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OncoBay Clinical Taps Montrium’s Quality Connect to Power Growing Quality & Regulatory Teams

OncoBay Clinical Selects Quality Connect to Simplify Compliance

Montreal, CA and Tampa, FL, USA – May X, 2021
Montrium, a leader in cloud-based software solutions for life sciences, today announced that OncoBay Clinical, Inc., a full-service boutique contract research organization (CRO) specializing in the simplification of complex oncology programs, has adopted Quality Connect to centralize the Quality operations of their fast-growing organization.
With a rapidly growing Quality and Regulatory team, OncoBay Clinical launched a technology evaluation and selection initiative with the goal of simplifying quality operations and training compliance. The company now benefits from a robust and powerful electronic Quality Management System in Quality Connect, allowing them to simply tackle their quality challenges head-on while driving compliance.
“OncoBay selected Montrium as our QA technology partner of choice,” said Krystyna Kowalczyk, President and Chief Executive Officer of OncoBay Clinical. “Quality Connect further enhances the OncoBay foundation of integrating all systems and driving centralized quality assessments through all aspects of the organization. With Quality Connect, we integrate quality management, training, and process assessment into our centralized information-driven operational hub.”
“Quality Connect plays a vital role in minimizing risk while providing real-time, proactive insights into OncoBay operations,” said Lisa Zimmerman, Vice President of OncoBay Regulatory and Quality Assurance. “Unlike many of the platforms we evaluated, Montrium Quality Connect represents a turn-key solution with the features we were looking for yet offered at a competitive price point.”
“We are thrilled to be working with OncoBay Clinical and helping them to automate the lifecycle of their controlled documents, ultimately allowing them to spend more time providing the highest quality CRO services to their sponsor partners. This partnership represents the enormous transformative power that cloud-based solutions have to streamline Quality operations for fast-growing, agile teams,” said Oliver Pearce, Director of Commercialization at Montrium.

Additional Information
• For more information, please visit: www.montrium.com and https://www.oncobay.com/ .com
• To learn more about how Quality Connect can improve your clinical trial operations, please visit https://www.montrium.com/quality-management/
• Connect with Montrium and OncoBay Clinical on LinkedIn.
About Montrium
Founded in 2005, Montrium is one of the leading providers of cloud-based collaborative content management software to the life sciences industry. With experience in serving over 200 life science customers in 20+ countries, Montrium is committed to delivering an unparalleled customer experience to emerging growth organizations as a true technology partner. Montrium has offices in Montreal, Canada, and Brussels, Belgium.
About OncoBay Clinical
OncoBay Clinical is a boutique CRO specializing in immuno-oncology/cell therapy, offering full-service custom curated CRO solutions for global pharmaceutical and biotech companies looking to advance their immuno-oncology product or device. As a wholly owned, for-profit subsidiary of Moffitt Cancer Center, OncoBay embeds scientific expertise, operational excellence, and integrated cell manufacturing capabilities providing true end-to-end control. Built on years of IO and cell therapy expertise, a streamlined technology framework, a highly trained site network, and a dedicated team of experienced professionals, OncoBay is committed to operational excellence from start to finish. For more information, visit Oncobay.com and follow us on Facebook, Twitter, and LinkedIn.
Media Contacts:

OncoBay Clinical
Krystyna Kowalczyk
President and CEO
kkowalczyk@Oncobay.com

Montrium
Shima Healey
Marketing Manager, Montrium
marketing@montrium.com
T: +1 514 .223. 9153 ext. 283 (North America)
T: +32.2.808.30.08 ext. 283 (Europe)

OncoBay Clinical announces Technology Partnership with Protocol First

OncoBay Clinical Announces Technology Partnership with Protocol First

OncoBay Adopts Protocol First Technology Solutions to Further Simplify the Complex

