FDA’s thinking on dietary ingredient status could hinder biotechnology advancements

April 3, 2019 | 18 views

The regulatory atmosphere contributes to the unsolved opportunity of biotechnology from a business perspective. Consider the spectrum of potential for future regulation(s). At one end of the spectrum, biotechnology can only be applied to drugs. As extreme a position as this appears, it is a viable one from a regulatory perspective. If the output of biotechnology were tightly controlled across all markets, compliance issues would be minimized. At the opposite end of the spectrum, the least restrictive positions would allow for a broader application and use of biotechnology. In either scenario, brands would need to gain clarity in interpretation of the existing regulations.

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IMS Health

IMS Health is a leading global information and technology services company providing clients in the healthcare industry with end-to-end solutions to measure and improve their performance. Our 7,500 services experts connect configurable SaaS applications to 10+ petabytes of complex healthcare data in the IMS One™ cloud platform, delivering unique insights into diseases, treatments, costs and outcomes.

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Advancement in Genomics Accelerating its Penetration into Precision Health

Article | April 17, 2020

Genomics is an interdisciplinary field of biology emphasizing the structure, editing, evolution, function, and mapping of genomes. It is creating deeper inroads across the precision health domain with the increasing introduction of advanced technologies such as quantum simulation, next-generation sequencing (NGS), and precise genome manipulation. As precision health focuses on providing the proper intervention to the right patient at the right time, genomics increasingly finds applications in human and pathogen genome sequencing in clinical and research spaces. Rising Hereditary Diseases Burden Paving the Way for Genomics in Precision Health In the last few years, a significant surge in the prevalence of diseases and ailments such as diabetes, obesity, baldness, and others has been witnessed across the globe. A history of family members with chronic diseases, such as cancer, diabetes, high blood pressure, hearing issues, and heart disease, can sometimes continue into the next generation. Hence, the study of genes is extensively being conducted for predicting health risks and early treatment of these diseases. It also finds use in CRISPR-based diagnostics and the preparation of precision medication for the individual. In addition, ongoing advancements in genomics are making it possible to identify different genetic traits that persuade people to more widespread diseases and health problems. The Emergence of Genomics Improves Disease Understanding Genomics refers to the study of the complete genetic makeup of a cell or organism. Increasing scientific research in the area substantially contributes to increasing knowledge about the human genome and assists in improving the ability to understand disease etiology, risk, diagnosis, treatment, and prevention. On account of these improvements, innovative genomic technologies and tools are being developed to enable better precision health not only for the individual but for various regional populations as well. The Way Forward With growing preference for personalized medicine and an increasing need for more accurate pathogen detection and diagnostics, genomics is gaining huge popularity across the precision health domain. Also, increasing research activities for developing novel high-precision therapeutics and rising importance of gene study in the prevention, diagnosis, and management of infectious and genetic diseases will further pave the way for genomics in the forthcoming years.

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INDUSTRIAL IMPACT

Top 10 biotech IPOs in 2019

Article | January 20, 2021

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

Article | April 19, 2020

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

Article | February 12, 2020

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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Spotlight

IMS Health

IMS Health is a leading global information and technology services company providing clients in the healthcare industry with end-to-end solutions to measure and improve their performance. Our 7,500 services experts connect configurable SaaS applications to 10+ petabytes of complex healthcare data in the IMS One™ cloud platform, delivering unique insights into diseases, treatments, costs and outcomes.

