New cancer treatment disguises drugs in fat

NATHAN GIANNESCHI | July 30, 2019 | 141 views

Every two minutes someone in the UK is diagnosed with cancer. And there are a range of options when it comes to treatment. Frequently, though, chemotherapy drugs, designed to hit fast-growing cells like cancers are used. But not all rapidly-growing cells are cancerous, so there are inevitably side effects. Now, scientists at Northwestern University have found that dressing up chemotherapy drugs as fat molecules makes it much easier to concentrate their actions on cancer cells alone. Izzie Clarke heard how it works from Nathan Gianneschi.

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TOPRA, The Organisation for Professionals in Regulatory Affairs, is a non-profit, non-political organisation which seeks to advance the status of the regulatory profession through education, and provision of information to its members.

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PHARMA TECH

Biomaterials Emerging as a Blessing in the Pharmaceutical Industry

Article | July 7, 2022

Biomaterials are materials (natural or synthetic) that are biologically compatible with the human body and are used to replace, restore, support, or enhance the biological functions of damaged tissues while being in constant contact with body fluids. Over the past couple of decades, biomaterials have made their mark in the rapidly evolving pharmaceutical and medical fields. These materials are designed to interact with living biological tissue and are used for therapeutic and diagnostic purposes. Previously, biomaterials were only used in medical devices to replace or treat tissues or improve organ functions. However, it was later discovered that the term "non-viable" was inappropriate as biomaterials can be used for a variety of medical applications other than implanted devices. Growing Cases of Chronic Wounds Deepen the Penetration of Biomaterials There is a significant rise in the side effects caused due to the use of non-biocompatible materials for the treatment of chronic wounds caused by conditions such as malignant tumors, diabetes, infections, and vasculopathy, among others. Using biodegradable and biocompatible drug carriers is one way to avoid or reduce the side effects that may result from drug delivery to cells with enhanced efficiency and performance during the health rehabilitation process. Also, the use of biomaterials assists in enhancing chronic wound healing through anti-infection and antioxidant effects, immunoregulation, debridement, extracellular matrix remodeling, and angiogenesis, further increasing the adoption of pharmaceutical products made using these materials. Due to their favorable properties, biomaterials are gaining massive traction across the pharmaceutical industry. Here are some of the applications of biomaterials as follows. Dental Injectable Medical Implants Organ Regeneration (Heart, Lungs, Knee, Tracheal graft, others) Drug Delivery Regenerative Medicines Tissue Engineering Wound Healing Disease Treatment The Way Forward Leading manufacturers of biomaterials are aiming at expanding their biomaterial production capacity to strengthen their footprint and gain a competitive edge in the industry. For instance, in 2020, Evonik Industries AG, a German specialty chemicals company, announced the launch of a new biomaterial manufacturing facility in Birmingham, the U.S. to expand the company’s territory across North America. Following the trend, biomaterials are anticipated to create massive investment prospects for pharmaceutical players.

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PHARMA TECH

Use of AI: Reshaping the Pharmaceutical Industry

Article | June 2, 2022

For decades, the pharmaceutical industry has counted on state-of-the-art technologies to ensure the market entry of safe and dependable medications. The recent pandemic has shown how important it is for drug companies to get new drugs and vaccines on the market as soon as possible. The incorporation of artificial intelligence and machine learning technologies has greatly benefited the consumer healthcare business and the pharmaceutical industry. These technologies have been indispensable in the field of augmented intelligence, where they are used for applications such as disease detection and diagnosis, research and development, drug manufacturing, and others. How is AI Being Used Across the Pharmaceutical Sector? AI and ML are finding a plethora of applications across the pharmaceutical sector, starting from managing the process of clinical trial databases to drug discovery and disease diagnosis and treatment. These advanced technologies have further gained immense popularity with the advent of the COVID pandemic and the race to discover effective vaccines. The top-level uses of AI across the pharmaceutical sector are as follows Personalized Treatment/ Digital Therapeutics – AI is extensively being used to identify and assist drug developers to provide reliable and accurate insights for developing personalized therapeutics. Disease Identification/ Suggestive Treatment – With robust assessing abilities, AI is finding applications for the diagnosis of diseases ranging from Covid-19 to oncology to degeneration in the eyes. Drug Discovery and Manufacturing – AI assists in screening and comparing the predicted success rate of drug compounds based on biological factors with the results of the initial screening process such as rapid RNA and DNA quantification. Clinical Trials – The technology helps in identifying the most suitable candidate for the clinical trial on the basis of disease conditions, history, and additional attributes covering infection rates, ethnicity, and demographics to study the impact of the drug. The Way Ahead With growing applications in the development of novel therapeutic medications, shifting patient inclination toward personalized medicines, and the introduction of advanced medical fields such as gene therapy, AI is estimated to transform the pharmaceutical

