Liz Cauldwell

SENIOR CONSULTANT

10+ years working in academic, biotech and contract development and manufacturing organizations with a primary focus on manufacturing allogeneic and autologous cell therapy products.

About Liz

Liz has spent over 11 years working with academic, biotech and contract development and manufacturing organizations, focusing on the manufacturing of allogeneic and autologous cell therapy products.

Liz began her career at the University of Pennsylvania, Clinical Vaccine Production Facility with a primary focus on early phases allogeneic and autologous cell therapy production. While at Penn, Liz expanded her working knowledge of cGMP cell therapy production and early phase regulatory submission and management.

In 2016, Liz joined Wuxi Advanced Therapies where she managed multiple manufacturing facilities: most recently, an FDA and EU compliant commercial cell therapy manufacturing facility. Liz developed a plethora of experience on capacity and forecast planning, budget and strategy plans for labor utilization, and internal and external technology transfers for both early and late/commercial phase cell therapy products. Liz has a proven track record of establishing and partnering within a cross-functional setting to continually drive progress and quality production of cell therapy products. Liz was extensively involved in building out systems within the organization, especially related to supply chain.

In 2020, Liz joined WindMIL Therapeutics, leading CMO activities and deliverables in support of the company’s core technologies and pipeline products. She drove activities to establish supply chain capabilities and increase the company’s manufacturing footprint.

Liz joined Dark Horse Consulting as Senior Consultant in September of 2021.

SELECTED PUBLICATIONS

  • Lowenfeld L, Mick R, Datta J, Xu S, Fitzpatrick E, Fischer CS, DeMichele A, Zhang PJ, Weinstein SP, Roses RE, Czerniecki BJ.”Dendritic Cell Vaccination Enhances Immune Resposnes and Induces Regression of HER2(pos) DCIS Independent of Router: Results of Randomized Selection Design Trial.” Clin Cancer Res 2017 Jun.
  • Lowenfeld L, Zaheer S, Oechsle C, Fracol M, Datta J, Xu S, Fitzpatrick E, Roses RE, Fischer CS, McDonald ES, Zhang PJ, DeMichele A, Mick R, Koski GK, Czerniecki BJ. “Addition of anti estrogen therapy to anit-HER2 dendritic cell vaccination improves regional nodal immune response and pathologic complete response rate in patients with ER pos/ HER2 post early breast cancer.” Oncoimmunology 2016 Jul.
  • Datta J, Rosemblit C, Berk E, Showalter L, Namjoshi P, Mick R, Lee K, Brod A, Yang R, Kelz R, Fitzpatrick E, Hoyt C, Feldman M, Zhang P, Xu S, Koski G, Czerniecki BJ. “Progressive loss of anti-HER2 CD4 + T- helper type 1 response in breast tumorigenesis and potential for immune restoration.” Oncoimmunology 2015 May
  • Datta J, Berk E, Xu S, Fitzpatrick E, Rosemblit C, Lowenfeld L, Goodman N, Lewis DA, Zhang PJ, Fisher C, Roses RE, DeMichele A, Czerniecki BJ. “Anti- HER2 CD4 (+) T-helper type 1 reponse is a novel immune correlate to pathologic response following neoadjuvant therapy in HER-2 positive breast cancer.” Breast Cancer Research 2015 May 23; 17(1):71.
  • Lam L, Czerniecki B J, Fitzpatrick EH, Xu S, Schuchter L, Xu X, Zhang “Interference-Free HER2 ECD as a Serum Biomarker in Breast Cancer.” J Mol Biomark Diagn. 2014 Nov 14;4(3):151
  • Lee MK 4th, Xu S, Fitzpatrick EH, Sharma A, Graves HL, Czerniecki “Inhibition of CD4+CD25+ regulatory T cell function and conversion into TH-1 like effectors by a toll like receptor activated dendritic cell.” PLoS One. 2013 Nov 11;8(11)
  • Fracol M, XU S, Mick R, Fitzpatrick E, Nisenbaum H, Roses R, Fisher C, Tchou J, Fox K, Zhang P, Czerniecki “Response to HER-2 pulsed DC1 vaccines is predicted by both HER-2 and estrogen receptor expression in DCIS.” Annuals of Surgical Oncology 2013 Jul 13.
  • Koski GK, Koldovsky U, Xu S, Mick R, Sharma A, Fitzpatrick E, Weinstein S, Nisenbaum H, Levine BL, Fox K, Zhang P, Czerniecki “A novel dendritic cell- base immunization approach for the induction of durable Th1-polarized anti-HER2/neu responses in women with early breast cancer.” Journal of Immunotherapy 35(1); 54-65. (2012).
  • Sharma A, Koldovsky U, Xu S, Mick R, Roses R, Fitzpatrick E, Weinstein S, Nisenbaum H, Levine BL, Fox K, Zhang P, Koski G, Czerniecki “HER-2 pulsed dendritic cell vaccine can eliminate HER-2 expression and impact ductal carcinoma in situ.” Cancer, 118(17); 4354-4362. (2012).
  • Xu S, Koldovsky U, Xu M, Wang D, Fitzpatrick E, Son G, Koski G, Czerniecki “High-avidity antitumor T-cell generation by toll receptor 8-primed, myeloid- derived dendritic cells is mediated by IL-12 production.” Surgery. 2006 Aug; 140(2):170-8.

PAST EXPERIENCE

WindMIL Therapeutics
Senior Director of Manufacturing and MS&T
Director of Manufacturing & Supply Chain

Wuxi Advanced Therapies
Senior Manager, Manufacturing, Sciences and Technology
Manufacturing Manager

Hospital of the University of Pennsylvania
Vaccine Manufacturing Manager

EDUCATION

Drexel University
B.S Biology

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