The Be The Match BioTherapies® leadership team brings a diverse skill set, proven track record of success and a wealth of industry knowledge to support companies around the world in developing innovative, lifesaving therapies while leveraging the cell sourcing, cell therapy supply chain, CRO services, and outcomes tracking capabilities of the National Marrow Donor Program® (NMDP)/Be The Match® and the CIBMTR® (Center for International Blood and Marrow Transplant Research®).
Amy Ronneberg, MBA
President, Be The Match BioTherapies
Chief Financial Officer, NMDP/Be The Match
Amy Ronneberg, MBA, is the President of Be The Match BioTherapies. She is responsible for developing and delivering a strategic plan to grow and expand our portfolio of product offerings. She is also the Chief Financial Officer for NMDP/Be The Match, and is responsible for planning, implementing and directing the organization’s finances, and collaborating with NMDP/Be The Match executives and Board of Directors to develop and implement strategic business plans to meet the changing health care environment.
Amy joined NMDP/Be The Match in July 2013. She has more than 20 years of experience in financial and operational leadership, most recently as Executive Vice President, Chief Financial Officer and Chief Operating Officer of North American Membership Group, a private equity-owned media company. Prior to that, she spent 12 years at Capella University, where she served as Vice President of Finance and led enterprise-wide operations and customer service.
Amy currently serves on the board for Magenta Therapeutics, Tmunity Therapeutics, the World Marrow Donor Association and the Women’s HealthCare Leadership Trust. She earned her MBA from Capella University and BBA in Accounting from the University of Wisconsin-Eau Claire.
Steven Devine, MD
Medical Director, Be The Match BioTherapies
Senior Vice President of Research and Associate Scientific Director, CIBMTR
Dr. Devine is the Medical Director for Be The Match BioTherapies. He is responsible for evaluating the science behind cellular therapies and their potential clinical impact, and helps the leadership team determine the best opportunities for leveraging the many assets of our organization to partner with cell and gene therapy companies who are bringing innovative therapies to patients.
He also serves as the Senior Vice President and Senior Medical Director of Research and Associate Scientific Director at the CIBMTR, providing oversight of the CIBMTR Minneapolis research team, defining strategy and setting direction. In addition, he works to identify, evaluate and acquire new business opportunities for the prospective clinical research program.
Prior to joining Be The Match BioTherapies and CIBMTR, he was Professor of Internal Medicine and Director of the Blood and Marrow Transplant program at the Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC-James). Before that, he held positions at Washington University in St. Louis, the University of Illinois in Chicago and Emory University, Atlanta.
He has also served on the graft-versus-host disease Advisory Boards of Bristol Myers Squibb,Incyte Pharmaceuticals, Kiadis Inc, and Genzyme. He is a past member of the boards of directors of the National Cancer Institute (NCI) Alliance for Clinical Trials cooperative group and the American Society of Blood and Marrow Transplantation. He is past chair of the National Heart Lung and Blood/NCI-sponsored Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Steering Committee, and of the transplant committee for the Alliance, part of the NCI’s National Clinical Trials Network.
Dr. Devine graduated from the University of Massachusetts Medical School and trained in hematology/oncology at the University of Chicago and Emory University. He is a member of the American Society of Hematology, The American Society of Clinical Oncology, The Association for the Advancement of Cancer Research and the American Society of Blood and Marrow Transplantation.
Julie Smolich, MBA
Senior Vice President, Product Delivery and Development
Julie Smolich, MBA, is Senior Vice President of Product Delivery and Development for Be The Match BioTherapies. She provides leadership to the cell and gene therapy operations, product development and provider services teams to ensure the delivery of products for clients and health care professionals.
Julie is responsible for developing, implementing and overseeing new products, including identifying and understanding industry needs, and delivering solutions to customer issues. She partners with the business development and sales team to operationalize product solutions for clients.
She has extensive and varied experience in leadership roles, product/portfolio management, new product development, strategic planning, and process development/improvement.
Prior to joining Be The Match BioTherapies, Julie spent 16 years at Capella Education Company where she held several leadership positions. Most recently, she was the Vice President and General Manager of a multi-million dollar business unit where she led the innovation of a ground-breaking academic delivery model called FlexPath. Earlier in her career, she worked in the financial services industry at Piper Jaffray and EY.
Julie has her CPA (inactive) and earned her MBA from Capella University and a B.S. in Accounting from St. Cloud State University.
Chris McClain, MBA
Vice President, Sales and New Business Development
Chris McClain is Vice President of Sales and New Business Development for Be The Match BioTherapies. He leads the sales and business development team, which engages with companies developing innovative, lifesaving therapies that can leverage the cell sourcing, cell therapy supply chain, CRO services, and outcomes tracking capabilities of the National Marrow Donor Program (NMDP) / Be The Match.
