Basic Drug Development Training 101

A DGE Professional Boot Camp
Register Now View Agenda

May 22-23, 2019 | Philadelphia, PA

The Inn at Penn, a Hilton Hotel

Course Overview

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.

EVENT VENUE

The Inn at Penn, a Hilton Hotel

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3600 Sansom St.
Philadelphia, PA  19104

(215) 222-0200
Hotel Website

Special Event Rate
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THREE DAYS OF EDUCATION AND FUN

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FEATURING

Speakers & Faculty

Lance Black MD

Lance Black MD

Med Device Innovation Lead
Texas Medical Center

Jon Speer

Jon Speer

Founder & VP
Greenlight.guru

Jason Spencer

Jason Spencer

Market Dev
Henkel

MB Privitera

MB Privitera

Principal
HS Design

Joe Hage

Joe Hage

Your Host
10x

Sarah Wright

Sarah Wright

Director
ResMed

Michael Drues

Michael Drues

Regulatory Strategy Consultant
Vascular Sciences

Tor Alden

Tor Alden

Principal
HS Design

Anne Leijsen

Anne Leijsen

Head of Medical Writing
Factory CRO

Bob Marshall

Bob Marshall

Chief Editor
Med Device Online

Doug Fankell

Doug Fankell

Engineer
Structural Integrity Associates

Hitesh Mehta

Hitesh Mehta

Engineer
Integer (formerly Greatbatch)

Bobby Boyer

Bobby Boyer

Director, Product Dev.
HS Design

Srihari Yamanoor

Srihari Yamanoor

R&D Engineer III
Stellartech Research

Christine Zomorodian

Christine Zomorodian

Principal Consultant
Gish Consulting

Arlen Ward

Arlen Ward

Modeling & Simulation Principal
System Insight Engineering

Scott Phillips

Scott Phillips

President
StarFish Medical

Martin Coe

Martin Coe

Systems Engineering Professional
Medical Devices, CSEP

Walt Maclay

Walt Maclay

President
Voler Systems

 

Download the Full Agenda

Wednesday, May 22nd, 2019 | Day 1

 

8:00 AM - 8:30 AM

Registration and Breakfast

8:30 AM - 8:45 AM

Opening Remarks

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

Networking Break

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

Networking Lunch

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
  • Exclusivity
  • RX to OTC switch
  • Pediatric development
  • Patient’s Right to Try
  • Appreciate the history of how we got to where we are today
  1. Practical Application Exercise: Map out considerations for your product and its requirements
  2. Practical App Ex.: Test your knowledge on the requirements of special programs to see if your products fits
  3. Discussion: What creative strategies can you employ to advance your products

3:15 PM - 3:30 PM

Networking Break

3:30 PM - 4:30 PM

Special Programs to Consider (Continued)


Thursday, May 23rd, 2019 | Day 2

 

8:00 AM - 9:00 AM

Continental Breakfast

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

Networking Break

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.

Download the Full Agenda

REGISTRATION PRICING


WORKSHOP

TWO-DAY WORKSHOP

$1,396

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Interested in sending groups of 7 or more? Contact us directly for pricing.

EVENT SPONSORS

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Contact Eric Morrin at (561) 221.6204
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