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Computers & Software Health & Medicine Pharmaceuticals & Biotech Science U.K

The Biggest Compliance Issues Faced by MedTech Companies Transitioning to Data-Enabled Solutions

In April, the UK Medicines and Healthcare Products Regulatory Agency (MHPRA) released a guidance document, called Software and Artificial Intelligence as a Medical Device. This document is a compilation of previous guidance, advice, and regulatory requirements for Software as a Medical Device (SaMD) and Artificial Intelligence as a Medical Device (AIaMD).

The document covers:

  • How software as a general medical device or an IVD should be classified
  • What the UK regulatory framework is for SaMDs
  • A change programme roadmap for software and AI as a medical device
  • How to qualify and classify one’s SaMD, including how to create an intended use statement
  • Reporting adverse events once the SaMD is in use, and requirements for field safety corrective actions
  • The guiding principles to inform the development of Good Machine Learning Practice (GMLP) for artificial intelligence

This document has been developed keeping in mind the goal of advancing software and AI medical device regulation. With these technologies becoming a growing part of the MedTech industry, this seems like a reasonable next step.

Data-Enabled Solutions in MedTech

Whilst software and AI as a medical device is a growing market which is now at the forefront due to the rapid rise in the use of AI, it’s not a completely new idea.

Technology has been in use in medicine and medical research for a while now. However, as computing grows more sophisticated, so do the devices.

In fact, across the pond, there is a growing concern about regulatory compliance issues surrounding MedTech. 

Earlier this year, an article in Med City News talked about the top five compliance issues faced by MedTech companies transitioning to data-enabled solutions.

Here they are.

Compliance Issues That MedTech Companies Face

Managing How the Data Is Collected, Used, and Shared

Smart MedTech solutions rely on data gathered from the people who use them. That is why the first issue to consider is related to data gathering and storage.

Companies that use MedTech-enabled data platforms are obligated to take appropriate care of any information collected, including,

  • Patient data
  • Drug development data
  • Customer or provider data
  • AI/ML-developed data sets

Any data collected, used, or shared must be prioritised with the following in mind:

  • Legal mandates
  • GDPR
  • HIPAA
  • Others
  • Ethical values
  • Patient rights and dignity
  • Patient care and care quality
  • Minimising patient risk and burden
  • Data access

Keeping the Changing Interactions Between Patients, Physicians, and Other Stakeholders in Mind

Medical care is shifting from treatment to preventative treatment, which has led to a change in how patients interact with healthcare providers.

This means that not only is the relationship between them changing, but there’s also an increase in the use of technology for patient monitoring and real-time data entry.

This data collection would require greater collaboration with stakeholders, which is something to consider when planning compliant protocols.

Planning New Regulation Regimes for Donation of EHR, Cybersecurity Technology, and Information Blocking

Electronic Health Records (EHR) are replacing the old paper documentation. These EHRs can be shared between health systems and providers for the sake of interoperability. 

However, those donations need to be adequately tracked.

There needs to be a system in place to ensure there is a legitimate need for the adoption and topics such as updates and replacements have been addressed

Additionally, the provider of this information must not engage in “information blocking”, which has been defined as any activity that impedes the exchange or use of the health information.

Addressing Value-Based Care Considerations and the Federal Anti-Kickback Statute Safe Harbours

Data-enabled MedTech has the potential to make patient care much more empathetic, streamlined, and comprehensive. However, these qualities rely on better design and regulations.

At the same time, MedTech companies also need to ensure that their practices align with the regulatory requirements of the federal Anti-Kickback Statute safe harbours.

Balancing the Lack of Advanced Industry Standards Against a Rapidly Growing Technology

MedTech and communication technologies have exploded in the last couple of decades. And, the rise of AI has been even more dramatic. As such, the existing rules and regulations need to evolve with these new developments.

Managing regulatory compliance, especially for an industry like MedTech, can be quite challenging. That is where companies like RegASK can help. Such a service can help one not only maintain compliance but also keep up with any changes.

As is evident from the rise of tools like ChatGPT, the world is going to see more automation through AI. The important thing is to design compliance regulations that are as effective and as scalable as that technology.

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Books & Literature Business Health & Medicine Pharmaceuticals & Biotech Technology

Canadian Nurse Launches Life Management Logbooks and App to Help People Organize and Protect Important Documents

British Columbia (April 23, 2023) – Organize your life and documents simply, safely and securely with the My Life Manager and My Health Manager logbooks and a mobile app developed by Canadian Registered Nurse, Katrina Mulberry.

The truth is that many people do not have a problem storing important documents but creating an organized system for quick retrieval is often where the rubber meets the road. Searching for unorganized documents can be time-consuming and frustrating, especially in emergencies. But not anymore.