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MEDICAL

Anitoa Launches Molecular Test (PCR) for Monkeypox

Anitoa | June 30, 2022

Anitoa Systems, market leader in fast, portable molecular testing, today announced the availability of a CE-marked turn-key PCR solution for testing Monkeypox. This portable solution includes one of a family small foot-print real time PCR instruments called the Maverick qPCR, with an extraction-free multiplex PCR reagent that tests OPXV/MPXV gene-targets in the skin lesion sample from patients suspected of infection with Monkeypox. Anitoa's Monkeypox test is designed to be carried out on-site, near patient, thus avoiding the need to transport patient samples to central labs for testing. The World Health Organization reported that over 2,100 people in 42 countries have been diagnosed with monkeypox as of June 15, nearly all during the past two months. As of June 17, the CDC reports 24 confirmed monkeypox cases in California, US. Although The CDC reports that the threat to the general U.S. population is considered low, it is important for healthcare providers worldwide to have a preparedness plan. Already having a presence in Africa, Anitoa Systems has started deloying its near-patient Monkeypox test in selected clinics in Africa. Anitoa is prepared to deliver its Monkeypox test solution world-wide when the need arises. Anitoa's Maverick line of multiplex real time PCR devices are lab-accurate, fast, portable and calibration-free. They can operate on battery power (including car battery) and takes up very little bench space. Maverick qPCR instruments are built on Anitoa's proprietary CMOS biosensor technology. They have been used widely for on-site testing of food, environment samples and agriculture products due to its rugged all solid-state design, small form factor, and lower operation cost. Anitoa's Monkeypox detection solution is part of an on-going program at Anitoa to develop tests to help combat a series of neglected tropical diseases in low resource settings. These tests currently include IVDR tests for Dengue, Yellow Fever, and Malaria We are closely monitoring the situation of Monkeypox infections around the world and tailoring our test solutions to the needs of the people affected." Zhimin ding, CEO of Anitoa Systems, LLC About Anitoa Anitoa Systems, a medical device technology start-up established in 2013 with headquarter in Sunnyvale, California, develops highly integrated and portable bio-sensor devices for molecular detection, based on its unique CMOS image sensor-based fluorescence and chemiluminescence molecular imaging. By replacing the traditional bulky and costly photon-multiplier tube (PMT) and CCD-based optical sub-systems, Anitoa's ultra-low-light CMOS sensor technology enables a new generation of compact and inexpensive molecular testing platforms targeting infectious, oncology and cardio-vascular markers. Anitoa manufactures its qPCR instruments and test kits in Hangzhou, China and Fremont, California.

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MEDICAL

Hillstream BioPharma to Announce Collaborating with Sapien Biosciences

Hillstream | June 30, 2022

Hillstream BioPharma, Inc., a U.S.-based biotechnology company developing novel therapeutic candidates targeting ferroptosis for cancer treatment, announced a collaboration with an Indian pioneer biobank and peonalized medicine company that leverages Saarum Innovation's global life sciences research expertise, Sapien Biosciences. The collaboration is aimed at assessing the compatibility of HSB-1216 with immune checkpoint inhibitors. HSB-1216, Hillstream’s most advanced candidate, is an IMCD modulator that targets various types of solid tumors. In an exhaustive study in Germany, the active drug in HSB-1216 was found to be efficacious in a clinical pilot for devastating cancers, including epithelial carcinomas and triple-negative breast cancer. Hillstream aims to build an early clinical proof-of-concept by beginning a clinical investigation with HSB-1216 in 2022. With this collaboration, Hillstream will be able to use Sapien’s patient samples and rich datasets to validate its HSB-1216 for the development of novel cancer therapeutics. We are initiating studies, in collaboration with Sapien Biosciences, to determine the synergy between HSB-1216, our ferroptosis inducer and nivolumab, an anti-PD1 antibody.” He stated, “In addition, we will also study the potential synergistic effects of HSB-1216 with the recently approved Bristol Myers Squibb drug Opdualag® (nivolumab + relatlimab), a fixed dose combination of an anti-PD1 MAb + anti-LAG3 MAb, to demonstrate that targeting a ferroptosis-associated metabolism in tumors may improve the efficacy of cancer immunotherapy.” Randy Milby, Hillstream’s Chief Executive Officer. We are excited to extend our collaboration with Hillstream Biopharma to evaluate potential synergy between their HSB-1216 molecule and ICIs using our expertise in establishing patient tissue-derived cell models in oncology, immunology and Immune-oncology Previously, Sapien demonstrated potent anti-cancer activity of HSB-1216 in primary triple negative breast cancer cells which were presented at AACR 2020.” Dr. Jugnu Jain, CEO, Sapien Biosciences.

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INDUSTRIAL IMPACT

ProPhase Labs to Announce Formation of a Subsidiary ProPhase BioPharma, Inc.

