Biotech Leaders Warn: Shortsighted Policies Threaten Miracle Breakthroughs

ANDREW SEGERMAN | August 6, 2019 | 91 views

Biomedical innovation is currently being jeopardized by a well-publicized minority of bad actors, drug companies that exorbitantly jack up prices on generic and branded drugs because they can and/or create frivolous patent extensions that game the system and prolong exclusivity for years or decades. Not all price increases are exorbitant, nor are all patent extensions frivolous, but the behavior of a few is laying waste to the reputation of the entire pharmaceutical industry at the worst possible time: as the genomic medicine revolution begins to deliver a new era of previously unimaginable cures.

Spotlight

Bio-protocol

Bio-protocol (ISSN: 2331-8325) is an e-journal created in 2011 by a group of Stanford researchers. Our mission is to make life science research more efficient and reproducible by curating high quality, open-access, life science protocols. We differ from other journals and online protocol depositories in a number of ways. We are free to publish with and we are free to use. Our protocols are of the highest quality because publication is by invitation only, and all of our articles undergo extensive peer review to ensure reproducibility.

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MEDTECH

Top 10 biotech IPOs in 2019

Article | July 16, 2022

The big question at the start of 2019 was whether the IPO window would stay open for biotech companies, particularly those seeking to pull off ever-larger IPOs at increasingly earlier stages of development. The short answer is yes—kind of. Here’s the long answer: In the words of Renaissance Capital, the IPO market had “a mostly good year.” The total number of deals fell to 159 from 192 the year before, but technology and healthcare companies were standout performers. The latter—which include biotech, medtech and diagnostics companies—led the pack, making up 43% of all IPOs in 2019. By Renaissance’s count, seven companies went public at valuations exceeding $1 billion, up from five the year before

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MEDICAL

Cell Out? Lysate-Based Expression an Option for Personalized Meds

Article | August 16, 2022

Cell-free expression (CFE) is the practice of making a protein without using a living cell. In contrast with cell line-based methods, production is achieved using a fluid containing biological components extracted from a cell, i.e., a lysate. CFE offers potential advantages for biopharma according to Philip Probert, PhD, a senior scientist at the Centre for Process Innovation in the U.K.

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MEDTECH

Closing bacterial genomes from the human gut microbiome using long-read sequencing

Article | July 20, 2022

In our lab, we focus on the impact of the gut microbiome on human health and disease. To evaluate this relationship, it’s important to understand the particular functions that different bacteria have. As bacteria are able to exchange, duplicate, and rearrange their genes in ways that directly affect their phenotypes, complete bacterial genomes assembled directly from human samples are essential to understand the strain variation and potential functions of the bacteria we host. Advances in the microbiome space have allowed for the de novo assembly of microbial genomes directly from metagenomes via short-read sequencing, assembly of reads into contigs, and binning of contigs into putative genome drafts. This is advantageous because it allows us to discover microbes without culturing them, directly from human samples and without reference databases. In the past year, there have been a number of tour de force efforts to broadly characterize the human gut microbiota through the creation of such metagenome-assembled genomes (MAGs)[1–4]. These works have produced hundreds of thousands of microbial genomes that vastly increase our understanding of the human gut. However, challenges in the assembly of short reads has limited our ability to correctly assemble repeated genomic elements and place them into genomic context. Thus, existing MAGs are often fragmented and do not include mobile genetic elements, 16S rRNA sequences, and other elements that are repeated or have high identity within and across bacterial genomes.

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Selexis Cell Line Development Strategies

Article | February 11, 2020

In today’s biotechnology landscape, to be competitive, meet regulations, and achieve market demands, “we must apply Bioprocessing 4.0,” said Igor Fisch, PhD, CEO, Selexis. In fact, in the last decade, “Selexis has evolved from cloning by limiting dilution to automated cell selection to nanofluidic chips and from monoclonality assessment by statistical calculation to proprietary bioinformatic analysis,” he added. Single-use processing systems are an expanding part of the biomanufacturing world; as such, they are a major component of Bioprocessing 4.0. “At Selexis, we use single use throughout our cell line development workflow. Currently, we have incorporated single-use automated bioprocessing systems such as ambr® and the Beacon® optofluidic platform for accelerated cell line development. By using these systems and optimizing our parameters, we were able to achieve high titers in shake flasks. Additionally, the Beacon systems integrate miniaturized cell culture with high-throughput liquid handling automation and cell imaging. This allows us to control, adjust, and monitor programs at the same time,” noted Fisch.

