How Can AI Be Used For Clinical Trials?

PARAM SINGH | May 9, 2019 | 93 views

The continuous innovation of technology is changing the way companies operate across different sectors. In particular, big data and artificial intelligence (AI) are expected to have the most significant impact. In this post, we’ll discuss how big data and AI can be used to support clinical trials in a variety of ways.

Spotlight

Juventas Therapeutics, Inc

Juventas Therapeutics is a private, clinical stage biotechnology company developing novel non-viral gene therapies that activate natural processes to repair the body. Our product candidate, JVS-100, is a non-viral gene therapy that expresses stromal cell-derived factor-1, or SDF-1, a naturally occurring signaling protein that has been shown to recruit the body’s own stem cells and promote tissue repair in a broad range of disease states.

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MEDTECH

Top 10 biotech IPOs in 2019

Article | July 13, 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 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 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

Juventas Therapeutics, Inc

Juventas Therapeutics is a private, clinical stage biotechnology company developing novel non-viral gene therapies that activate natural processes to repair the body. Our product candidate, JVS-100, is a non-viral gene therapy that expresses stromal cell-derived factor-1, or SDF-1, a naturally occurring signaling protein that has been shown to recruit the body’s own stem cells and promote tissue repair in a broad range of disease states.

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CELL AND GENE THERAPY

Matica Bio Announces Joint Research Agreement with Sartorius for the Development of Advanced Viral Vector Manufacturing Technology

Matica Biotechnology, Inc. | October 19, 2021

Matica Biotechnology, Inc, (Matica Bio) a contract development and manufacturing organization (CDMO) specializing in the clinical and commercial production of cell and gene therapies, today announced a joint research agreement (JRA) with Sartorius, a leading international partner of the biopharmaceutical industry. Under this agreement, Matica Bio and Sartorius will work on a number of studies together to streamline and optimize PAT technologies, automation software, and single-use platforms offered by Sartorius for large scale vector production. Michael Stewart, Chief Technology Officer at Matica Bio explained, "The generation of in-line real-time process data is one of the most significant obstacles to achieving consistent, high-producing viral vector titers during development that can be translatable to large scale production. In many respects, what is going on inside a bioreactor or within downstream operations is still a black box to us." Mr. Stewart continued, "Matica Bio's development, manufacturing and quality teams have decades of viral vector production experience. Applying our expertise together with Sartorius' industry-leading single-use and PAT technologies will allow us to provide more robust, consistent results for our clients, guiding informed decision-making throughout the manufacturing process and accelerating the overall development timeline to the clinic and market." "We are extremely excited to initiate this partnership with Sartorius. Our number one priority is to deliver for our clients. Our expert staff will be working to integrate more fully automated processes leading to an increase in the speed of information flow and a reduction in preventable errors. The end result will be increased product yields, higher quality as well as improved flexibility and responsiveness to our clients' ever-changing needs." Dr. Yun Jeong Song, Chief Executive Officer of Matica Bio The JRA with Sartorius underscores Matica Bio's commitment to applying integrated technology and bioprocess solutions to address production complexities like reduction of labor and risk while improving output efficiencies in the production of advanced therapies, including viral vector products. Together Sartorius and Matica Bio are dedicated to solving the challenges of large-scale cell culture and viral vector production, improving manufacturability and reducing the costs of novel cell and gene therapies, oncolytic vectors and vaccines. About Matica Biotechnology, Inc. Matica Bio is a contract development and manufacturing organization for gene therapies, cell therapies, vaccines, oncolytic vectors and other advanced biotherapeutic products. Our GMP facility in College Station, TX is designed for the rapid development, scale-up and production of clinical and commercial supply. Matica Bio offers process development, GMP production, product release and stability assessment, together with the quality oversight and regulatory guidance necessary to ensure our clients' success.

