“A common thread among our Worldwide team members is a passion to take care of our customers – we’re always looking for ways to improve our partnerships,” said Mike Mencer, Executive Vice President and General Manager, Early Phase. “As part of an ongoing $5 million upgrade to our CPU, this expansion aligns with our culture of quality and our dedication to continuous improvement and innovation to meet our customers’ growing needs as we work together to improve the lives of patients around the world.”

Pharmacy upgrades included end-of-life equipment replacements and relocation for an expanded footprint within the CPU.

“Expanding our pharmacy in size enables us to expand in volume, providing additional opportunities and efficiencies for our customers,” said Lona Sheeran, Sr. Vice President, Clinical Operations, Early Phase. “We can now manufacture onsite, in real time, for Phase 1 studies per FDA guidance, allowing our customers the option to pivot on their dose while their study is ongoing. This service is unique and can save our customers thousands of dollars and months of time – a huge advantage in this fast-paced industry.”

Operating since 2005, Worldwide’s CPU is a 200-bed, fit-for-purpose facility. Within this unit, studies are conducted in healthy volunteers, patients, and specialty populations. The CPU is located one hour from Worldwide’s Bioanalytical Center of Excellence, offering a comprehensive approach that benefits customers through streamlined vendor management, consistent standards, technical expertise, and overall efficiencies such as seamless sample transfer and rapid processing.

For more information on Worldwide’s CPU and to take a tour, click here; and to take a tour of the Bioanalytical Center of Excellence, click here.

About Worldwide Clinical Trials:
Worldwide Clinical Trials (Worldwide) is a leading full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Worldwide’s capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by an accessible team of clinicians, scientists, and researchers who bring first-hand expertise and a collaborative, personalized approach to each clinical program. Worldwide is therapeutically focused on neuroscience, oncology, rare diseases, and cardiometabolic and inflammatory disease. Its global footprint spans nearly 60 countries with more than 3,400 team members. For more information, visit www.worldwide.com.

Media Contact:
Jill Mastrangelo
Jill.Mastrangelo@Worldwide.com

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RESEARCH TRIANGLE PARK, N.C. – 15 February 2024 – Worldwide Clinical Trials (“Worldwide”), a privately held, leading global, full-service contract research organization (CRO), has launched the Rare Moments website to give the rare disease community an easily accessible space to connect, share stories, and uncover new possibilities and ways of thinking about rare diseases. The unique resource surfaces impactful, transformative stories from patients, family members, researchers, and others involved in rare disease care.

“We’ve heard from various rare disease community members that it’s difficult to stay updated on news, milestones, and developments in other rare diseases. The successes built out of one rare disease should and could be applied to another rare disease,” said Derek Ansel, Executive Director, Therapeutic Strategy Lead, Rare Disease for Worldwide Clinical Trials. “Those who live with, research, and treat rare diseases have a common bond, and there is power in sharing experiences as a community. By coming together in one place, these groups can learn about different viewpoints and discover new opportunities. Worldwide believes the voice of the patient should be an intrinsic part of rare disease research and care, and this website is one way we are working to amplify and spread that voice, as well as build connections and community.”

The Rare Moments website showcase experiences from diverse audiences that illustrate what it means to live with and work with rare diseases. Anyone can submit a Rare Moment, and they can be past experiences, significant highlights from the 2024 Rare Disease Week and Rare Disease Day, resources, and even hopes for the future. While the stories will evolve over time, several featured stories went live with the website’s launch on 1 February 2024. Rare disease community members are encouraged to submit their own Rare Moments leading up to Rare Disease Day on 29 February and beyond.

Around the world, 300 million people have a rare disease, and 72 percent of those diseases have genetic origins (source). A rare disease is generally considered to be a disease that affects fewer than 200,000 people in the United States or 5 in 10,000 people in the European Union at any given time. Patient populations for these diseases are small and geographically widespread – a challenge for achieving access to conduct patient education and rare disease clinical research.

Learn more about Worldwide’s commitment to excellence in rare disease clinical trial design here.

About Worldwide Clinical Trials:

Worldwide Clinical Trials (Worldwide) is a leading full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Worldwide’s capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by an accessible team of clinicians, scientists, and researchers who bring first-hand expertise and a collaborative, personalized approach to each clinical program. Worldwide is therapeutically focused on neuroscience, oncology, rare diseases, and cardiometabolic and inflammatory disease. Its global footprint spans nearly 60 countries with more than 3,400 team members. For more information, visit www.worldwide.com.