Touted as The Ultimate in Life and Healthcare Organization, Mulberry’s My Life Manager and My Health Manager guides are designed to help users store and organize important documents efficiently and securely for easy access. My Life Manager is a personal record keeper that allows users to record personal and legal documents and other information in one place. The logbook features a beautiful layout of tables and forms to help users effortlessly monitor and track finances, assets, insurance payments, debts, and life goals. My Health Manager is a 28-page healthcare guide that allows users to record and track health and lifestyle details, from medications, test results, family health patterns, and more. An essential tool for cargivers and those with health concerns.

My Life Manager app facilitates seamless and secure storage of documents and information for access on the go. Users can store important documents digitally, keep pictures of cards, and monitor important dates such as passport expiry! The app also serves as a backup for when My Life and Health Manager logbooks are not accessible and worse case when important documents are lost. No data is collected in this Locker App and biometrics are used for security.

My Life Manager and My Health Manager logbooks are an updated version of Mulberry’s original edition of a simple binder with tabs and plastic page holders for original documents and a “learn how to budget” section, which she designed with the advice from her financial planner and business associates. The logbooks received such positive reception especially from fellow parents wanting to teach money management to their teens. This motivated Mulberry to revise and improve the tools to reach a wider audience. The logbooks and app are part of the Manage Me ™ brand that also includes the Manage Me™ Life / Health USB portable data sticks.

According to Mulberry, the idea of creating a Life Management system was considered early in her nursing career after witnessing the inefficiency of sharing medical information. Explaining her motivation for creating the logbooks, she said: “Friends were always impressed at how I managed to juggle my own life and work with my homelife raising four daughters. I told them that the secret was life organization. I created the logbooks and app to share my knowledge with friends and those far and wide who needed who needed more organization in their lives.”

My Life Manager and My Health Manager are designed to be a personal record keeper and are ideal for anyone looking for life organization made simple – from students and entrepreneurs to homemakers and senior citizens. The logbooks are available for purchase on Amazon, Barnes and Noble, Walmart, and other online bookstores. My Life Manager app is available for download for Apple and Android devices. For further information, visit: https://manageme.ca

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Food & Beverage Leisure Activities Lifestyle Living Pharmaceuticals & Biotech

Thornton Park Hosts Cinco De Mayo Block Party In Orlando Florida.

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Orlando, FL – April 27th, 2023 – The Thornton Park Cinco De Mayo Block Party is back for local residents to enjoy and celebrate the day. The restaurants and bars of Washington Street in the Thornton Park District are teaming up to host this amazing event for the community.

A team effort from The 808 Orlando, Cavo’s Bar & Kitchen, and Burton’s Thornton Park will create this awesome event they are calling CINCO ON THE STREET.

Guests will enjoy street games including beer pong, flip cup, cornhole, and a 360-degree photo booth!

The event will offer exclusive drink specials, amazing local food, a mariachi band, and DJ Digital.

Guests will enjoy one complimentary drink with their event ticket between 4pm-8pm.

Admission to the event will be only $15 in advance and $20 the day of the event. Promo code WASHINGTON may be used to save $5 on each ticket.

The venues will give you a variety of dining and cocktailing experiences to enjoy throughout the day.

At The 808 guests are transported to an old-school, laid-back surf shack where the vibe is relaxed and everyone is welcome. Their Hawaiian “inspired” menu has offerings for every taste including fresh seafood, and plate lunches. Their full liquor bar features delectable tropical concoctions with fresh ingredients and exotic spirits.

Cavo’s Bar & Kitchen is a fun, casual sports bar in the heart of Thornton Park. They offer solid cocktails and Northeast (Philly & NYC) influenced cuisine. They have a cool comfortable vibe for hanging out or watching all the games.

Burton’s Thornton Park is a casual bar in the Thornton Park district popular amongst locals. They offer beer, booze, and wine to quench their patron’s thirst while they hang out and play pool, darts, golden tee, pinball, and watch sports on 16 TVs.

For anyone living or visiting the Orlando area The Thornton Park District’s CINCO ON THE STREET block party is the place to be for Cinco De Mayo fun. The party will start on Friday, May 5, 2023, at 4:00 PM at 808 East Washington Street in Orlando Florida 32801.

Get tickets and more info at: cincoTPD.eventbrite.com

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Fitness Health & Medicine Pharmaceuticals & Biotech Science Technology

Cyborgcare Launches as the Ultimate Online Marketplace for Health and Wellness Enthusiasts

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Israel, Tel Aviv: Cyborgcare, the ultimate online marketplace for cyborg technology products, smart medical devices, gadgets, and wearables. Our platform offers a comprehensive selection of over 500 items designed to improve your health and wellbeing, covering everything from skin, body, hair, eyes, teeth, and nails to medical equipment for fitness centers, beauty salons, clinics, and hospitals.

