DGE's Basic Drug Development training is convening on May 22-23 in Philadelphia, PA with the focus being to provide attendees with strategies and skills in FDA structure and organization, history of regulations and current framework within the US for development of drugs, biologics, medical devices, dietary supplements, and medical foods.
The following objective-driven sessions are for industry professionals wanting to expand their knowledge and enhance their skills in: >
FDA Scope & Organization: Understand the fundamental and challenges of the FDA regulations and how to achieve their mission and meet their priorities.
History of US Regulation: You may feel like there are massive requirements to get a product developed and approved. Come explore the interesting historical events leading to your current regulatory framework and the available pathways to drug approval.
Special Programs to Consider: To add the complexity of possibilities for development of drugs, there are several special programs available that you may want to consider for your product.
Wednesday, May 22nd, 2019 | Day 1
8:00 AM - 8:30 AM
Registration and Breakfast
8:30 AM - 8:45 AM
8:45 AM - 10:45 AM
FDA Scope & Organization
The scope of the FDA’s regulatory authority is very broad. With less than 8,000 employees, FDA regulates approximately 60% of the GDP in the US, including food, drugs, cosmetics, and veterinary products. Learn the full extent and impact of their activities on your life personally and professionally, and how they organize to do so much with so few.
- FDA’s mission in its regulation
- FDA’s top priorities for regulation
- How they organize to achieve their mission & meet their priorities
10:45 AM - 11:15 AM
11:15 PM - 12:15 PM
History of US Regulation
You may feel like there are massive requirements to get a product developed & approved. A system so complex and intricate that you may never learn to success fully navigate it. However, while there are complexities, it is navigable and understandable. This session will explore the interesting historical events leading to our current regulatory framework and the currently available pathways to drug approval.
- Learn the submissions required for study and approval for your drug, device, biologic, medical food, or dietary supplement
- Learn the format required for your submissions in an effort to give patients
- Overview of devices regulation for IDE/510(k)/PMA
- Address biologics and biosimilars including IND/BLA
- Touch on dietary supplements and medical foods
12:15 PM - 1:15 PM
1:15 PM - 2:15 PM
History of US Regulation (Continued)
2:15 PM - 3:15 PM
Special Programs to Consider
To add the complexity of possibilities for development of drugs, there are several special programs available that you may want to consider for your product. These special programs can provide any various advantages for your product, such as faster time to market, fewer studies, more FDA interaction and guidance, and cast-savings.
This session will go in depth on the advantages & qualifying requirements for the following:
- Orphan drugs
- Breakthrough therapy designation
- Parallel review
- Fast Track
- RX to OTC switch
- Pediatric development
- Patient’s Right to Try
- Appreciate the history of how we got to where we are today
- Practical Application Exercise: Map out considerations for your product and its requirements
- Practical App Ex.: Test your knowledge on the requirements of special programs to see if your products fits
- Discussion: What creative strategies can you employ to advance your products
3:15 PM - 3:30 PM
3:30 PM - 4:30 PM
Special Programs to Consider (Continued)
Thursday, May 23rd, 2019 | Day 2
8:00 AM - 9:00 AM
9:00 AM - 9:15 AM
Recap of Day One Sessions
9:15 AM - 10:45 AM
Meetings with the FDA
To assist in navigating the intricate web of regulations and requirements, the FDA offer several key points of interaction during the development process.
- Learn what meetings are possible for your products during your development life cycle and what you should aim to get out of them.
- Learn how to take advantage of these meetings from scheduling to planning and conducting the meeting to gain full understanding and actionable output.
- Review case studies of successful negotiation and communication during meetings.
- See lessons learned from less successful meetings and how to manage that during the meeting and recover after the meeting.
10:45 AM - 11:15 AM
11:15 AM - 1:15 PM
Beginning with the End Target in Mind
The largest goal of every development program is to help patients and enhance their lives. However, that cannot be accomplished philanthropically, so you have to consider what you need to have at the end of the day in order to make money. So how do you ensure that you will hit the target!
- What is a Target Product Profile (TPP) and how do you create it.
- One step beyond the TPP – the claims needed to resonate with customers.
- Materializing the development plan from your targets.
- Practical Application Exercise: Turn a TPP into a Development Program.