Search Results for: revolutionizing biotechnology

Cellaria Forms Strategic Partnership with AMS Biotechnology … – EconoTimes

Thursday, February 9, 2017 5:11 PM UTC

CAMBRIDGE, Mass., Feb. 09, 2017 -- Cellaria, LLC, a scientific innovator that develops revolutionary new patient-specific cancer models for challenging tumors, today announced the formation of a strategic partnership withAMS Biotechnology (AMSBIO). As part of the agreement, AMSBIO will distribute, market and sell Cellaria cell models and culture media throughoutEurope.The partnership enables Cellaria to better meet growing demand for its products outside the US.

Cellaria's unique patient-specific cell models and cell culture media products expand the current offering AMSBIO has for physiologically relevant cell culture products for drug discovery and other life science applications. Late in 2016, Cellaria announced the availability of new models for High Grade Serous and Endometriod Ovarian Cancer and an ER-positive breast model.

AMSBIOis a premier provider of quality life science research reagents and services helping customers develop innovative methods, processes, products and medicines. As a leading provider of scaffolds, matrices, kits and proteins for growing and screening spheroids and organoids, AMSBIO has contributed totheaccelerationof discovery programs in medical research.

Alex Sim, managing director at AMSBIO said, "The new partnership with Cellaria expands our existing portfolio by introducing patient-derived cancer models;allowing customers to conduct research and drug discoveryinitiatives to advanceprecision medicine.

"The unique value of our patient-specific cell models makesAMSBIOan ideal partner for Cellaria," said David Deems, chief executive officer at Cellaria. "Our products will expand theAMSBIOcancer product portfolio, and their technical expertise will enable them to support Cellaria's customers throughout Europe."

About Cellaria

Cellaria creates breakthrough oncology models that reflect the unique nature and complexity of a tumor. Using these informative models, cancer researchers are better able to select promising compounds and work towards personalized approaches that would enable physicians to identify the most effective treatment for each patient's needs. Cellaria's innovative products help lead the research community to more personalized therapeutics, revolutionizing and accelerating the search for a cancer cure. For more information, visitwww.cellariabio.comor to learn more about our cell models.

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Cellaria Forms Strategic Partnership with AMS Biotechnology ... - EconoTimes

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1. What is agricultural biotechnology? – GreenFacts

Broadly speaking, biotechnology is any technique that uses living organisms or substances from these organisms to make or modify a product for a practical purpose (Box 2). Biotechnology can be applied to all classes of organism - from viruses and bacteria to plants and animals - and it is becoming a major feature of modern medicine, agriculture and industry. Modern agricultural biotechnology includes a range of tools that scientists employ to understand and manipulate the genetic make-up of organisms for use in the production or processing of agricultural products.

Some applications of biotechnology, such as fermentation and brewing, have been used for millennia. Other applications are newer but also well established. For example, micro-organisms have been used for decades as living factories for the production of life-saving antibiotics including penicillin, from the fungus Penicillium, and streptomycin from the bacterium Streptomyces. Modern detergents rely on enzymes produced via biotechnology, hard cheese production largely relies on rennet produced by biotech yeast and human insulin for diabetics is now produced using biotechnology.

Biotechnology is being used to address problems in all areas of agricultural production and processing. This includes plant breeding to raise and stabilize yields; to improve resistance to pests, diseases and abiotic stresses such as drought and cold; and to enhance the nutritional content of foods. Biotechnology is being used to develop low-cost disease-free planting materials for crops such as cassava, banana and potato and is creating new tools for the diagnosis and treatment of plant and animal diseases and for the measurement and conservation of genetic resources. Biotechnology is being used to speed up breeding programmes for plants, livestock and fish and to extend the range of traits that can be addressed. Animal feeds and feeding practices are being changed by biotechnology to improve animal nutrition and to reduce environmental waste. Biotechnology is used in disease diagnostics and for the production of vaccines against animal diseases.

Clearly, biotechnology is more than genetic engineering. Indeed, some of the least controversial aspects of agricultural biotechnology are potentially the most powerful and the most beneficial for the poor. Genomics, for example, is revolutionizing our understanding of the ways genes, cells, organisms and ecosystems function and is opening new horizons for marker-assisted breeding and genetic resource management. At the same time, genetic engineering is a very powerful tool whose role should be carefully evaluated. It is important to understand how biotechnology - particularly genetic engineering - complements and extends other approaches if sensible decisions are to be made about its use.

