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 session 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 and identify the essential PK/PD studies required to support toxicological segments.
Topics covered include:
• Drug development regulatory bodies
• IND sections
• Submission process
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Regulatory Affairs
• Quality Assurance
• Clinical Trial Personnel
• Project Management
• Regulatory Operations
• Medical and Technical writers
• Professionals preparing INDs and other submissions
• IT Professionals
Preclinical scientists, academics with clinical trial interests and those generally interested in drug development will benefit a lot from this session.
Matthew M. Seavey, PhD, MBA,
Matthew M. Seavey, PhD, MBA – Founder & President of BioPoint Consulting, LLC, holds over a decade of drug development experience. Originally trained as an immunologist and an expert in preclinical animal models, Matthew has been involved in the development of different drug modalities (biologics, small molecules, cellular therapeutics, vaccines) across multiple therapeutic areas including, GI, immuno-oncology, inflammatory and cardio-metabolic diseases. Matt has held former positions as drug discovery team leader at Cephalon and global pharmacology project leader at Teva Pharmaceuticals. Matthew is a co-inventor on several patents and has contributed to the intellectual property base of Advaxis and the founding of Oncoceutics. Most recently, he served as program director at United Therapeutics where he was responsible for oversight of clinical oncology activities.
Review of Chemistry, Manufacturing and Controls (CMC) of an Investigational New Drug Application (IND)
LIVE : Scheduled on
26-February-2020 :02:00 PM EST
LIVE : Scheduled on
31-March-2020 :01:00 PM EST