AAOS Optimizing Clinical Use of Biologics in Orthopaedic Surgery February 15 17, 2018 Li Ka Shing Learning and Knowledge Center / Stanford, CA Program Chair: Constance Chu, MD Co Chairs: William Maloney, MD; Jeremy Mao, DDS, PhD; Scott Rodeo, MD; and Rocky Tuan, PhD National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) / NIH Collaborator: Fei Wang, PhD Thursday, February 15, 2018 6:00 6:30 PM Symposium Check In Stanford 6:30 8:30 PM Opening Dinner Reception Faculty Club Friday, February 16, 2018 7:00 8:00 AM Symposium Check In / Networking Breakfast Berg Hall Foyer 8:00 8:05 AM Symposium Welcome Constance Chu, MD Vice Chair of Research and Professor of Orthopaedic Surgery, 8:05 8:15 AM Planning Team Introductions / Overview of Symposium Goals Constance Chu, MD; William Maloney, MD; Jeremy Mao, DDS, PhD; Scott Rodeo, MD; Rocky Tuan, PhD; and Fei Wang, PhD General Session I: Determining Candidate Biologic Targets for Common Indications 8:15 8:20 AM Constance Chu, MD 1) Biology of Platelets and Platelet Rich Plasma 8:20 8:35 AM Rocky Tuan, PhD 2) Cartilage Injuries 8:35 8:45 AM Nidhi Bhutani, PhD 3) Knee Osteoarthritis 8:45 9:00 AM George Muschler, MD Cleveland Clinic Foundation 4) Acute Ligament and Chronic Tendon Injuries 9:00 9:20 AM Laurie Goodrich, DVM, PhD, ACVS Diplomate Colorado State University 5) Surgical Soft Tissue Repair 9:20 9:35 AM Scott Rodeo, MD 9:35 9:50 AM Session I Speakers Overview of Breakout Sessions / Transition time to Breakout Rooms 9:50 10:00 AM Constance Chu, MD i
Breakout Session: Targeting Biomarkers and Proteins Group 1A: Chronic Tendon Injuries: What are the candidate mechanisms of action for PRP treatment? Are we aiming to stimulate or to dampen inflammation? What about the role of growth factors? Moderators: Jeremy Mao, DDS, PhD and Allan Mishra, MD Group 1B: Acute Ligament and Muscle Injuries: What are the candidate mechanisms of action for PRP treatment? Are we aiming for antiinflammatory or pro inflammatory effects? What about the role of growth factors? 10:00 11:15 AM Moderators: Johnny Huard, PhD and Robert LaPrade, MD, PhD Group 1C: Knee Osteoarthritis: What are the candidate mechanisms of action for PRP treatment? Are we aiming for anti inflammatory treatment? What about the effects of cartilage anabolic growth factors? Moderators: Bert Mandelbaum, MD and Nidhi Bhutani, PhD Group 1D: Surgical Soft Tissue Repairs: What are the candidate mechanisms of action for PRP enhancement of rotator cuff repair? Of meniscus repair? Of Achilles tendon repair? Moderators: Scott Rodeo, MD and John Tokish, MD 11:15 11:35 AM Breakout Group Reports (5 minutes per group) 11:35 11:45 AM 11:45 AM Buffet Luncheon Among the Posters 12:30 PM Introduction of Keynote Speaker 12:30 12:35 PM Constance Chu, MD 6) Keynote Presentation: How Bringing the Advanced Therapies Community Together is Improving Confidence in Product Characterization 12:35 12:55 PM Anne Plant, PhD National Institute of Standards and Technology Berg Hall A Berg Hall B Berg Hall C LK 209 Berg Hall Foyer 12:55 1:05 PM Keynote General Session II: Standards for Biological Sample Collection and Analyses Moderator: Scott Rodeo, MD 1:05 1:10 PM Scott Rodeo, MD 7) PRP Proteomics 1:10 1:25 PM Jeremy Mao, DDS, PhD Columbia University 8) Banking and Assaying Blood Proteins 1:25 1:40 PM Virginia Byers Kraus, MD, PhD Duke University 9) Private Academic Partnership in Biologic Banking and Assessment 1:40 1:55 PM Johnny Huard, PhD University of Texas Health Science Center at Houston 10) Is there a Role for Molecular Markers of Disease State? 1:55 2:10 PM Miguel Otero, PhD 2:10 2:25 PM Session II Speakers ii