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Spotlight

Bio-protocol

Bio-protocol (ISSN: 2331-8325) is an e-journal created in 2011 by a group of Stanford researchers. Our mission is to make life science research more efficient and reproducible by curating high quality, open-access, life science protocols. We differ from other journals and online protocol depositories in a number of ways. We are free to publish with and we are free to use. Our protocols are of the highest quality because publication is by invitation only, and all of our articles undergo extensive peer review to ensure reproducibility.

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MEDICAL

Navigate BioPharma Services, Inc. launches new multiplex digital PCR assay for comprehensive quantification of up to 5 different CAR-T transgenes

PRNewswire | June 02, 2023

During this year's AAPS National biotechnology conference, Navigate BioPharma Services, Inc., a Novartis subsidiary and a leading provider of innovative biomarker solutions for drug development, announced the launch of its new multiplex digital PCR assays for comprehensive quantification of multiple chimeric antigen receptor (CAR) T cells, a type of cancer immunotherapy that involves genetically modifying T cells to recognize and destroy certain cancers. These assays are based on the Qiagen QIAcuity digital PCR System, which offers a powerful yet easy-to-use digital PCR experience through its unique nanoplate system. The new multiplex digital PCR assay enables simultaneous measurement of the number, function and persistence of CAR-T cells in clinical blood and bone marrow samples, without the need for a standard curve. It can detect as low as 0.01% of CAR-T cells among normal T cells, with a turnaround time of less than two hours. These assays can measure up to five different CAR-T cell markers in a single reaction, using specific probes for different CAR targets, to quantitate multiple CAR-domains, or combinations of commonly used therapeutic targets for CAR-T therapies. The assay can help clinicians monitor response or safety events during clinical trials to enable the development of new therapies. "CAR-T therapy is a promising and innovative approach to treat cancer, but it requires accurate and reliable quantification of CAR-T cells for successful drug development," said Dr. Nathan Riccitelli, Associate Director of Innovative Technologies at Navigate BioPharma Services, Inc. "Our new proprietary multiplex digital PCR assay provides a comprehensive and robust solution for measuring CAR-T cells in clinical samples with high sensitivity, specificity and reproducibility." Navigate BioPharma Services, Inc. has developed this assay for use in sponsors-led clinical trials. If interested, contact them about how this assay can be used in upcoming clinical trial studies. Navigate Biopharma Services, Inc. Navigate BioPharma Services, Inc., an independently operating subsidiary within the Novartis group of companies, is a leading provider of innovative biomarker and specialty bioanalytic solutions for clinical development. Over the past decade, Navigate BioPharma has built and developed its exclusive library of assays, methodologies, and biomarker solutions. Their extensive expertise offers unique, accurate, reliable, and cost-effective solutions for its customers and partners.

Read More

MEDTECH, INDUSTRY OUTLOOK

Mission Bio Launches Tapestri v3 to Rapidly Accelerate Rare Cell Detection Applications for Translational Research and Precision Therapeutics

PRNewswire | June 01, 2023

Mission Bio, Inc., the pioneer in high-throughput single-cell DNA and multi-omics analysis, announced breakthrough improvements to the Tapestri® Platform and its core chemistry that enable highly confident detection of rare cells for a range of applications. With Tapestri® v3 chemistry, researchers can discover tiny numbers of single cells that, until now, easily escaped detection and influenced disease in invisible ways. At the same time, drug developers can use the new capabilities for a more complete understanding of their advanced therapies, potentially leading to safer, more effective medicines. The new Tapestri® v3 chemistry increases the number of cells captured per sample by up to four times compared to the prior chemistry, a notable enhancement. With enhanced cell capture, the Tapestri® Platform can more reliably detect rare cells, opening incredible new possibilities like improving the assessment of measurable residual disease (MRD), a key metric used increasingly in clinical settings to estimate the risk of relapse with certain cancers. In the case of MRD in hematological cancers, rare subclonal variants are commonly missed by bulk NGS due to its averaging effect, hindering the detection of relapse-driving clones that potentially offer new therapeutic targets. With Tapestri®'s expanded capabilities, new integrated multi-omics tools like the Tapestri® scMRD Assay for Acute Myeloid Leukemia (AML) will offer clinicians additional therapeutic insights, rather than providing a binary 'yes or no' answer to the presence of residual disease. A team of investigators from Memorial Sloan Kettering Cancer Center (MSK) using the assay has reported a high sensitivity of 0.01% limit of detection in data presented at Mission Bio's Tapestri® scMRD for AML Summit last year. Tapestri®'s new capabilities also hold promise for cell and gene therapy developers looking to improve quality assessment throughout the therapy development process. Powered by Tapestri® v3 chemistry, the increase in cell throughput means Tapestri® Genome Editing Solution can measure gene editing outcomes at single-cell resolution – even for very low-frequency events like translocations, which can have significant effects on the safety of the therapy. Tapestri® v3 is the latest example of Mission Bio's continued focus on customer-centric product and service development. The company has recently implemented additional quality control measurements including design and development, release, and documentation processes compliant with the ISO 9001 standard. "Our customers' success is at the forefront of our mind," said Adam Abate, PhD, Co-founder and Interim Chief Executive Officer of Mission Bio. "Researchers and drug developers are demanding ever-greater sensitivity and highly robust products to effectively progress their research or advanced therapeutic program, and we are committed to serving our customers and helping them achieve their goals." The new v3 reagents will be available for shipping starting in mid-June. About Mission Bio Mission Bio is a life sciences company that accelerates discoveries and cures for a wide range of diseases by equipping researchers with the tools they need to better measure and predict our resistance and response to new therapies. Mission Bio's multi-omics approach improves time-to-market for new therapeutics, including innovative cell and gene therapies that provide new pathways to health. Founded in 2014, Mission Bio has secured investment from Novo Growth, Cota Capital, Agilent Technologies, Mayfield Fund, and others.

