joan obtained her Ph.D. in life science and is a licensed physician with board certification in Psychiatry. She had postdoctoral training in endocrinology, psychopharmacology, and clinical pharmacology. Being responsible for CNS global clinical development programs cross-phase 1-4, she worked at Eli Lilly & Co, Wyeth, and Pfizer in the US, and gained extensive experience of working with the FDA, EMEA, CFDA, PMDA, KFDA, etc.
Joan was sent by Pfizer in 2011 as the China Clinical Head. She later joined Hengrui Pharmaceutical as its CMO. In Hengrui, she built the largest clinical team among China's domestic pharma and led the successful conduction of clinical trials in China, the USA, and Australia. Joan joined Janssen Pharmaceutical Companies of Johnson & Johnson as the China Development Head in 2015, where she led multiple successful NDA approvals by CFDA (now NMPA). During this time, she was elected as the co-chair of the RDPAC R&D core team. Joan joined I-Mab Biopharma as the Head of R&D initially, and then was promoted to CEO afterward. During her tenure, I-Mab was successfully listed on Nasdaq and formed a CD47 alliance with AbbVie with lemzoparlimab. She endeavored a new adventure by starting up NeuShen Therapeutics, a company focusing on CNS drug development, at the beginning of 2022.
Echo: Joan, you shared with me becoming a doctor was not your dream as you were a little girl. But you got a medical degree and license from China and US. Can you share with us your personal story?
Joan: I was born and grew up in Chengdu, Sichuan. I grew up in a not easy condition at that time in China like everyone, but not shortening love and joy. My father has a passion for music, art, and is multi-talented. For me, academic achievement is not an option, it’s a must. I have two brothers and one sister, all older than me. They have all done very well with their academics. When I was 16 years old, I passed the national test then became a medical student. After graduating from medical school, I became a surgeon in China, however, I want to learn more about science. I pursued a Ph.D. degree in the US, I got a scholarship and fellowship from Indiana University for the neuroscience program. Then I passed the medical license examination continuing the medical practice. I chose psychologists for knowing more about human behavior and their psychological thinking. I became a certified psychiatrist. Because my continued curiosity is about learning more, I wanted to be a clinical research physician instead of just seeing patients that can expand my reach out to some larger populations. That is how my industry career began. I continue to see patients for quite a while and still have my license there.
Echo: What an accomplishment. I also remember you have a dream to become an artist.
Joan: That was my dream. My dad always said you cannot be a professional musician. But music will be your hobby to enrich your life. That's why we never gave up on that. But my next generation, my daughter is a full-time musician in New York now. During Christmas time, the whole family with three generations gathering, we play music. Music can enrich your life in a way, no matter how stressful your work is, make your life fulfilling. I think that's very important.
Echo: That's great because that's how I see you. You always have a smile and look relaxed. You were doing so much. Why did you give up your medical practice and start work in the industry?
Joan: That is a good question. I guess I have the gene in the family from my father. We are always pursuing excellencies, and higher destinations. When I finally became a physician in the US, I felt limited in a way to help patients, and wanted to understand more about the science behind it, and to learn how to develop medicines. I just felt so limited in the selection of the medicines for diversified patient populations. We just wanted to do more science and to reach out to more people. Especially in neuroscience areas, we are very limited in options.
Echo: How did you try to convince Pfizer to do clinical trials in China in 2005? How challenging was it?
Joan: That is a good question as well. I think it was all a good opportunity, and was perfect timing. When I was a medical monitor in Wyeth, we were stretched in patient enrollment speed when we were trying to accelerate the programs. And that moment, I had just come from China. China has so many patients and so many big hospitals. These are the places we should go conduct our clinical trials. It was such a simple need for Big Pharma at the time, but according to operational challenges, no were no territories. Big Pharma never had a formal assessment of how China can be involved in the clinical trials, and how to better understand China's dynamics, especially its commercial value. Nobody did a formal assessment, but they knew that. With just my simple passion and understanding according to my medical experiences in China - I said, “well, why wait for it?” My boss supported me to explore new territories and he said, “Joan, I believe in you. I will be here to support you.”
At that time, I brought Wyeth, later Pfizer, and quite a few executives to China. Of course, I made arrangements for them to visit the sites in Beijing, Shanghai, Nanjing, Chengdu, Huna and so many places to retrieve first-hand information, on what the hospitals look like, what patients look like, and also how the PI will be able to work with us. We included some of the sites in China because of global travel needs. Little by little, we expanded into greater territories, from mainland China to Taiwan, Hong Kong, Singapore, Korea, so all of this, I think, was starting with the groundwork of first-hand information.
It's becoming a Win-Win situation. What's needed are people like us who understood both sides, and also have the passion to explore the unknown territories and take on the challenges and regional complications. I still remember we immediately engaged with the China CDE in 2006. I did the first lectures in the CDE office. It was an eye-opening experience in the neuroscience area. They were so eager to interact with us, wanting to understand the global trial capacities and how to engage with FDA and with the global standard. I brought Pharma experts to China in 2009 to have a GCP training together with CDE. We learned from each other, and we built up trust and friendships.
