Kepler Vision Technologies Reports New Partnership

August 6, 2024

Kepler Vision Technologies continues to extend its reach across Europe by partnering with Norwegian company OneCo Technology. OneCo Technology, is a leader in cutting-edge technology solutions, and Kepler Vision, a renowned healthcare service provider with a deep understanding of local requirements, have joined forces to create a synergy that promises to revolutionise the way healthcare is delivered and managed in Norway.

The care industry is facing increasingly difficult challenges due to an aging population and workforce. While the population of 65+ continues to grow, the workforce sustaining care for this demographic is shrinking. At the core of this collaboration is the integration of advanced technologies into the existing healthcare infrastructure. Kepler Vision’s state-of-the-art innovations in artificial intelligence and digital healthcare solutions are seamlessly merging with OneCo Technology’s extensive experience in patient care, clinical workflows, and operational efficiency.

With the rise of AI, there has been a rapid acceptance of its benefits and use – albeit with some trepidation. With AI still in its infancy stage, there is much more room for growth. Both companies boast a wealth of experience and a passion for pushing boundaries that will lead to the development of innovative solutions that will undoubtedly set new benchmarks within the industry.

Utilising AI and computer vision learnings, Kepler Vision’s Night Nurse solution brings an exceptionally reliable fall detector. Pair this with OneCo’s expertise in patient care and there is potential for significantly improved patient outcomes and experiences.

This is the latest partnership that joins Kepler’s ever expanding network. It’s smart sensor technology is currently embedded in the Mobotix C71 camera but can be run with on any camera using on-premise servers. The product is being used in 8 European countries and is supported by Alcatel Lucent, KPN Health, Ascom, and others. Most recently, the health-tech company partnered with Yourizon, which added Kepler’s technology into its own product line.

Lene Høysæter Larsen, Head of Health Technology and Corporate Communications says: “This partnership between OneCo and Kepler is not just a collaboration; it’s a declaration of intent—a commitment to shaping the future of technology and data analytics. This alliance brings together the best of both worlds, fusing technological innovation with data-driven insights to empower businesses and drive unparalleled success.”

Harro Stokman, CEO of Kepler Vision Technologies says: “Working with companies like OneCo Technology provide so many benefits to not just eachother’s companies but also the patients and care workers using our products. As we continue to meet and collaborate with more innovative companies like OneCo across Europe, we can expect even better solutions to be developed.”

Northwell Health Cancer Institute appoints leader in robotic pancreas surgery

August 6, 2024

The Northwell Health Cancer Institute has chosen Steven Mitchell Cohen, DO, as its director of robotic pancreas surgery. Northwell has one of the largest cancer programs in New York State. Renowned for his expertise in the field, Dr. Cohen will further differentiate Northwell’s treatment of pancreatic disease with an emphasis on robotic Whipple procedures.

The Whipple is a complex surgery involving the pancreas, small intestine, gallbladder and bile duct. Dr. Cohen will report to Matthew J. Weiss, MD, MBA, vice president and vice chair of surgical service line, deputy physician-in-chief, and director of surgical oncology at Northwell Cancer Institute, and work to ensure that the program achieves new heights in excellence and innovation.

“We’re excited to add such an experienced leader in pancreas surgery, someone who has performed a high level with excellent outcomes on the leading edge of pancreatic cancer,” said Dr. Weiss. “The Whipple operation is already performed in high volume both robotically and open at Northwell Health. We’re confident Dr. Cohen will take this program to the next level.”

Prior to joining Northwell, Dr. Cohen served in roles at NYU Langone, from its gastrointestinal cancer management group to general surgery, as well as his involvement in Surgical Oncology NYC Health + Hospitals/Bellevue and NY Harbor VA Health Care System. Over the past five years, he focused extensively on robotic Whipple surgery in the Division of Hepatobiliary and Pancreatic Surgery. Dr. Cohen is board certified in general surgery and surgical critical care/trauma by the American Board of Surgery.

“The goal is to convert the more complicated pancreas surgeries to robotic procedures,” said Dr. Cohen. “Robotic pancreas Whipple surgery is preferable because it’s less invasive, there’s less blood loss and patients will experience less pain post-op. The robot allows for a great deal of suturing and stitching, similar to what I can do during an open surgery. And the visual is very impressive since you can see it in 3D. Additionally, the patient’s hospital stay will be shorter, and they’ll experience a slightly shorter healing process.”