Media Contact:
Jill Mastrangelo
Director, Global Corporate Communications
Jill.Mastrangelo@Worldwide.com

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RESEARCH TRIANGLE PARK, N.C. – 08 FEBRUARY 2024 – Worldwide Clinical Trials, a leading global full-service contract research organization (CRO), has released results of a recent industry survey. The report examines changing perceptions about large and midsize CROs within the pharmaceutical and biotech sectors. Derived from a diverse respondent base of clinical trial sponsors—including emerging, small, midsize, and large companies in the United States and Europe(1) —the findings unveil concerns about the impact of complicated market dynamics on large CRO performance and service delivery.

“This survey data reveals the current challenges pharma and biotech sponsors are facing while highlighting the importance of CRO partnerships and flexibility. We hear from our sponsors all the time that they want transparent communication, responsiveness, and personalized attention – they need these things for reassurance and to create a shared sense of ownership, especially during times of market uncertainty and CRO shake-ups,” stated Worldwide’s president and CEO, Peter Benton. He added, “Regardless of sponsor size, at the core of successful clinical research programs are high levels of customer service, ongoing proactive communication and collaboration, and the flexibility to adapt in an everchanging clinical landscape.”

Samir Shah, industry veteran and principal of Shah Pharma Consulting Services LLC, recently examined the structural changes across distinct customer segmentations, specifically midsize to large pharma and biotech, and the implications for CROs needing to further configure solutions based on their specific operating model. Shah commented, “Worldwide’s findings are supported by a McKinsey & Company report that includes data from the biotech segment and provides insights on how CROs can improve their partnership models. Both reports underscore the importance of CROs offering flexible and customized solutions that account for the size and needs of a specific customer.”

Large CRO Segment Dynamics

Of note, nearly 80% of survey respondents felt the “one-stop-shop” claim frequently marketed by large CROs is not a cost-effective business model, and often does not result in seamlessly integrated service delivery. Additionally, 50% of respondents shared that large CRO instability has impacted their willingness to partner due to project team disruptions, lack of access to top talent, poor service delivery, and more. In addition:

• 75% of respondents raised concerns regarding a lack of personalized attention.
• 71% of respondents voiced apprehension about higher clinical development costs when working with large CROs.
• 70% expressed worry about potential project team disruptions leading to extended turnaround times and deliverables.
• 69% were anxious about inefficiencies arising from operational differences between poorly integrated companies.

Challenges also surfaced among survey respondents regarding the talent, service delivery, and client prioritization offered by large CROs. Notably, 69% reported encountering a “B” team despite assurances of an “A” team, and 62% expressed reservations about their inability to provide consistent support to customers of all sizes.

These misgivings seem to underpin the anticipated outsourcing activity shift from 41% to 46% (net gain of 5%) from large CROs to midsize CROs over the next three years, as revealed by the data. This change in outsourcing behavior was demonstrated across trial sponsors from all company sizes and geographies. This signals a notable change in the market, strongest among midsize and large biopharma sponsors in Europe and the US.

Midsize CRO Takeaways

Survey participants noted that their inclination toward midsize CROs is driven by their belief that midsize CROs deliver more agility, personalized attention, and an advantageous balance of cost and value.

More than 80% of respondents concurred that midsize CROs not only align well culturally but also demonstrate the ability to swiftly adapt to evolving customer needs. Moreover, among the attributes respondents noted as beneficial factors when working with midsize CROs:

• 83% cited “agility.”
• 81% cited “rapid escalation of study-related issues.”
• 80% cited “access to senior-level scientific and medical expertise.”
• 79% cited “personalized attention/greater customer focus.”

For more detailed insights and access to the complete survey report, click here.

About Worldwide Clinical Trials:

Worldwide Clinical Trials (Worldwide) is a leading full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Worldwide’s capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by an accessible team of clinicians, scientists, and researchers who bring first-hand expertise and a collaborative, personalized approach to each clinical program. Worldwide is therapeutically focused on neuroscience, oncology, rare diseases, and cardiometabolic and inflammatory disease. Its global footprint spans nearly 60 countries with more than 3,400 team members. For more information, visit www.worldwide.com.

Disclaimer: When accessing the industry survey report, please note – The content of this report is proprietary to Worldwide Clinical Trials. Please note, no part of this report may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of Worldwide Clinical Trials except in the case of quotations embodied in reviews and non-commercial uses including press and media outlets. Any unauthorized reproduction or distribution of this report or any portion thereof may result in legal action taken by Worldwide Clinical Trials to protect its rights. For permissions or inquiries, please contact: Media@Worldwide.com.

