Mary Gunn succeeds James Cheong who has served as CEO for five and a half years

The Board of George Clinical extends its gratitude to James for his dedication and significant contributions to the company over this time.

For further information about Mary Gunn, click here.

The Phase I trial will be conducted under an open label in two stages across multiple sites in Australia, Hong Kong and South Korea. The first Phase Ia stage will study ascending doses of RC220 bisantrene to determine safety, tolerability, pharmacokinetics, m6 A RNA effects, and the maximum tolerated dose alone and in combination with doxorubicin. In the second Phase Ib stage, the optimal dosage of RC220 bisantrene in combination with doxorubicin will be assessed for additional safety, tolerability, and preliminary cardio-protective and anticancer efficacy signals. The Phase I trial will use a Bayesian design allowing for greater trial flexibility and speed. The final trial protocol and commencement of the trial is subject to human ethics and institutional approvals.

Race Chief Executive Officer Dr. Daniel Tillett commented

“This agreement with George Clinical is a significant milestone for Race to bring RC220 bisantrene to the clinic to potentially protect patients from the heart damage caused by anthracyclines while improving the treatment of their cancer. I welcome the opportunity for Race to work with George Clinical and wish to thank the Race clinical team for their hard work and dedication in reaching this agreement.”

Race Chief Medical Officer Dr. Michelle Rashford added

“This is a key foundational study to establish important safety and drug absorption kinetics for RC220 and provide appropriate doses for effective combination with doxorubicin to advance the development of RC220 for clinical cardiac benefit to patients treated with anthracyclines while providing improved outcomes. We are delighted George Clinical can support this significant step for Race and through the selection process their responsiveness and clinical insight has impressed us. I and the rest of Race clinical team look forward to working with George Clinical on this and future trials.”

In the lead up to the 2024 ASCO annual meeting, oncology professionals were invited to “Come for the science, stay for the connection and leave with an inspiration that will drive you forward.” Aside from the science, this year’s ASCO theme was also focused on art. “The Art and Science of Cancer Care: From Comfort to Cure” 2024 presidential theme placed patients and their families at the center of many discussions. In her opening address, ASCO President Lynn M. Schuchter stated, “What I’m advocating is a re-emphasis on a fundamental concept in medicine dating back to Hippocrates: “To cure sometimes, to relieve often and to comfort always is all that may reasonably be expected of medicine.”

With patient wellbeing a stronger focus than ever before, palliative care was given as a top priority for oncology patients. Research indicates that palliative integration at diagnosis significantly improves quality of life and overall well-being, with some studies suggesting a potential for longer survival times. Currently only 3–4% of oncology clinicians are dual-certified in oncology and palliative care, so ASCO is piloting an ACGME-approved combined Hematology/Oncology and Hospice and Palliative Medicine Fellowship. ASCO guidelines have also been updated to emphasize palliative care as an integrated, holistic part of patient treatment from the point of diagnosis.

Innovation in oncology research and clinical practice has always set the landscape for other therapeutic areas to explore, and the new grassroots initiative of Common Sense Oncology (CSO) is sure to create ripple effects in the future. The CSO vision is that patients will have access to treatments that provide meaningful improvements in outcomes that matter, regardless of where they live. Achieving this vision will require improvements in evidence generation, evidence interpretation and evidence communication. Headed by a group of clinicians, academics, policymakers and patient advocates from health systems around the world, CSO seeks to ensure that both industry and academia are focused on clinical trial endpoints that improve the quality of life for patients and do not come at the expense of compromised quality of life due to side effects, time toxicity and financial toxicity.

POSITIVE, ENERGIZED ATMOSPHERE

ASCO 2024 was the first full-blown, live-attendance conference since COVID, and the atmosphere was extremely positive with lots of collaborations, side conversations, relationship building and camaraderie. George Clinical was well-represented with Rachel Condjella, Project Director & Regional Therapeutic Area Lead, Oncology; Gillian Ryan, Global Head of Early Phase; multiple members of the business development team; and members of George Clinical’s global oncology scientific leadership team, including Dr. Herbert Loong, Dr. Mustafa Khasraw, Dr. Mitesh J. Borad, Dr. Ralph Boccia, Dr. Ari Vanderwalde and Dr. David Thomas. The team continues to reinforce our global oncology relationships and create new collaborations with sponsors, CROs, KOLs and partners such as Advarra who has helped us to expedite IRB approvals for clinical trials. 

