Is your early stage drug program “lost in translation?”

The failure rate from preclinical to clinical studies is high with only a third of drugs entering into human testing. There are several reasons for this high failure rate:

• Difficulty in identifying and advancing the most promising new drug candidates for further investigation
• Challenges in choosing the lab objectives for a chemical series that will achieve the target product profile (TPP)
• Inability to predict potential “show stopper” drug safety issues such as drug-drug interactions (DDIs)?

Here are our top blogs, webinars, and videos on how to navigate challenges in early-stage and translational drug development, from determining first-in-human dose to accelerating IND submission.

VIDEO:

Increase confidence in pre-IND decisions with Simcyp Discovery Simulator. Watch here

BLOG:

The safety of human participants in clinical trials, the intended patient population, and for the labeled indications at the point of introduction into the market is undoubtedly the paramount consideration of any drug hunting enterprise. Read more

BLOG:

Quantitative Systems Pharmacology (QSP) is a relatively new discipline with enormous potential to improve pharma R&D productivity and inform decision-making across the drug development process from early discovery to Phase 3. Read more

WHITEPAPER:

Knowing where to start is always a challenge, and selecting the initial dose of an investigational drug to be administered in the first clinical study in humans is no exception. “Where do I start?”: Strategies for selecting the first dose for human clinical trial. Read more

ON-DEMAND WEBINAR:

Speaking from first-hand experience across more than 50 marketing submissions, Certara's regulatory science experts demonstrate how you can improve and shorten your speed to drug submission with thorough planning. Watch here

CASE STUDY:

A global pharmaceutical company was looking for a simplified way to accelerate first-in-man (FIM) allometric scaling using Phoenix and pre-clinical PK data. Read more

Where is Certara this month?????

Conferences

• July 25,?Bio Connections Australia
• July 31-August 4, AAIC 2022 (Alzheimer Association International Conference)
• August 8-9, Fierce MedTech Summit
• August 12-13, CDIF China 2022 (Clinical Development and Innovation Forum)
• August 24-28,?38th ICPE Annual Conference

Webinars

• July 19,?Smarter Clinical Document Automation Now for your T&D Requirements Later, in partnership with TOPRA
• July 20 & August 17,?Summer Series: Introducing Simcyp? Discovery
• July 21,?What, Why and When of Postmarket Clinical Follow-up, in partnership with RAPS
• August 9,?Using Clinical Pharmacology & Pharmacometrics to Accelerate Cell Therapy Development: A Patient’s CAR-T Journey?
• August 24, Advantages of Engaging Ahead: How Partnership & Collaboration Enable eCTD Submission Publishing Success, in partnership with RAPS
• August 25,?Learn How to Streamline Your Drug Development Program’s Regulatory Writing

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About Certara

Certara?accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.

Corporate Headquarters: 100 Overlook Center, Suite 101, Princeton, NJ 08540 USA