Thermo Fisher Scientific Joins the Pistoia Alliance

MOLLY CAMPBELL | November 26, 2019 | 64 views

Recently, Thermo Fisher Scientific announced its membership of the Pistoia Alliance, a global, not-for-profit alliance of life science companies, vendors, publishers and academic groups working to lower barriers to innovation in life science and healthcare R&D through pre-competitive collaboration.

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Integrium, LLC

Integrium is a full-service Clinical Proof of Concept (PoC) Firm focused within the therapeutic areas of Cardiovascular, Metabolic, Renal, Inflammatory, Dermatology, Wound Healing, Regenerative, and Orphan Disease. Although we have the scientific, medical, operational, and regulatory expertise to cover all stages of clinical development (Phase I-IV), we are Experts in the Strategy, Design and Execution of Clinical PoC Trials. Integrium provides our clients with a full line of Clinical Trial Services either as a stand alone product or as a full "turn-key" clinical trial solution, including Protocol Design & Development, Study Start-up Services, Clinical Monitoring, Project Management, Medical Services /Drug Safety, Data Management, Biostatistics, Cardiovascular Core Lab Services, and Medical Writing.

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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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MEDTECH

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

Article | September 22, 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 12, 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

Integrium, LLC

Integrium is a full-service Clinical Proof of Concept (PoC) Firm focused within the therapeutic areas of Cardiovascular, Metabolic, Renal, Inflammatory, Dermatology, Wound Healing, Regenerative, and Orphan Disease. Although we have the scientific, medical, operational, and regulatory expertise to cover all stages of clinical development (Phase I-IV), we are Experts in the Strategy, Design and Execution of Clinical PoC Trials. Integrium provides our clients with a full line of Clinical Trial Services either as a stand alone product or as a full "turn-key" clinical trial solution, including Protocol Design & Development, Study Start-up Services, Clinical Monitoring, Project Management, Medical Services /Drug Safety, Data Management, Biostatistics, Cardiovascular Core Lab Services, and Medical Writing.

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CELL AND GENE THERAPY, INDUSTRIAL IMPACT

Scientist.com Announces the Launch of Compliance Mobile App for iOS

Scientist.com | February 02, 2023

On February 1, 2023, Scientist.com, the biopharma industry's largest R&D marketplace, announced the release of a new iOS mobile app. The app provides a new, easy-to-use, on-the-go experience for purchase request approvals and compliance. In addition, iPhone users receive untethered notifications for accepting, delegating, and clarifying requests without needing to use their computers. The result is speedier approvals and fewer delays in scientific discovery. Scientist.com has spent the past fourteen years developing a digital marketplace that allows scientists to devote more time to science and less time to paperwork. The platform enables researchers to test more ideas in less time and at a lesser cost. It digitizes a company's complete research activities, automatically tracking purchases, contract management, payment processing, and generating business intelligence reports. Scientist.com Founder and CTO Chris Petersen commented, "One of the major barriers to drug discovery is the time it takes to ensure all compliance measures are met for a given research project, and understandably so." He added, "Our goal in building the Compliance Mobile App is to put compliance in the pocket of approvers, therefore minimizing the time it takes for researchers to move through the R&D process." (Source – Business Wire) Registered users of the Scientist.com platform can now get the Compliance Mobile App free from the Apple App Store About Scientist.com Founded in 2007, Scientist.com is the world's largest medical research marketplace. Its digital research platform combines a custom-built, cloud-native technology stack with a white-glove customer and scientific support, helping pharmaceutical scientists discover life-saving drugs in less time and at a lower cost. As a result, Scientist.com is accelerating and lowering the cost of medical research by connecting scientists and allowing them to exchange ideas and transact online effortlessly. The company now has a presence in enterprise marketplaces for 20 of the world's top 30 pharmaceutical firms, 80 biotechnology enterprises, and the National Institutes of Health in the United States (NIH).