This chapter provides a brief description of current and emerging uses of biotechnology in crops, livestock, fisheries and forestry with a view to understanding the technologies themselves and the ways they complement and extend other approaches. It should be emphasized that the tools of biotechnology are just that: tools, not ends in themselves. As with any tool, they must be assessed within the context in which they are being used.

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U.S. Cell And Gene Therapy Manufacturing Market Size & Growth Report, 2033 – BioSpace

According to nova one advisor to the U.S. cell and gene therapy manufacturing market size was valued at USD 4.10 billion in 2023 and is projected to reach USD 45.46 billion by 2033, growing at a CAGR of 27.2% from 2024 to 2033.

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Advanced therapies have significantly impacted the treatment of numerous rare and life-threatening diseases and revolutionized thebiopharmaceuticalsector. The accelerated development of the advanced therapy industry is a crucial driving force for the market's growth. The market is witnessing substantial growth owing to key market players, including CDMOs offering GMP manufacturing services and adopting highly innovative manufacturing technologies for production. Major players are undertaking various strategic initiatives to boost their market presence, leading to market growth in the country. For instance, in January 2021, Fujifilm invested USD 40 million to develop a new manufacturing facility for viral vectors and innovative therapy products.

The National Cell Manufacturing Consortium (NCMC) has been established through collaboration between 15 academic institutes, more than 25 companies, and government agencies to enable cost-effective, large-scale manufacturing ofcell therapies. This consortium is focused on developing, maturing, and implementing innovative technologies for cell therapy manufacturing. With the presence of a high number of contract manufacturers and research organizations, the market space is highly competitive. In addition, the entry of new players and facility expansion by existing players has intensified the competition in the U.S. market.

In 2023, the U.S. cell & gene therapy manufacturing market accounted for a revenue share of over 38% in theglobal cell & gene therapy manufacturing market. This market's Major players include Thermo Fisher Scientific, Inc.; Fujifilm Diosynth Biotechnologies; Lonza; Merck; and Catalent, Inc. These companies undertake various strategies to strengthen their market presence. For instance, in March 2022, FUJIFILM Corporation announced the acquisition of Shenandoah Biotechnology, Inc. to strengthen its presence in cell culture solutions for cell & gene therapy manufacturing. Thus, such initiatives undertaken by key players are anticipated to impact market growth in the upcoming years positively.

What are the Importance of U.S. Cell And Gene Therapy Manufacturing Market?

Revolutionizing Medicine: Cell and gene therapies represent cutting-edge medical advancements, offering potential cures or treatments for previously incurable diseases. Manufacturing facilities in the U.S. are at the forefront of this revolution, driving innovation and progress in healthcare.

Economic Growth: The cell and gene therapy manufacturing sector contributes to economic growth by creating jobs, attracting investment, and fostering the growth of related industries such as biotechnology, pharmaceuticals, and medical devices. This sector's expansion boosts the overall economy and enhances competitiveness on a global scale.

Improving Healthcare Access: By establishing robust manufacturing capabilities within the U.S., the accessibility of cell and gene therapies can be improved for patients nationwide. Local manufacturing reduces logistical challenges associated with transporting sensitive biological materials and ensures timely access to treatments.

Regulatory Leadership: The U.S. has established itself as a leader in regulatory frameworks for cell and gene therapies, ensuring safety, efficacy, and quality standards. Strong manufacturing capabilities within the country facilitate compliance with these regulations, fostering trust among patients, healthcare providers, and regulatory agencies.

Research and Development Hub: Investment in cell and gene therapy manufacturing facilities fosters a collaborative environment that attracts top talent and encourages research and development initiatives. This concentration of expertise accelerates scientific discoveries and facilitates the translation of research findings into tangible therapies.

Global Leadership: A robust cell and gene therapy manufacturing market in the U.S. enhances the country's position as a global leader in biotechnology and healthcare innovation. It strengthens international collaborations, attracts foreign investment, and enables the export of high-value therapeutic products to global markets.

Overall, the importance of the U.S. cell and gene therapy manufacturing market lies in its ability to drive medical progress, stimulate economic growth, improve healthcare access, uphold regulatory standards, foster innovation, and solidify the country's position as a leader in the global biotechnology landscape.

Key Takeaways:

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Segments Insights:

Therapy Type Insights

The cell therapy manufacturing segment dominated the market with a revenue share of 56.12% in 2023. With the growing number of ongoing clinical trials and products entering the market, cell therapy is gradually gaining importance in immuno-oncology. Only a fewCAR T-cell therapieshave been approved by the U.S. FDA. Over 250+clinical trialsstudying CAR T-cell and other cell therapies indicate that potential indications are broadening to include solid & liquid tumours. Thus, the demand for advanced cell manufacturing services will increase in the coming years. As many cell therapy products are allogeneic and expected to have large market sizes, there is a growing need for commercial-scale production.