“Options for patients with cancer continue to advance with many new and modified treatments entering Early Phase trials. Whilst this focus on developing better treatments remains important, the focus on patient centricity in Early Phase oncology trials is an important shift in the landscape of better therapy development—not only from an efficacy viewpoint, but in terms of ensuring that the key needs of patients are at the forefront of treatment options.” Gillian Ryan, Global Head of Early Phase

ADVANCEMENT HIGHLIGHTS

With 200+ sessions, there was plenty of cutting-edge oncology research for the 40,000 attendees to explore and discuss.

Breast Cancer

There were rapid updates in the treatment guidelines for early breast cancer. Clinical data has previously proven CDK4/6 inhibitors as effective treatment for late-stage advanced breast cancer. With that efficacy well-established, further research into the effects of CDK4/6 in earlier stages is providing late-breaking data showing better outcomes in invasive disease free survival for this expanded group of patients.

Chronic Myeloid Leukemia

For patients with newly diagnosed chronic phase, chronic myeloid leukemia (CML), data from the ASC4FIRST trial suggest that asciminib may be a safer and more effective treatment option than tyrosine kinase inhibitors (TKIs). Not only did asciminib have superior efficacy over TKIs, but it also had a higher safety profile with fewer adverse events, drug interruptions and drug discontinuations. The results thus far are extremely promising. Longer follow-up is planned to determine long-term benefits and safety profile.

Non-small Cell Lung Cancer

The Phase III CROWN study evaluated the long-term outcomes of lorlatinib versus crizotinib in patients with previously untreated, advanced, ALK-positive non–small cell lung cancer with very favorable outcomes after five years of follow up. Lorlatinib has shown the longest-ever PFS in advanced, ALK+ NSCLC. This is considered an “unprecedented” improvement in outcomes for patients.

Colorectal Cancer

Treatment options for locally advanced MMR-deficient rectal cancer currently include chemotherapy, radiation and surgery. Although effective, these treatments are also associated with a decline in quality of life. Early results of a GSK Phase II study have shown a 6-month treatment of a PD-1 blocking monoclonal antibody resulted in no patients requiring additional therapy or experiencing disease recurrence. With PD-1 blocking showing such successes in sustained remission, the improvement in quality of life will be significant—especially as conventional treatments often become ineffective as the disease progresses.

AI in Oncology

ASCO 2024 certainly acknowledged the role that AI is soon going to have in benefiting research, clinical practice and patients. In order to ensure that this technology is understood and navigated carefully, ASCO is creating a framework of principles for AI’s responsible use in oncology care. With benefits like faster, more accurate diagnosis, AI will help patients get the most appropriate treatment for their specific cancer. AI can also free healthcare professionals from many routine tasks and give them more time to focus on patients. In a way, AI will become a major player in “The Art and Science of Cancer Care” by giving clinicians and researchers more time for the human interface—for compassion—for ensuring that cancer patients and their families receive the personal care and respect that will ensure they have the comfort, relief and guidance they need.

The Phase I trial will be conducted under an open label in two stages across multiple sites in Australia, Hong Kong and South Korea. The first Phase Ia stage will study ascending doses of RC220 bisantrene to determine safety, tolerability, pharmacokinetics, m6 A RNA effects, and the maximum tolerated dose alone and in combination with doxorubicin. In the second Phase Ib stage, the optimal dosage of RC220 bisantrene in combination with doxorubicin will be assessed for additional safety, tolerability, and preliminary cardio-protective and anticancer efficacy signals. The Phase I trial will use a Bayesian design allowing for greater trial flexibility and speed. The final trial protocol and commencement of the trial is subject to human ethics and institutional approvals.

Race Chief Executive Officer Dr. Daniel Tillett commented

“This agreement with George Clinical is a significant milestone for Race to bring RC220 bisantrene to the clinic to potentially protect patients from the heart damage caused by anthracyclines while improving the treatment of their cancer. I welcome the opportunity for Race to work with George Clinical and wish to thank the Race clinical team for their hard work and dedication in reaching this agreement.”

Race Chief Medical Officer Dr. Michelle Rashford added

“This is a key foundational study to establish important safety and drug absorption kinetics for RC220 and provide appropriate doses for effective combination with doxorubicin to advance the development of RC220 for clinical cardiac benefit to patients treated with anthracyclines while providing improved outcomes. We are delighted George Clinical can support this significant step for Race and through the selection process their responsiveness and clinical insight has impressed us. I and the rest of Race clinical team look forward to working with George Clinical on this and future trials.”

If you or a loved one suffered from a rare disease for which there is no treatment or cure, and there was a drug that had shown potential to give you some relief—some hope—you would want to have access to that drug as quickly as possible. That’s what was happening when the HIV/AIDS epidemic suddenly started taking lives at a rapid pace in the 1980s. AIDS activists demanded something—anything—to address the issue. They called on the FDA to offer greater flexibility in getting drugs approved, and it opened up new possibilities in the realm of drug development. The FDA allowed researchers to focus on surrogate endpoints that showed evidence of clinical benefits. AZT, approved in 1987, was the first drug approval based on a surrogate endpoint—and that ultimately led to the highly effective HAART drug that has allowed HIV/AIDS patients to live out their normal life spans.

