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This course will describe the various pharmacodynamic (PD), pharmacokinetic (PK) and toxicology studies that are required for an investigational drug application (IND) to the food and drug administration (FDA).  It will cover key concepts for the development of small and large molecules, with an emphasis on the 505(b)(1) regulatory submission route for new chemical entities (NCE) and new biological entities (NBE).


Bringing a new therapy to market is costly and evolving market pressures are changing the focus of the drug development industry.  With an average investment of $2.6 billion dollars and sometimes more than a decade in development, rarely is the path from discovery to the patient a straight line.  Multiple unexpected challenges arise, from regulatory hurdles to new safety concerns. Given these increasing pressures, understanding how and when to plan a preclinical IND-enabling program is an integral part of meeting specific milestones necessary for a timely and efficient IND submission.  This seminar will review the path from lead candidate selection to IND preparation and the necessary studies required for a successful submission.


After this seminar you should be able to identify:

  • The types of regulatory submissions required to conduct human trials in the US

  • The studies required to submit an IND

  • The various safety studies required for different phases of clinical development

  • Identify the essential PK/PD studies required to support toxicological segments

  • Understand how to pick a phase 1 starting dose based on NOAEL and PAD

  • ADME/PK, safety and CMC requirements to submit an IND


 

  • US Regulatory process for submission of an IND

  • Common regulatory agencies – US, EU, Japan, Australia

  • IND-submission process

  • Drug discovery, candidate selection, pharmacology

  • Safety pharm and toxicology

  • DMPK and ADME

  • Clinical Pharmacology

  • CMC


This seminar is intended for preclinical scientists, academics with clinical trial interests and those generally interested in drug development.  Key industries: Pharmaceutical, Biopharma, biotech, drug development, device, drug delivery, venture capital groups, regulatory, clinical, CRO, CDMOs


Matthew Seavey has over a decade of drug development experience in small to large pharmaceutical companies, biotech and start-ups.  He has lead discovery programs from bench to IND filing and has managed assets from clinical development to product launch. Matthew is the founder and president of BioPoint Consulting, LLC, where he continues to serve clients passionate about science and interested in changing the future of healthcare by addressing unmet medical needs with novel therapeutic strategies. 

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