Preclinical Development of Drugs with Special Emphasis on Biologicals

Why Should You Attend:

To successfully develop a therapeutic drug one needs to understand, in addition to the choice of target and indication and the segment of patients to treat. One needs to understand what the drug does to the patient (toxicological) and what the patient would do to the drug (metabolism and clearance). Preclinical development, utilizing relevant animal models, attempts to clear the later points.

In this webinar, we will discuss strategies needed to successfully develop a drug followed by a brief discussion of the stages of drug development and the functional groups associated with each of the three stages. We will demonstrate that preclinical development is a stage that spans the entire drug development phase.

Preclinical development activities start at discovery to help candidate selection, determining the safety of the drug and determining the therapeutic doses as well as calculates the first in human dose. Preclinical and nonclinical activities do not end when the drug enters clinical studies but continues until marketing or even after that.

Areas Covered in the Webinar:

• Strategy of drug development
• Stages of drug development and the functional groups associated with each stage
• Activities associated with preclinical development include
• Toxicological studies
• These comprise of many different studies, such as general toxicity, reproductive toxicity, carcinogenicity and others
• Pharmacokinetic and pharmacodynamic activity
• Determine metabolism and excretion of the drug
• Determine therapeutic dose
• Determine first in human dose
• Pre-IND Meeting with regulators
• Submitting an IND application

Who Will Benefit:

• Preclinical development scientists such as Bioanalytical scientist and toxicologists
• Research and development scientists developing drugs
• Manufacturing scientists

From industries including biotech and pharmaceuticals

Free Materials:

• Reference documents
• Rule documents or guidance
• Checklist
• SOP template
• Easy fill in forms
• Articles

Michel Awwad
Preclinical Development, Indivisual

Scientist with more than 20 years of experience in small biotechnology and large pharmaceutical companies. Developed protein-based (peptides, mAb, ADC, bispecific antibodies), small molecules and liposomal products. Carried these products from inception through preclinical development into early clinical development. Developed products for the treatment and diagnosis of cancer, for the treatment of immunological diseases, including those that can facilitate transplantation of solid organs, and for neurological dieses (Alzheimer’s). Directed the safety as well as bioanalytical studies (PK and Immunogenicity) of many of the products in the preclinical setting. wrote Preclinical sections of regulatory submissions.

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