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.

Spotlight

APEIRON Biologics

Apeiron Biologics AG is a privately financed Biotech company in Vienna, Austria. The company currently employs around 25 people and has a strong focus on immunological approaches to treat cancer. In 2010, Apeiron out-licensed itslead project (a recombinant enzyme for the treatment of Acute Respiratory Distress Syndrome and other diseases) to GSK in a deal potentially worth €236 million. Subsequently, Apeiron in-licensed several clinical projects (a liposomal formulation of SOD, a fusion protein and a monoclonal antibody against neuroblastoma) to complement its innovative in-house projects

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MedTech

Expansion of BioPharma: Opportunities and Investments

Article | July 12, 2022

Biopharmaceutical innovations are among the most ingenious and refined achievements of modern medical science. New concepts, techniques, and therapies are emerging, such as the cell therapy Provenge, which can be used to treat cancer, and gene therapies, which provide even more amazing promises of disease remission and regenerative medicine. In addition, the COVID-19 pandemic has caused a huge boom in the pharmaceutical industry. This is because more and more attention is being paid to increasing manufacturing capacity and starting new research on drug development. Biopharma: Leading the Way in the Pharma Sector In the past couple of years, the biopharmaceutical sector has deepened its roots across the medical and pharmaceutical industries, on account of the transformation of pharmaceutical companies towards biotechnology, creating opportunities for growth. Also, growing advancements in technologies such as 3D bioprinting, biosensors, and gene editing, along with the integration of advanced artificial intelligence and virtual and augmented reality are estimated to further create prospects for growth. According to a study, the biopharmaceutical sector makes nearly $163 billion around the world and grows by more than 8% each year, which is twice as fast as the traditional pharma sector. Massive Investments Directed Towards Biopharma Investing in biotech research and development (R&D) has yielded better returns than the pharma industry average. Hence, a number of pharmaceutical companies are shifting their presence toward biopharma to capitalize on the upcoming opportunities by investing in and expanding their biotechnology infrastructure. For instance, Thermo Fisher Scientific Inc., an American manufacturer of scientific instrumentation, reagents and consumables, and software services, announced an investment of $97 million to expand its bioanalytical laboratory operations into three new locations in the U.S. With this investment, the company will add 150,000 square feet of scientific workspace and install the most advanced drug development technologies to produce life-changing medicines for patients in need.

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MedTech

Better Purification and Recovery in Bioprocessing

Article | July 13, 2022

In the downstream portion of any bioprocess, one must pick through the dross before one can seize the gold the biotherapeutic that the bioprocess was always meant to generate. Unfortunately, the dross is both voluminous and various. And the biotherapeutic gold, unlike real gold, is corruptible. That is, it can suffer structural damage and activity loss. When discarding the dross and collecting the gold, bioprocessors must be efficient and gentle. They must, to the extent possible, eliminate contaminants and organic debris while ensuring that biotherapeutics avoid aggregation-inducing stresses and retain their integrity during purification and recovery. Anything less compromises purity and reduces yield. To purify and recover biotherapeutics efficiently and gently, bioprocessors must avail themselves of the most appropriate tools and techniques. Here, we talk with several experts about which tools and techniques can help bioprocessors overcome persistent challenges. Some of these experts also touch on new approaches that can help bioprocessors address emerging challenges.

