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Articles

Traditional approaches to HCP segmentation are no longer sufficient. The challenge now is to maintain personalization at scale while managing large territories and diverse customer bases.

Beyond the Data: Making HCP Analytics Actually Work for Commercial Teams

The argument for weighing clinical points more heavily in the access equation.


Creating a Gray Zone in Payer Messaging: Outflanking Comparability

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Asembia 2025: The Specialty Pharma Pipeline

CMS’ draft guidance on real-world data study protocols marks a significant move toward transparency and rigor in Medicare coverage decisions.

Making Real-World Evidence Work for Medicare: What CMS’ Draft Guidance Gets Right and What Needs Work 

Key trends in healthcare communication to build trust between healthcare providers and their patients.

The Evolution of Healthcare Communication: Bridging the HCP-Patient Divide

These therapies may provide more stable treatments than stem cell therapies.

Bringing Fibroblasts to the Spotlight: Q&A with FibroBiologics

LaShell Robinson, Head of Global Feasibility and Trial Equity at Takeda, talks about how Takeda aims to expand their efforts globally, adapting strategies to regional needs.

Ensuring Representative Psoriasis Clinical Trials on a Global Scale

 video interview, LaShell Robinson, head of global feasibility and trial equity at Takeda, discusses strategies to address underrepresentation in clinical trials, particularly in phase III psoriasis trials. Robinson also discusses the company's partnerships with community stakeholders like Inside Edge, Black Health Matters, and Hispanic Communication Global Network to improve engagement, address operational barriers, and prioritize sites with diverse patient demographics. Takeda has also enhanced investigator diversity through multilingual toolkits and educational sessions, and aims to expand these efforts globally by adapting strategies to regional needs.

Pharmaceutical Executive: Beyond the US, how is Takeda addressing the need for representative clinical trials globally, considering the 60 million people worldwide living with psoriasis? Are there unique challenges in different regions?

The US definitely has very specific aspects around trial diversity, and that doesn't necessarily translate to every single region. Takeda  intends to expand those efforts by drawing on that US strategy framework, but making sure that it's adapted to what is most important per country or region, specifically when it comes to talking about the patient perspective. What does underrepresented or underserved mean in a particular community? That could vary in the US. It could be race, ethnicity, gender, or even location.

When we start looking at the other parts of the world, it could even be how they're accessing healthcare. Gender or sex tends to be a factor that consistently plays a role that we're seeing regardless of geography, so that will be one of our areas of key focus as we start to broaden this into other geographies. While we have this global problem, it's extremely important that we're taking the time to understand what it means from a patient perspective in that region, and that's how we'll start expanding globally.

PE: Can you provide examples of how Takeda is ensuring that the data collected from these more diverse trials is translated into improved real-world outcomes for patients?

The first part was ensuring that our trials were representative of real-world patient populations. It can become difficult to even talk about outcomes if we don't have that inclusion. We're looking at this as a way to serve the patients that we aim to treat so that we have better outcomes from patients. We've studied how different populations may respond to different therapies, but that's usually after the drug is approved. We wanted to make sure that we're taking that into account in the context of our trial.

One of the aspects that we're really looking forward to is Takeda is also working to share the epidemiology data that we've collected to better help and support further research and understanding in the area. Stay tuned for that, because directionally, that can really help different areas of understanding in this area. 

Videos

LaShell Robinson, head of global feasibility and trial equity at Takeda, talks about Takeda's aims to expand its efforts globally by adapting strategies to regional needs.

LaShell Robinson, Head of Global Feasibility and Trial Equity at Takeda, discusses strategies to address underrepresentation in clinical trials, particularly in phase III psoriasis trials.

Addressing Disproportionate Underrepresentation of Racial & Ethnic Groups in Psoriasis Trials

 video interview, LaShell Robinson, head of global feasibility and trial equity at Takeda, discusses strategies to address underrepresentation in clinical trials, particularly in phase III psoriasis trials. Robinson also discusses the company's partnerships with community stakeholders like Inside Edge, Black Health Matters, and Hispanic Communication Global Network to improve engagement, address operational barriers, and prioritize sites with diverse patient demographics. Takeda also enhanced investigator diversity through multilingual toolkits and educational sessions, and aims to expand these efforts globally by adapting strategies to regional needs.

Pharmaceutical Executive: What specific strategies is Takeda implementing to address the disproportionate underrepresentation of racial and ethnic groups in clinical trials, particularly in its Phase III psoriasis trials and beyond?

