Clinical pharmacology

Crucial Data Solutions Forms Partnership with Durham Tech to Support Clinical Research Education

Retrieved on: 
Tuesday, May 26, 2020
Education, Data management, Technology, Mobile, Wireless, Software, Internet, University, Health, Articles, Medical research, Clinical pharmacology, Pharmaceutical industry, Clinical trials, Design of experiments, Pharmacovigilance, Clinical research, Outline of clinical research

Crucial Data Solutions, Inc. (CDS), a provider of innovative software to advance clinical research, and Durham Technical Community College, an academic institution in North Carolina, announced today they have formed an academic partnership.

Key Points: 
  • Crucial Data Solutions, Inc. (CDS), a provider of innovative software to advance clinical research, and Durham Technical Community College, an academic institution in North Carolina, announced today they have formed an academic partnership.
  • As of the spring semester 2020, Durham Techs Clinical Trials Research Associate and Medical Product Safety/Pharmacovigilance Programs have been using CDS data collection and study management platform, TrialKit, to teach students about regulatory-compliant clinical research processes.
  • Founded in 2010, Crucial Data Solutions (CDS) provides the most innovative and affordable data collection and clinical trial management technology on the market today.
  • The Durham Tech Clinical Trials Research Associate (CTRA) program is a member of the Consortium of Academic Programs in Clinical Research (CoAPCR) and is recognized as a leader in the clinical research academic community.

Algernon Submits Investigational New Drug (IND) Application with U.S. FDA for Multinational Phase 2b/3 Human Study to Evaluate Ifenprodil for COVID-19

Retrieved on: 
Monday, May 25, 2020
Health, Chemical compounds, Clinical pharmacology, Clinical research, Clinical trial, Design of experiments, Pharmaceutical industry

The clinical study for Ifenprodil, 20 mg tablets, is entitled, "A Randomized Open Label Phase 2b/3 Study of theSafety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Confirmed COVID-19 Infected Hospitalized Patients."

Key Points: 
  • The clinical study for Ifenprodil, 20 mg tablets, is entitled, "A Randomized Open Label Phase 2b/3 Study of theSafety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Confirmed COVID-19 Infected Hospitalized Patients."
  • As part of the multinational Phase 2b/3 COVID-19 clinical study, Algernon has already received clearance in Canada and has also filed for ethics approval in Australia.
  • The data will determine the number of expected patients needed to reach statistical significance in the Phase 3 trial.
  • Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

Scientists Use Virtual Reality to Refine New AI-Generated Drugs for COVID-19

Retrieved on: 
Thursday, May 21, 2020
Health sciences, Health, Natural sciences, Medicinal chemistry, Cheminformatics, Clinical pharmacology, Drug discovery, Pharmaceutics, Pharmacognosy, Severe acute respiratory syndrome-related coronavirus, Protease, Severe acute respiratory syndrome

But since the beginning of the COVID-19 outbreak, only a few studies on novel SARS-CoV-2 protease inhibitors have been published.

Key Points: 
  • But since the beginning of the COVID-19 outbreak, only a few studies on novel SARS-CoV-2 protease inhibitors have been published.
  • "One reason for this is the daunting number of chemical structures that can be generated from scratch," said Zhavoronkov.
  • To enable scientists to exploit the whole drug-like chemical space, scientists have developed a new type of computational method for drug discovery using recent advances in deep learning and AI.
  • The generation was followed by the selection of 10 representative examples and medicinal chemistry analysis in VR, provided by Nanome .

Antisense ATL1102 Final Phase II DMD Results Meet Primary Endpoint and Exceed Expectations on Secondary Endpoints

Retrieved on: 
Thursday, May 21, 2020
Biotechnology, Pharmaceutical, Health, Clinical trials, Health, Clinical pharmacology, Clinical research, Clinical trial, Design of experiments, Pharmaceutical industry, Pharmacology, Antisense Therapeutics Limited, ATL1102, ATL1102 DMD Trial, DMD

The primary objective of the ATL1102 trial was to assess the safety and tolerability of 25 mg of ATL1102 administered once weekly (subcutaneous injection) for 24 weeks in nine non-ambulatory DMD participants.

Key Points: 
  • The primary objective of the ATL1102 trial was to assess the safety and tolerability of 25 mg of ATL1102 administered once weekly (subcutaneous injection) for 24 weeks in nine non-ambulatory DMD participants.
  • ATL1102 is the only drug in clinical development for DMD targeting CD49d and one of a very limited number of treatments being tested in non-ambulant boys with DMD.
  • The results are highly supportive of the Companys plans for a Phase IIb clinical trial of ATL1102 in DMD.
  • The Company is conducting a Phase II clinical trial of ATL1102 in patients with DMD at the Royal Childrens Hospital, Melbourne.

Global Clinical Trial Packaging Market Analysis and Forecasts to 2025 - ResearchAndMarkets.com

Retrieved on: 
Thursday, May 21, 2020
Manufacturing, Health, Pharmaceutical, Packaging, Clinical trials, Health, Clinical research, Pharmaceutical industry, Design of experiments, Medical research, Clinical pharmacology, Clinical trial

The "Clinical Trial Packaging Market - Forecasts from 2020 to 2025" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Clinical Trial Packaging Market - Forecasts from 2020 to 2025" report has been added to ResearchAndMarkets.com's offering.
  • The clinical trials packaging market is projected to grow at a CAGR of 4.41% to reach US$1.482 billion by 2025.
  • The increasing importance of proper packaging techniques in order to preserve the quality of the medicines for clinical trials and the presence of the stringent guidelines is leading to market players providing effective and enhanced clinical trial packing solutions and services to end-users.
  • Consequently, it is putting a burden on the clinical trial packing companies and players to improve the state and the quality of their packing solutions as there is critical issue involved in the packaging and of sensitive drugs for the clinical trials.