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MedTech

Top 3 Biotech Clinical Data Management Trends to Watch in 2022

Article | September 22, 2022

Introduction The administration of medical records and data has advanced significantly during the past few decades. Clinical data management, which was once only a small subset of biotech research organizations, has now developed into a mission-critical, specialized unit. In the late 1990s, electronic data capture (EDC) began to alter the traditional function of clinical data management. After that, the data configuration and management of data queries for the EDC system fell under the purview of clinical data management services. Today, clinical data management is not only responsible for managing the clinical data configuration and data queries but also developing and implementing data administration plans, ensuring data accuracy and completeness, and maintaining optimum data security. In recent years, as digital technologies have gained acceptance around the globe, data has become a vital aspect in decision-making across numerous industries, and the life sciences and biotechnology sectors are no exception. Using data has provided granular insights to biotech organizations, assisting them in creating breakthroughs in drug development and medical research and signifying the importance of clinical trial management systems in these medical verticals. The Biggest Biotech Clinical Data Management Trends to Know About Today The future of clinical data management is contingent upon the implementation of systems and regulations. It is imperative for all organizations participating in a medical or life science trial to have transparent rules in place for sharing and retaining patient data. Also, there is a need to have a standardized format for maintaining these records and documents related to trials. This assists biotech organizations in reducing the chances of ambiguity regarding who owns what kind of data or paperwork at any given time. Over the past couple of years, the focus of the life science and biotechnology industries has shifted towards developing more effective medications and therapies, implementing personalized treatment, and finding cures for diseases such as cancer and AIDS. In response to this, a substantial rise in the number of clinical trials is being witnessed globally. As the number of clinical trials continues to accelerate, the spending on these trials rises as well. In response to this, the worldwide cost of conducting clinical trials is anticipated to reach US$ 49.80 billion in 2022. With the transition of the world from traditional to digital, medical professionals and biotech businesses are increasingly shifting towards adopting high-tech and reliable clinical trial management systems for various applications, starting from diagnosis and clinical trials to patient data documentation. But, what are the future trends in biotechnology clinical data management? Let’s discuss. Cloud-Based Clinical Metadata Repositories Automation is emerging as a new frontier in the biotech clinical data management domain, along with other innovative technologies such as artificial intelligence and machine learning. Because of this, life science establishments are witnessing a huge shift from paper-based documentation toward data-based documentation, which is creating mountains of research, compliance, and clinical data. The growing demand for new and more effective medications and drugs is augmenting the need to expedite clinical trials. This is resulting in an increased number of initiatives aimed at optimizing clinical trial processes to prepare and launch successful trials. However, pharmaceutical and biotechnology laboratories are encountering several challenges in collecting, managing, and analyzing metadata due to its complexities. So, what is the best solution to this problem? The answer to this is cloud-based clinical metadata repositories. Clinical research facilities are leveraging advanced, all-in-one, cloud-based clinical metadata repositories to assist them in centralizing and managing metadata; increasing metadata quality, consistency, and accuracy; and speeding up clinical trial management, documentation, and compliance processes. Shift Towards Digital Solutions Electronic Case Report Form Adequate research and accurate data are crucial for a clinical trial to succeed. Whether developing new drugs, medication, or therapies; conducting life science research; or studying the latest clinical trial systems, it is best to use electronic solutions as it reduces the room for mistakes during the transition of clinical data from paper-based format. Realizing this, biotech organizations are shifting towards using electronic case report forms to speed up record retrieval, improve record security, and cut down on operational costs associated with running clinical trials. The electronic case report form assists in lowering the failure rate of the clinical trial, enhancing efficiency, and optimizing security along with improving clinical trial documentation and productivity, further driving its adoption in the medical space. Electronic Clinical Outcome Assessment Electronic clinical outcome assessment is surfacing as one of the fast-growing future trends in biotechnology. It allows clinical trial facilities to automate data entry and improve the reliability of the collected information. The technology enables clinical trial institutions to automatically record patient-provided information about side effects, symptoms, drug timing, and other aspects during the clinical trial for increased precision. It also helps these institutions analyze the results of medication or therapy in clinical trials and lets clinical researchers use medical technologies like biosensor-enabled devices, self-service applications, and medical wearables for evaluation. Hence, biotech clinical facilities are increasingly deploying advanced electronic clinical outcome assessment systems to ensure adherence to protocols and regulations. Clinical Trial Customization The success of a new drug is determined by numerous factors other than its effectiveness, safety, and creativity of its developers, such as a successful clinical trial. Each clinical trial involves a number of decision-making points, and one wrong choice in any of these aspects can jeopardize the success of the entire endeavor. A crucial component of making well-informed decisions is data management, which is a part of clinical study as a whole. Clinical trial customization is emerging as one of the most prominent biotech clinical trial management trends. Every clinical trial is unique and needs a tailored approach to be successful. With the emergence of the trend of personalized treatment around the globe, biotech and pharmaceutical organizations are adopting innovative customized clinical trial management solutions to accelerate the pace of clinical trials and approvals. This is giving clinical researchers innovative ways to come up with new medicines for patients and streamline the clinical data as per the requirements for faster approvals. What Are the Key Clinical Data Management Challenges Faced by Biotech Companies? Groundbreaking medical interventions are of no use without reliable, accurate, and extensive clinical trial data. Without the data, biotech and pharmaceutical companies will not be able to provide the assurance of safety and efficacy required to bring the medication to market. Regulatory bodies such as the Food and Drug Administration (FDA), the Medicines and Healthcare Products Regulatory Agency (MHRA), and others are putting stricter rules in place to ensure the quality of clinical data. In addition, the fast-changing clinical development environment is creating more obstacles for biotech and medical spaces to ensure the accuracy, standard, and completeness of the clinical trial data. Hence, clinical teams are spending valuable time cleaning up data instead of analyzing it. Time spent trying to figure out issues with clinical trial data is detrimental and expensive but also mission-critical. This is because a small issue in the data can lead to numerous consequences, from small delays to calamitous setbacks, making it necessary to rerun clinical trials. This problem will only get more challenging to address as the volume of data and the types of data sources continue to grow. Here are some of the major clinical data management challenges that biotech firms encounter Standardization of Clinical Metadata Stringent Regulatory Compliance Increased Clinical Trial Complexity Mid-Study Changes Why Are Clinical Data Management Systems Garnering Popularity in the Biotech Industry? With the changing regulatory and clinical landscape, biotech and pharmaceutical companies are facing several obstacles in the management of clinical data and clinical trials. In addition, regulatory agencies are moving toward integrated electronic systems, which is making it more and more important for clinical laboratories to change the format of their submissions. Because of this, several biotech clinical labs are focusing on adopting innovative laboratory solutions, such as biotech clinical data management systems, to meet the need for standardized data inputs and replace all manual ways of working with electronic systems. A clinical data management system establishes the framework for error-free data collection and high-quality data submission, resulting in speedier drug discovery and shorter time-to-market. These solutions are gaining huge traction among biotech and pharmaceutical companies, owing to their ability to effectively manage clinical data, accelerate clinical trials, and ensure compliance. Let’s see some of the features of biotech clinical data management software that are most sought after by life-science companies Controlled, standardized data repository. Centralized data analysis and administration. Reduced operational expenditures for clinical data processes. Enhanced process effectiveness. Superior submission quality Compliance with predefined standards. Clinical Data Management Systems: The Future The role of clinical data management systems is evolving at a rapid pace as the life science and medical industries continue to incorporate digital solutions for diverse operations. These systems are being used in a variety of biotech clinical settings, ranging from clinical data compliance to data science and analytics, to help them analyze large and growing volumes of clinical data. Hence, a number of high-tech medical companies are aiming at integrating innovative technologies, such as artificial intelligence and machine learning, into clinical data management software to automate clinical data management tasks, improve clinical data submission, and enhance data quality. These new biotech clinical management technologies are anticipated to help life science laboratories gain a better understanding of diseases and speed up clinical trials in the coming years. FAQ What is a clinical data management system? A clinical data management system (CDMS) is a tool used in clinical research to track, record, and manage clinical trial data across medical establishments such as biotech laboratories. What are the key functions of the biotech clinical data management system? Some of the key functions of biotech clinical data management system are Documentation of Protocols and Regulations Patient Recruitment Real-time Clinical Study Analytics Reporting Investigator Relationship Management Electronic Visit Report Why is a clinical data management system needed for clinical trials today? A clinical data management system helps shorten the time from drug development to marketing by assisting in the collection of high-quality, statistically sound, and accurate data from clinical trials.

