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Ashley Stufano

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Demystifying Biosimilar Development Regulations: Key Considerations for Sponsors

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Biosimilars – biological medicines highly similar to another already approved biologic – have emerged in recent years as an area of rapid development activity, especially for Inflammatory bowel diseases (IBD) such as Crohn’s disease (CD) and ulcerative colitis (UC). While these drugs have historically faced the common misconception that they are less safe and less effective compared to the original biologic product, biosimilars undergo very rigorous and extensive testing before receiving regulatory approval, and public perceptions are starting to shift. As these drugs continue to grow in popularity with physicians and patients alike, it is crucial for sponsors to understand what these changes mean for current and future IBD development activity.

In our new white paper, Similar But Different: Regulatory and Operational Considerations for Biosimilar Clinical Development in IBD, we discuss how biosimilars have transformed the treatment landscape for IBD in the past decade, their current therapeutic uses in CD and UC, and global regulatory considerations for running biosimilar clinical trials in IBD. This post reviews some of the regulatory factors that are evaluated for biosimilar medications during the course of a trial. The list of full regulatory requirements varies by country; however, these factors are common parts of the evaluation process by many regulatory bodies.

Comparability

Even licensed biologics undergo changes in relevant molecular attributes over time.1 In a study of biologics licensed for use in rheumatology, all reported changes to the production process over time, including change of cell culture supplier and modification of the protein purification procedure.2 The original medicines available today are therefore not identical but comparable to those available in previous years. 

Biosimilars must demonstrate clinical comparability with the reference drug (the original biologic) in order to receive regulatory approval. The following table outlines the properties and methods used to demonstrate comparability in a biosimilar for infliximab (IFX).3,4 

Properties How was similarity determined? 
Protein structure and production quality  Detailed laboratory analysis of the structural characteristics of different batches of the drug 
Pharmacokinetic, pharmacodynamic and toxicological tests on animals  "In vitro" and "in vivo" tests on different species 
Pharmacokinetic, pharmacodynamic and toxicological tests on humans  Initial clinical trials 
Clinical efficacy and safety  Major clinical trials
Safety in everyday practice  Risk management plan , Post-marketing trials (Phase 4),  Routine reporting of side effects,  Pharmacovigilance 

Extrapolation

The initial comparability tests are conducted in the indication and population that are considered the most sensitive to detect clinically significant differences in safety, immunogenicity, and efficacy between the original and biosimilar drug. If the biosimilar product is highly similar to the reference medicine and has comparable safety and efficacy in this therapeutic indication, safety and efficacy data may then be extrapolated to indications already approved for the reference medicine.5

Extrapolation must be supported by all the scientific evidence generated in other comparability studies. In these cases, clinical trials are often not required to be repeated for all indications; instead, changes are approved based on data from quality and in vitro comparability studies. The possibility of extrapolation is dependent on the regulatory landscape of the particular country or countries in which the clinical trial is being conducted. In the EU, which pioneered biosimilar regulation by establishing a solid framework for approval, decisions based on extrapolation are dependent on a number of criteria:5,6

  • Mechanism of action: The mechanism of action of the active substance should be mediated by the same receptor in both the initial and extrapolated indication. If the mode of action is complex, involving multiple receptors or building sites, additional studies may be needed to prove that the biosimilar and reference medication will behave similarly.
  • Study population: Comprehensive comparability studies must demonstrate that the biosimilar is highly similar to the reference medicine in a “key population” in which potential differences can be detected.
  • Clinical setting: Data from one indication may not be directly applicable to an indication within another therapeutic area where the mode of action, posology, or pharmacokinetics may be different. Additional studies may be needed in this case.
  • Safety data: A comparable safety profile for the proposed indication must be established in one therapeutic indication before extrapolation. Comparability must be shown at the structural, functional, pharmacokinetic, and pharmacodynamic levels, and efficacy must be comparable.
  • Immunogenicity data: Extrapolation of immunogenicity data always requires justification as immunogenicity is determined by more than product-related characteristics. Factors relating to patient (age, immune status), disease (comorbidities, concomitant treatments) and treatment-related factors (route of administration, length of exposure) must be considered.

