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Alta Sciences
JANUARY 23, 2024
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Clinical Pharmacology Related Topics 
Are Gaps in Your Clinical Pharmacology Program Jeopardizing Your Drug’s Approval?
Fierce BioTech
OCTOBER 26, 2023
Are Gaps in Your Clinical Pharmacology Program Jeopardizing Your Drug’s Approval? Eva Gil Berglund, PhD Justin Hay, PhD Paola Coppola, MSc Duration 60 Minutes Clinical pharmacology information comprises more than 50% of a drug label. Click here to login. Listing Image Certara-LogoListing-12052023.png
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Clinical Pharmacology Considerations for Peptide Drug Products
thought leadership
SEPTEMBER 20, 2023
The FDA has recently issued this draft guidance to address clinical pharmacology considerations for peptide drug products. A peptide is any polymer with 40 or fewer amino acids. These products fall somewhere between drugs and biologics and do not have the usually well-defined characteristics of either category.
Preparing the next generation of drug discovery scientists
Drug Discovery World
NOVEMBER 29, 2022
After just one cohort of students, the Clinical Pharmacology degree at St George’s University has been named the UK’s best pharmacology course. Due to this approach, the Clinical Pharmacology degree has various features that make it different to other courses that are currently available. Starting with the drug.
What recent paediatric guidelines mean for drug developers
Drug Discovery World
JULY 25, 2023
General clinical pharmacology This FDA draft guidance was previously issued in 2014 but was re-issued for comments again in 2022. The guidance covers three main areas: clinical pharmacology considerations, ethical considerations, and the paediatric study plan design including points to consider.
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Antibody for gastric cancer progresses to Phase III trials
Drug Discovery World
OCTOBER 12, 2023
The interim safety, clinical pharmacology and efficacy data we presented fostered a productive dialogue with the FDA. “We are delighted with the positive outcome of the EOP2 meeting,” said Dr Caroline Germa, Transcenta Executive Vice President, Global Medicine Development and Chief Medical Officer.
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Translating complex data into actionable insights, to create big value for smaller biotech companies
BioPharma Drive: Drug Pricing
FEBRUARY 20, 2024
Why clinical pharmacology is critical to accelerating drug development, and how it can help drive value in a complex and rapidly evolving landscape.
Altasciences Appoints New General Manager, Clinical Operations
Alta Sciences
JANUARY 23, 2024
With close to a decade of experience in the healthcare and pharmaceutical sectors, including clinical pharmacology, James will apply his knowledge to oversee the day-to-day management of clinical operations at Altasciences’ 140-bed, Phase I clinical pharmacology unit in Kansas City. “It
Drug repurposing: The benefits, risks and what we learned from Covid-19
Drug Discovery World
JULY 20, 2023
Diana Spencer summarises the key messages from the ‘Drug Repurposing: Challenges and Opportunities’ Symposium held at the 19th World Congress of Basic & Clinical Pharmacology (WCP) 2023.
Partners will develop targeted miRNAs to treat pancreatic cancer
Drug Discovery World
MARCH 3, 2023
The aim of the collaboration is to develop a replacement therapy combining both miR506-3p and miR24-3p for a more powerful effect, using SiSaf’s Bio-Courier drug delivery platform that leverages the unique properties of elemental silicon to optimise lipid nanoparticle technology for RNA therapeutics. Professor Achim Aigner, Clinical Pharmacology (..)
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Angel Reyes Joins Altasciences as General Manager of CDMO Services
Alta Sciences
OCTOBER 5, 2023
About Altasciences Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services.
Altasciences Completes Expansion of New State-Of-The-Art Laboratory in Columbia, Missouri
Alta Sciences
OCTOBER 31, 2023
About Altasciences Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies , including formulation, manufacturing, and analytical services.
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Webinar: Assessing Cognition Impairment Using Driving Simulators in Clinical Trials
Alta Sciences
FEBRUARY 8, 2024
Utilizing 10 state-of-the-art simulators available in-house at our Montréal clinical facility (with the capacity for more than 20), we are equipped to measure a range of studies; from impairment in cognition and comparing compounds to assessing the impact on new formulations have on impairment.
New adjunctive antidepressant elevates serotonin in Phase I trial
Drug Discovery World
APRIL 12, 2023
Administered in addition to a first-line antidepressant, the drug is intended to elevate extracellular serotonin beyond the first-line antidepressant effect, which convergent clinical pharmacology, brain imaging, and neuroanatomical data support would augment antidepressant efficacy.
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News from ESMO: Challenging the Status Quo of Early Phase Clinical Trial Design — Moving from “Why” to “How”
Cytel
OCTOBER 27, 2023
Written by Natalia Muehlemann, Vice President, Clinical Development; Martin Frenzel, Research Principal, Statistical Consulting; and Michael Fossler, Vice President, Clinical Pharmacology The importance of dose selection and early phase clinical trial design was on the scientific agenda of the ESMO (European Society of Medical Oncology) Congress, which (..)