Thegene therapysegment is expected to grow significantly during the forecast period. With many products in clinical trials, production process improvement is a major need for the gene therapy manufacturing sector. With increased investments from players and the clinical success of more products, several gene therapy companies are focusing on manufacturing & commercialization. Evaluating the existing process & its scalability and deciding on in-house or outsourced manufacturing are some of the major factors to be considered while designing the manufacturing process for gene therapy products.

Scale Insights

Pre-commercial/ R&D scale manufacturing captured a significant revenue share of 72.4% in 2023. The rapidly changing market environment for cell and gene therapies is the main contributing factor for innovation in R&D about gene & cell therapy. The pre-commercial manufacturing segment is anticipated to grow as the market witnesses more positive data from ongoing clinical trials. More than 400 companies in North America were actively developing cell and gene therapy products for various diseases.

Commercial scale manufacturing segment is projected to garner the fastest CAGR during the forecast period. Large biopharmaceutical companies, such as Bristol-Myers Squibb (BMS), Novartis AG, and Merck KGaA, are investing significant money in cell & gene therapy programs and manufacturing facilities. These companies have capabilities, resources, and skilled professionals, enabling quicker entry into clinical trials and shorter time to market. Such companies are expected to propel the market for commercial-scale manufacturing by the increasing number of products entering the market.

Mode Insights

The contract manufacturing segment held the highest revenue share of 65.11% in 2023. With the increasing demand for cell & gene therapies, the challenges with adequate manufacturing capacity have created opportunities for contract manufacturing service providers. With the rapid transformation in the industry, outsourcing services is projected to deliver a competitive edge to market participants in terms of expertise and experience.

The in-house manufacturing segment is projected to exhibit the fastest CAGR during the forecast period. Building a small in-house manufacturing facility can be a suitable option for gene therapy companies having difficulty finding contract manufacturing service partners or securing production time slots in the required time frame. However, the capital associated with building a manufacturing facility for a single cell or gene therapy product can be challenging for emerging & small pharmaceutical orbiotechnologyfirms.

Workflow Insights

The process development segment had a significant revenue share of 16.9% in 2023. The surge in therapies transiting from clinical trials to receiving regulatory approvals is significantly driving the segment growth. The development of robust and organized methods for cell therapy production has become crucial. Process development strategies deliver efficiency while enhancing candidate programs' safety and quality profiles.

The vector production segment is estimated to register the fastest CAGR during the forecast period. Viral vectors are being increasingly adopted for treating multiple health conditions, including metabolic, muscular, infectious, cardiovascular, hematologic, and ophthalmologic, as well as various types of cancer. The most widely deployed viral vectors are adenoviral, lentiviral, AAV, retroviral, and herpes simplex virus. Viral vectors are manufactured using different cell lines with unique growth and transfection characteristics.

Recent Developments

Cell & Gene Therapy Research and Manufacturing Solutions

The global cell and gene therapy manufacturing market size was estimated at USD 9.95 billion in 2023 and is projected to hit around USD 106.03 billion by 2033, growing at a CAGR of 26.7% during the forecast period from 2024 to 2033.

Cell and gene therapies are set to become the new standard of healthcare, but nevertheless remain variable, complex, and difficult to manufacture with consistency.

As an industry, we are building collective knowledge and experience that will help to accelerate development, approval, and delivery of therapies, but we still have some bottlenecks to solve while attempting to bring cost of goods down:

To overcome these challenges and set yourself up for regulatory approval, you need high-quality raw materials, cutting-edge manufacturing solutions, and precision analytics that empower you to accelerate development and standardize processes.

Immune Cell Therapy

Demonstrating comparability and reproducibility is essential for the advancement of your immune cell therapy. Understanding your therapys mechanism of action and quantifying CQAs are complex and can be the source of costly clinical and regulatory setbacks.

Our high-quality, GMP-grade raw materials coupled with precision analytics technology enable you to provide robust, reliable data to determine proof of concept, ensure regulatory approval and accelerate time to patient.

These scalable, flexible solutions can help you adapt to an ever-changing regulatory landscape. Were also here to help to embed flexibility into your process, so that you can easily adapt your process to meet changing requirements.