Tampa, Florida and Salt Lake City, Utah – May 10, 2021

OncoBay Clinical Inc., a full-service boutique contract research organization (CRO) specializing in the simplification of complex oncology programs, today announced a strategic partnership with Protocol First, Inc., a software solutions provider focused on accelerating clinical research. The partnership combines OncoBay’s industry leading oncology operations with Protocol First’s world class proprietary Clinical Pipe software to integrate data from leading EHR systems into electronic data capture (EDC). The adoption of Clinical Pipe allows OncoBay to further simplify complex oncology trials by improving data quality, reducing data entry timelines, reducing queries as well as the need for on-site monitoring visits to verify source data.
“From OncoBay’s inception, we have embraced a virtual vision to simplify Oncology clinical operations. At every step of the clinical trial process, we have reconsidered traditional paradigms including direct EMR to EDC integration afforded by Protocol First’s Clinical Pipe,” said Krystyna Kowalczyk, President and CEO of OncoBay Clinical. “Though OncoBay offers sponsors multiple EDC platforms, we have also invested in the development of Protocol First’s P1 EDC libraries of CRFs, with predefined and sophisticated edit checks, as well as CRFs pre-mapped to Clinical Pipe. As such, OncoBay offers unprecedented go-live timelines and the ability to source upload and remote monitor within a few short weeks.”
“Protocol First is clearly aligned with OncoBay’s vision to transform clinical research through technology,” said Hugh P. Levaux, Ph.D., Founder and CEO of Protocol First. “Our mission is to leverage novel technologies to create breakthrough efficiencies in support of precision medicine and decentralized clinical trials. Our partnership with OncoBay further validates the contribution of our forward thinking and innovative solutions towards streamlining complex clinical trials.”
The partnership supports the interest of both sponsors as well as sites. Together, OncoBay and Protocol first will efficiently operationalize oncology clinical trials, ensuring fast, high quality/clean data, allowing site staff more time to take care of patients with less time spent on administrative tasks associated with data entry.
About OncoBay Clinical
OncoBay Clinical is a boutique contract research organization (CRO) specializing in immuno-oncology/cell therapy, offering full- service custom-curated CRO solutions for global pharmaceutical and biotech companies looking to advance their immuno-oncology product or device. As a wholly owned, for-profit subsidiary of Moffitt Cancer Center, OncoBay embeds scientific expertise, operational excellence and integrated cell manufacturing capabilities providing true end-to-end control. Built on years of IO and cell therapy expertise, a streamlined technology framework, a highly trained site network, and a dedicated team of experienced professionals, OncoBay is committed to operational excellence from start to finish. For more information, visit Oncobay.com and follow us on Facebook, Twitter, and LinkedIn.
About Protocol First
Protocol First, Inc., founded in 2015 and headquartered in Salt Lake City, UT, develops next-generation technology solutions for complex clinical trials in the Life Sciences industry. In addition to its flagship Protocol First suite of cloud-based solutions (eProtocol, Source Upload and EDC), Protocol First has launched Clinical Pipe, the industry’s first connector app that offers system-agnostic EHR-to-EDC interoperability. The application supports major EHR and EDC systems including Epic, Cerner, Allscripts and Athena, as well as Medidata Rave, Oracle InForm, and its own P1 platform. For additional information visit www.protocolfirst.com.
Media Contact
OncoBay Clinical
Krystyna Kowalczyk
President and CEO
kkowalczyk@Oncobay.com

OncoBay Clinical Announces Addition of Anna Averitt as Counsel and Chief Privacy Officer

OncoBay Clinical Continues to Drive a Culture of Compliance

TAMPA, Fla. (March 15, 2021) — OncoBay Clinical, Inc., a full-service boutique contract research organization (CRO) specializing in complex cancer therapies, is pleased to announce the appointment of Anna Averitt as OncoBay Counsel and Chief Privacy officer. In addition to leading the legal organization, in her new role, Anna will be managing legal compliance and will spearhead the implementation of privacy best practices across the organization.
A graduate of Campbell University, School of Law, Anna brings more than 20 years of senior legal experience, having served as Associate Counsel for a global Clinical Research Organization, as well as having supported a number of law firms in the private sector. In addition, she is a Certified Information Privacy Professional/US by the International Association of Privacy Professionals.
“Anna’s proven success providing counsel to diverse organizations, makes her a great addition to the OncoBay senior leadership team,” said Krystyna Kowalczyk, President and CEO of OncoBay”. “Her extensive legal and business operations experience, coupled with her exemplary negotiation skills, will be instrumental to the success of our Biotech Sponsors and to OncoBay directly, as we further our growth and expansion.” “Additionally, Anna’s role as OncoBay’s Chief Privacy Officer reflects OncoBay’s continued commitment to compliance and to the privacy function as a whole”.
“I am delighted to join the OncoBay team at this exciting phase of the company’s growth,” said Anna. “As the ecosystem evolves, OncoBay will remain at the forefront of legal, safety and data compliance”.
To learn more about OncoBay Clinical, please visit www.OncoBay.com.

