Yin Hwa Lai, a director and principal scientist at Cardinal Health, has extensive pharma experience. She now focuses on providing Chemistry, Manufacturing, and Controls (CMC) regulatory consulting and strategy in small molecules, biologics and cell and gene therapy.
In the following interview, Yin touches on what first piqued her interest in the pharmaceutical industry and provides insights into how to encourage more young women to enter the field. She also provides perspective on diversity and inclusion initiatives in the pharma and biotech industry.
The responses have been lightly edited.
What first piqued your interest in the pharma industry?
Yin: I was a curious child. I always was interested in how things work. My grandparents exposed me in childhood to herbs and Chinese medicine. They used herbs to treat symptoms such as cough and fever. That sparked my interest in pharma.
During my undergrad, I majored in chemistry. In my graduate coursework, I studied drugs and biologics formulation and development.
What do you find most rewarding about working in pharma?
Yin: The most rewarding thing is to see a drug or biologic that you were involved in developing win regulatory approval and find use globally to help patients. In my previous role, I helped develop a monoclonal antibody for oncology that was later approved. It now has six indications.
Now I’m working more in cell and gene therapy. It is also a fascinating area. It’s a cutting-edge field, and it is blooming right now.
We are seeing advances in gene editing. Using continuous manufacturing in cell and gene therapy requires making various adjustments. For instance, next-generation sequencing (NGS) has been around, but the industry hadn’t used it widely until recently. Now, NGS is a standard approach. There are also different advances in manufacturing to make it more modular. In addition, cell and gene therapy has its own characteristics compared to traditional biologics, such as monoclonal antibodies. Manufacturing has to adapt.
Can you say more about your interest in cell and gene therapy?
Yin: It is exciting to explore new technologies and processes to address cell and gene therapy challenges. One of the things that is rewarding about cell and gene therapy is that it provides the opportunity to correct mutations in our genome to cure or mitigate disease.
There are currently a few approved cell and gene therapy products. A lot of people know about CAR-T. There are currently about six approved CAR-T products in the U.S.
Other types of cell and gene therapy products in development are in Phase 1 or Phase 2 trials. One category involves induced pluripotent stem cells (iPSCs).
There is also more interest in using alternatives to viral vectors to deliver genes to the target cells, such as polymeric or lipid nanoparticles.
Can you share more about your educational background?
Yin: My training is in development in pharmaceutical science — mainly formulation development and analytical testing for biologics and drugs. So those are my core scientific skills.
I have a regulatory interest because I have worked on a few late-stage pipeline drugs where we had to file with agencies. Working a lot on regulatory submissions sparked my interest in that area. That’s why I decided to earn a master’s in regulatory affairs at John Hopkins. It helped. Your educational background and work experience are important to build your career in either pharma or regulatory. Those two are not separate. If you decide to go into regulatory, it is much better if you have a science background.
What projects are you most looking forward to?
Yin: The currently marketed CAR-T products have relied on CRISPR/Cas9 nucleus technology. But I would like to get my hands on other gene editing technologies, such as ‘prime’ genome editing technology.
In addition, a lot of cell therapy is autologous — meaning it uses the patient’s own cells that are modified and infused back into the patient. In the other category, allogenic, the manufacturer uses donor material from a healthy donor, which is pre-processed. Then, a different patient receives that allogeneic product. Hopefully, in the future, I will be able to get work on allogeneic CAR-based cell therapy.
What are the most significant barriers you see women facing in today’s pharma and biotech industry?
Yin: Unconscious bias is an issue in the workplace. Pharma is not an exception there.
This is my personal opinion, but I feel this issue is more prevalent at the higher technical and management levels. It can be an issue, in particular, for career advancement and promotion.
For example, women can be passed over for a given position or passed over by the management. Sometimes, management will promote men over women in some instances, but not always.
Many factors result in such outcomes. First, there’s the misconception that men can do a better job. The decision-makers are often men, and it is human nature to promote somebody who is like them also.
But I also think unconscious bias is a barrier women face in pharma. This situation is even worse for a woman of color.
How can the industry improve how it acknowledges the contributions of women of color in the industry?
Yin: Diversity and inclusion efforts are essential. This is a focus at Cardinal Health. Many pharma companies have diversity and inclusion initiatives that include employee training. Cardinal Health, for example, has unconscious bias training for all our employees. Cardinal Health has other diversity and inclusion initiatives as well. We also have different ESG groups. For example, there are groups for Latino and Asian employees.
In addition to such initiatives, pharma companies can also work on creating a more inclusive culture at work. Organization-wise, regarding hiring or career advancement for women, you may need to change how you screen your candidates. You can have software screen potential employees without human bias. There are also trainings for hiring managers to mitigate bias. Organizations need to explore their hiring and promotion practices to minimize bias and create a more diverse workforce. In the end, that is good for the organization. Such initiatives can also help with talent retention and for women to advance their pharma careers.
What is the biggest challenge you’ve encountered professionally?
Yin: Change is the only constant. Change is not easy for an organization or a team.
We work in a very regulated industry. If a team needs to, for example, submit a marketing application to a regulatory agency, the team needs to be prepared. Maybe the regulatory agency requested data that the sponsor was not ready to provide. We need to be prepared to address that because it will impact that sponsor’s marketing application. A lot hinges on the marketing submission for a product. As a team leader, communication is key between the different stakeholders. As a leader, you need to communicate whatever change is coming in a time-sensitive way and explain why the change happened and how we as a team manage it.
I also work to involve team members to discuss how to mitigate a change to minimize the impact on the project. I work to get them involved and listen to the ideas they have. I may have in my mind a strategy I want to implement, but I always want to listen to other people because they have different perspectives.
So I think communication is key to letting sponsors know what is going on. There may be some sacrifices we need to make, or we might have to work longer hours. So this timeline may be impacted, and we must get the bad news to management.
What pharma and biotech companies can do to promote greater participation of young women?
Yin: We need to instill in the younger generation that there are vast career possibilities in pharma and biotech. And we need to empower young women to venture into new territories and showcase and celebrate the success of successful women in the industry to our younger generation.
Many pharma companies provide summer or graduate internships and outreach programs to high school students. It can be helpful to have different departments demonstrate what they do in pharma. For example, the manufacturing group can give a presentation telling students what is involved in their day-to-day job. It is the same thing for the QA and QC people and scientists.
Similarly, graduate students come to us because they want to work in pharma. We can help them explore their opportunities working in manufacturing, formulation, analytical, QC/QA, regulatory, clinical or preclinical areas. We have subject matter experts in those domains who can explain what they do and also offer mentorship. A graduate student can pair with one of our staff members who can receive mentorship. I think such programs can spur greater participation of younger women in pharma.