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BUSINESS INSIGHTS

How Pharma Is Utilizing AI and Analytic Capabilities to Produce Positive Results

Article | June 30, 2022

Applications for AI are as diverse as the industries that employ them, and pharma has identified the particular varieties of AI that are most effective in attaining quicker, more fruitful results across a variety of business activities. In a world where every second counts, pharma and biotech businesses are under pressure to shorten the time to insight and deliver success. As a result, leading organizations quickly realize the potential of artificial intelligence (AI) as a crucial tool for advancing their operations. Leading pharma and biotech firms have realized the potential of AI and are utilizing it to boost productivity and innovation across the board, from production to drug discovery. Their procedures have significantly benefited from the application of machine learning (ML) and natural language processing (NLP), and the results are only becoming better because AI gets stronger and "smarter" the more data it processes. Advantages Pharma Industry Can Leverage Increased effectiveness across the spectrum in the pharmaceutical industry Drug discovery accelerates Superior disease surveillance, detection, and prevention Clinical trials with lower risk Greater insight into the client NLP is used to turn clinical trial data that is text-intensive and highly categorized into the data utilized in machine learning (ML) models, allowing the computer system to apply patterns to the data and generate insights. Clinical trial data is structured and enriched, making it possible to analyze and visualize the data for use in successful plans and strategies for clinical trial design, manufacturing, marketing, and other areas. Faster time to insight and improved business outcomes are the end results. A particularly true principle of machine learning applications is that the outcomes from using AI applications are only as reliable as the data itself. The Pharma Intelligence offering, which combines high-quality, extensive data from the pharmaceutical and biotechnology industries with advanced analytics and AI applications, has assisted customers with high-value products in resolving some of their most difficult key problems, including target prioritization, modalities innovation, competitive benchmarking, clinical trial design and deployment, and more.

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BUSINESS INSIGHTS

Why Is Diversity of Thought Essential for Developing a Winning Strategy?

Article | June 30, 2022

In developing or evolving a strategy, there are key decision moments. Those are the moments where you are deciding where you need to focus, what you need to excel at to win there, and where and how to allocate resources to get to a point in the future. At these moments, it is the contest of ideas that matters. Having choices matters. Having a cross-functional team participating in the development of strategy is one way of ensuring that you are going to be more successful at generating choices before you start making choices. What Is a Cross-functional Team? A cross-functional team is a collection of individuals with varied skillsets from different areas of a business collaborating to achieve a common goal. Why Are Cross-functional Teams Essential for Business Success? Having this diverse set of minds analysing the situation, considering the big picture and the organisation’s capabilities, and the needs of all stakeholders, inspires teams to think about the choices they have differently and more creatively. For example, in a pharmaceutical setting, the medical affairs team brings knowledge of the data, unmet needs, and insight into clinical practice. Access and reimbursement teams identify the right data and take the lead in building that value story to accelerate market access and product uptake. It is incumbent upon commercial to hear their ideas, obtain their perspective and secure their alignment to all strategy decisions. Cross-functional collaboration can help break down silos. Research suggests that working in silos and not sharing data with team members from other departments can cost a company close to $8,000 per day in wasteful expenses. Time is widely recognised as a scarce resource: we need quick access to accurate and real-time insights to make effective business decisions. Real time insight will come from those closest to the customer, so it is important for cross-functional members from different geographies to participate in the development of strategy. Improved insight is a source of sustainable competitive advantage. One single version of the truth is what is required for the right narrative to take place. The right narrative will lead to the right decisions. One single version of the truth is more easily achieved by cross-functional team members working closely together. Better Innovation & Creativity: Individuals with diverse skillsets often explore a problem in different ways. When different people working in different capacities come together, they think outside the box to significantly improve outcomes. It is a great way to come up with concepts that distinguish companies from their competitors. Achieving alignment with strategy across functions and geographies: Today, businesses are moving faster than ever and organisations are seeing possible competitors in areas they never knew existed before. With so much choice about where to focus, you really want your workforce to align around one strategy. Underperformance is inevitable if everybody is off working in ten different directions. Improving the customer experience: Creating an effective customer experience is about more than just ensuring your customers receive the products and services they desire in a timely and efficient manner. It’s also about creating touchpoints with real people who can organically evangelise and grow your brand through their social media and offline interactions with friends and family. Your customers are engaging with multiple communication channels– official websites, social platforms, virtual platforms, medical science liaisons, sales reps, and more. Everyone needs to be aware of, and understand, the moments that matter to your customer and the business along that customer journey and how they contribute to delivering that positive experience. This is more likely to be achieved with a cross-functional approach to strategy development. Business Agility: Cross-functional teams are typically small, adaptable, and flexible. Such teams can move faster as they don’t have to wait and rely on other departments or external sources. They can help in tackling any silo mentality and bridge gaps between team members. They can come together to consider new information and/or changes to adapt the strategy if necessary and/or react to any setbacks immediately. They are better placed to make decisions when problem-solving amidst uncertainty. In summary, the rapidly changing environment and new information requires medical affairs, along with access and reimbursement and commercial, to work together, to ensure that patient’s benefit from the value of new innovative therapies. Companies stand a better chance of creating a winning strategy if it is created by a cross-functional and geographically diverse team. With every team member bringing their abilities and knowledge to the table, the strategy over time can only move from strength to strength. However, if not supported correctly, a cross-functional team working on strategy can be dysfunctional and chaotic, and result in a laborious and time-consuming approach to strategy development. Digital strategy platforms such as Nmblr offer an inclusive and structured process to facilitate a strategy discussion and allow people to bring forward ideas. They do this by: working against silos – the structure provided, levels the playing field. The guidance provided equips people from different disciplines to contribute to the conversation.