New strategy for COVID-19 prophylaxis?
The Pharma Data
MARCH 8, 2022
Dr. Gunther Hartmann from the Institute of Clinical Chemistry and Clinical Pharmacology at the University Hospital Bonn, in cooperation with other members of the cluster of excellence ImmunoSensation2 at the University of Bonn, have shown this in mice. Researchers led by Prof. Participating institutions and funding.
Strategies for Recovering from an Unsatisfactory Pre-IND Meeting
The Premier Consulting Blog
JUNE 8, 2023
The goal is to minimize regulatory and execution risks through a well-defined clinical, clinical pharmacology, nonclinical, and CMC (chemistry, manufacturing, and controls) development plan and a time and cost analysis for market entry. This robust plan will form the foundation of your pre-IND meeting preparation and discussion.
Rapid High-Precision Flow Cytometry Solutions
Alta Sciences
JUNE 14, 2023
and Canada are near our clinical pharmacology units, ensuring seamless transitions and swift sample analysis. With our expertise in exploratory and GLP studies, we offer tailored panels for immunophenotyping and cellular activation. In addition, our labs in the U.S. Speak with one of our flow cytometry experts. jpg Weight 3
Janssen submits EMA filing for bladder cancer treatment
Drug Discovery World
SEPTEMBER 14, 2023
Prognostic value and clinical significance of FGFR genomic alterations (GAs) in metastatic urothelial cancer patients. Expert Review of Clinical Pharmacology. J Clin Med. 2022;11(15): 4483. Montazeri K & Bellmunt J. Erdafitinib for the treatment of metastatic bladder cancer.
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Mastering Drug Safety: Your Passport to Successful Pharmacology
Alta Sciences
SEPTEMBER 22, 2023
You can expect a robust program suited to your unique needs to support your IND submission and minimize potential risks, so you can transition smoothly from preclinical to clinical pharmacology. cardiovascular and respiratory); and • safety pharmacology endpoints in general toxicity studies.
A Closer Look At Our On-Site Compounding Pharmacies
Alta Sciences
DECEMBER 14, 2023
Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units. Regulatory Excellence - Licenses for Schedule I through IV drug substances. Exceptional inspection results from major regulators such as the FDA, HC, EMA, and MHRA.
Biomarker identification in the realm of rare diseases
Drug Target Review
MAY 7, 2024
About the author Dr Luke Piggott, Associate Principal Scientist, Debiopharm Luke Piggott possesses extensive experience in developing novel therapeutics, spanning from discovery to clinical trials. At Debiopharm, he has overseen both preclinical and clinical pharmacology of assets from phase I to III.
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Why Proactive AME Studies are Critical to Accelerating Your Approval Journey
Conversations in Drug Development Trends
FEBRUARY 21, 2024
The on-site cGMP Phase 1 pharmacy must have radiolabel drug preparation experience A clinical pharmacology unit (CPU) must be licensed and experienced in handling radioactive investigational drugs in order to complete your AME study.
Antibody Drug Conjugates: windows of opportunity
Drug Target Review
JULY 4, 2023
Translational and Clinical Pharmacology [Internet]. Clinical Pharmacology & Therapeutics. 2022 [cited 2023 Feb 10];30(2):71. Liao MZ, Lu D, Kågedal M, Miles D, Samineni D, Liu SN, et al. 2021 Jul 8;110(5):1216–30.
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First clinical trial for MDMA and LSD combination set to go ahead
The Pharma Data
AUGUST 28, 2020
Dr Matthias Liechti, a Professor of Clinical Pharmacology at the University of Basel and head of the research lab that will be working on the study, said: “The potential of MDMA-LSD is to create a psychological state that may have the benefits of both substances and have longer lasting effects than standalone psilocybin or LSD.
Eplontersen
New Drug Approvals
DECEMBER 24, 2023
. “Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. 88 (12): 5389–5398. doi : 10.1111/bcp.15468. PMID 35869634. S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S.
Trends & Insights: Spotlight Winter Edition
DrugBank
FEBRUARY 9, 2023
Read the paper Jörn Lötsch Biomedical scientist at the Goethe - University Frankfurt am Main, Germany Research Focus: Knowledge discovery by combining artificial and human intelligence for information reduction of biomedical data with a focus on data science, pain, and clinical pharmacology.
Our new Chairman: Dr Charles Woler
Sygnature Discovery
JANUARY 13, 2022
He gained a PhD in Clinical Pharmacology from the University of Lyon and an MD from Université Paris Diderot (Paris VII), and has since spent more than 35 years in the pharmaceutical, biotech and medical sectors in Europe and North America.