Apollomics, Inc. Announces Initiation of SPARTA Phase 2 Clinical Trial for c-MET Inhibitor APL-101

Health, Medical research, Clinical research, Pharmaceutical industry, Clinical pharmacology, Clinical trial, Design of experiments, Tislelizumab

The APL-101 Phase 1/2 clinical trial is an international multicenter, open-label study evaluating the safety, pharmacokinetics, and preliminary efficacy of APL-101.

Key Points: 
  • The APL-101 Phase 1/2 clinical trial is an international multicenter, open-label study evaluating the safety, pharmacokinetics, and preliminary efficacy of APL-101.
  • In NSCLC, the trial will evaluate both c-MET inhibitor nave and experienced patients with mutations that lead to MET exon 14 skipping.
  • Apollomics expects to present the results of the Phase 1 portion of the study at an upcoming medical meeting.
  • Details on the Phase 1/2 SPARTA clinical trial can be found on clinicaltrials.gov: NCT03175224 .

Parexel and Society for Clinical Research Sites Host Joint Summit of Site and Patient Advisory Councils Focused on Optimizing Site and Patient Relationships in Clinical Trials

Retrieved on: 
Wednesday, May 20, 2020
Health, Pharmaceutical industry, Clinical pharmacology, Clinical research, Medical research, Clinical trial, Design of experiments, Clinical

The virtual meeting, attended by 20 patient, caregiver and site representatives acrossEurope and the U.S., focused on strategies for optimizing site-patient relationships, facilitating continued access to trials during the pandemic through innovative decentralized clinical trials, and harnessing pandemic awareness to educate people about the importance of clinical research.

Key Points: 
  • The virtual meeting, attended by 20 patient, caregiver and site representatives acrossEurope and the U.S., focused on strategies for optimizing site-patient relationships, facilitating continued access to trials during the pandemic through innovative decentralized clinical trials, and harnessing pandemic awareness to educate people about the importance of clinical research.
  • Parexels Patient and Site Advisory Councils are integral to the delivery of its clinical trials.
  • Founded in 2012, SCRS is a global organization that unifies the voice of the clinical research site community to create greater site sustainability.
  • SCRS is an influential voice for sites and an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise.Our Voice.

Targeted Protein Degradation (TPD) Insights Report 2020 - Includes Profiles of TPD Technologies, Drug Candidates, TPD Technology Companies, and Major Pharma Companies with Stakes in TPD

Retrieved on: 
Wednesday, May 20, 2020
Clinical pharmacology, Drug discovery, Pharmaceutics, Pharmacognosy, Articles, Life sciences, Natural sciences

At the same time, nearly all major pharmaceutical companies have some kind of stake in the field of targeted protein degradation, with many of them pursuing in-house TPD technology development and TPD drug discovery.

Key Points: 
  • At the same time, nearly all major pharmaceutical companies have some kind of stake in the field of targeted protein degradation, with many of them pursuing in-house TPD technology development and TPD drug discovery.
  • Targeted protein degradation has recently emerged as a novel pharmacological modality that promises to overcome small molecule limitations whilst retaining their key advantages.
  • This report evaluates the industry landscape of targeted protein degradation with novel PROTAC and molecular glue technologies and compounds.
  • Provided that sufficiently detailed information was available, eight different targeted protein degradation technologies were described in more detail and their profiles are provided in the Chapter "Technology Profiles".

Macrogen Approved for Export of its COVID-19 Test Kit

Retrieved on: 
Wednesday, May 20, 2020
Health, Articles, Clinical research, Design of experiments, Clinical pharmacology, Clinical trial, Pharmaceutical industry, Test

Hence, the test kit is evaluated as more appropriate to screen patients with trace amounts of COVID-19.

Key Points: 
  • Hence, the test kit is evaluated as more appropriate to screen patients with trace amounts of COVID-19.
  • of COVID-19 patients, and conducted a clinical trial with its test kit AxenTM COVID-19 RT.
  • Even before this export approval, a surge of inquiries about how to purchase Macrogen's test kit rushed in from many countries including Brazil and Uruguay.
  • Macrogen CEO Sukang Lee said, "We are planning to supply our test kit to major countries, which contacted us even during the test kit development phase and were looking forward to export approval together with us, first and as early as possible.

COUCH Health Demands the Clinical Research Industry Improves Participant Diversity

Retrieved on: 
Wednesday, May 20, 2020
Education, Articles, Health, Clinical pharmacology, Pharmaceutical industry, Clinical research, Clinical trial, Design of experiments, Inclusion

As advocates of diverse and inclusive clinical trials, patient engagement agency COUCH Health is calling on the industry take action to make clinical research more inclusive and representative of all populations.

Key Points: 
  • As advocates of diverse and inclusive clinical trials, patient engagement agency COUCH Health is calling on the industry take action to make clinical research more inclusive and representative of all populations.
  • Demand Diversity has launched with the aim to raise awareness of the lack of diversity in clinical research and make change happen.
  • MANCHESTER, England, May 20, 2020 /PRNewswire/ --Lack of diversity and inclusion is one of the clinical research industry's biggest issues failing to be effectively addressed.
  • "We all have a duty to create meaningful engagement with diverse groups that improves the data that's generated from clinical research studies.