Before joining Be the Match BioTherapies full-time, Chris was co-Founder of Nora Therapeutics, Inc., a venture-backed biopharmaceutical company developing novel therapies in areas of significant unmet medical need in reproductive health. While at Nora Therapeutics, Chris and his team raised more than $50 million in venture capital to fund pre-clinical and clinical development of Nora’s lead asset and build out a world-class executive team. Prior to founding Nora Therapeutics, Chris held a variety of management consulting and operational roles in the technology sector.
He has served as an advisory member of the University of Minnesota Office for Technology Commercialization Venture Center, a guest lecturer in the Life Sciences program at the University of Minnesota’s Carlson Graduate School of Management, a mentor to the annual MNCup startup competition, and a co-chair of Medical Alley’s Biotech Shared Interest Group.
Chris has an MBA and B.A. in Economics from the University of California, Berkeley.
Jamie Margolis, PhD
Director, Cell and Gene Therapy Operations
Jamie Margolis, PhD, is the Director of Cell and Gene Therapy Operations for Be The Match BioTherapies, and has more than 9 years of experience managing the complexities of cell and gene therapies. Jamie and her team work closely with clients to understand their unique needs and determine how Be The Match BioTherapies can best support delivery of services based on client specifications.
It is her team’s responsibility to ensure the smooth operational delivery of products and services to clients, such as supply chain management, development and management of collection networks, identifying and sourcing allogeneic donor cells, as well as regulatory compliance.
Jamie joined Be The Match BioTherapies’ parent organization, the NMDP/Be the Match, in 2009 and spent the first 6 years in patient case management supporting the operational needs of health care providers for stem cell transplant and developing solutions to overcome unexpected disruptions to the complex product delivery process. Jamie has worked for Be The Match BioTherapies since it was established in 2016.
She holds her PhD in Molecular Biology and Genetics from the University of Minnesota and received her B.S. in Biology from Clarke University in Dubuque, IA.
Amy Hines, BSN, RN
Director, Collection Network Management
Amy Hines, BSN RN, is the Director of Collection Network Management for Be The Match BioTherapies. In her role, Amy oversees the performance of apheresis and marrow collection centers and cell therapy labs in the network, and ensures their on-going compliance with FDA and International standards and criteria, industry best practices, and appropriate regulatory and accrediting entities.
She joined NMDP/Be The Match in 2013 and managed the NMDP/Be The Match apheresis and marrow collection center network of more than 90 apheresis centers and 80 marrow collection centers.
Amy has nearly 20 years of experience in the cellular therapy field. Her career in this field began as a stem cell transplant registered nurse at Spectrum Health/Helen DeVos Children’s Hospital in Grand Rapids, Mich., in 1999. Over the course of 12 years in Grand Rapids, Amy held a wide range of positions including Staff Nurse on a 15-bed pediatric unit, Transplant Coordinator, Program Manager, Clinical Research Coordinator of the Children’s Oncology Group (COG), and finally Program Administrator for the pediatric and adult stem cell transplantation programs.
She received her B.S. in Nursing from Grand Valley State University in Allendale, Mich.
Ann Kemp, MT (ASCP), CQA, RAC
Senior Manager, Quality and Regulatory Compliance and Standardization
Ann Kemp, MT (ASCP), CQA, RAC, is the Senior Manager of Quality and Regulatory Compliance and Standardization for Be The Match BioTherapies. She provides regulatory support for compliance to FDA regulations applicable to human cells, tissues and cellular and tissue-based products (HCT/P); (21 CFR 1271, 21 CFR 210/211, 21 CFR 312) to clients and network centers. She manages and performs audits of Be The Match BioTherapies collection centers, in conjunction with NMDP/Be The Match Quality and Regulatory Services, to ensure compliance with FDA and international regulatory requirements.
Ann joined NMDP/Be The Match in 2012 as manager of the regulatory compliance department. She transitioned to Be The Match BioTherapies in 2016.
Ann has been a Certified Quality Auditor (CQA) since 2005, per the American Society for Quality and received Regulatory Affairs Certification (RAC) in 2009 from the Regulatory Affairs Professionals Society.