1. The web-based, quantitative research survey was fielded with key CRO decision makers across emerging, small, midsize, and large pharma and biotech companies (N=140). Regional representation included 66% US/Canada (N=93), 34% Europe (N=47). The research was conducted by a third-party market research partner, and research participants were recruited from a panel of experts involved in the evaluation, selection, and use of CROs.

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RESEARCH TRIANGLE PARK, N.C. – 12 December 2023 – Worldwide Clinical Trials (“Worldwide”), a privately held, leading global, full-service contract research organization (“CRO”), has announced the closing of its previously announced recapitalization that gives funds managed by Kohlberg & Company, LLC (“Kohlberg”), a leading private equity firm with over 35 years of experience partnering with management and companies like Worldwide, a majority stake in the company. Middle-market private equity firm TJC, which has been Worldwide’s sole investor since 2007, retains a meaningful minority equity stake in the CRO.

“This is a significant milestone for Worldwide – one that positions us for further growth and expands our ability to deliver best in class partnerships for our customers while cultivating a culture for our team members to do their best, mission-oriented work,” said Peter Benton, President and CEO, Worldwide Clinical Trials. “Our customers have told us directly that our responsive, flexible, and accessible partnership model benefits them. This investment by Kohlberg, and continued investment by TJC, elevates our approach to best support our customers and continue delivering customized clinical research programs.”

With this transaction, Matt Jennings, Operating Partner of Kohlberg, becomes Chairman of Worldwide’s Board of Directors. Worldwide remains a privately held company with no other changes to its leadership team, employee base, or customer experience.

“The addition of Worldwide Clinical Trials to the Kohlberg portfolio builds a vital piece of our pharma services ‘ecosystem’ by which we have thoughtfully connected non-competing companies that are driven by similar missions and visions – ultimately, to help improve the lives of patients around the world,” said Jennings. “Worldwide’s achievements to date, and its promising growth trajectory, are unmatched in the industry. We look forward to bringing valuable synergies and additional investment opportunities for the CRO in the years to come.”

As a result of its deliberate, therapeutically focused growth strategy, aligned with industry trends and customer needs, Worldwide has demonstrated market leading year-over-year growth since 2019. The company has experienced consistent increases in its annual Late Phase studies across the key therapeutic areas of neuroscience, oncology, rare diseases, and cardiometabolic and inflammatory disease; and has made significant investments to expand its Early Phase services and capabilities, including opening a state-of-the-art Bioanalytical Center of Excellence and launching its large molecule services in 2022.

“Worldwide Clinical Trials is now a valuable part of Kohlberg’s Pharmaceutical and Medical Products & Services industry practice, joining companies that are committed to offering high-value services to the life sciences industry, like PCI Pharma Services and Trinity Life Sciences, to create trusted collaborations while operating independently,” said Chris Anderson, Partner at Kohlberg. “For Worldwide, this means accelerating its next growth journey phase and continuing to expertly partner with its customers to bring new life-changing medications and treatments to patients around the world, and we are excited to support that imperative mission.”

Over the past 10 years, Worldwide has been recognized as a top CRO in the annual CRO Leadership Awards, based on primary market research from the Industry Standard Report (ISR) – earning top marks in the categories of Capabilities, Compatibility, Expertise, Quality, and Reliability. In 2023, the company was honored as the year’s Most Innovative CRO in TBJ’s Life Sciences Awards, a program that celebrates the achievements of companies making critical advancements in pharmaceuticals, biotech, and beyond.

To learn more about Worldwide or to connect, visit www.Worldwide.com.

About Worldwide Clinical Trials:
Worldwide Clinical Trials (Worldwide) is a leading full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Worldwide’s capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by an accessible team of clinicians, scientists, and researchers who bring first-hand expertise and a collaborative, personalized approach to each clinical program. Worldwide is therapeutically focused on neuroscience, oncology, rare diseases, and cardiometabolic and inflammatory disease. Its global footprint spans nearly 60 countries with more than 3,300 team members. For more information, visit www.worldwide.com.

