The Drug Development Process from Concept to Market

This oncology clinical trial management training course provides an understanding of the interrelated activities throughout the drug development cycle and is designed for R&D, operations, and/or marketing and sales management. The course is often customized to address specific organizational, departmental or functional issues.

Upon completion, participants will:

• Understand the regulatory definition and classification of drugs, biologics and vaccines
• Describe the drug discovery process and early development decision points
• Explain pre-clinical study requirements and how they support IND submissions
• Distinguish the objectives, structure and challenges of phases one to four clinical studies
• Interpret core Good Clinical practice (GCP) principles and the role of IRBs/IECs
• Recognize the components and regulatory structure of NDA, BLA and MAA submissions
• Understand post-approval obligations, including safety compliance and commercialization considerations

• Identify the impact of GMP controls, scale-up and process validation in commercial manufacture

Welcome

• Introductions
• Course Objectives
• Agenda Review

Section 1 - Drug Discovery

• Regulatory Definition of a “drug/biologic/vaccine”
• Regulations for DDP
• Types of medications and how they are produced
• Approaches to discovery
• Patents and Exclusivity
• Intro to the Project Team
• Exercise # 1 Drug Discovery

Section 2 - Drug Development

• Challenges in drug development
• Drug Development life cycle
• Industry Perspective
• Non-Clinical Studies

1. GLP
2. Animal Models
3. Biomarkers
4. Required Pre-Clinical Studies

• Clinical Studies

1. The CDP/IND/CTA/DSUR
2. Phase I – IV
3. Adaptive Clinical Trials
4. Exceptions in Development

• Group Exercise: Case Studies
• Exercise # 2 Drug Development

Section 3 - Good Clinical Practices

• Purpose and Principles
• The IRB and IEC
• Exercise # 3 GCP

Section 4 - Components of a Clinical Study

• Regulatory Requirements

1. History, Regulations (U.S./EU)

• Key Players

1. Roles and Responsibilities

• Documentation

1. DMF and TMF

• Monitoring

1. Traditional and Risk Based

• Data Processing
• Exercise # 4 Clinical Study

Section 5 - The NDA/BLA/MAA

• Definition and Contents
• Process

1. Fees, Submission, Review and Approval

• Abbreviated NDA/MAA
• Exercise # 5 NDA/CTD

Section 6 - Post Approval

• Sales Training
• Role of Marketing
• Using Investigator IND Data
• Promotional Advertising
• Post Marketing Safety Compliance
• Line Extension and Rx to OTC
• Generics
• Exercise # 6 Post Approval

Section 7 - GMP

• Impact
• Commercial Manufacture
• GMP Controls
• Scale-up Issues
• Process Validation
• Exercise # 7 GMP

Section 8 - DDP Workshop

• Break into working groups
• Work on Case Study
• Present findings

Course Review and Wrap-up

• Final Q&A

"Great course, I will be returning for Certification."

Amanda G., Quality Control Analyst, Wright Medical

"This truly focused on the topic at hand and was a great, high-level overview of what I was hoping to get out of the course.  I really enjoyed the detailed course material to follow along and the extensive experience of the Course Director, he was great!"

Joanne B., Carmot Therapeutics, Manager, CMC Program Management

"The best course I have ever attended as it was exactly what I needed to know. I really enjoyed the course structure and the real life examples."

Elena S., Principal Research Assoc., Moderna Therapeutics

"Top notch! Course content was relevant, up-to-date, given with context to applications and examples of case studies. Very valuable information learned. Examples and anecdotal stories were peppered in to give the information context."

Leanna Y., Associate Scientist, Centre for Drug Research and Development (CDRD)

"I was very involved in this course. The course director was very patient in delivery and made sure that everybody understood the topic before moving on."

Fahimeh S., Associate Scientist, Centre for Drug Research and Development (CDRD)

"The course director made this training so enjoyable and easy to follow with his expertise and well-organized course material. The workshop exercises helped us put the material and ideas together. Thank you for a great workshop!"

Catrina, K., Senior Research Tech, Centre for Drug Research and Development (CDRD)

"This course was very well organized and the interactive workshops were very helpful. The instructor actually cared that we learned."

Adam F., Associate Scientist, Flexion Therapeutics

"I would highly recommend this course to anyone wanting an overview of the drug development process. It will serve me well in my new position. I enjoyed the friendly atmosphere of this course which has not been my experience with training providers. This was a great course!"

Erin B., Project Management, Tetra Bio-Pharma

"This course compared much more favorably than courses with other training companies. I thought the material was presented in a good, straightforward manner. I liked the organization of topics, it made it very easy to follow along and understand."