About OncoBay Clinical
OncoBay Clinical is a boutique contract research organization (CRO) specializing in immuno-oncology/cell therapy, offering full- service custom-curated CRO solutions for global pharmaceutical and biotech companies looking to advance their immuno-oncology product or device. As a wholly owned, for-profit subsidiary of Moffitt Cancer Center, OncoBay embeds scientific expertise, operational excellence and integrated cell manufacturing capabilities providing true end-to-end control. Built on years of IO and cell therapy expertise, a streamlined technology framework, a highly trained site network, and a dedicated team of experienced professionals, OncoBay is committed to operational excellence from start to finish. For more information, visit OncoBay.com and follow us on Facebook, Twitter and LinkedIn.

About Moffitt Cancer Center
Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 51 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s scientific excellence, multidisciplinary research, and robust training and education. Moffitt is a Top 10 cancer hospital and has been nationally ranked by U.S. News & World Report since 1999. Moffitt’s expert nursing staff is recognized by the American Nurses Credentialing Center with Magnet® status, its highest distinction. With more than 6,500 team members, Moffitt has an economic impact in the state of $2.4 billion. For more information, call 1-888-MOFFITT (1-888-663-3488), visit MOFFITT.org, and follow the momentum on Facebook, Twitter, Instagram and YouTube.

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MEDIA CONTACT:
Richard Busby
OncoBay Clinical, Vice-President Business Development
Phone: 919.604.2329
RBusby@oncobay.com

AiCure and OncoBay Clinical Partner to Improve Oncology Clinical Trials and Patient Care

Expanded access to AI for oncology sponsors will empower actionable insights to optimize drug development and help improve patients’ quality of life

New York, N.Y. – February 24, 2021
AiCure, an AI and data analytics company focused on improving clinical trials, and OncoBay Clinical, a full-service boutique contract research organization (CRO) specializing in the simplification of complex oncology programs, today announced a strategic partnership to provide oncology sponsors with scalable, AI-powered insights to improve patient care and optimize drug development. A subsidiary of the Moffitt Cancer Center, OncoBay will make AiCure’s proprietary AI platform available for oncology trials, providing sponsors and sites with a more holistic understanding of patient health and site optimization.
“Cancer treatment – particularly during clinical trials – is a complex experience for patients both physically and emotionally. By partnering with OncoBay, we hope increased access to technology will help improve the quality of life for these patients and make their treatment journey as simple as possible,” said Dr. Ed Ikeguchi, CEO of AiCure. “Through their own smartphones, patients are able to get much needed support without leaving their homes. Enhancing the quality of trial data collected in between clinic visits will also help sites with decision-making to create meaningful, data-driven trials.”
The oncology drug pipeline has grown by 63% since 2013, but the average success rate of oncology drugs is only 3.4%. To address this discrepancy and the unique challenges of oncology trials, particularly given the complex treatment regimens, AiCure and OncoBay aim to improve patient support and trial retention, while also providing sponsors and sites with greater visibility into patient behavior. Through AiCure’s patient engagement solution, Patient Connect, oncology sites can remotely monitor patients and use real-time communication tools to guide them through complex treatment protocols, including which medication to take and when, as well as allow direct access to a clinician. Verified patient compliance information makes pharmacokinetic data instantly more robust, and these actionable insights into trial and site performance empower sponsors to make proactive, data-driven decisions, ultimately accelerating trial timelines and lowering costs of high-quality drugs.
“With oncology clinical trials growing in complexity, we need to arm our sponsors with the tools to drive informed decisions that will improve study outcomes,” said Krystyna Kowalczyk, President and CEO of Oncobay Clinical. “By partnering with AiCure and leveraging their unique AI-powered insights, our sponsors will gain a deeper understanding of patient behavior through high-quality data capture and develop comprehensive views of the impact of study drug administration and compliance on other data points. We’re excited to further our overall mission of collaborating with innovative, forward-thinking companies to make a difference for our customers and their patients.”

