Catawba Research Appoints Julie Arnold as New Head of Project Management to Drive Growth and Innovation

CHARLOTTE, N.C.; March 7, 2024 (Business Wire)Catawba Research, a prominent global clinical research organization (CRO), today introduced Julie Arnold as its vice president of project management. The continued addition of top-tier talent to the leadership team exemplifies Catawba Research’s unwavering commitment to partnering in the advancement of groundbreaking new drugs, devices and diagnostics. 

With a 20-year career, distinguished by leadership across multiple therapeutic areas, Julie is a pivotal addition to Catawba Research’s growing operational team. Previously the Senior Vice President of Project Management at Elligo Health Research® and holding key roles at Syneos Health, Julie’s experience strategically positions her to optimize Catawba Research’s clinical and project management teams and processes — ensuring a seamless continuation of quality-driven, on-time project delivery. 

“I couldn’t be more excited about the addition of Julie to our leadership team. Her outstanding track record of project leadership and her strategic prowess align seamlessly with our vision for the future. By bringing in talented leaders like Julie, Catawba Research is poised for continued growth, consistently exceeding our customers’ expectations,” said Andy Silverman, Ph.D., CEO at Catawba Research. 

In her role, Julie will be dedicated to ensuring operational efficiency and supporting the continued and successful project outcomes that have been at the core of Catawba Research’s industry reputation for the past decade. Her expertise and oversight are set to play a pivotal role in the company’s mission to bring groundbreaking therapies to underserved populations through continuous innovation and collaborative partnerships with sponsors, vendors and sites. 

About Catawba Research 
Catawba Research is a leading contract research organization specializing in clinical research and development services for the pharmaceutical, biotechnology, and medical device industries. With a strong commitment to quality, innovation, and client satisfaction, Catawba Research delivers comprehensive solutions to advance healthcare products from concept to market. For more information, please visit www.catawbaresearch.com

CHARLOTTLE, N.C.; Feb. 29, 2024 (Business Wire)Catawba Research, a prominent global clinical research organization (CRO), welcomes Syed Faridi as its Vice President of Global Business Development. This strategic expansion of Catawba Research’s leadership team underscores its commitment to remain well-positioned in the dynamic clinical trials market to exceed expectations, drive innovation, and deliver even greater value to its clients and stakeholders.  

Syed, an industry veteran with nearly two decades of experience in clinical research, brings an unparalleled level of expertise as a sales leader. His track record of consistently surpassing targets and fostering deeply collaborative client relationships speaks volumes. Having made significant contributions at Clinical Ink, Medidata Solutions, and Parexel, Syed's arrival is a game-changer for Catawba Research, elevating its ability to drive business and accelerate revenue growth. 

"I am thrilled about Syed joining our leadership team. His ability to be a true partner to his customers is key to our organization’s values, and his business development expertise is an asset in further establishing Catawba Research as a market leader. The consistent recruitment of top-tier leaders like Syed ensures that we not only maintain, but elevate our trajectory of unparalleled growth," said Andy Silverman, Chief Executive Officer (CEO) at Catawba Research. 

In his role, Syed will spearhead the cultivation and expansion of strategic client relationships, champion transformative sales and marketing practices, and develop and execute go-to-market strategies that demonstrate how Catawba Research’s experience and expertise align with the industry’s needs. His arrival further highlights Catawba Research's dedication to strong and innovative industry collaborations to help patients in need. 

About Catawba Research 
Catawba Research is a leading contract research organization specializing in clinical research and development services for the pharmaceutical, biotechnology, and medical device industries. With a strong commitment to quality, innovation, and client satisfaction, Catawba Research delivers comprehensive solutions to advance healthcare products from concept to market. For more information, please visit www.catawbaresearch.com

CHARLOTTE, N.C.; Feb. 6, 2024 Catawba Research, a leading global clinical research organization (CRO) that has established itself as a trusted partner in the development of new drugs, devices, and diagnostics with a strong focus on delivering high-quality tech-enabled research solutions, announced a new collaboration with Bingli Inc., which provides AI- guided diagnosis, disease management, and navigation for patients and healthcare providers. All Catawba’s clinical studies may now offer candidates pre-screening via Bingli’s smart clinical trial technology that includes rigorous disease scoring system outcomes and delivers a highly enriched candidate pool for real-time recruitment management. 

“At Catawba Research, we are creating value in clinical research by identifying and incorporating the best technology solutions to speed recruitment, the biggest challenge currently facing our industry,” said Catawba Chief Executive Officer Andrew Silverman, Ph.D. “Partnering with Bingli gives us a powerful tool to streamline participation, reduce site burden, and save time for potential participants as they explore their clinical trial options.” 

Applying Bingli’s technology platform will allow Catawba to reduce trial costs, eliminating a higher proportion of ineligible subjects compared to traditional pre-screening methods. The AI solution sends approximately 3% of candidates to sites, reducing failed screens by up to 75%. With a Bingli referral, a candidate is three to four times as likely to be eligible. Bingli delivers extraordinary value to sponsors and CROs by reducing site burden and delivering candidates highly likely to convert to enrolled subjects. 