Echo: How did you solve all of the challenges to make sure the clinical trial data from China met global standards?
Joan: With the training and communication on both sides, China started to accept ICH standards. Especially after China joined the ICH in 2017, things changed dramatically, and the government reinforced the global healthcare standard. 80% of the trials without global standards were asked to be withdrawn from drug applications. I always wanted to bring global trials to China. Big Pharma invested in the energy and provided training for the sites in the past 10 years. Many of the PI got trained, and educated in the west.
I feel very comfortable now with the standard, the clinical trial data from China. For example, I-Mab made the deal with AbbVie for CD47 in 2020. During the due diligence process, AbbVie scrutinized all the data which met all the global standards. Quality is always an issue. You have to be highly alert. I wouldn't say it's a single country hurdle anymore. It is a whole global standard mindset of how we need to scrutinize and monitor.
Echo: Next is how to convince the FDA to accept clinical trial data from China, which is a new concept for them.
Joan: I don't think it's just a matter of convincing. It's the data itself. The companies have to follow it, to begin with. It's just a matter of following the SOP, the global standard, and doing it ethically. You need to set up the governance and the regulations/ compliance processes to monitor every single step, as we do global trials. That is how we ensure quality. It's our responsibility as a sponsor.
Echo: Recently, the FDA oncology advisory panel rejected the NDA submitted by Innovent and Lilly for their partnered anti-PD-1 antibody. What's your advice to western biopharma when they decide to do trials to include China - to make sure of producing good results?
Joan: I wouldn't want to judge the entire thing, but I did listen to the ODAC meeting. The major concern was not because of the quality of the trial. The major concern was that the trials were not inclusive of the US population. My thoughts were that the population should be more dynamic and/ or include more of a representation of the US. demographic.
Moving forward, we'll continue to emphasize the importance of being accepted by the FDA. We need to be more proactive in the communications with the FDA before trials even start. What is the target population? What is the inclusion/exclusion criteria then they can accept. “Communication, it's extremely important.”
Echo: What do you think over the next five years, China place in global biopharma?
Joan: That's what I am trying to do here. New drug development without borders, because our patients have similar needs. We want to develop drugs for everybody in the world, instead of the siloed or territorially, repeating what we need to do for local registrations. The earlier, the better; the more efficacious, safer, the better for our patients. The world is more ready now, than any other time to have global pharma development and to be headquartered any place in the world instead of just in the US. We need to be more open-minded to accept the diversity of Pharma or Biotechs globally. As long as it's innovative enough and for developing transformational medicines for our patients, China Pharma is going global.
A lot of small biotechs from China started to get into the US. life science industry. I-Mab was a good example, where we were able to develop drugs, and conduct trials in both US and China. Within the next five years, some of China’s biotech should be ready for the global stage, and that is very inspiring for a lot of scientists. China will simultaneously be developing more innovative and novel drugs. Globally, people will see more drugs originating from China. Some of them will be very competitive.
Echo: How does a small biotech company manage the risk of going global? It would be very valuable to have your insights, because you have dealt with a small local biotech company to become a billion dollar+ Nasdaq company.
Joan: Thank you. I would not take all credits for I-Mab success. I think it was the founder and chairman of I-Mab, Dr. Zang, who was very strong in science, and had a good vision with successful strategies for global development. When we were working together, he set the company’s goals as a global biotech, to begin with. It was unlike other China pharma who transformed from domestic to international like Hengrui, where I worked as a CMO.
I-Mab was set for global biotech. That's why we set the operations team on both sides (China and US). We selected compounds very carefully to meet global standards. We had a first in human studies to assist with our operations in the US. Everything we knew was the global standard we wanted to set. That's why I-Mab was able to develop very fast globally. With that vision and the strategy, we chose the talents who were able to have the capacity to work on both sites and have the language skills and the culture and the capability, all fitting the needs. In such a short time, the compound was able to quickly move in the US. and China for phase I and II studies. If we wanted to be global, then we needed to move to US. I think that's a story, which inspired many biotechs in China who want to be successful in the setting up in both the US and China. You can see many other companies similar to this.
Echo: How did you make the big transition from CMO in big pharma to CEO?
Joan: You have to have the inner drive to make things better. I never believed or never dreamed of myself as a CEO. I continued to pursue a better career, and also always felt like I can always improve. When I came back to China, Pfizer sent me to the US to build up its global development capability. At the time, the company needed more people like me to help. I joined Hengrui as its CMO helping them to build its global capacities. I learned to bridge communication between the US and China by building a team that delivered on global development.
I went to J&J to become the head of development where I knew how global pharma operated. And I wanted to be part of its successful component to be at a brand-new company where you didn't have any historical burden. That's why I felt I-Mab was the perfect place to do this work. I realized that I was able to transform from a scientist to a businessperson where you witnessed the business side and the needs of the company. That when I felt ready, more than any other time, to run a new company using my new experiences, and having new ideas to build a new company.