About Kohlberg & Company:
Kohlberg is a leading U.S. middle market private equity firm based in Mount Kisco, New York. Over the firm’s 36-year history, the firm has organized 11 private equity vehicles totaling in aggregate over $14 billion. Since inception, the firm’s private equity investments have generated over $10 billion in realized returns with no realized losses since Fund VI (2007 vintage). The firm invests in leading middle market businesses that are identified through its rigorous thematic research and the firm’s White Paper Program in its six core practice areas. For more information, please visit www.kohlberg.com.

About TJC, L.P.:
TJC, founded in 1982, is a middle-market private equity firm that has raised funds with original capital commitments in excess of $22 billion with a 40-year track record of investing in and contributing to the growth of many businesses across a wide range of industries, including Diversified Industrials; Technology, Telecom & Power; Logistics & Supply Chain and Consumer & Healthcare. The senior investment team has been investing together for over 20 years, and they are supported by the Operations Management Group, which was established in 1988 to initiate and support operational improvements in portfolio companies. TJC has offices in New York, Miami, Chicago, and Stamford. For more information, visit: www.tjclp.com.

Media Contacts:
For Worldwide:
Jill Mastrangelo
Director, Global Corporate Communications
Jill.Mastrangelo@Worldwide.com

For Kohlberg:
Sophia Templin and Elizabeth Chaconas
Kohlberg-US@fgsglobal.com

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*Press release and imagery courtesy of the American Heart Association

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RESEARCH TRIANGLE PARK, N.C. – 29 November 2023 – Worldwide Clinical Trials (Worldwide), a leading global, full-service contract research organization (CRO), has appointed Jayaprakash (JP) Kotha, MBBS, Ph.D, ASCP (SH), as Vice President, Bioanalytical. Kotha now leads lab operations and all activities in Worldwide’s Bioanalytical Center of Excellence, located in Austin, Texas.

The Bioanalytical Lab at Worldwide continues to grow with the industry to provide customers with small and large molecule bioanalysis, PK/PD analysis, and genotyping expertise. In 2022, the company opened the Bioanalytical Center of Excellence, a state-of-the-art, 60,000 square foot facility outfitted with a full automation suite, modern infrastructure, and efficient, fit-for-purpose lab space to flexibly support current and future research demands while enabling optimized workflows to ensure critical customer timelines are met. The Bioanalytical Center of Excellence is also set up to meet and exceed the increasing demand within the large molecule bioanalytical testing services market with an additional 15,000 square foot lab dedicated to large molecule.

“JP’s extensive scientific background makes him the perfect fit to lead our Bioanalytical laboratory, particularly at a time when we are growing our service offerings to best meet the needs of our customers,” said Mike Mencer, Executive Vice President and General Manager, Early Phase. “I am confident that JP’s leadership will drive further success that helps our customers improve the lives of patients by bringing new drugs and treatments to market.”

“It is exciting to join the Worldwide Clinical Trials team, especially during a time of such transformation and progress,” said Kotha. “Worldwide is known for its specialized approach to bioanalytical services and clinical trials – one that prioritizes personalized partnerships and accessible technical expertise for its customers. I look forward to contributing greatly to the business.”

As a scientist with more than 25 years of diagnostic and research laboratory experience in cardiovascular, hematology, oncology, and immunology, Kotha is well versed in leading cross-functional teams engaged in clinical and translational research for the development of biologics and small-molecule therapeutics. He offers extensive experience in development and validation of bioanalytical assays for pharmacodynamic, pharmacokinetic, biomarker, and immunogenicity testing for novel therapeutics on diverse technological platforms and in guiding research scientists and project managers engaged in laboratory testing for clinical research.

Learn more about Worldwide’s bioanalytical services, click here.

About Worldwide Clinical Trials:
Worldwide Clinical Trials (Worldwide) is a leading full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Our capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by our accessible team of clinicians, scientists, and researchers who bring first-hand expertise and a collaborative, personalized approach to each clinical program.

Anchored in our company’s scientific heritage, we are therapeutically focused on neuroscience, oncology, rare diseases, and cardiometabolic disorders. Our deep therapeutic knowledge and country-specific operational acumen enable us to develop flexible plans and quickly solve problems for our customers.

Our team of 3,300+ professionals spans 60+ countries, and believes that through a culture that embraces diversity, equity, inclusion, and belonging (DEI&B), everyone plays a vital role in making a world of difference for patients and their caregivers. We are united in cause with our customers to improve the lives of patients through new, innovative therapies.

