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Birgit Hutter-Paier, Senior Director and Head of Neuropharmacology2020 was a year of upheaval around the world, with the Covid-19 pandemic disrupting business-as-usual across almost every sector, including Drug Development and Clinical Trials. With business “on-hold” for much of the first half of the year, pharmaceutical and biotech companies raced into the second half of 2020, moving at “pandemic speed” to develop not only the drugs already in the pipeline, but more importantly, new drugs and vaccines to fight the pandemic. This surge in demand for drug development services highlighted the need for companies like QPS, who have the capability to streamline multiple service lines to yield faster outcomes. With companies like QPS, LLC, this might seem like a cakewalk for pharmaceutical and biotech firms.
QPS is a CRO providing support from early drug development to clinical trial services at several sites in US, Asia, and EU. Specifically in Europe, our Austria location offers unique pharmacological services in all areas of neurodegeneration, using validated cell and animal models, and late phase Clinical Trial services. In the Netherlands, we offer Bioanalysis and early phase Clinical Trial services. QPS is a significant player in the Phase 1 to 2a study field and an ideal partner for small to mid-size pharma and biotech companies. With a wealth of expertise and experienced personnel the company can provide soup to nuts Clinical Trial services, including > 500 Phase I beds for Healthy Normal Volunteers (HNV) or patients, Bioanalysis, and Clinical Research Services for Phase 1/2/3 studies across the US, EU, and Asia. “Our clients mostly work under time constraints to start the clinical phase as early as possible. We easily integrate the multiple service lines that are difficult to align and impart flexibility to them,” remarks Wim Tamminga, Senior Vice President and Global Head of Early Phase Clinical, QPS Holdings LLC.
Wim expresses that the unique blend of deep knowledge of QPS experts and the scientific approach taken by them is precisely what distinguishes the company from its counterparts. QPS is particularly specialized in Neuropharmacology, Bioanalysis, and Phase 1/2a studies. Unlike others who consider Phase 1/2a as “one of their areas of competencies,” Phase1/2a studies and support services form the core of the QPS Clinical offering. The company offers clinical trials in healthy volunteers, as well in patients diagnosed with AD, PD, T2DM, hypogonadism, and many more. QPS also offers high-end specialized services like brain imaging, continuous cerebrospinal fluid (CSF) sampling, human mass balance studies, sedation studies, bioanalytical services including method development and validation, data management, statistics, PK/PD and DDI studies, medical writing, clinical monitoring, and study consultancy services.
A reverberating question here is: what makes QPS different from the others?
“High-quality results combined with years of deep-seated knowledge and a can-do mentality,” answers Birgit Hutter-Paier, Senior Director, and Head of Neuropharmacology, QPS Holdings LLC.
Wim Tamminga, Senior Vice President and Global Head of Early Phase ClinicalBirgit highlights that QPS draws strength from its diversified suite of services. QPS is a global CRO working in close collaboration with a large international network of scientists, investigators, and professionals. It delivers full services programs for small to mid-size pharma organizations, often conducting conduct multiple studies at a time to speed up timelines. The company also conducts bioanalysis of study samples according to the regulations set by GLP and CLIA. Banking on its ingrained expertise and stellar services, QPS brings to the table unprecedented quality that helps clients stay ahead of the competition. Irrespective of investor pressure or complicated internal procedures, QPS works hard to ensure that pre-clinical and clinical work is done within the agreed upon timelines.
It is qualities like the above that have cemented QPS’ position as a trusted partner to many pharma and biotech clients. Birgit points out that building a strong relationship is a tough, but rewarding, journey, and providing deep expertise related to the drug development processes is one key differentiator that helps to develop those relationships. The agility, flexibility and speed that QPS offers, coupled with its robust service offerings, helps create strong ties with clients and prospective clients. To that end, QPS always paves the way for open communication with customers to assess risks, discuss impending challenges, and analyze market demands in detail. This allows the company to draw a clear outline of the study and design the most appropriate plan of action.
We easily integrate the multiple service lines that are difficult to align and impart flexibility to them
To further illustrate the client engagement process, Birgit cites a case study wherein QPS joined hands with a Swedish company, which was slowed in their attempt to develop mucopolysaccharidosis compounds within their academic research site. Unable to solve the challenge, they reached out to consult with QPS and find a faster way forward. QPS evaluated the work done to date and scrutinized the proposed study designs. The experts at QPS were able to identify the key challenges in the plan and propose a modified approach to ensure success. Result? The company successfully conducted a phase 1 trial of their lead compound last year and achieved its goal in time.
