Revolutionary Collaboration Between Pierian Biosciences and Clatterbridge Cancer Centre Sets New Benchmark in Ovarian Cancer Treatment Innovation
Pierian Biosciences was thrilled to be joined by key stakeholders of the City of Liverpool, Oncology Academics, and the press to mark the signing of a groundbreaking collaboration with the esteemed Clatterbridge Cancer Centre – NHS Foundation Trust.
Based in Nashville, Tennessee, USA, Pierian Biosciences is a diagnostic development and laboratory service organisation, specifically focused on personalised cancer intelligence. Pierian’s diagnostics provide personalised treatment for patients diagnosed with cancer and autoimmune diseases.
Hosted at the Novotel in the City of Liverpool, the home of both Pierian Biosciences’ UK Laboratory and The Clatterbridge Cancer Centre, this signing marks a significant milestone in their mission to revolutionise cancer treatment through innovative and cutting-edge research and development.
The primary objective of this collaborative endeavour is to develop cutting-edge algorithms that will play a pivotal role in advancing the understanding and management of Ovarian Cancer. Pierian Biosciences is the Biotechnology Company and Sponsor of the research and development study, with The Clatterbridge Cancer Centre acting as the Clinical Research Organisation (CRO) leveraging its exceptional expertise and vast resources to bolster the study’s resounding success.
Robert E. Henry, Pierian’s President and CEO stated: “The Pierian Team is excited about the future of cancer care as we enter this partnership with The Clatterbridge Cance Centre to continue developing our groundbreaking Assays. The Clatterbridge Team has welcomed us to Liverpool and has embraced our Mission ‘To profoundly change the approach to treatment selection for patients with cancer and auto-immune diseases by providing information to enable healthcare providers to deliver on the promise of personalized medicine.’ This strategic alliance between Pierian and The Clatterbridge Cancer Centre signifies a significant step forward in the quest to provide personalized medical solution for patients facing cancer and auto-immune diseases. The combined expertise and resources of both organizations are poised to drive innovation and contribute to improving the lives of countless individuals.”
Distinguished as a world-leading institution in cancer research, The Clatterbridge Cancer Centre will oversee critical aspects of the study, including site onboarding, patient screening, coordination with laboratory operations, and meticulous data entry andlogging of de-identified patient clinical information including treatment regiment, adverse reactions, and clinical outcomes. Their expertise and dedication will be instrumental in driving this transformative research forward.
Dr Gillian Heap, CCC’s Director of Research and Innovation Operations, said: “We are delighted that Pierian Biosciences has chosen Liverpool and The Clatterbridge Cancer Centre to partner with in this exciting, pioneering research. Clatterbridge has huge experience in leading cutting-edge clinical research trials and has world-leading cancer experts who can help bring success to this collaboration and the ground-breaking science it will bring about.”
Dr Maria Maguire, CCC’s Head of Research Governance and Sponsorship, said: “It has been very rewarding for our team to support Pierian Biosciences in establishing this important study and we look forward to launching this research with the hope that it can benefit future Clatterbridge patients and lead to further understanding in this exciting area of personalised medicine.”
The study will comprehensively track and analyse patient responses to diverse chemotherapeutic and treatment agents, offering invaluable clinical insights and contributing to a deeper understanding of the efficacy and impact of different treatment approaches. All resulting data will be securely stored in a dedicated clinical database, seamlessly integrated with laboratory-measured in vitro diagnostic metrics, facilitating robust statistical analysis and for the development of advanced algorithms with the potential to transform cancer care.
What sets this collaboration apart is The Clatterbridge Cancer Centre’s access to an extensive network of sites across the United Kingdom, ensuring a diverse and representative patient population. This, in turn, strengthens the validity and generalisability of the research findings, promising a profound impact on the field of Oncology.
As the algorithm development study progresses, the next phase will involve a comprehensive clinical validation study. Expanding the collaboration to include additional renowned sites will further enrich the research and ensure the real-world applicability of the findings.
