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10 18 22 -- New Therapies Require New Development Approaches And Regulatory Interactions

10/18/22 Pharmaceutical Online Newsletter

Erin harrisAnixa biosciencesSarah howellAmit kumarDario neriScott cleveMurat kalayogluMatt pillarBioprocess online

What s True Of Mice ≠ What s True Of Men

As ATMPs advance, scientists are calling out the limited value of mouse models in pharmacological re-search and testing. LIfT Biosciences’.

United kingdomAlex blythMatthew pillarBioprocess online

Navigating A Clinical Hold

FDA-ordered clinical holds are on the rise, and biologics IND are driving them. Immunome CEO Purnanand Sarma, Ph.D. shares his take on the role of.

Purnanand sarmaMichael yeeMatthew pillarBioprocess onlineClinical biopharmaImmunome president

The Coming Wave Of Radio(bio)pharmaceuticals

Convergent Therapeutics is bullish on the combination of radioisotopes and antibodies to direct radiation directly to cancer cells. As enabling.

Philip kantoffPluvicto luAlex brownDepartment of energyDevelopment burgeonCardinal healthHarvard medical school professorMemorial sloan kettering cancer centerConvergent therapeuticsa brown university medicalDana farber cancer instituteMatthew pillarBioprocess onlineHarvard medical school professor emeritusConvergent therapeuticsconvergentNew product planningGlobal oncology

How To Evaluate Manage Safety Risks In Biopharma

Safety risks can be described and modelled as cause-and-effect relationships using system risk structures. This article structures risks beginning.

Markf witcherInternational organization for standardizationBayesian networksDanger risk structureUsing protectiveHandling antibody drugSystem risk structuresManaging risksBioprocess onlineRisk managementInternational organizationRating risk eventsWhy adjusted risk likelihoodShould replace risk priority numberProcess onlineHazard analysis techniques

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