July 1, 2020 PAP-Q2-20-CL-010
Today, there is a tremendous need to condense speed to the clinic and market, increase efficiency, and reduce overall costs. Beyond these fundamental challenges, the transitions from blockbuster drugs to personalized medicines and from centralized clinical trials to virtual/dispersed studies is driving a departure from traditional development approaches and creating greater need for innovative technologies.
Celerion (from the Latin celeritas, meaning swiftness and speed) was founded in 2010 as a full-service, early clinical CRO to address the need for faster drug development, and today is the leader in accelerating development for phase I–IIb. Our strategy is to be an early adopter of technologies that provide agility to respond to our clients’ needs. For example, our bioanalytical labs employ automated, high-throughput laboratory solutions and electronic data collection systems, which align with our expertise in evaluating biomarkers that enable deeper, earlier insight into drug effects during clinical drug development.
Leveraging smarter strategies that pre-identify potential issues, Celerion significantly reduces development timelines by avoiding delays. Celerion helps clients define what a successful clinical proof-of-concept study should entail and strategizes with the endpoint in mind to determine which phase I/II study design will provide appropriate assessment of safety and pharmacokinetics, which in turn will impact how and what toxicity studies should be conducted.
Thus, the keys to our approach include prospective thinking, a decision-gate structure, interactive communication with regulatory authorities, and operational input from investors and study managers during trial design. This is rational drug development, not reactive drug development.
Everything we do at Celerion is focused on accelerating the translation of scientific ideas into potential medicines. We provide full study services designed to optimize outcomes, reduce risks, and optimize development timelines, even for the most complex phase I trials. With facilities across North America, Europe, and Asia, in 30 countries worldwide, we conduct trials with the right patients, in the right places, to get the data each client needs.
Our unique combination of medical expertise, clinical operations experience, and scientific excellence enables clients to make timely decisions with expert advice and high-quality data. Our ongoing investment in new technologies enables us to continuously enrich data collection and analysis and expedite data delivery. From data acquisition strategies to advanced facilities, we are leaders in leveraging new technology to provide faster, more accurate data, at less cost. In addition, by applying Celerion’s experience managing more than 6,000 clinical research studies, we offer valuable insights from protocol development through study conduct and analysis.
Our areas of specialized expertise include respiratory and inhaled drug products; metabolic disease testing methods and hands-on operational experience that support early proof of concept in the development of diabetes, obesity, NAFLD/NASH, and cardio-metabolic interventions; clinical trials with certain drugs used in oncology settings, including pharmacokinetic and safety studies in healthy subjects when scientifically and medically justified; biomarker assays to assess effects on tumors, inflammation, and immune response; traditional clinical project management and clinical monitoring; vaccines; and biologics/biosimilars.
Achieving clinical proof of concept is a critical milestone for drug candidates. When a sponsor demonstrates that a drug works in humans in the manner that preclinical study results suggested, that drug for the first time acquires real value. Good results often attract investors and create a range of business opportunities. Celerion has therefore established a global clinical group dedicated to accelerating project movement from first-in-human to early patient studies that provide early patient readout data.
One consequence of the shift to targeted therapies and personalized medicine has been the emergence of small biopharma companies as the engine of innovation in the pharma industry. Celerion has enjoyed success in supporting these small and virtual new product generators by providing highly personalized attention and establishing long-term relationships. We work with more than 10 companies in a closer, preferred-provider or partnering model where Celerion is much more engaged in program development and planning. This approach provides significant benefits for all parties, including operational efficiencies, the more effective use of collective knowledge, increased mutual respect and trust, and ultimately the shared satisfaction of contributing to new medicines that impact people’s lives.
Our technology platform enables these partners to review data in real time and adjust studies on the fly in response to emerging results — flexibility that is highly valued during early clinical research, when the fate of new drug candidates is being judged on information built from data gathered from the first people to receive the drug.
We also have the capability to compound drugs in the research setting within our qualified pharmacies. In 2019, Celerion’s pharmacies were updated to meet new USP requirements for the compounding of unapproved drugs, which are now considered to be hazardous. This differentiates us among phase I CROs.
Indeed, Celerion is constantly investing in our capabilities across the board, using technology in innovative ways that provide real value. We seek technologies that can impact our business significantly with respect to providing more useful, higher-quality data faster and at lower cost. We were at the forefront of highly automated electrocardiogram overread, which provides more accurate results and alerts the reviewing cardiologist to abnormal or more difficult-to-interpret data.
Celerion was also the first laboratory to move completely to electronic lab notebooks. Lab technicians now spend just 15% of their time on data documentation for the GLP environment — rather than 50% — providing a tremendous boost in productivity. The accuracy and quality of study execution is also improved, as the electronic system keeps track of expiration of solutions and reagents, instrument service and maintenance, sample storage environments, inventory, and chain of custody.
We have also been a leader in leveraging the use of apps on tablets and smartphones for patients to provide data on an ongoing basis once they leave the clinic. Not only are the data provided electronically, the resulting volume of data is greater, which can add statistical power to the eventual analysis. In addition, the data do not need to be transcribed, so errors are reduced and significant time is saved.
Our science-driven approach and commitment to applying innovation have led to the development of several proprietary solutions geared toward accelerating early clinical research. Developed to address the most challenging aspects of data collection, data management, and clinical operations, ClinQuick® is Celerion’s industry-leading eSource solution that electronically captures data in real time.
A CFR Part 11–compliant barcoded system that automates all aspects of clinical operations, ClinQuick ensures that we can provide faster delivery of high-quality data, benchmark level study execution times, and consistently execute clinical trials across Celerion’s global facilities. By combining our processes with Omnicomm’s TrialMaster® electronic data capture system (EDC), we are able to design, build, and deploy databases quickly, which is crucial for studies in early development.
