Spring Intro 2023

06/03/2023

Drug Development has broadly the same focus as small molecules

Commercial Operations and Sales

Preclinical Studies

Lead Optimization of Drug Candidates

Clinical Trials

MAAfi ling

Discovery Research

FDA/ EMA review

Product Launch!

CTA filing

Bio/Chemical Process Development

Scale-Up / Manufacturing

Phase IIIB/IV Trials

Discovery Research Preclinical Studies Clinical Development and Regulatory Affairs

Many compounds

7  1-2

1 in 10

About 15 years and > $1B!

But there are important differences to consider

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Overview

• What is a biotechnology product

• Key regulatory aspects to consider ● Manufacturing and Quality ● Non clinical Safety ● Clinical Efficacy and Safety

• Filing Biotechnology Products

• Advanced Therapy Medicinal Products

• Hot Topics and Conclusions

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