These scalable, flexible solutions enable you to seamless move from the lab to the clinic and adapt to an ever-changing regulatory landscape:

Regenerative Medicine

Minimizing variability is the keystone to success when developing regenerative therapies. With consistent, scalable solutions coupled with a reliable supply of high-quality raw materials, we can help you to forge a pathway towards safe, life-changing therapies.

We recognize the challenges you face to scale-up production - thats why all our regenerative medicine solutions are made with scalability at their core.

We provide tailored solutions to help you throughout the regenerative medicine development workflow, including:

Gene Therapy

Achieving safe and effective transgene delivery is among the greatest challenges faced by gene therapy developers. The inherent complexity of viral vectors makes them difficult to characterize with consistency throughout development and manufacturing stages.

Thats why we provide precision analytical tools for critical quality attribute analysis to ensure safe, high quality, consistent, and efficacious therapies.

These customizable, flexible, and fast assay and analytics systems provide the high-specificity, automation, and reliable results you need throughout the gene therapy development workflow:

Some of the prominent players in the U.S. Cell And Gene Therapy Manufacturing Market include:

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. Cell And Gene Therapy Manufacturing market.

By Therapy Type

By Scale

By Mode

By Workflow

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Effect of gamma rays on the essential oil and biochemical characteristics of the Satureja mutica Fisch & C. A. Mey ... - Nature.com

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Genascence Announces Data From Phase 1 Clinical Trial on GNSC-001, Company’s Lead Program in Osteoarthritis, Presented at American Society of Gene…

Additional safety data, including 12-month follow-up on all subjects, demonstrated GNSC-001 is safe and well tolerated

Injection of GNSC-001 was associated with increased synovial concentrations of IL-1Ra and improved pain and function scores

Osteoarthritis affects more than 30 million Americans, and is leading cause of disability

PALO ALTO, Calif., May 17, 2022 /PRNewswire/ -- Genascence Corporation ("Genascence"), a clinical-stage biotechnology company revolutionizing the treatment of prevalent musculoskeletal diseases with gene therapy, today announced that additional safety data from the Phase 1 clinical trial of GNSC-001 for the treatment of osteoarthritis (OA), including 12-month follow-up on all subjects, demonstrated that it was safe and well tolerated. These data will be delivered in a poster presentation today at the American Society of Gene & Cell Therapy's (ASGCT) 25th Annual Meeting being held virtually and in-person May 16-19, 2022, in Washington, D.C.

Genascence Corporation (PRNewsfoto/Genascence)

GNSC-001 is the company's lead program in OA. GNSC-001 is a genetic medicine a recombinant adeno-associated vector (AAV) carrying a coding sequence for interleukin-1 receptor antagonist (IL-1Ra), a potent inhibitor of interleukin-1 (IL-1) signaling. IL-1 is considered one of the key mediators involved in the pathogenesis of OA, causing inflammation as well as cartilage destruction. GNSC-001 is designed to offer long-term, sustained inhibition of IL-1 following a single injection into the affected joint.

"Osteoarthritis is incapacitating, causing years of pain and disability for people living with the disease. Further, patients have limited treatment options, and nothing is currently available that is able to slow down progression of OA," said Thomas Chalberg, Ph.D., founder and CEO of Genascence. "We are excited by these findings as they demonstrate the initial safety of GNSC-001 and provide encouraging data to pursue GNSC-001 as a novel treatment for OA patients. We look forward to advancing the clinical program for GNSC-001 so that we can deliver transformative results for patients suffering from this disabling disease."

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Title: A Phase I Trial of Osteoarthritis Gene Therapy (NCT02790723)Date: May 17, 2022 5:30-6:30 PM ETSession: Gene and Cell Therapy Trials in ProgressAbstract Number: 799Location: Walter E. Washington Convention Center, Hall DPresenter: Christopher H. Evans, Ph.D.

In this investigator-sponsored Phase 1 single-arm, open-label, dose-escalation clinical trial of GNSC-001, a total of nine subjects with knee OA were enrolled and monitored for one year. Three subjects were treated in each of three cohorts, receiving either 1x1011 vg, 1x1012 vg, or 1x1013 vg GNSC-001 delivered by intra-articular injection. The primary endpoint is safety and tolerability. Additional measures include levels of circulating viral genomes, immune response to the vector, blood and urine analysis, and physical examination. Although the study was not powered for efficacy and had no control group, patients reported pain via VAS (0-10) and pain and function via WOMAC. Knee joints were imaged by X-ray and MRI upon study entry and after one year.