Hayley F., Senior Scientist, Janssen

"The class size was very beneficial as it allowed more peer and instructor interaction. I enjoyed learning the regulatory requirements in a more detailed, applicable capacity. The content was applicable to my job and assisting my clients."

Ashley D., Finished Product Testing Group Leader, Eurofins/Lancaster Laboratories

"Good level of engagement between the instructor and the attendees. The material covered was the right level of depth. We didn’t waste time with industry basics and dove into the next couple of layers of detail which is what I was looking for. I liked the reviews at the end of each chapter as it helped test/reinforce the concepts."

Kara K., Transactions Lead, Shire

"Phenomenal instructor! Very Knowledgeable."

David M., Project Manager, Biomarin

"First regulatory course, very well done! The course director used great anecdotes and personal experience that made the material more relatable."

Charles C., Research Scientist, Tetra Bio-Pharma

"It was a highly interactive course. I learned a lot, especially in terms of understanding the clinical development procedure."

Vinit K., Senior Investigator, Bristol-Myers Squibb

"The Course Director is a very inspiring instructor, with a lot of interesting examples from real life, which really gives an extra dimension to the course."

Helle C., Project Coordinator, H. Lundbeck A/S

"The course director was really good at communicating and pacing the training sessions. Even though I did not have any pharma or medical background, I could still easily and comfortably follow the course material."

Siew L., Project Information Coordinator, H. Lundbeck A/S

"The Course Director was a very engaging and knowledgeable instructor! I would highly recommend his course on the Drug Development process to others who wish to gain a good understanding of the main concepts for Clinical Trials and Drug Development. I thought the workshop was a great exercise where we were able to combine everything we learned and put it into comprehensive use."

Bianca F., Project Coordinator, BioMarin Pharmaceutical

"This was the first training program I attended; I thought the Course Director did a great job. He was very informative on multiple subject matters. He made it easy to pull the big picture together."

Megan, Project Coordinator, US WorldMeds

"Excellent job covering various aspects of clinical operations and complexities involved. In general, several of my colleagues commented that this is an excellent training in understanding the overall drug development and involvement of various functions."

Ravi R., Director, Forest Labs

"Very much enjoyed the course. It was simple, clear, direct knowledge. OVERALL – it was very refreshing to have a course that was not "soft" on knowledge. I have questions I am going back to my team with!"

Sharon B., Global Project Manager, UCB

"Very useful. Helped to fill in the gaps of my previous knowledge."

Timothy T., Sr. Research Scientist, Forest Labs

"The Course Instructor was extremely knowledgeable. He made what could be dry course material very engaging and interesting. The course was the right length and the exercise was effective at enforcing the course learnings."

James H., Senior Project Manager, Integrated Project Management

"The course was fantastic! The course director shared his vast experience with us and illustrated many topics with real life examples. Thank you!"

Pia P., Project Coordinator, Merck Serono

"This course should be mandatory for all professionals who wish to gain a comprehensive understanding of the Pharmaceutical Industry!"

Dr. Asher H., Associate Medical Director, Sanofi-Synthelabo

"This is a wonderful course. I always work in a lab and see only a small part of the whole process of drug development. Now I know my "position" in the whole picture. It makes work more meaningful and enjoyable."

Fong Z., Senior Scientist, Shire Labs

"This is a very good course that allows one to fully understand the drug development process. ANYONE who works for a pharmaceutical company should attend this course. The knowledge that I gained during this course will help me to assist not only my boss, the president of the company, but also other staff members in the company."

Hiromi G., Executive Assistant, Kyowa Pharmaceutical, Inc.

"I will be going back to my organization and recommending that we have this course delivered in-house for the benefit of a wide number of our associates. The Course Director was very knowledgeable and his ability to communicate his expertise in GCPs would complement our clinical efforts. The GMP aspects of drug development will give us a better appreciation of the "big picture" and how one's work fits into the overall process leading up to the approval of the NDA."

Ruth M., Assistant Director Pharmaceutical Analysis, Shire Labs.

"I think this course is extremely useful. It provides a good overview of the drug development process, which is very helpful for me to look at in a big picture. The Course Director is very knowledgeable and answered all the questions being asked. I look forward to more courses presented by CfPIE."

Wu Y., Sr. Scientist, Allergan

"A very comprehensive overview of the Drug Development Process, and was particularly strong regarding the IND and NDA process."

Richard E., Manager, Compliance & Training, Sanofi Pasteur