Drug Discovery World

MARCH 21, 2023

The In Vitro Diagnostic Regulation (IVDR) came into effect in May 2022. The regulation aims to ensure patients’ safety, provide a more transparent framework for IVDs and deliver access to innovative medical technologies. Up to 400 trials are expected to enrol fewer patients, meaning some people missing out on innovative new treatments.

In-Vitro 52

In-Vitro Regulation Clinical Trials Clinical Trials 52

Advarra

JUNE 12, 2023

Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring an institutional biosafety committee (IBC) to provide additional oversight and risk assessment. What do the Regulations Say about IBC Review? What Does an IBC Review?

Genetic Engineering 98

Genetic Engineering Gene Therapy Genetics Engineer 98

Cloudbyz

SEPTEMBER 16, 2023

Addressing data privacy and data protection concerns when implementing ChatGPT in clinical trial operations management is crucial to maintain compliance with regulations, safeguard sensitive patient information, and build trust among stakeholders. This may involve conducting regular audits and assessments to maintain compliance.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Compliance 59

Drug Discovery World

FEBRUARY 12, 2024

In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. Ensuring sufficient and timely patient enrollment in a rapidly growing number of cell and gene therapy clinical trials is becoming a bottleneck to advancing potentially life-saving therapies.

Genome 139

Genome Genomics Life Science Gene Therapy 139

XTalks

JUNE 12, 2023

The manufacturing process for cell therapies, like autologous T cell therapy, is complex and labor-intensive, involving numerous procedures that can affect regulatory compliance and consistency. Therefore, it is crucial to ensure a reliable, high-quality supply with rapid turnaround time for cell therapy manufacturing.

Manufacturing 95

Manufacturing Gene Therapy FDA Approval Gene 95

Pharmaceutical Technology

OCTOBER 27, 2022

The increasing regulation of biotech and manufacturing deals in the US could prompt foreign companies such as Chinese contract development and manufacturing organisations (CDMOs) to seek alternative targets in Europe or elsewhere.

Manufacturing 267

Manufacturing Contract Manufacturing Gene Therapy Gene 267

Drug Discovery World

JANUARY 30, 2024

Viral vector manufacturing At the Advanced Therapies Awards ceremony, Dr Luigi Naldini, Director of the San Raffaele Telethon Institute for Gene Therapy, was awarded a Lifetime Achievement Award in recognition of ‘extraordinary contributions to gene therapy’, a field he has helped shape through his pioneering work on lentiviral vectors.

Gene Therapy 71

Gene Therapy Manufacturing Gene Clinical Trials 71

Cloudbyz

JUNE 11, 2023

DCTs employ digital platforms for remote interaction and consultation, maintaining patient engagement and providing necessary support virtually, which may reduce appointment no-shows and increase protocol compliance. They often come with in-built compliance mechanisms to ensure adherence to regulations and good clinical practice guidelines.

Clinical Trials 72

Clinical Trials Clinical Trials Trials Compliance 72

Cloudbyz

AUGUST 9, 2023

As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. Integrated Compliance and Governance With stringent regulations governing clinical trials, compliance is of utmost importance.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

ACRP blog

APRIL 5, 2023

A special feature in the forthcoming April issue of ACRP’s Clinical Researcher journal puts a spotlight on how the life sciences sector has been undergoing an immense transformation, driven by the adoption of artificial intelligence (AI), machine learning, and natural language processing, and by the exploitation of “big data” sources in new and powerful (..)

Big Data 52

Big Data Clinical Trials Clinical Trials Life Science 52

Advarra

JANUARY 11, 2024

Personalized medicine using genetic resequencing techniques, such as cell and gene therapies, enables researchers to create more customized therapies for combatting cancer. Many monoclonal antibodies are used to treat cancer by targeting specific cell structures regulating cell activity, causing the death of tumor cells.

Vaccination 52

Vaccination Vaccine Protein Antibody 52

XTalks

MARCH 13, 2024

These advancements have not only helped improve the precision of glaucoma management but have also considerably improved patient compliance and quality of life. One example is Glaukos’ iDose TR , an intracameral implant designed to provide continuous drug therapy inside the eye for up to three years.

