How Can Emerging Biotechs Ensure Their Collaboration with CROs is Successful?

November 25, 2019 | 94 views

As the complexity of drug discovery and development steadily increases, so do the costs. With average expenditures for prescription drug R&D ranging between $2.5 and $3 billion, small and medium-sized biotech companies are facing a number of challenges. In 2018, more than two-thirds of late-stage pipelines were owned by emerging biotechs, reflecting a shift within the industry from large biopharma companies to small and medium-sized enterprises (SMEs). Often limited by a lack of liquidity, in-house resources, infrastructure, or expertise, emerging biotechs are continuously looking for more cost-effective ways to develop medicines.

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ARCEDI Biotech

ARCEDI Biotech ApS is a Danish biotech company involved in developing technologies for rare cell detection, a widely sought after application in the prenatal as well as cancer diagnostics.

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MEDTECH

Top 10 biotech IPOs in 2019

Article | October 7, 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 | July 13, 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 11, 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

ARCEDI Biotech

ARCEDI Biotech ApS is a Danish biotech company involved in developing technologies for rare cell detection, a widely sought after application in the prenatal as well as cancer diagnostics.

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European Biotechs Showcase Multiple Sclerosis Treatments in Stockholm

Labiotech.eu | September 17, 2019

Genmab, GeNeuro and other companies presented their latest data on next-generation treatments for multiple sclerosis at a conference in Stockholm. The European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) gathered experts and companies working on multiple sclerosis in Sweden this year. Companies such as Genmab and GeNeuro revealed the progress of their treatments, with Genmab’s drug at the verge of reaching the market. Multiple sclerosis is a neurological autoimmune condition where the immune system attacks the cells that keep nerve cells healthy, causing neurodegeneration and eventual disability. Its has received attention from the biotech industry because the condition has no cure, and there are limited drugs approved to slow the progression of the disease. In particular, many companies aim to stop relapses in the most common form of the condition, known as relapsing-remitting multiple sclerosis. The Danish antibody developer Genmab presented results from its drug ofatumumab, which is licensed to Novartis. In two phase III trials, the ability of the antibody drug to prevent relapse was compared to that of teriflunomide, an oral drug routinely used to treat relapsing forms of multiple sclerosis. Patients given Genmab and Novartis’ antibody had an annualized relapse rate of around 0.1 in the two trials, which is less than half of those given teriflunomide in both trials, with an annualized relapse rate of around 0.22.

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Fund for Late-Stage European Biotechs Closes Final Round With 120M Euors

labiotech.eu | June 25, 2019

The Luxembourg-based investor Vesalius Biocapital III has completed the final closing of a €120M fund to boost late-stage life science companies. Around 10-15 companies will receive investments from the fund, including specialists in drug development, med-tech, and diagnostics. Three companies have become beneficiaries so far, including the Finnish women’s health drug company Forendo Pharma, German prosthetics company Mecuris, and US digital therapy company SWORD Health. Vesalius Biocapital has secured more than €65M for the first closing of a new fund targeting European biotechs in late stages of development. Vesalius Biocapital has announced today the first closing of its third fund, VBC III, which will be aimed at biotech companies developing not only drugs and diagnostics, but also medtech and digital health products. Unlike the first two funds, VBC III will focus the investments on companies at late stages of development and closer to the market. The first closing has secured Vesalius over €65M. Over the following 18 months, the investment firm is aiming to reach €150M for the final closing. This objective is way higher than for previous funds, but the number of companies invested in, 10 to 15, will not increase; late development stages require bigger injections.

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Ocular Biotechs Histogenics, Ocugen Announce Stock-For-Stock Merger

Histogenics Corporation | April 08, 2019

Histogenics Corporation and privately held Ocugen announced a merger Monday that will create a new, Nasdaq-listed company aiming to develop novel ocular gene therapies and biotherapeutics under the Ocugen name. The agreement calls for Ocugen stockholders to become the majority owners of outstanding Histogenics common stock upon closing. The deal is a stock-for-stock transaction. Upon closing, the combined company will be headquartered in Malvern, Pennsylvania and will operate under Ocugen's present leadership, the companies said. No Histogenics employees will remain employed by the combined company, according to Monday's announcement.

Read More

European Biotechs Showcase Multiple Sclerosis Treatments in Stockholm

Labiotech.eu | September 17, 2019

Genmab, GeNeuro and other companies presented their latest data on next-generation treatments for multiple sclerosis at a conference in Stockholm. The European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) gathered experts and companies working on multiple sclerosis in Sweden this year. Companies such as Genmab and GeNeuro revealed the progress of their treatments, with Genmab’s drug at the verge of reaching the market. Multiple sclerosis is a neurological autoimmune condition where the immune system attacks the cells that keep nerve cells healthy, causing neurodegeneration and eventual disability. Its has received attention from the biotech industry because the condition has no cure, and there are limited drugs approved to slow the progression of the disease. In particular, many companies aim to stop relapses in the most common form of the condition, known as relapsing-remitting multiple sclerosis. The Danish antibody developer Genmab presented results from its drug ofatumumab, which is licensed to Novartis. In two phase III trials, the ability of the antibody drug to prevent relapse was compared to that of teriflunomide, an oral drug routinely used to treat relapsing forms of multiple sclerosis. Patients given Genmab and Novartis’ antibody had an annualized relapse rate of around 0.1 in the two trials, which is less than half of those given teriflunomide in both trials, with an annualized relapse rate of around 0.22.

Read More

Fund for Late-Stage European Biotechs Closes Final Round With 120M Euors

labiotech.eu | June 25, 2019

The Luxembourg-based investor Vesalius Biocapital III has completed the final closing of a €120M fund to boost late-stage life science companies. Around 10-15 companies will receive investments from the fund, including specialists in drug development, med-tech, and diagnostics. Three companies have become beneficiaries so far, including the Finnish women’s health drug company Forendo Pharma, German prosthetics company Mecuris, and US digital therapy company SWORD Health. Vesalius Biocapital has secured more than €65M for the first closing of a new fund targeting European biotechs in late stages of development. Vesalius Biocapital has announced today the first closing of its third fund, VBC III, which will be aimed at biotech companies developing not only drugs and diagnostics, but also medtech and digital health products. Unlike the first two funds, VBC III will focus the investments on companies at late stages of development and closer to the market. The first closing has secured Vesalius over €65M. Over the following 18 months, the investment firm is aiming to reach €150M for the final closing. This objective is way higher than for previous funds, but the number of companies invested in, 10 to 15, will not increase; late development stages require bigger injections.

Read More

Ocular Biotechs Histogenics, Ocugen Announce Stock-For-Stock Merger

Histogenics Corporation | April 08, 2019

Histogenics Corporation and privately held Ocugen announced a merger Monday that will create a new, Nasdaq-listed company aiming to develop novel ocular gene therapies and biotherapeutics under the Ocugen name. The agreement calls for Ocugen stockholders to become the majority owners of outstanding Histogenics common stock upon closing. The deal is a stock-for-stock transaction. Upon closing, the combined company will be headquartered in Malvern, Pennsylvania and will operate under Ocugen's present leadership, the companies said. No Histogenics employees will remain employed by the combined company, according to Monday's announcement.

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