Prior to joining Be The Match, Ann worked for 15 years in a variety of quality and regulatory roles at the Regulatory and Clinical Research Institute, Inc., and Medtronic, Inc., both in Minneapolis, MN, and University of Vermont Medical Center in Burlington, VT. Ann conducted audits to assess compliance to ISO 9001, ISO 13485, 21 CFR 820 QSR and 21 CFR 58 (GLP) for various medical device companies. She provided regulatory support for a variety of medical devices, including evaluation of design and manufacturing changes, labeling and promotional materials, assessment for regulatory impact and preparation of necessary documentation for compliance to U.S. and international regulations. Ann prepared global (U.S., E.U., Canada, Japan, Asia Pacific, Latin America) regulatory submissions and/or submission support for medical devices including PMA, IDE, 510(k), Design Dossiers and Technical Files, and designed and conducted quality system training for various medical device companies.
Prior to her roles in quality and regulatory, Ann spent 30 years working in the clinical laboratory in hematology, immunology, autologous stem cell therapy and transfusion services.
She received her B.S. in Medical Technology from Hartwick College in Oneonta, NY.
Vice President, Business Development and Strategic Partnerships
Mark Flower is the Vice President of Business Development and Strategic Partnerships for Be The Match BioTherapies. He is responsible for aligning the organization’s objectives with a firm business strategy, overseeing research and development of new markets for products and services, proactively assessing existing sales organization support investments, and leading development initiatives to grow sales and new business development for the organization.
Mark brings more than 12 years of experience working in the field of immuno-oncology, cell based gene and immunotherapy, cell therapy manufacturing and bioprocessing. Previously, he served as the Executive Director of Sales and Marketing at Hitachi Chemical Advanced Therapeutics Solutions, and as Senior Manager, Global Strategic Marketing, in the Therapeutic Systems business unit at Terumo BCT. In those roles he successfully launched multiple devices and technologies in the field of stem cell collection via leukapheresis, cell isolation, cell processing and culture.
Mark is a member of the International Society for Cell and Gene Therapy (ISCT) and the Society for Immunotherapy of Cancer (SITC). He graduated from the University of California, San Diego with a B.S. in Biological Sciences.
Senior Director, Sales and New Business Development
Erin Rasch is the Senior Director of Sales and New Business Development for Be The Match BioTherapies. In her role, she assists in the assessment, creation and management of strategic partnerships, alliances and acquisitions, and new business opportunities.
Erin has more than 10 years of biotechnology development services experience. Previously, she served as Vice President of Sales and Marketing at Cell Culture Company (C3), a Minneapolis-based contract manufacturing organization focused on providing cell culture services to clinical-stage pharmaceutical and diagnostic organizations.
Prior to C3, she worked at DCI-Biolafitte in Minnesota as a Sales Engineer specializing in bioreactors and other process equipment. She began her biomanufacturing career at Verenium Corporation in San Diego as a Manufacturing Process Engineer.
She holds an M.S. in Bioengineering from the University of California, San Diego, and graduated summa cum laude with a B.S. in Chemical Engineering from Auburn University. She is involved in multiple life science industry organizations.
Gregg Bodnar, PMP
Client Engagement Manager, New Business Development
Gregg Bodnar, PMP, is the Client Engagement Manager in New Business Development for Be The Match BioTherapies. He is responsible for overall client satisfaction and retention. Gregg oversees all client proposals and responses to ensure quality and timeliness expectations are met.
He joined NMDP/Be The Match in 2015 in the Enterprise Portfolio Management Organization and coordinated sales and delivery efforts for BioTherapies before transferring into New Business Development.
Gregg has over 20 years of experience in client engagement and project management. His background is in information technology, where he has been accountable for multi-million dollar software development portfolios in healthcare and retail. He has worked with Fortune 500 clients for both web and software development. Prior to working on information software, Gregg was a business writer specializing in healthcare and human services organizations.
He received his B.A. in Journalism and Mass Communications from the University of Minnesota and has a Project Management Professional certification from the Project Management Institute.
Petr Machalik, M.S.
International Collection Network Manager
Petr Machalik is the international collection network manager for Be The Match BioTherapies. He manages operations of the international BioTherapies Collection Network with an emphasis on developing and managing complex international relationships, and maintaining an effective and stable network of international collection centers for clients of Be The Match BioTherapies. He provides guidance to centers in the collection and processing of cells that are compliant with country-specific laws and regulations, in addition to international standards and regulatory requirements.
Petr has more than 10 years of experience managing international projects in the health care industry, including positions in pharmaceuticals, medical devices and clinical research. In his previous role, he was the lead apheresis network manager for Sotio, a European company developing cellular immunotherapies. Along with managing the collection network covering more than 20 European countries, Petr was involved in quality surveillance of China-based operations, including case analyses and inquiry and communication of quality issues.
Petr earned his M.S. in Hydrobiology from Mendel University in Brno, Czech Republic, as well as a B.S. in Political Science from Charles University in Prague, Czech Republic.