Remove Definition Remove Licensing Remove Pharmacokinetics
article thumbnail

Some Thoughts on Biotech vs Pharma for Computational Chemists

Practical Cheminformatics

It is rare for graduate students to be exposed to tasks like optimizing pharmacokinetics or off-target binding. Goals and definitions of success vary from person to person. In these cases, broadening your skillset into other areas like medicinal chemistry, pharmacology, biophysics, pharmacokinetics, and disease biology is important.

article thumbnail

Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

FDA Law Blog: Drug Discovery

The definition goes on to list potential options for such tests: cell-based assays, organ chips and microphysiological systems, computer modeling, other nonhuman or human biology-based test methods such as bioprinting, as well as animal tests. FDORA § 3209(a)(2). 42 U.S.C. § 262(k)(2)(A)(i)(I).

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Building collaborations to fight a pandemic

The Pharma Data

Fortunately, as a member of the Novartis Business Development & Licensing (BD&L) department, she was in a position to try to help. Jennifer Leeds , Head of West Coast Search and Evaluation, NIBR Business Development & Licensing. We are also supporting the consortium’s preclinical safety and pharmacokinetics workstreams.

Virus 52
article thumbnail

Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

Agency IQ

The guidance “is intended to inform prospective and current applicants of the nature and type of information that applicants should provide in support of manufacturing changes to licensed biosimilars and licensed interchangeable biosimilars in different reporting categories.” Back to the questions: Q2, reference materials.

article thumbnail

United Therapeutics Corporation Reports Third Quarter 2020 Financial Results

The Pharma Data

See definition of non-GAAP earnings, a non-GAAP financial measure, and a reconciliation of net income to non-GAAP earnings below. License-related fees (5). License-related fees (5). . 1. %.

FDA 40
article thumbnail

Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

Agency IQ

Another guidance will focus on pharmacokinetics in pregnancy, likely replacing a 2004 guidance document that the FDA never finalized, while a guidance the creation of a “REMS Logic Model” framework is meant to “link program design with assessment” – something called for in the most recent PDUFA VII commitment letter.

article thumbnail

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

CDRH FY2024 Guidance Agenda Device software Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers CDRH Final By 10/1/24 Priority B List CDRH FY2024 Guidance Agenda Post-approval reporting 3D Printing Medical Devices at the Point of Care CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority B List.

FDA 40