Lead Optimization Services and Deliverables

Successful lead optimization in drug discovery and safety requires knowledgeable and collaborative scientists at a CRO that regularly invests in technology. In order to give your small or large molecule the best chance to turn into a preclinical candidate, a rigorous approach to translational study design and risk mitigation is required.

In addition to optimizing the lead compound’s safety profile, researchers must develop a clear understanding of the mode of action, nature of the target, and establish the biological relevance of the animal species used in pharmacological studies, as well as explore potential differences between animal models and humans.

Services we offer for lead selection and optimization include:

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Lead Identification and Optimization

We offer a comprehensive suite of drug discovery services, and our lead optimization scientists work collaboratively with our target ID, hit identification, and hit-to-lead teams to offer a seamless solution for our clients.

 

Below is a partial list of guided lead optimization studies:

digital

Webinar: Aligning Program Design to Your Target Product Profile
In this webinar, our experts will show you how to align program design with your Target Product Profile (TPP) to support your early discovery efforts. Achieve your ultimate therapeutic goals, save time, reduce risk, and improve your chances of success.
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Lead Optimization Non-GLP Toxicology Studies

This phase of drug development requires speed, consistency, and dependability to move compounds forward. As you near the end of the discovery phase, you can conduct exploratory toxicology studies to get exposure and safety data earlier, potentially saving you months in development time.

Exploratory and Expedited Toxicology Studies: What Does Saving Time Mean to You?
Making reliable go, no-go decisions are critical when developing new drugs and therapies and doing that within rapid timeframes may prove to be as critical. Our scientific experts have deep knowledge with all molecule types to provide toxicology data fast for IND decision making.

Thinking with the future in mind and preparing your drug development programs accordingly, digital options have to be part of that strategy. Artificial intelligence options for histopathology and digital pathology evaluations accompany the toxicology data. With the exploratory toxicology data paired with automation, this can both aid in decision making and reduce development time by months.

With this program, developers will receive a comprehensive assessment of pathologic changes is integral to preclinical and clinical studies for determining safety, efficacy, and mechanism of action for novel therapeutic agents.

Study Outlines and What to Expect
The following specialty groups provide rapid study starts, complete with the evaluations listed below to provide drug developers with data to make critical go/no-go decisions.

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Path to Preclinical Candidate and Clinical Candidate Success

With years of laboratory experience, scientific expertise through publications and patents, and a proven track record conducting lead optimization programs, partnering with us can give your program a leg up on the competition. Having already worked on 85% of drugs currently on the market, find out how we can turn your small and large molecules into preclinical candidates and, eventually, therapeutics.

10 Regulatory Truths for Biotech Founders
Do not leave your breakthrough to a chance; download this complimentary infographic as a concise checklist to help you stay on track and reach your milestones.
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Frequently Asked Questions (FAQs) About Lead Optimization

  • What are lead optimization non-GLP toxicology studies?

    These exploratory in vivo toxicology studies can be conducted in the discovery phase or in preparation for the preclinical phase of drug development. These studies are conducted for small molecules, large molecules, and cell and gene therapies. These studies are accompanied with dose formulation strategies, comprehensive i-life data options to evaluate toxicity, targeted functional assessments of key organs (e.g., heart, brain), bioanalysis (from multiple source media), and digital pathology to ensure complete data sets for key decision making.

  • Why conduct lead optimization toxicology studies?

    These lead optimization toxicology studies provide a preliminary view in the safety assessment endpoints to identify any potential unforeseen risks that may occur. Finding these risks prior to conducting the IND-enabling program will save time in the long run. IND-enabling programs can cost more than $500,000, so identifying and/or de-risking your program to avoid potential setbacks conducting the IND-enabling GLP studies will save you time and money to market.

  • What is GLP versus non-GLP acute toxicology testing?

    Good Laboratory Practice (GLP) regulations outline study conduct and documentation practices to ensure that studies can be reconstructed and repeated in a reliable fashion. The purpose of the regulations is not to provide data interpretation guidance nor dictate the safety characteristics of the test article/item. Non-GLP studies are conducted under high quality following SOPs, utilizing trained staff, in an accredited facility. The standard quality metrics are evaluated in a non-GLP lab (e.g., protocol and SOP deviations) and staff training is focused on the standard study designs, test systems, and skill sets.

  • What is lead identification and lead optimization?

    Lead identification and optimization is the process of discovering a small molecule or large molecule lead compound and progressing it towards a safe and efficacious drug therapy and successful commercialization into the market.

  • How is lead optimization done?

    Lead optimization services are selected based on individual drug discovery and development projects but commonly include medicinal chemistry, artificial-intelligence (AI) based optimization, predictive modeling using computer aided drug design (CADD), absorption, distribution, metabolism, and excretion (ADME)/drug metabolism and pharmacokinetics (DMPK) studies, mechanism of action (MoA) research, and formulation studies.

  • How long does lead optimization take?

    Individual drug discovery and development projects vary, however lead optimization in drug discovery takes an average of 18 months. To receive cost and timeline estimates for your project, see our Lead Optimization in Drug Discovery Planning Guide or contact us for a scientific consultation.