Top 10 Life Science Resources
Alta Sciences
OCTOBER 30, 2023
Find out what the key factors are when developing nonclinical cell and gene therapies, including expert approaches to vindicating complex challenges, making your studies more efficient, and maximizing translational opportunities to first-in-human (FIH) trials. Read or listen now.
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FDA Advisory Committee Review of 2021
Eye on FDA
JANUARY 5, 2022
Here is where FDA currently has vacancies: Bone, Reproductive and Urologic Drugs Advisory Committee – 4 vacancies Gastrointestinal Drugs Advisory Committee – 1 vacancy Pharmaceutical Science and Clinical Pharmacology Advisory Committee – 4 vacancies Pharmaceutical Compounding Advisory Committee – 1 vacancy.
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CMC Considerations for Pre-IND Meetings
The Premier Consulting Blog
NOVEMBER 4, 2023
Conclusion The goals of a pre-IND meeting always include minimizing regulatory and execution risks in a drug development program through well-defined clinical, clinical pharmacology, nonclinical, and CMC development plans.
Astellas and Seagen Announce Initial Results of PADCEV® (enfortumab vedotin-ejfv) in Patients with Muscle-Invasive Bladder Cancer Not Eligible for Cisplatin Chemotherapy
The Pharma Data
FEBRUARY 15, 2022
Astellas and Seagen will also present updates from the broader enfortumab vedotin program in four posters at ASCO GU 2022, including: EV-302: A 2-arm, open-label, randomized controlled phase 3 trial of enfortumab vedotin in combination with pembrolizumab vs chemotherapy in previously untreated advanced urothelial carcinoma (aUC) (Trial in Progress) (..)
Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024
Agency IQ
MAY 3, 2024
Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)
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Mission Therapeutics Appoints Dr Suhail Nurbhai as Chief Medical Officer
The Pharma Data
NOVEMBER 1, 2020
Suhail’s initial industry experience was at Pfizer, where he spent 12 years, initially in Sandwich, UK and then at Global R&D Headquarters in Connecticut, USA.
Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder (MDD)
The Pharma Data
MAY 2, 2022
Data from the completed studies of zuranolone in the LANDSCAPE and NEST clinical development programs, including data from the ongoing open-label SHORELINE Study in MDD, as well as data from the completed clinical pharmacology studies, will comprise the full submission package.
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Pharmaron Acquires Absorption Systems in the USA
The Pharma Data
NOVEMBER 8, 2020
With over 10,000 employees, and operations in China, the United States, and the United Kingdom, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China. www.pharmaron.com.
Article FDA Thank You In new contract notices, FDA seeks help on user fee commitments and moving opioid, oncology priorities forward
Agency IQ
JULY 28, 2023
This proposal is an exciting example of how new approaches at the forefront of clinical pharmacology can be leveraged to address the problems being discussed in other forums (e.g., While the exact timeline to publication varies after OIRA clearance, AgencyIQ expects publication to occur this quarter, if not sooner.
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Bristol Myers Squibb Data at the EADV 30th Anniversary Congress Highlight the Growing Body of Evidence on Deucravacitinib and Scientific Advancements for Patients with Serious Dermatologic Diseases
The Pharma Data
OCTOBER 1, 2021
The research, which spans clinical, health economics and outcomes research, translational, clinical pharmacology and preclinical presentations, highlights the breadth and depth of the company’s data on deucravacitinib, a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor, also because the emerging dermatology pipeline.
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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine
Agency IQ
SEPTEMBER 15, 2023
FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. First, Cathy Gelotte, a clinical pharmacology consultant, made the case that low bioavailability does not necessarily indicate a lack of efficacy.
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Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions
Agency IQ
OCTOBER 20, 2023
Biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinical pharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability. Developing biosimilars is an extensive and expensive process.
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XPhyto Secures Exclusive Psychedelic Drug Development Agreement
The Pharma Data
NOVEMBER 9, 2020
He is also a current member of the Health Canada Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology and the Scientific Advisory Panel on Opioid Analgesic Abuse.
Metabolism of macrocyclic drugs
Metabolite Tales Blog
JULY 5, 2023
[link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION. APPLICATION NUMBER: 208261Orig1s000 [link] [10] SUMMARY OF PRODUCT CHARACTERISTICS for Viekirax [link] [11] CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S).
Metabolism of de novo designed macrocyclic drugs
Metabolite Tales Blog
JULY 5, 2023
[link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION. APPLICATION NUMBER: 208261Orig1s000 [link] [10] SUMMARY OF PRODUCT CHARACTERISTICS for Viekirax [link] [11] CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S).
Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)
Agency IQ
FEBRUARY 2, 2024
Start Date End Date Event Event Type Center 01/10/2024 01/10/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Bringing Innovation to People Facing Cancer” Webcast Office of the Commissioner 01/26/2024 01/26/2024 Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) (..)
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