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Machine learning can help investors dive deeper into trial data to evaluate the true potential of an asset and uncover new hidden opportunities.

Turning Uncertainty into Opportunity: Smarter Clinical Asset Evaluation Powered by Causal Machine Learning 

Video interview with Sepehr Shojaei, VP, Design Solutions, Lightship

Lightship's Approach to Accessible, Representative, and Impactful Clinical Trials

Lightship prioritizes patient accessibility and centricity in clinical trials, ensuring a seamless and positive experience for every participant. Learn more about:

Lightship's mission and core purpose as a company

How Lightship’s mobile nursing teams and home visits enhance study participation and retention

The role of mobile research units in the community and how they enhance participant education, accessibility, and convenience

Sepehr Shojaei, VP of Design Solutions at Lightship, talks about how the company works with pharma and contract research organization (CRO) partners to support clinical trials that are patient-first and accessible.

Latest Conference Coverage

Lightship’s Approach to Accessible, Representative, and Impactful Clinical Trials

Video interview with David MacMurchy, CEO of Lightship

Accelerate Inclusive Enrollment and Delivery with Lightship

Lightship focuses on patient accessibility and centricity in clinical trials, ensuring the patient experience is a positive one. Learn more about:

Lightship's impact on achieving diversity in clinical trials by engaging underrepresented patient populations

How Lightship utilizes hybrid and decentralized trial designs to reduce patient burden

The impact a patient centric model has on clinical trial participation and outcomes

David MacMurchy, Chief Executive Officer at Lightship, offers some insights into the company's mission toward improving equity and diversity in clinical trials. 

In this video interview, Rachael Higgins, chief commercial officer, PicnicHealth, talks traditional research methods in clinical trials and why industry leaders remain reliant on them.

Reliance on Traditional Research Methods

, Rachael Higgins, chief commercial officer, PicnicHealth, discussed the company’s recently released 

2025 Annual State of Observational Research Report

. She highlighted some of the key findings including the persistence of more traditional research methods as well as how patient retention and incomplete data are creating challenges for the industry.

ACT: Why do you think so many industry leaders are still reliant on more traditional research methods?

I think about this all the time. I think this is probably the number one thing that people in my space think about. I think it's just comfort. I think people are comfortable with what they know, right? While the industry has mounting pressures to do things differently, and they know this, it's kind of like the devil you know, right? Even though they find they're spending way more money than they need to, things are taking way too long, they're not retaining patients, they’re certainly not getting the data that they need, they're like, “Well, we know this. It's tried and true, so we're more comfortable doing that.” That being said, as we mentioned those stats before, 78% of the folks that we actually interviewed are definitely open to doing things in other ways. I think it's just going to have to be continually talking to them, educating them, explaining to them that while it is different, different doesn't necessarily mean scary, and it could certainly be advantageous for them in the end.

In this video interview, Rachael Higgins, chief commercial officer, PicnicHealth, discusses findings from the report and the identification of current challenges being faced by the industry.

Implementing Virtual Models in Clinical Trials: Results from PicnicHealth’s Annual State of Observational Research Report

ACT: Could you tell our audience a bit about the 

 and highlight some of its most noteworthy findings?

The research report that PicnicHealth ran basically shows that the industry is definitely at a turning point. The stats show that 80% of the leaders that we interviewed are either using or they're open to virtual models. I think the exact number was 78% and I think this is happening because they are number one, getting pressures from the regulators, payers, and patients for number one, real-world data. They also are leveraging AI and tech-enabled solutions to be able to deliver this in a more systematic, efficient way. If I look at all the stats that were out there, I think one of the major stats that came out is data completeness, and this is the industry's biggest hurdle, 64% of them said that incomplete data is their top challenge and if you think about traditional methods, like a site-based study or a traditional chart review, it just isn't able to deliver that data completeness or capture the entire patient record, if you will, which is why they're actually looking for other options for that. Another area, which again, is no surprise, is patient retention, the loss to follow up with any trial, is one of the biggest issues for life science partners, and they are looking for ways to actually solve that, so having a direct connection to the patient is one of the ways that can increase keeping patients engaged, which then, in turn, would, obviously, enhance the retention. Another thing that we highlighted was 60% of leaders actually flagged that long-term follow up studies was a top priority for 2025 and we know that there are so many pressures and demands on life sciences with all of the cost-cutting measures that are happening, so they're looking for innovative ways to do that. Then last, but certainly not least is AI. If you think about some of the releases from JP Morgan, if you think about some of the questions that folks had answers with our survey, they are having a lot of pressure to leverage AI, not because it's the fun thing to do, but really because it is an innovative, efficient way to really be able to hone in on what it is that you're looking for and then get those answers really quickly. I think 61% of them are either using it or open to actually being able to do that.

In this video interview, Rachael Higgins, chief commercial officer, PicnicHealth, discusses findings from the report and the industry's willingness to adopt technology.

Based on data from the Phase II DAHLIAS (NCT04968912) trial, the FDA has granted Fast Track designation (FTD) to nipocalimab for the treatment of moderate-to-severe Sjögren’s disease.

 The FTD, which is the first ever granted to an FcRn blocker for Sjögren’s disease, will help to advance the development of the investigational therapy, which if approved, would be the first FcRn blocker indicated for the autoantibody-driven disease.

“This marks an additional important step forward in our efforts to bring meaningful advancements to people living with Sjögren’s disease, a serious and debilitating condition,” Katie Abouzahr, MD, vice president, Autoantibody Portfolio and Maternal Fetal Disease Area Leader, Johnson & Johnson Innovative Medicine, said in a press release. “We look forward to continuing to work closely with the FDA to advance the clinical development of nipocalimab and potentially provide a much-needed treatment option for this community.”

