A Changing World Demands Changing Biopharmaceutical Strategies

Protocols are becoming more stringent and tougher to enroll, and the biopharmaceutical industry faces the need to expand its patient access and diversity globally. Additionally, with the backdrop of global instability, the industry is also shifting its global strategies to mitigate risks should instability continue to increase. In this interview, Melika Davis, SVP of Global Clinical Operations at BeiGene, will discuss her perspectives.

Moe Alsumidaie: BeiGene has spoken about the need to expand the clinical trial ecosystem and bring more patients into that system. Can you explain what you and BeiGene are doing to add more trial sites to that ecosystem and why this is so important?

Melika Davis: Expanding the clinical trial ecosystem means more options for underserved patients. The major clinical trials have historically been run in the G7 countries—and ours have as well—but we also realized that we needed to expand our trials beyond our start. We recognized the opportunity at BeiGene to place clinical trials in China because a significant, underserved population was there. About a quarter of the world’s cancer cases are in China, but over the years, and specifically in the last four to five years, we have grown tremendously beyond China to serve additional populations—which is critically important for patients. We are now running multi-regional clinical trials around the world. Now we're looking at South Korea, Latin America, and beyond the main G7 countries in Europe. But we have to be careful—we're a small biotech. We're not a big pharma company. We're trying to be as strategic as possible in where we need to go. Our expansion plan is in its infancy, but we've made tremendous progress.

Alsumidaie: What are you doing to plan for global instability risks and wars?

Davis: We quickly put a business continuity plan together because of COVID. When COVID first started occurring, we didn't know what to expect. I think we are well prepared to handle global instability—but wars are complicated. First and foremost, we are humanitarian. The first thing that I always think about is the patients. No matter who they are, they are global citizens. How do we make sure that they get their study drug? That is of the most importance. It's challenging to do this in a time of war, but we're working with and hearing what the regulators are saying and looking at NGOs and other organizations to assess their plans. We're also trying to build bonds with them to ensure that we don't disrupt the supply chain.

It isn't easy to do. We're open to different solutions and trying to be as creative as possible without violating any regulations or any sanctions that may be happening. We have to be mindful of that, too.

Alsumidaie: You've talked about expanding your study system geographically, and you've looked to expand your trials outside of the largest cancer sites. What are you and your team doing to bring the physician and patient communities together into your building ecosystem?

Davis: We're approaching this on two fronts. One front is the data. We strongly believe that the data needs to be globally available. That is important because as we generate our data, we should share that data regularly and as soon as possible. We are following, of course, all of the practices and the ethics and compliance regulations, the data transparency and disclosure guidelines. But it's also essential to get this information out to the scientific community as quickly as possible. The sooner we share this information, the sooner the community can develop an evidence-based understanding of our treatments.

The other front is operations. From an operational perspective, we always look at how we can make sure that patients know that clinical trials are available to them. It's the same thing for the community physicians. Are they interested in participating in a clinical trial? If so, we would work with them and look to make this participation a lot less burdensome. We recently talked about potentially creating a forum of community physicians, nurses, those taking care of patients, patients themselves, and patient advocacy to speak to us about our clinical trials. How can we improve them? What are their thoughts? Really considering that in the future.

We're also looking at the technologies we can use to make patient participation easier, for example, electronic informed consent and wearables. Also, how can we ensure that patients can go to sites close to their community and do lab tests, for example? I think COVID has taught us that it can be done.

Alsumidaie: Decentralization is a topic on everyone's minds now, and everyone's talking about it at medical meetings. Do you think that decentralized clinical trial approaches are here to stay? Or do you think it's a fad?

Davis: I think they are here to stay. It's been, what now? More than ten years that we've been talking about decentralized trials? I hope that they will continue because the future is utilizing technology as much as we can and being as transparent and collaborative as we can. I'm talking about biotech companies, pharma companies, research institutions, and regulators. If we want to beat cancer, that's what we should be doing.

Alsumidaie: What are your thoughts on the patient diversity movement?

Davis: As part of our mission, patient diversity, equity and inclusion is key. We want to make sure that we have diverse patients with diverse backgrounds. The FDA's recent 2020 guidance was beneficial. We set up a task force and created a cross-functional BeiGene clinical trial diversity initiative. We set our objectives to build on the existing efforts that we had done. We've also established a BeiGene Clinical Trial Diversity Institute, which is geared towards training clinicians and making sure that we understand where underserved patients are and which support staff are helping these patients. We need to understand the landscape. We also have patient education and advocacy efforts.

I think it does not just work that we as an industry have to do, but also the research centers. We're looking at a lot of ideas. First, going into community centers will help. We can do some good work there to ensure a diverse population of patients and facilitate community-engaged clinical development. We are starting to implement these initiatives. I'll add that we are very particular when we do our study feasibility to understand where diverse patients are, and then make sure we include community centers into our line of sight.

Hopefully, all of that and the other actions we are taking should help us have a more representative patient population in clinical trials.

Alsumidaie: Excellent. Why is BeiGene predominately CRO-free? Since you're expanding into different regions of the world and need to build clinical trial infrastructures, how is BeiGene establishing these infrastructures in other countries, and why not use CROs? Why have you vertically integrated all your operations internally?

Davis: I like how you say it. It is vertically integrated. Although it's vertical, it's also horizontal...we built an internal capability in our clinical development team, specifically in clinical operations. We believe that by having an internal team, we will allow for more flexibility, which will allow for faster decision making and better clinical site relationships, which I think is important. In addition, by doing all of this, we will be more cost-efficient. Before 2018, 100% of our trials were handled through CROs. Looking at our portfolio today, more than 90% of our trials are handled internally.

In four years, we are seeing that we're able to start our clinical trials a lot faster. We joke with our team that the speed at which we go is fast, and what takes weeks or takes months for a CRO to do with starting trials, it takes us days or weeks to get it done. That disrupts the standards by creating new ones, which we're very proud of. It speaks towards the relationship that we have with our clinical sites. I think that's incredibly important. You cannot do that through third parties. You have to do it in-house.