We understand that keeping up with the latest advancements in cyborg technology can be overwhelming, which is why we’ve created a transparent and user-friendly ecosystem that empowers you to explore and purchase the products you need with ease. Our platform offers an intuitive shopping experience with a wide range of categories and filters to help you find the right products for your unique needs.

At Cyborgcare, we’re dedicated to providing you with qualified online support. Our team of experts is here to answer your questions, offer product recommendations, and help you make informed decisions about your health and wellbeing. Whether you’re new to the world of cyborg technology or an experienced biohacker, our support team is here to help you every step of the way.

We also provide a directory of local services, doctors, consultants, and technicians. Our platform helps you connect with local experts who can provide personalized guidance and support for your biohacking lifestyle. From finding a qualified technician to install your smart medical device to booking a consultation with a top-rated doctor, our directory is a valuable resource for anyone interested in improving their health and wellbeing with the latest technology.

Cyborgcare is committed to promoting a biohacking lifestyle that helps people stay healthy, confident, and happy. Our mission is to empower you with the tools and resources you need to achieve your health and wellness goals. We’re excited to announce that worldwide sales and distribution will be coming soon, so stay tuned for updates and be sure to check out our website to explore our products and services.

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Pharmaceuticals & Biotech Science Technology U.K U.S

ObvioHealth and Sterling IRB Partner to Accelerate Access to Clinical Trials

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On February 2, 2023, Sterling IRB and ObvioHelath reportedly declared a collaboration to make clinical trials more accessible and step up the decentralisation of clinical studies.

With this announcement, Sterling IRB has emerged as ObvioHealth’s preferred Institutional Review Board (IRB) to help the virtual trial organisation (VRO) with the regulatory requirements, according to Clinical Trial Arsena.

The Shift to Decentralisation Drives Efficiency

Conducting clinical trials is critical to ensuring the safety and effectiveness of therapeutic interventions. However, several steps associated with data compilation, participant enrollment, and more in on-site clinical trials are suboptimal, thus stymieing the development of new therapeutics.

The requirement for frequent hospital visits, complications with transportation, instructions, scheduling, etc., create friction for patients, thus increasing their likelihood of dropping out.

While around 80% of clinical trials fail to meet the enrollment timeline, 55% terminate because of inadequate enrollment. 

Patient drop-off rates in traditional clinical trials (phase III) can often be substantially high (sometimes even over 30%), causing expensive delays for sponsors. Enrolling one participant can cost roughly $6,533 and the cost of replacing them is even higher. 

However, by streamlining communications while allowing patients to volunteer for clinical studies from the comfort of their homes, DCTs can significantly shift the paradigm to a much higher enrollment and retention rate. 

DCTs and hybrid clinical study models are here to stay, and their long-term benefits outweigh the technical and financial challenges related to on-site trials.

However, despite holding great potential to bring new drugs to the market faster, the adoption of DCTs has been slow. 

Some roadblocks to DCT may be down to patient-physician interaction, immature digital infrastructure, and the regulatory issues facing sponsors when implementing and using data from decentralised trials. 

As a new process, the regulatory reception of DCTs is still not well-defined, thereby creating obscurity regarding the oversight of trial processes and governing regulations. 

While the regulatory landscape is constantly evolving, VROs must ensure they design DCT tools that comply with the latest regulatory guidelines. 

The Collaboration Will Facilitate the Regulatory Review Process

By designing and running patient-centric, end-to-end, and tech-enabled DCTs, ObvioHealth helps sponsors get robust therapeutic evidence. 

As part of its effort to ensure zero trade-offs between data accuracy and reduced patient burden, the VRO implements high-end data capture techniques such as tele-health visits, online patient diaries, sensors, wearables, etc.

ObvioHealth expects its partnership with Sterling IRB will act as a step-change in helping it win regulatory acceptance faster for its trial designs.

Since the onset of the COVID-19 pandemic, Sterling IRB has been helping sponsors navigate the ambiguous regulatory guidelines to support fully or partially decentralised trial designs.

“The flexibility of our DCT platform, combined with our full-service virtual site team, gives us the freedom to build studies that will best deliver on a sponsor’s endpoints. This often means we’re navigating uncharted regulatory terrain. We needed a partner willing to collaborate through regulatory challenges and support our next-generation trial designs,” stated Ivan Jarry, CEO of ObvioHealth.

“Sterling IRB and ObvioHealth are like-minded, both sharing a common goal of building stronger DCTs,” said Kathye Richards, vice president of Client Services, Institutional Official at Sterling IRB. “Flexibility and out-of-the-box thinking are becoming increasingly important for continued decentralised trial success. This partnership will enable earlier involvement to help interpret regulations, work through challenges, and collaborate for solutions, all essential for making DCTs less burdensome for all.”

