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Vice President, Technical
Parexel International

Dr. Winitsky spent more than 11 years at the FDA as a medical officer, a team leader, and acting branch chief in the Center for Biologics Evaluation and Research’s Office of Tissues and Advanced Therapies, which has recently been renamed the Office of Therapeutic Products. He has extensive experience with the review and supervision of CGT applications, including sponsor requests for Breakthrough Therapy and Regenerative Medicine Advanced Therapy designations.

In the rare disease issue of New Medicines, Novel Insights from Parexel, experts and former regulators share insights for developing effective regulatory strategies earlier. 

Effective regulatory strategies for rare disease

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, Krinx Kong, chief commercial officer, Cognivia, discusses how trial design and timelines could be impacted by a potential mandate for placebo use across all vaccine trials.

How Vaccine Trials Could be Affected by Potential Policy Changes

, Krinx Kong, chief commercial officer, Cognivia, discussed the potential impacts of policy shifts on vaccine trial design and patient perceptions. Stricter regulations could increase trial complexity, affecting recruitment and retention. Kong emphasized behavioral insights as crucial to understanding patient motivation and mitigating dropouts. Looking forward with the potential for policy changes in vaccine trials, clinical operations professionals must focus on flexibility, behavioral visibility, and effective communication to ensure success.

ACT: US Health and Human Services Secretary Robert F. Kennedy Jr. recently 

 on supporting placebo-controlled trials for all new vaccines. How could a potential policy shift in this area affect trial design and timelines?

First, it's important to clarify that placebo-controlled trials are already the gold standard in vaccine development, and are required by both the FDA and EMA when no approved alternatives exist. Therefore, the notion that these aren't already in use is misleading, or at least lacks context. Now, if a policy shift were to mandate placebo use in all vaccine trials, even where active comparators might be more appropriate, we'd likely see significant impacts on both design complexity and timelines. First, ethics boards may push back. If an effective vaccine already exists, withholding it in favor of placebo could be viewed as unethical. This leads to delays, extra review cycles, and potential public concern. Next, placebo-controlled designs often require longer follow ups, which can prolong timelines by months or even years. Lastly, these designs are frequently more difficult to recruit for, patients and parents may be reluctant to participate if there's a genuine chance of receiving no active protection. If policy does shift, having tools that can adapt trial design without compromising data integrity or patient trust will be essential.

A pharmaceutical company aimed to launch a Phase III clinical trial for a new oncology drug, focusing on efficient and effective patient recruitment across diverse regions. They evaluated patient populations by analyzing demographics, social determinants of health, and geography. Investigator profiling included practice details, affiliations, referral networks, and clinical trial experience. The final step involved selecting and extracting target lists for implementation.



Optimizing Phase III Oncology Trial Recruitment with Data-Driven Insights

Clinical trials are crucial for drug development but often face delays due to poor site selection, which can lead to protocol violations, poor data quality, and increased costs. Ninety percent of clinical trials fail to meet their timelines, and issues like inadequate staffing and patient recruitment are significant challenges. Traditional site selection methods are inefficient, and the COVID-19 pandemic has further complicated the process. Data-driven insights can optimize site selection by evaluating current data on patient populations, investigators, and site capabilities.



Data-Driven Insights can Optimize Clinical Trial Site Selection

This white paper presents findings from the PurpleLab Migraine Study, which leverages real-world data to analyze migraine prevalence, treatment variations, and provider insights. The study examines data from approximately 10 million Americans diagnosed with migraines, focusing on patient demographics, treatment pathways, and healthcare provider specialties. Key findings include the high prevalence of migraines among females aged 18-54, racial and ethnic disparities in treatment, and the significant role of specialized providers like psychiatrists and neurologists in managing migraine care. It highlights the importance of tailored treatment approaches and the potential benefits of complementary and alternative medicine therapies.


Dr. Steve Winitsky, MD

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