Medical Foods Workshop: Science, Regulation and Practical Aspects

Opening Session (8:30am – 9:30am)

• Introductions & Workshop Objectives
  • Speakers: Sarah Ohlhorst, American Society of Nutrition and Madeline Jurch, Healthcare Nutrition Council
• Medical Foods: Challenges and Opportunities
  • Speaker: Tim Morck, Spectrum Nutrition LLC
• The Current Regulatory Framework of Medical Foods
  • Speaker: U.S. Food and Drug Administration (invited)
• Learnings from the 2018 NASEM Workshop on Examining Special Nutritional Requirements in Disease States
  • Speaker: Barbara Schneeman, UC Davis

From Essentiality to Quality of Life: Assessing “Distinctive Nutritional
Requirements” in Different Clinical Contexts (9:30am – 10:45am)

• The Role of Nutrition in Managing a Disease
  • Speaker: Sarah Ohlhorst, American Society of Nutrition
• Improving Clinical Outcomes: Immunonutrition and Surgery
  • Speaker: Dr. Juan Ochoa, Geisinger Medical Center
• The Role of Mode of Delivery and the Patient Spectrum (Long Term Care to ICU)
  • Speaker: Susan Lessar, Winchester Medical Center
• Malnutrition and Gastrointestinal Impairment in Meeting Patient Nutritional Needs
  • Speaker: Dr. Mark DeLegge, Medical University of South Carolina
• The Role of Clinical Guidelines in “Distinctive Nutritional Requirements”
  • Speaker: Ainsley Malone, American Society of Parenteral and Enteral Nutrition
• Q&A with Speakers

Coffee/Tea Break (10:45am – 11:15am)

Practical Aspects for Meeting Distinctive Nutritional Requirements
through Modification of the Diet Alone (11:15am-1:10pm)

• Modification of the Diet Alone in the Context of Medical Foods’ Traditional Focus
  • Speaker: Patsy Brannon, Cornell University
• Current Regulatory and Legal Context on Modification of the Diet Alone
  • Speaker: Jessica O’Connell, Covington & Burling
• Practicality of the Usage of Medical Foods to Assure Compliance and Meet Nutritional Requirements: Healthcare Providers Perspectives on Three Disease States
  • Speaker: Dr. Eric Kossoff, Johns Hopkins Medicine (Intractable Epilepsy)
  • Speaker: Dr. Osama Hamdy, Harvard Medical School (Spectrum of Diabetic Patients)
  • Speaker: Alison Steiber, Academy of Nutrition and Dietetics (End-Stage Renal Disease)
• Practicality of the Usage of Medical Foods to Assure Compliance and Meet Nutritional Requirements: Patient Perspective
  • Speaker: Laura Wingate, Crohn’s and Colitis Foundation
• Q&A with Speakers

Lunch (1:10pm – 2:10pm)

International Perspective on Patient Foods Intended for the Dietary
Management of a Disease or Condition (2:15pm -3:15pm)

• Foods for Special Medical Purposes (FSMP) in Europe
  • Speaker: Basil Mathioudakis, former European Commission – DG SANTE’ (invited)
• Canadian Modernization of Division 24
  • Speaker: Genevieve D’Annunzio, Abbott Laboratories
• Q&A with Speakers

New Types of Evidence and Product Innovation: From Patient Needs to
Product Design and Development (3:15pm-4:45pm)

• Moderator: Sarah Ohlhorst, American Society of Nutrition
• Panelists:
  • Dr. Peggi Guenter, American Society of Parenteral and Enteral Nutrition (ASPEN’s Research Value Proposition Project)
  • Dr. Satya Jonnalagadda, Abbott Nutrition (Product Design Considerations)
  • Dr. Krys Araujo Torres, Nestle Health Science (Research & Evidence Development)
• Q&A with Panelists

Wrap-Up & Adjourn (4:45pm-5:00pm)

• Madeline Jurch, Healthcare Nutrition Council