Together, Pierian Biosciences and The Clatterbridge Cancer Centre are committed to pushing the boundaries of cancer research, striving to improve patient outcomes, and leaving an enduring impact on the field of Oncology.
Pierian Biosciences Blog
US-Based Pierian Biosciences Opens Its First UK Laboratory In Liverpool With Support From Liverpool City Region Inward Investment Fund
Harrogate International Advisory has successfully welcomed its US client Pierian Biosciences into Liverpool with the opening of Pierian’s first laboratory in the United Kingdom. It will be based within the highly prestigious Liverpool Science Park. The US-based laboratory diagnostic and pharma support services has also successfully received investment from the Inward Investment Facilitation Fund (I2F2), which was set up as part of the £75m Business Growth Package introduced by Steve Rotheram, Mayor of the Liverpool City Region.
ABOUT PIERIAN BIOSCIENCES
Based in Nashville, Tennessee, USA, Pierian Biosciences is a diagnostic development and laboratory service organisation. The company has invested $42m into the development of this project, which will be taken through to commercialisation with a further £25m of investment. Pierian Biosciences aims to deliver the most innovative, treatment-directing testing possible while providing analytical approaches that lead the way for personalised medicine and translational science. The organisation specifically focuses on personalised cancer intelligence by offering guidance for healthcare providers to offer a personal treatment for patients suffering from cancer and auto-immune diseases.
PIERIAN BIOSCIENCES EXPANDING INTO THE UK
Pierian Biosciences’ decision to open a permanent laboratory within the United Kingdom has been several years in the making. As the organisation seeks to expand its work towards helping patients and informing medical professionals around the world, the board of directors determined that it would be most valuable to have a permanent laboratory base within the European continent and chose Liverpool as its base. The United Kingdom was chosen based on Pierian Biosciences having clearer communication with key opinion leaders from the medical field within Great Britain, as well as the increased opportunities for access to the wealth of scientific research facilities that the UK offers.
The Liverpool City Region in particular serves as a central hub for national health studies, with the local medical facilities being prevalent towards research and testing for a wide variety of conditions, treatments, and illnesses, which includes cancer treatment. Based on the work that Pierian Biosciences delivers, Liverpool was an appropriate choice for the company’s new UK laboratory given the wealth of top-level cancer research that the region provides. In addition, the city has numerous central locations that focus primarily on cancer treatment and cancer research. These include the Liverpool Cancer Research Institute, the world-class Clatterbridge Cancer Centre, Liverpool University Biobank (LUB), Cancer Research UK’s Cancer Trial Units, and the Royal Liverpool University Hospital.
COMMENTS FROM PIERIAN BIOSCIENCES
Robert Henry, President and Chief Executive Officer of Pierian Biosciences, commented: “We’re delighted to bring our work to the city of Liverpool. Right now, we have two assays that we are developing right here in the UK, and we will provide further information once they receive full approval.
“It makes perfect sense for us to come to Liverpool. The opportunity to gain access to tissue samples of cancerous tumours needed to conduct our studies is far greater in the UK and Europe right now than in the United States. And Liverpool Science Park’s laboratory facilities are of the highest possible standard for the work that we carry out. We have been overwhelmed by the offers of collaboration by local academics and oncology specialists. We look forward to working alongside some of the world-class facilities that Liverpool has to offer in the realms of Life Sciences to continue this game-changing project.”
Norman Purvis, Chief Scientific Officer, Head of Research and Development at Pierian Biosciences, has moved to the UK to setup and manage the Liverpool laboratory on a permanent basis. The opening of the Liverpool laboratory will also create new employment opportunities as the UK team expands.
The inward investment project of Pierian was mandated to Harrogate International Advisors. Sue Wright, managing director at Harrogate, commented: “We started working on this project in 2021. Tony Reeves, the then-CEO of Liverpool City Council, gave the project huge support to ensure with us that it landed into Liverpool. The collaboration from local academics, professors of oncology, city council stakeholders and Colin Sinclair of the Knowledge Quarter has been exceptional. This really shows that we can successfully bring Big Pharma to Liverpool.”
