Drug Discovery: The Path from Development to Marketing Approval

This course will introduce the concept of translational approach in clinical research and examine its application. An overview of state-of-the-art translational technologies will be provided. Topics will include review of molecular and pathophysiological aspects of several diseases, and the exploration basis for drug design, pre-clinical,and clinical testing. Additional topics will include clinical evaluation, regulatory approval of biological drugs, and frontiers in translational research. We will review requirements for transitions from the pre-clinical phase of drug development to the clinical trial process and subsequently to marketing of a new drug. In addition, the phases of clinical drug development that are part of the InvestigationalNew Drug (IND) application will be discussed. The New Drug Application (NDA) pre-market application process and regulatory requirements will then be reviewed with insight into possible post-NDA activities that may be required.

• Apply an in-depth understanding about pre-clinical research and the steps necessary for transition to clinical phases of the drug development process
• Identify translational approach in clinical researchDescribe current considerations in reporting adverse events in clinical trials: timing, terminology, consent, blinding, device-related versus procedural complication, and follow-up
• Describe the concept of molecular targeted therapeutics
• Identify the information required in an IND and IND amendments, NDA, or a Biologic License Application (BLA)
• Describe how to write an Inestigational NDA

• Investigators involved in pre-clinical and clinical phases of drug development
• Site Study Team Members
• Clinical Research Associates
• Regulatory Affairs Associates
• Project Managers
• New Industry Professionals with a need to understand the drug development process

The course will be led by one of the following instructors:

Marina Malikova, Ph.D., M.S., M.A., C.C.R.A.

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Day 1: 8:30 a.m. – 5:00 p.m.

• An Overview of Modern Drug Discovery and Development Research: Drug discovery, pre-clinical,and clinical research development; translational approach; new frontiers; economics of drug development process 
• Pharmacogenetics and Pharmacogenomics Types of High Throughput (HTP) Assays: DNA/RNA-based technologies in pre-clinical research;
  biochemical assays, binding assays, ELISA, fluorescence polarization, FRET; protein-based technologies
• Small Drug Molecules: Chemical compound libraries, natural and combination products; physicochemical properties of drug molecules
• Large Drug Molecules and Protein-Based Therapies (Vaccines, Gene Therapy, Growth Factor, etc.): Disease pathophysiology; treatment; mechanism
  of action; and methods of drug discovery and development
• Drug/Discovery — Targets and Receptors: Target identification and validation; review process of drug interactions with targets or receptors; types of receptors
• Pre-Clinical Studies in Drug Development: In vitro functional assays; animal models

Day 2: 8:30 a.m. – 5:00 p.m.

• Overview of Main Pharmacology and Toxicology Parameters as Applicable to Drug Development: Pharmacodynamics, pharmacokinetic, toxicology, and
  formulation of drug delivery systems
• Overview of GLPs, GMPs, and QSRs at Pre-Clinical Stages
• Clinical Trial Regulatory Requirements for Drugs and Biologics: Transition from pre-clinical phase of drug development to clinical phases; types of clinical trials; procedures/requirements for applications to regulatory authorities
• Investigational New Drug Application: Investigational New Drug (IND) content and application process Good Clinical Practice (GCP) Regulations
• Transition from Clinical Research to Clinical Practice: Requirements for a New Drug Application (NDA) and Biologic License Application (BLA)
• Post Approval (Phase IV Clinical) Responsibilities of the Sponsor: Requirements for safety and efficacy reporting post-FDA approval; advertisement and labeling change

• Drug Development Process
• Review of Form FDA 1571 for an IND application
• Review of FDA Form 1572, Statement of Investigator for conducting a clinical trial
• Review of Form FDA 356h for an NDA application

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.

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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE# 0778-0000-15-036-L01-P. Released 5/15.

Hold this course at your company!

For more information, contact Naila Ganatra at (215) 413-2471.