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MEDTECH

Outcomes4Me Partners with Invitae to Offer Genetic Testing to Breast Cancer Patients

Outcomes4Me | October 12, 2021

Outcomes4Me Inc., developer of a leading free mobile app and platform to navigate cancer treatment and care, today announced that it has partnered with Invitae Corporation (NYSE: NVTA), a leading medical genetics company, to expand education and access to genetic testing to breast cancer patients and survivors. The collaboration leverages the strengths of Invitae, which supplies clinical grade genetic testing, and Outcomes4Me’s 360-degree, validated and evidence-based cancer support and treatment options via its free and easy-to-use app. Initially and currently available in the United States, patients can now receive genetic counseling through Invitae’s partnership with Genome Medical, get testing, and upload their results within the Outcomes4Me app.There is a misconception that genetic testing is only useful as a preventative tool prior to a cancer diagnosis. According to Outcomes4Me patient data, almost half of users (46 percent) who qualified for testing (based on NCCN Guidelines®) did not receive testing or did not know if they had received testing. However, genetic testing can provide insights that can help inform and refine precision therapy use and clinical treatment trial enrollment. In addition, genetic testing results can be used to help prevent recurrence and reduce incidence of other inherited cancers. A cancer diagnosis is often overwhelming for patients and their families. Outcomes4Me demystifies cancer by providing the most up-to-date and validated research, support, and treatment options, all grounded in science and data and curated according to the patient’s specific diagnosis. Outcomes4Me partners with the researchers, doctors, and academics that set the rigorous standards of cancer care for all treatment providers, including the National Comprehensive Care Network® (NCCN®), Vanderbilt-Ingram Cancer Center (VICC) and Massachusetts General Hospital (MGH). The collaboration with Invitae expands access to genetic testing, a vitally important tool in the patient’s cancer care arsenal. “Outcomes4Me is an indispensable platform for patients with breast cancer, giving them the personalized knowledge and access to timely new trials and targeted therapies that could lead to better health outcomes. By providing access to our comprehensive genetic testing and counseling services, Outcomes4Me is adding a valuable resource that will empower patients to advance their knowledge, understanding, and therefore, self-advocacy during treatment and survivorship.” Ed Esplin, M.D., Ph.D., FACMG, FACP, Clinical Geneticist at Invitae Unlike popular direct-to-consumer genetic testing services, which test for a few specific genetic variants for certain genes, Invitae provides state-of-the-art clinical grade next-generation sequencing-based (NGS) genetic testing that comprehensively analyses more than 80 genes, including all known mutations of the important BRCA1/BRCA2 genes. This comprehensive approach, combined with associated genetic counseling, not only provides insights for cancer patients, but also for family members who may be at risk. “Our collaboration with Invitae reinforces Outcomes4Me’s mission to give patients back control. Because of this work with Invitae, our valued community now has rare direct access to a much-needed testing service. Outcomes4Me will proudly continue to democratize the best in cancer treatment, research, and support by removing barriers and bias in information flow.” Maya R. Said, Sc. D., Founder and CEO of Outcomes4Me About Invitae Invitae Corporation (NYSE: NVTA) is a leading medical genetics company whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices. About Outcomes4Me Outcomes4Me is on a mission to improve health outcomes by empowering patients with understandable, relevant and evidence-based information. Outcomes4Me has developed a platform for shared decision-making between patients and providers. The platform harnesses regulatory-grade, real-world data and patient experiences generating deeper insights and better outcomes to improve care and accelerate research. The Outcomes4Me mobile app enables cancer patients to make decisions and take control of their care based on information that is personalized to their specific condition, including finding treatment options, matching to clinical trials, and tracking and managing symptoms. Based in Boston, Massachusetts, Outcomes4Me, a woman-led company, comprises seasoned healthcare, oncology, pharmaceutical, consumer and technology veterans.

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MEDTECH

Aesthetics Biomedical® Announces Collaboration with U.S. Dermatology Partners Offering Consumers Luxury Experiential Aesthetic Treatments