To mark the occasion of Pierian Biosciences’ expansion into the UK, the company held a prestigious dinner at LuBan Restaurant Liverpool. It was attended by numerous key stakeholders, academics and members of Liverpool City Council. Attendees included Robert Henry, President and CEO of Pierian Biosciences; Norman Purvis, Chief Scientific Officer and head of R&D at Pierian Biosciences, Joanne Anderson, Mayor of Liverpool; and Mark Bourgeois, Interim City Development Director of Liverpool City Council and Sue Wright and Faisal Arif of Harrogate International Advisors. In addition, eight key oncologists and other leading figures from Liverpool City Region were in attendance.
Pierian Biosciences Blog
Clinical Trials–Making Good News Better
Recent published results (AACR 2018 and NEJM) from the Merck KEYNOTE-189 trial in non-squamous non-small cell lung cancer (NSCLC) proved to be very exciting in the world of oncology. The study showed that patients treated with pembrolizumab (Keytruda™) plus chemotherapy had significantly longer overall survival (OS) and progression-free survival (PFS) compared with those who received chemotherapy alone, meeting both its primary endpoints.
Great news for patients! But, could this be even better news?
Pierian Bioscience’s ChemoINTEL™ platform is designed to determine the sensitivity of tumor cells to an array of chemotherapeutic drugs, including the two (carboplatin and cisplatin) chosen at the discretion of the treating physician in the trial. Neither drug is 100% effective in treating NSCLC, but one may be more or less effective than the other in an individual patient. Rather than assigning the drug by chance as was done in this study, if quality information regarding the activity of both is available before treatment is even begun, such as that generated by ChemoINTEL™, then the more appropriate and effective therapy can be directed to the patient. This would have the effect of improving patient outcomes and the overall success rate of the therapy—let alone improving the results of the clinical trial.
Analogously, ImmunoINTEL™ was devised to inform on the detailed immune response state of the tumor undergoing treatment. This is important as the immune response to tumors is quite complex. Normally, cells of the immune system can inhibit tumor growth and progression through the recognition and rejection of malignant cells, a process referred to as immunoediting. Frequently, tumors have altered the normal immunological responses in order to escape detection and elimination. This can also promote tumor cell growth and survival through the induction of oncogenic inflammation. Thus, a more detailed analysis of the relationship between tumors and the immune system can help to determine which immune-oncology drug might be most effective, and whether or not a particular patient will respond to the biotherapeutic of choice.
Together, ChemoINTEL™ and ImmunoINTEL™ may help to positively impact the approach to cancer treatment for both patients and providers in an effort to deliver on the promise of personalized medicine: the right treatment for the right patient at the right time.
Pierian Biosciences Blog
A Second Chance at Personalized Treatment through Secondary Cytoreductive Surgery
In June 2017, clinical staff from Pierian Biosciences attended the annual meeting of the American Society of Clinical Oncology (ASCO) held in Chicago, IL. The ASCO annual meeting brings together approximately 35,000 oncology professionals from around the world to present and discuss the results of the latest cancer research trials, potential new therapies and diagnostics, and state-of-the-art treatment options. In short, ASCO offers attendees informative educational and scientific sessions that highlight the latest in cancer research and treatment.
Three overarching themes of the ASCO meeting revolved around the increased push for personalized medicine; most notably, using advanced diagnostics to find the right drug for the patient at the right time, as well as significant progress being made in the areas of “targeted” therapeutics and immuno-oncology. For the second consecutive year, ASCO President Dan Hayes, MD remarked that a bad test or a bad biomarker is as bad or worse than receiving an ineffective drug. Hayes went on to explain that any diagnostic test that “inappropriately” directs an oncologist to give a patient a certain therapy can result in denying that patient an effective treatment.
There were active discussions regarding the need to improve clinical trial designs to ensure that the appropriate population is being studied. On the topic of clinical trials and personalized medicine, researcher Andreas Du Bois presented his team’s recent findings from their randomized controlled phase III study evaluating the impact of secondary cytoreductive surgery in patients with recurrent ovarian cancer—a study with conclusions that align with Pierian Biosciences’ mission, vision, and product development.