Meet the challenges of your IBD trial with confidence

Understanding each country’s regulatory intricacies of biosimilar development is crucial for the success of your trial. With a network of more than 3,900 global IBD sites, and a regulatory team with local regulation expertise, PSI specializes in delivering studies on time and with quality data.

Discover the full white paper here, or contact us to learn more about running your pivotal Phase 2 and 3 IBD trials with PSI.

1 Schiestl M, Stangler T, Torella C, Cepeljnik T, Toll H, Grau R. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol. 2011;29(4):310-312. doi:10.1038/nbt.1839. https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview

2 Schneider C. Biosimilars in rheumatology: the wind of change. Annals of the Rheumatic Diseases. 2013;72(3):315-318. doi:10.1136/annrheumdis-2012-202941

3 European Medicines Agency. Assessment report Inflectra. European Medicines Agency. June 27, 2013. https://www.ema.europa.eu/en/documents/assessment-report/inflectra-epar-public-assessment-report_en.pdf

4 Krznarić Ž. Biosimilars in Inflammatory Bowel Disease: From Theory to Practice. Presented at: PSI Internal Training; June 27, 2023.

5 European Medicines Agency, European Commission. Biosimilars in the EU – Information Guide for Healthcare Professionals. European Medicines Agency. 2019. https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf.

6 European Medicines Agency. Biosimilar Medicines: Overview. European Medicines Agency. April 26, 2023. Accessed July 3, 2023. https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview.

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Similar But Different: Regulatory and Operational Considerations for Biosimilar Clinical Development in IBD  

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The rise of IBD biosimilars and what comes next

Biosimilars present untapped potential for expanding patient access and improving treatment options in Inflammatory Bowel Disease (IBD) and other therapeutic areas, but these trials also bring unique challenges and regulatory considerations.

In this white paper, you’ll learn how biosimilars have transformed the treatment landscape for IBD in the past decade, their current therapeutic uses in Crohn’s disease and ulcerative colitis, and global regulatory considerations for running biosimilar clinical trials in IBD.

Download our new white paper to learn about:

  • IBD epidemiology and current biosimilar treatment methods
  • Regulatory considerations and other challenges for biosimilar trials
  • Future opportunities for biosimilar therapeutics
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Read our IBD White Paper Here
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PSI FAQs: How does PSI reduce CRA staff turnover on your project?

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Project team turnover can have a severe impact on your study’s timelines, leading to delays in everything from patient recruitment and site activation to data collection and study management. Clinical Research Associate (CRA) turnover rates in particular have climbed in recent years due to the COVID-19 pandemic and shifting economies, being reported as high as 30% in the US.

Despite this, PSI’s turnover has remained historically low with a company-wide staff turnover rate of only 14%. This kind of employee retention doesn’t just happen – it’s part of our commitment to stability for our biotech partners over the past 25 years.

While PSI offers competitive benefits and opportunities for employee recognition, we also support our CRAs in a number of other ways. We launched a CRA Academy to provide to help our team members develop therapeutic expertise as well as soft skills to manage key relationships with sites.

PSI also ensures that your study is effectively resourced by CRAs with manageable workloads by being selective about the projects take on. We are a specialized global CRO committed to pivotal Phase 2 and 3 clinical trials in select therapeutic areas, including oncology, hematology, gastroenterology, multiple sclerosis, and many rare diseases. This allows a more focused approach to resourcing, including providing additional study-specific training for CRAs on all new projects.

To learn more about how PSI ensures stability on your pivotal trial, contact us today.

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

Learn More

Case Study

PSI managed to demonstrate swift feasibility and start-up ahead of schedule, leveraging site relationships, and fostering team consistency and stability. 

Learn More

Global Reach

Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases rely on PSI’s guidance and experience. 

Learn More

The PSI Advantage

For the sixth year in a row, PSI CRO has been named a CRO Leadership Award winner in the categories of Expertise, Quality, and Reliability in the Overall (combined Big and Small pharma) respondent group. The CRO Leadership Awards are presented by Life Sciences Leader and Clinical Leader based on research conducted by ISR Reports. The awards recognize CROs that are voted by sponsors to meet or exceed expectations.