“Bingli’s candidate pre-screening application was added to our overall healthcare AI, self-learning platform to quickly provide real-time, deep understanding of pre-screening eligibility results,” said Bingli U.S. Chief Medical Officer Cees Wortel, M.D., Ph.D. “Our solution uses a unique, smart white box AI technology that incorporates sophisticated disease ratings aided by examples, such as diagnostic example images and eligibility assessments. At Bingli we care about clinical trial participation as a cornerstone of healthcare and health provision and our solution delivers shorter timelines and lower site workload all while increasing the success potential of each participant asynchronously.” 

About Catawba Research 
Catawba Research is a leading contract research organization specializing in clinical research and development services for the pharmaceutical, biotechnology, and medical device industries. With a strong commitment to quality, innovation, and client satisfaction, Catawba Research delivers comprehensive solutions to advance healthcare products from concept to market. For more information, please visit www.catawbaresearch.com

About Bingli Inc. 
Bingli delivers person centered, digital health solutions through dynamic, intelligent medical history and patient assessments. Bingli’s AI-powered medical practice and clinical research optimization platform is built around self-learning diagnostic reasoning and virtual patient engagement solutions for both patients and healthcare professionals. For more information, please visit www.bingli.us

CHARLOTTE, N.C.; Dec. 6, 2023 Catawba Research, a leading global clinical research organization (CRO) that has established itself as a trusted partner in the development of new drugs and therapies, with a strong focus on delivering high-quality research solutions, announced a new partnership with Elligo Health Research, the largest healthcare-enabling research organization, that will expand access to clinical trials. All Catawba’s clinical studies will now be available through Elligo’s new Study Marketplace platform to drive participation and increase efficiencies for research sites and sponsors. 

“At Catawba Research, we are focused on driving innovation in clinical research and delivering agile solutions across an evolving portfolio of therapeutic areas,” said Catawba CEO Andrew Silverman, Ph.D. “This fits our mission and partnering with Elligo helps create greater access to research as studies are being delivered to hundreds of experienced research and healthcare-first sites.”  

Through Study Marketplace, Catawba’s studies are listed to more than 500 subscribing sites that can easily apply for those studies and track progress. Sites can quickly browse a curated portfolio of available studies that are the right fit for their site, apply for those of interest, track progress, and collaborate among team members. Ultimately, sites are receiving more effective site selection and patient recruitment, leading to accelerated timelines for trials. 

“Study Marketplace was built to create more transparency and streamline the sales and site selection process between clinical trial sponsors, clinical research organizations (CROs), and sites,” said Elligo CEO  John Potthoff, Ph.D. “At Elligo, we understand how challenging it is for sites to identify new study opportunities and manage the sales cycle. Moving Catawba trials from a manual process to Study Marketplace will allow sites to avoid jumping between countless systems and communication methods to manage trials, which means more time can be spent on trial execution and patient care.” 

About Catawba Research 
Catawba Research is a leading contract research organization specializing in clinical research and development services for the pharmaceutical, biotechnology and medical device industries. With a strong commitment to quality, innovation and client satisfaction, Catawba Research delivers comprehensive solutions to advance health care products from concept to market. For more information, please visit www.catawbaresearch.com

Catawba Research President and CEO Zaidoon A. Al-Zubaidy recently announced that the global CRO will relocate its home office operations to a larger space in the Charlotte, N.C. area. The news comes as the organization continues to grow in size, taking on Sponsors from around the world. Watch the press video now to learn more!

DUBLIN--(BUSINESS WIRE)--ICON plc, (NASDAQ: ICLR), a global provider of outsourced drug and device development and commercialisation services to the pharmaceutical, biotechnology and medical device industries, and government and public health organisations, today announced it has entered into a definitive agreement to acquire PRA Health Sciences, Inc. (NASDAQ: PRAH) in a cash and stock transaction valued at approximately $12 billion, with the per share merger consideration consisting of $80 in cash and 0.4125 shares of ICON stock. The consideration represents an approximately 30% premium to PRA’s closing price as of February 23rd, 2021.

The transaction brings together two high-quality, innovative and growing organisations with similar cultures and a shared focus on high quality and efficient clinical trial execution from Phase 1 to post-approval studies.


Read the full article at: https://www.businesswire.com/news/home/20210224005484/en/ICON-to-Acquire-PRA-Health-Sciences-Creating-a-World-Leader-in-Healthcare-Intelligence-and-Clinical-Research#.YDZJEgExMLE.linkedin


This acquisition is an integral part of Altasciences’ strategic growth plan to provide a comprehensive, fully integrated early phase drug development solution to address the ever-changing outsourcing challenges of biopharmaceutical companies across the globe. We look forward to working side by side with our new team of clinical experts in California, a team that shares our values for excellence, quality, and customer focus,” explained Chris Perkin, CEO at Altasciences.

WCCT Global was founded in 1998 and has conducted over 600 Phase I studies – an area it specializes in – out of over 1,000 Phase I-IV studies the company has conducted to date.


