Advarra

MARCH 31, 2023

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. The post Risk Assessment for use of Engineered Genetic Materials in Clinical Research appeared first on Advarra.

Engineering 52

Engineering Clinical Research Research Virus 52

The Premier Consulting Blog

APRIL 18, 2024

Development of cell and gene therapies is growing rapidly, given the major advances in genomic technologies and increasing scientific understanding of genetic regulation and immunology. This blog will outline three characteristics of a successful nonclinical program to support entry into clinical trials for a cell or gene therapy product.

Therapies 52

Therapies Clinical Trials Small Molecule Immune Response 52

PPD

JANUARY 5, 2023

In an industry survey led by PPD, Thermo Fisher Scientific’s clinical research business, rare diseases emerged as a top therapeutic area in drug developers’ pipelines, with 39% of global biotech and biopharma leaders pursuing therapies in the broad rare disease space.

Disease 52

Disease Trials Clinical Trials Clinical Research 52

National Drug & Alcohol Research Centre Blog

JULY 13, 2021

NCCRED was funded through the Strategy, and commenced in 2018, to build clinical research capacity and work towards establishing evidence-based treatment approaches for both methamphetamines and other emerging drugs of concern. Why do a clinical research priority setting study?

Clinical Research 52

Clinical Research Research Clinical Trials Trials 52

Alta Sciences

APRIL 16, 2024

Inside The Altascientist: The Benefits of PCR for Your Gene Therapy Programs pmjackson Tue, 04/16/2024 - 19:04 The gene therapy landscape continues to accelerate in preclinical and clinical research, with programs constantly in development for targeted, personalized medicines. But how are PCR analysis techniques applied?

Therapies 52

Therapies DNA RNA Laboratories 52

Drug Target Review

FEBRUARY 21, 2024

Stem cell transplants have saved patients’ lives time and time again, which led us to launch our own Stem Cell Transplant and Cellular Therapy Program. Regarding CAR-T cell therapy, could you highlight the promising findings that have been identified in the early stages of drug discovery, as well as potential challenges?

Therapies 65

Therapies Treatment Vaccine FDA Approval 65

Advarra

NOVEMBER 29, 2022

The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. 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.

Therapies 52

Therapies Clinical Trials FDA Production 52

PPD

MAY 18, 2023

Yet, four out of five care partners of people with neurodegenerative disorders have never been informed of clinical trial opportunities , according to a survey of more than 250 caregivers conducted by PPD, the clinical research business of Thermo Fisher Scientific. PPD has local teams across Europe and the U.S.

Clinical Trials 86

Clinical Trials Trials Clinical Research Doctors 86

Conversations in Drug Development Trends

JANUARY 24, 2024

However, clinical research around Fragile X is considerably robust, making the possibility of clinical trial participation a potential motivation for parents to choose to undergo genetic testing for their children. As of July 2023, the American Society of Cell + Gene Therapy stated there were 3,905 therapies in development.

Trials 75

Trials Disease Clinical Trials Clinical Research 75

Agency IQ

FEBRUARY 12, 2024

BY RACHEL COE, MSC | FEB 7, 2024 10:21 PM CST The Bespoke Gene Therapy Consortium A collaborative effort, the Bespoke Gene Therapy Consortium (BGTC) was launched in October 2021 to “accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease.”

FDA 40

FDA Therapies Clinical Trials Disease 40

Advarra

OCTOBER 15, 2024

The International Council for Harmonisation (ICH) good clinical practice (GCP) guidelines are critical in ensuring the safety and rights of clinical trial participants. Risks to CtQs factors should be proactively managed and risk language/monitoring adjusted according to new and changing information during the clinical trial.

Clinical Trials 52

Clinical Trials Trials Clinical Research International 52

Olympian Clinical Research

NOVEMBER 9, 2022

The more you know, the better equipped you’ll be to make informed decisions about your care. Radiation therapy. Immunosuppressive therapy may also be used to treat bullous pemphigoid. This therapy uses drugs such as azathioprine to suppress your body’s immune response. Certain medications, such as penicillin.

