PBPK modeling solutions as a potential risk mitigation strategy for pH dependent DDIs

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Parexel Insights

On the precipice of an impending avalanche of regulatory compliance activity: Are you prepared?

03.15.21 - 5 min - The COVID-19 pandemic brought into sharp focus the vulnerabilities in supply chains for medical products and the importance of ensuring their integrity to provide patient access to critical products. This historical event has also engendered an unprecedented pace in developing, testing, and producing COVID-19 tests, treatments, and vaccines – and triggered extraordinary flexibility among regulatory authorities. However, this flexibility could have unintended consequences for medical product manufacturing and testing facilities.

Leveraging the draft FDA Guidance on PBPK for your drug development program

02.24.21 - 2 min - In October of 2020, the Food and Drug Administration (FDA) issued draft guidance for the pharmaceutical industry on The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls. The draft guidance offers several high-level workflows that include defining the objective of a PBPK model, model development including structure, assumptions and parameterization, model validation, and the critical step of application of the model to purpose. The guidance is only applicable for biopharmaceutics applications of orally administered drugs.

We need faster endpoints for targeted cancer drugs, and there is one

02.19.21 - 3 min - As a former regulator, Jorge shares his perspectives for the need of more faster endpoints to measure how targeted cancer drugs can benefit patients. He believes it can be created by combining two commonly used measures. Read more in this short blog.

Three ways to improve your chances that insurers will pay for a new CGT

02.18.21 - 4 min - When developing cell and gene therapies (CGTs), drug companies face significant hurdles. One of which is getting insurance companies to pay for these treatments that can potentially cure patients of debilitating diseases such as spinal muscular atrophy and retinal dystrophy but at a very high cost. In this blog, Ned outlines three steps that can help improve the chances of getting a new cell or gene therapy reimbursed by payers.

Getting the small steps right for our biotech customers to make an exponential difference in patients’ lives

01.13.21 - 4 min - Biotech companies are the driving force behind the industry’s R&D pipeline as they develop and launch increasingly complex treatments. With more than 80% of the assets in development managed by small and mid-sized biopharma companies, it is a thrilling time to be working in this field.

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