Aesthetics Biomedical® Inc. | October 07, 2021

Aesthetics Biomedical® Inc. (ABM), is pleased to announce their long-term partnership with U.S. Dermatology Partners, the largest physician-led dermatology practice in the United States. With years of experience and more than 90+ locations throughout Arizona, Colorado, Kansas, Maryland, Missouri, Oklahoma, Texas, and Virginia, U.S. Dermatology Partners combines the personal level of care found in private dermatology practices with the benefits of a network of physician experts working closely together. As a result, U.S. Dermatology Partners can provide premier medical and cosmetic dermatological care, along with the latest technology, treatments, and management support. Striving to innovate, generate solid clinical and laboratory research, and to enrich the physician as well as the patient experience are principles that Aesthetics Biomedical® was founded on. It is these foundational principles that have led to our synergy with U.S. Dermatology Partners. -Chief Executive Officer & Founder, MaryAnn Guerra U.S. Dermatology Partners, a pinnacle network of specialty experts found a lifetime partner in excellence and innovation with Aesthetics Biomedical®. Beginning in 2021, U.S. Dermatology Partners installed Vivace® into four initial practices. A pilot project between the two organizations launched the partnership that resulted in over 170 consumer treatments being sold within the first four weeks. U.S. Dermatology Partners and ABM marketed the Vivace Experience® concept with the objective of delivering an immediate ROI supporting the purchase of the initial device for the organization. Vivace® is a primary driver expected to positively impact U.S. Dermatology Partners' market growth exponentially and rapidly, already generating significant revenue in six locations across the US, in under six (6) months. Having access to ongoing knowledge and clinical data is critical to U.S. Dermatology Partners physicians who are committed to continuous and consistent superior patient care. U.S. Dermatology Partners is thrilled to be collaborating with Aesthetics Biomedical® to bring the Vivace Experience® to our patients and our growing network to Aesthetics Biomedical®. We expect the innovative technology and outstanding results that Vivace offers will be well-received by both our physicians and patients and will provide another opportunity to deliver superior care to the communities we serve. - U.S. Dermatology Partners Chief Executive Officer Paul Singh Vivace® is a minimally invasive, FDA-cleared, radiofrequency microneedling treatment that stimulates the natural production of collagen and has been shown by physicians to be effective in alleviating facial wrinkles, fine lines, and tightening the face and neck. Aesthetics Biomedical's Vivace® is currently offered in multiple U.S. Dermatology Partners practices across 50% of the markets nationwide with rapid expansion plans in Q4. ABM will help to drive U.S. Dermatology Partners's practice success with superior technology, devices, and products supported by science, customer-focused market recognition, rigorous and continuing education, and strong continuous return on investment. Both organizations are aligned in their commitment to excellence and share a common goal for elevating the consumer experience at the forefront of the partnership. ABOUT AESTHETICS BIOMEDICAL Aesthetics Biomedical® Inc., headquartered in Phoenix, Ariz., is committed to the development and distribution of novel aesthetic devices, products, and services in the global market. Aesthetics Biomedical's innovation center is a leader in breakthrough technologies and combination therapies for its clients, physician network, and the aesthetic arena, creating novel patient treatment experiences that benefit from ongoing research, approved clinical indications for use, as well as a personalized approach designed for consumer benefit. ABOUT U.S. DERMATOLOGY PARTNERS As one of the largest physician-owned dermatology practices in the country, U.S. Dermatology Partners patients not only have access to general medical, surgical, and cosmetic skin treatment through its coordinated care network, but also benefit from the practice's strong dermatology subspecialty thought leaders and medical advisory board. To be the best partners to its patients, U.S. Dermatology Partners is fervently focused on providing the highest level of patient-first care, and its team, therefore, includes recognized national leaders in areas such as clinical research, psoriasis, and Mohs Surgery.

Read More

CELL AND GENE THERAPY

Matica Bio Announces Joint Research Agreement with Sartorius for the Development of Advanced Viral Vector Manufacturing Technology

Matica Biotechnology, Inc. | October 19, 2021

Matica Biotechnology, Inc, (Matica Bio) a contract development and manufacturing organization (CDMO) specializing in the clinical and commercial production of cell and gene therapies, today announced a joint research agreement (JRA) with Sartorius, a leading international partner of the biopharmaceutical industry. Under this agreement, Matica Bio and Sartorius will work on a number of studies together to streamline and optimize PAT technologies, automation software, and single-use platforms offered by Sartorius for large scale vector production. Michael Stewart, Chief Technology Officer at Matica Bio explained, "The generation of in-line real-time process data is one of the most significant obstacles to achieving consistent, high-producing viral vector titers during development that can be translatable to large scale production. In many respects, what is going on inside a bioreactor or within downstream operations is still a black box to us." Mr. Stewart continued, "Matica Bio's development, manufacturing and quality teams have decades of viral vector production experience. Applying our expertise together with Sartorius' industry-leading single-use and PAT technologies will allow us to provide more robust, consistent results for our clients, guiding informed decision-making throughout the manufacturing process and accelerating the overall development timeline to the clinic and market." "We are extremely excited to initiate this partnership with Sartorius. Our number one priority is to deliver for our clients. Our expert staff will be working to integrate more fully automated processes leading to an increase in the speed of information flow and a reduction in preventable errors. The end result will be increased product yields, higher quality as well as improved flexibility and responsiveness to our clients' ever-changing needs." Dr. Yun Jeong Song, Chief Executive Officer of Matica Bio The JRA with Sartorius underscores Matica Bio's commitment to applying integrated technology and bioprocess solutions to address production complexities like reduction of labor and risk while improving output efficiencies in the production of advanced therapies, including viral vector products. Together Sartorius and Matica Bio are dedicated to solving the challenges of large-scale cell culture and viral vector production, improving manufacturability and reducing the costs of novel cell and gene therapies, oncolytic vectors and vaccines. About Matica Biotechnology, Inc. Matica Bio is a contract development and manufacturing organization for gene therapies, cell therapies, vaccines, oncolytic vectors and other advanced biotherapeutic products. Our GMP facility in College Station, TX is designed for the rapid development, scale-up and production of clinical and commercial supply. Matica Bio offers process development, GMP production, product release and stability assessment, together with the quality oversight and regulatory guidance necessary to ensure our clients' success.