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TOPRA

TOPRA, The Organisation for Professionals in Regulatory Affairs, is a non-profit, non-political organisation which seeks to advance the status of the regulatory profession through education, and provision of information to its members.

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AstraZeneca, Daiichi Sankyo push Enhertu closer to the blockbuster frontier with stomach cancer

Daiichi | January 20, 2021

Daiichi Sankyo and partner AstraZeneca have taken their HER2-targeted cancer drug Enhertu another step toward blockbusterland. The FDA cleared Enhertu for HER2-positive gastric or gastroesophageal junction cancer patients who previously received Roche’s standard-of-care Herceptin, the companies said Monday. An antibody-drug conjugate, Enhertu is the first HER2-directed therapy approved in gastric cancer in a decade, the companies said. And it earned the green light after showing—for the first time in this patient population—that an HER2 drug could top chemotherapy at helping patients live significantly longer. In the pivotal Destiny-Gastric01 trial in Japan and South Korea, Enhertu cut the risk of death by 41% versus chemotherapy in patients who had progressed on at least two previous treatments, including Herceptin. At an interim analysis, patients on Enhertu had lived a median 12.5 months, versus 8.4 months with chemotherapy, according to data presented at the 2020 American Society of Clinical Oncology (ASCO) meeting. On the study’s primary endpoint of overall response rate, Enhertu shrank tumors in 40.5% of patients, compared with a response rate of 11.3% in the chemo arm. Previously treated HER2-positive stomach cancer now becomes Enhertu’s second U.S. approval, on top of its original nod in third-line HER2-positive breast cancer. Both Daiichi and AZ are banking their oncology revenue growth on Enhertu. Daiichi’s in the middle of a transformation that puts oncology front and center as the Japanese pharma pivots away from the cardiovascular and metabolic fields. As part of the overhaul, the company’s targeting JPY500 billion ($5 billion) in peak oncology drug sales. Enhertu could take about half of that load: It now bears a 2024 sales estimate of around $2.5 billion, with some bullish industry watchers projecting peak sales above $4 billion.

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BeiGene-Novartis PD-1 deal; Sinovac vaccine; Celltrion antibody COVID-19 data