Gene Therapy 111

Gene Therapy Gene Life Science DNA 111

pharmaphorum

JUNE 11, 2021

These trends combine to increase the pace of innovation and the precision of therapies. Leading academic research institutions and pharma/biopharma players exploring therapeutic areas such as immuno-oncology or cell and gene therapy no longer start ‘analogue only’ projects because of time and productivity shortcomings.

Clinical Trials 108

Clinical Trials Clinical Trials Trials Compliance 108

Cloudbyz

OCTOBER 19, 2023

Regulatory Compliance: Streamlining processes aids in meeting stringent regulatory requirements and maintaining data integrity. Conclusion A unified clinical trial management platform is no longer a luxury but a necessity for pharmaceutical companies aiming to thrive in an increasingly competitive and regulated industry.

Clinical Trials 86

Clinical Trials Clinical Trials Trials Compliance 86

Cloudbyz

JUNE 13, 2023

Regulatory Compliance: Ensuring compliance with regulatory requirements is essential but can add to the budget. Compliance and Auditing: Ensure adherence to financial regulations, industry standards, and sponsor requirements throughout the trial. This includes transportation costs, lodging, meals, and incidentals.

Clinical Trials 68

Clinical Trials Clinical Trials Trials Marketing 68

Drug Discovery World

JUNE 16, 2023

The International Society for Cellular Therapy (ISCT) is a global society of clinicians, regulators, technologists, and industry partners with a shared mission to drive the translation of all cell and gene (CGT) therapies for the benefit of patients worldwide.

Manufacturing 52

Manufacturing In-Vivo Production Compliance 52

Pharmaceutical Technology

FEBRUARY 20, 2023

The formal signing ceremony of the MoU today at Cerba Research’s Ghent office was led by Mario Papillon, CEO of Cerba Research, and Xu Yi, CEO of Teddy Lab, on behalf of their respective organisations. About Teddy Clinical Research Laboratory : As a joint venture company established in 2016 by Dian Diagnostics (300244.SZ) SZ) and Tigermed (300347.SZ

Research 130

Research Clinical Trials Clinical Trials Clinical Research 130

Cloudbyz

SEPTEMBER 25, 2023

Regulatory Compliance: Depending on the jurisdiction you operate from, your CTMS needs to be compliant with all the requirements and conditions set forth by the relevant regulatory authorities. This integration is advantageous for oversight and regulation, money, time, and labor.

Clinical Trials 81

Clinical Trials Clinical Trials Trials Compliance 81

Drug Discovery World

MAY 15, 2024

Currently in a Phase Ib/IIa study, it is believed to stabilise GAP-junction activity through regulation of connexin-43. To be widely adopted, there is an urgent need to develop non-invasive therapies that will improve patient welfare as well as compliance, and preserve vision long-term. Pete Adamson is CSO at Breye Therapeutics.

Development 64

Development Gene Therapy Compliance Production 64

pharmaphorum

JULY 4, 2022

Together, the webinar panellists explored the potential of medical informatics solutions and methods in rare disease research, studies, data optimisation, and usability to overcome these challenges, all whilst maintaining compliance with data protection regulations and a patient-centric approach.

Genome 103

Genome Genomics Research Medicine 103

Drug Discovery World

NOVEMBER 3, 2022

Ten years ago, cell and gene therapy (CGT) was really finding its feet as success stories such as that of Emily Whitehead began to hit the news. The cost of a process failure on these therapies is high, as is the resulting pressure on actors within the supply chain. TrakCel recently announced the launch of its latest platform.

Gene Therapy 52

Gene Therapy Production Development Business Development 52

pharmaphorum

NOVEMBER 30, 2022

As an industry, pharma has specific needs; it is driven by targeted regulations and rules and has not been well served by technology. The whole pharma industry is built on compliance. Founded in 2007 by Peter Gassner, a luminary of Silicon Valley with a net worth of circa $5.25 That, he said, is commercial excellence.

Life Science 95

Life Science Pharma Companies Sales Marketing 95