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MEDTECH, INDUSTRY OUTLOOK

IPA's Subsidiary, BioStrand, Solves the Information Integration Dilemma (IID) for Systems Biology

Businesswire | May 31, 2023

ImmunoPrecise Antibodies Ltd. an AI-driven biotherapeutic research and technology company, announced that its subsidiary, BioStrand®, has successfully solved the Information Integration Dilemma (IID) by developing a unique technology design that enables their patented HYFT Technology to encapsulate and unify diverse data modalities - including syntactical (sequence) data, 3D structural data, unstructured scientific information (e.g. scientific literature), and beyond - into a singular, integrated framework. This breakthrough approach facilitates efficient data fusion, enabling a comprehensive analysis and interpretation of complex biological data. With HYFTs, BioStrand effectively addresses the IID, paving the way for quicker and more potent biological discoveries. This innovation has the potential to bring a paradigm shift in various domains including drug development, biomarker discovery, and the study of disease pathology, among others. The IID has long been a significant challenge for the biotechnology industry, as researchers and investors have grappled with the complexities of integrating various data types to gain meaningful insights. In the rapidly evolving field of biotechnology, data is generated from multiple sources such as scientific literature, experimental data, and genomic information. The integration of these different data types is critical for accelerating innovation and driving the discovery of novel therapeutics. However, traditional approaches have struggled to efficiently combine and analy ze this diverse data, often leading to incomplete or inaccurate conclusions. BioStrand's breakthrough approach leverages its patented HYFT® technology and LENSaiTM platform, which together enable the efficient analysis and understanding of complex biological data. By solving the IID, BioStrand has unlocked new possibilities for the discovery and development of novel therapeutics, which is expected to benefit both patients and the investor community. Dirk Van Hyfte, Co-Founder and Head of Innovation of BioStrand, said, "We are thrilled to have overcome the Information Integration Dilemma, which has long been a major hurdle in our industry. Our HYFT technology and LENSai platform are now poised to revolutionize the way researchers and AI-driven systems process and analyze complex biological data, ultimately leading to faster and more effective drug discovery and development." BioStrand's HYFT technology extracts unique patterns, known as Universal Fingerprint™ patterns, from the entire biosphere, and integrates them with various data sources, such as scientific papers and medical records. The resulting Knowledge Graph encompasses over 660 million HYFTs and more than 25 billion relations, providing a powerful resource for researchers and AI-driven analysis. The LENSai platform, powered by HYFT technology, takes advantage of the latest advancements in large language models (LLMs) to bridge the gap between syntax (sequences) and semantics (functions). This enables the platform to extract valuable insights from vast amounts of data, without the limitations of traditional LLMs. IPA's support of BioStrand's pioneering work reinforces its commitment to investing in cutting-edge biotechnology solutions with the potential to transform the industry. The successful resolution of the Information Integration Dilemma not only demonstrates the innovative nature of BioStrand's technology but also highlights the Company's dedication to improving the lives of patients worldwide. About ImmunoPrecise Antibodies Ltd ImmunoPrecise Antibodies Ltd. has several subsidiaries in North America and Europe including entities such as Talem Therapeutics LLC, BioStrand BV, ImmunoPrecise Antibodies (Canada) Ltd., and ImmunoPrecise Antibodies (Europe) B.V. The IPA Family is a biotherapeutic research and technology group that leverages systems biology, multi-omics modeling, and complex artificial intelligence systems to support its proprietary technologies in bioplatform-based antibody discovery. Services include highly specialized, full-continuum therapeutic biologics discovery, development, and out-licensing to support its business partners in their quest to discover and develop novel biologics against the most challenging targets.

