Virtual Workshop: Development of Function Promoting Therapies: Public Health Need, Molecular Targets, and Drug Development

Workshop Agenda from March 20-22, 2022

Note: This agenda is in Eastern Daylight Time.

Day 1 (Sunday, March 20, 2022)

4:00 p.m.: Opening Remarks and Introductions, Rosaly Correa-de-Araujo, National Institute on Aging

4:05 p.m.: Plenary Talk: The Epidemiology and Societal Impact of Aging-related Functional Limitations: A Looming Public Health Crisis, Speaker: Anne Newman, University of Pittsburgh; Chair: Shalender Bhasin, Howard University

Session 1: Pathobiology of Functional Limitations Associated with Aging and Chronic Disease
Chairs: Elena Volpi, UTMB and Lee Sweeney, University of Florida

• 4:35 p.m.: Targeting the Myostatin Signaling Pathway, Se-Jin Lee, UConn Health
• 4:55 p.m.: Neural Mechanisms of Age-related Loss of Muscle Strength, Brian Clark, Ohio University
• 5:15 p.m.: Regulation of Muscle Regeneration in Aging, Indranil Sinha, Harvard University
• 5:35 p.m.: Discussion
• 5:50 p.m.: Mechanisms of Skeletal Muscle Atrophy, Sue Bodine, University of Iowa
• 6:10 p.m.: Molecular Circuitry of Stem Cell Fate in Skeletal Muscle Regeneration and Aging, Lee Sweeney, University of Florida
• 6:30 p.m.: Maladaptive Activation of Immune System in Age-related Functional Decline, Maxim Artyomov, Washington University
• 6:50 p.m.: Panel Discussion

7:15 p.m.: Adjourn

Day 2 (Monday, March 21, 2022)

8:00 a.m.: Opening Remarks, Evan Hadley, National Institute on Aging

Session 2: Pharmacologic Interventions to Prevent and Treat Age-related Functional Limitations
Chairs: Adrian Dobs, Johns Hopkins University and Shalender Bhasin, Harvard University

• 8:05 a.m.: Therapeutic Applications of Testosterone and Other Androgens to Treat Functional Limitations Associated with Aging and Disease, Shalender Bhasin, Harvard University
• 8:25 a.m.: Selective Androgen Receptor Modulators (SARMS), Adrian Dobs, Johns Hopkins University
• 8:45 a.m.: Growth Hormone Secretagogues and the Somatotroph Axis, Michael Thorner, Lumos Pharma
• 9:10 a.m.: Orphan Nuclear Receptors: Emerging Therapeutic Targets for Skeletal Muscle Disorders, Vihang Narkar, University of Texas
• 9:30 a.m.: Discussion
• 9:40 a.m.: Myostatin/ActRIIB Blockers, Dan Rooks, Novartis
• 10:00 a.m.: Small Molecule Fast Skeletal Muscle Troponin Activation as a Potential Therapeutic Approach for Neuromuscular and Non-neuromuscular Skeletal Muscle Dysfunction, Fady Malik, Cytokinetics
• 10:20 a.m.: Mas Receptor Agonists for Age-related Mobility Limitation, Waly Dioh, Biophytis
• 10:40 a.m.: Discussion

10:50 a.m.: Break

• 11:05 a.m.: Targeting Inflammation to Improve Health in Older Persons, Luigi Ferrucci, National Institute on Aging
• 11:25 a.m.: Urolithin A, a Gut Microbiome Derived Natural Compound that Activates Mitophagy and Improves Muscle Decline Associated with Aging, Anurag Singh, Amazentis
• 11:45 a.m.: Panel Discussion, Chairs, Speakers, Marina Zemskova and Geanina Roman-Popoveniuc, FDA

12:15 p.m: Lunch Break

Session 3: Drugs Targeting Mechanisms of Aging
Chairs: Sara Espinoza and Nicolas Musi, UT Health

• 12:45 p.m.: Plenary Talk: The Mechanisms of Aging and Functional Decline, Rafael De Cabo, National Institute on Aging
• 1:15 p.m.: NAD Augmentation, Joseph Baur, University of Pennsylvania
• 1:35 p.m.: Metformin: A Potential Agent to Prevent Frailty and Improve Healthspan in Older Adults, Sara Espinoza, UT Health
• 1:55 p.m.: Discussion
• 2:05 p.m.: Senolytics, Sundeep Khosla, Mayo Clinic
• 2:25 p.m.: Panel Discussion, Chairs, Speakers, and Marina Zemoskova and Geanina Roman-Popveniuc, FDA

2:45 p.m.: Break

Session 4: Physical Exercise Interventions
Chairs: Margie Lachman, Brandeis University and Roger Fielding, Tufts University