About AiCure
AiCure is an AI and advanced data analytics company that monitors patient behavior and enables remote patient engagement in clinical trials. AiCure improves predictability of study timelines, reduces costs and accelerates timelines through remote patient engagement and assessments, including measuring digital biomarkers and real-time monitoring of patient dosing. Founded in 2010 and funded by the National Institutes of Health (NIH) and leading institutional investors, AiCure has more than 65 issued patents and works with global clients in over 30 countries. AiCure is globally recognized and is a recipient of the Scrip Award, AI 100 and Digital Health 150. For more information, please visit www.aicure.com.

About OncoBay Clinical
OncoBay Clinical is a boutique contract research organization (CRO) specializing in immuno-oncology/cell therapy, offering full- service custom-curated CRO solutions for global pharmaceutical and biotech companies looking to advance their immuno-oncology product or device. As a wholly owned, for-profit subsidiary of Moffitt Cancer Center, OncoBay embeds scientific expertise, operational excellence and integrated cell manufacturing capabilities providing true end-to-end control. Built on years of IO and cell therapy expertise, a streamlined technology framework, a highly trained site network, and a dedicated team of experienced professionals, OncoBay is committed to operational excellence from start to finish. For more information, visit Oncobay.com and follow us on Facebook, Twitter and LinkedIn.

Media Contact
Siobhan Zablocki
aicure@fleishman.com
617-986-5784

OncoBay Clinical Appoints Lisa Zimmerman as VP of Regulatory and Quality Assurance

TAMPA, Fla. (February 15, 2021) — OncoBay Clinical, Inc., a full-service boutique contract research organization (CRO) specializing in immuno-oncology/cell therapy, today announced the appointment of Lisa Zimmerman to the position of Vice President, Regulatory Affairs and Quality Assurance reporting to Krystyna Kowalczyk, President and Chief Executive Officer.

“I am excited to join an organization such as OncoBay, where my personal and professional vision is aligned. I look forward to working together with this team where there is a clear roadmap to transform IO research through innovation, collaboration and partnership, and most importantly to positively impact cancer patients’ lives ,” said Zimmerman.

Lisa Zimmerman is an accomplished professional with a proven track record of success in Quality Assurance, Regulatory Affairs, Regulatory Compliance, and Clinical Operations in the in the Pharmaceutical, Device and Biotechnology industries. As a 27-year pharmaceutical veteran she brings to OncoBay, broad experience in all phases of drug and device development in multiple therapeutic areas, yet with a specialty in immune mediated diseases and oncology. Lisa has held senior leadership positions in Quality, Regulatory Affairs and Clinical Operations and has consulted with small pharmaceutical and biotechnology companies to assist in their navigation of the constantly evolving regulatory landscape across the globe. Ms. Zimmerman obtained her Bachelor of Science Degree in Biology from the University of North Carolina and attended Central Michigan University while pursuing her Master of Science in Business Administration in Healthcare.

“Lisa is an accomplished professional with a proven track record of success. We feel extremely fortunate to appoint someone of Lisa’s caliber and reputation in the field of oncology drug development,” said Krystyna Kowalczyk, President and CEO of OncoBay, “ As a critical member of our leadership team, Lisa will provide expert regulatory consultation, guidance and oversight to our Sponsors and Network Sites while leading the management and continual improvement of our organization-wide quality management system.”
To learn more about OncoBay Clinical, please visit www.OncoBay.com.

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MEDIA CONTACT:
Deborah Turunjian
OncoBay Clinical, Vice-President Business Operations
970-535-0835
dturunjian@oncobay.com

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Cohortias International and OncoBay Clinical Form Strategic Partnership to Expand Clinical Research in Latin America