Case Study: How VISIONAL™ is Helping to Accurately Predict Study Enrollment Timelines

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At a Glance: AI and ML-powered insights for your next trial

A sponsor of a challenging breast cancer study needed to identify the optimal mix of countries and sites with similar experience and access to a hard-to-recruit subpopulation of breast cancer. Using internal and external data sources, PSI’s VISIONAL™ platform compared thousands of feasible country-site combinations and recommended the optimal enrollment scenario to meet the sponsor’s timelines and cost constraints.

Trial Enrollment Recommendations from VISIONAL™
key metrics for VISIONAL case study. 520 patients with heart in hand symbol. 126 trial sites with a target in a human head symbol. 7 countries with a world symbol. all in white text.

Sponsor Challenges

The study targeted patients pretreated with recently approved drugs. Our key criteria for country and site selection included local standards of care, historical performance in the indication, and current competition. After the initial planning had begun, the sponsor also requested 20% of patients from Latin America.

How VISIONAL™ Helps Make Strategic Decisions

Working with internal and external data sources and KOLs, PSI feasibility team quickly pulled all available data on standards of care, site performance, and historical enrollment rates, carefully curated for similarity. The dataset included 40+ countries in North America, South America, Europe, Asia-Pacific, and Africa. Using this trove of data, VISIONAL™ compared hundreds of country/site combinations, taking into account study costs and probability of success.

We were able to easily adjust the constraints for regional patient quotas as well as additional requirements from the FDA and EMA after two rounds of protocol review.

Results

1. Optimal Enrollment Scenario

VISIONAL™ recommended the most optimal combination of sites, countries, and timelines based on the current landscape and historical benchmarks, while taking into account all constraints set by the sponsor and the FDA.

2. Cost vs. Speed
The system recommended the fastest and most cost-efficient scenario within the sponsor’s budget range and timelines. We were also able to quickly evaluate alternative options:

  • Faster scenarios with an acceptable risk level
  • Longer but less expensive scenarios
  • Scenarios that buffer for unexpected delays

3. Customizable and Adaptive Reports
The initial work done during the planning stage also provided the sponsor with peace of mind during the study launch with the ability to rapidly model new scenarios based on additional constraints/new requirements.

Download the PDF Here

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

Learn More

Therapeutic Areas

Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases rely on PSI’s guidance and experience. 

Learn More

Global Reach

Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases rely on PSI’s guidance and experience. 

Learn More
up close image of a small clear vial, a CT scan of a brain and a stethoscope

Case Study: Phase 3 Radiopharmaceutical Clinical Trial in Oncology

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At a Glance: FDA Approval in 4 Years

Radiopharmaceutical clinical trials face a host of logistical challenges from startup through the clinical phase. A sponsor of a pivotal Phase 3 prostate cancer study investigating a radiopharm product approached PSI for support based on our experience and established network of over 400 global radiopharmaceutical sites. By working closely with our sites and vendors, PSI met or beat all critical milestones, helping our client secure FDA approval for their radiopharmaceutical product in under four years.

graph representing predicted vs. actual patient enrollment and patient screening numbers
Patient Screening and Enrollment Numbers
key metrics for radiopharmacy case study. 1200 patients with heart in hand symbol. 860 trial sites with a target in a human head symbol. 10 countries with a world symbol. 90 trial sites with a hospital symbol. all in white text.

Sponsor Challenges

The major challenges in global nuclear medicine trials include the complexity of regulatory requirements in each country and the necessity for experienced, highly trained sites either within close proximity to the material’s manufacturing site or with the ability to provide at the site level. The investigational product in this study had a half-life of three days, necessitating diligent time management and site engagement to deliver the study on schedule.

PSI Strategy

To make sure eligible patients didn’t miss these three-day windows, PSI’s CRAs encouraged sites to maintain frequently updated pre-screening logs and regularly discuss the pool of potential patients with the investigators. We also worked closely with sites and the manufacturing facilities to time the inclusion of each patient appropriately, especially around local bank holidays when a manufacturing facility would not be available.

Results

1) Expedited Study Timelines
PSI met or beat all critical milestones during the study, including achieving FPI in the US in less than 3 months and completing NDA submission one month ahead of schedule.

2) 99% Enrolling Sites
Only one out of all initiated sites did not enroll a patient.