Nipocalimab is a high-affinity, fully human, aglycosylated, effectorless, monoclonal antibody, acting as an anti-neonatal Fc receptor (FcRn). In addition to the FTD for Sjögren’s disease, the novel therapy has previously been granted FTD for hemolytic disease of the fetus and newborn (HDFN), warm autoimmune hemolytic anemia, generalized myasthenia gravis (gMG), and fetal neonatal alloimmune thrombocytopenia (FNAIT). Nipocalimab has also been granted Orphan drug designation for warm autoimmune hemolytic anemia, HDFN, gMG, chronic inflammatory demyelinating polyneuropathy, and FNAIT. Additionally, it has been awarded FDA Breakthrough Therapy designation for HDFN and for Sjögren’s disease, with Priority Review status granted for gMG late last year.

The multicenter, randomized, placebo-controlled double-blind, DAHLIAS trial analyzed the efficacy of nipocalimab in patients with primary Sjögren’s disease. The dose-ranging study included 163 patients aged 18-75 years with moderately-to-severely active primary Sjögren’s disease who are seropositive for anti-Ro60 and/or anti-Ro52 IgG antibodies.

Patients were randomly assigned in a 1:1:1 ratio to receive either intravenous nipocalimab at a dose of 5 mg/kg, 15 mg/kg, or placebo every two weeks for 22 weeks, as well as protocol-permitted background standard of care. The trial’s primary endpoint was change from baseline in the Clinical European League Against Rheumatism Sjögren’s Syndrome Disease Activity Index (ClinESSDAI) score at 24 weeks.

The results showed improvements across key measures of disease activity in patients administered nipocalimab. These patients experienced a significant decrease in immunoglobulin G (IgG) of more than 77% with the 15 mg/kg dose level administered every two weeks. Investigators said this reinforces the mechanism of action of nipocalimab through interaction with the neonatal Fc receptor.

Patients administered the 15 mg/kg dose of nipocalimab experienced a significant improvement in the ClinESSDAI score at 24 weeks, showing a greater than 70% relative average improvement in systemic disease activity, which met the trial’s primary endpoint. Nipocalimab also achieved the trial’s key secondary endpoints, including reduced disease activity both systemically and in multiple organ systems, and in improved physician assessments and composite Sjögren’s disease assessments.

Compared with placebo, there were also numerical improvements reported in symptoms identified as most important to participants, which included mouth dryness, eye dryness, vaginal dryness, fatigue, and joint pain.

“The observed reduction in IgG and pivotal autoantibodies, particularly the anti-Ro antibodies, in association with improvement in systemic disease activity and saliva production, represent an exciting advance in our understanding of the disease and how it may be treated effectively,” Ghaith Noaiseh, MD, associate professor, Allergy, Clinical Immunology, and Rheumatology, The University of Kansas Medical Center, said in a press release. “I am also encouraged by the observed trend in many patient-reported measures as they are most important to patients. I look forward to future research to confirm these observations.”

1. Nipocalimab, the first and only investigational treatment to be granted U.S. FDA Breakthrough Therapy designation for the treatment of adults with moderate-to-severe Sjögren’s disease, has now received Fast Track designation. News release. Johnson & Johnson. March 18, 2025. Accessed March 18, 2025. 

https://www.jnj.com/media-center/press-releases/nipocalimab-the-first-and-only-investigational-treatment-to-be-granted-u-s-fda-breakthrough-therapy-designation-for-the-treatment-of-adults-with-moderate-to-severe-sjogrens-disease-has-now-received-fast-track-designation

2. A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS). ClinicalTrials.gov. Updated March 4, 2025. Accessed March 18, 2025. 

https://clinicaltrials.gov/study/NCT04968912

3. Nipocalimab demonstrates significant clinical improvement in disease activity and IgG reduction in Phase 2 Sjögren’s disease study. News release. Johnson & Johnson. November 14, 2024. Accessed March 18, 2025. 

https://www.jnj.com/media-center/press-releases/nipocalimab-demonstrates-significant-clinical-improvement-in-disease-activity-and-igg-reduction-in-phase-2-sjogrens-disease-study

FDA grants Fast Track designation to Johnson & Johnson’s investigational therapy nipocalimab for the treatment of moderate-to-severe Sjögren’s disease, which could be the first FcRn blocker ever approved for the autoimmune condition.

Phase II DAHLIAS Trial Results Lead to Fast Track Designation for Nipocalimab for Sjögren’s Disease

Join experts from PPD FSP solutions as they discuss the latest FSP trends and opportunities in clinical development, innovative FSP strategies and models, and keys to successfully leveraging an FSP model to drive on-time and on-budget delivery.

https://www.appliedclinicaltrialsonline.com/act_w/fsp-outsourcing-trends


Join experts from PPD FSP solutions—part of the PPD clinical research business of Thermo Fisher Scientific—as they discuss the latest utilization and growth projections of FSP partnerships in the clinical research and development landscape, innovative FSP strategies to address drug development challenges and opportunities, and keys to successfully leveraging an FSP model to drive on-time and on-budget delivery.

Understand the latest utilization and growth projection of FSP partnerships in the clinical research and development landscape

Learn about innovative FSP strategies and models to address drug development challenges and opportunities

Identify the keys to successfully leveraging an FSP model to drive on-time, on-budget delivery


Biopharma and biotech company employees involved in:

Lori Boyce has more than 25 years of experience in the field of clinical research and more than 18 years of experience in clinical operations. She has a broad range of experience working with clients to identify innovative solutions to operational and strategic priorities.



Mike Lydon has more than 16 years of experience within the clinical research industry and has held various leadership roles within the FSP sales and talent resourcing space for top clinical research organizations. His consultative approach to partnerships helps his customers practice innovation, accelerate quality, and reduce burdens.




Raviv Pryluk, PhD

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