Design of experiments

PharmaMar and Bionical Emas Launch Expanded Access Program for Lurbinectedin in Relapsed Small Cell Lung Cancer in the U.S.

Retrieved on: 
Monday, January 27, 2020
Health, Pharmaceutical industry, Clinical pharmacology, Pharmacology, Clinical research, Food and Drug Administration, Clinical trial, Design of experiments, Medication

We are excited to be able to provide access to lurbinectedin to eligible patients across the U.S.," said Tom Watson, Executive Vice President, Bionical Emas.

Key Points: 
  • We are excited to be able to provide access to lurbinectedin to eligible patients across the U.S.," said Tom Watson, Executive Vice President, Bionical Emas.
  • Bionical Emas is a specialist CRO combining Clinical Development, Early Access Programs and Clinical Trial Supply.
  • Its Early Access Programs provide companies a route to allow access to pre-approved medicines to help patients with unmet medical needs.
  • 2SEER Cancer Stat Facts Lung and Bronchus Cancer, https://seer.cancer.gov/statfacts/html/lungb.html (accessed December 17, 2019)

PharmaMar and Bionical Emas Launch Expanded Access Program for Lurbinectedin in Relapsed Small Cell Lung Cancer in the U.S.

Retrieved on: 
Monday, January 27, 2020
Health, Pharmaceutical industry, Clinical pharmacology, Pharmacology, Clinical research, Food and Drug Administration, Clinical trial, Design of experiments, Medication

We are excited to be able to provide access to lurbinectedin to eligible patients across the U.S.," said Tom Watson, Executive Vice President, Bionical Emas.

Key Points: 
  • We are excited to be able to provide access to lurbinectedin to eligible patients across the U.S.," said Tom Watson, Executive Vice President, Bionical Emas.
  • Bionical Emas is a specialist CRO combining Clinical Development, Early Access Programs and Clinical Trial Supply.
  • Its Early Access Programs provide companies a route to allow access to pre-approved medicines to help patients with unmet medical needs.
  • 2SEER Cancer Stat Facts Lung and Bronchus Cancer, https://seer.cancer.gov/statfacts/html/lungb.html (accessed December 17, 2019)

Fishbat Discusses Advances in Clinical Trials and 2020 Outlook

Retrieved on: 
Monday, January 27, 2020
Health, Clinical research, Medical research, Design of experiments, Clinical pharmacology, Pharmaceutical industry, Clinical trial

With this in mind, fishbat discusses advances in clinical trials and 2020 outlook.

Key Points: 
  • With this in mind, fishbat discusses advances in clinical trials and 2020 outlook.
  • One certainty regarding advances in clinical trials is the set of technologies used.
  • It would also behoove clinical trials recruitment agencies to focus on numerous therapeutic areas in 2020.
  • By using this insight, clinical trials that yield results will become that much more prominent in 2020.

Innovation Pharmaceuticals Completes Dosing in Phase 1 Trial for New Oral Ulcerative Colitis Drug

Retrieved on: 
Friday, January 24, 2020
Health, Design of experiments, Medical research, Clinical research, Academic disciplines, Medical statistics, Pyrrolidines, Clinical trial, Pharmaceutical industry, Brilacidin, Placebo-controlled study, Cohort

In the Phase 1 clinical trial, nine subjects were enrolled in the single-center, randomized, single-blinded, placebo-controlled, single dose-escalation trial, three subjects per cohort.

Key Points: 
  • In the Phase 1 clinical trial, nine subjects were enrolled in the single-center, randomized, single-blinded, placebo-controlled, single dose-escalation trial, three subjects per cohort.
  • In each cohort, two subjects received Brilacidin (cohort 1: 50mg; cohort 2: 100mg; and cohort 3: 200mg) and one subject placebo.
  • The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources.
  • Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS).

Applied Statistics for Scientists and Engineers (San Francisco, CA, United States - March 19-20, 2020) - ResearchAndMarkets.com

Retrieved on: 
Friday, January 24, 2020
Engineering, Science, Other Science, Manufacturing, Research methods, Statistics, Knowledge, Psychometrics, Design of experiments, Statistical tests, Analysis of variance, Actuarial science, Analysis of covariance, Statistical hypothesis testing, Descriptive statistics, Control chart

The "Applied Statistics for Scientists and Engineers" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Applied Statistics for Scientists and Engineers" conference has been added to ResearchAndMarkets.com's offering.
  • This course provides instruction on how to apply the appropriate statistical approaches: descriptive statistics, data intervals, hypothesis testing, ANOVA, regression, ANCOVA, and model building.
  • Once competence in each of these areas is established, industry-specific applications are presented for the participants.
  • Descriptive statistics (distribution, summary statistics), run charts, and probability (distributions) are used for developing process control charts and developing process capability indices.

CStone successfully hosted the first U.S. R&D Day in New York

Retrieved on: 
Friday, January 24, 2020
Health, Financial markets, Pharmaceutical industry, Clinical research, Pharmaceuticals policy, Clinical trial, Design of experiments, Pharmaceutical industry in China, Hong Kong Exchanges and Clearing, Translational medicine

CStone plans to release top-line data from the seven ongoing clinical trials of these three drug candidates.