From that experience, the FDA created pathways for expediting drug development including the Accelerated Approval (AA) program initiated in 1992. AA provisions state that “the FDA may grant accelerated approval to a product for a serious or life-threatening disease or condition upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality (IMM) or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.”

For drugs granted accelerated approval, postmarketing confirmatory trials are required to verify and describe the anticipated effect on IMM or other clinical benefit. As of December 31, 2023, 307 drugs have received accelerated approval, giving millions of patients reduction of disease symptoms, renewed hope and even extension of lifespan. As an example, for patients with non-small cell lung cancer (NSCLC) that had progressed or did not respond to prior therapy, two drugs that have received accelerated approval have resulted in earlier access for over 500,000 patients and nearly 200,000 additional years lived compared with expected survival had the drugs not been available.¹
 

AA PROGRAM BENEFITS

Currently, greater than 80% of drugs in the AA program are for orphan indications for rare diseases—those that affect fewer than 200,000 people. In 1983, the Orphan Drug Act was passed, recognizing the fact that there were more than 20 million patients suffering from rare diseases that were being left out of scientific advancements in disease therapies. When patients came to testify in the congressional hearings—many of them children, Representative Henry A. Waxman, instrumental in passing this act stated, “It was as if someone had pulled back a curtain to reveal an entire segment of society that no one knew was there. Gathered together in a congressional hearing room before the national media were human beings with diseases so disabling or disfiguring that they never came out in public.”²

The passing of the Orphan Drug Act removed barriers for pharmaceutical companies and provided them financial incentives to research these diseases. There are >7,000 recognized rare diseases affecting nearly 350 million worldwide, and more than 90% do not have FDA-approved therapies. Nearly 80% of AA drugs are for rare cancers, which according to the International Agency for Research on Cancer (IARC), have fewer than six newly diagnosed cases per 100,000 people per year. Although individually these cancer types are rare, taken as a whole, they account for about 25–30% of all cancer diagnoses and 25% of cancer deaths.

The benefits of the AA program are undeniable. Where a traditional drug approval process can take as many as 15 years, drugs in the AA program, on the average, are available more than three years earlier. Earlier access to treatments for patients, smaller more efficient trials that take far less time to conduct, and a potential faster path to even better drugs make the AA program valuable.
 

 

WHAT ABOUT RISKS?

All aspects of new drug development come with risks, and the AA program is not an exception. Can patients be exposed to a drug that is ineffective or even unsafe? Do the smaller, shorter trials collect enough information on rare or delayed adverse effects? What if postmarketing confirmation is not done in a timely manner—or not at all? Will the high cost of these drugs mean that they get to only a few of the patients who need them? Will patients who are needed in future clinical trials be reluctant to join if they are already taking an accelerated approved drug? All of these risks have consequences. In some cases, the solution is determining risk vs. reward. In others, the risk can be mediated.

Of all of these issues, perhaps compliance with the postmarketing confirmation requirement has been the most controversial. Research has oft and clearly documented the slow and sometimes non-existent progress of these studies, with some AA drugs staying on the market for years without confirmation—all the while earning the drug company millions. One such drug was found to have been on the market for 25 years without completing its confirmatory studies while earning more than $200 million. In response to the issue, Congress has empowered the FDA to set more stringent requirements and timelines for these confirmation trials. There have been updates in 2023 and more reforms are being proposed.

Organizations such as the National Organization for Rare Disorders (NORD) who fully support the AA program are working with Congress and HHS to ensure that changes ultimately benefit the rare disease community—that’s 30 million Americans and 350 citizens worldwide who are waiting and hoping. And a recent analysis³ of the AA program determined that it is overall very successful, with half of all AA approvals converted to traditional approval in an average of little more than three years.
 

CONCLUSION

The AA program has proven to have tremendous benefits for people whose diseases are understudied and lack effective treatments. The drugs being given accelerated approval are held to the same gold standard as those in traditional approval and there is no question that these treatments are changing lives—not just for cancer patients, but also for kidney patients whose disease trajectory ultimately leads to dialysis or death. Before the FDA was prepared to consider urine protein-to-creatinine ratio (UPCR) as a surrogate endpoint, there were only one or two Phase II trials for IgA Nephropathy (IgAN) and no Phase III trials. Since UPCR was accepted there are now >150 Phase II and Phase III trials in progress and the first ever IgAN drugs have received accelerated approval status.