3) Successful Regulatory Approval
After passing three FDA inspections without major findings, PSI’s regulatory experts helped our client secure FDA approval in under four years.

“I would personally like to acknowledge and thank the entire PSI team and leadership for the dedication, perseverance and determined support that supported the early completion of the study. Your team have showcased all the capabilities and attributes of a best-in-class CRO for project delivery.”
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--Global Head
External Relationship Management
Download the PDF Here

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

Learn More

Therapeutic Areas

Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases rely on PSI’s guidance and experience. 

Learn More

Global Reach

Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases rely on PSI’s guidance and experience. 

Learn More
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Case Study: Optimizing Feasibility and Start-Up for a Phase III HemOnc Clinical Trial

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At a Glance

No trial is ever easy. But with the continued effects of the global pandemic and the war in Ukraine, the sponsor had larger than average challenges. Nonetheless, PSI managed to demonstrate swift feasibility and start-up ahead of schedule, leveraging site relationships, and fostering team consistency and stability. In the end the study completed enrollment of nearly 900 patients on time at as many as 370 sites all around the world. Italy and Australia showed up as the top enrolling countries.
graph depicting planned vs. actual patient enrollment for the hemonc case study. There is a red and blue line
Patient Enrollment Numbers
Key metrics for HemOnc case study 900 patients enrolled with heart in hand symbol. 425 sites activated with target in a persons head symbol. 30 countries with a world symbol.

Sponsor Challenges

Enrolling over 900 patients and in a clinical trial of this complexity would pose a challenge even in the most mundane of years. Add to that continual pandemic consequences and a global conflict, the stage is set for every possible delay and communication breakdown. The sponsor needed a CRO willing to tackle an aggressive recruitment plan and provide a solid partnership in order for the trial to succeed.

Start-Up in Sync

Staying on time means starting on time. Working closely with sites to understand how the pandemic affected their ability to meet site activation, PSI offered them several technical options that allowed for remote site selection visits. PSI managed to identify over 3000 sites and select about 500 sites 3 months ahead of schedule.

Additionally, feasibility projections were actually reflected in enrollment, not merely a best-case scenario or wishful thinking. This is due in large part to knowing the sites. Today, PSI would have also added machine-learning-powered tool, VISIONAL™, to generate the most optimal enrollment scenarios that could potentially further reduce the study time and cost.

Racalibrating the Geo-mix

Not every CRO can offer flexibility and adaptability, especially in a short amount of time. During enrollment, a change of strategy on the sponsor side called for more sites, and swiftly. In order to do this, countries with initially smaller projected sites and patients had to ramp up with little to no interruption. The only way this could be accomplished was with previously established solid global site relationships and coordination and stellar communication on every level of the study team.

Managing Motivation, Staffing, & Velocity

To motivate teams on a country level, PSI staff focused on maintaining a sense of competition between teams. This helped create a friendly sense of excitement as countries saw their recruitment numbers grow.

Continuity of the study team also played an enormous role in the study’s success. This not only helped keep the study on track when the client had changes to their own staff but provided a sense of consistency and reliability throughout the course of the trial at every level. Key roles project supervisor, project manager and other key staff stayed on for the whole of two years of study duration, something almost unheard of in this ever-changing industry. They are still with PSI running the trial as we write these lines.

Download the PDF Here

The PSI Advantage

For the sixth year in a row, PSI CRO has been named a CRO Leadership Award winner in the categories of Expertise, Quality, and Reliability in the Overall (combined Big and Small pharma) respondent group. The CRO Leadership Awards are presented by Life Sciences Leader and Clinical Leader based on research conducted by ISR Reports. The awards recognize CROs that are voted by sponsors to meet or exceed expectations.

PSI Receives Three More CRO Leadership Awards in 2023 

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Global CRO continues track record of success with sixth consecutive year of awards based on research conducted by ISR Reports

PSI Receives 3 CRO Leadership Awards
PSI CRO, 7 June 2023 – For the sixth year in a row, PSI CRO, a leading full-service, global contract research organization (CRO), has received CRO Leadership Awards in the categories of Expertise, Quality, and Reliability in the Overall (combined Big and Small Pharma) respondent group.