Read More

MEDTECH

Outcomes4Me Partners with Invitae to Offer Genetic Testing to Breast Cancer Patients

Outcomes4Me | October 12, 2021

Outcomes4Me Inc., developer of a leading free mobile app and platform to navigate cancer treatment and care, today announced that it has partnered with Invitae Corporation (NYSE: NVTA), a leading medical genetics company, to expand education and access to genetic testing to breast cancer patients and survivors. The collaboration leverages the strengths of Invitae, which supplies clinical grade genetic testing, and Outcomes4Me’s 360-degree, validated and evidence-based cancer support and treatment options via its free and easy-to-use app. Initially and currently available in the United States, patients can now receive genetic counseling through Invitae’s partnership with Genome Medical, get testing, and upload their results within the Outcomes4Me app.There is a misconception that genetic testing is only useful as a preventative tool prior to a cancer diagnosis. According to Outcomes4Me patient data, almost half of users (46 percent) who qualified for testing (based on NCCN Guidelines®) did not receive testing or did not know if they had received testing. However, genetic testing can provide insights that can help inform and refine precision therapy use and clinical treatment trial enrollment. In addition, genetic testing results can be used to help prevent recurrence and reduce incidence of other inherited cancers. A cancer diagnosis is often overwhelming for patients and their families. Outcomes4Me demystifies cancer by providing the most up-to-date and validated research, support, and treatment options, all grounded in science and data and curated according to the patient’s specific diagnosis. Outcomes4Me partners with the researchers, doctors, and academics that set the rigorous standards of cancer care for all treatment providers, including the National Comprehensive Care Network® (NCCN®), Vanderbilt-Ingram Cancer Center (VICC) and Massachusetts General Hospital (MGH). The collaboration with Invitae expands access to genetic testing, a vitally important tool in the patient’s cancer care arsenal. “Outcomes4Me is an indispensable platform for patients with breast cancer, giving them the personalized knowledge and access to timely new trials and targeted therapies that could lead to better health outcomes. By providing access to our comprehensive genetic testing and counseling services, Outcomes4Me is adding a valuable resource that will empower patients to advance their knowledge, understanding, and therefore, self-advocacy during treatment and survivorship.” Ed Esplin, M.D., Ph.D., FACMG, FACP, Clinical Geneticist at Invitae Unlike popular direct-to-consumer genetic testing services, which test for a few specific genetic variants for certain genes, Invitae provides state-of-the-art clinical grade next-generation sequencing-based (NGS) genetic testing that comprehensively analyses more than 80 genes, including all known mutations of the important BRCA1/BRCA2 genes. This comprehensive approach, combined with associated genetic counseling, not only provides insights for cancer patients, but also for family members who may be at risk. “Our collaboration with Invitae reinforces Outcomes4Me’s mission to give patients back control. Because of this work with Invitae, our valued community now has rare direct access to a much-needed testing service. Outcomes4Me will proudly continue to democratize the best in cancer treatment, research, and support by removing barriers and bias in information flow.” Maya R. Said, Sc. D., Founder and CEO of Outcomes4Me About Invitae Invitae Corporation (NYSE: NVTA) is a leading medical genetics company whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices. About Outcomes4Me Outcomes4Me is on a mission to improve health outcomes by empowering patients with understandable, relevant and evidence-based information. Outcomes4Me has developed a platform for shared decision-making between patients and providers. The platform harnesses regulatory-grade, real-world data and patient experiences generating deeper insights and better outcomes to improve care and accelerate research. The Outcomes4Me mobile app enables cancer patients to make decisions and take control of their care based on information that is personalized to their specific condition, including finding treatment options, matching to clinical trials, and tracking and managing symptoms. Based in Boston, Massachusetts, Outcomes4Me, a woman-led company, comprises seasoned healthcare, oncology, pharmaceutical, consumer and technology veterans.