Tarpeyo (budesonide) was granted accelerated approval in December 2021 and followed with full approval in December 2023 based on clinical trial results for treatment of adults with primary IgAN. George Clinical is proud to have been a part of the PROTECT study that resulted in Filspari, the first non-immunosuppressive therapy for the reduction of proteinuria in IgAN, being granted accelerated approval in February 2023. The ongoing Phase III global, randomized, multicenter, double-blind, active-controlled clinical trial is designed to demonstrate whether Filspari slows kidney function decline. Topline results from the two-year confirmatory endpoints are expected in the fourth quarter of 2023 and are intended to support traditional approval of the drug.

These are proof that accelerated approval can function in the way it was intended, given the collaboration and partnership of sponsors, scientific leadership, trial managers and the FDA to ensure best practices. These approvals have built confidence in starting to look at other kidney diseases such as focal segmental glomerulosclerosis (FSGS) that could benefit from this approach.

As the science of drug development evolves, the AA program will need to make adjustments, and there are many invested experts willing to work closely with the FDA to ensure success. Industry needs to do their part by designing trials that account for the use of accelerated approval drugs and that can efficiently move into confirmatory studies. More education and stronger labeling is also needed for physicians and patients to explain what accelerated approval is and identify the drugs as such.

The goal is to keep drug development advancing, especially for rare diseases, so that lessons learned from early treatments generate even better solutions and more options for future patients. Accelerated approval is a critical cog in the drug development ecosystem to provide access to new, safe and effective drugs where there is currently no meaningful alternative. Patients who are suffering are waiting and hoping. And if you or a loved one is one of those patients, accelerated approval could literally change the trajectory of your life.
 
 
¹ Partnership for Health Analytic Research, Issue Brief 7//26/22, Clinical Benefits of Accelerated Approval.
² Institute for Clinical and Economic Review (ICER), The Next Generation of Rare Disease Drug Policy: Ensuring Both Innovation and Affordability, April 7, 2022.
³ Beakes-Read G, Neisser M, Frey P, Guarducci M. Analysis of FDA’s Accelerated Approval Program Performance December 1992–December 2021. Ther Innov Regul Sci. 2022 Sep;56(5):698-703. doi: 10.1007/s43441-022-00430-z. Epub 2022 Jul 28. PMID: 35900722; PMCID: PMC9332089.

At the opening plenary of Kidney Week 2023, ASN President Michelle A. Josephson acknowledged the contributions that the 12,000 attendees are making in the fight against kidney diseases who are “mounting a daily fight on behalf of your patients—working on matters of existential importance on both an individual and a global scale.” She urged everyone to “never stop fighting this fight.”

For decades, kidney patients have had few treatment options, with therapeutic advances lagging far behind research in other diseases. But times have changed, and at Kidney Week 2023, it was evident that a new era is rapidly dawning. Recent developments are finally changing practice—giving new hope. Breakthroughs across the board—from CKD to IgA nephropathy and FSGS, are signaling the possibility of delaying time to kidney failure and extending the quality and duration of life for many kidney patients. 

Genetic profiling was a hot topic as we gained a growing understanding of the pathogenesis of kidney disease. Leading the way is the discovery of the APOL 1 gene which has been identified as a “kidney risk” gene and is now known to account for nearly all excess risk of kidney failure in African Americans arising from causes other than diabetes.

Nephrology trials have evolved from large CKD studies into much smaller and more complex studies for rare diseases. It now seems possible that, in the not-so-distant future, we will have the capability to target distinct stages in an individual’s disease with novel, more precise therapies that do much more than manage symptoms. For a disease whose treatments have basically remained static for decades, this is indeed a momentous time.

George Clinical’s global renal team well represented.

The central place and worldwide influence of ASN was clearly evident with an impressive diversity of worldwide participants. George Clinical’s global renal team was well represented with team members from the USA, UK, Australia, Sri Lanka, Singapore, Argentina, Brazil and China. This included leaders from both operational and Scientific Leadership teams—many of whom are proud to have been a part of high-impact trials that were discussed for CKD, IgAN and FSGS.

Dr. Manthinda Hettiarachchi, Renal Global Therapeutic Head stated, “The best moment of Kidney Week for me was unveiling the study data from a Phase II IgA nephropathy study in which George Clinical played a major role in making a great success. It happened during the height of the pandemic, but our efforts made it possible to recruit more patients than needed and retain all of them. Dr. Muh Geot Wong and Professor Vivekanand Jha played a major role in encouraging the principal investigators to keep going forward in their regions. This is a great example of George Clinical’s commitment to success.”

