Team

Our Team

BioIT Solutions was founded in 2006 to serve emerging and established biotechnology companies. Company founders have worked in the biotechnology sector for 20 years in a variety of information-technology capacities, including senior positions as CIO, and directors of Bioinformatics, Quality Systems and Clinical Systems.

We have managed the demanding requirements of genomic research and bioinformatics, the complexity of drug development projects, and the challenges of launching clinical operations and product development functions. The breadth of our experience makes us an ideal partner for early-stage companies, as well as those with legacy systems in need of modernization.

Michael R. Fannon

President

Michael Fannon has over 20 years of direct experience in the design, development and management of systems focused on Biotechnology research, development, clinical trials and product manufacturing. Mike advises emerging biotechnology companies in business strategy, process engineering, customer relationship management, IT infrastructure development and laboratory automation. Mike is the chief architect of the BioIT Solutions Portal Products that provides a suite of services for capturing, presenting and analyzing information along the full biotech product lifecycle.

Mike was Vice President and Chief Information Officer of Human Genome Sciences, Inc. from 1994 through September 2005. Mike managed the design and implementation of computerized systems to support HGS’s high-volume laboratory data collection, biological research, clinical data management, product development, manufacturing and business operations. Prior to joining HGS, Mike was the founder and president of TSI Consulting, Inc. in Silver Spring, MD, and held a series of technical and management positions with Martin Marietta’s Information Systems Group.

Mike is an author of publications in scientific journals and business magazines; he is co-inventor on two patents for microbial genomes. Mike serves as the Chairman of the Board of Trustees for the Barrie School, an independent Pre-K through 12th grade school in Silver Spring, Maryland.

Mike earned an MBA in Operations Analysis from The American University, and a Bachelor’s degree in Physics from Rollins College in Winter Park, Florida.

Bob Beliveau

Vice President - Pharmaceutical Research and Development IT Systems

Bob Beliveau has worked in the life science industry for over 25 years in a variety of information technology positions. He has expertise in project and organizational management and process reengineering with an emphasis on research, development, manufacturing, and quality systems. Bob works closely with a number of biotechnology, diagnostic, and medical device companies advising then on regulatory compliance, software development and integration and business process reengineering.

Bob is the architect for BioIT’s 1PLATFORM4® Product Development and Analytical Testing (PDAT). 1PLATFORM4 PDAT combines material management (product genealogy), with inventory, and laboratory informatics (LIMS). This unique combination of features brings capabilities to emerging biotech companies that were once only available to top-tier pharma, provides unparalleled visibility into product development data, and empowers the chemical, manufacturing, and controls (CMC) functions to bring drugs to market sooner.

Bob was Senior Director of Production Systems at Human Genome Sciences (HGS) between 2001 and 2006. Since leaving HGS, he has devoted his professional energy to building BioIT Solutions into a leading provider of specialty informatics services. He is a major contributor to the company’s quality system (SOPS & Policies) and also a focal point for the technical infrastructure on which the company’s computing assets are built.

Bob is a member of the World Batch Forum (WBF) and the Society of Quality Assurance (SQA). He is actively involved in a number of charities such as Western Upper Montgomery County (WUMCO) Help, San Mar Children’s home, and Son Servants. Bob is also an avid soccer player and coach and has recently coached high school boys and girls soccer teams.

Bob earned his Bachelor’s degree in Computer Science from the University of Maryland, College Park, Maryland.

Jeff Schumack

Vice President – Molecular Diagnostics and Clinical IT Systems

Jeff Schumack has over 30 years of experience in the IT industry, mostly in the biotechnology sector. His experience includes managing complex projects, leading multi-disciplinary teams, building validation programs in response to regulations including FDAs 21 CFR, Part 11, architecture and development of custom laboratory software, and a deep understanding of business processes used by Clinical Research & Development organizations.

Jeff has been instrumental in building the BioIT Solutions’ molecular diagnostics and clinical platforms to support the growing needs of diagnostics and bio/pharmaceutical companies. He has worked closely with clients to implement enterprise systems that address the unique requirements of these industries.

Jeff was the Associate Director of Clinical & Regulatory Systems at Human Genome Sciences. In this role, he directed the implementation of a clinical and regulatory informatics infrastructure to support HGS’ clinical trials. Jeff successfully implemented this program by working closely with all groups in the research and development organization including; clinical data management (Clintrial, Integic), clinical operations (CTMS), clinical immunology (CSTrack), drug safety (ARISg), regulatory affairs (Documentum and Insight Publisher) and biostatistics (SCE).