Echo: What was most challenging for you at I-Mab, starting with 20 people to a billion-dollar company?
Joan: There were many challenges. I would say first, with global pharma like AbbVie, our global strategic partnership, and global investors, it was to better understand our business model, and help improve our future, our innovations. The science and conducting clinical trials, for me, was much easier versus the business side. Learning the business side was one of the major challenges.
Echo: What was the strategy to make I-Mab a big name in the global biopharma industry?
Joan: The strategy and vision were set by Dr. Zang, our founder. We wanted to be a global biotech. What we did was to set up the infrastructure, and the team with the global standard. One of the major challenges was to find the right people. I still remember we hired people one by one with the global standard characteristic. It was not easy. Fortunately, during these years, we had the experience of building, part of our reputation. Our people have similar passions and visions and literally, everyone worked day and night. We submitted three INDs to FDA in one month.
We were lucky during this time. Biotech was thriving. We were able to have people recognize our capacity, to support us financially, and also to join us on our journey together. This work ethic plus luck, made us successful.
Echo: Why and how did you convince Hengrui to conduct its global expansion?
Joan: I think Hengrui was one of the very first few companies domestically developing innovative drugs in China at that time. Hengrui hired me only to do the trials in China. I received a limited budget to do the trials in US and Australia for a few compounds. And the other thing I did was to convince Hengrui to do a global trial, and collaborate with US academic institutes. I arranged the visit to M.D. Anderson with Chairman Sun. Our leadership team saw how M.D. Anderson was able to do cutting-edge science and treat patients around the world. I still remember collaboration deals being done on the spot. I think that was also helping leaders in China see the potential to collaborate with the top-tier academic institutes around the world. The mindset has changed. The successful stories we built. I'm glad, there is somebody like me or some people like me who did the grunt work, and planted the seeds for future successes.
Echo: What inspired you to start a new company from scratch, and take on probably the most challenging sector?
Joan: I am always finding something new to be excited about. Neuroscience has always been my passion, and I’ve always paid attention to the scientific advancement in these areas. Somebody has to take this lead. And then I was chosen, I guess, by myself and by my friends to lead a new company to especially target those disease areas, which still have a lot of unmet and unresolved issues. For example, Alzheimer's and Parkinson's disease, even though there are some symptomatic drugs, and a psychiatric disease even though you have medicines, everyone is different. How do you more precisely target the patient population, with the specific medicines? There are a lot of questions not resolved, even though it's very challenging. But with my experience in deep science and also clinical experiences I feel I am already especially with many others including a group of friends, who are willing to work together. That inspired me to take the lead to build a new company to develop transformational medicines for our patients in these areas. I'm very excited and looking forward to the hard work and challenges. I feel very confident that we are assembling a good team, and looking forward to advancement in these areas.
Echo: Congratulations. Would you like to explain the company name NeuShen to our audience?
Joan: NeuShen, of course, neuroscience, something new. Combined with New York and Shanghai, where my family lives, was educated, currently work (in New York), the company was created in Shanghai. Also, Shen happens to be my last name. I am carrying the torch of my whole family’s dream. All this helped me to have energy and passion for doing these things, because my family and friends are watching us create a world with New York and Shanghai together. It's global visions, combined with global aspirations.
We have three new ones: New York, Europe, and Shanghai. When people saw our name New York, Europe and Shanghai. This was/ is my aspiration.
Echo: As a female leader, how do you balance your family and your work?
Joan: I'm always energetic and multitasking. But on the other hand, I just always felt the passion. As a psychiatrist, what I learned the most is about each different stage of your life. You need to do the appropriate things at each stage, to make your life fulfilling. I can be fulfilled on a personal level, and have a fulfilling life. I have to do all of this to make myself happy. It's not because I feel so obligated to do these things, I just need it.
I go to work and I do very intensive work. Then, when I come home, I take care of my family, do yard work, and do house chores, because that relaxes me – it helps me recharge. That's the way I make myself efficient, and able to multitask.
Echo: We have a question from our audience Victor. Are you planning to attack the disease from basic medical science or more of a developmental role from existing targets?
Joan: Our new company will target the root cause of these neurodegenerative diseases, and use cutting-edge science. For example, our new technology will look into the property barrier penetrations, or help some of the compounds to penetrate the brain to target the right side. That is one approach that will take time, and it's a high bar, high risk. On the other hand, we will develop drugs with low-hanging fruit. For example, to modify the current compound, which has shown the efficacy for some of US psychiatric diseases, such as depression and schizophrenia, but with some of the limitations, for example, cognitive impairment, obesity, and also sexual dysfunctions. All of those are a mechanism by maintaining those current compounds using some of the AI or bioinformatics platforms. We will be able to mend or redesign some of the compounds to make them better. We have short-term and long-term plans, and the long term is to make a transformational change to patch the root cause, and for the short term it is to develop the drugs, which will be a better fit to the needs of the patients now.
Echo: That's a very dynamic strategy. Thank you, Joan, for sharing your inspiring story.