Translating Radiolabeled Biologics – Strategies for Successful IND Submission

Presenters: Vince Carroll, Ph.D. | Senior Director of Radiochemistry, Invicro

Ohad Ilovich, Ph.D. | Senior Director of Translational Research, Invicro

Novel radiolabeled biologics from full antibodies to small engineered protein binders are increasingly used as SPECT and PET tools to investigate different molecular pathologies. In order to enable a successful Investigational New Drug (IND) submission, several important non-clinical experiments, including dosimetry and toxicology must be collected. Also, a radiolabeling strategy that will allow for producing a clinical-grade tracer must be developed. In this talk, we will discuss several successful pathways for IND submission.

During this webinar, presenters will review:

  1. What non-clinical data should be submitted in an IND for a novel radiolabeled biologic
  2. The use of biologically relevant animal models
  3. Radiochemical strategies for GMP manufacturing of clinical doses
Recorded Date: Monday, October 12
8:00am EDT

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Vince C

VINCE CARROLL, PH.D.

Senior Director of Radiochemistry, Invicro

Dr. Carroll brings significant experience to Invicro in PET and SPECT diagnostic tool development, from synthetic discovery through early phase preclinical work and into clinical application. During his time at Invicro, he has led over 20 successful IND submissions, ranging from small-to-large biomolecules for various neuro and oncology applications. In his current role, he oversees preclinical translation efforts in support of First-in-Human studies and the GMP manufacturing and quality control of FDA approved radiotracers supporting early phase clinical trials.

ohad2

OHAD ILOVICH, PH.D.

Senior Director, Translational Research, Invicro

Dr. Ilovich leads the Scientific and Medical Science department's oncology and systemic disease effort. In this role, he oversees the scientific aspects of development and utilization of imaging biomarkers first-in-human and late phase clinical studies. He is an expert in the development and evaluation of novel radiolabeled agents for both imaging and targeted radiotherapeutics with a focus on oncology and immuno-oncology.