Monterrey, Mexico and Tampa, Fla., U.S. January 2021 OncoBay Clinical, Inc., a full-service boutique contract research organization (CRO) specializing in the simplification of complex oncology programs, and Cohortias International, a boutique Latin America CRO with a foundation in scientific leadership, today announced a strategic partnership to further build on their joint mission of eliminating patient barriers to access for the most advanced and potentially lifesaving clinical trials.
Despite a population of over 600 million and over 24,000 hospitals, around 24% of the world’s total, Latin America has been largely underserved with clinical trials, especially when compared to the U.S. and Europe. Considering its size and expansive healthcare infrastructure, as well as the strong bond between patients and physicians, the region provides a very significant opportunity for patient recruitment and retention that has been underexploited to date.
“Our partnership with Cohortias International, further solidifies our commitment to both patients and sponsors by providing access to clinical trials for an underserved population, while also providing high enrolling oncology sites and best-in-class operational expertise,” said Krystyna Kowalczyk, President and CEO of OncoBay Clinical. “We recognize, however, that in order to maximize on the enrollment potential of Latin America, it is crucial to have a local CRO with the expertise to efficiently execute within the region’s regulatory framework, staffed with on the ground teams that speak the language, understand the culture and are familiar with navigating the nuances of the region.
Martijn Wallert, CEO of Cohortias, added, “Clinical research in Latin America has been expanding steadily over the last decade, mainly because of cost effectiveness, excellent patient recruitment and the emergence of FDA approved regulatory agencies, Cohortias has established strong clinical relationships with key opinion leaders and first-class hospitals across the region, and we have an intimate knowledge of the considerable capabilities of our network of Oncology sites throughout Latin America. Our reach extends to both urban and rural regions in Argentina, Brazil, Colombia, and Mexico, providing our sponsors with access to a much greater pool of patients, while offering the hope of life saving treatments to the medically underserved.
Both OncoBay and Cohortias have a shared commitment to support our sponsors, sites and patients with deep operational expertise, fueled by innovation that is grounded in scientific leadership. Our vision and our mission are aligned as we offer hope – one patient at a time.

About OncoBay Clinical
OncoBay Clinical is a boutique contract research organization (CRO) specializing in immuno-oncology/cell therapy, offering full- service custom-curated CRO solutions for global pharmaceutical and biotech companies looking to advance their immuno-oncology product or device. As a wholly owned, for-profit subsidiary of Moffitt Cancer Center, OncoBay embeds scientific expertise, operational excellence and integrated cell manufacturing capabilities providing true end-to-end control. Built on years of IO and cell therapy expertise, a streamlined technology framework, a highly trained site network, and a dedicated team of experienced professionals, OncoBay is committed to operational excellence from start to finish. For more information, visit Oncobay.com and follow us on Facebook, Twitter and LinkedIn.

About Cohortias International

The ‘Cohortias concept’ finds its genesis in the personal experience of one of its co-founding board members. After one of his close relatives had been diagnosed with a then untreatable condition, he pursued alternative options through clinical research and discovered the lack of resources available in Latin America.

This motivated him to start a dialogue between physicians and leaders in clinical research through an International CRO (Julius Clinical). After a long period of exploration and planning between the two, Cohortias was formed with one goal in mind: To provide the Latin American population with the opportunity to participate in potentially lifesaving treatments through clinical research.

Now, almost 4 years after founding, Cohortias’s growth throughout Latin America has been unprecedented; with over 200 active clinical sites and a network of internationally recognized and prestigious Academic Leaders, Doctors and Scientific Counselors. This network and the quality of our work have been the key factors driving our growth. Our business model is based on a foundation of peer-to-peer communication. This has allowed us to adapt to the changing clinical research landscape by taking advantage of the local expertise that our network provides, while speeding up processes through a more seamless and direct line of communications.

As a truly locally based CRO in Latin America with offices in Argentina, Brazil, Colombia and Mexico, we can firmly say that we are the CRO of Latin America. Our commitment is to always pursue the interests of its population, bringing innovative and potentially lifesaving treatments through clinical research. To learn more about the CRO of Latin America, please visit Cohortias.com and follow us on LinkedIn, Facebook and Twitter.

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Media Contacts for Cohortias
Pedro Alvarez
p.alvarez@cohortias.com

Media Contacts for OncoBay Clinical
Deborah Turunjian
dturunjian@oncobay.com

TrialJectory and OncoBay Clinical Partner to Connect All Cancer Patients to Advanced Treatment Options

Partnership’s Mission Aims to Eradicate Socioeconomic, Racial and Geographic Barriers to Effective Cancer Care

