Drug Discovery World

JUNE 20, 2024

Now, you might wonder: how exactly can these advanced artificial intelligence models propel clinical research forward? In the context of clinical trials, these models can help us add context to insights. Conventional AI models allow us to extract insights from the clinical data but they do lack context.

Clinical Research 147

Clinical Research Research Clinical Trials Trials 147

PPD

SEPTEMBER 6, 2023

Under the stresses of the COVID-19 pandemic, drug development organizations faced difficult decisions about keeping staff employed and productive. Benefits of Rebadging Under an FSP Model in Clinical Research A functional service partnership (FSP) model in clinical research can help sponsors navigate unforeseen staffing challenges.

Clinical Research 59

Clinical Research Regulations Packaging Compliance 59

Conversations in Drug Development Trends

AUGUST 9, 2024

Advantages and Operational Challenges in Adaptive MRCTs Adaptive trial designs are gaining popularity in clinical research due to their ability to improve trial efficiency and uphold ethical standards, resulting in faster and more reliable outcomes.

Trials 80

Trials Clinical Trials Regulations FDA 80

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 52

Trials Clinical Trials Therapies Drug Development 52

Drug Discovery World

DECEMBER 8, 2023

Investments in AI and related technologies are driving this seismic shift where modest improvements in early-stage drug development success rates enabled by AI and machine learning could lead to an additional 50 novel therapies over 10 year s, a more than $50 billion opportunity.

Therapies 162

Therapies Clinical Trials Small Molecule Production 162

Conversations in Drug Development Trends

JUNE 21, 2024

The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Interested in hearing more insights from Matt?

Clinical Trials 64

Clinical Trials Clinical Research Immune Response Therapies 64

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

Alta Sciences

DECEMBER 14, 2023

Regulatory Excellence - Licenses for Schedule I through IV drug substances. Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units. Exceptional inspection results from major regulators such as the FDA, HC, EMA, and MHRA.

Compounding Pharmacies 40

Compounding Pharmacies Pharmacy Clinical Pharmacology Clinical Supply 40

Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. This approach replaces paper sources, supports productivity-enhancing workflows, and ensures compliance with relevant regulations.

Clinical Trials 52

Clinical Trials Trials Compliance Clinical Research 52

PPD

OCTOBER 18, 2023

Access to a laboratory partner that already possesses the equipment, knowledge and personnel can save time and money. For rapid expansion of late-stage assay platforms, speed and a proven track record are pivotal.

Laboratories 52

Laboratories Assay Development Small Molecule Packaging 52

Vial

FEBRUARY 15, 2024

Sponsors often contract a CRO to delegate specific day-to-day tasks, streamlining their research processes and enhancing efficiency. Patient recruitment and retention : Recruiting and retaining a sufficient number of eligible participants is one of the major challenges in conducting clinical trials.

Pharma Companies 52

Pharma Companies Clinical Trials Compliance Trials 52

Drug Discovery World

AUGUST 3, 2023

Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance. There is, however, one cannabis-derived drug product that the FDA has approved, which is Epidiolex (cannabidiol).

Clinical Trials 130

Clinical Trials Regulations Production FDA 130

Drug Discovery World

NOVEMBER 8, 2023

Harnessing AI, researchers have significantly expedited the drug discovery process, achieving what traditionally takes years in just 30 days. This method not only promises more efficient drug development but could also revolutionise clinical research and accelerate trials.

Clinical Trials 182

Clinical Trials Trials Disease Medical Schools 182

Perficient: Drug Development

FEBRUARY 1, 2024

The SCOPE (Summit for Clinical Ops Executives) conference is a premier event in the field of clinical operations, providing a comprehensive platform for professionals to explore the latest trends and innovations in clinical research. Reach out to connect with us.

Science 59

Science Clinical Research Clinical Trials Trials 59

PPD

NOVEMBER 7, 2023

The underrepresentation of diverse groups in clinical research is an area of regulatory, scientific and industry focus, partly due to the recent U.S. Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.”

Clinical Trials 59

Clinical Trials Trials Clinical Research Disease 59

Drug Discovery World

APRIL 14, 2023

By Lucy Radley , Senior Vice President, Head of European Regulatory Development at ProPharma Group. Clinical trials are, undoubtedly, an essential part of the drug development process, providing us with valuable information about the safety and efficacy of new treatments and therapies.

Clinical Trials 130

Clinical Trials Trials Pharmaceuticals Vaccine 130

Drug Discovery World

JULY 5, 2023

What is clear is that what is needed are methods which can start in the research lab and ‘cross the chasm’ to routine use in a regulated environment. RA: Is Europe a leader in global cancer research? MG: I meet regularly with the brilliant European scientists driving cutting edge global cancer research.

Research 246

Research Immune Response Pharmaceutical Companies Treatment 246

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. Can you identify a safe AND efficacious clinical dose? Prior to clinical trials, the focus is typically on evaluating safety.

Therapies 52

Therapies Clinical Trials Small Molecule Immune Response 52

Crown Bioscience

MAY 4, 2021

In addition, owing to the rarity of these diseases, it can be extremely challenging to gain to patients and perform the clinical research necessary for regulatory approval. In August 2020, new US legislation was passed which promises to have a major influence on the way companies approach pediatric drug development.

Research 52

Research Pharmaceutical Companies Licensing Licensing 52

The Pharma Data

DECEMBER 15, 2020

It is funded by the world’s leading charities dedicated to diabetes research, JDRF, and Diabetes UK, guided by both organizations’ strong commitment to facilitate deep interrogation of consolidated community-wide trial data as a means to accelerate clinical research and therapeutic development for T1D.

