Vice Chair of Research and Professor of Orthopaedic Surgery, Stanford University

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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

1 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 Advisor: Fei Wang, PhD Thursday, February 15, :00 6:30 PM Symposium Check In / Poster Set Up Foyer 6:30 8:30 PM Opening Dinner Reception and Poster Session Friday, February 16, :00 8:00 AM Networking Breakfast 8:00 8:05 AM Symposium Welcome Constance Chu, MD (confirmed) 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 Moderator: Constance Chu, MD 8:15 8:20 AM Constance Chu, MD (confirmed) 1) Platelet Biology Rocky Tuan, PhD (confirmed) 8:20 8:35 AM Director, Center for Cellular and Molecular Engineering / Associate Director, McGowan Institute for Regenerative Medicine / Professor, 2) Acute Ligament and Cartilage Injuries 8:35 8:50 AM Lisa Fortier, DVM, PhD (confirmed) Vice President of the International Veterinary Regenerative Medicine Society / Professor of Surgery, Cornell University 3) Knee Osteoarthritis George Muschler, MD (confirmed) 8:50 9:05 AM Founder, Clinical Tissue Engineering Center (CTEC), Director, Regenerative Biology Laboratory, and Professor, Cleveland Clinic Foundation 4) Chronic Tendon Injuries 9:05 9:20 AM Laurie Goodrich, DVM, PhD, ACVS Diplomate (confirmed) Professor of Equine Surgery and Lameness, Colorado State University, College of Veterinary Medicine 5) Surgical Soft Tissue Repair 9:20 9:35 AM Scott Rodeo, MD (confirmed) Co-Director of the Tissue Engineering, Regeneration, and Repair Program, and Professor, Hospital for Special Surgery 9:35 9:50 AM Session I Speakers i

2 Overview of Breakout Sessions / Transition time to Breakout Rooms 9:50 10:00 AM Constance Chu, MD (confirmed) 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? Moderator: Jeremy Mao, DDS, PhD (confirmed) and TBD American Orthopaedic Foot and Ankle Society (AOFAS) Rep 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? Moderator: Johnny Huard, PhD (confirmed) and TBD American Orthopaedic Society for Sports Medicine (AOSSM) 10:00 11:15 AM Rep 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? Moderator: Lisa Fortier, DVM, PhD (confirmed) and TBD Orthopaedic Research Society (ORS) Representative 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? Moderator: Scott Rodeo, MD (confirmed) and TBD J. Robert Gladden Orthopaedic Society (JRGOS) Rep 11:15 11:35 AM Breakout Group Reports (5 minutes per group) 11:35 11:45 AM ii 11:45 AM 12:30 PM Buffet Luncheon Among the Posters Introduction of Keynote Speaker 12:30 12:35 PM Constance Chu, MD (confirmed) 6) Keynote Presentation: How Bringing the Advanced Therapies Community Together is Improving Confidence in Product Characterization 12:35 12:55 PM Anne Plant, PhD (confirmed) Chief of the Biosystems and Biomaterials Division National Institute of Standards and Technology 12:55 1:05 PM Keynote General Session II: Standards for Biological Sample Collection and Analyses 1:05 1:10 PM 1:10 1:25 PM 1:25 1:40 PM Moderator: Scott Rodeo, MD Scott Rodeo, MD (confirmed) Hospital for Special Surgery 7) PRP Proteomics Jeremy Mao, DDS, PhD (confirmed) Director of the Tissue Engineering and Regenerative Medicine Laboratory and Professor of Dentistry (in Orthopedic Surgery), Columbia University 8) Banking and Assaying Blood Proteins Virginia Kraus, MD, PhD (confirmed) Immediate Past President of OARSI and Co-Chair Foundation for NIH OA Biomarkers Consortium and Professor of Medicine, Pathology, Orthopaedic Surgery, Duke University

3 9) Private-Academic Partnership in Biologic Banking and Assessment 1:40 1:55 PM Johnny Huard, PhD (confirmed) Professor and Vice Chair for Research, Department of Orthopaedic Surgery, 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 (confirmed) Assistant Scientist in the Tissue Engineering Regeneration and Repair Program, Hospital for Special Surgery 2:10 2:25 PM Session II Speakers General Session III: Lessons from Existing Orthopaedic Registries Moderator: Rocky Tuan, PhD 2:25 2:30 PM Rocky Tuan, PhD (confirmed) 11) American Joint Replacement Registry 2:30 2:45 PM William Maloney, MD (confirmed) Chair, School of Medicine - Orthopaedic Surgery, and Professor, 12) Kaiser Registry (Single Health System) 2:45 3:00 PM Ronald Navarro, MD (confirmed) Regional Coordinating Chief of Orthopedic Surgery, Southern California Permanente Medical Group, Kaiser Permanente 3:00 3:15 PM 13) Local Registry: VA Palo Alto Constance Chu, MD (confirmed) 3:15 3:30 PM 14) ICRS International Registry Leela Biant, FRCS (Ortho), MS (confirmed) Academic Head, Department of Trauma & Orthopaedic Surgery; Honorary Consultant Trauma and Orthopaedic Surgeon, Central Manchester University Hospitals; Lead Clinician for Cartilage Repair and Regeneration University of Manchester 3:30 3:45 PM Session III Speakers 3:45 3:50 PM Overview of Breakout Sessions Rocky Tuan, PhD (confirmed) 3:50 3:55 PM Transition Time to Breakout Discussions - Breakout Session: Feasibility of Establishing a Registry for Data Collection Group 2A: Proteins and Markers of Interest in PRP Moderators: Jeremy Mao, DDS, PhD (confirmed) and 3:55 5:00 PM Virginia Kraus, MD, PhD (confirmed) Group 2B: Implementing a Biorepository Linked Registry Moderators: George Muschler, MD (confirmed) and Robert LaPrade, MD, PhD (confirmed) 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 TBD iii