In the study, patients with recurrent Epithelial Ovarian cancer were randomly selected to receive surgery to remove the tumor followed by standard of care chemotherapy or only chemotherapy. The conclusions indicate that patients receiving the secondary debulking surgery seemed to fare better and have lower morbidity rates than those without surgery.
The goal of personalized medicine is not just to guide the initial treatment of each patient’s cancer, but instead personalization is needed for each cancer recurrence in the same patient. For many patients, cancer may be a chronic condition that they will fight their entire lives.
At Pierian Biosciences, we are developing a chemosensativity assay, ChemoINTEL™, to test tumor tissue and accurately predict its response to a variety of chemotherapy drugs. Using multiple markers, the ChemoINTEL™ assay is designed to measures the in vitro apoptotic response of a patient’s tumor to a variety of chemotherapy drugs in an effort to determine the tumor’s sensitivity within 72 hours of the tissue’s arrival in the lab. With a cancer recurrence, oncologists must be able to quickly and accurately personalize the treatment again, while pushing aside the knowledge of any prior treatment success, because the new tumor may well have different biology than the previous tumor. The ChemoINTEL™ assay can test tumor tissue at each recurrence to reveal its sensitivity and to significantly influence the resulting treatment regimen(s).
Any follow-up data and subsequent studies on the recurrent ovarian cancer study will help to determine how the second-line treatments fare in the long term. This study may spur similar trials in other recurrent solid tumors and further emphasize the need for personalized diagnostics and treatment with each recurrence.
Complementing the ASCO meeting’s push for personalized medicine and the recurrent ovarian cancer study results, Pierian Biosciences’ platforms (ChemoINTEL™, PathwayINTEL and ImmunoINTEL™) are being designed and tested to deliver specific, actionable, personalized information regarding the most appropriate cancer treatment for each patient and each tumor. Pierian Biosciences is focused on enhancing the quality of life for cancer patients by providing actionable information to allow personalized treatment every time cancer occurs.
Pierian Biosciences Blog
The Cancer Moonshot May Have to Wait, Yet There’s Still Room for Hope
What we learned from ASCO 2017
Former Vice President Joe Biden’s cancer moonshot may have to wait, due to proposed cuts in the National Institutes of Health (NIH) budget. But for the more than 30,000 cancer researchers, biopharma executives, investors, and public health officials who gathered at the annual meeting of The American Society of Clinical Oncologists (ASCO) recently, there’s still plenty of reason for optimism in cancer treatment. Here’s what caught our attention at ASCO 2017:
Drug combinations may seem random now, but more are embracing it as a treatment model
If one is good, two or three seem to be better. While immunotherapy holds great promise, what looks even more promising is combining therapies, whether it’s two immunotherapy medications together or putting them together with more conventional treatments like chemotherapy and radiation. However, there’s a level of randomness to the combinations put forward that bears further scrutiny. The combinations haven’t been shown to be effective in a majority of patients, and the approaches, according to some, “are a bit like throwing spaghetti at the wall to see what sticks.” Most researchers agree the combination approach, while still in need of greater refinement, is a worthwhile pursuit for cancer treatment.
Medicaid expansion states saw earlier diagnosis of colorectal cancer (CRC)
CRC is often asymptomatic in its earliest and most treatable stages. Screening is critical for bringing down the mortality rate of one of the country’s deadliest cancers. In states where Medicaid expanded, thus expanding the number of people eligible for having their CRC screening covered by the Affordable Care Act, there were earlier diagnosis rates for CRC. While the ACA is headed for an overhaul, cancer researchers were encouraged by the trend.
“Financial toxicity” plagues patients and their families
Cost is a bigger issue than ever – it even has a new term: financial toxicity. Duke University’s Yousuf Zofar, MD, MHS, an associate professor of medicine, has studied the financial effects of cancer care on patients and their families, and finds that they can be just as damaging as the cancer itself. According to the American Journal of Managed Care, results of a panel discussion moderated by Dr. Zofar emphasize the need for the cancer treatment community to come up with a single solution for financial toxicity.