General Session III: Lessons from Existing Orthopaedic Registries Moderator: Rocky Tuan, PhD 2:25 2:30 PM Rocky Tuan, PhD 11) American Joint Replacement Registry 2:30 2:45 PM William Maloney, MD 12) Kaiser Registry (Single Health System) 2:45 3:00 PM Mark Dillon, MD Kaiser Permanente 13) Local Registry: VA Palo Alto 3:00 3:15 PM Constance Chu, MD 14) ICRS International Registry 3:15 3:30 PM Leela Biant, FRCS (Ortho), MS University of Manchester 3:30 3:45 PM Session III Speakers Overview of Breakout Sessions 3:45 3:50 PM Rocky Tuan, PhD 3:50 3:55 PM Transition Time to Breakout Discussions Breakout Session: Feasibility of Establishing a Registry for Data Collection 3:55 5:00 PM Group 2A: Proteins and Markers of Interest in PRP Moderators: Jeremy Mao, DDS, PhD and Rocky Tuan, PhD Berg Hall A Group 2B: Implementing a Biorepository Linked Registry Moderators: George Muschler, MD and Constance Chu, MD 5:00 5:10 PM Breakout Group Reports (5 minutes per group) 5:10 5:15 PM 5:15 6:00 PM Break 6:00 PM Group Dinner and Poster Reception Berg Hall Foyer / Hall A Saturday, February 17, 2018 7:15 8:15 AM Breakfast Among the Posters Berg Hall Foyer 8:15 8:30 AM Morning Welcome and Introduction of Keynote Speaker William Maloney, MD 15) Keynote Presentation: The Power of Adaptive Clinical Trials 8:30 9:00 AM Ying Lu, MS, PhD 9:00 9:15 AM Keynote General Session IV: Outcome Measures for Clinical Trials Moderator: James J. Irrgang, PhD, PT, ATC 9:15 9:20 AM James J. Irrgang, PhD, PT, ATC 16) Can We Agree on Outcomes Metrics? 9:20 9:35 AM Robert LaPrade, MD, PhD Steadman Philippon Research Institute iii
17) Computer Adaptive Outcomes Metrics 9:35 9:50 AM James J. Irrgang, PhD, PT, ATC 18) Innovative Outcomes Collection 9:50 10:05 AM Kurt Spindler, MD Cleveland Clinic 19) Imaging Considerations for Clinical Trials 10:05 10:20 AM Hollis Potter, MD 10:20 10:35 AM Session IV Speakers Overview of Breakout Session / Transition Time to Breakout Rooms 10:35 10:40 AM James J. Irrgang, PhD, PT, ATC Breakout Session: Designing a Clinical Trial to Evaluate the Efficacy of PRP Group 3A: Chronic Tendon Injuries: What are the recommended outcome metrics for assessment of PRP effects on chronic tendinopathy of the patellar tendon and tennis elbow? How can an adaptive trial be done? LK 203 Moderators: Laurie Goodrich, DVM, PhD and Allan Mishra, MD Group 3B: Acute Ligament and Muscle Injuries: What are the recommended outcome metrics for assessment of PRP effects on MCL tear, ACL partial tear, and muscle strain? How can an adaptive trial be performed? LK 204 10:40 11:40 AM Moderators: Christian Lattermann, MD and Leela Biant, MD Group 3C: Knee Osteoarthritis: What are the recommended outcome metrics for assessment of PRP effects on knee osteoarthritis? How can an adaptive trial be performed? LK 205 Moderators: Kurt Spindler, MD and Kenneth Zaslav, MD Group 3D: Surgical Soft Tissue Repairs: What are the recommended outcome metrics for assessment of PRP effects on rotator cuff repair, Achilles tendon repair, and ACL reconstruction? What trial design(s) to use? LK 206 Moderators: Jay Irrgang, PhD, PT, ATC and Lou McIntyre, MD 11:40 AM Breakout Group Reports (5 minutes per group) 12:00 PM 12:00 12:05 PM 12:05 12:45 PM Luncheon Among the Posters Berg Hall A PRP Patient Panel: Minimally Manipulated, Minimally Effective? Moderators: Constance Chu, MD, Jason Dragoo, MD, and Allan Mishra, MD 12:45 1:45 PM Patient Panelists: Scott Buttinger, Marco Fontani, and Doug Oliver 1:45 2:00 PM Panelists General Session V: Regulatory Pathways: Facilitating Evidence Based Evaluation of Biologics Session Overview 2:00 2:05 PM Constance Chu, MD 20) Keynote Presentation: Product Development in CBER 2:05 2:25 PM Celia Witten, MD, PhD Center for Biologics Evaluation and Research, Food and Drug Administration 2:25 2:35 PM Keynote 21) Lessons from an Acute ACL Intervention Trial 2:35 2:50 PM Christian Lattermann, MD University of Kentucky iv
2:50 3:05 PM 3:05 3:20 PM 3:20 3:30 PM 22) Getting to Human Clinical Trial: Innovative Pathways for Academic Center Clinical Trials Norimasa Nakamura, MD, PhD Osaka Health Science University (Japan) 23) Government Private Partnership for Stem Cell Therapies Rodrigo Mardones, MD Clinica Las Condes (Chile) Session V Speakers The Collective Agenda 3:30 4:30 PM Putting it all Together Coming to Consensus 4:30 5:00 PM Next Steps 5:00 PM Adjourn 6:00 PM Faculty Dinner (Invitation only) MacArthur Park v