4 Saturday, February 17, :30 8:15 AM Breakfast Among the Posters 8:15 8:30 AM Morning Welcome and Introduction of Keynote Speaker William Maloney, MD (confirmed) 15) Keynote Presentation: The Power of Adaptive Clinical Trials 8:30 9:00 AM Ying Lu, MS, PhD (confirmed) 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 (confirmed) Chair and Professor, Department of Physical Therapy, Director of Clinical Research, Department of Orthopaedic Surgery, and Scientific Director of the American Physical Therapy Association s Physical Therapy Outcomes Registry 9:20 9:35 AM 16) Can We Agree on Outcomes Metrics? Robert LaPrade, MD, PhD (confirmed) Chief Medical Officer/Co-Director of the Sports Medicine Fellowship Program, Steadman Philippon Research Institute 9:35 9:50 AM 17) Computer Adaptive Outcomes Metrics James J. Irrgang, PhD, PT, ATC (confirmed) 9:50 10:05 AM 18) Innovative Outcomes Collection Kurt Spindler, MD (confirmed) Vice Chairman of Research in the Orthopaedic & Rheumatologic Institute; Director of Orthopaedic Clinical Outcomes; Academic Director of Cleveland Clinic Sports Health, Cleveland Clinic 10:05 10:20 AM 19) Imaging Considerations for Clinical Trials Hollis Potter, MD (confirmed) Chairman and Director of Research, Department of Radiology and Imaging and Professor of Radiology, Hospital for Special Surgery 10:20 10:35 AM Session IV Speakers 10:35 10:40 AM Overview of Breakout Session / Transition Time to Breakout Rooms James J. Irrgang, PhD, PT, ATC (confirmed) 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? Moderator: Laurie Goodrich, DVM, PhD (confirmed) and 10:40 11:40 AM TBD Arthroscopy Association of North America (AANA) Rep 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? Moderator: Christian Lattermann, MD (confirmed) and TBD Ruth Jackson Orthopaedic Society (RJOS) Representative iv

5 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? Moderator: Kurt Spindler, MD (confirmed) and TBD Knee Society Representative 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? Moderator: Ronald Navarro, MD (confirmed) and TBD American Shoulder and Elbow Surgeons (ASES) Rep 11:40 AM 12:00 PM Breakout Group Reports (5 minutes per group) 12:00 12:05 PM 12:05 12:45 PM Luncheon Among the Posters PRP Patient Panel: Minimally Manipulated, Minimally Effective? Moderator: Constance Chu, MD and Jason Dragoo, MD Panelists: Young Athlete and parent 12:45 1:45 PM Pro-Athlete OA Patient Patient Going Abroad for Stem Cells 1:45 2:00 PM Panelists General Session V: Regulatory Pathways: Facilitating Evidence-Based Evaluation of Biologics Moderator: Constance Chu, MD Session Overview 2:00 2:05 PM Constance Chu, MD (confirmed) 20) Keynote Presentation: Product Development in CBER Celia Witten, MD, PhD (confirmed) 2:05 2:25 PM Deputy Director of the Center for Biologics Evaluation and Research Food and Drug Administration 2:25 2:35 PM Keynote 21) Lessons from an Acute ACL Intervention Trial Christian Lattermann, MD (confirmed) 2:35 2:50 PM Vice Chairman for Orthopaedic Research and Professor for Orthopaedic Surgery and Sports Medicine, University of Kentucky 22) Getting to Human Clinical Trial: Innovative Pathways for Academic Center Clinical Trials Norimasa Nakamura, MD, PhD (confirmed) 2:50 3:05 PM Immediate Past President of the International Cartilage Repair Society (ICRS) and Professor of the Institute for Medical Science in Sports, Osaka Health Science University (Japan) 23) Government-Private Partnership for Stem Cell Therapies Rodrigo Mardones, MD (confirmed) 3:05 3:20 PM Director of the Stem Cells for Cartilage Repair Project; Assistant Professor Clinica Las Condes (Chile) 3:20 3:30 PM Session V Speakers v

6 The Collective Agenda Moderator: Constance Chu, MD 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 TBD Meeting participants should book return flights for 7 PM or later on Saturday, February 17. Departure Sunday, February 18 is permissible. vi

Symposium Welcome Constance Chu, MD Vice Chair of Research and Professor of Orthopaedic Surgery, Stanford University

Symposium Welcome Constance Chu, MD Vice Chair of Research and Professor of Orthopaedic Surgery, Stanford University AAOS Optimizing Clinical Use of Biologics in Orthopaedic Surgery February 15-17, 2018 Li Ka Shing Learning and Knowledge Center / Stanford, CA Program Chair: Co-Chairs: William Maloney, MD; Jeremy Mao,