Basic Drug Development Training

December 2-3, 2019

Philadelphia, PA

Course Overview

This course provides an overview of the FDA structure and organization, regulatory history and current framework within the US for development of drugs, biologics, medical devices, dietary supplements and medical foods.

The course focuses on phase appropriate considerations and decision-making, roles involved in each stage, regulatory strategy and evolution, and agency meetings. General topics will cover all phases of the development process (including manufacturing, nonclinical and clinical development, and necessary compliance for each), options for effective and streamlined regulatory strategies that will be commercially successful, and product launch and marketing.

Benefits of Attending

  • Understand the historic evolution to the current framework for product development.
  • Be able to identify the basic steps in pharmaceutical development.
  • Gain hands-on experience of concepts and practical application of learnings.
  • Learn key aspects and considerations in the regulatory processes.
  • Understand key roles and responsibilities applicable to product development success.

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Monday, December 2nd, 2019 | Day 1

8:00 AM - 8:30 AM

Registration & Continental Breakfast

8:30 AM - 8:45 AM

Opening Remarks

8:45 AM - 10:45 AM

FDA Scope & Organization

With US spending on Healthcare among the highest in the world with some of the lowest rates of life expectancy, it’s time to change our patterns of care. This overview will set the stage for contracting in 2020 and beyond and will examine how to contract and build your network. Learn how to seamlessly move away from the fee-based system and gain the trust of all stakeholders.

  • What is the impact of new technologies and adding approved services to your overall plan?
  • How to design value-based contracts and get buy-in from all parties
  • Understand what new ancillary services will be best for your organization’s contracting goals
  • Explore strategies in network development designed to cover newly approved areas of service and technology

10:45 AM - 11:15 AM

Networking & Refreshment Break

11:15 AM - 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 successfully 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 & Refreshment Break

3:30 PM - 4:30 PM

Special Programs to Consider (Continued)

Tuesday, December 3rd, 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.




2019 Speaker Faculty

Dawn Anderson

Dawn Anderson

Managing Director, Life Sciences Strategy and Operations, R&D Practice

Craig Lipset

Craig Lipset

Head of Clinical Innovation
Pfizer Inc.

Kyle Faget

Kyle Faget

Special Counsel
Foley & Lardner, LLP

Jeff Kingsley

Jeff Kingsley

IACT Health

Ross Friedberg

Ross Friedberg

General Counsel & Chief Privacy Officer
Doctor on Demand

Monica Chmielewski

Monica Chmielewski

Foley & Lardner, LLP

Amir Lahav

Amir Lahav

Digital Medicine and Clinical Innovation Lead

Michael Song

Michael Song

Senior Manager, Drug Delivery and Device Development

Jane Fang

Jane Fang

Director, R&D Information Head for Clinical Biologics

Hassan Kadhim

Hassan Kadhim

Director, Head of Clinical Trial Business Capabilities
Bristol-Myers Squibb

Kayla Kostelecky

Kayla Kostelecky

PhD Candidate, Health Care Ethics
Saint Louis University

Terri Ellsworth

Terri Ellsworth

Director of Professional Relations, Patient Advocacy
Accreditation Council for Medical Affairs (ACMA)

MarlaJan Wexler

MarlaJan Wexler

Patient Advocacy & Education

Jonathan Cotliar

Jonathan Cotliar

Chief Medical Officer

Kelly Conway

Kelly Conway


John Reites

John Reites

Chief Product Officer & Partner

Michelle Smith

Michelle Smith

Product Delivery, Advisor, Technical Center of Excellence
Eli Lilly and Company

Holly Merrill

Holly Merrill

Senior Director, Training & Education
Science 37

Jeffrey Zucker

Jeffrey Zucker

SVP Global Clinical Operations, Site Management & Trial Optimization
Worldwide Clinical Trials

Karen Beyers

Karen Beyers

Senior Director, MAF Clinical Operations
Johnson & Johnson




Before 7/18/19



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Contact Michael Goldberg at (561) 221-6202

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