M&A Report takes the Pulse of Biotech post-Brexit

The numbers from the first quarter after Britain voted to leave the EU are in. How is biotech faring? A new report shows a decline in deals. Merger Market has crunched data on the biotech, pharma and medical deals made thus far in 2016, and it ain’t so great: biotech is holding its own, but Brexit has driven mergers and acquisitions in the pharma, medical and biotech (PMB) space sharply downwards. Moreover, the earthquake in the EU has sent shocks through the global market.

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Student Biotechnology Network

The Student Biotechnology Network's mission is to Inspire students to be the next innovative leaders in biotechnology through education about career opportunities and connection with today’s industry leaders.

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MedTech

Nanostructures: Emerging as Effective Carriers for Drug Delivery

Article | October 7, 2022

Natural remedies have been employed in medicine since antiquity. However, a large number of them fail to go past the clinical trial stages. In vivo instability, poor solubility and bioavailability, a lack of target-specific delivery, poor absorption, and side effects of the medication are only a few of the problems caused by the use of large-sized materials in drug administration. Therefore, adopting novel drug delivery systems with targeted medications may be a solution to address these pressing problems. Nanotechnology has received tremendous attention in recent years and has been demonstrated to help blur the boundaries between the biological and physical sciences. With great success, it plays a vital part in enhanced medication formulations, targeted venues, and controlled drug release and delivery. Limitations of Traditional Delivery Trigger the Adoption of Nanoparticles The field of nanotechnology and the creation of drug formulations based on nanoparticles is one that is expanding and showcasing great potential. It has been thoroughly researched in an effort to develop new methods of diagnosis and treatment and to overcome the limitations of several diseases' current therapies. As a result, nanoparticles are being used to improve the therapeutic effectiveness and boost patient adherence to treatment by increasing medication bioavailability, drug accumulation at a particular spot, and reducing drug adverse effects. The nanoparticles could be transformed into intelligent systems housing therapeutic and imaging agents by manipulating their surface properties, size, correct drug load, and release with targeted drug delivery. Nanostructures facilitate the release of combination medications at the prescribed dose since they remain in the blood circulation system for a long time. Therefore, they result in fewer plasma fluctuations with decreased side effects. Due to their nanoscale, these structures can easily enter the tissue system, promote the absorption of drugs by cells, make medication administration more effective, and ensure that the medicine acts at the targeted location. The Way Ahead Nanomedicine and nano-delivery systems are a comparatively new but fast-evolving science in which nanoscale materials are used as diagnostic tools to deliver drug molecules at precisely targeted sites in a controlled manner. It is finding applications for the treatment of diseases such as cardiovascular, neurodegenerative, cancer, ocular, AIDS, and diabetes, among others. With more research and technological advancement, these drug delivery solutions will open up huge opportunities for companies that work with them.

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MedTech

How to Choose a Reliable Biotech Clinical Trial Management System?

Article | July 13, 2022

Introduction The medical and life-science industries are experiencing a robust transformation with the increasing prevalence of various types of diseases, including infectious diseases, chronic disorders, and acute conditions around the world. As a result, a significant rise in demand for more effective therapeutic drugs and bionics is being witnessed, leading to a swift increase in the number of clinical trials. For a successful trial, it is important for biotech companies to ensure the data submitted to regulatory bodies regarding clinical trials is accurate, reliable, and definitive from an ethical point of view. A reliable clinical trial management system plays a vital role in collecting, monitoring, and managing clinical data. The availability of high-quality clinical data also helps clinical research institutions make efficient treatment decisions and provide proper patient care. Hence, a number of biotech companies and research organizations are focusing on leveraging innovative clinical trial management solutions to handle a large amount of data, particularly in multi-center trials, and generate reliable, high-quality, and statistically sound data from clinical trials. However, selecting the most appropriate and reliable clinical trial management system is vital for the clinical trial's success. Let's see some of the steps that will assist these firms in choosing the right CTMS. Key Steps for Selecting Right Biotech Clinical Trial Management System Prioritize Study Needs Considering and prioritizing study needs is a crucial step in choosing the most reliable clinical trial management system for biotech companies. Prioritizing helps them to identify a solution that improves the study's quality and removes uncertainty for researchers when faced with difficult choices. Hence, biotech and life-science organizations should choose a clinical trial system that is simple to use, well-organized, and suitably designed to minimize the number of clicks required to complete a task. Select CTMS with Multiple Integrations Integrated clinical trial management systems provide the best value for the companies’ funds as they guarantee the smooth functioning of research protocols. In addition, integrations are necessary to fully understand the importance and advantages of clinical trial management software for ensuring smooth transitions between site management and data collection. Biotech and clinical research should look for CTMS platforms that can integrate with electronic medical record (EMR) platforms and clinical research process content (CRPC) billing grids. This will allow them to use the same billing designations and ensure compliance while minimizing the need for duplicate processes. Ensure System Compliance and Security Clinical research organizations need to adhere to a plethora of complex regulations in order to ensure compliance with one of the most challenging environments of principles, which is information security and privacy. Security and system compliance are vital aspects of choosing the right CTMS solutions for biotech firms as they assist in building trust and form a part of the system’s duties. While selecting CTMS systems, it is essential for companies engaged in clinical research to ensure that these platforms are able to configure both, group and individual permissions, along with having a data backup and recovery plan for hosted systems. This will allow companies to assess the privacy and security implications of research and anticipate complications that may arise in each phase of the project. Assess the Scalability Choosing a scalable CTMS that can accommodate various types of fluctuations and expansions enables biotech and clinical firms to quickly adapt to fast-changing trends and demand spikes while reducing maintenance costs and enhancing user agility. As scalability also means secure and expanded data storage, these businesses should instead use SaaS solutions than manually manage an ever-growing collection of hard drives. The right CTMS ensures accommodating the firm’s availability requirements without incurring the capital costs associated with expanding a physical infrastructure. The Closing Thought A well-executed and successful clinical trial involves multiple stages and processes. Several quality controls and stringent adherence to regulations are essential for the steps, along with efficient cross-departmental processes and procedures. Incorporating the right CTMS paves the way for paperless data collection, regulatory filing, and fiscal management tools for biotech researchers and administrative personnel.