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MEDICAL

Navigate BioPharma Services, Inc. launches new multiplex digital PCR assay for comprehensive quantification of up to 5 different CAR-T transgenes

PRNewswire | June 02, 2023

During this year's AAPS National biotechnology conference, Navigate BioPharma Services, Inc., a Novartis subsidiary and a leading provider of innovative biomarker solutions for drug development, announced the launch of its new multiplex digital PCR assays for comprehensive quantification of multiple chimeric antigen receptor (CAR) T cells, a type of cancer immunotherapy that involves genetically modifying T cells to recognize and destroy certain cancers. These assays are based on the Qiagen QIAcuity digital PCR System, which offers a powerful yet easy-to-use digital PCR experience through its unique nanoplate system. The new multiplex digital PCR assay enables simultaneous measurement of the number, function and persistence of CAR-T cells in clinical blood and bone marrow samples, without the need for a standard curve. It can detect as low as 0.01% of CAR-T cells among normal T cells, with a turnaround time of less than two hours. These assays can measure up to five different CAR-T cell markers in a single reaction, using specific probes for different CAR targets, to quantitate multiple CAR-domains, or combinations of commonly used therapeutic targets for CAR-T therapies. The assay can help clinicians monitor response or safety events during clinical trials to enable the development of new therapies. "CAR-T therapy is a promising and innovative approach to treat cancer, but it requires accurate and reliable quantification of CAR-T cells for successful drug development," said Dr. Nathan Riccitelli, Associate Director of Innovative Technologies at Navigate BioPharma Services, Inc. "Our new proprietary multiplex digital PCR assay provides a comprehensive and robust solution for measuring CAR-T cells in clinical samples with high sensitivity, specificity and reproducibility." Navigate BioPharma Services, Inc. has developed this assay for use in sponsors-led clinical trials. If interested, contact them about how this assay can be used in upcoming clinical trial studies. Navigate Biopharma Services, Inc. Navigate BioPharma Services, Inc., an independently operating subsidiary within the Novartis group of companies, is a leading provider of innovative biomarker and specialty bioanalytic solutions for clinical development. Over the past decade, Navigate BioPharma has built and developed its exclusive library of assays, methodologies, and biomarker solutions. Their extensive expertise offers unique, accurate, reliable, and cost-effective solutions for its customers and partners.

Read More

MEDTECH, INDUSTRY OUTLOOK

Mission Bio Launches Tapestri v3 to Rapidly Accelerate Rare Cell Detection Applications for Translational Research and Precision Therapeutics

PRNewswire | June 01, 2023

Mission Bio, Inc., the pioneer in high-throughput single-cell DNA and multi-omics analysis, announced breakthrough improvements to the Tapestri® Platform and its core chemistry that enable highly confident detection of rare cells for a range of applications. With Tapestri® v3 chemistry, researchers can discover tiny numbers of single cells that, until now, easily escaped detection and influenced disease in invisible ways. At the same time, drug developers can use the new capabilities for a more complete understanding of their advanced therapies, potentially leading to safer, more effective medicines. The new Tapestri® v3 chemistry increases the number of cells captured per sample by up to four times compared to the prior chemistry, a notable enhancement. With enhanced cell capture, the Tapestri® Platform can more reliably detect rare cells, opening incredible new possibilities like improving the assessment of measurable residual disease (MRD), a key metric used increasingly in clinical settings to estimate the risk of relapse with certain cancers. In the case of MRD in hematological cancers, rare subclonal variants are commonly missed by bulk NGS due to its averaging effect, hindering the detection of relapse-driving clones that potentially offer new therapeutic targets. With Tapestri®'s expanded capabilities, new integrated multi-omics tools like the Tapestri® scMRD Assay for Acute Myeloid Leukemia (AML) will offer clinicians additional therapeutic insights, rather than providing a binary 'yes or no' answer to the presence of residual disease. A team of investigators from Memorial Sloan Kettering Cancer Center (MSK) using the assay has reported a high sensitivity of 0.01% limit of detection in data presented at Mission Bio's Tapestri® scMRD for AML Summit last year. Tapestri®'s new capabilities also hold promise for cell and gene therapy developers looking to improve quality assessment throughout the therapy development process. Powered by Tapestri® v3 chemistry, the increase in cell throughput means Tapestri® Genome Editing Solution can measure gene editing outcomes at single-cell resolution – even for very low-frequency events like translocations, which can have significant effects on the safety of the therapy. Tapestri® v3 is the latest example of Mission Bio's continued focus on customer-centric product and service development. The company has recently implemented additional quality control measurements including design and development, release, and documentation processes compliant with the ISO 9001 standard. "Our customers' success is at the forefront of our mind," said Adam Abate, PhD, Co-founder and Interim Chief Executive Officer of Mission Bio. "Researchers and drug developers are demanding ever-greater sensitivity and highly robust products to effectively progress their research or advanced therapeutic program, and we are committed to serving our customers and helping them achieve their goals." The new v3 reagents will be available for shipping starting in mid-June. About Mission Bio Mission Bio is a life sciences company that accelerates discoveries and cures for a wide range of diseases by equipping researchers with the tools they need to better measure and predict our resistance and response to new therapies. Mission Bio's multi-omics approach improves time-to-market for new therapeutics, including innovative cell and gene therapies that provide new pathways to health. Founded in 2014, Mission Bio has secured investment from Novo Growth, Cota Capital, Agilent Technologies, Mayfield Fund, and others.