For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

Media Contact:
Jill Mastrangelo
Jill.Mastrangelo@Worldwide.com

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Research Triangle Park, N.C. – 14 September, 2023 – Worldwide Clinical Trials, a leading global, full-service contract research organization (CRO), has announced its Early Phase Clinical Pharmacology Unit (CPU) has been awarded accreditation from the College of American Pathologists (CAP). To achieve accreditation, the clinic passed a rigorous evaluation process that involved an in-depth inspection of its clinical laboratory facilities, equipment, processes, quality control measures, and personnel qualifications – conducted onsite by CAP inspectors.

“The College of American Pathologists is known for the highest standards in laboratory quality,” said Mike Mencer, Executive Vice President and General Manager, Early Phase. “The CAP Laboratory Accreditation Program provides a clear roadmap for running a high-quality clinical laboratory, with checklists updated annually to ensure we stay current with rapidly evolving advances in medicine, technology, and regulatory compliance as we partner with our customers to develop new medications and treatments. As the latest in our series of investments in facilities, capabilities, and certifications, this accreditation upholds our culture of quality and our commitment to provide customized services to every clinical research program we launch, while adhering to stringent regulatory requirements.”

Operating since 2005 and located in San Antonio, Texas, Worldwide’s CPU is a 200-bed, fit-for-purpose facility. Within this unit, studies are conducted in healthy volunteers, patients, and specialty populations. The CPU is located one hour from Worldwide’s Bioanalytical Center of Excellence, offering a comprehensive approach that benefits customers through streamlined vendor management, consistent standards, technical expertise, and overall efficiencies such as seamless sample transfer and rapid processing.

Worldwide opened the Bioanalytical Center of Excellence in June 2022 in Austin, Texas, to support its Early Phase development and expansion. The state-of-the-art, 57,000 square foot facility offers about 20 percent more usable space than the previous lab, and is outfitted with modern infrastructure, improved air control, and efficient lab space to flexibly support current and future early phase research demands while enabling optimized workflows to ensure critical customer timelines are met. The expansion also included the addition of large molecule capabilities and services, led by Dr. Tom Zhang, with a 15,000 square foot large molecule lab within the Bioanalytical Center of Excellence. With the addition of this large molecule dedicated lab, Worldwide positioned itself to meet and exceed the increasing demand within the large molecule bioanalytical testing services market.

For more information on Worldwide’s CPU and to take a tour, click here; and to take a tour of the Bioanalytical Center of Excellence, click here.

About Worldwide Clinical Trials

Worldwide Clinical Trials (Worldwide) is a leading full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Our capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by our accessible team of clinicians, scientists, and researchers who bring first-hand expertise and a collaborative, personalized approach to each clinical program.

Anchored in our company’s scientific heritage, we are therapeutically focused on neuroscience, oncology, rare diseases, and cardiometabolic disorders. Our deep therapeutic knowledge and country-specific operational acumen enable us to develop flexible plans and quickly solve problems for our customers.

Our team of 3,200+ professionals spans 60+ countries, and believes that through a culture that embraces diversity, equity, inclusion, and belonging (DEI&B), everyone plays a vital role in making a world of difference for patients and their caregivers. We are united in cause with our customers to improve the lives of patients through new, innovative therapies.

For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

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The transaction is expected to close in the fourth quarter of 2023, subject to regulatory approvals and customary closing conditions. The terms of the transaction are not disclosed.

Headquartered in Research Triangle Park, N.C., Worldwide works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. The Company’s capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by its accessible team of clinicians, scientists, and researchers who bring first-hand expertise and a collaborative, personalized approach to each clinical program. With more than 3,200 employees across nearly 60 countries, Worldwide is therapeutically focused on cardiovascular, metabolic, neuroscience, oncology, and rare diseases.

“Over the past few years, we’ve been on a growth journey at Worldwide driven by a deliberate strategy centered on deep scientific expertise and aligned with industry trends and customer needs – one that sets us apart from others in our space,” said Peter Benton, President and CEO of Worldwide. “Our team members and their trusted customer relationships are the driving force behind our success, and I thank our partners at TJC for their many years of support helping us build to where we are today. We are thrilled to team up with Kohlberg, who brings us considerable depth of experience across the full continuum of outsourced pharma services, and I look forward to the next phase of our growth journey and continuing to help our customers bring new life-changing medications and treatments to patients around the world.”

Upon close of the transaction, Matt Jennings, Operating Partner of Kohlberg, will become Chairman of Worldwide’s Board of Directors.