New York, N.Y., and Tampa, Fla. – September30,2020– TrialJectory, an AI-powered technology platform that empowers cancer patients to find advanced new treatment options that fit their precise profile, and OncoBay Clinical, Inc., a full-service boutique contract research organization (CRO) specializing in the simplification of complex oncology programs, today announced a new partnership to more effectively connect cancer patients with advanced treatment options through improved access to clinical trials. With this collaboration, OncoBay will leverage TrialJectory’s AI-based advanced treatment matching solution to supercharge its clinical trial recruitment efforts and expedite enrollment of the right cancer patients in the right studies. In addition, TrialJectory’s platform will be employed across OncoBay’s network of community-based sites, significantly increasing patient reach.
“OncoBay’s foundation is built on our vision to transform cancer research through innovation, collaboration and partnership to positively impact cancer patients’ lives,” said Krystyna Kowalczyk, President and CEO of OncoBay. “Our unique partnership with TrialJectory is tapping into the power of AI and technology to do just that. Together, we are eliminating patient barriers to access for the most advanced and potentially lifesaving treatments that are out there today.”
Cancer patients who do not live by major research hospitals in the U.S. are at an extreme disadvantage. Since accessing patients through their physician communities is fundamental, OncoBay has established core site relationships through its specialized oncology networks, including community-based sites, which have been vetted specifically for their ability to activate quickly, identify large numbers of patients and integrate successfully within the OncoBay Clinical technology ecosystem. Working with these sites allows for unparalleled patient access.

TrialJectory uses AI to curate, structure and personalize massive quantities of data produced by cancer research every day and makes the experience of being matched to the right trial fast and patient friendly. Once patients have been matched to an advanced treatment, they are connected with trial specialists who support the patients’ needs from beginning to end as they apply, enroll, and participate in the study.

“Accessing clinical trials should be easy for all patients, no matter where they are located, as they often provide better alternatives compared with the standard of care,” added Tzvia Bader, Co-Founder and CEO of TrialJectory. “On top of fighting for their lives every day, cancer patients are up against countless barriers to entry when it comes to finding advanced treatment options that are a perfect fit for them. To truly enact meaningful change in the cancer space, we must bring technology directly into the hands of cancer patients to help them find the best treatment options. OncoBay and TrialJectory are tackling these issues head-on in hopes of bringing advanced new treatments to the forefront of cancer care. Together, TrialJectory and OncoBay are connecting patients to hope.”

About TrialJectory
TrialJectory is a patient-first digital health company with a mission to democratize access to advanced cancer treatment. TrialJectory uses artificial intelligence (AI) to empower patients to own their cancer journey and analyzes its global patient community’s real-world data to empower cancer patients to make the most informed decisions about their care. For more information, please visit www.trialjectory.com.

About OncoBay Clinical
OncoBay Clinical is a boutique contract research organization (CRO) specializing in immuno-oncology/cell therapy, offering full- service custom-curated CRO solutions for global pharmaceutical and biotech companies looking to advance their immuno-oncology product or device. As a wholly owned, for-profit subsidiary of Moffitt Cancer Center, OncoBay embeds scientific expertise, operational excellence and integrated cell manufacturing capabilities providing true end-to-end control. Built on years of IO and cell therapy expertise, a streamlined technology framework, a highly trained site network, and a dedicated team of experienced professionals, OncoBay is committed to operational excellence from start to finish. For more information, visit Oncobay.com and follow us on Facebook, Twitter and LinkedIn.

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Media Contacts for TrialJectory
Caitlin Kasunich / Shana Marino
KCSA Strategic Communications
ckasunich@kcsa.com / smarino@kcsa.com

Media Contacts for OncoBay Clinical
Deborah Turunjian
dturunjian@oncobay.com

OncoBay Clinical Partners with Vineti to transform access to CTx logistics

OncoBay Clinical and Vineti form strategic alliance to deliver integrated clinical trial solutions and supply chain automation for cell and gene therapies

Integrated Custom-Curated IO Clinical Trial Services and Personalized Therapy Management systems to seamlessly manage advanced therapy clinical journeys for cancer patients

TAMPA, Florida and SAN FRANCISCO, Calif. and – August 25, 2020 – OncoBay Clinical, Inc., a full-service boutique contract research organization (CRO) specializing in complex oncology programs including cellular therapy, and Vineti, a company that offers a digital platform to enable broad access to advanced therapeutics, today announced a fully integrated solution to provide advanced therapy developers with a complete suite of clinical trial systems and services.