Precision medicine is a promise not yet delivered
Pierian Biosciences is uniquely focused on developing treatment-directing assays that help clinicians target exactly which chemotherapeutic, targeted agent, biologic, or immunotherapeutic agents kill a specific patient’s cancer cells. These assays offer the hope of truly individual, personalized cancer treatment plans. But at ASCO, there was a lot of discussion about how “precise” precision medicine actually is at this time. Larotrectinib, as pointed out by Health News Review, received a lot of attention at ASCO. The new drug showed that “76 percent of patients had tumor shrinkage across 17 different types of tumors. Of those with tumor shrinkage, nearly 80 percent did not have the original tumors rebound — or any new tumors grow — after a year of therapy.” The drug has received Breakthrough Therapy Designation from the Food and Drug Administration (FDA). But tumor shrinkage is only one of many data points to capture in determining the drug’s overall effectiveness. Benchmarks such as median progression-free survival, median overall survival, or duration of response still need to be determined.
There’s reason for optimism
Siddhartha Mukherjee, author of “The Emperor of All Maladies” and “The Gene,” encouraged the ASCO audience to see the silver lining in some of the uncertainty surrounding the future of cancer treatment. From an article in the Washington Post, Mukherjee spoke with hope for the future: “Cancer treatment is entering a promising, if challenging, adolescence…and his fellow oncologists, after years of being hamstrung by a lack of technological tools and treatments, now have therapies to deploy in a thoughtful, reasoned and compassionate way. ‘Always keep in mind, Mukherjee urged the physicians, what it feels like to be a patient in this world.’” We at Pierian Bioscience are dedicated to developing very accurate and reproducible treatment-directing assays that will fulfill the promise of personalized medicine: the right drug for the right patient at the right time. We are focused on helping clinicians target exactly which chemotherapeutic, targeted agent, biologic or immunotherapeutic agent(s) will be most effective against a specific patient’s tumor to allow the physician to truly individualize or personalize each patient’s cancer treatment plan.
Pierian Biosciences Blog
Immunotherapy Making Strides at ASCO-SITC Immuno-Oncology Symposium
In late February, the American Society of Clinical Oncology (ASCO) partnered with the Society for Immunotherapy of Cancer (SITC) to host the first ASCO-SITC Clinical Immuno-Oncology Symposium, held in Orlando. We learned, along with 1000 other attendees, about the leading clinical research regarding immunotherapy (IO) treatment and the exciting, yet, gradual move from IO research to actual patient application.
The concept of immunotherapy, using the body’s immune system to help fight cancer, is making tremendous strides in today’s cancer research. In just the last five years, research has proven that manipulation of the immune system can control, or in some cases, completely eradicate tumors. As chemotherapy, targeted therapy, radiation therapy, and surgery are used to aggressively destroy cancer cells, with IO, researchers are working to develop strategies to harness the body’s own immune system to combat cancer. When the immune system is strengthened, risk on the patient’s long-term health is reduced in comparison to more aggressive cancer treatment approaches.
What happens when IO therapy is combined with traditional treatment approaches? The potential for positive outcomes in the oncology field grows even more substantially. Researchers have been testing immunotherapy as one component in combination cancer treatment, and the idea is gaining traction. At ASCO’s symposium, many presenters mentioned the theory of the “abscopal effect” (ab meaning “away from,” and scopus meaning “target”), a term coined in the 1950s to describe the phenomenon when treating metastatic cancer with radiation. The abscopal effect occurs when the localized treatment of a tumor causes not only a shrinking of the treated tumor, but also a shrinking of other tumors outside the scope of irradiated area. In 2015, EB Golden and colleagues ran a clinical trial which demonstrated that abscopal responses were consistently detected in patients treated with the combination of radiation therapy and immunotherapy. In practice, a breast cancer patient receiving IO combined with radiation has been shown to demonstrate a positive response on a spinal lesion or other location in addition to the irradiated tumor. The thinking is that radiation primes the immune system to recognize tumor-specific targets as those cells die, which is then translated into a systemic effect.