Dr. Cohen received a Bachelor of Science degree from University of Arizona. He went on to earn his medical degree from Kirksville College of Osteopathic Medicine and completed his postdoctoral training, residencies and internships at Brookdale University Hospital in Brooklyn.

In recognition of his achievement in the field of robotic pancreas surgery, Dr. Cohen received the Mentor, Resident Grant Award from the American Pancreatic Association. His writings have appeared in such prestigious publications as Annals of Surgery and Pancreas in 2024, Journal of the American College of Surgeons, and the Journal of Surgical Oncology, to name a few.

Dr. Cohen will perform robotic Whipple procedures at Long Island Jewish Medical Center in New Hyde Park, Lenox Hill Hospital in Manhattan and South Shore University Hospital in Bay Shore.

Plaque Quantification In Coronary Arteries Is a ‘Game-changer’ | By Campbell Rogers, M.D., F.A.C.C., Executive Vice President & Chief Medical Officer, HeartFlow

August 5, 2024

Coronary artery disease (CAD) is the most common type of heart disease, affecting an estimated 18.2 million Americans, or about one in 20 adults. It is the leading cause of death in the U.S., claiming the lives of 375,476 people in 2021 alone, 20% of whom were younger than 65.^[1] By 2050, 61% of adults are expected to have some type of cardiovascular disease.^[2]

Although CAD is highly prevalent, it is preventable and treatable. Effective treatment plans depend on accurately assessing the severity of the disease. The current standard of care for determining CAD risk based on risk factors like high cholesterol often gives an incomplete picture of a patient’s overall heart health. Quantitative analysis of plaque can be an effective way to obtain a more complete picture by including measurement of the patient’s total heart atherosclerosis burden. However, manual assessment by physicians is time-consuming and prone to subjectivity.^[3]

Artificial intelligence (AI) provides a simpler and faster alternative and could be a potential game-changer for their heart patients. For example, HeartFlow’s AI-enabled Plaque Analysis tool leverages an automated, deep learning-based, non-invasive method for identifying, characterizing, and segmenting plaque throughout the coronary arteries. By offering a more comprehensive view, plaque analysis tools can improve diagnostic accuracy, enhance treatment planning, and help stratify risk.

Improving diagnosis and stratifying risk

Diagnostic protocols vary, but electrocardiography (EKG), stress testing, single photon emission computed tomography (SPECT) and coronary CT angiography (CCTA) are commonly used options. CCTA scans visualize the patient’s plaque burden, but manual quantification of plaque is highly labor-intensive, which has proven to be challenging due to time requirements and limited inter- and intra-observer reproducibility.^[4]

Information gained from analyzing plaque using AI and proprietary algorithms can help physicians understand critical components of a patient’s plaque burden. More specifically, plaque analysis can help effectively identify, characterize, and segment plaque in the coronary arteries. By being able to assess the type of plaque, its characteristics, location and severity, physicians can stratify a patient’s risk for CAD.

When Plaque Analysis data are paired with insights from Fractional Flow Reserve – Computed Tomography (FFR_CT), physicians can have lesion-specific FFR_CTvalues to determine the need for immediate intervention as well as accurate quantification of calcified, non-calcified and low attenuation plaque, the latter of which is a marker of plaque instability and a major predictor of risk.^[5]

Clinical implications of proper analysis of plaque

HeartFlow’s Plaque Analysis assessment of a patient’s CAD and risk of other cardiovascular events is highly correlated to invasive intravascular ultrasound (IVUS) for quantified plaque volumes for each vessel and lesion. The technology provides physicians with actionable information, such as specific plaque characteristics that correlate with higher risk.^[6],[7],[8] According to the REVEALPLAQUE study, Plaque Analysis has 95% agreement for total plaque volume measures compared with the IVUS gold standard.^[9] The ability to reference the cross-sectional views with plaque by type while reviewing a patient’s workup instills confidence in physicians that the insights are accurate and actionable. The quantitative measurement of a patient’s plaque volume enables physicians to more accurately assess risk and then develop a personalized, targeted treatment plan.

In fact, using the Plaque Analysis tool prompted physicians to modify medical management for two thirds of patients, according to the 2024 DECODE study.^[10] Furthermore, nearly 50% of patients with a calcium score of zero were reclassified following clinician review of the Plaque Analysis, highlighting the importance of quantifying total plaque beyond calcium score.