Read More

MEDTECH, INDUSTRY OUTLOOK

IPA's Subsidiary, BioStrand, Solves the Information Integration Dilemma (IID) for Systems Biology

Businesswire | May 31, 2023

ImmunoPrecise Antibodies Ltd. an AI-driven biotherapeutic research and technology company, announced that its subsidiary, BioStrand®, has successfully solved the Information Integration Dilemma (IID) by developing a unique technology design that enables their patented HYFT Technology to encapsulate and unify diverse data modalities - including syntactical (sequence) data, 3D structural data, unstructured scientific information (e.g. scientific literature), and beyond - into a singular, integrated framework. This breakthrough approach facilitates efficient data fusion, enabling a comprehensive analysis and interpretation of complex biological data. With HYFTs, BioStrand effectively addresses the IID, paving the way for quicker and more potent biological discoveries. This innovation has the potential to bring a paradigm shift in various domains including drug development, biomarker discovery, and the study of disease pathology, among others. The IID has long been a significant challenge for the biotechnology industry, as researchers and investors have grappled with the complexities of integrating various data types to gain meaningful insights. In the rapidly evolving field of biotechnology, data is generated from multiple sources such as scientific literature, experimental data, and genomic information. The integration of these different data types is critical for accelerating innovation and driving the discovery of novel therapeutics. However, traditional approaches have struggled to efficiently combine and analy ze this diverse data, often leading to incomplete or inaccurate conclusions. BioStrand's breakthrough approach leverages its patented HYFT® technology and LENSaiTM platform, which together enable the efficient analysis and understanding of complex biological data. By solving the IID, BioStrand has unlocked new possibilities for the discovery and development of novel therapeutics, which is expected to benefit both patients and the investor community. Dirk Van Hyfte, Co-Founder and Head of Innovation of BioStrand, said, "We are thrilled to have overcome the Information Integration Dilemma, which has long been a major hurdle in our industry. Our HYFT technology and LENSai platform are now poised to revolutionize the way researchers and AI-driven systems process and analyze complex biological data, ultimately leading to faster and more effective drug discovery and development." BioStrand's HYFT technology extracts unique patterns, known as Universal Fingerprint™ patterns, from the entire biosphere, and integrates them with various data sources, such as scientific papers and medical records. The resulting Knowledge Graph encompasses over 660 million HYFTs and more than 25 billion relations, providing a powerful resource for researchers and AI-driven analysis. The LENSai platform, powered by HYFT technology, takes advantage of the latest advancements in large language models (LLMs) to bridge the gap between syntax (sequences) and semantics (functions). This enables the platform to extract valuable insights from vast amounts of data, without the limitations of traditional LLMs. IPA's support of BioStrand's pioneering work reinforces its commitment to investing in cutting-edge biotechnology solutions with the potential to transform the industry. The successful resolution of the Information Integration Dilemma not only demonstrates the innovative nature of BioStrand's technology but also highlights the Company's dedication to improving the lives of patients worldwide. About ImmunoPrecise Antibodies Ltd ImmunoPrecise Antibodies Ltd. has several subsidiaries in North America and Europe including entities such as Talem Therapeutics LLC, BioStrand BV, ImmunoPrecise Antibodies (Canada) Ltd., and ImmunoPrecise Antibodies (Europe) B.V. The IPA Family is a biotherapeutic research and technology group that leverages systems biology, multi-omics modeling, and complex artificial intelligence systems to support its proprietary technologies in bioplatform-based antibody discovery. Services include highly specialized, full-continuum therapeutic biologics discovery, development, and out-licensing to support its business partners in their quest to discover and develop novel biologics against the most challenging targets.

Read More

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