Treatment 52

Treatment Clinical Research Immune Response Therapies 52

Olympian Clinical Research

APRIL 18, 2023

Medical and surgical therapy may reduce the symptoms and keep them under control. To learn more about the causes and treatments for HS, Olympian Clinical Research ( OCR ) is hosting a research study on the condition. These rules include informed consent procedures, ethical considerations, and monitoring of adverse events.

Research 52

Research Clinical Research Doctors Treatment 52

Vial

JUNE 18, 2024

Lack of representation in clinical trials, e.g., a lack of racial and ethnic diversity, leads to suboptimal patient recruitment, skewed findings, limitations in the generalizability of study results to a broader population, inequitable health outcomes, and suboptimal development of innovative therapies for all. Specifically, U.S.

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

Drug Target Review

MAY 7, 2024

Small patient populations often result in difficulty in determining a significant effect of a therapy, given the low confidence power associated with the statistics. For instance, AI algorithms could facilitate patient-trial matching, encompassing medical records, genetic information, demographics, and personal preferences.

Disease 59

Disease Clinical Trials Clinical Pharmacology Trials 59

PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. Researchers often employ cell therapy studies for oncology indications, and the U.S.

Trials 64

Trials Clinical Trials Drug Development Therapies 64

Precision for Medicine

APRIL 7, 2023

These labs are an integral part of the transformational infrastructure of capabilities Precision has built to accelerate the development of complex therapies.” For more information, visit PrecisionForMedicine.com. Precision for Medicine is part of Precision Medicine Group, with 3,200 people in 40 locations in the U.S.,

Laboratories 52

Laboratories Clinical Research Clinical Trials Cell Biology 52

Olympian Clinical Research

AUGUST 19, 2022

In addition, clinical research may provide new information and breakthrough treatments. . Your child’s pediatrician will also be able to provide you with more information about pediatric psoriasis and the available treatment options. The Benefits of Clinical Research for Pediatric Dermatology Conditions.

Clinical Research 52

Clinical Research Treatment Doctors Licensing 52

PPD

AUGUST 14, 2024

According to research commissioned by the PPD clinical research business of Thermo Fisher Scientific, 55% of respondents reported patient recruitment in clinical trials as the top challenge facing their organization, followed closely by increasing trial complexity.

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

Advarra

AUGUST 14, 2023

The clinical research industry is only becoming more complex and competitive as organizations are inundated with multiple trials and tight deadlines. The clinical trial process is both expensive and time-consuming, and ends more often in failure than success. of respondents reported they know what clinical trials are.

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

Advarra

JUNE 13, 2024

Because these therapies often use live viral vectors, there is the risk of accidental transmission that is not encountered with non-biological drugs and therapeutics. Synthetic mRNA-based therapeutics used in clinical research today also fall into this self-limiting class of recombinant therapeutics.

Clinical Trials 52

Clinical Trials Engineering Trials Virus 52

Agency IQ

NOVEMBER 3, 2023

regulatory landscape for probiotics and other microbiome-based therapies Probiotics, a type of microbiome-based therapy containing live micro-organisms, are broadly available on drug store and grocery store shelves, but the regulatory classifications for products containing the same micro-organism can differ dramatically.

Therapies 40

Therapies Science FDA Production 40

Precision for Medicine

JUNE 26, 2023

Unraveling the complexity of manufacturing next-gen biologics is critical to the shared mission of accelerating patient access to new therapies,” said Chad Clark, President of Precision for Medicine. This convergence is driving faster clinical development and approval. For more information, visit PrecisionForMedicine.com.

Science 40

Science Small Molecule Clinical Research Engineering 40

H1 Blog

MAY 4, 2023

Insights for Thought Leading Stakeholder Engagement to Decrease Medication Non-Adherence Pharmaceutical companies have long recognized the importance of engaging key opinion leaders (KOLs) to gain insight and support for clinical research, drug development, and medical education.

Pharmaceutical Companies 52

Pharmaceutical Companies Clinical Research Pharma Companies Pharmaceuticals 52

Vial

FEBRUARY 8, 2024

To advance new therapies, pharmaceutical, biotech, and medical device companies engage contract research organizations (CROs) for their know-how in navigating the complex landscape of drug development and regulatory pathways and to run clinical trials. As von Itzstein et al.