Zhenfei Yi, Regional Head Project Operations China was able to speak to sponsors about our passion for and commitment to conducting renal trials in China, where kidney disease behaves in a more aggressive manner than in Western populations. Sergio Godoy, Associate Director, Scientific Services Argentina spoke with sponsors on the value of our differentiating Scientific Leadership model in renal trials, reflecting the fact that many of our Scientific Leaders had work prominently highlighted in conference presentations as well as in such esteemed publications as The Lancet and NEJM. 

“My ASN experience was a success,” said Sergio. “The ASN was a special moment for smiling and meeting with people that you regularly talk to, but you do not have the opportunity to see and speak to in person often. And it was fabulous to be able to have dinner with two inspiring National Leaders I have worked with. I also participated in a Steering Committee Meeting for the first time and celebrated how much I learned.”

George Clinical’s Senior Scientific Leaders came from around the world to participate and network. Dr. Chee Kay Cheung from the UK remarked, “A personal highlight for me was seeing results announced from clinical trials on IgA nephropathy and other kidney diseases I have been working on for many years, both as an investigator and with George Clinical. There have been rapid developments in the field which are changing practice and how we think about these diseases, with a lot more exciting work to come.”

Professor Roberto Pechoits-Filo agreed, stating, “I felt that the Kidney Week vibe was back to pre-pandemic level. I was thrilled to see several of the high-impact trials presented and simultaneously published in top-notch journals, reflecting the amazing moment that Nephrology is going through.” And Dr. Brendon Neuen, Senior Research Fellow from Australia reflected, “It was fantastic to see our work on GFR slope as a surrogate endpoint help inform the design, conduct and reporting of trials evaluating new therapies for glomerular diseases, particularly IgA nephropathy. We are really only just embarking on what will be a golden age for kidney disease clinical trials.”

The need to address the global renal burden is real—and for George Clinical, the mission is vital. The work we are doing in renal trials is creating a community of medical practitioners globally who are treating their patients to the highest available standards — regardless of their location. We are dedicated to creating the next generation of KOLs—actively educating the next generation of clinicians and researchers who will carry the mission forward. As a global CRO specializing in Kidney & Metabolic, George Clinical strives to contribute to defining the future of clinical care for worldwide kidney disease patients in this promising new renaissance of kidney research.

In a world where more efficient and better targeted treatments are being approved at an unprecedented rate, patients are understandably eager to take advantage of the new discoveries, especially when it comes to rare diseases such as Immunoglobulin A nephropathy (IgAN) where safe and effective treatment options are very limited.

IgAN is a rare disease that damages the kidneys’ tiny filtering units and can lead to kidney failure, requiring a kidney transplant or dialysis. It may go unseen for years and can happen at any age, but symptoms most often start before the age of 40. The causes of IgAN aren’t well known other than that immune and genetic factors may be involved. Disease progression depends on many factors and varies from person to person — and from ethnicity to ethnicity. 

There is no cure for IgAN, and for decades treatments have focused on managing symptoms and slowing the progression of kidney disease. However, for the first time, effective treatment options beyond supportive care are becoming available, signifying a new era. Recently the FDA granted accelerated approval for Spartensan and Budesonide in adults with primary IgAN at risk of rapid disease progression. These drugs act in different ways to reduce the amount of protein that leaks into the urine, which in turn helps to protect the kidney.

This is obviously great news for patients, many of whom are eager to start the new therapy immediately. But early research successes are creating a new challenge for drug development. As new treatments become available, patients may well be reluctant to join new clinical trials where there is only hope — not yet proof — that the therapy will be effective. Some patients already enrolled in trials may wish to leave studies where they are receiving an experimental drug or even a placebo.

As this plays out in real time, our current and future clinical trials may be in jeopardy. The cascading effect of patients’ reluctance to enter new trials or, worse still, choosing to leave an ongoing trial, could eventually have a paralyzing effect on the development of new, even more effective treatments. Will this new era mean we are approaching a time when the old saying, “There is nothing that fails like success” might apply to the drug discovery process that has for decades yielded new, more effective treatments for chronic disease?

We are currently faced with just such a dilemma where we have several ongoing trials that are targeting different ways of treating IgAN. Physicians face an ethical dilemma when trying to determine whether to keep patients in studies or enroll them for a multi-year trial when new treatments are already available — especially in blinded trials where even the physician does not know if the patient is receiving an experimental drug or a placebo. There is also an increasing problem of patients taking prohibited medications without the knowledge of the investigators, which results in censoring of their data and affecting the integrity of the trial. A key example is the use of Ambrisentan in China. Even though there is no data for its effectiveness in IgAN, the announcement of the accelerated approval of Sparsentan resulted in an increase in the use of Ambrisentan, a similar class of drug approved for pulmonary hypertension in China.