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MEDTECH, INDUSTRIAL IMPACT

INOVIO Announces Strategic Reorganization to Deliver DNA Medicines to Patients

INOVIO Pharmaceuticals, Inc. | February 01, 2023

On January 31, 2023, INOVIO, a leading biotechnology firm focused on the development and commercialization of DNA medicines to protect and treat people from cancer, HPV-associated diseases, and infectious diseases, announced a strategic reorganization to meet operational efficiency commitments and better position the company to deliver DNA medicines to patients. Following the previously announced end of clinical development projects in late 2022, the restructuring is estimated to result in yearly savings of roughly $4.3 million and an 11% reduction in full-time personnel. These and other strategic initiatives divert resources needed to progress critical programs, such as INOVIO's product candidate INO-3107 for the treatment of Recurrent Respiratory Papillomatosis (RRP). INOVIO anticipates a $1.1 million one-time restructuring charge in the first quarter of 2023. Its 2022 fourth-quarter and year-end financial results announcement, scheduled for March 2023, will provide more precise financial guidance. INOVIO's lead initiatives include therapies for HPV-related disorders, such as INO-3107 for RRP and VGX-3100 for cervical high-grade squamous intraepithelial lesions (HSIL). In the first quarter of 2023, INOVIO is anticipated to release the results of its Phase 3 REVEAL2 study for VGX-3100 and the second cohort of its Phase 1/2 trial for INO-3107. About INOVIO Pharmaceuticals, Inc. Headquartered in Plymouth Meeting, PA, INOVIO Pharmaceuticals, Inc. is a biotechnology firm dedicated to bringing precisely designed DNA therapeutics to market in order to treat, cure, and protect individuals from infectious diseases, cancer, and HPV-related diseases. INOVIO's in-development DNA medications are delivered utilizing its investigational proprietary smart device, CELLECTRA®, to elicit immune responses against targeted pathogens and malignancies. Its DNA medicines platform and the proprietary smart device can target almost any DNA sequence. With 15 clinical studies in development, the company has the potential to save and protect lives throughout the world and fuel a new decade of DNA medicines.

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INDUSTRIAL IMPACT, DIAGNOSTICS

Kite and Arcellx Close Deal to Develop and Market Late-stage Clinical CART-ddBCMA

Kite Pharma and Arcellx | January 31, 2023

On January 30, 2023, Kite and Arcellx, Inc. informed that they have completed their previously-announced global strategic collaboration to co-develop and co-market CART-ddBCMA. CART-ddBCMA is Arcellx's lead late-stage candidate for treating patients with relapsed or refractory multiple myeloma. For the majority of patients, multiple myeloma is an incurable disease; hence, there is a continuing demand for treatments that are not only effective but also secure and easily available. Arcellx's T-cell treatment, CART-ddBCMA, uses the company's unique synthetic binder, the D-Domain, and is now being studied in Phase 2 pivotal trials. Kite and Arcellx will work together to develop and market the CART-ddBCMA asset in the United States, while Kite will handle sales and marketing for the product in all other regions. About Kite Pharma Kite, a Gilead company, is a global biopharmaceutical company with its headquarters in Santa Monica (California). Cell therapy, which aims to treat and maybe even cure cancer, is the company's main area of research and development. Kite, the industry leader in cell therapy, has successfully administered CAR T-cell treatment to more patients than any other company. Process development, vector production, clinical trial supply, and commercial product manufacturing are all part of Kite's expansive in-house cell therapy manufacturing network, the most extensive in the world. About Arcellx Clinical biotechnology firm Arcellx, Inc. is rethinking cell treatment by developing novel immunotherapies for patients with cancer and other fatal diseases. The company considers cell therapies one of the most promising areas of modern medicine. Its goal is to improve the quality of life for people everywhere by creating safer, more effective, and widely available cell therapies. CART-ddBCMA is the principal product candidate being developed by Arcellx and is now in Phase 2 pivotal trials for treating relapsed or refractory multiple myeloma (r/r MM). The FDA has recognized CART-potential ddBCMAs by designating them as a regenerative medicine advanced therapy, an orphan drug, and a fast-track product.

Read More

CELL AND GENE THERAPY, INDUSTRIAL IMPACT

Scientist.com Announces the Launch of Compliance Mobile App for iOS

Scientist.com | February 02, 2023

On February 1, 2023, Scientist.com, the biopharma industry's largest R&D marketplace, announced the release of a new iOS mobile app. The app provides a new, easy-to-use, on-the-go experience for purchase request approvals and compliance. In addition, iPhone users receive untethered notifications for accepting, delegating, and clarifying requests without needing to use their computers. The result is speedier approvals and fewer delays in scientific discovery. Scientist.com has spent the past fourteen years developing a digital marketplace that allows scientists to devote more time to science and less time to paperwork. The platform enables researchers to test more ideas in less time and at a lesser cost. It digitizes a company's complete research activities, automatically tracking purchases, contract management, payment processing, and generating business intelligence reports. Scientist.com Founder and CTO Chris Petersen commented, "One of the major barriers to drug discovery is the time it takes to ensure all compliance measures are met for a given research project, and understandably so." He added, "Our goal in building the Compliance Mobile App is to put compliance in the pocket of approvers, therefore minimizing the time it takes for researchers to move through the R&D process." (Source – Business Wire) Registered users of the Scientist.com platform can now get the Compliance Mobile App free from the Apple App Store About Scientist.com Founded in 2007, Scientist.com is the world's largest medical research marketplace. Its digital research platform combines a custom-built, cloud-native technology stack with a white-glove customer and scientific support, helping pharmaceutical scientists discover life-saving drugs in less time and at a lower cost. As a result, Scientist.com is accelerating and lowering the cost of medical research by connecting scientists and allowing them to exchange ideas and transact online effortlessly. The company now has a presence in enterprise marketplaces for 20 of the world's top 30 pharmaceutical firms, 80 biotechnology enterprises, and the National Institutes of Health in the United States (NIH).