ProPhase Labs, Inc. | June 29, 2022

ProPhase Labs, Inc., a diversified biotech, genomics, and diagnostics company manufacturing homeopathic and health products, announced the formation of a new wholly-owned subsidiary, ProPhase BioPharma, Inc. (PBIO), for the development and licensing of new therapeutic compounds, drugs, and biotechnology. The subsidiary will be focused on advancements in technology across the biochemical industry and creating and developing new solutions that can transform the outcomes of healthcare. The company has also entered into a license agreement with a wholly-owned subsidiary of DSS, Inc., Global BioLife, Inc. (Global BioLife), for Equivir G and Equivir, proprietary compounds that were developed by Global Research and Discovery Group (GRDG). According to the terms of the contract, ProPhase Labs will be the only company that can develop and sell Equivir G and Equivir, globally. “We are thrilled to announce the formation of ProPhase BioPharma, our new wholly-owned subsidiary tasked with licensing and developing novel drugs, compounds, and biotechnology. We are equally pleased with our first licensing agreement for Equivir and Equivir G, which we believe have significant potential to improve human health outcomes worldwide.” Ted Karkus, ProPhase Lab’s Chief Executive Officer He further added, “We plan to pursue commercialization of Equivir as an OTC supplement, leveraging our distribution in over 40,000 Food Drug and Mass retail stores and online direct to consumer. We also look forward to applying to the FDA for an IND for Equivir G as a prescription antiviral.” Frank. D. Heuszel, Chief Executive Officer of DSS, said “We are excited to team up with ProPhase Labs, which will apply its nearly three decades of experience enhancing the health of the public to Equivir, which we believe to be a ground-breaking treatment that will positively impact health in the U.S. and globally.”

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MEDICAL

Anitoa Launches Molecular Test (PCR) for Monkeypox

Anitoa | June 30, 2022

Anitoa Systems, market leader in fast, portable molecular testing, today announced the availability of a CE-marked turn-key PCR solution for testing Monkeypox. This portable solution includes one of a family small foot-print real time PCR instruments called the Maverick qPCR, with an extraction-free multiplex PCR reagent that tests OPXV/MPXV gene-targets in the skin lesion sample from patients suspected of infection with Monkeypox. Anitoa's Monkeypox test is designed to be carried out on-site, near patient, thus avoiding the need to transport patient samples to central labs for testing. The World Health Organization reported that over 2,100 people in 42 countries have been diagnosed with monkeypox as of June 15, nearly all during the past two months. As of June 17, the CDC reports 24 confirmed monkeypox cases in California, US. Although The CDC reports that the threat to the general U.S. population is considered low, it is important for healthcare providers worldwide to have a preparedness plan. Already having a presence in Africa, Anitoa Systems has started deloying its near-patient Monkeypox test in selected clinics in Africa. Anitoa is prepared to deliver its Monkeypox test solution world-wide when the need arises. Anitoa's Maverick line of multiplex real time PCR devices are lab-accurate, fast, portable and calibration-free. They can operate on battery power (including car battery) and takes up very little bench space. Maverick qPCR instruments are built on Anitoa's proprietary CMOS biosensor technology. They have been used widely for on-site testing of food, environment samples and agriculture products due to its rugged all solid-state design, small form factor, and lower operation cost. Anitoa's Monkeypox detection solution is part of an on-going program at Anitoa to develop tests to help combat a series of neglected tropical diseases in low resource settings. These tests currently include IVDR tests for Dengue, Yellow Fever, and Malaria We are closely monitoring the situation of Monkeypox infections around the world and tailoring our test solutions to the needs of the people affected." Zhimin ding, CEO of Anitoa Systems, LLC About Anitoa Anitoa Systems, a medical device technology start-up established in 2013 with headquarter in Sunnyvale, California, develops highly integrated and portable bio-sensor devices for molecular detection, based on its unique CMOS image sensor-based fluorescence and chemiluminescence molecular imaging. By replacing the traditional bulky and costly photon-multiplier tube (PMT) and CCD-based optical sub-systems, Anitoa's ultra-low-light CMOS sensor technology enables a new generation of compact and inexpensive molecular testing platforms targeting infectious, oncology and cardio-vascular markers. Anitoa manufactures its qPCR instruments and test kits in Hangzhou, China and Fremont, California.