To make matters more complicated, IgAN progresses at different speeds in different populations. Where the disease is progressing slowly, it can be argued that holding off the new treatment for trial participation can have more longterm benefits. But in patients where the disease is much more aggressive, there may well be organ-saving benefits to opting out of research efforts.

Innovation in the treatment of disease has been based on clinical trials, and it has worked very well to advance medicine. But something works until it doesn’t work anymore, and we are fast approaching the time when relying on what worked in the past may lead instead to failure if we do not begin to discuss and address this challenge.

The current landscape of clinical trials for IgAN is exciting indeed with nearly 50 trials listed on clinicltrials.gov testing different ways of targeting the disease. The hope for the future of IgAN treatments is to have multiple therapies available in order to best match a therapy to each patient’s unique medical and personal situation. The only way that we can achieve this goal is in partnership with patients who understand the value of participating in randomized clinical trials — our best mechanism for translating scientific discoveries into therapies that advance the standard of care. 

It is a daunting thought that future innovations could be stymied by incremental success. We must clearly define the issue and, after careful consideration of all consequences, determine how we can keep innovation moving ahead while patients continue to reap the benefits of new treatments as they become available.

New Perspectives — New Models are Needed

Some new perspectives may be needed as we move forward, and all stakeholders should consider their roles in addressing ways to keep scientific innovation moving forward while best serving our global patients.

Value of Scientific Leaders in Clinical Trials — Scientific Leaders who are involved from the very beginnings of a study can have influence over their design and protocol. When Scientific Leaders are both clinicians and researchers, their perspective includes not only the potential benefits of the research but also how a specific trial might affect patients. As we move forward, these Scientific Leaders will be key in maintaining strong communication channels that flow between trialists, patients and their physicians. They can help physicians understand which patients are best suited for studies and most likely to stay till completion. They can also begin to include provisions in trial designs and protocols that address the possibility of patients desiring to leave studies early. For example, potential trial designs could include rescue therapy, basket trials and those designed to complete faster and more efficiently. In addition there could be potential incentives created in trials that insures early access to new therapies for patients, especially those who have participated in parts of the world where access to newly approved drugs is frequently delayed.

Need for Joint Care Plans for Patients — The idea of opening better communication between all healthcare professionals treating a patient is not a new one, but it becomes more critical when deciding to enroll a patient in a clinical trial. Whereas a nephrologist may clearly understand the nuances of the disease and whether or not a new treatment is the patient’s best option, their GP may see the situation differently. With a Joint Care Plan in place, patients could be assured that everyone involved was making the most beneficial decisions. This would lead to trials where participants are the most likely to benefit from and to complete a study.

Role of influential IgAN-specific organizations — We can also consider how organizations that patients rely on can help patients better understand their options. If patients are educated fully about all potential benefits and risks of trial participation, it could help ensure that those who choose to participate will complete the study. If could be beneficial to studies if patients had already considered that a new treatment might become available during the study and had discussed this possibility in advance with their nephrologist.

Role of Industry — Industry determines what the protocols look like, so by taking all factors into consideration at the very early planning stages they can make provisions that consider all possibilities for participants. Collaboration with Scientific Leaders, IgAN organizations and patients in the planning stages can help ensure that their trial is designed with the big picture in mind. Acknowledgement of these new challenges and proactive planning can help avoid issues that might derail a trial.

Role of Patients — Patients come in all forms. Some are extremely engaged in their care and do everything they can to learn about their disease and the options available to them. Others trust their healthcare providers and expect that the best decisions for them are being made. Therefore, although it is advisable for patients to learn all they can about their disease and take ownership of their healthcare journey, it is quite unfair to assume that all patients are going to have the experience or take the opportunities to engage in that manner. Therefore, there is a greater burden of responsibility on the professionals to ensure that patients remain knowledgeable, monitored and protected.

Conclusion

Kidney disease has had a long wait for new treatments, and these forerunners of, hopefully, many more to come are very exciting to patients and physicians alike. But it is yet to be proven that these are the right solutions for all patients, and there is much more work to be done. Everyone in the clinical research ecosystem needs to acknowledge the possibility that as new treatments become available, we could witness an increased difficulty in clinical trial enrollment. Together we should openly discuss the potential affects of such a phenomenon and work as a team to address the issue and determine the best way forward. A higher quality of life and greater longevity for patients is everyone’s ultimate goal, and research is the essential element in making even more beneficial discoveries. Our creative thinking and careful planning can help to avoid our early successes leading to future failures. 

