Camargo

MAY 2, 2021

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. Source: Medicines in Development | 2020 Update: Cell and Gene Therapy , PhRMA.

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Drug Discovery World

JANUARY 30, 2024

Natalia Elizalde, Chief Business Development Officer, VIVEbiotech, says that Dr Naldini’s award represents the significant benefits and demonstrated safety of the therapies developed using lentiviral vectors that are being used for more and more clinical trials and more prevalent diseases.

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The Pharma Data

DECEMBER 14, 2020

Description of the problem : WHO has received user feedback on an elevated risk for false SARS-CoV-2 results when testing specimens using RT-PCR reagents on open systems. . In the early phases of the COVID-19 pandemic, in vitro diagnostics (IVDs) were rapidly developed, validated and verified, and then rolled out. Source link.

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Advarra

NOVEMBER 29, 2022

However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines. Recent Problems in Cell and Gene Therapy Development. Recent Problems in Cell and Gene Therapy Development.

Gene Therapy 52

Gene Therapy Gene Production Clinical Trials 52

Drug Discovery World

FEBRUARY 15, 2023

However, over the last few decades, it has been widely accepted that interaction between the tumour and host immune response plays a critical role in regulating tumour biology and hence its progression. To date, several preclinical IO models have been developed, with each type having their respective strengths and weaknesses.

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Drug Discovery World

MARCH 13, 2023

While there is no silver bullet for increasing the availability of CGTs, improving manufacturing processes that enable their development at scale can help reduce the cost of these treatments and get them to those who need them most. But now, the increased efficiency is likely making drug development cheaper.

Gene Therapy 52

Gene Therapy Gene Manufacturing Development 52

Drug Discovery World

JULY 18, 2023

Years of development and fast-paced research have continued to unlock its potential, expanding how CRISPR can be used to treat, detect, and prevent common diseases such as cancer and Covid-19. CRISPR also addresses another limitation in CAR T therapies related to the insufficient quantity and poor quality of autologous T cells.

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Drug Discovery World

MAY 16, 2023

Skills gap Bruce Levine, International Society for Cell & Gene Therapy (ISCT) Immediate Past President and Chair, Strategic Advisory Council, says a critical challenge that has become apparent for the CGT sector is the need for workforce development and training resources. The solution?

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Pharmaceutical Technology

FEBRUARY 3, 2023

With scientists fervently developing mRNA vaccines, nucleic acid therapeutics, and viral vector-based gene therapies, clinicians are set to have a growing number of tools available to treat a wide range of conditions, from infectious diseases to genetic disorders and more. So, we set out to solve some of the problems,” she explains.

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The Pharma Data

DECEMBER 23, 2020

The agreement includes a £500,000 upfront payment to Avacta which gives Astrea the rights to generate and develop Affimer reagents in-house for affinity separation. The proceeds will be used to refine the company’s development of its molecular NAAT COVID-19 tests: FRANKD, SAVD, and ICED. It is a division of Gamma Biosciences.

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The Pharma Data

OCTOBER 19, 2020

DB ( Becton, Dickinson and Company ) received a CE mark for its BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes for assessing immune function in COVID-19 patients. Army Medical Research and Development (USAMRDC ) initiated a Phase I clinical trial of its novel vaccine against COVID-19. Please read more here. .

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Vaccination Vaccine Trials Clinical Trials 52

Drug Discovery World

DECEMBER 15, 2022

Possible solutions: A new generation of gene editing tools is being developed to avoid double stranded breaks altogether and to be potentially less destructive than traditional nuclease systems. In all cases, viral delivery vectors have limited payload capacity which can limit various use cases.

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The Pharma Data

MAY 15, 2023

The Sandoz Board of Directors will have 10 members in total and 3 sub-committees: a Science, Innovation & Development Committee, a Human Capital & ESG Committee and an Audit, Risk & Compliance Committee. She is also a board member at BBI Solutions, a UK based diagnostic reagents and a Novo Holdings company.

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Sales Production Doctors Doctor 40

Drug Discovery World

AUGUST 23, 2023

Research team leaders are being asked to find more and better drug targets and to take on more projects throughout the research and development process. Consider, for a moment, a hypothetical cell line development lab. ELNs then and now A few decades ago, ELNs were at the forefront of the digital migration for pharmaceutical labs.

Laboratory Information Management System 52

Laboratory Information Management System Scientist Compliance Development 52

FDA Law Blog

AUGUST 3, 2022

Mullen — Happy Birthday Laboratory Developed Tests (LDTs). Thirty years ago today, FDA announced that it had the authority to regulate you. These two sentences turned out to be the opening salvo in a thirty-year battle – and counting – over how LDTs should be regulated. By Jeffrey N. Gibbs & Allyson B. 92P-0405 (Aug.

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FDA Law Blog

MAY 19, 2023

Baumhardt, Senior Medical Device Regulation Expert & Richard A. As we stated previously, this submission took well over nine (9) months to review and develop the Special Controls. After reviewing the Special Controls, we understand what took so long.

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Drug Discovery World

OCTOBER 20, 2022

Identification of markers specific to tumours and their composite cells can lead to the development of highly specialised therapies, and flow cytometry-based techniques are at the forefront of these advances. CAFs are critical regulators of desmoplasia characteristic of this cancer, yet they are poorly characterised. Elyada et al.

Antibody 52

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FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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FDA Law Blog

OCTOBER 6, 2023

Javitt & Philip Won — As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs). The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. By Allyson B. Mullen & Gail H.

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XTalks

OCTOBER 1, 2020

And although academia and industry have often been pitted against each other in the realm of scientific discovery and development, there may be more similarities and synergies between the two than we may think. WeiQi Lin, MD, PhD, executive vice president of research & development and principal scientist, DURECT Corporation.

Scientist 52

Scientist In-Vitro Research Life Science 52

Roots Analysis

OCTOBER 16, 2023

DNA cloning is a largely accepted technique, however, it has been regulated carefully. Further, the labor and reagent cost incurred in cloning procedures is reduced with customized cloning. Further, there are ethical issues as well, along with reproductive and mutation challenges as well associated with DNA cloning and gene cloning.

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