The CRO Leadership Awards are presented by Life Science Leader and Clinical Leader based on research conducted by ISR Reports. For the 2023 awards, 46 contract research organizations were assessed on 20+ performance metrics in five core categories in ISR’s annual CRO Quality Benchmarking survey. Respondents evaluate only those companies with which they have worked on an outsourced project within the past 18 months to ensure survey responses are based on actual involvement with CROs and clear experiential data.

PSI has received CRO Leadership Awards in multiple categories each year since 2018.

“At PSI, we strive to achieve global excellence, as gauged by the satisfaction of our valued employees, clients, investigative sites, and vendors,” says Nick Sinackevich, President of PSI. “We are proud to be honored in the CRO Leadership Awards for the sixth year in a row, especially in these categories that speak directly to our shared mission: delivering quality clinical trials reliably while earning the continued trust of our sites and clients.”

To learn more about ISR Reports and the research behind the CRO Leadership Awards, please visit ISRreports.com.

About PSI: PSI CRO is a privately-owned, full-service clinical research organization (CRO) operating globally. PSI’s global reach supports clinical trials across multiple countries and continents and specializes in the planning and execution of global pivotal registration clinical trials. With an exceptionally high repeat and referral business rate combined with minimal staff turnover, PSI is committed to being the best CRO in the world as measured by its employees, customers, investigators, and vendors.

Global headquarters are located in Switzerland at 113a Baarerstrasse, Zug 6300. www.psi-cro.com

For Media Inquiries:

Ashley Collins, Marketing Specialist

919-972-9572 |ashley.stufanocollins@psi-cro.com

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Operationalizing Radiopharmaceutical Clinical Trials: Opportunities and Challenges  

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When PSI published a blog post on the current state of radiopharmaceutical clinical trials in 2019, we had no way of knowing of the changes that would transform the clinical trial industry – along with every other one on earth – just a few months later.

Of course, managing global nuclear medicine trials has never been easy due to the complexity of regulatory requirements in each country and the necessity for experienced, highly trained sites either within close proximity to the material’s manufacturing site or with the ability to provide at the site level. However, travel restrictions and supply chain challenges have only exacerbated these obstacles. While some of these issues are starting to ease, the need for an experienced, global perspective toward managing these studies has only increased.

Success starts with understanding the risk factors that can impact your radiopharmaceutical trial from startup through the clinical phase. Drawing on our experience as we continue to run radiopharm studies in multiple oncology indications, we’ve highlighted some of the most common challenges to consider below – and how to overcome them.

1. Country-specific Regulatory Requirements for Radiopharmaceutical Agents

As development interest in this new class of agents has continued to grow, so has the complexity of the regulatory landscape. Additional approvals should be considered for studies in both the United States and the United Kingdom, as outlined in the table below:

Country Consideration
USA Radiation Safety Committees approvals typically obtained before submissions to IRBs
UK HRA radiology review prior to submission is needed, as well as approval of Administration of Radioactive Substances Advisory Committee (ARSAC). ARSAC review goes in parallel to the ethics/regulatory review

The European Union’s Clinical Trial Regulation has streamlined the process for submitting clinical trial applications in the EU, but many countries still encourage or require additional approvals. An in-depth understanding of each specific country’s requirements in your trial is essential to proactively anticipate requirements and potential questions that can delay approvals. Drawing on our experience with these studies, PSI maintains a library of country-specific radiopharmaceutical requirements and regulations within VISIONAL™, our machine-learning-powered system for data-driven feasibility and enrollment forecast. This pairing of regulatory expertise and technology allows us to accurately predict timelines and model hundreds of country and site combinations, their budgets, and probability of success within minutes.

2. Site Imaging Qualifications and Other Common Delays in Site Activation

Site qualification can be time-consuming for sites, so sponsors should confirm timelines during the feasibility process and ensure that sites are well-trained and supported with any study-specific calibration or camera requirements. PSI created the role of Site Support Specialist to help support sites in the qualification and camera process as well as during the study, saving them time and frustration. An example of the site imaging qualification process is shown below.

Site Imaging Qualifications

This is a simplified example, and the process can be much lengthier if dosimetry is included as part of the study. We have found having a dedicated Site Support Specialist assigned to work one-on-one with each site during the qualification process significantly decreases delays in site activation due to camera qualification.