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

The Pharma Data

MARCH 17, 2022

Spanning from translational to large, prospective, multi-centre, phase III clinical trials that evaluate new therapies and treatment strategies as well as patient quality of life, its activities are coordinated from EORTC Headquarters, a unique international clinical research infrastructure, based in Brussels, Belgium.

Therapies 52

Therapies Clinical Trials Disease Treatment 52

PPD

NOVEMBER 14, 2023

Clinical research requires vast talent across a variety of roles and specialties, as well as across global locations. In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development.

Clinical Research 52

Clinical Research Clinical Development International Engineering 52

PPD

AUGUST 7, 2024

Clinical trials are the backbone of medical research, enabling the development of new treatments and therapies that can improve patient outcomes. However, conducting successful clinical trials requires efficient communication and coordination among various stakeholders.

Clinical Trials 52

Clinical Trials Trials Compliance Clinical Research 52

Advarra

OCTOBER 19, 2023

The clinical trial startup process has seen significant shifts over the past five years: growth in decentralized trials, improved technology, and an increased demand for accelerated timelines in getting therapies to market. Each of these have contributed to a rapidly evolving clinical research landscape.

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

Olympian Clinical Research

OCTOBER 14, 2021

We’ve outlined five reasons why joining a clinical trial might be in your best interest. The whole point of clinical trials is to gather information about new treatments and drugs. When you join a clinical trial, you’ll be assigned to a team of doctors and researchers who will monitor your health very closely.

Clinical Trials 52

Clinical Trials Trials Doctors Therapies 52

PPD

OCTOBER 16, 2023

There has been continuous growth in the variety and volume of available health care data, and newer applications for use of real-world data (RWD) and real-world evidence (RWE) to enhance the speed of patient access to new therapies. Consent development: Informed consent is the most important step in the tokenization process.

Clinical Trials 98

Clinical Trials Trials Research Therapies 98

The Pharma Data

MARCH 23, 2022

The only large-scale prospective study in dermatology designed to generate key disease insights among Black, Hispanic, Asian, Indigenous and other people of color Study reinforces Janssen’s commitments to inclusive clinical research and addressing health inequities.

Pharmaceutical Companies 52

Pharmaceutical Companies Clinical Research Disease Therapies 52

Conversations in Drug Development Trends

APRIL 3, 2024

By: Sue Batchelor, Executive Director, Oncology Project Management Radiopharmaceuticals represent a cutting-edge frontier in oncology treatment, offering the promise of highly targeted therapy with the potential to revolutionize cancer care. These include ensuring informed consent, particularly around the risks and benefits of participation.

Trials 81

Trials Clinical Trials Compliance Treatment 81

Vial

APRIL 10, 2024

The strong commitment to innovation allows IQVIA to provide advanced analytics, technology solutions, and industry-specific expertise in the health information technologies and clinical research domains. IQVIA has a vast collection of healthcare information, including over 1.2 increase on a reported basis and an 4.8%

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52

Vial

DECEMBER 11, 2023

Despite the essential role of the clinical research industry, initiating a clinical study at a new site often takes a considerable amount of time, which can postpone the overall timeline of the research. weeks for Phase II and Phase III studies. Observational. Bars represent the standard error for each mean value.

Clinical Trials 52

Clinical Trials Clinical Research Trials Research 52

Precision for Medicine

MAY 24, 2023

CRO Leadership Awards recognize companies judged by customers as exceeding expectations BETHESDA, MD, May 25, 2023 – Precision for Medicine, the first biomarker-driven clinical research organization (CRO), announces its wide recognition in the 2023 CRO Leadership Awards. For more information, visit PrecisionForMedicine.com.

Clinical Trials 40

Clinical Trials Clinical Research Science Trials 40

Advarra

JUNE 20, 2023

Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community. Often, medical innovations are first explored in oncology research (e.g., cell and gene therapies), with other therapeutic areas then pushing it further.

Trials 52

Trials Clinical Trials FDA Approval Therapies 52