SYDNEY, July 28, 2023 – George Clinical recognises and applauds its collaborative partner Omico, with whom it is aligned in a common goal to revolutionize oncology clinical trial access for patients and improve the efficiency of study enrollment, on the launch of their landmark program PrOSPeCT–a program that brings precision oncology trials to the Australian community by linking genomic technology to trials of new therapeutic products. 

Omico is an Australian government-backed national network of leading researchers, clinicians and industry partners, including George Clinical, that are using precision medicine to unlock new potential in Australian research and turn the tide on cancer. With fast-tracked molecular screening, biomarker-led trial set up and patient enrolment across the entire nation, Omico is accelerating access to next-generation treatments and preventive strategies improving outcomes for all Australians affected by cancer.  

“Omico provides a faster, better way to perform cancer molecular screening, enroll patients and set up biomarker-led clinical trials thereby offering George Clinical, our sponsor partners, sites, and patients, the ability to match genetically eligible patients to cutting edge oncology clinical trials being conducted in Australia in a non-traditional, more efficient and direct model,” said Susan Cole, global head therapeutic strategy, oncology for George Clinical.

Through the PrOSPeCT initiative, Omico is further expanding its reach by opening up new treatment paths across Australia for people with difficult-to-treat cancers including those with ovarian cancers, pancreatic cancers, sarcomas, and advanced and metastatic cancers. PrOSPeCT has three main aims: to screen a magnitude of patients that is beneficial to the Australian public and the economy with 23,000 patients to access free, cutting edge genomic screening; to match patients to precision medicines in clinical trials that are being conducted across Australia; and to create a database of real-world data that will be useful in the future for further research. 

”Omico is committed to supporting the Australian life sciences industry. It is through organizations like George Clinical that we support more clinical trials in Australia, creating new jobs, while bringing hope to our patients battling cancer”, says Professor David Thomas, oncologist, founder and CEO of Omico. 

George Clinical’s success with oncology trials has been driven by scientific expertise and operational excellence. The synergy between the two organizations is no better demonstrated than the current collaboration undertaking early phase molecular screening dependent trials in Australia that require the ability to combine the targeted identification of patients through the use of the Omico’s PrOSPeCT initiative to accelerate access to precision oncology, and George Clinical’s focus on the scientific objective leading to success through maximizing site selection, recruitment, and overall trial efficiencies for the best result possible. 

About George Clinical

George Clinical is a leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence. With over 20 years of experience and more than 500 people managing over 39 geographical locations throughout the Asia-Pacific region, USA, and Europe, George Clinical provides the full range of clinical trial services to biopharmaceutical, medical device, and diagnostic customers, for all trial phases, registration and post-marketing trials.     

• Website: https://www.georgeclinical.com
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For more information, contact:

Matthew Reabold

Head, US Business Development

• T: +1-760-645-0496
• E: mreabold@georgeclinical.com
• W: georgeclinical.com | georgeinstitute.org

ASCO’s 2023 Annual Meeting drew oncology professionals from around the world to learn about new clinical advances in cancer research, gain real-time insights from world-renowned experts and connect with one of the largest, most diverse audiences in global oncology. Peer-to-peer interaction is the most exciting aspect of these meetings for many attendees, and is extremely valuable in progressing research. The theme of this year’s meeting –“Partnering With Patients: The Cornerstone of Cancer Care and Research” was a reminder that interaction with patients who participate in clinical trials is just as important. They are actually the most important partners in research, and it is their participation that has made virtually all progress in cancer care or the last 50+ years possible.

Patient centricity has long been a buzz-word in the clinical trial community, but the concept is slowly beginning to take hold. It’s a re-setting of goals beyond collecting data from “subjects,” to the intentional inclusion of the real-world needs of patients and their caregivers. The pandemic actually helped to move the needle when it forced creative solutions that ultimately reduced patient burdens connected to clinical studies. Remote monitoring, allowing patients to get lab work at locations closer to home and even shipping drugs to patients homes are now finding their way into standard trial practice.

While these logistical improvements are beneficial, we still have a long way to go to making patients true partners in clinical research, and ASCO 2023 president Eric P. Winer, set a challenge to “,,, unequivocally recommit ourselves to patients . . . Better, more equitable and engaged cancer care hinges on forging deeper, more meaningful relationships between oncology clinicians and the people we care for.”

When everyone from trial designers to those who review and analyze data recognizes the value of this approach, both the efficiency and effectiveness of trials will be improved. Costs will be reduced and lessons learned will be more quickly translated into clinical practice. CROs who innovate and evolve in guiding studies to serve the greater healthcare community and patients in all parts of the world will play a large part in this transformation. At George Clinical it has always been our mission to improve the quality of life and the access to the best treatments for all people regardless of their demographic or economic background, and this mission drives the way we approach clinical trials. 