Jeff was instrumental in the creation of HGS’s computerized system validation program, serving as the lead IT interface for all validation activities. He authored several Policies and SOPs in support of this program. Jeff was also the lead IT contact on IT matters during FDA and partner audits.

While a majority partner at TSI Consulting, Inc., Jeff managed several client accounts providing IT services to biotechnology companies. He and his team developed custom applications for various clients including companies performing biologic testing and Genomic research.
Jeff has presented his work at a number of conferences including; the American Statistical Association, Immunogenicity for Protein-Based Therapeutics and EMCs Momentum conference.

Jeff earned a BS degree in Computational Mathematics from Michigan State University, East Lansing, Michigan.

Dori Gonzalez-Acevedo

Vice President of Quality Assurance

Dori Gonzalez-Acevedo has 20 years experience in the pharmaceutical industry, specializing in regulatory compliance strategy and computer systems validation. She started her pharmaceutical career developing FDA-approved manufacturing processes. She then moved to operations quality groups in biotechnology firms where she established Risked-Based Quality Systems.

Dori’s focus has been on risk-based strategy and compliance since she started consulting at Genilogix, continuing through to her role as Director of Quality Systems for Healthcare and Life Sciences at Avnet. As the VP of Strategic Solutions at Tx3, Dori expanded Tx3’s services with a focus on increasing current use of tools and advancing client understanding of compliance, automation, testing, and beyond.

Dori received her bachelors degree in Biochemistry from Hofstra University and completed her masters degree in Biochemistry at Bryn Mawr College.

John Labarge

Senior Consultant

John Labarge has been working in the life sciences industry for almost 25 years in a variety of Information Technology roles. John works with biotechnology organizations to develop custom Laboratory Information Management Systems (LIMS) that fit their specific operational requirements. He develops computerized system validation program documentation to assist organizations with the regulatory compliance of their systems and processes.

John was the Associate Director, Computer Validation and IT Compliance, at Sucampo Pharmaceuticals. Here he developed and served as program manager for the Computerized System Validation (CSV) Program and functioned as liaison between IT and applicable functional business departments to ensure understanding of operational compliance requirements and to establish how IT projects met requirements. Prior to Sucampo, John consulted as the project manager of CSV projects and software implementations, managing implementations and validation teams for multiple pharmaceutical and biotechnology companies. John led the implementation and validation effort for Hewlett Packard Application Life-Cycle Management (ALM) system for a global Fortune 500 biotechnology company, including requirements gathering, customization, qualification, training, and deployment.

John enjoys coaching his son’s touch football team.

John earned his Bachelor’s degree in Computer Science from Virginia Tech, Blacksburg, Virginia.

Ken Koeser

Senior Consultant

Ken Koeser has twenty years of experience in the life sciences industry. At BioIT, he works with clients to ensure their deployment of the 1PLATFORM4 adds value to their business processes and evolves as their processes improve.

As an Associate Director at Human Genome Sciences, he deployed and improved many of the company’s validated computerized systems, including those for Quality Management, Learning Management, Enterprise Asset Management, Document Management, and Manufacturing Intelligence. He has spoken at industry and vendor conferences about the broad COTS configurations created to address multiple business processes. As the IT Business Partner at GSK biopharmaceutical manufacturing sites, he managed use and continuous improvement of corporate services to ensure they provided value. In particular, he was the implementation manager for the Rockville site’s ERP deployment, impacting all aspects of the manufacturing and quality processes.

Ken earned his bachelor’s degree from Virginia Tech in Engineering Science and Mechanics.

Charlie Boucher

Senior Technical Analyst

Charlie Boucher has 8 years of experience working in the biotechnology industry with a focus on enhancing operations using technology. Charlie acts as lead in the implementation and troubleshooting for several instances of the BioIT platform.

Charlie’s experience with BioIT began as a client in 2014. After struggling for years with an outdated LIMS, Charlie partnered with Mike Fannon to develop an animal study module on the BioIT platform. By removing the friction caused by legacy system Charlie was able to focus on software development. Subsequently, he transitioned to the BioIT team in 2018. Coming from the client side of development, Charlie has a unique perspective on the iterative development process.

Charlie earned a Bachelor’s Degree in Biotechnology from James Madison University, Harrisonburg Virginia.

Blog Post

Learning from Experience

August 26, 2012

By Mike Fannon. During my long tenure with Human Genome Sciences (from late 1992 through 2005), I had the good fortune to participate in a biotech startup from the ground floor. It was a real learning experience to work for an entrepreneurial company staking a claim on the genomic frontier in the mid 1990s.

Our Team