2nd CNE Seminar, Technologiepark Basel, Switzerland, 6th of March 2018
Dr. Alberto Lodola:
”Nonclinical development of combination drugs”
The development of drugs for monotherapy is to date the most common approach to drug development. Increasingly the benefits of combination drug therapy (two or more chemical entities combined in one pill) are being exploited. The nonclinical development of combination drugs poses the challenge of characterizing the potential risk of a chemical mixture.
We will review the nonclinical issues arising from the development of combination drugs and how understanding of the regulatory climate allows cost and time effective nonclinical strategies to be deployed to address these issues. Combination drug development is in part defined by the therapeutic indication and whether the combination is of new chemical entities and/or legacy drugs. The impact of these different combination types on the nonclinical strategy adopted will be discussed.
Dr. Alberto Lodola:
“Repurposing of Drugs, from a Nonclinical Development Perspective”
Legacy drugs are potential a rich source of new drugs for new indications. Repurposing legacy drugs can be a simple and straight forward process or can involve significant nonclinical work. The danger in such projects is that through an excess of caution unnecessary nonclinical studies are undertaken. This is not only costly but also time consuming.
We will review the (nonclinical) regulatory environment and toxicological issues which underpin nonclinical strategy development and risk management involved in repurposing drugs. The legacy drugs discussed will be recently developed drugs, drugs with a long history of clinical use and drugs which have been abandoned because of unacceptable human toxicity. The impact of these different legacy drug types on the nonclinical strategy adopted will be discussed with a focus on time and cost-effective approaches.
The presentations will be detailed but high level and are aimed at a general drug development audience.
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