Read More

MEDTECH

Aesthetics Biomedical® Announces Collaboration with U.S. Dermatology Partners Offering Consumers Luxury Experiential Aesthetic Treatments

Aesthetics Biomedical® Inc. | October 07, 2021

Aesthetics Biomedical® Inc. (ABM), is pleased to announce their long-term partnership with U.S. Dermatology Partners, the largest physician-led dermatology practice in the United States. With years of experience and more than 90+ locations throughout Arizona, Colorado, Kansas, Maryland, Missouri, Oklahoma, Texas, and Virginia, U.S. Dermatology Partners combines the personal level of care found in private dermatology practices with the benefits of a network of physician experts working closely together. As a result, U.S. Dermatology Partners can provide premier medical and cosmetic dermatological care, along with the latest technology, treatments, and management support. Striving to innovate, generate solid clinical and laboratory research, and to enrich the physician as well as the patient experience are principles that Aesthetics Biomedical® was founded on. It is these foundational principles that have led to our synergy with U.S. Dermatology Partners. -Chief Executive Officer & Founder, MaryAnn Guerra U.S. Dermatology Partners, a pinnacle network of specialty experts found a lifetime partner in excellence and innovation with Aesthetics Biomedical®. Beginning in 2021, U.S. Dermatology Partners installed Vivace® into four initial practices. A pilot project between the two organizations launched the partnership that resulted in over 170 consumer treatments being sold within the first four weeks. U.S. Dermatology Partners and ABM marketed the Vivace Experience® concept with the objective of delivering an immediate ROI supporting the purchase of the initial device for the organization. Vivace® is a primary driver expected to positively impact U.S. Dermatology Partners' market growth exponentially and rapidly, already generating significant revenue in six locations across the US, in under six (6) months. Having access to ongoing knowledge and clinical data is critical to U.S. Dermatology Partners physicians who are committed to continuous and consistent superior patient care. U.S. Dermatology Partners is thrilled to be collaborating with Aesthetics Biomedical® to bring the Vivace Experience® to our patients and our growing network to Aesthetics Biomedical®. We expect the innovative technology and outstanding results that Vivace offers will be well-received by both our physicians and patients and will provide another opportunity to deliver superior care to the communities we serve. - U.S. Dermatology Partners Chief Executive Officer Paul Singh Vivace® is a minimally invasive, FDA-cleared, radiofrequency microneedling treatment that stimulates the natural production of collagen and has been shown by physicians to be effective in alleviating facial wrinkles, fine lines, and tightening the face and neck. Aesthetics Biomedical's Vivace® is currently offered in multiple U.S. Dermatology Partners practices across 50% of the markets nationwide with rapid expansion plans in Q4. ABM will help to drive U.S. Dermatology Partners's practice success with superior technology, devices, and products supported by science, customer-focused market recognition, rigorous and continuing education, and strong continuous return on investment. Both organizations are aligned in their commitment to excellence and share a common goal for elevating the consumer experience at the forefront of the partnership. ABOUT AESTHETICS BIOMEDICAL Aesthetics Biomedical® Inc., headquartered in Phoenix, Ariz., is committed to the development and distribution of novel aesthetic devices, products, and services in the global market. Aesthetics Biomedical's innovation center is a leader in breakthrough technologies and combination therapies for its clients, physician network, and the aesthetic arena, creating novel patient treatment experiences that benefit from ongoing research, approved clinical indications for use, as well as a personalized approach designed for consumer benefit. ABOUT U.S. DERMATOLOGY PARTNERS As one of the largest physician-owned dermatology practices in the country, U.S. Dermatology Partners patients not only have access to general medical, surgical, and cosmetic skin treatment through its coordinated care network, but also benefit from the practice's strong dermatology subspecialty thought leaders and medical advisory board. To be the best partners to its patients, U.S. Dermatology Partners is fervently focused on providing the highest level of patient-first care, and its team, therefore, includes recognized national leaders in areas such as clinical research, psoriasis, and Mohs Surgery.

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