To evaluate how physicians are changing their treatment decisions when afforded more detailed information about plaque, earlier this year HeartFlow established the DECIDE Registry, which will collect multi-site, real-world information from approximately 10,000 patients at about 25 sites across the U.S.

More detailed information about plaque could enable providers to perform a more detailed and accurate CAD risk assessment and identify more appropriate thresholds for preventive care, which are currently being underestimated by risk assessment scores.^[11] This information may also help providers to assess response to therapeutic interventions and potentially identify patients with residual risk factors at an earlier stage in their disease process. By more accurately assessing patient CAD risk, physicians can produce more effective personalized treatment plans and

[1] Web MD. What is Coronary Artery Disease. https://www.webmd.com/heart-disease/coronary-artery-disease. Retrieved July 25, 2024.

[2] Heart disease and stroke could affect at least 60% of adults in U.S. by 2050. www.heart.org. (2024, June 4). https://www.heart.org/en/news/2024/06/04/heart-disease-and-stroke-could-affect-at-least-60-percent-of-adults-in-us-by-2050

[3] Rinehart S, et al. Utility of Artificial Intelligence Plaque Quantification: Results of the DECODE Study. JSCAI (2024)3;3:: https://www.jscai.org/article/S2772-9303(24)00003-6/fulltext?dgcid=raven_jbs_etoc_email

[4] Narula J, et al. Prospective Deep Learning-based Quantitative Assessment of Coronary Plaque by CT Angiography Compared with Intravascular Ultrasound. Eur Heart J Cardiovasc Imaging. 2024 May 3: jeae115. doi: 10.1093/ehjci/jeae115. https://academic.oup.com/ehjcimaging/advance-article/doi/10.1093/ehjci/jeae115/7663685

[5] Meah MN, Wereski R, Bularga A, et al. Coronary low-attenuation plaque and high-sensitivity cardiac troponin. Heart 2023;109:702-709. https://heart.bmj.com/content/109/9/702

[6] Lee, et al. JACC Cardiovasc Imaging 2019.

[7] Narula J, et al. Prospective Deep Learning-based Quantitative Assessment of Coronary Plaque by CT Angiography Compared with Intravascular Ultrasound. Eur Heart J Cardiovasc Imaging. 2024 May 3:jeae115. doi: 10.1093/ehjci/jeae115. https://academic.oup.com/ehjcimaging/advance-article/doi/10.1093/ehjci/jeae115/7663685

[8] Newby D. et al. Lancet 2015.

[9] Lee, et al. JACC Cardiovasc Imaging 2019.

[10] Rinehart S, et al. Utility of Artificial Intelligence Plaque Quantification: Results of the DECODE Study. JSCAI (2024)3;3:: https://www.jscai.org/article/S2772-9303(24)00003-6/fulltext?dgcid=raven_jbs_etoc_email

[11] Rinehart S, et al. Utility of Artificial Intelligence Plaque Quantification: Results of the DECODE Study. JSCAI (2024)3;3:: https://www.jscai.org/article/S2772-9303(24)00003-6/fulltext?dgcid=raven_jbs_etoc_email

Editor’s Note: Campbell Rogers, M.D., F.A.C.C. serves as the Chief Medical Officer. Prior to joining HeartFlow, he was the Chief Scientific Officer and Global Head of Research and Development at Cordis Corporation, Johnson & Johnson, where he was responsible for leading investments and research in cardiovascular devices. Prior to Cordis, he was Associate Professor of Medicine at Harvard Medical School and the Harvard-M.I.T. Division of Health Sciences and Technology, and Director of the Cardiac Catheterization and Experimental Cardiovascular Interventional Laboratories at Brigham and Women’s Hospital. He served as Principal Investigator for numerous interventional cardiology device, diagnostic, and pharmacology trials, is the author of numerous journal articles, chapters, and books in the area of coronary artery and other cardiovascular diseases, and was the recipient of research grant awards from the NIH and AHA.

What are the Benefits of Couple Counselling & How Does it Works?

August 4, 2024

Love is a beautiful journey, but like any journey, it can encounter rough patches. Communication breakdowns, unresolved conflicts, and emotional hurt can leave couples feeling lost and disconnected. This is where couple counselling, also known as couples therapy, steps in. It’s a safe space for partners to navigate challenges, rebuild trust, and strengthen their relationships. Whether you’re in Brampton or anywhere else, couple counselling can be a powerful tool for couples seeking to reignite the spark and create a more fulfilling connection.