• 3:00 p.m.: Innovations in Geroscience to Enhance Mobility in Older Adults, Marco Pahor, University of Florida
• 3:20 p.m.: Physical Activity - SPRINT-T, Matteo Cesari, University of Milan
• 3:40 p.m.: Discussion
• 3:50 p.m.: Prehab to Improve Functional Recovery After Orthopedic Surgery, Linda Woodhouse, Tufts University
• 4:10 p.m.: Behavior Change Strategies to Increase and Maintain Physical Activity, Margie Lachman, Brandeis University
• 4:30 p.m.: Panel Discussion, Chairs, Speakers, and Bruno Vellas, University of Toulouse

5:00 p.m.: Adjourn

Day 3 (Tuesday, March 22, 2022)

8:00 a.m.: Prior Day Brief Recap, Shalender Bhasin, Harvard University

Session 5: Nutritional Interventions
Chairs: Caroline Apovian, Brigham and Women's Hospital, and Heike Bischoff-Ferrari, University of Zurich

• 8:05 a.m.: Dietary Protein Quantity, Quality, and Timing Influences on Muscle with Aging, Wayne Campbell, Purdue University
• 8:25 a.m.:High Protein Intake to Reverse Age-related Loss of Muscle Mass and Strength: The Optimen Trial, Caroline Apovian, Brigham and Women's Hospital
• 8:45 a.m.: Vitamin D Supplementation: Vitamin D and OmegA-3 Trial (VITAL), Meryl LeBoff, Brigham and Women's Hospital
• 9:05 a.m.: Vitamin D Supplementation: DO-HEALTH, Heike Bischoff-Ferrari, University of Zurich
• 9:25 a.m.: Discussion
• 9:35 a.m.: Nutraceuticals for Frailty, Nicolaas EP Deutz, Texas A&M University
• 9:55 a.m.: Time Restricted Feeding to Align Food Intake with Circadian Rhythms, Satchin Panda, Salk Institute
• 10:15 a.m.: Effect of Caloric Restriction on Muscle and Bone Health, Dennis Villareal, Baylor College of Medicine
• 10:35 a.m.: Panel Discussion, Chairs and Speakers

11:05 a.m.: Break

Session 6: Optimizing the Design of Clinical Trials of Function Promoting Therapies
Chairs: Peggy Cawthon, UCSF, and Shalender Bhasin, Harvard University

• 11:20 a.m.: Framing the Indications, William Evans, University of California, Berkeley
• 11:40 a.m.: Operationally Defining Sarcopenia in Clinical Trials, Peggy Cawthon, UCSF
• 12:00 p.m.: Inclusion/Exclusion Considerations for Clinical Trials, Roger Fielding, Tufts University
• 12:20 p.m.: Selection of Endpoints in Clinical Trials of Function Promoting Therapies, Shalender Bhasin, Harvard University
• 12:40 p.m.: Outcomes: FDA Perspective, Jeffrey Siegel, FDA

1:00 p.m.: Lunch Break

• 1:30 p.m.: The Need for Adjunct Functional Training for Achieving Functional Improvements and Reducing Disability, Tom Storer, Brigham and Women's Hospital
• 1:50 p.m.: Standardizing Nutritional Intake and Outcomes Assessment Across Trial Sites, Elena Volpi, UTMB
• 2:10 p.m.: Discussion, Chairs, Speakers, and Marina Zemskova and Geanina Roman-Popveniuc, FDA
• 2:40 p.m.: Plenary Talk: Translating Extraordinary Advances in Muscle Biology into Approvable Drugs: The NExt Leap Forward, William Evans, University of California Berkeley
• 3:10 p.m.: Discussion
• 3:15 p.m.: Postmortem of Two Success Stories: The Extraordinary Success of COVID Vaccine and Drug Development Programs: What Went Right with Warp Speed?, Peter Marks, FDA
• 3:40 p.m.: Discussion
• 3:45 p.m.: Postmortem of Two Success Stories: The Development of Oncology Drugs: Critical Ingredients of the Recent Success of the Pharmaceutical Cancer Drug Development Programs, Malcolm Smith, National Cancer Institute
• 4:10 p.m.: Discussion

4:15 p.m.: Break

4:25 p.m.: Expert Panel Discussion: Building Synergistic Collaborations Across Government, Academia, and Industry to Accelerate the Development of Function Promoting Pharmaceutical Therapies, Government, Academia, Industry, and Professional Societies

5:25 p.m.: Summary and Next Directions, Rosaly Correa-De-Araujo, National Institute on Aging, and Shalender Bhasin, Harvard University

5:30 p.m.: Adjourn