This is but one of the many success stories scripted by QPS. The company has proved its mettle with many of the biggest and smallest players in the pharma and biotech industries. With its comprehensive suite of offerings including assay development and validation, neuropharmacology, toxicology, DMPK, bioanalysis, clinical trials, and clinical research services, QPS is a highly capable global partner. Already proving its merit in the US, EU, and Asia, the company plans to continue to expand its footprint. “Over the last few months, we have witnessed a surge in all areas of our business. We aim to continue maintaining the same growth curve in the months and yearsto come,” concludes Birgit.
Company
QPS, LLC
Management
Birgit Hutter-Paier, Senior Director and Head of Neuropharmacology and Wim Tamminga, Senior Vice President and Global Head of Early Phase Clinical
Description
QPS is a global CRO providing custom-built research services in Neuropharmacology, Toxicology, DMPK, Cell & Gene Therapy, and Pre-clinical & Clinical Drug Development. The unique blend of deep knowledge of QPS experts and the scientific approach taken by them is precisely what distinguishes the company from its counterparts. Unlike others who consider Phase 1/2a as “one of their areas of competencies,” Phase1/2a studies and support services form the core of the QPS Clinical offering. The company offers clinical trials in healthy volunteers, as well in patients diagnosed with AD, PD, T2DM, hypogonadism, and many more. QPS also offers high-end specialized services like brain imaging, continuous cerebrospinal fluid (CSF) sampling, human mass balance studies, sedation studies, bioanalytical services including method development and validation, data management, statistics, PK/PD and DDI studies, medical writing, clinical monitoring, and study consultancy services
QPS announces the grand opening of its newest clinical trials unit in Miami, Florida. This new 21 bed unit will complement the existing 85 bed clinical trials unit currently serving the Biotech and Pharmaceutical community. With this new capacity, QPS is poised to accommodate the rapidly increasing demand for obesity trials, as well as continue to support complex, early phase studies in special populations. QPS has extensive experience in allergies, asthma, cell & gene therapy, CNS, COPD, diabetes, elderly, oncology, pediatrics, rheumatoid arthritis, vaccines, women’s health, and many more therapeutic areas.
“We have expanded our Phase I clinical trial capabilities to better serve the hundreds of companies developing potential new obesity-related drugs. We have completed more than 1,500 Phase I-IV clinical trials for drug candidates and this expansion will enable us to support exponentially more sponsors as they progress compounds through proof of concept and First-in-Human trials to the point of candidate nomination,” said Benjamin Chien, Chairman, President, and CEO, QPS Holdings, LLC.
“Our pipeline is filled with sponsors that need this level of support. The number of First-in-Human studies is rapidly increasing and there are very few sites across the country that can conduct them,” said Jose Marcos, Vice President of Clinical Operations, QPS Miami. “QPS is well-known for its success in First-in-Human studies. We excel at complex and special population Phase I trials, and our enrollment and completion rates are among the best in the industry.”
With the expansion comes an increased focus on quality. “To ensure the quality of our clinical trials is maintained, QPS has hired an additional full-time principal investigator to ensure dedicated, physician-involvement at every stage of our trials,” said Chien. “We now have five full-time principal investigators, and a network of more than 25 board-certified subspecialty physician investigators to support the increased volume of studies in our pipeline.”
Wendy Marquina, MD, American Board of Obesity Medicine certified physician, has joined QPS as a primary investigator dedicated to Phase I trials. She brings Board Certification in Obesity, as well as expertise in internal medicine and women’s health to QPS. Since the discovery of the anti-obesity effects of GLP1 and GIP inhibitors, the number of obesity-related clinical trials has dramatically increased. More than 2,300 clinical studies related to obesity are listed as ongoing on clinical trials.gov, and the number is increasing as more companies join the effort to tackle this serious disease and its related comorbidities.
“We expect this demand for obesity-related studies to continue,” said Marquina. “Obesity trials are specialized and unique. And they are in high demand, particularly for companies that want to find an effective solution to this debilitating disease. The road so far is littered with failures in this space, so there is real excitement in the medical community that there may finally be a pathway to help these patients.”
Supporting this expansion in Miami, QPS has co-located its specialty lab services within its Miami-based clinical site. “In the market, you’ll find CROs that offer clinical services, and then you’ll find specialized labs. At QPS, we now we have the unique combination of clinical services and a specialized lab combined under one roof,” said Chien. “That’s important because many of our studies require lab samples to be processed quickly, in less than eight hours. This is only possible by having the clinical site and specialty lab co-located.”
With this newly expanded facility and additional leadership specializing in obesity, QPS is satisfying the need for agility, flexibility, and speed in the global drug development community, with a focus on serving the needs of the Biotech and Pharmaceutical industry to support global drug development from preclinical through post-marketing needs.