Read the full article at: https://www.businesswire.com/news/home/20210219005254/en/Altasciences-Acquires-WCCT-Global


Catawba Research is proud to have served as the CRO for Vyome Therapeutics on their successful Phase 2 Trial of VB-1953 for Moderate to Severe Acne. Needless to say, Catawba Research is excited for our client and honored to be by their side.

Vyome Therapeutics is a clinical-stage company developing locally-acting, next generation therapeutics for immuno-inflammatory diseases. The group recently announced positive data from its Phase 2 trial of VB-1953, a first-in-class topical bactericidal and TLR-MD2 inhibitor being developed for the treatment of moderate to severe inflammatory facial acne vulgaris.

Catawba Research CEO, Zaidoon Al-Zubaidy, shared his excitement in seeing Vyome meet this amazing milestone.  “When our Sponsors succeed, we do, too.  I couldn’t be prouder of our team behind the trial and of our relationship with Vyome Therapeutics.  We look forward to working with them in the future and continue to support them in moving this valuable product to market.”

Results from the trial demonstrated a statistically significant difference in the primary endpoint, the mean absolute change in inflammatory lesions at week 12, for VB 1953 when applied once a day (QD) vs. combined vehicle group (p <0.012). In the comparison between the VB-1953 QD arm versus vehicle QD, the mean absolute change in the inflammatory lesions at week 12 in the intent to treat (ITT) group showed 20.4 and 17.8 respectively, with p<0.003, and 20.4 and 16.6 respectively in per protocol group with p<0.001. In addition, VB-1953 exhibited an excellent safety profile and there were no drug related adverse or serious adverse events.

“These results demonstrate that VB-1953, with its dual mechanism of action directly killing resistant and non-resistant C. acnes strains while blocking inflammation through TLR-MD2 inhibition, has the potential to become a safe and effective topical treatment for facial acne and an alternative to oral, systemic drugs,” Dr. Shiladitya Sengupta, Scientific Co-Founder of Vyome, said in a press release issued by the company.

The Phase 2 randomized, multicenter, double-blind, dose-ranging study was designed to evaluate the safety and efficacy of VB-1953 topical gel when applied once daily and twice daily for 12 weeks in subjects with moderate to severe inflammatory facial acne vulgaris. Vyome enrolled 471 patients across 13 trial sites in the U.S.  Once daily application was found to be as effective as twice daily application in the mean absolute change in the inflammatory lesions.

In the press release, Venkat Nelabhotla, Chief Executive Officer of Vyome Therapeutics, added, “We are very pleased to have met the primary endpoint of the study, and to demonstrate the continued safety of the molecule. Patients need a highly effective drug, and our data shows a very high response, which is encouraging as we plan to advance to Phase 3 with a once daily dose. We look forward to delivering a next-generation solution to patients.”

Although the study was not powered to test for significance in secondary end points, the drug (VB-1953 QD group) achieved a 66.6% mean reduction in inflammatory lesions at week 12 with p<0.020 in ITT and p<0.004 per protocol group versus vehicle group, and a 49.6% successful improvement in the IGA score (minimum two-grade improvement and achieving clear or almost clear IGA score at week 12) with p<0.361 in ITT group and p<0.069 per protocol group versus vehicle group.  

About VB-1953
Vyome’s lead clinical drug candidate, VB-1953, is a first-in-class, topical, bactericidal small molecule with a novel mechanism of action in acne. VB-1953 reduces inflammatory lesions in C. acnes by blocking inflammatory cytokine production through TLR-MD2 inhibition and has demonstrated the ability to treat antibiotic-resistant C. acnes strains. VB-1953 is the first bactericidal drug candidate to be tested for the treatment of C. acnes. VB-1953 is delivered topically with a microtechnology gel system that ensures the drug is retained at the site of infection and minimizes systemic exposure. Acne caused by antibacterial-resistant C.acnes currently poses an emerging and unmet need for patients worldwide, with a potential $2B market opportunity in the US alone.

About Vyome Therapeutics
Vyome Therapeutics is a Princeton, New Jersey based clinical stage specialty pharmaceutical company working to treat inflammatory diseases of unmet need with locally acting, next-generation therapeutic solutions. Vyome’s portfolio of therapeutic assets are identified and developed to address validated targets with novel drugs for site-targeted applications. Vyome has assembled a world-class team of experts.

Catawba Research is heading to Washington, D.C. March 1–3 to attend the American Academy of Dermatology (AAD) 2019 Annual Meeting. During our visit, we will be huddling up with site networks, sponsors, and others to discuss their CRO needs in the year ahead and beyond. With more than 26 studies completed in the last five years, our Catawba Research team of experts is excited to guide other pharmaceutical companies to a successful FDA Approval. If you plan to be at AAD, let us know so we can explore solutions to bring your product to market!

To arrange an opportunity to share your needs with Catawba Research, contact Shannon Weatherly, Director of Operations at 980-242-3980 or via email at Shannon@CatawbaResearch.com.

Here is a sample of our latest training video on plaque psoriasis with Dr. Zoe Draelos, a leader in clinical and research dermatology.

To learn more about our training program or see some our videos, contact us!

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