Read More

MEDICAL

Hillstream BioPharma to Announce Collaborating with Sapien Biosciences

Hillstream | June 30, 2022

Hillstream BioPharma, Inc., a U.S.-based biotechnology company developing novel therapeutic candidates targeting ferroptosis for cancer treatment, announced a collaboration with an Indian pioneer biobank and peonalized medicine company that leverages Saarum Innovation's global life sciences research expertise, Sapien Biosciences. The collaboration is aimed at assessing the compatibility of HSB-1216 with immune checkpoint inhibitors. HSB-1216, Hillstream’s most advanced candidate, is an IMCD modulator that targets various types of solid tumors. In an exhaustive study in Germany, the active drug in HSB-1216 was found to be efficacious in a clinical pilot for devastating cancers, including epithelial carcinomas and triple-negative breast cancer. Hillstream aims to build an early clinical proof-of-concept by beginning a clinical investigation with HSB-1216 in 2022. With this collaboration, Hillstream will be able to use Sapien’s patient samples and rich datasets to validate its HSB-1216 for the development of novel cancer therapeutics. We are initiating studies, in collaboration with Sapien Biosciences, to determine the synergy between HSB-1216, our ferroptosis inducer and nivolumab, an anti-PD1 antibody.” He stated, “In addition, we will also study the potential synergistic effects of HSB-1216 with the recently approved Bristol Myers Squibb drug Opdualag® (nivolumab + relatlimab), a fixed dose combination of an anti-PD1 MAb + anti-LAG3 MAb, to demonstrate that targeting a ferroptosis-associated metabolism in tumors may improve the efficacy of cancer immunotherapy.” Randy Milby, Hillstream’s Chief Executive Officer. We are excited to extend our collaboration with Hillstream Biopharma to evaluate potential synergy between their HSB-1216 molecule and ICIs using our expertise in establishing patient tissue-derived cell models in oncology, immunology and Immune-oncology Previously, Sapien demonstrated potent anti-cancer activity of HSB-1216 in primary triple negative breast cancer cells which were presented at AACR 2020.” Dr. Jugnu Jain, CEO, Sapien Biosciences.

Read More

INDUSTRIAL IMPACT

ProPhase Labs to Announce Formation of a Subsidiary ProPhase BioPharma, Inc.

ProPhase Labs, Inc. | June 29, 2022

ProPhase Labs, Inc., a diversified biotech, genomics, and diagnostics company manufacturing homeopathic and health products, announced the formation of a new wholly-owned subsidiary, ProPhase BioPharma, Inc. (PBIO), for the development and licensing of new therapeutic compounds, drugs, and biotechnology. The subsidiary will be focused on advancements in technology across the biochemical industry and creating and developing new solutions that can transform the outcomes of healthcare. The company has also entered into a license agreement with a wholly-owned subsidiary of DSS, Inc., Global BioLife, Inc. (Global BioLife), for Equivir G and Equivir, proprietary compounds that were developed by Global Research and Discovery Group (GRDG). According to the terms of the contract, ProPhase Labs will be the only company that can develop and sell Equivir G and Equivir, globally. “We are thrilled to announce the formation of ProPhase BioPharma, our new wholly-owned subsidiary tasked with licensing and developing novel drugs, compounds, and biotechnology. We are equally pleased with our first licensing agreement for Equivir and Equivir G, which we believe have significant potential to improve human health outcomes worldwide.” Ted Karkus, ProPhase Lab’s Chief Executive Officer He further added, “We plan to pursue commercialization of Equivir as an OTC supplement, leveraging our distribution in over 40,000 Food Drug and Mass retail stores and online direct to consumer. We also look forward to applying to the FDA for an IND for Equivir G as a prescription antiviral.” Frank. D. Heuszel, Chief Executive Officer of DSS, said “We are excited to team up with ProPhase Labs, which will apply its nearly three decades of experience enhancing the health of the public to Equivir, which we believe to be a ground-breaking treatment that will positively impact health in the U.S. and globally.”

Read More

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