Who needs couple counselling?

Contrary to popular belief, couple counselling isn’t just for couples on the brink of separation. It’s beneficial for anyone looking to improve their relationship. Here are some signs that couple counselling could be helpful:

Frequent arguments and conflicts: If disagreements turn explosive and leave you feeling unheard or disrespected, counselling can equip you with healthier communication skills.
Lack of intimacy: Feeling emotionally or physically distant from your partner can be a sign of underlying issues. Counselling can help you rediscover intimacy and connection.
Infidelity or betrayal: Rebuilding trust after a betrayal is a complex process. Counselling can provide a safe space to address the hurt, rebuild trust, and decide on the future of the relationship.
Life transitions: Major life changes like job loss, illness, or having children can put stress on a relationship. Counselling can help you navigate these changes together.
Difficulty communicating: Feeling unheard or misunderstood can lead to frustration and resentment. Counselling can teach you active listening skills and effective communication strategies.

How does couple counselling work?

The specific approach used in couple counselling will vary depending on the therapist and the specific needs of the couple. However, here’s a general idea of what to expect:

Initial Assessment: The therapist will meet with both partners individually and together to understand the dynamics of the relationship, identify areas of concern, and establish goals for therapy.
Communication Exercises: Therapists often use communication exercises to help couples learn to express their needs and feelings assertively while listening to their partner with empathy.
Identifying Underlying Issues: Many relationship issues stem from deeper problems like childhood experiences or attachment styles. Therapy can help couples understand these underlying causes and develop healthier patterns.
Conflict Resolution Skills: Therapists equip couples with conflict resolution skills, teaching them how to navigate disagreements constructively and find solutions that work for both partners.

The Transformative Power of Couple Counselling:

The benefits of couple counselling extend far beyond simply resolving immediate conflicts. Here are some of the profound ways it can improve your relationship:

Improved Communication Skills: Counselling equips couples with the tools to communicate effectively, fostering a deeper understanding and connection.
Healing Old Wounds: Unresolved past hurts can fester and poison the present. Counselling provides a safe space to address these issues and find healing.
Awareness of Each Other’s Needs: Through open communication, couples gain a deeper understanding of each other’s desires, fears, and expectations. This allows them to become more supportive and understanding partners.
Setting Goals as a Couple: Counselling facilitates collaborative goal setting, allowing couples to work towards a shared vision for their future.
Understanding Your Role: Sometimes unhealthy relationship patterns stem from unconscious dynamics. Therapy can help each partner recognize their role in the dynamic and work towards a more balanced relationship.
Learning Conflict Resolution: Disagreements are inevitable, but counselling equips couples with the skills to navigate them constructively and find solutions that work for both partners.
Seeing Other Perspectives: Learning to view situations from your partner’s perspective fosters empathy and understanding, leading to stronger relationships.
Active Listening: Counselling teaches couples how to truly listen to each other, creating a safe space for open and honest communication.
Developing a Closer Relationship: By resolving issues and fostering better communication, couples build a stronger foundation for intimacy and connection.
Disclosing Your Feelings in a Safe Space: Therapy provides a safe and non-judgmental environment for partners to express their feelings and vulnerabilities without fear of criticism.
Getting an Unbiased Opinion: Therapists offer an objective perspective, helping couples see their situation from a different angle and identify areas for improvement.
A Sounding Board: Sometimes, all couples need is a neutral party to bounce ideas off of and gain a fresh perspective. Therapists can provide this valuable sounding board.
Restoring Trust: Rebuilding trust after a betrayal can be challenging. Therapy can provide a framework for forgiveness, reconciliation, and rebuilding trust.
Clarifying Your Feelings about the Relationship: Counselling can help couples gain clarity about their feelings and work towards a future together, or decide if a separation is the healthiest option.

Finding the Right Therapist in Brampton and Taking the First Step

If you’re considering couple counselling in Brampton, here are some tips to help you find the right therapist:

Do your research. Look for therapists specializing in couple counselling. Many therapists list their areas of expertise on their websites or online profiles. You can also search directories like Psychology Today or Therapy Den.
Consider your needs: Some therapists utilize specific approaches like the Guttmann Method or Emotionally Focused Therapy (EFT). Research different approaches to find one that aligns with your goals.
Read reviews: Client reviews can offer valuable insights into a therapist’s style and effectiveness.
Schedule consultations: Many therapists offer free consultations. This allows you to get a sense of their personality and determine if you feel comfortable opening up to them.