“Worldwide Clinical Trials is positioned for long-term growth and success due to a rigorous high science-based approach to executing successful clinical trials, driven by the strength of their people across key therapeutic areas such as oncology, neuroscience, and rare disease,” said Jennings. “Peter and the Worldwide team have an exceptional track record, and we look forward to partnering with them to add value and further accelerate their growth.”

“The scientific heritage runs deep at Worldwide – it’s a true competitive advantage and a key component of the breadth of services the CRO offers to its customers through its accessible team of clinicians, scientists, and researchers,” said Chris Anderson, Partner at Kohlberg. “Worldwide’s business aligns with the themes we have successfully invested behind in our Pharmaceutical & Medical Products & Services industry practice, and we look forward to supporting Peter and the Worldwide team with our capital base and resources to help achieve their growth goals.”

“There has been one constant since our initial investment in the Worldwide team – that the market needed a CRO who was a true drug development partner driven by medicine and science, and manifested in deep therapeutic expertise,” said Dave Butler, Partner at TJC. “That culture has attracted the best talent in the industry, which is why we believe Worldwide wins, and will continue to win. We are proud to have been partnered with such an exceptional team and excited to support the Company’s next chapter of success through our continued investment.”

Jefferies LLC served as financial advisor to Worldwide and Kirkland & Ellis acted as legal counsel to TJC and Worldwide in connection with the transaction. Centerview Partners LLC served as financial advisor and Paul, Weiss, Rifkind, Wharton & Garrison LLP acted as legal counsel to Kohlberg.

About Worldwide Clinical Trials

Worldwide Clinical Trials (Worldwide) is a leading full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Worldwide’s capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by an accessible team of clinicians, scientists, and researchers who bring first-hand expertise and a collaborative, personalized approach to each clinical program. Worldwide is therapeutically focused on neuroscience, oncology, rare diseases, and cardiometabolic. Its global footprint spans nearly 60 countries with more than 3,200 team members. For more information, visit www.worldwide.com.

About Kohlberg & Company

Kohlberg is a leading U.S. middle market private equity firm based in Mount Kisco, New York. Over the firm’s 36-year history, the firm has organized 11 private equity vehicles totaling in aggregate over $14 billion. Since inception, the firm’s private equity investments have generated over $10 billion in realized returns with no realized losses since 2007. The firm invests in leading middle market businesses that are identified through its rigorous thematic research and the firm’s White Paper Program in its six core practice areas. For more information, please visit www.kohlberg.com.

About TJC, L.P.

TJC, founded in 1982, is a middle-market private equity firm that has raised funds with original capital commitments in excess of $22 billion with a 40-year track record of investing in and contributing to the growth of many businesses across a wide range of industries, including Diversified Industrials; Technology, Telecom & Power; Logistics & Supply Chain and Consumer & Healthcare. The senior investment team has been investing together for over 20 years, and they are supported by the Operations Management Group, which was established in 1988 to initiate and support operational improvements in portfolio companies. TJC has offices in New York, Miami, Chicago, and Stamford. For more information, visit: www.tjclp.com.

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Research Triangle Park, N.C. – 18 May 2023 – In response to the growing and ever-changing clinical research landscape and the need to bring innovative treatments to patients faster, Worldwide Clinical Trials (Worldwide), a leading global, full-service contract research organization (CRO), has expanded its Site Alliance Collaboration with new partners across the United States and Europe. Additions include new relationships with NEXT Oncology in Spain and the pan-European Pratia Research Platform, along with its oncology research units – supported by a dedicated Global Site Alliances role, established at Worldwide last year.

“Pratia is excited to collaborate more strategically with Worldwide Clinical Trials to reduce the time to market for sponsors and, more importantly, for patients,” said Jack Evans, Executive Director, Portfolio Management, Pratia SA. “Through earlier engagement, closer collaboration, and alignment, we can collectively improve patient access to clinical trials and, critically, access to new therapies.”

Early engagement with experienced sites is vital to the success of a clinical trial, especially in oncology trials. Worldwide’s Site Alliance model includes various research sites, from major academic centers to regional private hospitals and community-based sites. Worldwide’s close relationship with the Alliance sites provides the opportunity to interact with sponsors as early as possible in the protocol development process, with a focus on communication and feedback about patient needs. This early engagement, along with Worldwide’s global relationships and extensive knowledge of oncology sites, results in many customer benefits, such as visibility of both trials in progress and upcoming trials for seamless resourcing and planning; and protocol feedback from principal investigators. This model also provides increased awareness for products in competitive markets, expedited feasibility process for quicker selection, and the opportunity to leverage existing relationships with other Worldwide Alliance sites.