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MedTech

Data Analytics: A Groundbreaking Technology in Biotech

Article | July 20, 2022

Biotechnology is a vast discipline of biology that employs diverse biological systems to create solutions that can significantly alter the ways in which they operate across various domains. That said, biotechnology is not a new notion. It has existed for millennia, with ancient civilizations using its earliest incarnations to cultivate crops and create alcoholic beverages. Today, the biotechnology industry has developed by leaps and bounds and has amassed a vast quantity of scientific data through study and research. Given the importance of data in the biotechnology business, it is not difficult to understand why biotech companies utilize data analytics. Modern data analytics tools have made it possible for researchers in the biotech industry to build predictive analytics models and gain knowledge about the most efficient approaches to accomplish their desired goals and objectives. Data analytics is increasingly being adopted by biotech businesses to better understand their industry and foresee any problems down the road. How is Data Analytics Revolutionizing Fields in Biotechnology? Today's business and scientific fields greatly benefit from data. Without the analysis of vast information libraries that provide new insights and enable new innovations, no industry can really advance. Being highly reliant on big data analytics, biotech is not an exception in this regard. With the tools and methods that help scientists systematize their findings and speed up their research for better and safer results, data analytics is making deeper inroads into the biotechnology industry. It is emerging as a crucial link between knowledge and information and is extensively being used for purposes other than just examining the information that is already available. The following are a few of the cutting-edge biotechnology applications of data analytics Genomics and Disease Treatment Pharmaceutical Drug Discovery Drug Recycling and Safety Agriculture and Agri-products Environmental Damage Mitigation Data Analytics Possibilities in Biotechnology With data analytics becoming an integral part of how biotech businesses operate, biotechnologists and related stakeholders need to understand its emergence and crucial role. Data analytics has opened new frontiers in the realm of biotechnology. Thanks to developments in data analytics, research and development activities that once took years may now be accomplished in a matter of months. Also, now scientists have access to biological, social, and environmental insights that can be exploited to create more effective and sustainable products. By understanding the importance of data-related tools and techniques applications, biotech companies are aiming to invest in the popularizing technology to stay updated in the fast-paced biotechnology industry.

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Spotlight

APEIRON Biologics

Apeiron Biologics AG is a privately financed Biotech company in Vienna, Austria. The company currently employs around 25 people and has a strong focus on immunological approaches to treat cancer. In 2010, Apeiron out-licensed itslead project (a recombinant enzyme for the treatment of Acute Respiratory Distress Syndrome and other diseases) to GSK in a deal potentially worth €236 million. Subsequently, Apeiron in-licensed several clinical projects (a liposomal formulation of SOD, a fusion protein and a monoclonal antibody against neuroblastoma) to complement its innovative in-house projects

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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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