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Computers & Software Pharmaceuticals & Biotech Science Technology

Data Capture in Laboratories: Exploring the Barriers and Ways to Overcome Them

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Substantial investments should be made in strategising and combining data from a set of instruments in order to turn a medley of free-floating data points into a coherent, integrated message. 

With that said, failing to automate data collection and standardisation via instrument integration is the biggest bottleneck that causes substantial lag in laboratory operations. 

In a recent article published in European Pharmaceutical Review, Samantha Kanza, a senior enterprise fellow at the University of Southampton, sheds light on the leading challenges of adopting digital technologies in the laboratory data collection process and how to overcome them. 

What Is Data Integration?

Data integration means accumulating datasets from multiple sources and equipment and merging them to get a unified view.

Data integration across the value chain—from discovery all the way through production to commercialisation—is critical to strengthening decision-making. 

Even though the massive troves of data a laboratory generates are a great asset, most of it remains unexploited due to failure to connect data and processes.

Leading Data Integration Challenges

The researcher underscores the lack of data standardisation and data standard saturation as two major roadblocks to laboratory data integration. 

Inconsistent datasets, proprietary data formats, and a lack of compatible instruments are a few of the many barriers worth mentioning.

Let’s dive deeper into the issues with proprietary data formats: 

One of the key aspects of successful data integration is to have all datasets from all sources in the same format (or at least convertible into a single format). 

However, in many cases, data attributes in two different sources may conceptually convey the same information, but the datasets are in two different formats, which are sometimes difficult to convert into a desired format. 

These lexical and structural disparities in datasets may cause unfixable errors or even data loss if data gets integrated without standardising or cleaning.

The Solution

Overcoming data standard issues is paramount to enabling a fully integrated and digitally interconnected laboratory.

The research fellow at the University of Southampton advises laboratories to carefully evaluate the software programs they would leverage while generating data and the file formats these systems support. 

On the other hand, software providers should also ensure their programs don’t use intricate proprietary formats that could hinder data integration, sharing, and reuse.

According to Dr. Kanza, researchers must be provided with specific guidelines on the standard process of data structure to efficiently evade the risk of data inconsistencies. 

On top of that, all datasets generated directly from the instruments should include metadata to ensure effective utilisation.

Electronic Systems Adoption Barriers

For laboratories looking to accelerate their R&D, using Laboratory Information Management Software (LIMS) or Electronic Lab Notebook (ELN) as the core part of their research activities is critical. 

Besides enabling instrument integrations for automatic data capture, ELN or LIMS helps automate workflows and ensure efficient management of samples and associated data. 

The result: streamlined operations and quick recognition of bottlenecks across experiments leading to substantially improved efficiency

Despite all the benefits, the adoption of electronic systems in labs has been slow.

Let’s flesh out the reasons:

First off, transitioning away from familiar methods to use a new system may seem challenging for some researchers.

“Whether rightly or wrongly, researchers don’t necessarily trust ELN systems, particularly if they are in the cloud…While trust is important, some of this comes down to a lack of education and understanding on data security coupled with some learned behaviour that needs to be addressed,” explained Dr. Kanza.

Secondly, the scepticism of lab operators about the security of the stored data in cloud-based LIMS or ELN is another leading reason behind the slow adoption rate of LIMS. 

Thirdly, even though digital systems help labs streamline the data capture and management processes, the greatest concern arises when labs aim to leverage these digital systems in their daily operations. The full ELN/LIMS adoption requires buy-in from everyone involved. For some users, the learning curve may seem steeper. 

Overcoming the Electronic System Adoption Challenges

For laboratories looking to address the above challenges and centralise data once siloed in multiple systems to turbocharge their R&D efforts, cashing in on a high-end digital lab notebook like Sapio Sciences is a sensible decision. 

A class-leading ISO-certified system ensures top-notch data security while also offering easy training so that users can get the hang of it in a short time.

On top of that, some high-end integrated LIMS-ELN systems offer automated data capture from instruments via integration that helps minimise experimental redundancy. 

Plus, these systems foster decision-making by enabling interactive visualisation of all data points.

However, digitally transforming a laboratory needs a complete overhaul of lab culture, a change of attitude, and a willingness to learn. 

Besides, before investing in a system, laboratories should evaluate the disparities between the system and their laboratory requirements. Through careful vendor evaluation, they can choose the most profitable compromise between the features offered by a seller and a fully customizable solution. 

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Health & Medicine Pharmaceuticals & Biotech Science Technology U.S

Underrepresentation & Overconsumption: Analysing the Diversity Gaps in Clinical Trials

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Randomised clinical trials (RCTs) have long been considered the bedrock for evidence-based treatment (EBT). Thus they should be designed to be pragmatic and accumulate data representing the larger population for the disease profile. However, the research output is jeopardised severely by the limited enrollment of social, racial, and ethnic minority groups.

