Qualifications

Experience

Patrick Leamy, PhD, RAC, CISS has over 20 years experience in biomaterials and tissue banking R&D and quality assurance with a focus on sterilization process development and ensuring efficient and compliant sterilization programs. Patrick brings specific expertise in developing and sterilizing tissue-based biomaterials, biopolymers and other materials where balancing sterilization effectiveness and minimizing material modifications are critical to product performance.

Qualifications: About Me

Patrick has built sterilization programs from the ground up including

Selection of sterilization methods and process parameters based on published data and original experiments on material structure/properties as part of research and new product development.
Developing manufacturing processes that result in a low and consistent product bioburden to ensure consistent sterilization while maintaining product performance.
Sterilization process development and validation: Radiation and Ethylene Oxide.
Bioburden monitoring and dose audit programs.
Engineering studies and validations to ensure product and package performance after sterilization.
Data to support regulatory submissions.
Conducting internal audits and gap analyses.
Supplier audits for sterile or aseptically manufactured components.
Supporting regulatory audits and inspections.
Finding the root cause and implementing corrective and preventive actions related to out of trend bioburden and endotoxin related to raw materials or processing.

Certifications and Affiliations

RAC-Devices Regulatory Affairs Certification
CISS-RAD AAMI Certified Industrial Sterilization Specialist
American Association of Tissue Banks Scientific and Technical Affairs Committee

Education

University of Florida – PhD Materials Science/Biomaterials 2003
Penn State University – MS Materials 1997
Worcester Polytechnic Institute – BS Mechanical/Biomedical Engineering 1994

Employment

LifeLink Foundation, Director R&D 2019 – 2023
Zimmer Biomet Associate Director, Sterility Assurance 2018-2019
LifeCell Corporation, Branchburg NJ positions of increasing responsibility culminating in Associate Director, R&D 2006 – 2018
Materials Engineer, Synthes, West Chester PA 2003-2006

Publications

C. D. Batich, P.J, Leamy and B.J. Willenberg: "Polymeric Biomaterials". Book Chapter in Biomedical Engineering Fundamentals, Myer Kutz editor. McGraw Hill 2021.
Sandor, M., Leamy, P., Assan, P., Hoonjan, A., Edwards, M., Zuo, W., Li, H. and Xu, H., “Relevant In Vitro Predictors of Human Acellular Dermal Matrix-Associated Inflammation and Capsule Formation in a Nonhuman Primate Subcutaneous Tissue Expander Model”. eplasty, 17: 1-21 January 2017.
H. Ansorge, J. R. Garza, M. C. McCormack, P. J. Leamy, S. Roesch, A. Barere, J. Connor. “Autologous Fat Processing using the RevolveTM System: Quality and Quantity of Fat Retention Evaluated in an Animal Model. Aesthetic Surgery Journal, 34(3), 438-447, 2014.
P. J. Leamy and C. D. Batich: "Biopolymers". Book Chapter in Biomedical Engineering and Design Handbook Myer Kutz editor. McGraw Hill 2009.
Q. Q. Qiu, P. J. Leamy, J. Brittingham, J. Pomerleau, N. Kabaria, J. Connor. "Inactivation of Bacterial Spores and Viruses in Biological Material Using Supercritical Carbon Dioxide with Sterilant". Biomedical Materials Research B: Applied Biomaterials, 91: (2) 572-8, November 2009.
J. Krebs, N. Aebli, B. G. Goss, S. Sugiyama, T. Bardyn, I. Boecken, P. J. Leamy, S. J. Ferguson. "Cardiovascular Changes after Pulmonary Embolism from Injecting Calcium Phosphate Cement". Biomedical Materials Research B: Applied Biomaterials, 82: (3) 526-32, August 2007.
P. J. Leamy and C. D. Batich: "Biopolymers". Book Chapter in Standard Handbook of Biomedical Engineering and Design. Myer Kutz editor. McGraw Hill 2002.
P. J. Leamy, P. W. Brown, C. A. Randall, K. S. Tenhuisen: “Fluoride Incorporation in to Hydroxyapatite (HAp) Formed from the Hydration of α-TCP.” Journal of Biomedical Materials Research, 42: (3) 458-464 DEC 5 1998.
R. I. Martin, K. S. Tenhuisen, P.J. Leamy, P. W. Brown: “Enthalpies of Formation of Compounds in the P2O5-CaO-H2O System.” Journal of Physical Chemistry B, 101: (45) 9375-9379 NOV 6 1997.

Patents

Jessop, M. Shah, P. Leamy “Tissue Matrices With Controlled Porousity or Mechanical Properties” International Patent DK3247413T3
Y. Chen, P.J. Leamy, K. Wang, H. Xu “Method for Enzymatic Treatment of Tissue Products. US Patent 10207025B2”
P. J. Leamy, Q. Q. Qiu, M. S. Pohle, J. M. Pomerleau, J. R. Connor “Systems and Methods for Sterilization” US Patent Application 2014/0193299
B.M. Armitage, I. Ison, M.T. Fulmer, S. Kerr, M. Lehmicke, P.J. Leamy, W. Schiffer. "Bone Cement Compositions Having Fiber-Reinforcement and/or Increased Flowability". US patent 8057595.