Key Points: 
  • CStone plans to release top-line data from the seven ongoing clinical trials of these three drug candidates.
  • CStone will leverage its unique and highly efficient R&D platform to bolster its pipeline and sustain the competitiveness of its portfolio.
  • SUZHOU, China, Jan. 23, 2020 /PRNewswire/ -- CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) announced that it successfully hosted its 2020 U.S. R&D Day in New York on January 21.
  • CStone has established a clinical development-driven business model and built a world-class clinical team with significant experience in translational medicine and clinical development.

AGTC Reports Encouraging Interim Six-Month Data from the Dose Escalation Cohorts of its Ongoing Phase 1/2 Clinical Trials in Achromatopsia

Retrieved on: 
Thursday, January 23, 2020
Health, Clinical research, Design of experiments, Toxicology, Clinical trial, Pharmaceutical industry, Dose

The interim results from both studies demonstrate encouraging signs of biologic activity and a favorable safety profile.

Key Points: 
  • The interim results from both studies demonstrate encouraging signs of biologic activity and a favorable safety profile.
  • The company plans to report data from additional dose groups, age groups and time-points in the second half of 2020.
  • We are continuing dose escalation in order to determine the highest safe dose with the potential to provide maximal benefit, said Sue Washer, President and CEO of AGTC.
  • AGTC will review the interim six-month data from the dose-escalation cohorts of the Phase 1/2 achromatopsia clinical trials at the companys R&D day taking place Tuesday, January 28, 2020, in New York.

OncoSec Secures Phesi ClinSite™ License to Select Clinical Trial Investigator Sites

Retrieved on: 
Wednesday, January 22, 2020
Technology, Genetics, Other Technology, Clinical trials, Software, Biotechnology, Pharmaceutical, Health, Data management, Oncology, Health, Clinical research, Clinical pharmacology, Medical research, Clinical trial, Design of experiments, Pharmaceutical industry, Phesi, OncoSec Medical Incorporated

ClinSiteis a self-service, artificial intelligence (AI)-powered tool that allows biopharmaceutical companies to search for and select top-performing investigator sites for clinical trials in all therapeutic areas.

Key Points: 
  • ClinSiteis a self-service, artificial intelligence (AI)-powered tool that allows biopharmaceutical companies to search for and select top-performing investigator sites for clinical trials in all therapeutic areas.
  • View the full release here: https://www.businesswire.com/news/home/20200122005086/en/
    As a ClinSite licencee, OncoSec can utilize this novel tool to select the right investigator sites for their immune-oncology clinical trials across a range of tumor types, said Gen Li, PhD, MBA, Phesi founder and president.
  • Many drug studies fail or are unnecessarily prolonged due to the lack of timely and precise data to inform trial protocols and investigator site selection.
  • We are therefore excited to deploy ClinSite to optimize our clinical development planning processes, and are eager to see the results as Phesis ClinSite reporting capabilities evolve.

Proteostasis Therapeutics Announces Keystone Symposia Presentation of Organoid Study from More than 300 Adult CF Patients

Retrieved on: 
Wednesday, January 22, 2020
Health, Medicine, Clinical research, Articles, Design of experiments, Clinical trials, Stem cells, Biotechnology, Organoid, Personalized medicine, Crossover study

Data from the organoid study will be used to select a subset of patients for a confirmatory clinical trial, known as the CHOICES trial (Crossover trial based on Human Organoid Individual response in CF - Efficacy Study).

Key Points: 
  • Data from the organoid study will be used to select a subset of patients for a confirmatory clinical trial, known as the CHOICES trial (Crossover trial based on Human Organoid Individual response in CF - Efficacy Study).
  • Based on the outcome of the study, this transition from precision to personalized medicine for the treatment of CF could begin in patients with less common mutations.
  • Organoid cultures frommore than370 adult CF patients have been established to date.
  • Data from the organoid study will be used to select a subset of patients for the confirmatory CHOICES clinical trial.

Propanc Biopharma Receives Advance Overseas Finding from Innovation and Science Australia

Retrieved on: 
Tuesday, January 21, 2020
Biotechnology, General Health, Pharmaceutical, Health, Health, Clinical pharmacology, Clinical research, Clinical trial, Design of experiments, Pharmaceutical industry, Cashback, Cancer, Expense, Articles

Propanc Biopharma, Inc. (OTC: PPCB) (Propanc or the Company), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, announced today that a Certificate for Advance Overseas Finding was received from the Board of Innovation and Science Australia to receive up to a 43.5% cash back benefit from overseas R&D expenses.

Key Points: 
  • Propanc Biopharma, Inc. (OTC: PPCB) (Propanc or the Company), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, announced today that a Certificate for Advance Overseas Finding was received from the Board of Innovation and Science Australia to receive up to a 43.5% cash back benefit from overseas R&D expenses.
  • The finding from the Board agreed there is a significant link between the two supporting activities and the planned Phase 1 clinical trial, and the two activities cannot be conducted solely in Australia.
  • To qualify for the advance overseas finding, R&D expenditure incurred overseas will not exceed expenditure on local, Australian R&D activities, which will also receive up to a 43.5% cashback benefit.
  • In other words, overseas versus Australian R&D expenses must not exceed a 50:50 split.