The FDA (US Food and Drug Administration) has reported that only 5% of patients partaking in clinical trials are Black, less than 2% are Asian, and as for Latinos, the percentage is as low as 1%.

This disparity is threatening, as it causes trials to show variance in effectiveness. 

Releasing a draft guidance, the FDA has placed emphasis on enhancing diversity in industry-sponsored clinical trials (iCTs), reported Clinical Leader. 

The agency urges investors and sponsors to devise and present a Race and Ethnicity Diversity Plan early in the trial process as per the framework delineated in the guideline.

Why Does Diversity in Clinical Trials Matter

Even though racial and ethnic populations in the United States have a disproportionate burden for specific ailments, they are most often underrepresented in biomedical studies, said the FDA.

With “underrepresented racial and ethnic populations,” the FDA indicates ethnic groups like “Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian and Other Pacific Islanders, and other persons of colour.”

Considering the response and exposure of over 20% of drugs vary with racial differences, the FDA marks race and ethnic minority inclusion in iCT as a pressing need.

According to a study, white Americans are predicted to become a minority by 2045. The white demographic decline in the USA makes clinical trial diversification critical to confirm that newly developed drugs are safe and effective for whoever may use them across the country. 

“The U.S. population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health,” said FDA Commissioner Robert M. Califf, M.D. “Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities.”

Barriers to Improving Patient Participation Diversity in Clinical Trials

According to the FDA, the scepticism of the trial process stemming from several historical events deter ethnic minorities from participating in iCTs.

Other factors include limited access to healthcare for ethnic minorities, socioeconomic conditions, insufficient patient recruitment and retention efforts, time and monetary restraints, etc.

The result: gaps in clinical trial diversity that affects the trial success rate.

How to Fill the Diversity Gaps

What can help bridge the diversity gaps in iCT and accelerate effective products to market?

Decentralised Clinical Trial (DCT) Platforms 

The COVID-19 outbreak has made sponsors realise the significance of DCTs in filling the diversity gaps in healthcare research and accelerating the long-overdue changes in trial design.

Let’s see how:

  • DCTs and hybrid study models allow trial teams to expand their participant pools. 
  • DCT platforms such as ObvioHealth that include ePRO and eConsent enable patients to contribute to clinical trials from the comfort of their homes.
  • By helping overcome barriers to participant recruitment, DCTs and hybrid models have encouraged a much higher enrollment rate.

The result: augmented trial outcomes that represent real-world patient populations.

Ethnically Diverse Workforce

According to research, the lack of workforce diversity in the USA has been highlighted as a leading factor impeding the inclusion of diverse populations and causing disparities in oncology trial results.

The good news? Studies found that 74% of Black and 81% of Latinx people are willing to volunteer for clinical trials if their physicians advise. With that said, engaging the workforce in clinical trials from underrepresented groups can help build trust with at-risk participants. 

On top of that, the NHS recognised workforce diversity as the key factor to bring clinical trials closer to underserved folks. 

Patient Expense Reimbursement

The FDA recognised patient expense reimbursement as an effective way to enhance clinical trial diversity. However, the lack of a consistent approach among CROs and regulators makes the process slow and ineffective. 

Wrapping Up

The FDA sheds light on the significance of global efforts in increasing patient diversity. DCT can be a step change in helping sponsors improve the enrollment of participants from underrepresented racial and ethnic populations in clinical trials. 

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Pharmaceuticals & Biotech Technology U.S

Cell Therapy Bioprocessing Market Projected to Reach $30M by 2028

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The healthcare industry is heavily investing in developing safe and effective treatments using cell therapy technologies as an alternative to traditional treatments.

The result: The cell therapy bioprocessing market is ballooning at breakneck speed. 

The global cell therapy bioprocessing market size is predicted to hit a revenue of a staggering $30,052.61M by 2028—up from $ 11,192.50M in 2020. The market is expected to grow at a CAGR of 13.14% during the forecast period between 2020 and 2028, according to a report by Insight Partners published in medgadget. 

Cell therapy bioprocessing

Cell therapy bioprocessing is a subfield of bioprocess technology that blurs the lines between bioprocessing (biopharmaceutical manufacturing) and cell therapy. 

The goal is to develop robust and reproducible manufacturing processes for producing therapeutic cells by substituting, rebuilding, repairing, or regenerating damaged cells, tissues, and organs. 

Cell therapy bioprocessing holds great promise to revolutionize healthcare and treat chronic conditions—such as cancers, age-related blindness, macular degeneration, stroke, and more.