Because ClinQuick is integrated not only with TrialMaster and our clinical and laboratory equipment but also our proprietary client data portal, Celexus®, clients see clinical study results in real time online, allowing for faster, data-driven decision making. In addition, all critical study documentation and reports are maintained in a centralized location. In addition, all electronic trial master files (eTMFs) are DIA TMF formatted and accessible to clients and trial monitors through a secure portal managed by experienced eTMF personnel.
Celerion’s ECG Core Lab provides quality data in a fast, cost-efficient manner while also allowing cardiologists, clinical pharmacologists, biometrics specialists, statisticians, and data management experts to actively collaborate with clients as the study progresses. Our bioanalytical electronic laboratory notebook system, Labnotes, allows us to document observations, control procedures, exchange information with other software solutions, and easily find and collaborate on scientific results while operating more efficiently in a compliant manner.
While we believe these innovative solutions set Celerion apart as a leading early-phase CRO, we realize that ongoing advances are required to maintain that leadership position. We will therefore be expanding our Celexus client portal to allow more real-time access to data for sponsors, including our laboratories, which will be valuable for SAD/MAD dose-escalation studies and aspects of real-time monitoring. We are also employing FibroScan® (Echosens, Paris) as a noninvasive procedure for detecting early signals of efficacy for drugs targeting nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH).
Cell-based therapies and 3D-printed tissues/organs are just two examples of future modalities for curing diseases rather than treating symptoms. More current are advances being made in drug delivery, such as antibody–drug conjugates, patches, and implantable wafers. Such next-generation medicines and devices present both clinical and analytical challenges. We believe that Celerion has an important role to play in mapping out the impacts of these therapies using our expertise in biomarkers and clinical study design and conduct.
Going forward, we also anticipate leveraging artificial intelligence/machine learning to more quickly and effectively analyze data to advise protocols and provide other crucial insights. The use of augmented reality tools to virtually engage with potential trial participants, educate them about a study, and gain their consent is also being explored to facilitate virtual/siteless/direct-to-patient trials and other evolving clinical trial models.
The COVID-19 pandemic is contributing to the accelerated adoption of some new technologies by everyone in the pharmaceutical industry. Companies that would normally be hesitant to adopt remote monitoring solutions and accept patient-reported data, for instance, have found that, driven by necessity, these technologies present effective solutions.
Celerion was already positioned to implement many remote technologies before the emergence of the novel coronavirus, including remote auditing, virtual site tours, and remote viewing of dose preparations. We believe our clients will continue to use many of these systems going forward, because they are effective and can boost productivity and efficiency while reducing cost.
We also expect that there will continue to be changes in the way clinical research is performed. Flexibility and an open mind on new approaches while still maintaining the high quality standards required of our business will be key to successfully managing the many impacts of the pandemic.
In addition to the use of personal protective equipment, Celerion has implemented novel working procedures and facility changes to accommodate COVID-19 concerns and federal, state, and local working requirements around social distancing. Creating more bed and lab space and ensuring controlled entry and exit are other challenges Celerion is addressing.
We also have our own highly sensitive assay to detect very low levels of the SARS-CoV-2 virus, which is necessary to establish that an asymptomatic individual does not have the virus. Diagnostic tests to show that someone with symptoms has COVID-19 or another infection are not sufficiently sensitive for screening of asymptomatic people. Our test provides results in six hours, and we are using it to test both trial participants and staff at our clinics. We expect testing in both society at large and in the research environment will be necessary for the foreseeable future.
In March 2020, Celerion celebrated 10 years of industry leadership providing early clinical research services to the biopharmaceutical industry’s most innovative companies. Unlike very large CROs that are too big to allow flexible, direct, and personal interactions, Celerion has adopted a disruptive service model focused on building close, long-term relationships that enable direct connections among the right people.
We are, in fact, like Goldilocks: not too big and not too small, but just the right size for the clients we serve with our relationship-driven, science-based approach to accelerating projects from preclinical to proof-of-concept studies. Our management team is led by Dr. Susan Thorton, who leverages her experience as a scientist CEO to understand key industry trends and evolving client needs. As a result, they consistently make the right decisions about investments in technologies that will have a measurable impact on our ability to reduce time to market while ensuring the highest-quality data.
In 2019, regulatory bodies approved 48 new drugs; Celerion conducted 32 studies with 11 of those drugs. This impressive track record demonstrates our overriding goal of advancing new drugs to market to help those in need of innovative drug therapies.
Celerion’s second decade of growth will continue from locations spanning North America, Europe, and Asia and expand on the global recognition we have achieved as the premier provider of early stage clinical research. Driven by our strong scientific foundation and demonstrated capabilities in the drug-development process, we will continue to focus resources on early clinical development to proof of concept. We will also continue to build strong collaborative relationships with our customers and invest in the knowledge, talent, and technologies necessary to help them make rapid, informed decisions and rapidly bring new medicines to the patients that need them.
As Vice President, Scientific Strategy and Commercial Development, Dr. Rusch identifies scientifically compelling drug development trends aligned to Celerion’s commercial offerings. Dr. Rusch constantly evaluates new offerings for Celerion to drive its evolution and innovation as a life sciences service leader, specializing in the early clinical research space of drug development. Lorraine trained in biology as an undergraduate, received a master’s degree in clinical chemistry, and completed her training as a research fellow in the Cleveland Clinic’s Lerner Foundation with a degree in laboratory medicine and bioanalytical chemistry (Cleveland State University).