Existing Site Alliance relationships for Worldwide include The Christ Hospital™ Health Network and NEXT Oncology (U.S.), among others. “Our goal has always been to grow the NEXT Oncology infrastructure to create access to potentially lifesaving therapies for our cancer patients and those around the globe,” said Dr. Anthony Tolcher, MD, founder of NEXT Oncology. “Not only does this alliance bring new therapies to more patients but also the ability to deliver data to sponsors more quickly with less errors, which helps improve quality of life for those on trials.”

In addition to the new relationships mentioned above, Worldwide has increased its relationships in the United States with the addition of the MultiCare Institute for Research & Innovation, Alliance for Multispecialty Research (AMR), and HonorHealth Research Institute.

“Through our affiliation with Worldwide and its Site Alliance Collaboration, HonorHealth Research Institute is aligned with some of the world’s leading biomedical research institutes,” said Mark A. Slater, Ph.D., CEO, HonorHealth Research Institute. “This global partnership will bring hope and answers to an ever-greater population and provide medical benefit to patients who need our help today, especially those right here in Arizona.”

“As a community-based health system, our patient population has benefited from several oncology and pediatric neurology trials through our relationship with Worldwide,” said Annie Reedy, Chief Research and Education Officer at MultiCare. “We are excited to grow those opportunities through this partnership.”

“Over the past three years, the clinical trials industry has seen unprecedented change and demand, with upward trends for the number of new trials, but limited site capacity often causes delays for complex trials,” said Clare Wallis, President, Oncology Business Unit, Worldwide. “Through our Site Alliance Collaboration, we are able to focus on addressing time-limiting hurdles to reduce the activation period for our sponsors, while sharing the latest feedback from our Alliance sites – with the ultimate goal of ensuring patients have access to advanced clinical trial options.”

For more information on Worldwide’s Site Alliance Collaboration, click here, and to learn more about Worldwide’s dedicated focus on oncology clinical trials, click here

About Worldwide Clinical Trials

Worldwide Clinical Trials (Worldwide) is a leading full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Our capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by our accessible team of clinicians, scientists, and researchers who bring first-hand expertise and a collaborative, personalized approach to each clinical program.

Anchored in our company’s scientific heritage, we are therapeutically focused on cardiovascular, metabolic, neuroscience, oncology, and rare diseases. Our deep therapeutic knowledge enables us to develop flexible plans and quickly solve problems for our customers.

Our team of 3,000+ professionals spans 60+ countries, and believes that through a culture that embraces diversity, equity, inclusion, and belonging (DEI&B), everyone plays a vital role in making a world of difference for patients and their caregivers. We are united in cause with our customers to improve the lives of patients through new, innovative therapies.

About the HonorHealth Research Institute

HonorHealth Research Institute is an international destination that is at the forefront of providing patients with a better quality of life through its clinical trials and innovative treatment options. Headquartered in Scottsdale, Arizona, the institute’s team of physicians and researchers collaborate with experts from across the nation to offer life-changing therapies, drugs and devices. At the HonorHealth Research Institute, patients have access to tomorrow’s interventions today.

About NEXT Oncology

NEXT Oncology is dedicated to the development of new anticancer agents for patients whose current cancer therapy is no longer working to benefit them and are looking for their next option. NEXT is partnered with Texas Oncology, the largest private oncology practice in the United States with more than 400 referring oncologists, and US Oncology, a network of independent, community-based oncologists in the U.S. This formidable size and reach provide NEXT unprecedented opportunities to transform what has come to be expected from clinical trials of new agents.

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Research Triangle Park, N.C. – 11 May 2023 – Worldwide Clinical Trials (Worldwide), the industry’s leading global, full-service contract research organization (CRO), has partnered with Every Cure, a nonprofit organization that unlocks new, often undiscovered uses for existing approved drugs by leveraging data, artificial intelligence (AI), and efficient clinical trials.

Through this new partnership, Worldwide will serve as Every Cure’s clinical trial and drug development partner. The CRO will use its clinical development and rare disease expertise to assist in identifying links between rare diseases and generic drugs on the market – all facilitated through the nonprofit’s comprehensive, open-source database of drug-repurposing opportunities. Once links and drug targets are identified and validated, Worldwide will run clinical trials for Every Cure with expedited timelines and a goal to unlock the full potential of existing medications to treat every disease possible and help rare disease patients around the world.

