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8:15am 9:00am (45 mins)

Main agenda

Registration and Morning Coffee

9:00am 9:15am (15 mins)

Main agenda

Chairperson's Opening Remarks

  • Ann L. Daugherty, Ph.D. - Senior Manager, Drug Delivery, Pharmaceutical Development, Genentech Inc.
  • Richard Korsmeyer, Ph.D. - Independent Consultant, Korsmeyer Consulting, LLC

9:15am 9:45am (30 mins)

Main agenda

OPENING FDA KEYNOTE

The following speakers have been invited to speak on their topic of expertise:

3D Printing Tablets or New Polymers (or related topic)
Dr. Sau (Larry) Le, Office of Emerging Technology, US Food and Drug Administration

Connected Health (or related topic)
Ashley Boam, Director, Office of Policy for Pharmaceutical Quality, CBER

Combination Products (or related topic)
Thinh X. Nguyen, Director, Office of Combination Products, US Food and Drug Administration

Lawrence X. Yu, Ph.D., Deputy Director, Science and Chemistry, Office of Generic Drugs, US Food and Drug Administration


  • Ashley Boam (Invited) - Director, Office of Policy for Pharmaceutical Quality, CBER, Food and Drug Administration (FDA)
  • Sau Lee, Ph.D. (Invited) - Office of Emerging Technology, Food and Drug Administration (FDA)
  • Thinh Nguyen (Invited) - Director, Office of Combination Products, Food and Drug Administration (FDA)
  • Lawrence Yu, Ph.D. (Invited) - Deputy Director, Science and Chemistry, Office of Generic Drugs, Food and Drug Administration (FDA)

9:45am 10:15am (30 mins)

Main agenda

35 Years in Drug Deliver: Successes, Failures, and Next Challenges

  • Richard Korsmeyer, Ph.D. - Independent Consultant, Korsmeyer Consulting, LLC

10:15am 10:45am (30 mins)

Main agenda

Morning Refreshment Break

10:45am 11:30am (45 mins)

Main agenda

Opening Panel - Marry to Market: Making the Most of Partnerships

Moderator from Enable Injections

Panelists:

  • Matthew Burke, Head of Drug Delivery, GSK
  • Neil Mathias, Research Fellow, Drug Delivery, BMS
  • Keith Horspool, Ph.D., Vice President Pharmaceutics, Boehringer Ingelheim
  • Panelist Matthew Burke - Head of Drug Delivery, GlaxoSmithKline
  • Panelist Neil Mathias - Research Fellow, Drug Delivery, Bristol-Myers Squibb
  • Panelist Keith Horspool, Ph.D. - Vice President Pharmaceutics, Boehringer Ingelheim

11:30am 12:00pm (30 mins)

Main agenda

FDNA: Rare Disease Early Detection for Better Outcomes

  • Dekel Gelbman - Chief Executive Officer, FDNA

12:00pm 12:45pm (45 mins)

Main agenda

Special Populations and Rare Diseases

12:45pm 2:00pm (75 mins)

Main agenda

Networking Luncheon

2:00pm 3:15pm (75 mins)

Workshops

Regulatory, Risk Management, and Human Outcomes

Moderator:

Lee Leichtner, President of P/L Biomedical

Talks by:

Amgen, Inc.
Biogen

  • Lee Leichter - President, P/L Biomedical

3:15pm 4:00pm (45 mins)

Workshops

Late Breaking Workshop

4:30pm 5:30pm (60 mins)

Workshops

Workshop Presented by Becton Dickinson

  • Speaker TBA, Becton Dickinson

2:00pm 4:00pm (120 mins)

Drug Delivery Technologies to Watch II

Late Breaking Presentations

4:30pm 5:30pm (60 mins)

Drug Delivery Technologies to Watch II

Late Breaking Presentations

2:00pm 2:30pm (30 mins)

Drug Delivery Technologies to Watch I

Presentation by Stevanato Group

  • Speaker TBA, Stevanato Group

2:30pm 2:45pm (15 mins)

Drug Delivery Technologies to Watch I

Presentation by Credence MedSystems

2:45pm 3:00pm (15 mins)

Drug Delivery Technologies to Watch I

Presentation by Portal Instruments

  • Speaker TBA, Portal Instruments

3:00pm 3:30pm (30 mins)

Drug Delivery Technologies to Watch I

Presentation by Haselmeier

  • Speaker TBA, Haselmeier

3:30pm 4:00pm (30 mins)

Drug Delivery Technologies to Watch I

Late Breaking Presentations

4:30pm 5:30pm (60 mins)

Drug Delivery Technologies to Watch I

Late Breaking Presentations

4:00pm 4:30pm (30 mins)

Main agenda

Afternoon Refreshment Break

5:30pm 6:30pm (60 mins)

Main agenda

Cocktail Reception