Read More

MEDTECH, INDUSTRIAL IMPACT

INOVIO Announces Strategic Reorganization to Deliver DNA Medicines to Patients

INOVIO Pharmaceuticals, Inc. | February 01, 2023

On January 31, 2023, INOVIO, a leading biotechnology firm focused on the development and commercialization of DNA medicines to protect and treat people from cancer, HPV-associated diseases, and infectious diseases, announced a strategic reorganization to meet operational efficiency commitments and better position the company to deliver DNA medicines to patients. Following the previously announced end of clinical development projects in late 2022, the restructuring is estimated to result in yearly savings of roughly $4.3 million and an 11% reduction in full-time personnel. These and other strategic initiatives divert resources needed to progress critical programs, such as INOVIO's product candidate INO-3107 for the treatment of Recurrent Respiratory Papillomatosis (RRP). INOVIO anticipates a $1.1 million one-time restructuring charge in the first quarter of 2023. Its 2022 fourth-quarter and year-end financial results announcement, scheduled for March 2023, will provide more precise financial guidance. INOVIO's lead initiatives include therapies for HPV-related disorders, such as INO-3107 for RRP and VGX-3100 for cervical high-grade squamous intraepithelial lesions (HSIL). In the first quarter of 2023, INOVIO is anticipated to release the results of its Phase 3 REVEAL2 study for VGX-3100 and the second cohort of its Phase 1/2 trial for INO-3107. About INOVIO Pharmaceuticals, Inc. Headquartered in Plymouth Meeting, PA, INOVIO Pharmaceuticals, Inc. is a biotechnology firm dedicated to bringing precisely designed DNA therapeutics to market in order to treat, cure, and protect individuals from infectious diseases, cancer, and HPV-related diseases. INOVIO's in-development DNA medications are delivered utilizing its investigational proprietary smart device, CELLECTRA®, to elicit immune responses against targeted pathogens and malignancies. Its DNA medicines platform and the proprietary smart device can target almost any DNA sequence. With 15 clinical studies in development, the company has the potential to save and protect lives throughout the world and fuel a new decade of DNA medicines.

Read More

INDUSTRIAL IMPACT, DIAGNOSTICS

Kite and Arcellx Close Deal to Develop and Market Late-stage Clinical CART-ddBCMA

Kite Pharma and Arcellx | January 31, 2023

On January 30, 2023, Kite and Arcellx, Inc. informed that they have completed their previously-announced global strategic collaboration to co-develop and co-market CART-ddBCMA. CART-ddBCMA is Arcellx's lead late-stage candidate for treating patients with relapsed or refractory multiple myeloma. For the majority of patients, multiple myeloma is an incurable disease; hence, there is a continuing demand for treatments that are not only effective but also secure and easily available. Arcellx's T-cell treatment, CART-ddBCMA, uses the company's unique synthetic binder, the D-Domain, and is now being studied in Phase 2 pivotal trials. Kite and Arcellx will work together to develop and market the CART-ddBCMA asset in the United States, while Kite will handle sales and marketing for the product in all other regions. About Kite Pharma Kite, a Gilead company, is a global biopharmaceutical company with its headquarters in Santa Monica (California). Cell therapy, which aims to treat and maybe even cure cancer, is the company's main area of research and development. Kite, the industry leader in cell therapy, has successfully administered CAR T-cell treatment to more patients than any other company. Process development, vector production, clinical trial supply, and commercial product manufacturing are all part of Kite's expansive in-house cell therapy manufacturing network, the most extensive in the world. About Arcellx Clinical biotechnology firm Arcellx, Inc. is rethinking cell treatment by developing novel immunotherapies for patients with cancer and other fatal diseases. The company considers cell therapies one of the most promising areas of modern medicine. Its goal is to improve the quality of life for people everywhere by creating safer, more effective, and widely available cell therapies. CART-ddBCMA is the principal product candidate being developed by Arcellx and is now in Phase 2 pivotal trials for treating relapsed or refractory multiple myeloma (r/r MM). The FDA has recognized CART-potential ddBCMAs by designating them as a regenerative medicine advanced therapy, an orphan drug, and a fast-track product.

Read More

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