Every Cure is on a mission to alleviate suffering for the 300 million people globally who are battling diseases with no approved treatments. The nonprofit launched in 2022 in partnership with the Clinton Global Initiative to scale up an innovative “drug-repurposing” approach to identify treatments for rare diseases – generally considered to be a disease that affects fewer than 200,000 people in the United States or 5 in 10,000 people in the European Union at any given time, with small and geographically widespread patient populations. Affecting these patient populations are the more than 9,000 diseases that have no approved treatment, which drives Every Cure’s goal to discover the full potential of the estimated 3,000 drugs currently on the market.

“Our new partnership with Every Cure is anchored in our collective passion for accelerating rare disease research to help as many patients as possible, as quickly as possible,” said Dave Bowser, Executive Vice President and Chief Operating Officer at Worldwide. “Every Cure’s method of mining medical records and real-world data to discover new uses for drugs that are already approved and available is commendable, and the Worldwide team is committed to helping scale these approaches to all drugs and all diseases.”

“We are so excited to be partnering with a like-minded patient-driven company such as Worldwide Clinical Trials,” said David Fajgenbaum, Every Cure co-founder and Director of the Center for Cytokine Storm Treatment & Laboratory, University of Pennsylvania. “The combination of Every Cure’s computational AI algorithm with Worldwide’s clinical trial expertise will have a substantial impact on finding and advancing cures for years to come.”

“Despite tremendous advancements in health care and clinical research, only five percent of rare diseases have an FDA-approved medication,” said Derek Ansel, Executive Director, Therapeutic Strategy Lead, Rare Disease, at Worldwide. “Every Cure’s model is truly transformative and based on the concept that every drug on the market has multiple effects on the body – and cures can be found in unexpected places. David and his team have been an inspiration to so many who live with rare diseases, and we are excited to kick off this partnership to help more patients around the world.”

Every Cure was co-founded by Dr. David Fajgenbaum, Dr. Grant Mitchell, and Tracey Sikora in 2022. During Dr. Fajgenbaum’s third year of medical school, he became critically ill with Castleman disease (CD) and was hospitalized in critical condition for months. This experience launched his mission to find treatments to save his own life and others. Dr. Fajgenbaum’s team discovered an overactive pathway in his immune system and began testing a 25-year-old drug, which had never been used for CD, to block it. He has now been in remission for more than nine years.

To learn more about Dr. Fajgenbaum’s journey and Every Cure’s mission, visit www.everycure.org.

To learn more about Worldwide’s commitment to excellence in rare disease clinical trial design, visit https://www.worldwide.com/expertise/rare-disease.

About Worldwide Clinical Trials

Worldwide Clinical Trials (Worldwide) is a leading full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Our capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by our accessible team of clinicians, scientists, and researchers who bring first-hand expertise and a collaborative, personalized approach to each clinical program.

Anchored in our company’s scientific heritage, we are therapeutically focused on cardiovascular, metabolic, neuroscience, oncology, and rare diseases. Our deep therapeutic knowledge enables us to develop flexible plans and quickly solve problems for our customers.

Our team of 3,000+ professionals spans 60+ countries, and believes that through a culture that embraces diversity, equity, inclusion, and belonging (DEI&B), everyone plays a vital role in making a world of difference for patients and their caregivers. We are united in cause with our customers to improve the lives of patients through new, innovative therapies.

For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

About Every Cure

Every Cure is a nonprofit organization dedicated to unlocking the full potential of every existing medicine to treat every disease possible. Repurposing existing drugs is the fastest and most efficient way to treat diseases with the greatest return on investment for saving lives. However, systemic barriers impede repurposing, so patients suffer while potential treatments are not fully utilized. Every Cure overcomes these barriers to systematically identify and advance promising repurposing opportunities and save lives. Every Cure is taking a revolutionary and disruptive approach to overcome these systemic barriers by developing a comprehensive, open-source data engine to generate predictive efficacy scores for all 3,000 drugs against all 12,000 diseases and rapidly advance treatments to patients. In partnership with academia, industry, and government, Every Cure is integrating proprietary and public data into a comprehensive dataset, optimizing AI ranking algorithms, validating the most promising drug-disease matches, performing trials, and ensuring patient access to effective therapies.

For more information, please visit EveryCure.org or connect with us on Twitter, LinkedIn, Facebook, and Instagram.

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