Along with the discussions about re-committing to patients that were woven throughout ASCO 2023 meetings, there were many exciting presentations on the latest cancer treatment research. Those that promise major shifts in cancer treatment were particularly noteworthy. 

mRNA moves beyond COVID-19 to personalized cancer vaccines.

Cancer vaccines are poised on a new era with the data from the Merck/Moderna study of the mRNA-4157 vaccine in conjunction with Merck’s Keytruda showing a reduced risk of distant metastasis or death by 65% in stage III & IV melanoma patients. It’s another positive by-product of the pandemic, which proved that the mRNA technology used to create COVID-19 vaccines was safe and effective. That opened the door for the greater possibility of personalized vaccines that train the immune system to attack a specific type of cancer cells in tumors. 

Cancer vaccines actually refers to vaccines that will help prevent cancer from returning after initial treatment. While the COVID-19 vaccine used a string of mRNA encoding to prevent the disease from occurring, cancer vaccines hold mRNA that encodes for proteins found on the vaccine recipient’s cancer cells. Specifically, they are neoantigens — proteins that are made because of mutations in the cancer cells’ DNA. The vaccine stimulates immune cells like T cells to attack the neoantigens and therefore the cancer.

Cancer vaccines can be personalized to each individual patient and produced in as little as eight weeks after a person’s cancer is biopsied. They promise a generation of cancer therapies that would be a new paradigm in treatment. The Merk/Moderna collaboration is one of many investigating this technology, and it is only a matter of time before these breakthroughs find their way into clinical practice. The hope is that soon there will be a cancer vaccine for almost any type of patient.

Research continues to reach for paradigm shifts in breast cancer.

Approximately one-third of those diagnosed with stage II, and more than half of those diagnosed with stage III HR+/HER2- EBC, experience cancer recurrence. Patients who have responded to treatment live with the constant underlying fear that their cancer will return. Researchers have been dedicated to finding treatments designed to keep that from happening, but there have been limited advancements in reducing that risk while maintaining quality of life for patients diagnosed with early breast cancer.

Data presented from the Novartis Phase III NATALEE trial at ASCO 2023 showed that Kisqali® (ribociclib) plus endocrine therapy (ET), compared to ET alone, lowered the risk of cancer recurrence by 25.2% in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (HR=0.748; 95% CI: 0.618, 0.906; p=0.0014), along with a consistent and clinically meaningful invasive disease-free survival benefit across key pre-specified subgroups.

These are extremely encouraging results that could fundamentally change the way we treat patients with stage II and III HR+/HER2- early breast cancer — giving them a well-tolerated option for a healthier future.  NATALEE creates the possibility to keep a broad population of patients cancer-free without the negative side effects that can disrupt the quality of so many cancer patients’ daily lives.

The NATALEE presentation was close to the heart of attending George Clinical team members, as we were partners in the study for the Chinese portion of the trial. We are proud to have been a part of this study and to have achieved a record-breaking recruitment rate for China and a lower screen fail rate compared to the rest of the sites in the world. We shared the same goal as our partners in the study of conducting clinical trials that could ultimately make a fundamental difference and improve the lives of patients.

Rave Grants Manager manages the entire investigator grant life cycle of clinical trials and provides sponsors and contract research organizations (CROs) with a completely automated solution and live dashboard. Using a comprehensive and data-driven way to develop investigator grant budgets, the solution helps to streamline the site budgeting process, as well as ensure transparency through timely report generations. George Clinical will be able to use the solution to concurrently control the budget model across 50 studies. As Grants Manager is powered by PICAS database, which is one of the industry’s largest investigator-negotiated budget databases, it will help George Clinical in site retention and improve patient recruitment by site. Medidata has also provided training for George Clinical personnel to ensure seamless use of the software.

“At George Clinical, our mission is to improve the health of millions of people worldwide through clinical research supported by global service delivery, world-class scientific leadership, and therapeutic expertise. With Rave Grants Manager, we can ensure that we provide clients with innovative solutions to engage patient populations and reduce sponsor R&D costs. Our clients can now ensure that their clinical trials have an impact on patients, while maintaining the highest scientific integrity,” said Susan Cole, Regional Head Project Operations USA & Europe, George Clinical.

“Currently, 80% of our sponsor’s time and effort in their financial planning is being consumed by manual processes and workarounds. With solutions such as Rave Grants Managers, we want to ensure companies like George Clinical can optimize their output by reducing inefficiencies. With the power of partnership, we build trust for patients, which in turn accelerates clinical trials,” said Edwin Ng, Senior Vice President, Asia Pacific, Life Science, Dassault Systèmes.