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Medical

Making Predictions by Digitizing Bioprocessing

Article | August 16, 2022

With advances in data analytics and machine learning, the move from descriptive and diagnostic analytics to predictive and prescriptive analytics and controls—allowing us to better forecast and understand what will happen and thus optimize process outcomes—is not only feasible but inevitable, according to Bonnie Shum, principal engineer, pharma technical innovation, technology & manufacturing sciences and technology at Genentech. “Well-trained artificial intelligence systems can help drive better decision making and how data is analyzed from drug discovery to process development and to manufacturing processes,” she says. Those advances, though, only really matter when they improve the lives of patients. That’s exactly what Shum expects. “The convergence of digital transformation and operational/processing changes will be critical for the facilities of the future and meeting the needs of our patients,” she continues. “Digital solutions may one day provide fully automated bioprocessing, eliminating manual intervention and enabling us to anticipate potential process deviations to prevent process failures, leading to real-time release and thus faster access for patients.” To turn Bioprocessing 4.0 into a production line for precision healthcare, real-time release and quickly manufacturing personalized medicines will be critical. Adding digitization and advanced analytics wherever possible will drive those improvements. In fact, many of these improvements, especially moving from descriptive to predictive bioprocessing, depend on more digitization.

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2 Small-Cap Biotech Stocks You Haven't Heard of, But Should Know About

Article | April 17, 2020

With everything that's going on with the COVID-19 pandemic, many healthcare companies have grabbed plenty of spotlight during these challenging times. At the same time, a number of otherwise promising businesses have slipped under the radar. That's especially true for small-cap biotech stocks that aren't actively involved in developing tests, vaccines or treatments for COVID-19. Vaccine developers, protective equipment producers, and healthcare service providers are all attracting plenty of attention during this pandemic, but there are just as many promising biotech stocks that aren't involved in these areas. Here are two such companies that you might have missed, but they deserve a spot on your watch list.

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Student Biotechnology Network

The Student Biotechnology Network's mission is to Inspire students to be the next innovative leaders in biotechnology through education about career opportunities and connection with today’s industry leaders.

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Industry Outlook

Expanding Diagnostics Business: SCHOTT Signs Agreement to Acquire Applied Microarrays Inc.