Results showed that intra-articular injection of GNSC-001 produced no severe adverse events; blood chemistries and hematologies remained normal during the 12-month follow-up period with no evidence of neutropenia. There were no vector-related adverse events in eight of the nine subjects; one subject experienced a mild/moderate knee effusion following injection which resolved with ice and rest. Clinical trial participants developed various degrees of anti-AAV neutralizing antibodies after injection of GNSC-001, as seen in preclinical studies. Small amounts of viral genomes were found in peripheral blood, beginning one day after injection and clearing within four weeks. Injection of GNSC-001 was associated with increased concentrations of IL-1Ra in synovial fluid, which remained elevated after 12 months of follow up. Pain and function scores improved following injection of GNSC-001.

"These additional data from the Phase 1 trial of GNSC-001 in patients with osteoarthritis showed that it safe and well tolerated including after one year," said Dr. Evans. "These results are encouraging as we believe this therapy has the potential to reduce structural disease progression in osteoarthritis patients."

The study was supported by funding from the U.S. Department of Defense Peer Reviewed Medical Research Program (PRMRP). More information is available at https://clinicaltrials.gov/ct2/show/NCT02790723.

Abstracts can be accessed via the conference website at annualmeeting.asgct.org.

About Osteoarthritis (OA) of the Knee

Osteoarthritis (OA), or degenerative joint disease, is the leading cause of disability. It is characterized by destruction of cartilage and structural changes in bone within the joint, which contribute to pain and loss of joint function. Osteoarthritis affects more than 30 million Americans and is increasing as a result of the aging population and increasing prevalence of obesity. Osteoarthritis represents a major economic burden, owing to direct medical costs and loss of productivity. Each year, millions of patients are treated for knee OA with NSAIDs, opioids, and steroid injections into the knee to manage their knee pain. There are no currently available therapies known to alter or slow down OA progression.

About Genascence Corporation

Genascence, a clinical-stage biotechnology company revolutionizing the treatment of prevalent musculoskeletal diseases with gene therapy, is developing life-changing treatments for highly prevalent conditions affecting millions of people. The company was founded in 2017 with technology licensed from three leading U.S. research institutions: Mayo Clinic, University of Florida, and NYU Langone Health. Headquartered in Palo Alto, California, Genascence's founders and leadership team have deep experience in the design, development, and manufacturing of successful gene therapies and biological medicines. For more information, please visit http://www.genascence.com.

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Biotech Voices: Next-gen therapies are evolving fast. The drug development model needs to keep up – Endpoints News

A team of genome engineers at a startup biotech has been working for years to create a cell therapy with the hope that it will cure an aggressive form of cancer. After much grueling trial and error at the editing bench, they are ready to evaluate their drug candidate in clinical trials. Things are going well, and theyre ecstatic to see that tumors are shrinking, T cell counts are rising, and the disease is retreating. But theres a cloud on this bright horizon. A side effect is showing up with some of the patients in the trial, one which might have long-term consequences for their well-being. The scientists have an idea: What if they can flip what they call an off-switch on one pair of genes theyve identified that could turn off this side effect of the drug while retaining the new drugs curative powers? It sounds like an easy fix but its implementation is going to take a long time.

In the current regulatory environment, after an important discovery is made, a trial alteration is required, which is a costly and lengthy process that limits the ability to bring novel unique therapies quickly to patients with high unmet needs. If those genome engineers at the startup want to make even the slightest improvement to their drug candidate, which may attenuate the previously mentioned serious side effect, theyll be required to start all over again with a 2.0 version. This kind of versioning is customary in the biotech industry and can often be a race against time.

In our current climate of drug innovation, pharmaceuticals are being developed through hyper-precise genetic editing. No longer relegated to a siloed discipline, blockbuster drugs are being developed by the team efforts of gene therapy, cell therapy, gene editing, protein engineering, synthetic biology and artificial intelligence. These combined disciplines provide limitless capabilities to develop new therapies. This agile capacity could make in-trial drugs incrementally safer and more effective.

An example of what can emerge from this multidisciplinary world, that is making it relevant, is the invention of allogeneic CAR-T cell therapies. An artificial gene coding for a designed Chimeric Antigen Receptor (the CAR part of the word) is delivered by a synthetic vessel called lentivirus into T cells, white cells which are our bodies immune response fighters. Then, through synthetic biology, T cells are edited out (or in) to gain or lose specific functions. This process is made possible by using a gene editing tool called TALEN, which are enzymes that can be engineered to cut specific sequences of DNA. The engineering of TALEN is powered by deep learning algorithms. We may refer to the treatments that arise from this work as cell therapy or gene therapy, but its high concentration of sophisticated technologies working together.