Driving Forces Behind the Cell Therapy Bioprocessing Market Growth

The growing need to efficiently treat chronic ailments has pushed research activities in cell and gene therapy bioprocessing which, in turn, is likely to propel the market’s growth over the coming years.

The increasing number of clinical trials conducted or underway is another leading factor contributing to the rapid growth of the cell therapy bioprocessing market.

Case in point: as of 2022, 1221 active clinical trials were conducted on cell and gene therapies, among which 342 were in phase 1/1b.

The report marks the advancement in genome editing as another driving force behind the cell therapy market growth. 

By allowing scientists to add, remove, or alter DNA in the genome at specific points, genome editing can provide effective treatment solutions for chronic ailments. 

Medical scientists hope that genome editing will act as a step-change in treating monogenic hereditary diseases—such as hemophilia, cystic fibrosis, muscular dystrophy, and Huntington’s disease. 

Interventions into the immune system can also help cure acquired diseases—e.g., AIDS or cancer. The potential of genome editing technologies, such as TALENs and Zinc-finger nuclease, has opened avenues in the modern therapeutic sector having the potential to accelerate market growth. 

Furthermore, the gradual invention of innovative technologies to support the development of avant-garde therapies has further aided market expansion. For example, CRISPR-Cas9 is one of the widely adopted genome editing technologies that yield higher accuracy. Being the cheapest yet highly efficient system to alter genetic traits in a cell, CRISPR-Cas9 has significantly fueled research activities. 

The Cell Therapy Bioprocessing Market Segmentation

According to the report, by technology, the market is segmented into a) lyophilization, b) bioreactor, c) electro-spinning, d) ultrasonic lysis, e) control-flow centrifugation, f) viral vector technology, g) cell immortalization technology, and h) genome editing technology. The bioreactor segment reigned in the cell therapy bioprocessing market, accounting for the largest revenue share in 2020. On the other hand, the genome editing technology segment is forecast to grow at the highest CAGR of 14.5% through the projection period.

By cell type, the market is segmented into a) immune cell, b) stem cell, c) hematopoietic stem cells, d) pluripotent stem cell, and e) human embryonic stem cell. The stem cell was the highest market-share segment in 2020 and is projected to record the highest CAGR of 14.0% during the forecast period.

In addition, by indication, the market is segmented into a) oncology, b) orthopedics, c) cardiovascular disease (CVD), c) wound healing, and more. Among the segments, oncology held the largest market share in 2020 and is foreseen to record the highest CAGR of 14.3% through the projection period.

The report highlights some of the key players in the market, such as Fresenius Kabi AG, Asahi Kasei Corporation, and Sartorius AG. Being at the forefront of adopting growth strategies, these companies strive to capitalize on the vast untapped potential of the cell therapy bioprocessing market.

How COVID-19 Impacted the Cell Therapy Bioprocessing Market Growth

The market growth of cell therapy bioprocessing was affected to a certain extent, with more focus put on curbing the onslaught of the COVID-19 pandemic. Research activities halted for a certain period as research institutions had to slow down their trial enrollment process. 

In addition, the global pandemic harmed the production and supply chain efforts in the biopharma industries. 

However, the market now continues to advance, with many leading businesses planning to make their therapies more accessible. 

Navigate Challenges to Success

Researchers are trying to reap the full therapeutic and commercial benefits of cell therapy bioprocessing technologies. For that, emphasis must be placed on overcoming the challenges regarding today’s existing capabilities to generate clinical-grade cells at commercially relevant scales.

However, the development process for bringing cell therapies to patients is highly intricate. The process involves multiple bio-production and bioprocessing steps that need to be executed optimally to confirm the required safety and effectiveness of the final product.

With that said, for cell therapy products to hit the expected success, taking a process-driven approach to bioprocessing operations is critical.

The solution: leveraging a high-end bioprocessing solution with predefined workflow templates for each step in the pipeline

Such a class-leading system like Sapio Sciences’s Bioprocessing solution includes extensive sample, material, and instrument management, charting capabilities, and native data analysis. The result: streamlined operations and seamless collaboration across teams that accelerate product to market. 

Wrapping Up

After decades of relentless efforts, gene and cell therapy bioprocessing is set to flourish incredibly in the coming future. A flurry of recent successes has led to the approval of multiple life-improving therapeutics—and many more are under development. 

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Health & Medicine Pharmaceuticals & Biotech Science Technology U.S

Decentralization Plays a Key Role in Enhancing Oncological Care, Says ObvioHealth

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New York, NY, Jan 20 — Leading Virtual research organization (VRO), ObvioHealth sheds light on the role of decentralized clinical trials(DCTs) in improving the quality of care for oncology patients.

“Extending the survivability of an illness is a key goal in the development of new medications, medical devices, and treatment protocols,” explains a spokesperson from ObvioHealth. “Increasing overall quality of care is an equally worthwhile objective. Incorporating DCT elements facilitates both goals.”