Taking the first step

Opening up about relationship struggles can feel daunting, but taking the first step towards a healthier relationship is a courageous act. Here are some tips to help you navigate the initial conversation with your partner:

Choose a calm and quiet moment. Pick a time when you’re both relaxed and have time to talk uninterrupted.
Start by expressing your desire for improvement: Focus on wanting to strengthen your relationship rather than placing blame.
Be open and honest. Share your concerns and frustrations in a respectful and non-accusatory way.
Be willing to listen. Give your partner the space to express their feelings as well.
Set realistic expectations: Couple counselling isn’t a quick fix, but with dedication and effort, it can lead to significant improvements in your relationship.

Remember, Brampton couples counselling is an investment in your future together. Taking this step can be a transformative experience, bringing you and your partner closer and fostering a more fulfilling relationship.

Marcus Neuroscience Institute, part of Baptist Health, Now Offers High-Intensity Focused Ultrasound for Patients with Essential Tremor

August 2, 2024

Marcus Neuroscience Institute, part of Baptist Health South Florida, at Boca Raton Regional Hospital, is now treating patients with high-intensity focused ultrasound (HIFU) for those suffering from essential tremor.

The technology uses concentrated ultrasound waves to heat the brain tissue and block signals causing the tremor. Under MRI guidance, sound waves are precisely focused on the small spot in the brain considered to be responsible for causing the tremors. There is no incision or general anesthesia used during the treatment.

“We are pleased to be able to offer HIFU treatment at Marcus Neuroscience Institute and help those dealing with essential tremor, which may have impacted their routines and daily activities,” said Timothy Miller, M.D., neurosurgeon anddirector of functional neurosurgery at Marcus Neuroscience Institute. “By having the ability to now target and treat specific areas of the brain with precision, we can improve the quality of life for so many in our community, allowing them to regain control and confidence in their lives.”

Some of the benefits of HIFU include the following:

• Incisionless treatment.

• Outpatient procedure.

• No general anesthesia.

• Immediate results on the treated hand.

• Safe and effective with minimal side effects.

The ability to offer the HIFU treatment at Marcus Neuroscience Institute was made possible through philanthropy.

DePuy Synthes Launches VELYS Active Robotic-Assisted System | First Active Spine Robotics and Navigation Platform

August 2, 2024

Today, Johnson & Johnson MedTech* announced that DePuy Synthes, The Orthopaedics Company of Johnson & Johnson**, is launching a proprietary dual-use robotics and standalone navigation platform developed in collaboration with eCential Robotics. The system, called the VELYS™ Active Robotic-Assisted System (VELYS™ SPINE), received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and is intended for use in planning and instrumenting spinal fusion procedures in the cervical, thoracolumbar and sacroiliac spine.

This new spine technology was designed to help surgeons tackle their most complex challenges. The VELYS SPINE system is dual-use, meaning it features both a standalone navigation and an active robotics platform that can enable surgeon flexibility in their approach and plans. Active robotics allows for surgical guidance tailored to surgeon preference. The distinctive features and capabilities of active robotics technology are set to establish a new standard in spine surgical care.

“We are shaping the next frontier of orthopaedic innovation with a relentless focus on digital advancements and excellence in the field of surgical robotics and navigation. Our dedication extends to enhancing patient care through significant strides in spine surgery,” said Aldo Denti***, Company Group Chair, DePuy Synthes. “This is a major step in growing our VELYS™ Portfolio and in our commitment to supporting spine surgeons and their patients with advanced tools.”

The VELYS SPINE system is designed to address the uniquely complex needs of spine surgeons; the system offers a customizable experience with pathology-specific workflows, aided by capabilities such as VELYS™ ADAPTIVE TRACKING TECHNOLOGY and VELYS™ Trajectory Assistance. It will be used with the DePuy Synthes core Spine portfolio of products, including the TriALTIS™ Spine System and Navigation Enabled Instruments, the SYMPHONY™ Occipito-Cervico-Thoracic (OCT) System, VIPER PRIME™ System and EXPEDIUM VERSE® Systems.