Novartis | January 19, 2021

Novartis plunked down up to $2.2 billion for BeiGene's China-approved PD-1 drug tislelizumab to complement its own checkpoint inhibitor. Hear what BeiGene CEO John Oyler has to say about tislelizumab's position in and outside China. Sinovac's COVID-19 vaccine reported confusing data from Brazil, raising doubt about its true efficacy. Celltron's anti-SARS-CoV-2 antibody improved patients' outcomes in a phase 2/3 trial. And more. Novartis paid $650 million upfront and committed up to $1.55 billion in milestones to license certain rights to BeiGene’s PD-1 inhibitor tislelizumab in major markets outside China. The Swiss pharma is not abandoning its own checkpoint inhibitor spartalizumab despite a recent phase 3 trial failure; instead, it views the two PD-1s as “complementary.” BeiGene retains the right to co-market tislelizumab in North America. The Novartis deal gives the Chinese biotech a chance to get help “learning how to commercialize and build some capabilities” beyond China, BeiGene CEO John Oyler said in an interview. He believes the drug could compete in Asian-prevalent cancer types and its value in large indications will show over time. The CEO also believes the PD-1/L1 class has reached a pricing sweet spot in China where additional major price cuts aren’t likely. Brazilian researchers first said Sinovac’s COVID-19 vaccine, CoronaVac, was 78% effective in a local phase 3 trial. But then, a few days ago, they released new data of just 50.4% efficacy. The gap was caused by the omission of “very mild” infections in the previous data. The misstep led to criticism of the trial organization, Brazil’s Butantan biomedical center, as well as suspicion about CoronaVac’s true efficacy. Turkey just authorized the shot for emergency use based on a reported 91.25% efficacy in an interim analysis of its local trial.

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CareRx Applauds Ontario Ministry of Health's Pause of Planned Fee Changes

CareRx | January 18, 2021

CareRx Corporation ("CareRx" or the "Company") (TSX: CRRX), Canada's leading provider of specialty pharmacy services to seniors, is pleased that the Ontario Ministry of Health has announced that it will pause for one year previously scheduled changes to long-term care pharmacy funding, which were scheduled to go into effect on April 1, 2021. Under certain amendments to the Ontario Drug Benefit Act that came into effect on January 1, 2020, the reimbursement model for long-term care pharmacies in Ontario was changed from a fee-for-service model to a fee-per-bed capitation model under which pharmacies receive a fixed professional fee for all pharmacy services provided to residents in long-term care homes. The fee for 2020, which was prescribed at $1,500, was scheduled to decline to $1,400 per bed serviced on April 1, 2021. The step-down in capitation has now been paused until April 1, 2022. "Long-term care homes and their staff have faced unprecedented challenges during COVID-19," said David Murphy, President and Chief Executive Officer of CareRx. "This pause will ensure that pharmacies like CareRx can continue to deliver the same exceptional partnership and service offering to long-term care homes and help alleviate the burden COVID-19 has placed on home staff. We want to thank Minister Elliott, Minister Fullerton and the Ontario Government for their ongoing dialogue and commitment to protecting the wellbeing of residents in long-term care." About CareRx Corporation CareRx is Canada's leading provider of specialty pharmacy services to seniors. We serve approximately 50,000 residents in over 900 seniors and other communities (long-term care homes, retirement homes, assisted living facilities, and group homes). We are a national organization with a large network of pharmacy fulfillment centres strategically located across the country. This allows us to deliver medications in a timely and cost-effective manner and quickly respond to routine changes in medication management. We use best-in-class technology that automates the preparation and verification of multi-dose compliance packaging of medication, providing the highest levels of safety and adherence for individuals with complex medication regimes. We take an active role in working with our home operator partners to promote resident health, staff education, and medication system quality and efficiency.

Read More

PHARMA TECH

AstraZeneca, Daiichi Sankyo push Enhertu closer to the blockbuster frontier with stomach cancer

Daiichi | January 20, 2021

Daiichi Sankyo and partner AstraZeneca have taken their HER2-targeted cancer drug Enhertu another step toward blockbusterland. The FDA cleared Enhertu for HER2-positive gastric or gastroesophageal junction cancer patients who previously received Roche’s standard-of-care Herceptin, the companies said Monday. An antibody-drug conjugate, Enhertu is the first HER2-directed therapy approved in gastric cancer in a decade, the companies said. And it earned the green light after showing—for the first time in this patient population—that an HER2 drug could top chemotherapy at helping patients live significantly longer. In the pivotal Destiny-Gastric01 trial in Japan and South Korea, Enhertu cut the risk of death by 41% versus chemotherapy in patients who had progressed on at least two previous treatments, including Herceptin. At an interim analysis, patients on Enhertu had lived a median 12.5 months, versus 8.4 months with chemotherapy, according to data presented at the 2020 American Society of Clinical Oncology (ASCO) meeting. On the study’s primary endpoint of overall response rate, Enhertu shrank tumors in 40.5% of patients, compared with a response rate of 11.3% in the chemo arm. Previously treated HER2-positive stomach cancer now becomes Enhertu’s second U.S. approval, on top of its original nod in third-line HER2-positive breast cancer. Both Daiichi and AZ are banking their oncology revenue growth on Enhertu. Daiichi’s in the middle of a transformation that puts oncology front and center as the Japanese pharma pivots away from the cardiovascular and metabolic fields. As part of the overhaul, the company’s targeting JPY500 billion ($5 billion) in peak oncology drug sales. Enhertu could take about half of that load: It now bears a 2024 sales estimate of around $2.5 billion, with some bullish industry watchers projecting peak sales above $4 billion.

