MADE Scientific · Mayo Clinic

Rochester Visit — Thursday 3 September

Every Mayo program MADE is tracking, by site and investigator. Each card opens the technical evaluation and the deep dive written for it.

9:30–17:00 · Siebens 4-05A (badge access) Meet at the Man and Freedom sculpture, Gonda subway level Text Julie on arrival — she escorts up Lenae Barkey 507.538.8314 Confidential — under CDA

Running order9:30–17:00 · Siebens 4-05A

TimeSessionMayo presentersPackage
9:30Welcome & IntroductionsBreakfast, coffee and beverages availableJulie Allickson, PhD
10:00Project Overview & CollaborationBoth joining remotelyJulie K. Heimbach, MD · Robert C. Huebert, MDAutologous Adipose-MSC
10:30Research Executive Leadership TeamExecutive Dean of Research; Chair and Associate Administrator, Research AdministrationVijay Shah, MD · Heidi Dieter · Jolene Summer Bolster
11:05MADE Scientific Overview & CollaborationClinical Genomics — joining remotelyDavid Deyle, MDGene-corrected cells for osteogenesis imperfecta
11:30Project Overview & CollaborationSaranya P. Wyles, MD, PhDAllogeneic MSC-derived extracellular vesicle (EV)
12:00LunchSiebens 4 Café open 11:00–13:00
12:30Project Overview & CollaborationDr. Knutson and Dr. Gustafson joining remotelyMatthew S. Block, MD, PhD · Keith L. Knutson, PhD · Michael P. Gustafson, PhDFRαDC dendritic-cell vaccine (FAROUT) — NCT06639074Cancer vaccine portfolio — dendritic cell, DNA, RNA,
13:00MADE Scientific Overview & CollaborationMedical Director, Regenerative Biotherapeutics (RST)Wen Lu, MDassessment in preparation
13:30MADE Scientific Overview & CollaborationDivision Chair, Hematology (RST)Stephen M. Ansell, MD, PhDassessment in preparation
14:00Open time
14:30Open time
15:00Project Overview & CollaborationDr. Revzin joining remotelyAlexander Revzin, PhD · Michael Slama, MSTT + GMP of HEK-293 based Biologics Factory
15:30Project Overview & CollaborationDaniel Saris, MD, PhDPhase III MSC MCB & WCB manufacturing
16:00Project Overview & CollaborationDr. Park joining remotelyYi Lin, MD, PhD · Jonas Paludo, MD · Lewis Roberts, MB, ChB, PhD · Sean S. Park, MD, PhDTT + GMP Autologous DC for Liver Cancer
16:45Wrap-up & Next StepsJulie Allickson, PhD
17:00Adjourn

Programsby site and investigator

Rochester13 programs

Alexander Revzin, PhD

TT + GMP of HEK-293 based Biologics Factory

Encapsulated allogeneicNew
Phase
PH-1/IND
Starting material
NA
Tech evaluationDeep dive

Julie K. Heimbach, MD and Robert C. Huebert, MD

Autologous Adipose-MSC

MSCTechnical AppraisalON 23735-2026
Phase
PH-1/2 (Combined)
Starting material
Stem Cells: Mesenchymal (MSCs) | Adipose Tissue
Tech evaluationDeep dive

Saad J. Kenderian, MB, ChB

TT Comparability and GMP Manufacture of TSHR CAR-T

Autologous CAR-TTechnical AppraisalON 23725-2026
Phase
PH-1/IND
Starting material
Whole Blood
Tech evaluationDeep dive

Saranya Wyles, MD, PhD

Allogeneic MSC-derived extracellular vesicle (EV)

Extracellular vesiclesEngagedON 23785-2026
Phase
PH-1/2 (Combined)
Starting material
Stem Cells: Mesenchymal (MSCs) | Other
Tech evaluationDeep dive

Daniel B. F. Saris, MD, PhD

Phase III MSC MCB & WCB manufacturing

MSCEngagedON 23555-2026
Phase
PH-3
Indication
Meniscus tears
Starting material
Adipose Tissue (SVF / Lipoaspirate)
Tech evaluationDeep dive