Issues with technical transfer, or IND amendments (if the drug will be manufactured on-site), can also lead to delays. In some instances, choosing a central procurement facility may be effective, allowing one facility to execute the contract and technical transfer independent of site startup and activation.

3. Logistical Issues During Clinical Phase

As noted in our previous article, cooperation and coordination are imperative every step of the way for the successful delivery of radiopharmaceutical trials: from the facilities and procedures that produce the nuclear material to their handling and storage to the transportation of the drug and dispensation. Understanding the patient journey and which procedures must be completed at each step, including when the investigational product should be ordered, is recommended as a proactive foundational tool. At PSI, we have developed a detailed and unique visual patient journey utilized at the site and project levels.

In addition, other tools for clinical staff, such as a patient visit and MRI/whole brain PET scan tracker calendar, biopsy procedure schedule, source template, and automatic calculator for time-dependent procedures, will help provide additional clarity and compliance. We also recommend tracking key steps via Interactive Response Technology.

4. Central Radiology Review and Delays in Submitting Scans

It is critical to manage and track all steps in the imaging process at each site, including navigating the technical dialogue between nuclear medicine technologists, nuclear physicians/radiologists, investigators, and other stakeholders. Sponsors should ensure clear communication and receipts from the central reader for all scans received and that the appropriate project team members are copied on any queries to the site. PSI’s Site Support Specialist is key in ensuring every stage is performed accurately and on time, including monitoring site submissions in real time and assisting sites with submissions when needed. This role has also proven beneficial in managing and providing oversight of all site queries, cutting the site team’s time spent on imaging queries in half.

5. Development and Implementation of Site-Specific Enrollment Plans

Solid tumor oncology trials represent one of the most competitive markets in clinical research, with over 3,000 trials ongoing or planned, according to data from clinicaltrials.gov, Citeline, and GlobalData. With additional obstacles presented by sites’ limited proximity to manufacturing centers, sponsors and their partners should have detailed site-specific enrollment plans that consider the patient journey at each site, from identifying prospective patients to scheduling the needed imaging assessments and surgeries or biopsies. Walking through this patient journey helps both the site and the CRA to identify all the involved team members so that potential risk factors can be mitigated. PSI’s dedicated Site Support Specialists may meet with sites as soon as they’re selected by clients to understand this patient journey and put together a tailored site enrollment strategy based on site referral patterns, facilities, capabilities, and other key factors.

Meet the challenge of your radiopharmaceutical pivotal trial with PSI

Every study is different, and there is no one-size-fits-all solution for ensuring success. With an established and proven network of almost 300 global radiopharmaceutical sites, PSI specializes in delivering radiopharm studies on time and with quality data. Seventy-nine percent of PSI CRAs have oncology experience, and PSI has developed therapeutic-specific training and resources for radiopharmaceutical trials to achieve the highest level of quality for your study. In addition, PSI’s Site Support Specialist role has led to a dramatic improvement in site activation and enrollment.

Contact us here to learn more about running your pivotal Phase 2 and 3 radiopharmaceutical trials with PSI.

SNMMI 2023 Annual Meeting: PSI Team Spotlight

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The SNMII 2023 Annual Meeting is coming up June 24 – 27, and our team at PSI is excited to join the conversation with nuclear medicine and molecular imaging sponsors and partners like you. The team will be walking the floor, ready to speak with you about your upcoming study. Schedule some time to speak with PSI experts helping to support innovators across the globe. Meet two of our experts packing their bags for Chicago below!

Dylan Stoy with pink circle border
Meet Dylan

Dylan Stoy
Associate Director, Therapeutic Strategy

Dylan Stoy, PSI’s Therapeutic Strategy Director, is dedicated to conducting and executing better clinical studies in PSI’s core therapeutic areas. Dylan has worked in radiopharmaceutical research for about 9 years, with research interests in targeted drug delivery systems and optimizing the conduct of studies. Dylan has overseen radiopharmaceutical research from various roles including onsite research, design and trial conduct, clinical operations oversight, project management, and therapeutic strategy.