Qualifications: Text

Qualifications

Patrick has built sterilization programs from the ground up including

Selection of sterilization methods and process parameters based on published data and original experiments on material structure/properties as part of research and new product development.

Developing manufacturing processes that result in a low and consistent product bioburden to ensure consistent sterilization while maintaining product performance.

Sterilization process development and validation: Radiation and Ethylene Oxide.

Bioburden monitoring and dose audit programs.

Engineering studies and validations to ensure product and package performance after sterilization.

Data to support regulatory submissions.

Conducting internal audits and gap analyses.

Supplier audits for sterile or aseptically manufactured components.

Supporting regulatory audits and inspections.

Finding the root cause and implementing corrective and preventive actions related to out of trend bioburden and endotoxin related to raw materials or processing.

​​

Certifications and Affiliations

RAC-Devices Regulatory Affairs Certification

CISS-RAD AAMI Certified Industrial Sterilization Specialist

American Association of Tissue Banks Scientific and Technical Affairs Committee

​​

Education

University of Florida – PhD Materials Science/Biomaterials 2003

Penn State University – MS Materials 1997

Worcester Polytechnic Institute – BS Mechanical/Biomedical Engineering 1994

​​

Employment

LifeLink Foundation, Director R&D 2019 – 2023

Zimmer Biomet Associate Director, Sterility Assurance 2018-2019

LifeCell Corporation, Branchburg NJ positions of increasing responsibility culminating in Associate Director, R&D 2006 – 2018

Materials Engineer, Synthes, West Chester PA 2003-2006

Publications​

C. D. Batich, P.J, Leamy and B.J. Willenberg: "Polymeric Biomaterials". Book Chapter in Biomedical Engineering Fundamentals, Myer Kutz editor. McGraw Hill 2021.

Sandor, M., Leamy, P., Assan, P., Hoonjan, A., Edwards, M., Zuo, W., Li, H. and Xu, H., “Relevant In Vitro Predictors of Human Acellular Dermal Matrix-Associated Inflammation and Capsule Formation in a Nonhuman Primate Subcutaneous Tissue Expander Model”. eplasty, 17: 1-21 January 2017.

H. Ansorge, J. R. Garza, M. C. McCormack, P. J. Leamy, S. Roesch, A. Barere, J. Connor. “Autologous Fat Processing using the RevolveTM System: Quality and Quantity of Fat Retention Evaluated in an Animal Model. Aesthetic Surgery Journal, 34(3), 438-447, 2014.

P. J. Leamy and C. D. Batich: "Biopolymers". Book Chapter in Biomedical Engineering and Design Handbook Myer Kutz editor. McGraw Hill 2009.

Q. Q. Qiu, P. J. Leamy, J. Brittingham, J. Pomerleau, N. Kabaria, J. Connor. "Inactivation of Bacterial Spores and Viruses in Biological Material Using Supercritical Carbon Dioxide with Sterilant". Biomedical Materials Research B: Applied Biomaterials, 91: (2) 572-8, November 2009.

J. Krebs, N. Aebli, B. G. Goss, S. Sugiyama, T. Bardyn, I. Boecken, P. J. Leamy, S. J. Ferguson. "Cardiovascular Changes after Pulmonary Embolism from Injecting Calcium Phosphate Cement". Biomedical Materials Research B: Applied Biomaterials, 82: (3) 526-32, August 2007.

P. J. Leamy and C. D. Batich: "Biopolymers". Book Chapter in Standard Handbook of Biomedical Engineering and Design. Myer Kutz editor. McGraw Hill 2002.

P. J. Leamy, P. W. Brown, C. A. Randall, K. S. Tenhuisen: “Fluoride Incorporation in to Hydroxyapatite (HAp) Formed from the Hydration of α-TCP.” Journal of Biomedical Materials Research, 42: (3) 458-464 DEC 5 1998.

R. I. Martin, K. S. Tenhuisen, P.J. Leamy, P. W. Brown: “Enthalpies of Formation of Compounds in the P2O5-CaO-H2O System.” Journal of Physical Chemistry B, 101: (45) 9375-9379 NOV 6 1997.

Patents

Jessop, M. Shah, P. Leamy “Tissue Matrices With Controlled Porousity or Mechanical Properties” International Patent DK3247413T3

Y. Chen, P.J. Leamy, K. Wang, H. Xu “Method for Enzymatic Treatment of Tissue Products. US Patent 10207025B2”

P. J. Leamy, Q. Q. Qiu, M. S. Pohle, J. M. Pomerleau, J. R. Connor “Systems and Methods for Sterilization” US Patent Application 2014/0193299

B.M. Armitage, I. Ison, M.T. Fulmer, S. Kerr, M. Lehmicke, P.J. Leamy, W. Schiffer. "Bone Cement Compositions Having Fiber-Reinforcement and/or Increased Flowability". US patent 8057595.

Publications