As the head for global feasibility and trial equity, my day-to-day job is focused on making sure that all of our trials have the representation of patients that reflect the real world, including these psoriasis trials. It goes without saying that our ambition from the very beginning was to ensure that our phase III trials for psoriasis had better reflection of the real-world patient population, because we did see a gap. When we were looking at the real-world data, we noticed that things like under diagnosis, longer treatment paradigms, or longer pathways to diagnosis also impacted the people that were represented in our clinical trials. We wanted to ensure that from the very beginning, we were really thinking about this and implementing our tested, tried and true PAVE strategy, which is our strategy to make sure that underrepresented and underserved populations are included in our trial.

First, our P is partnering with community stakeholders. We partnered with organizations such as Inside Edge, Black Health Matters, and Hispanic Communication Global Network to ensure that we have better engagement with communities that were underrepresented and underserved, specifically for psoriasis. These organizations have tried and true relationships, and we were able to leverage that to connect with patients in a more authentic manner, not only educating them about psoriasis, but also around the importance of them participating in clinical research and how that helps contribute to better science.

We have the A, which is addressing operational barriers that impede patient access. This is where we spend a lot of time around planning, operations, and looking at the protocol. One of the things that we did immediately was incorporate multicultural imagery. We know that most of the imagery for plaque psoriasis is of patients that are white. The impact that has is it creates a longer diagnosis pathway, we see gaps in the teaching around dermatology, etc. We wanted to make sure that we had multi-racial and multiethnic imagery with skin-of-color and multiple images represented so that we could start closing that gap. We also did careful site selection, where we prioritized sites that had a broader reach and patient representation in our feasibility process. We even went so far as to ask our sites to tell us about the demographics of their patients so we could prioritize the selection.

Then V is verifying that any goal we had around representation was truly reflective of the patient data. One of the things we saw at the very beginning is even though psoriasis is one of the most common skin disorders, there's a lack of epidemiology data that is specific to race, ethnicity, and gender breakdown. One of the other elements that we did in addition to looking at literature review and epidemiology was ask our sites what their real-world patient population is and used that to actually develop a goal that we felt was more reflective of the patients with psoriasis.

Then finally E was enhancing the diversity of our investigative sites. This is where we really deepen the education and sharing the best practices to support more accurate diagnosis of psoriasis in skin-of-color at the very beginning. We offered sites multilingual toolkits where they could actually discuss what the general sense of clinical research is, and how it transmits to our particular trial. We even had an investigator do a session at  an investigator meeting. This is where we pull all of our sites and those participating together to really educate them on the protocol, give them the opportunity to ask questions, and use the opportunity to share best practices around diagnosing skin-of-color. In fact, we had two sessions that were dedicated to that, so that at the end of the day our sites were very well prepared. We're also thinking a bit differently around how they could connect patients that are traditionally left out of research.

LaShell Robinson, head of global feasibility and trial equity at Takeda, discusses strategies to address underrepresentation in clinical trials, particularly in phase III psoriasis trials.

Addressing Underrepresentation of Racial & Ethnic Groups in Psoriasis Trials

Kimberley Chiang, vice president of biopharma commercial solutions, CoverMyMeds, highlights gaps in data sharing and cross-functional collaboration as major bottlenecks that are causing delays, rework, and increased patient burden.

The 2025 Medication Access Report: Biggest Bottlenecks for Patients

 video interview, Kimberley Chiang, vice president of biopharma commercial solutions at CoverMyMeds, discusses "The 2025 Medication Access Report.

 She highlights gaps in data-sharing and cross-functional collaboration as major bottlenecks that cause delays, rework, and increased patient burden. Chiang shares that only 3% of patients utilize support programs due to a lack of awareness. A large majority of the report's respondents plan to expand funding for patient support programs within the next 5 years due to large number of new therapies expected to come to market. The report emphasizes the need for interoperability to streamline data and improve patient outcomes.

Pharmaceutical Executive: "The 2025 Medication Access Report" highlights significant fragmentation due to gaps in data-sharing and cross-functional collaboration. Can you elaborate on the most critical areas where these gaps are causing the biggest bottlenecks for patients? Specifically, what are the tangible effects you've observed on patient timelines and outcomes?


The lack of cross-functional collaboration in our industry adds fragmentation, and the seamlessness of the flow of data and the patient experience is impacted. Whenever we impact seamlessness, we impact the data that is arriving to help us make decisions or anticipate gaps in patient care. It causes delays, rework, and for the burden to fall on the patient to piece together all the elements to find the best way to cover some of the barriers that they’re experiencing in their own healthcare ecosystem.

