Medical Foods Workshop: Science, Regulation and Practical Aspects

Workshop Objective

To foster a dialogue on regulatory framework of medical foods in the U.S. by discussing topics such as distinctive nutritional requirements, modification of the diet alone, usage under medical supervision, and clinical guidelines.

Speakers at a Glance

Satya Jonnalagadda
Abbott Nutrition
Madeline Jurch
Healthcare Nutrition Council
Eric Kossoff
Johns Hopkins University
Susan Lessar
Valley Health
Sarah Ohlhorst
American Society for Nutrition
Jena Rostorfer
Abbott Nutrition

August 13, 2019

Opening Session (8:30am – 9:30am)

  • Introductions & Workshop Objectives
    • Speakers: Sarah Ohlhorst, American Society of Nutrition and Madeline Jurch, Healthcare Nutrition Council
  • The Current Regulatory Framework of Medical Foods: Challenges and Opportunities
    • Speaker: Tim Morck, Spectrum Nutrition LLC
  • 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
  • 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

August 14, 2019

Opening – Review of Workshop Objectives and Learning from Day 1 (8:30am-9:00am)

  • Speakers: Madeline Jurch, Healthcare Nutrition Council and Sarah Ohlhorst, American Society for Nutrition

Differentiating Foods for Special Dietary Uses and Medical Foods (9:00am-10:30am)

  • The Current FDA Regulation around Foods for Special Dietary Uses
    • Speakers: U.S. Food and Drug Administration (invited) and Jessica O’Connell,
      Covington & Burling
  • Concepts around Differentiating Medical Foods and FSDU
    • Speakers: Jena Rostorfer, Abbott Nutrition, and Alexandre Biella, Nestle Health Science
    • Panel Discussion (Reflections on Medical Food and FSDU concepts)
      • Panelist: Xin Tao, Hogan Lovells
      • Panelist: Barbara Schneeman, UC Davis
      • Panelist: Tim Morck, Spectrum Nutrition
  • Q&A with Panelists

Final Panel on Learnings from the Workshop and Actionable Next Steps (10:30am-12:00pm)

  • Moderator: Tim Morck, Spectrum Nutrition
  • Panel Discussion and Q&A with Panelists
    • Panelists: Joan Bishop, Oley Foundation; Barbara Schneeman, UC Davis

Closing (12:00pm-12:15pm)

  • Speakers: Madeline Jurch, Healthcare Nutrition Council and Sarah Ohlhorst, American Society for Nutrition

Sponsorship Opportunities

  • Speaker Dinner: $2,500
  • Breakfast: $2,000-$2,500
  • Lunch: $2,000-$2,500
  • Workshop Sponsorship: $1,500
  • Reception: $1,000
  • Coffee/Tea Break: $500

Contact Urooj Sheikh at 202-207-1129 or [email protected] with any sponsorship questions.

Workshop Location

Covington & Burling at One CityCenter

850 Tenth St NW, Washington, DC 20001

Hotel Accomodations

Grand Hyatt Washington DC
1000 H Street NW
Washington, DC 20001

HNC has a room block for the group rate of $159. To make a reservation, click here or call 202-582-1234 and reference HNC.

Transportation

Ronald Reagan Washington National Airport is approximately 4 miles from the Grand Hyatt.

Washington Dulles International Airport is approximately 20 miles from the Grand Hyatt.

For information on Ground Transportation, including Metrorail, Taxis, Uber, and Lyft, please see here.