An Inside Look into TransCelerate BioPharma

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In this exclusive Q&A with Applied Clinical Trials, Janice Chang, CEO of TransCelerate BioPharma, provides an inside look into her career journey, her work at the company, how the industry has changed in the last 10 years, as well as her thoughts on where the industry should put its efforts in clinical trials.

Janice Chang, CEO, TransCelerate BioPharma

Janice Chang, CEO, TransCelerate BioPharma

Janice Chang, CEO of TransCelerate BioPharma, has been with the not-for-profit pharma consortium since 2013. She has held roles of increasing responsibility and was appointed CEO at the beginning of this year. We interviewed Chang at DIA 2023, where TransCelerate member organizations, as well as Chang herself, were presenting their innovative initiatives. In this exclusive Q&A with Applied Clinical Trials®, Chang discusses her background and the many ways that TransCelerate has changed the pre-competitive model for pharma for good.

ACT: Can you describe your career journey?

Chang: I'm the youngest of three daughters. And growing up, culturally, I was always raised to follow the rules...especially when you're the youngest, you're just being told this is the way things are done. But I remembered early on, I always had this curiosity to challenge and say, there is a different way of solving the same problem.

I started my career in management consulting, and I think a big part of it was to fill that curiosity of solving problems differently. Management consulting started my career in life sciences. I’ve been exposed to different businesses and their unique challenges, working in a team environment and consulting. This often requires players from different functional disciplines to help solve challenges. But I always thrive in environments where I know if I can get different players to the table, really understand their perspectives and find the common shared goals, then we could solve those business challenges.

ACT: What about the pharmaceutical industry that keeps you interested in the TransCelerate BioPharma mission?

Chang: I came to the United States to learn. I know the immense sacrifice my parents made for me to be here. That instills a sense of purpose, to maximize the time you have, and fulfill your dreams, but also to make sure that you generate impact and give back to those around you.

As a young child, I vividly remember watching my grandmother pass away from ovarian cancer. And then very shortly after my uncle passed away from pancreatic cancer, and then my father, at the age of 91 in 2015, passed away from lung cancer. Those experiences—watching them struggle in their patient journey, particularly with language barriers and certainly not well versed in medicine—continue to drive me in what I do in the pharmaceutical industry. And if I can find ways to help bring different parts of the ecosystem together in how we develop and bring drugs to patients in a way that helps enhance a patient’s journey, that gives me a sense of purpose.

ACT: What has been your primary focus for TransCelerate for the first half of the year?

Chang: While I’ve been with TransCelerate for 10 years, my new role requires a different perspective. I’ve been getting a better focus on what we as TransCelerate are known for—a nimble, pragmatic, neutral organization.

The relationships we have built with sponsors, regulators, clinical trial sites, patients, and the technology community, allows us to focus our efforts on amplifying our impact.

I’ve also been very inspired in working with our board members to think about how we look to the future and perhaps set additional visionary goals that align to our strengths. Together we have put the foundational building blocks in place, and we’re excited about the future as we focus on collaboration across the global biopharmaceutical community to support the development of new medicines.

ACT: How has the industry changed in the past 10 years, and then how that translates to your goals?

Chang: There was a very different set of pressures 10 years ago...the pipeline was decreasing, while patents on blockbuster drugs were expiring. There were immense operational inefficiencies. So, kudos to the founding members of TransCelerate, instead of talking the talk, they committed to setting up the infrastructure of a not-for-profit and dedicating the talent at their companies to be accountable for solving these challenges. Over the past 10 years, we’ve seen different stakeholders joining us in the journey including regulators, patients, sites, and technology vendors. And this collaboration is making a difference. So, as we enter incredibly exciting times with generative AI, cell, and gene therapy—all those new technologies require new methods, new analytic tools, to ensure that we can actually operationalize them in a consistent, effective, and sustainable way.

One of the reasons I felt a sense of obligation to take on the CEO role was a need to ensure continuity. TransCelerate has played a key role in fostering collaboration across the biopharmaceutical ecosystem and that needs to continue. If you think back 10 years ago, collaboration, especially pre-competitive collaboration, was not the norm.

But we've demonstrated that, if we find the right challenges, provide the right infrastructure, even in a fiercely competitive industry, collaboration can be successful and deliver results. We have conversations with regulators, who absolutely have the appetite and desire to come along on the [collaboration] journey. But they don't want the many consortia coming to them. For that reason, I have conversations on a quarterly basis with Innovative Medicines Initiative [and others] on how TransCelerate operates at a global level.

ACT: Where do you think industry should put its efforts in to clinical trials?

Chang: There is a real opportunity, particularly post COVID, to further advance clinical trial trials and leverage what we’ve learned and proven that can be done. As an industry, we must always focus on how we can continue to advance in a pragmatic way. We must look at who are the stakeholders that need to be at the table. We must examine new models that are evolving in clinical research.

Clinical trial sites today are very different from sites five years ago, and they will be different years from now. TransCelerate, as a group of member sponsors, can ensure that we are supporting those sites, so they can be both equipped to engage with the patients and to build trust with patients. That is a very pragmatic opportunity we can lean into.

There is also an immense opportunity around data sharing with common data standards. We have continued to make progress on that, and we are working to achieve data interoperability across the different solutions in clinical research. That's easier said than done, but certainly an area we will continue to advance.

ACT: How does the organization optimize its goals?

Chang: It's okay to have a lofty vision, but you have to break it down. And that's how we approach all of our initiatives. As a team we examine what can we develop and share—not just for the member companies—but also for the ecosystem to adopt. It's a stepwise approach that is so important for us to continue. It provides us with an approach that delivers tangible results in 12-18 months as we contemplate a longer five-year vision.

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