Alta Sciences

JANUARY 23, 2024

James joined Altasciences, having previously worked as Vice President of Research at Akron Children’s Hospital, and most recently as Vice President of Research Operations for Circuit Clinical. Altasciences helps sponsors get better drugs to the people who need them, faster.

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Alta Sciences

OCTOBER 31, 2023

Our integrated CRO/CDMO services combine bioanalytical services with preclinical and clinical study solutions, manufacturing services, and all complementary research support services, for maximum efficiency.” This is Altasciences’ third purpose-built laboratory.

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Drug Target Review

AUGUST 7, 2024

However, making informed labelling decisions during preclinical stages is complex and requires expertise in a variety of areas, including clinical pharmacology, toxicology, regulatory affairs and medical writing. Precise labelling and artwork help prevent confusion and enhance overall patient safety.

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Alta Sciences

FEBRUARY 8, 2024

In this on-demand webinar, Ingrid Holmes , Vice President of Global Clinical Operations at Altasciences, and Dr. Gary G. President of Cognitive Research Corporation , examine simple and cognitive domains in clinical and pharmacology studies, including analysis of driving impairment.

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The Pharma Data

AUGUST 28, 2020

Researchers are set to investigate a combined dose of LSD and MDMA to treat patients undergoing psychotherapy. The researchers will assess how each combination affects a participant’s blood pressure, heart rate and body temperature. Coaster420.

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Alta Sciences

MAY 28, 2024

Altasciences Receives 2024 CRO Leadership Award for Capabilities aasimakopoulos Wed, 05/29/2024 - 17:54 Laval, Québec, May 29, 2024 – Altasciences announced today that it has been recognized for excellence in contract research with a 2024 CRO Leadership Award for Capabilities.

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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.

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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.

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Drug Target Review

MAY 7, 2024

What breakthroughs or advancements do you hope to see in the near future regarding rare disease biomarker research? 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.

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DrugBank

FEBRUARY 9, 2023

DrugBank is passionate about equipping leading researchers with the data they need for new discoveries. As a trusted partner to world-renowned researchers, we are proud to be contributing to groundbreaking research and aiding in solving some of the industry's most pressing issues. Throughout their research, Dutta et al.

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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. png Tags Preclinical Research Weight 10

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The Pharma Data

NOVEMBER 1, 2020

Dr Nurbhai has more than 25 years of experience and a strong track record in the strategic and operational leadership of all phases of clinical research and development at companies across Europe and the US. Mission has strong links with key academic and research centers, including Prof. Photo: Business Wire).

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Alta Sciences

DECEMBER 14, 2023

Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units. Clinical Supply Manufacturing Integration with our manufacturing team, ensuring flexibility and adaptability to meet the evolving needs of your studies throughout your drug development program or study.

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Alta Sciences

SEPTEMBER 20, 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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Alta Sciences

OCTOBER 30, 2023

Discover the considerations and assessments necessary for performing preclinical research for ophthalmic therapies in this new eBook, that covers everything you need to know, from species selection and routes of administration, to preparing for first-in-human trials. Read or listen now. Listen here.

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The Pharma Data

FEBRUARY 15, 2022

Given there is no standard of care for neoadjuvant treatment in cisplatin-ineligible patients, these results are important and support further research.”. “After treatment with enfortumab vedotin, all patients proceeded to surgery. Senior Vice President and Head of Late-Stage Development at Seagen.

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The Pharma Data

NOVEMBER 8, 2020

HK) (“Pharmaron”), a fully integrated contract research and manufacturing organization offering laboratory, CMC and clinical development services for the life science industry, announced today that it has acquired 100% of the equity of Absorption Systems for up to US$137.5 9, 2020 00:00 UTC. Limited (Stock Code: 300759.SZ/3759.HK)

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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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The Premier Consulting Blog

SEPTEMBER 11, 2024

From a clinical pharmacology perspective, the sponsors also needed to establish a scientific bridge for relying on the data contained in the product labeling of the LD. This nonclinical study required good manufacturing practice (GMP) drug product, sham product, and vehicle to qualify the novel excipient used to modify absorption.

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The Pharma Data

NOVEMBER 9, 2020

Dr. Löbenberg holds Health Canada licences for research and analytical testing of a wide range of psychedelic compounds under the Controlled Drugs and Substance Act and research and analytical testing licences for cannabis under the Cannabis Act. DMT (N,N-dimethyltryptamine). Prof.

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Agency IQ

SEPTEMBER 15, 2023

Of the other three comments on the Citizen Petition docket, one supportive comment came from researchers who conducted studies supportive of the petitioner’s assertion of lack of symptomatic efficacy for phenylephrine. Their research showed that consumers prefer oral formulations over intranasal at a rate of 3 to 1.

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The Pharma Data

DECEMBER 17, 2020

The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021. Development pace for ophthalmology program TLC399 will relax to focus on the development of pain management programs, as the pain management market is more expansive than ophthalmology. About TLC.

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New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7]

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Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

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Agency IQ

JULY 8, 2024

Title Type Comments Close Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 Draft Guidance July 5 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance July 5 Financial Transparency and Efficiency of the Prescription (..)

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Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

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Alta Sciences

AUGUST 28, 2023

We wish the team at Ischemix continued success on the next Phase of clinical research.” That is incredibly rewarding,” stated Dr. Morelli, MD, Chief Medical Officer and Principal Investigator for Altasciences. “We Altasciences helps sponsors get better drugs to the people who need them, faster.

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The Pharma Data

MARCH 8, 2022

Researchers led by Prof. 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. . Participating institutions and funding.

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Agency IQ

DECEMBER 11, 2023

In 2015, the FDA, along with the American Association for Cancer Research (AACR), held a workshop on dose optimization for small molecules. Friends of Cancer Research (FOCR) has also been working to improve tolerability and dose optimization programs in collaboration with various stakeholders. months, according to the GSK presentation.

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The Premier Consulting Blog

JUNE 18, 2023

A Modern Twist for the Gold Standard of Clinical Research The gold standard for clinical research intended for regulatory approval is the randomized controlled trial that compares an investigational drug candidate to either a placebo, active control, or standard of care (SoC).

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Agency IQ

OCTOBER 6, 2023

BY AMANDA CONTI | OCT 4, 2023 10:40 PM CDT A quick note: How AgencyIQ gathers data on drug approvals AgencyIQ reviews drug approvals from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). Featuring previous research by Kedest Tadesse, Kari Oakes and Alec Gaffney.

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Alta Sciences

JULY 31, 2024

Regulatory organizations like Health Canada, the International Council for Harmonisation (ICH), and the European Medicines Agency (EMA) have long emphasized the importance of including diverse populations in clinical research. Discover how drug developers, researchers, and regulators are ensuring this happens.

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Clinical Trials Trials Clinical Pharmacology Drug Development 52

Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

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Agency IQ

FEBRUARY 12, 2024

A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year.

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Agency IQ

JUNE 16, 2023

Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation. The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda.

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Alta Sciences

MAY 15, 2023

Starting at formulation, through to preclinical testing, clinical manufacture, early phase clinical trials, and bioanalysis up to Phase IV, Altasciences' Proactive Drug Development Solution offers an innovative and seamlessly integrated drug development journey, with mulitple points of entry.

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Agency IQ

JULY 28, 2023

FDA intends to award a sole source award to Eastern Research Group, Inc. The project leveraged the association’s Toxicology Investigators Consortium (ToxIC), which it describes as a “unique multicenter toxicosurveillance and research network comprised of physicians specifically qualified in the field of medical toxicology.”

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