Research combining chemotherapy and immunotherapy was also presented and discussed. To change the tumor’s microenvironment, researchers are using doses of chemo to destroy cells that are blocking the immune system from functioning, instead of using the dosage required to kill cancer cells. This process converts the “unresponsive” cancers to responsive, allowing immunotherapy to work effectively.
But what dose and schedule of chemotherapy is enough to kill the cells blocking the immune system, yet not so strong that it wipes out the body’s defense mechanism? Which cytotoxic is best, what is the best dose and schedule, is this approach beneficial for all tumor types and all patients? Which patients would respond better to a combination of immunotherapy plus chemotherapy as opposed to those who would fare better with one treatment or the other? There are clearly more questions than answers at this time.
At the symposium, a recognized leader in the field, Lisa Butterfield, led a session on “Immune Biomarkers in the Blood” featuring research findings on immune biomarkers and their ability to offer insight into the interactions between the immune system and cancer. These interactions can help to define which immunotherapy should be selected to best defend the body using its immune system.The current research focus is on finding markers that suggest a patient will respond to any immunotherapy (IO), rather than using the biomarker to determine which IO would work best for their specific tumor and cancer.
The more we know, the better the outcome. At Pierian Biosciences, we’ve invested years of research in developing a series of functional assays including our latest platform, ImmunoINTEL™. The ImmunoINTEL™ platform is being developed as a functional I-O platform incorporating information from intra-tumoral as well as peripheral immune mediators that will predict which immunotherapeutic will be of greatest benefit for each individual patient. Our goal is for the information provided by the assay to deliver the intelligence needed to determine which treatment or combinations of treatment will be most effective based on a patient’s actual tumor response in the lab, before introducing the treatment to the patient. A functional assay should more precisely predict a cancer treatment outcome and thereby increase efficacy cut costs by eliminating ineffective treatments, avoid the toxicity associated with ineffective therapies and improves the patients overall quality of life, resulting in a more effective and successful treatment experience from day one. We call that a win/win.
Immunotherapy is making great strides in the treatment of cancer, evidenced by the fact that the ASCO-SITC Immuno-Oncology Symposium drew 1,000 of us who came to listen. At Pierian, we too, are embracing immunotherapy by providing the tools that oncologists need to develop customized treatments that result in significantly improved treatment outcomes.:
 Winslow, R. Cancer’s Super-Survivors/How the Promise of Immunotherapy Is Transforming Oncology. Wall Street Journal. Dec 4 2016.
 Disis, M.L. & Kaufman, H.L. Cancer Immunotherapy: The End of the Beginning or the Beginning of the End. Ummunsym.org Daily News, published February 17, 2017.
 Mole, R.H. Whole body irradiation; radiobiology or medicine? Br J Radiol 1953; 26:234-41. 10.1259/0007-1285-26-305-234
 Golden EB, Chhabra A, Chachoua A, et al. Local radiotherapy and granulocyte-macrophage colony-stimulating factor to generate abscopal responses in patients with metastatic solid tumours: a proof-of-principle trial. Lancet Oncol 2015;16:795-803. 10.1016/S1470-2045(15)00054-6
 Thaker, P. H. (2017, February). Phase I study of the safety and activity of formulated IL-12 plasmid administered intraperitoneally in combination with standard neoadjuvant chemotherapy in patients with newly diagnosed advanced stage ovarian cancer. Poster session presented at the ASCO-SITC Clinical Immuno-Oncology Symposium, Orlando, FL. Retrieved from: http://meetinglibrary.asco.org/content/178595-194
 Nyberg, K. (2017, February 24). Leveraging Immune Biomarkers in the Blood to Guide Immunotherapy—Current Application and Future Prospects [Daily News]. Retrieved from http://immunosym.org/daily-news/leveraging-immune-biomarkers-blood-guide-immunotherapy-current-application-and-future
Pierian Biosciences Blog
Response to FiercePharma Article
CLIENT: Pierian Biosciences
DATE: February 17, 2017
PROJECT: PR – Blog post – Response to FiercePharma article
A recent FiercePharma article on the top 15 cancer drugs for 2022 predicts they will total nearly $90 billion in sales. That’s a big jump, considering global spending on all cancer drugs was $107 billion last year. Immunotherapy-based drugs, largely described as checkpoint inhibitors, are a big driver in these price increases. According to FiercePharma, “This brand-new category of cancer drugs works by activating the immune system, enabling it to recognize cancer cells and destroy them. The class of drugs has achieved unprecedented efficacy in a broad range of cancers and provides a much-needed new treatment approach alongside chemotherapy and targeted cancer drugs, which tend to lose efficacy over time.”
