Completing nonclinical studies to support FDA investigational new drug applications is an essential milestone for progressing a new drug into the clinic. Conducting studies according to relevant regulatory requirements, such as good laboratory practices, and guidelines from the FDA and the International Council for Harmonisation is essential for ensuring acceptance by the FDA and that IND-opening clinical trials can proceed without a clinical hold.
For outsourced animal studies, it is tempting to rely solely upon the nonclinical laboratory for study design, conduct, and reporting. However, these laboratories and their study directors have many competing pressures, and it’s important for sponsors to provide appropriate oversight of their studies to verify that they are receiving adequate attention.
Also, IND-enabling studies require significant input on design, conduct, and reporting from the sponsor. It is important to confirm that a lab has appropriate processes and controls in place to conduct studies that meet the applicable regulatory requirements or, if not, to provide even greater input and oversight than might otherwise be required. Although the scientific results are dependent upon the drug, this webinar will provide practical guidance for designing, contracting, monitoring, and reporting nonclinical/toxicology studies to ensure regulatory acceptance by the FDA.
Register for this webinar to find out how to best prepare for conducting and managing IND-enabling nonclinical studies and meeting FDA guidelines.
William Salminen, PhD, DABT, PMP, Vice President, Nonclinical Safety and Toxicology, Premier Consulting
William Salminen is board certified in toxicology and project management and has over 20 years of drug development experience for an array of drug products and indications. He oversees the Nonclinical/Toxicology and Clinical Pharmacology/Pharmacokinetic groups within Premier Consulting, which provide clients with nonclinical safety, toxicology, clinical pharmacology and pharmacokinetic support for drug product development, such as nonclinical and clinical pharmacology strategies, study requirements and designs, pharmacokinetic modeling, input on regulatory submissions and addressing nonclinical and clinical issues (e.g., Clinical Holds) with regulatory authorities (e.g., US FDA).
William’s key experience includes but is not limited to regulatory strategy and advice, nonclinical safety and toxicology strategy and advice, US FDA pre-IND meetings, IND applications and maintenance and NDA and BLA submissions. He has significant experience with 505(b)(2) NDAs and the unique regulatory, nonclinical and clinical strategies involved with developing drugs under the 505(b)(2) pathway.
Andrew Emanuel, Senior Director, Nonclinical Development, Premier Partners
Andrew Emanuel has spent nearly 25 years working in various aspects of nonclinical development. A toxicologist working within the Premier Partners, Andrew supports the client in all aspects of their nonclinical program, with a focus on operational tasks. Having worked in CROs, Industry and for the last 8 years within the Premier Partners, Andrew has experience in all aspects of nonclinical drug development.
Open and direct communication with Sponsors ensures a complete understanding the drug and its intended clinical indication, which allows a bespoke nonclinical program to be designed. The management of this program is not only limited to the study plan preparation and day-to-day oversight of the studies during their in-life phase, but also review of data and study reports, thereby ensuring robust data to support the Clients development plan.
Andrew has acted as the nonclinical subject matter expert in numerous regulatory submissions from IND to NDA/BLA, not only through 505(b)(1)/(2) but also under the Animal Rule (601 (H)).
Who Should Attend?
Senior professionals from Pharma, Biotech and Medtech companies involved in:
- Clinical Trials
- Clinical Operations
- Drug Development
- Preclinical Trials
- Project Management
- Regulatory Affairs
What You Will Learn
Attendees will gain insights into:
- Critical aspects of nonclinical laboratory qualification
- Obtaining comparable laboratory quotes
- Logistics of study startup through reporting
- Monitoring best practices
- Ensuring GLP compliance and regulatory acceptance by the FDA
Premier Consulting is a strategic product development and global regulatory consulting company dedicated to helping biotech innovators transform their life-changing ideas and breakthrough science into new medical treatments. Our end-to-end solutions in strategy, regulatory, nonclinical, CMC, quality, and commercial help sponsors build and execute development plans that meet regulatory requirements and deliver results for sponsors and the patients they serve.