According to the VRO, conducting clinical trials is an effective way of improving the quality of life for cancer patients during and after treatment. However, clinical research in oncology isn’t reaching the patients who could benefit the most. 

Even though the barriers to clinical trial participation have been a topic of frequent research, no subsequent policy changes have shifted the paradigm enough to vastly change trial participation rates over time.  

Case in point: Clinical barriers (e.g., not meeting eligibility criteria) and structural barriers (e.g., the absence of an available clinical trial, travel cost, etc.) make trial participation unachievable for more than three-quarters of oncology patients, according to a study published in the Journal of the National Cancer Institute. 

For cancer patients with rare, irremediable, or life-threatening physical conditions, DCT designs can bring new care options by increasing their access to innovative therapeutics. 

However, due to having logistic constraints, full decentralization is not feasible for some types of clinical trials in the oncology space. 

Delivering drugs to a patient’s home, maintaining drug stability, and hiring certified nurses to administer drugs to patients at home are some of the constraints to oncology trial decentralization. 

Despite these hurdles, adopting DCT elements through hybrid trial models is rapidly gaining momentum. 

As a more patient-centric approach to oncology trials, DCTs can streamline trial processes while also significantly enhancing trial logistics. 

A DCT’s potential to facilitate access by eliminating geographic barriers to entry is a game-changer for cancer research and treatment. With DCTs in place, local oncologists can refer patients to trial screenings without overwhelming a small community hospital that can’t support centralized research.

The VRO highlights DCT and hybrid clinical studies as the way forward to reduce patient burden in oncology trials. 

Even though much of oncology research still requires on-site participation, specific appointments are more administrative than interventional and don’t need the one-on-one involvement of a physician.

Allowing participants to volunteer for trials from the comfort of their homes, DCTs minimize the need for in-person visits, thus decreasing patient burden substantially.

In addition, participants’ reluctance to report symptoms or hesitation to contact their trial support staff if they develop side effects can impact data quality and ultimately, the accuracy of trial endpoints. 

DCT solutions include convenient in-app messaging tools that help patients communicate with physicians and flag symptoms that they might otherwise consider insignificant.

On top of this, by enabling real-time reporting and communication, DCT solutions drive data quality and allow study teams to make evidence-based, data-driven decisions around the effect of a treatment on a participant’s quality of life.

Instead of capturing a brief snapshot of a patient’s health during a clinical visit, DCT solutions enable study teams to gain a longitudinal view of how their patients’ health may be trending. Continuous monitoring of risk factors, health outcomes, or both, based on the symptoms logged by patients with ePRO, helps sponsors make data-driven decisions about patient care.

To navigate challenges to success and extend access to life-improving treatments for cancer patients, adopting the modular approach (e.g., leveraging digital questionnaires or online recruitment) to oncology trials is critical, explains ObvioHelath.

Headquartered in New York, NY, ObvioHealth is a global digital health company committed to driving innovation in healthcare. With its tech-enabled nextGen DCT platforms, ObvioHelath helps sponsors effortlessly produce robust therapeutic evidence. 

Interested parties can find more information about ObvioHealth by visiting https://www.obviohealth.com

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Health & Medicine Pharmaceuticals & Biotech U.S

UltraPharmRX’s Online Telehealth Service Launches with Industry-leading Convenience and Pricing for Erectile Dysfunction Medication

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NEW YORK, Jul. 11, 2022 – UltraPharmRX (UPRX) today officially launched its online telehealth service (www.ultrapharmrx.com) that mainly focuses on the safe, convenient, and affordable distribution of essential erectile dysfunction medication. The launch came months ahead of the initial launch date, as the company was able to complete the framework and secure the logistics operations ahead of schedule.

According to the Massachusetts Male Aging Study, the prevalence of erectile dysfunction in men is 52%, with an increasing prevalence with age. The study estimates that 40% of men over 40 experience the symptoms of erectile dysfunction, which translates to about 27 million men in the United States as of 2020. The United States ranks the highest in self-reported cases of erectile dysfunction, but unfortunately, the monthly cost of treating erectile dysfunction is also among the most expensive in the world.

 Common erectile dysfunction medications offered by UltraPharmRX are:

1.   Cialis – Tadalafil

a.    Retail price without insurance – approx. $400 every month

b.    Lowest price cost – $230 every month

c.    UltraPharmRX price: $167 every month

2.   Viagra – Sildenafil

a.    Retail price without insurance – approx. $560 every month

b.    Lowest price cost – $250 every month

c.    UltraPharmRX price: $72 every month

Erectile dysfunction medications are not typically covered by health insurance as these medications are thought to be more of a lifestyle benefit, rather than a medical necessity. The additional cost of doctor’s appointments, redundant tests, and commuting could drive up an average person’s erectile dysfunction medication expenses every month.