The industry needs a cohesive and efficient approach that takes cost out of the system and adds data at the right time to help HCPs make the right decisions. We need to get out of our silos because we’re still in our own way. The lack of a clear view drives delays, creates barriers, and doesn’t look at the holistic needs of the patient.

For example, pharmacies and providers see certain needs, and pharma is paying for patient support programs to provide other needs for patients. However, we’re not talking to each other, and that’s where the challenge lies. If we’re looking for the best outcomes for patients and the urgency to get them the medications they need quickly and efficiently with all the education and support for the patient journey, we need to improve integration.

The second element is the knowledge gap. Forty-six percent and 52% of providers don’t know what’s out there for patients. They may be able to identify a gap, but they don’t know where to go to fill that gap. Therefore, the pieces still don’t get put together in that puzzle for the patient and causes delays in looking up what’s available for that patient in their community.

The knowledge gap worsens the delay and puts the burden back on the patient to put together the pieces of their healthcare ecosystem themselves.

The pharma industry is committed to increasing the funding for patient-support programs. But if patients don’t know about them, the utilization stays at about 3%. The majority of the biopharma customers we talked to said that in 5 years, they plan to expand support and funding for these programs. That’s based on the fact that important new therapies are coming to market in the next 5 years and 75% of them have increased complexity because they’re in the specialty realm.

Complexity drives gaps and needs. If we don’t bring this ecosystem together and have data sharing across the portfolio to reduce fragmentation, we are going to continue to see delays which effectively reduce outcomes for patients.

Kimberley Chiang, vice president of biopharma commercial solutions at CoverMyMeds, highlights gaps in data sharing and cross-functional collaboration as major bottlenecks that are causing delays, rework, and increased patient burden.

Developing Non-Addictive Pain Medication

Pharmaceutical Executive: Can you describe South Rampart’s work in pain medication?


 For several years now, we've been working on the development of a novel manipulated small molecule to reduce pain without having the addictive potential of opioids. We’ve submitted an IND with FDA to get into the clinic and are now working on phase two. Our molecules is ready in three different pipelines, and we are eyeing the very first one as acute pain. I'm the PI of two funded NIH grants. We just submitted two others in January and February of this year.

The NIH has had an incredibly supportive Small Business Office that has been very entrepreneurial with a lot of critical resources that have allowed small biopharmas like ours to move forward and go all the way from concept to pre-clinical characterization into the clinic.

PE: Since the situation with NIH is a bit unpredictable at the moment, how are you strategizing around that?


 The NIH has been an immense supporter of our work and of others in this field, particularly through the HEAL (helping end addiction long-term) Initiative, which was actually started by Congress almost six years ago. Our project is a prime example of taking academic knowledge and supporting it based on strong foundational science, coupled with significant commercialization plans that must be submitted. We also had to demonstrate to the study section about how the assets are going to be commercialized.

In these study sections, both researchers were neuroscientists and had good fundamental understandings of how to relieve pain in the brain or in the periphery. The set of sections were also grouped with individuals who had done this before, who had commercialized assets, so they understand the different obstacles that could occur. They knew what could happen. They evaluated us based on both their scientific rigor as well as the commercialization potential. And because it goes through such a thorough process, the funding rate has sometimes been in the single digits.

You learn a lot from the process, and you really streamline, so that as you execute, you're doing so the best way possible. There are a lot of market resources that they share through the EIR (entrepreneurs-in-residence) Program that can give you feedback on different things. It's a good networking opportunity. Obviously, you learn a lot from other people that are going through it.

In regard to what’s happening now with NIH, the main thing to do is diversify. You raise both non-dilutive funding through NIH which is the very best, obviously, and then as well as dilutive and to try to move the program forward.

PE:How risky is the traditional pain medication market still to this day?


The pain market has really had a blemish on it going as far back as 15-to-20 years. I think there were not well-validated targets that were being developed based on not the most stringent science. When these molecules were being developed into clinical trials, the endpoints that were being utilized were questionable. One of the challenges with pain is that the endpoints are have to be really well designed, because pain is something that is subjective.

In clinical medicine, pain is something that a patient says that they feel. Your assessment of pain, your threshold, may be much higher than mine, or vice versa. It's so important when designing a trial to objectify something that's objective as much as possible. Clearly there's a science to that. There are individuals and a few groups that have had a lot of experience and success doing that, and that has obviously come with experience in the last 10-15 years.

I think we're now, fortunately, in a really good state.

Dr. Hernan Bazan, CEO of South Rampart Pharma, discusses his company’s current pipeline.

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