The emerging field of immuno-oncology shows great promise, despite the high price of immunotherapy drugs. That’s not the case for some chemotherapy agents. According to a study in JAMA Internal Medicine, several chemotherapy drugs did not to offer the long-term survival rates to justify their high price.
For cancer warriors – clinicians, patients and researchers – it’s time to deploy new weapons in the fight against cancer. We’re entering this fight with technology platforms based on the MiCK and CEER assays, now renamed ChemoINTEL™ and PathwayINTEL respectively, to help clinicians identify the most effective targeted therapy for cancer patients. They provide patient-centric, personalized intelligence on the effectiveness of chemotherapy and targeted therapy treatments, to help support clinical decision-making and drug development. Our strategy is to conduct clinical studies to support regulatory approval of these platforms by the Food and Drug Administration.
Cancer isn’t going away. Chemotherapy drug prices aren’t going down. Providers and researchers need more tools in their toolkit. At Pierian, we’re working hard to bring our treatment directing diagnostics to transform the cancer treatment experience for cancer patients across the globe.
Pierian Biosciences Blog
PR – Op-Ed: Response to New Clinical Trials Requirements from HHS
Client: DiaTech Holdings/Pierian Biosciences, Inc.
Date: September 21, 2016
Project: PR – Op-Ed: Response to New Clinical Trials Requirements from HHS
Cancer deaths have declined substantially in the past decade. According to the National Cancer Institute, from 2003 to 2012, cancer deaths rates decreased by 1.8 percent per year among men, 1.4 percent per year among women, and 2.0 percent per year among children. While these are certainly promising developments, cancer isn’t going away any time soon.
For many cancer patients, hope for a cure lies in the results of clinical trials, which might point to newer, more effective treatments. The 2016 announcement from the Department of Health and Human Services, which calls for making information about clinical trials more widely available, offers these patients a ray of hope. It improves people’s ability to find clinical trials in which they may be able to participate and access investigational therapies.
As a member of the biotech community, I’m delighted about the new requirements. No matter what the results might be, the more clinical trial information is shared, the faster we develop transformational diagnostic tools and therapies.
These requirements coincide with our own clinical trials journey. Our technology platforms based on the MiCK and CEER assays and now renamed ChemoINTEL™ and PathwayINTEL respectively, help clinicians identify the most effective targeted therapy for cancer patients. They provide patient-centric, personalized intelligence on the effectiveness of chemotherapy and targeted therapy treatments, to help support clinical decision-making and drug development. Our strategy is to conduct clinical studies to support regulatory approval of these platforms by the Food and Drug Administration.
Prior to the new rules going into effect, the sharing of summary results for clinical trials was inconsistent. Effective January 18, 2017, summary results must be posted within a year of a trial’s completion, even if the product being tested is not yet FDA-approved.
This is a step forward for patients and their families looking for promising new treatments. According to FDA Commissioner Robert M. Califf, M.D., “When people participate in clinical trials, they are volunteering to create generalizable knowledge to help others in the future and we want their participation honored by ensuring that the existence of trials and their results are available to all patients and their healthcare providers, as well as researchers.”
Some in the biotech community may be wary that all this transparency might interfere with their proprietary solutions. But clinical trials are everyone’s risk, responsibility and ultimately, reward.
The more information we share, whether positive or negative, the more we can drive down the cancer death rate even further. That’s good news for everyone.
Robert Henry is the president and chief executive officer of Pierian Biosciences.