“Today’s landscape of enabling technologies features first-generation robotics systems that may face challenges in adapting to individual surgeon needs,” said Russell Powers†, Worldwide President, Spine, DePuy Synthes. “We recognize the urgent need for innovative solutions that offer new ways to engage with enabling technologies, returning control to surgeon’s hands. We believe that the unique features and capabilities of active robotics technology will set a new standard in surgical care for spine patients everywhere.”

Starting today, the VELYS™ SPINE system will be displayed throughout the U.S. in the MedTech Innovation Experience mobile lab, alongside other technologies and products currently available in DePuy Synthes’ comprehensive Spine portfolio. The MedTech Innovation Experience offers hands-on learning opportunities to surgeons, fellows, residents, and other healthcare professionals. Commercial availability is expected in the first half of 2025. Learn more about the VELYS™ SPINE system at www.ActiveRoboticAssistance.com.

Labcorp Receives FDA De Novo Marketing Authorization for PGDx elio plasma focus Dx

August 2, 2024

Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today it has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for PGDx elio™ plasma focus Dx – the industry’s first and only kitted, pan-solid tumor liquid biopsy test.

PGDx elio plasma focus Dx builds on the success of PGDx elio™ tissue complete and enables laboratories to perform genomic profiling when tissue is limited or unavailable.

“The launch of PGDx elio plasma focus Dx represents a landmark expansion of Labcorp’s suite of precision oncology solutions,” said Shakti Ramkissoon, M.D., Ph.D., MBA, vice president, medical lead for oncology at Labcorp. “This latest liquid biopsy test offers laboratories and oncologists a convenient, cost-effective and highly targeted tumor-profiling solution that spans a wide range of solid-tumor types – particularly when tumor tissue is limited or unavailable. When paired with PGDx elio tissue complete, Labcorp now offers laboratories access to tissue and liquid genomic-profiling assays that operate on the same instrument, enabling seamless integration of these precision oncology products into routine laboratory workflows. The ability to test tissue or liquid will provide critical data and insights needed to inform more personalized treatments and care plans for patients.”

PGDx elio plasma focus Dx is a qualitative next-generation sequencing-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for the detection of single nucleotide variants (SNVs), insertions and deletions (indels) in 33 genes, copy number amplifications (CNAs) in five genes, and translocations in three genes. The assay targets guideline-recommended biomarkers to enable more accurate clinical assessments and is coupled with automated bioinformatics to deliver accelerated results. This solution enhances oncologists’ ability to make timely treatment decisions in conjunction with other laboratory and clinical findings while also promoting sample and data ownership.

PGDx elio plasma focus Dx is part of Labcorp’s comprehensive precision oncology portfolio of testing solutions. For more information, visit https://www.personalgenome.com

Sensitech Completes Acquisition of Berlinger & Co. Monitoring Solutions Expanding Life Sciences Cold Chain Solutions

August 2, 2024

Carrier Global Corporation, on behalf of its Sensitech business, a world leader in supply chain visibility, has completed its acquisition of the Monitoring Solutions business of Berlinger & Co. AG, a Swiss family-owned company that specializes in innovative and customized solutions for monitoring temperature-sensitive goods in the pharmaceutical and life science, clinical trial and global health segments. Sensitech is part of Carrier Global Corporation (NYSE: CARR), global leader in intelligent climate and energy solutions.

“This successful acquisition marks a strategic milestone for Sensitech, creating comprehensive and differentiated cold chain monitoring and visibility solutions for the pharma and life sciences industry,” said Bhasker Kaushal, Vice President & General Manager, Sensitech and Refrigeration Aftermarket. “We are excited to welcome the Berlinger team as our new colleagues and look forward to bringing together the best of Berlinger and Sensitech to enable our customers’ cold chains to become more connected, automated, intelligent and sustainable.”

Berlinger expands Sensitech’s end-to-end cold chain monitoring portfolio with a suite of innovative solutions, including high-quality proprietary conventional and real-time monitoring, value-added software and analytics capabilities. Additionally, it broadens Sensitech’s addressable market reach into adjacent segments of stationary monitoring and global health.

The Monitoring Solutions business of Berlinger includes approximately 85 employees operating in Switzerland, the Netherlands and the United States.

Lenz & Staehelin provided external legal counsel in this transaction.

FDA Approves First Gene Therapy to Treat Adults with Metastatic Synovial Sarcoma

August 2, 2024

Today, the U.S. Food and Drug Administration approved Tecelra (afamitresgene autoleucel), a gene therapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA antigen(s) A02:01P, -A02:02P, -A02:03P, or -A02:06P positive, and whose tumor expresses the MAGE-A4 antigen as determined by FDA authorized companion diagnostic devices.