Today, many processes and workflows for cell and gene therapy clinical trials are managed using manual processes that can hamper scale, speed, and patient safety. The OncoBay Clinical-Vineti collaboration will provide an innovative alternative truly connecting clinical operations and manufacturing.

Together, OncoBay Clinical and Vineti will implement end-to-end solutions that simplify and accelerate the clinical trial logistics process and oversight for cell therapies, gene therapies, and personalized cancer vaccines. Advanced therapy operations and supply chains are among medicine’s most complex, with operational needs and regulatory requirements that can be demanding for early-phase therapy manufacturers. OncoBay Clinical and Vineti will focus on integrated solutions that support and drive advanced therapy clinical trial operations and enable advanced therapy developers to focus on their science.

OncoBay Clinical, a wholly owned subsidiary of H. Lee Moffitt Cancer Center, leverages scientific expertise and experience when implementing oncology clinical trials, including immuno-oncology research initiatives. OncoBay Clinical’s CRO offerings provide an advanced technology infrastructure, a highly trained clinical site network, and the vast expertise of staff that integrates one of the nation’s leading cancer treatment centers to provide an innovative approach to cell and gene therapy clinical trials, which often focus on cancer. According to the Alliance for Regenerative Medicine, more than half of all advanced therapy clinical trials address oncology.

“As a CRO specializing in complex oncology programs including cellular therapies, Oncobay Clinical specializes in operational excellence and most importantly, helping our sponsors to simplify the complex as they navigate the many operational steps involved with biospecimen chain of custody”, said Krystyna Kowalczyk, President and CEO of Oncobay. “As a wholly owned subsidiary of Moffitt Cancer Center, we understand the challenges our sites are faced with and together, with Vineti, can provide the platform and operational support necessary to ensure a successful trial at a price point that is affordable.”

Personalized therapies, at any clinical phase, require a software system to manage the complex value chain associated with patient-based treatments. Vineti’s software platform will help OncoBay Clinical’s biopharmaceutical sponsors advance their clinical trial by supporting treatment locations and manufacturing sites, cell collection scheduling, logistics orchestration, manufacturing traceability, and overall visibility for each patient’s individual drug product.

“Advanced therapies require advanced software, at every clinical phase, and Vineti is honored to support them,” said Vineti CE0 and Co-founder Amy DuRoss. “We’re very excited to collaborate with OncoBay Clinical to serve their advanced therapy clinical trials and help get breakthrough treatments to cancer patients faster.”

The OncoBay Clinical-Vineti solution is available from both company’s business development teams. The new collaboration follows the news of the growth of the OncoBay Clinical Business Development team, and Vineti’s collaboration with Avobis Bio.

About OncoBay Clinical

OncoBay Clinical is a boutique contract research organization (CRO) specializing in immuno-oncology/cell therapy, offering full- service custom-curated CRO solutions for global pharmaceutical and biotech companies looking to advance their immuno-oncology product or device. As a wholly owned, for-profit subsidiary of Moffitt Cancer Center, OncoBay embeds scientific expertise, operational excellence and integrated cell manufacturing capabilities providing true end-to-end control. Built on years of IO and cell therapy expertise, a streamlined technology framework, a highly trained site network, and a dedicated team of experienced professionals, OncoBay is committed to operational excellence from start to finish. For more information, visit Oncobay.com and follow us on Facebook, Twitter and LinkedIn.

About Vineti Inc.

Vineti is the first commercial, configurable cloud-based platform to expand patient access to life-saving cell and gene therapies. Vineti was co-founded by GE and the Mayo Clinic to solve the key challenges that patients, medical providers, biopharmaceutical companies and regulators face in the delivery and commercialization of individualized therapies. Now a fully independent company, Vineti offers a digital platform of record to integrate logistics, manufacturing and clinical data for personalized therapies. The Vineti platform supports the full continuum of patient-specific therapies, including cancer vaccines and autologous and allogeneic therapies. The company is expanding rapidly, and Vineti’s Personalized Therapy Management (PTM) platform was in use in hundreds of leading medical centers worldwide in 2019, on behalf of multiple biopharmaceutical partners. In 2019, the World Economic Forum selected Vineti as a global Technology Pioneer.

Media Contacts

Vineti

Stacy Henry

press@vineti.com

OncoBay Clinical

Deborah Turunjian

dturunjian@OncoBay.com

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