David R. Deyle, MD

Gene-corrected cells for osteogenesis imperfecta

MSCPre-IND — discovery and large-animal model. No registered cell trial
Indication
Osteogenesis imperfecta
Starting material
Patient bone-derived stromal cells
Tech evaluation

Jian L. Campian, MD, PhD

Neuro-oncology cell therapy — recurrent glioblastoma

Autologous CAR-TAnticipatory — no SFDC opportunity
Deep dive

Laura J. Lambert, PhD

XIAP HSC Gene Editing

Gene-modified HSCProposal (Delivered)ON 23155-2026
Phase
PH-1/IND
Starting material
Stem Cells: Hematopoietic (HSCs)
Tech evaluationDeep dive

Lewis R. Roberts, MB, ChB, PhD

TT + GMP Autologous DC for Liver Cancer

Dendritic cellNewON 23745-2026
Phase
PH-1/IND
Starting material
NA
Tech evaluationDeep dive

Matthew S. Block, MD, PhD

FRαDC dendritic-cell vaccine (FAROUT) — NCT06639074

Dendritic cellAnticipatory — no SFDC opportunity
Deep dive

Richard G. Vile, PhD

Program not yet defined with MADE

Anticipatory — no SFDC opportunity
Assessment in preparation

Timucin Taner, MD, PhD

Mayo Clinic-Hepatic-derived, Kidney Targeted MSC Program

MSCProposal (Delivered)ON 22345-2026
Phase
Develop/Non-Clinical
Indication
Kidney Inflammation
Starting material
Other
Tech evaluationDeep dive

Wenchun Qu, MD, PhD

Autologous adipose MSC — spinal cord injury

MSCPhase 2 recruitment and injection complete - last patient injected July 2025, 2-year follow-up matures mid-2027
Indication
Spinal cord injury, ASIA classification B and above
Starting material
Autologous adipose-derived MSC
Tech evaluationDeep dive

Jacksonville6 programs

Hong Qin, MD

BAFF-R CAR-T (MC10029) — relapsed/refractory B-cell malignancies

Autologous CAR-TPhase 1/2, recruiting
Indication
B-cell malignancies including patients who have failed CD19 CAR-T
Starting material
Autologous T cells, apheresis
Tech evaluationDeep dive

Keith L. Knutson, PhD

Cancer vaccine portfolio — dendritic cell, DNA, RNA, peptide, nanoparticle

Dendritic cellRoughly 7 clinical trials running, enrolling 700-800 patients
Indication
Treatment, secondary prevention and primary prevention of cancer; Phase 2 in triple-negative breast cancer recurrence prevention; two Phase 2 dendritic-cell vaccine trials in ovarian cancer
Tech evaluationDeep dive

Mohamed A. Kharfan-Dabaja, MD, MBA

BAFF-R CAR-T (MC10029) — NCT06191887

Autologous CAR-TAnticipatory — no SFDC opportunity
Deep dive

Wenchun Qu, MD, PhD

CELLKINE — allogeneic bone-marrow MSC, lumbar facet arthropathy

MSCPhase 2 active
Indication
Lumbar facet arthropathy
Starting material
Bone-marrow-derived MSC, allogeneic
Tech evaluationDeep dive

Wenchun Qu, MD, PhD

mRNA-engineered MSC-EV — IL-1RA-EV and GH1-EV, intradiscal

Extracellular vesiclesPre-IND — FDA INTERACT letter finalized 2026-08-11, submission targeted September 2026
Indication
Degenerative disc disease, intradiscal injection
Starting material
Placenta-derived MSC master cell bank; mRNA-engineered, harvested for EVs only (no whole-cell product)
Tech evaluationDeep dive

Yanyan Lou, MD, PhD

Thoracic and medical oncology — allogeneic cell therapy

Anticipatory — no SFDC opportunity
Assessment in preparation