UltraPharmRX positions itself as the premier online erectile dysfunction source, by linking customers with US-licensed healthcare professionals to secure an online prescription, with a seamless transition to the discreet delivery of FDA-approved erectile dysfunction medication straight to the customers’ doorstep.

The cost-effective, convenient, and time-saving solutions offered by UltraPharmRX effectively cuts down on the most expensive aspects of procuring erectile medication for patients. Customers can expect savings of up to 60-70% compared to the traditional methods, while still adhering to the strict guidelines set forth by the FDA.

Changing the stigma of erectile dysfunction medication

Although the United States ranks the highest in self-reported cases of erectile dysfunction, experts believe that the actual number of men afflicted with erectile dysfunction is much higher than the data shows. With plenty of alternative solutions that claim to cure erectile dysfunction, such as male enhancement supplements and non-FDA-approved erectile medication sold online, millions of American men are drawn to solutions that they believe are more convenient and affordable.

UltraPharmRX’s 100% online telehealth service aims to resolve the situation and bring convenience and affordability to customers who need it most. A typical UltraPharmRX transaction starts with a quick health survey to evaluate the patient’s health history and status. Once reviewed and approved by a US-licensed physician, the customer may proceed and select the erectile medication treatment applicable to their lifestyle and budget.

The entire process takes less than 5 minutes to complete, and with 100% genuine, FDA-approved Sildenafil and Tadalafil medication offered at extremely affordable pricing, customers may no longer feel the need to go with illicit erectile dysfunction medication or unproven solutions.

Affordable Viagra (Sildenafil) and Cialis (Tadalafil) medication

UltraPharmRX makes erectile dysfunction medication more affordable and accessible to men who need it most. The company’s main focus is to provide affordable, FDA-approved medication, with identical potency and effectiveness to more well-known brands, such as Viagra and Cialis. Through its streamlined process, UltraPharmRX allows customers to enjoy extremely affordable options, without sacrificing the quality and effectiveness of erectile dysfunction medication.

From the late 90s to the early 2000s, two brands have dominated the entire erectile dysfunction medication market. Viagra and Cialis are both exclusively patented by the world’s biggest pharmaceutical conglomerates, which essentially allowed the companies to dictate the price of these medications without any competitors affecting pricing considerations.

Viagra (Sildenafil) became the first FDA-approved medication for the treatment of erectile dysfunction symptoms in the late 90s, followed by Cialis (Tadalafil) in the early 2000s. Both brands are known for their highly effective results in alleviating the symptoms of erectile dysfunction, making the brands essential in the lives of men suffering from erectile dysfunction.

The distinction between the two brands became more apparent over the years, with Viagra being better known as the faster-acting erectile dysfunction medication, while Cialis became known as the more economical choice for its prolonged effectiveness.

The exclusive patents for Viagra and Cialis had since expired, allowing generic Sildenafil and Tadalafil to be offered at much more affordable price points. While erectile dysfunction medication became more affordable, the process to acquire a prescription to legally purchase Sildenafil and Tadalafil remains largely expensive and time-consuming.

Uncompromising safety and convenience

Sildenafil and Tadalafil are both generally safe, barring contraindications with other medications, such as nitrates, and associated health risks, such as cardiovascular health problems. In popular media, celebrities and athletes are known for the recreational use of erectile dysfunction medication. While the health risks are uncommon, physicians warn against the recreational and unsupervised intake of erectile medication, as they could lead to serious, and fatal consequences.

Federal regulations are in place to provide oversight and regulate the disbursement of erectile dysfunction medication, and UltraPharmRX adheres to these strict regulations by working with US-licensed physicians to evaluate a prospective customer’s health condition before allowing customers to purchase medication. While this may exclude certain individuals from being eligible to purchase medication, UltraPharmRX maintains its commitment to follow FDA regulations to limit the risk to individuals with high health risks.

Fully online interactions with US-licensed healthcare professionals are completely legal and regulated by appropriate state and federal agencies. UltraPharmRX alleviates the cost of doctor’s appointments by completely shouldering the cost of telehealth consultations and allowing customers to provide relevant health information completely online.

About UltraPharmRX

UltraPharmRX aims to bring high-quality, affordable, FDA-approved erectile dysfunction medication, such as Sildenafil (Viagra) and Tadalafil (Cialis), to men who need the treatment the most. The company provides the complete services needed to acquire appropriate e-prescriptions from US-licensed physicians, at no cost to the customer. UltraPharmRX provides exceptional convenience, affordability, and safety that allows men to minimize costs without sacrificing critical healthcare oversight. To know more about UltraPharmRX, please visit their website at www.UltraPharmRX.com.