In 2015, during the annual meeting of the American Society of Hematology (ASH), the complete remission of the first patient treated with off-the-shelf CAR-T cells was announced. It took nearly 20 years of trial and error at the editing bench to go from concept to the first patient treatment. Now, five years later, the number of ongoing trials in the sector of cell and gene therapy is rapidly increasing. A report released in March 2020 by the Pharmaceutical Research and Manufacturers of America (PhRMA) identified 362 investigational cell and gene therapies currently in clinical development, a 20% increase since 2018.

Though the increase in trial numbers and the multitude of advances in the way we utilize gene and cell therapies seem positive, there is not a direct correlation between the advance in research we see in the lab and the way patients are treated in the clinic. Furthermore, the drugs that these patients receive were invented many years ago. To prove this point: Approved cellular therapies providing revolutionizing cures, like the first two autologous CAR-T products Yescarta and Kymriah, were invented over 15 years ago, and have side effects, due to the CAR-T persistence resulting in B cell aplasia (disappearance of B cells). Improvements have yet to be implemented in the compound and will need to be evaluated in a clinical setting.

The current paradigm in pharmaceutical development is that patients will get the Older Gen drugs with the afferent side effects rather than the Next Gen therapies that could solve the issue, because of the length, cost and complexity of the current regulatory framework not allowing for the implementation of improvements in the drug development phase.

While rapid, responsive versioning is the norm in other industries, like software, computer or rocket science development, the obvious difference in the pharmaceutical sector is that there are distinct ethical and safety concerns in conducting responsive versioning in trials on human beings; the safety of patients in clinical trials is paramount. That being said, what if we could expedite the process and bring innovation to patients faster within a fitted regulatory framework?

In recent years, several new clinical processes were created, intended to streamline and expedite drug development and clinical trial evaluation. To name a few: the creation of Phase 0, basket, and umbrella clinical trials. Though Phase 0 trials seem to address the expedition of the trials themselves, if any changes are made within this phase, a full IND application with the usual three pre-approval phases is still required to re-version your Phase 0 trial. Essentially, with simple proposed modifications, you are being asked to start from scratch, from a regulatory standpoint.

When the chance for failure in clinical trials (specifically in anti-cancer drug clinical trials) is so high (failure rate is more than 90%) and when more than half of these new drug candidates in oncology fail during later stages of clinical development, the path to expediting the implementation of versioning and revision during early-stage trials is fundamental to address patients needs, in a timely manner.

If a mechanism existed, by which series of versions of a product line could be tested, then adapt it or tune it up, according to the response observed in clinical trials, patients would have access to innovation faster and the modern medicine will progress further at a quick pace. Of course, preclinical proof of concept requirements and CMC must be part of the regulatory equation, but the ability to streamline testing of various versions of a therapeutic concept in the clinic could trigger a huge developmental acceleration to the benefit of patients.

The proposal would be to open a new era in drug development and adapt the regulatory environment to the speed of innovation and its opportunities in the interest of patients. The current regulatory framework and IND process (Investigational New Drug) seems set in stone for a single product development.

What if different versions of a product candidate could enter in clinical development phase under the same Investigational New Therapy (INT) number? In this INT, and under an initial umbrella Core Protocol (without making any shortcuts on product candidates manufacturing, quality and control or preclinical assessment of any of the versions of the therapy), incremental versions of the product candidate could enter in small clinical cohorts. Once there is a sign of meaningful efficacy and good safety profile on one of the versions, then this version of product candidate would be pushed into expansion and pivotal trial targeting a registration. In jurisdiction without the IND concept, the proposed Core Protocol will be associated with a Core Product Dossier holding the required information for each of the product candidate versions.

The goal of this process would be to get away from the track to get onto a larger road, with boundaries, where nimbleness is allowed to adapt the right version before moving to commercialization. This would be in the best interest of patients to get the latest therapy faster in a safe setting.

Andr Choulika is a virologist and a biotechnologist. He is the founder & CEO of Cellectis, a biotechnology company. He is also one of the inventors of nuclease-based genome editing in the 90s.

Biotech Voices is a contributed column from select Endpoints News readers. Read previous pieces here.

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Biotech Voices: Next-gen therapies are evolving fast. The drug development model needs to keep up - Endpoints News

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