Drug Development 40

Drug Development Clinical Trials Vaccine Trials 40

Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Read AgencyIQ’s analysis of a lower court’s ruling.

FDA 40

FDA Science Clinical Trials Regulations 40

Perficient: Drug Development

JULY 24, 2023

How are you making a difference for our clients, colleagues, and communities? As a lead business consultant in the computer system validation department, I plan, write, implement, and review the computer systems validation plan and protocols within highly regulated industries. Thanks for joining me today, Kaushal.

Regulations 52

Regulations Science Clinical Research Pharmaceuticals 52

Drug Discovery World

SEPTEMBER 28, 2022

Acts such as General Data Protection Regulation (GDPR) in the UK and the Health Insurance Portability and Accountability Act (HIPAA) in the US protect users’ health data from being used for commercial purposes. NEC, the Japanese IT and electronics corporation, has pivoted towards drug discovery with a focus on personalised medicines.

Pharma Companies 130

Pharma Companies Hospitals Clinical Trials Drugs 130

Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Read AgencyIQ analysis here for a detailed discussion of these issues. ].

FDA 40

FDA Trials Regulations Therapies 40

Conversations in Drug Development Trends

APRIL 3, 2024

Complying with Unique Radiopharmaceutical Regulations The regulatory landscape for radiopharmaceuticals is intricate, reflecting the drugs’ complexity. By emphasizing transparency and patient autonomy, trials can maintain ethical standards while fostering trust and participation.

Trials 81

Trials Clinical Trials Compliance Treatment 81

Conversations in Drug Development Trends

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Yet, it becomes a manageable aspect of drug development with careful planning, strategic engagement, and flexible problem-solving.

Clinical Research 69

Clinical Research Trials Research Clinical Trials 69

Agency IQ

FEBRUARY 12, 2024

The consortium is funded by a public-private partnership called the Accelerating Medicines Partnership (AMP) , through which the Foundation for the NIH (FNIH) administers funds provided by industry, government, and nonprofits to scientists working on applicable basic or clinical research to advance gene therapy development for rare diseases.

FDA 40

FDA Therapies Clinical Trials Virus 40

Conversations in Drug Development Trends

NOVEMBER 10, 2023

 Instead, the medical community and regulating agencies need to balance all aspects when making decisions, working in partnership with their patients. Collaborating This desperation is apparent through the higher suicide rates for individuals suffering from high levels of pain. However,

Clinical Trials 75

Clinical Trials Trials Compliance Doctors 75

The Pharma Data

DECEMBER 15, 2020

As the world’s first PPAR pan agonist that completed two confirmatory phase III clinical trials, Chiglitazar Sodium has shown significant and long-lasting hypoglycemic effects in a series of clinical studies, as well as other comprehensive effects including significant insulin sensitization and blood lipid regulation.

Pharmaceuticals 40

Pharmaceuticals Small Molecule Clinical Trials Production 40

Drug Discovery World

JULY 12, 2023

This paid-for advertorial by BC Platforms appeared in DDW Volume 24 – Issue 3, Summer 2023 The use of real-world data (RWD) is demonstrating significant potential to enhance rare and orphan disease clinical research and development. How can researchers gain access to rare and orphan disease patient data, including RWD?

Disease 130

Disease Research Clinical Trials Clinical Research 130

Conversations in Drug Development Trends

FEBRUARY 22, 2023

Cure GM1 Foundation’s mission is to fund research for the benefit of all those who suffer from GM1 gangliosidosis, a lysosomal storage disease that attacks the brain and spinal cord. Richie Kahn: I’m a public health and advocacy guy by training, a clinical researcher by trade, and a patient advocate by necessity.

Disease 52

Disease Clinical Trials Trials Treatment 52

Advarra

AUGUST 10, 2023

Given the relatively small populations affected by any one rare disease or condition, a pharmaceutical company developing an orphan drug may reasonably expect the final approved drug to generate relatively small sales (when compared with the drug development costs) and consequently incur a financial loss.

Drug Development 52

Drug Development Disease Engineering Therapies 52

NIH Director's Blog: Drug Development

JULY 20, 2017

Years of hard work, supported by the National Institutes of Health and the Cystic Fibrosis Foundation, painstakingly worked out the normal function of the protein that is altered in CF, called the cystic fibrosis transmembrane regulator (CFTR). Credit: Zhang & Chen, 2016, Cell 167, 1586–1597.

Clinical Trials 52

Clinical Trials Small Molecule Disease Therapies 52

The Pharma Data

JANUARY 25, 2021

The AD-SAB will work closely with NervGen as the Company plans its upcoming preclinical studies and clinical trials and in the analyses of the results from these studies. Corey Davis Ph.D., LifeSci Advisors LLC cdavis@lifesciadvisors.com. Follow NervGen on Twitter (@NervgenC) and LinkedIn (NervGen Pharma Corp.)

Disease 40

Disease Clinical Development Molecular Biology Treatment 40

NIH Director's Blog: Drug Development

JANUARY 5, 2016

Although NIH was not involved in this specific trial, researchers from our National Institute of Allergy and Infectious Diseases (NIAID) and Clinical Research Center were involved in this vaccine’s early Phase I clinical testing in collaborations with the Walter Reed Army Institute of Research [3].

Vaccine 52

Vaccine Science Engineering Disease 52

PPD

JUNE 20, 2023

As some drug development organizations right-size their workforces , a strong CRO partner will rehire your talent — avoiding destabilization of your clinical research — via rebadging through functional service provider (FSP) engagements. The drug development industry is undoubtedly in a season of change.

Clinical Trials 52

Clinical Trials Drug Development Trials Biosimilars 52