Read More

PHARMA TECH

BeiGene-Novartis PD-1 deal; Sinovac vaccine; Celltrion antibody COVID-19 data

Novartis | January 19, 2021

Novartis plunked down up to $2.2 billion for BeiGene's China-approved PD-1 drug tislelizumab to complement its own checkpoint inhibitor. Hear what BeiGene CEO John Oyler has to say about tislelizumab's position in and outside China. Sinovac's COVID-19 vaccine reported confusing data from Brazil, raising doubt about its true efficacy. Celltron's anti-SARS-CoV-2 antibody improved patients' outcomes in a phase 2/3 trial. And more. Novartis paid $650 million upfront and committed up to $1.55 billion in milestones to license certain rights to BeiGene’s PD-1 inhibitor tislelizumab in major markets outside China. The Swiss pharma is not abandoning its own checkpoint inhibitor spartalizumab despite a recent phase 3 trial failure; instead, it views the two PD-1s as “complementary.” BeiGene retains the right to co-market tislelizumab in North America. The Novartis deal gives the Chinese biotech a chance to get help “learning how to commercialize and build some capabilities” beyond China, BeiGene CEO John Oyler said in an interview. He believes the drug could compete in Asian-prevalent cancer types and its value in large indications will show over time. The CEO also believes the PD-1/L1 class has reached a pricing sweet spot in China where additional major price cuts aren’t likely. Brazilian researchers first said Sinovac’s COVID-19 vaccine, CoronaVac, was 78% effective in a local phase 3 trial. But then, a few days ago, they released new data of just 50.4% efficacy. The gap was caused by the omission of “very mild” infections in the previous data. The misstep led to criticism of the trial organization, Brazil’s Butantan biomedical center, as well as suspicion about CoronaVac’s true efficacy. Turkey just authorized the shot for emergency use based on a reported 91.25% efficacy in an interim analysis of its local trial.

Read More

PHARMA TECH

CareRx Applauds Ontario Ministry of Health's Pause of Planned Fee Changes

CareRx | January 18, 2021

CareRx Corporation ("CareRx" or the "Company") (TSX: CRRX), Canada's leading provider of specialty pharmacy services to seniors, is pleased that the Ontario Ministry of Health has announced that it will pause for one year previously scheduled changes to long-term care pharmacy funding, which were scheduled to go into effect on April 1, 2021. Under certain amendments to the Ontario Drug Benefit Act that came into effect on January 1, 2020, the reimbursement model for long-term care pharmacies in Ontario was changed from a fee-for-service model to a fee-per-bed capitation model under which pharmacies receive a fixed professional fee for all pharmacy services provided to residents in long-term care homes. The fee for 2020, which was prescribed at $1,500, was scheduled to decline to $1,400 per bed serviced on April 1, 2021. The step-down in capitation has now been paused until April 1, 2022. "Long-term care homes and their staff have faced unprecedented challenges during COVID-19," said David Murphy, President and Chief Executive Officer of CareRx. "This pause will ensure that pharmacies like CareRx can continue to deliver the same exceptional partnership and service offering to long-term care homes and help alleviate the burden COVID-19 has placed on home staff. We want to thank Minister Elliott, Minister Fullerton and the Ontario Government for their ongoing dialogue and commitment to protecting the wellbeing of residents in long-term care." About CareRx Corporation CareRx is Canada's leading provider of specialty pharmacy services to seniors. We serve approximately 50,000 residents in over 900 seniors and other communities (long-term care homes, retirement homes, assisted living facilities, and group homes). We are a national organization with a large network of pharmacy fulfillment centres strategically located across the country. This allows us to deliver medications in a timely and cost-effective manner and quickly respond to routine changes in medication management. We use best-in-class technology that automates the preparation and verification of multi-dose compliance packaging of medication, providing the highest levels of safety and adherence for individuals with complex medication regimes. We take an active role in working with our home operator partners to promote resident health, staff education, and medication system quality and efficiency.

Read More

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