Synovial sarcoma is a rare form of cancer in which malignant cells develop and form a tumor in soft tissues of the body. This type of cancer can occur in many parts of the body, most commonly developing in the extremities. The cancerous cells may also spread to other parts of the body. Each year, synovial sarcoma impacts about 1,000 people in the U.S. and most often occurs in adult males in their 30s or younger. Treatment typically involves surgery to remove the tumor and may also include radiotherapy and/or chemotherapy if the tumor is larger, returns after being removed or has spread beyond its original location.

“Potentially life-threatening cancers such as synovial sarcoma continue to have a devastating impact on individuals, especially those for whom standard treatments have limited efficacy due to tumor growth and progression,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). “The approval of this state-of-the-art immunotherapy technology provides a critical new option for a patient population in need and demonstrates the FDA’s dedication to the advancement of beneficial cancer treatments.”

Tecelra is also the first FDA-approved T cell receptor (TCR) gene therapy. The product is an autologous T cell immunotherapy composed of a patient’s own T cells. T cells in Tecelra are modified to express a TCR that targets MAGE-A4, an antigen (substance that normally triggers your immune system) expressed by cancer cells in synovial sarcoma. The product is administered as a single intravenous dose.

Tecelra was approved using the Accelerated Approval pathway, under which the FDA may approve drugs for serious or life-threatening diseases or conditions where there is an unmet medical need and the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients (improving how patients feel or function, or whether they survive longer). This pathway can allow earlier approval while the company conducts further trials to verify the predicted clinical benefit. A confirmatory trial is ongoing to verify Tecelra’s clinical benefit.

“Adults with metastatic synovial sarcoma, a life-threatening form of cancer, often face limited treatment options in addition to the risk of cancer spread or recurrence,” said Nicole Verdun, M.D., director of the Office of Therapeutic Products in CBER. “Today’s approval represents a significant milestone in the development of an innovative, safe and effective therapy for patients with this rare but potentially fatal disease.”

The safety and effectiveness of Tecelra was evaluated in a multicenter, open-label clinical trial including patients with inoperable and metastatic synovial sarcoma who had received prior systemic therapy and whose tumor expressed the MAGE-A4 tumor antigen. Effectiveness was evaluated based on overall response rate and the duration of response to treatment with Tecelra. Among the 44 patients in the trial who received Tecelra, the overall response rate was 43.2% and the median duration of response was six months.

The most common adverse reactions associated with Tecelra included nausea, vomiting, fatigue, infections, fever, constipation, dyspnea (shortness of breath), abdominal pain, non-cardiac chest pain, decreased appetite, tachycardia (abnormally fast heart rate), back pain, hypotension, diarrhea and edema (swelling due to buildup of fluid in body tissues).

Patients treated with Tecelra may experience cytokine release syndrome (CRS), which is a dangerous type of aggressive immune system response, including potentially life-threatening reactions. CRS was observed following administration of Tecelra during clinical trials. A Boxed Warning is included in the label containing information about this risk.

Patients may also exhibit Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), an immune system-related syndrome that can occur following some immunotherapies, infections, secondary malignancies, or hypersensitivity reactions, and severe cytopenia (an abnormally low level of blood cells) for several weeks following lymphodepleting chemotherapy and Tecelra infusion. Patients receiving this product should be monitored for signs and symptoms of infection and are advised not to drive or engage in hazardous occupations or activities for at least four weeks after receiving Tecelra.

The FDA granted Tecelra Orphan Drug, Regenerative Medicine Advanced Therapy and Priority Review designations for this indication.

This application was reviewed using a coordinated, cross-agency approach, including CBER, the FDA’s Oncology Center of Excellence and the Center for Devices and Radiological Health.

The FDA granted the approval of Tecelra to Adaptimmune, LLC.

Top Scientists Shaping the Biopharma Industry

August 1, 2024

The biopharma industry is at the forefront of medical innovation, driven by the groundbreaking work of leading scientists. These individuals are not only advancing our understanding of complex biological systems but also developing new treatments and technologies that have the potential to transform healthcare. This article highlights some of the top scientists shaping the biopharma industry and their contributions to the field.