Applied Microarrays Inc. | September 30, 2021

SCHOTT MINIFAB, a subsidiary of SCHOTT that develops and manufactures microfluidic devices for point-of-care and life sciences consumables, has had a long-standing close customer relationship with Applied Microarrays Inc. (AMI). Together, they develop biotech substrates for diagnostics applications. The expertise of AMI will further strengthen SCHOTT’s ability to offer a single-source contract manufacturing solution. The deal is expected to close in early October. Through this acquisition, SCHOTT MINIFAB significantly expands its biosensor printing capabilities. This is of particular importance as demand is growing for the manufacturing of point-of-care microarray consumables, especially in applications such as infectious disease detection. “We pride ourselves on being an end-to-end partner for the global diagnostics industry. Our expansive offering allows us to provide an integrated single-source collection of value-intensive services and products. With the added bioscience knowledge of AMI, we become an even stronger partner, enhancing our capability in surface modification, functionalization and deposition for both glass and polymer products.” - Greg Wolters, Head of SCHOTT MINIFAB. AMI will soon be moving to a larger facility in the Phoenix, Arizona area. Its new location will greatly increase SCHOTT’s manufacturing footprint in the United States to serve its global customer base. Pioneering – responsibly – together These attributes characterize SCHOTT as a manufacturer of high-tech materials based on specialty glass. Founder Otto Schott is considered its inventor and became the pioneer of an entire industry. Always opening up new markets and applications with a pioneering spirit and passion – this is what has driven the #glasslovers at SCHOTT for more than 130 years. Represented in 34 countries, the company is a highly skilled partner for high-tech industries: Healthcare, Home Appliances & Living, Consumer Electronics, Semiconductors & Datacom, Optics, Industry & Energy, Automotive, Astronomy & Aerospace. In the fiscal year 2020, its 16,500 employees generated sales of 2.24 billion euros. With the best teams, supported by the best digital tools, the group intends to continue to grow. SCHOTT AG is owned by the Carl Zeiss Foundation, one of the oldest foundations in Germany. It uses the Group's dividends to promote science. As a foundation company, SCHOTT has anchored responsibility for employees, society and the environment deeply in its DNA. The goal is to become a climate-neutral company by 2030. About Applied Microarrays (AMI) AMI is a company headquartered in Tempe, AZ, which designs, optimizes and manufactures DNA and protein biosensors, and other microarrays on glass, plastic and semiconductors. AMI operates under ISO 9001 and ISO 13485 certification. Since acquiring GE Healthcare’s microarray business in 2007, AMI has evolved to become a full service provider for RUO and Dx devices.

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Industry Outlook

Expanding Diagnostics Business: SCHOTT Signs Agreement to Acquire Applied Microarrays Inc.

Applied Microarrays Inc. | September 30, 2021

SCHOTT MINIFAB, a subsidiary of SCHOTT that develops and manufactures microfluidic devices for point-of-care and life sciences consumables, has had a long-standing close customer relationship with Applied Microarrays Inc. (AMI). Together, they develop biotech substrates for diagnostics applications. The expertise of AMI will further strengthen SCHOTT’s ability to offer a single-source contract manufacturing solution. The deal is expected to close in early October. Through this acquisition, SCHOTT MINIFAB significantly expands its biosensor printing capabilities. This is of particular importance as demand is growing for the manufacturing of point-of-care microarray consumables, especially in applications such as infectious disease detection. “We pride ourselves on being an end-to-end partner for the global diagnostics industry. Our expansive offering allows us to provide an integrated single-source collection of value-intensive services and products. With the added bioscience knowledge of AMI, we become an even stronger partner, enhancing our capability in surface modification, functionalization and deposition for both glass and polymer products.” - Greg Wolters, Head of SCHOTT MINIFAB. AMI will soon be moving to a larger facility in the Phoenix, Arizona area. Its new location will greatly increase SCHOTT’s manufacturing footprint in the United States to serve its global customer base. Pioneering – responsibly – together These attributes characterize SCHOTT as a manufacturer of high-tech materials based on specialty glass. Founder Otto Schott is considered its inventor and became the pioneer of an entire industry. Always opening up new markets and applications with a pioneering spirit and passion – this is what has driven the #glasslovers at SCHOTT for more than 130 years. Represented in 34 countries, the company is a highly skilled partner for high-tech industries: Healthcare, Home Appliances & Living, Consumer Electronics, Semiconductors & Datacom, Optics, Industry & Energy, Automotive, Astronomy & Aerospace. In the fiscal year 2020, its 16,500 employees generated sales of 2.24 billion euros. With the best teams, supported by the best digital tools, the group intends to continue to grow. SCHOTT AG is owned by the Carl Zeiss Foundation, one of the oldest foundations in Germany. It uses the Group's dividends to promote science. As a foundation company, SCHOTT has anchored responsibility for employees, society and the environment deeply in its DNA. The goal is to become a climate-neutral company by 2030. About Applied Microarrays (AMI) AMI is a company headquartered in Tempe, AZ, which designs, optimizes and manufactures DNA and protein biosensors, and other microarrays on glass, plastic and semiconductors. AMI operates under ISO 9001 and ISO 13485 certification. Since acquiring GE Healthcare’s microarray business in 2007, AMI has evolved to become a full service provider for RUO and Dx devices.

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