Dylan and his team are devoted to making participation for sites and patients in complex radiopharmaceutical studies more attainable and ensuring that PSI teams are highly trained and equipped to handle any challenges your program might encounter. Dylan works closely with the core business units within PSI, overseeing research throughout the study lifecycle, providing strategic leadership to our teams and collaborators (both internally and externally), and delivering corporate-wide trainings to make PSI your full-service CRO for all things radiopharmaceutical development.

 
Wes Ross with teal circle border

Wes Ross
Site Support Specialist

Wes Ross, Site Support Specialist, is one of PSI’s keys to addressing the complexities that lie in the conduction of radiopharmaceutical trials. Wes has a BS in Radiologic Sciences and an AS in Radiology and is also a licensed nuclear medicine technologist with over 22 years of hands-on experience working in the field. He has worked as a nuclear medicine technologist, working on the development and oversight of nuclear medicine research, and has worked in the creation of testing and controls for digital PET/CT technology. Wes uses his breadth of experience to drive PSI ahead of the curve for conducting successful research in the industry, developing new and exciting ways to get radiopharmaceutical studies up and running.

Wes manages the site qualification process for imaging studies and manufacturing radiopharmaceutical products, oversees the process of image acquisition and quality control, and is responsible for training trial sites, project teams, and vendors to deliver meaningful research in the requirements and strategies for the programs he works on. Wes works closely with other core units both within PSI and sponsor companies, such as project management, clinical operations, CMC, and supply chain to help design studies, project plans, and training materials in the radiopharmaceutical space.

Meet us at SNMMI 2023

Dylan, Wes, and the rest of our team are excited to discuss your upcoming study at SNMMI 2023. Click here to reserve your spot today.

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ASCO 2023: PSI Team Spotlight

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ASCO 2023 is coming up June 3 – 5, and our team at PSI is excited to join the conversation with oncology sponsors and partners like you. Stop by Booth #19020 for a chance (or schedule a meeting here) to speak with PSI experts helping to support oncology innovators across the globe. Meet our team members who are packing their bags for Chicago.

Vince Calderon with teal circle border

Vince Calderon
Director Project Management

Vince serves as a Director and supervisor of Project Management, overseeing PSI’s team of Project Management staff and several studies in oncology and hematology. Vince has been with PSI since December 2019, and is based in Texas. He has over 19 years’ clinical research experience, 15 years of project management experience, and has delivered 20+ oncology studies in both solid tumors and hematology-oncology.

Vince has professional affiliations with the Project Management Institute in the US and has been a certified Project Management Professional since 2012.

Emily Mcinturf with pink circle border

Emily McInturf
Director, Feasibility

Emily McInturf, Director Feasibility, has worked in the clinical research industry for the past 15 years. As a leader within PSI’s global feasibility team, Emily specializes in strategy development across multiple therapeutic areas – focusing on aligning a study’s design with top enrolling investigators in the right countries.

Using PSI’s INTELIA platform, a machine-learning-powered system for data-driven feasibility and enrollment forecast, Emily models and compares hundreds of country and site combinations, their budgets and probability of success, ultimately recommending the most optimal enrollment scenario in line with each sponsor’s key objectives.

As a Director, Emily provides oversight for global feasibility and site identification activities for both pre- and post-award opportunities and projects.

Rhonda Critchlow with teal circle border
Meet Rhonda

Rhonda Critchlow
Senior Director, Operations

Rhonda Critchlow, Senior Director of Therapeutic Strategy, currently oversees all of PSI’s core indications, and specializes in operational strategy within oncology and radiopharmaceuticals. With over 25 years of research experience, she provides valuable leadership and management working both regionally and globally.

Overseeing the therapeutic strategy department, which includes our Site Support Specialist, Rhonda brings guidance and oversight to specialty vendor management, patient recruitment and retention for our sponsors.

Prior to working at PSI, her experience includes working within oncology research as a Coordinator and Director, CRA, Clinical Trial Manager, Head of Monitoring and Vice President of Early Phase Oncology before joining PSI. Rhonda also has experience working with general radiology and nuclear medicine in large hospital organizations, providing valuable input for clinical development, study management and operational considerations.

Meet us at ASCO 2023

Vince, Emily, and the rest of our team are excited to discuss your upcoming oncology study at ASCO 2023. Click here to reserve your spot today.

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