Dr. Jennifer Doudna

Dr. Jennifer Doudna is a pioneer in the field of gene editing, known for her co-discovery of the CRISPR-Cas9 system. This revolutionary technology allows for precise and targeted modifications of DNA, which has significant implications for genetic research and therapeutic development. Her work has opened new avenues for treating genetic disorders, enhancing our ability to develop personalized medicine, and advancing agricultural biotechnology.

Dr. Doudna’s contributions have been widely recognized, earning her numerous awards and accolades. Her research continues to drive innovations in genetic engineering and has positioned her as a leading figure in the biopharma industry.

Dr. Katalin Karikó

Dr. Katalin Karikó’s work on mRNA technology has been instrumental in the development of COVID-19 vaccines. Her research laid the foundation for the use of messenger RNA (mRNA) as a therapeutic tool, enabling the rapid development of effective vaccines during the pandemic. The success of mRNA vaccines represents a significant milestone in vaccine technology and has broad implications for future vaccine development and other therapeutic applications.

Dr. Karikó’s pioneering work has not only contributed to the fight against COVID-19 but also holds promise for the treatment of other diseases, including cancer and genetic disorders.

Dr. Robert Langer

Dr. Robert Langer is a renowned scientist in the field of biomedical engineering and drug delivery. His research has led to the development of innovative drug delivery systems, including controlled-release implants and biodegradable polymers. These advancements have improved the efficacy and safety of drug therapies, offering new solutions for chronic disease management and targeted drug delivery.

Dr. Langer’s contributions extend beyond drug delivery, with significant impact on tissue engineering and regenerative medicine. His work has been instrumental in advancing biopharmaceutical technologies and improving patient outcomes.

Dr. David Baltimore

Dr. David Baltimore is a prominent immunologist and Nobel laureate recognized for his work on the immune system and the development of antiviral therapies. His research has provided crucial insights into the mechanisms of immune response and the role of viruses in disease progression. Dr. Baltimore’s work has contributed to the development of novel antiviral drugs and vaccines, playing a key role in addressing infectious diseases.

Dr. Baltimore’s ongoing research continues to influence the field of immunology and virology, with implications for the development of new therapeutic strategies and vaccines.

Dr. Frances Arnold

Dr. Frances Arnold is celebrated for her work on the directed evolution of enzymes. Her research has led to the development of novel enzymes with applications in drug discovery, environmental remediation, and industrial processes. By harnessing the power of evolution to engineer enzymes, Dr. Arnold has advanced our ability to create new biological catalysts and optimize biochemical processes.

Her contributions to enzyme engineering have had a significant impact on the biopharma industry, enabling more efficient and sustainable manufacturing processes.

Dr. Shinya Yamanaka

Dr. Shinya Yamanaka is known for his groundbreaking work in stem cell research. He developed a method to reprogram adult cells into induced pluripotent stem cells (iPSCs), which have the potential to differentiate into various cell types. This discovery has profound implications for regenerative medicine, offering new possibilities for cell-based therapies and disease modeling.

Dr. Yamanaka’s research has paved the way for advancements in personalized medicine and cell therapy, positioning him as a key figure in the biopharma industry.

Dr. Emmanuelle Charpentier

Dr. Emmanuelle Charpentier, along with Dr. Jennifer Doudna, co-discovered the CRISPR-Cas9 gene-editing technology. Her work has been instrumental in advancing our ability to precisely modify genetic material, with far-reaching implications for genetic research and therapeutic development. Dr. Charpentier’s contributions have had a significant impact on the biopharma industry, driving innovation and progress in gene editing.

The Role of LNP Formulation

In the realm of drug delivery and vaccine development, lipid nanoparticle (LNP) formulation has emerged as a critical technology. LNPs are used to encapsulate and deliver therapeutic agents, including mRNA, to specific cells or tissues. The advancement of LNP formulation technology is essential for the development of effective and targeted therapies. For those interested in the latest innovations in LNP formulation, DIANT offers valuable insights and solutions that highlight the potential of this technology in advancing drug delivery systems.

Conclusion

The biopharma industry is continuously evolving, driven by the pioneering work of leading scientists who push the boundaries of knowledge and technology. Their contributions to fields such as gene editing, mRNA technology, drug delivery, and stem cell research are shaping the future of medicine and improving patient outcomes.

As we look forward to further advancements in biopharma, the work of these top scientists remains central to the development of innovative therapies and technologies. The future of biopharma holds great promise, and these scientists are at the forefront of driving progress and innovation in the industry.

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