Basic Drug Development Training

August 24-25th, 2020

Via Live Stream

What to Expect

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.

Hilton East Brunswick

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3 Tower Center Blvd.
East Brunswick, NJ 08816

(732) 828-2000

Hotel Website

About the Chairperson

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Dr. Matthew T. Roe has been a faculty member at Duke University School of Medine and the Duke Clinical Research Institute (DCRI) since 1999. As a senior investigator at the DCRI, he has been the principal investigator for numerous phase II-IV cardiovascular clinical trials and is currently a co-principal investigator for the ADAPTABLE trial—the first large-scale pragmatic trials being conducted in the PCORnet network. He has also served in leadership roles for several observational registries focusing upon the treatment and outcomes of patients with cardiovascular disease and has served as the Director of the DCRI Clinical Research Fellowship since 2010.

Featured Speakers

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Craig Lipset

Head of Clinical Innovation
Pfizer

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Jeff Kingsley

Chief Executive Officer
IACT Health 

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Dawn Anderson

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

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Ross Friedberg

General Counsel & Chief Privacy Officer
Doctor on Demand

Why Attend?

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

Attendee Profile

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Monday

August 24th, 2020 | Day 1

8:00 AM - 8:30 AM

Registration & Login

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 8000 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.

  • Analyze FDA’s mission in its regulation
  • Clarify FDA’s top regulatory priorities
  • Understand how they organize to achieve their mission and meet their priorities

10:45 AM - 11:15 AM

Networking Break

11:15 AM - 12:15 PM

History of U.S. Regulation

The regulatory requirements for drug development are complex and intricate; however, they are navigable. This session will explore the historical underpinnings of our current regulatory framework and the current pathways to getting drug approval.

  • Learn the submissions required for study and approval for your drug, device, biologic, medical food, or dietary supplement
  • Ensure the use of the proper required format
  • Overview of device regulations 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 U.S. Regulation (Continued)

2:15 PM - 3:15 PM

Special Programs to Consider

There are many FDA special programs available that offer different strategic advantages for your products. Learn about qualifying requirements and considerations you need to make for:

  • 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

3:15 PM - 3:30 PM

Networking Break

3:30 PM - 4:30 PM

Special Programs to Consider (Continued)

Tuesday

August 25th, 2020 | Day 2

8:30 AM - 9:00 AM

Registration

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 offers several key points of interaction during the development process.

  • Specify which meetings are possible for your products during the development life cycle, and what you should aim to get out of them
  • Plan how to take advantage of these meetings: from scheduling and planning, to conducting the meeting, to gaining full understanding and actionable output
  • Review case studies of successful negotiation and communication during meetings
  • Learn from less successful meetings, and how to manage and recover afterwards

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

FEATURED SPEAKERS

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Oscar Segurado

ASC Therapeutics

Chief Medical Officer

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Judy Hsiung

Arena Pharmaceuticals

Vice President Safety & Pharmacovigilance

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Israel Gutierrez

Geron Corporation

Vice President, Pharmacovigilance and Drug Safety

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Joan A. Chambers

The Center for Information & Study on Clinical Research Participation (CISCRP)

Senior Director, Marketing & Outreach

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Michael Forstner

PrimeVigilance

Senior Vice President and Head of Pharmacoepidemiology and Risk Management

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Sheila Bose

SB Lifesciences Consulting, Inc

President

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Christine Von Raesfeld

More Than Lupus

Patient Advocate and Board Member

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Angela Ramirez Holmes

Cal Rare

Founder/President

CONFERENCE REGISTRATION


VIRTUAL LIVE-STREAM PRICING

Before 6/12/20

$796

After 6/12/20

$896

Interested in sending groups of 10 or more? Contact us directly for pricing.

EVENT SPONSORS



SPONSOR THIS EVENT

Contact Amy Chapman at (561) 571-7687
or achapman@dgeconfs.com


MEDIA PARTNERS

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PREMIER MEDIA PARTNER


Why Become Board Certified in Medical Affairs?

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Certification is becoming an important factor in the healthcare industry in general. A survey of over 1000 key opinion leaders (KOLs) found that over 90% preferred medical affairs professionals who had a Board Certified Medical Affairs Specialist (BCMAS) designation.

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