Corporate Technology-Constructed 18-month, and 2-year technology strategies to support continued discovery acceleration, pipeline growth, automation/AI-Built and deployed Xilio’s security stack along with comprehensive awareness training; deployed IT Change Control and data governance for corporate IP; created a risk management model and supported SOX audit completion-Eliminated costly MSP and relocated all services internally by hiring key members of IT-Created an agnostic cloud data model (using the FAIR standard approach) using Box, Google Workspace, Slack, and AWS to ensure that all data was searchable and organized-Led an enterprise technology curriculum & provided hundreds of hours of training to get all employees on the same page regarding tech-ed-Championed an ethical-first approach towards implementation of GenAI and deployed it company-wide using the Claude platformResearch and Clinical Support-Migrated home-built sample management system into corporate ELN; deployed corporate research library platform to support in-house research and experimentation management-Built a novel lab data architecture for 48 data-generating devices; consolidated all unstructured data into an organized source of access for both on-site and remote employees-Built a mouse-modeling platform using Airtable and deployed to Vivarium usersCulture-Created an IT Prioritization and Strategy cross-functional committee focused on prioritizing resources, spending, and programs-Created and led Xilio's first ethics council focused on the development, deployment, and use of GAI at Xilio-Led Xilio's DEIB and Respect in the Workplace program, which included training of employees and managers, company-wide surveys, instructor-led training campaigns, and a resolution-based approach designed to foster an inclusive experience for all Xilio staff-Worked with HR to redesign the overall approach towards performance management, manager training, data gathering, and promotion management.

As the Head Teacher at Luminaries Forge, I am the architect and expert teacher of an innovative and immersive IT Leadership Development program designed to cultivate the next generation of tech visionaries. In this role, I, along with several leading industry experts, will lead future Luminaries through a bespoke educational experience that transcends traditional learning paradigms, combining personalized attention, practical curriculum, and real-world problem-solving, which are immediately actionable in their role. I am committed to empowering a select cohort of professionals with the leadership skills, critical thinking, and strategic acumen required to excel and lead in the ever-evolving landscape of technology. At Luminaries Forge, we don't just teach IT—we inspire leaders to forge the future.

An exploration into the intricacies of "creating" IT in a corporation. Each week, Michael Crispin and Nathan McBride go through another chapter of the Life Sciences IT Survival Guide and discuss how it applies to IT today. Additionally, we will explore today's technology and keep it in a fun, easy-listening format while having a few cocktails with friends.

First Round’s mentorship program for established technology leaders looking to give back to the technology community. Fast Track matches seasoned startup leaders with rising stars for structured mentorship. This is my second time as a mentor and it’s awesome to be a part of this program.

Headquartered in Massachusetts, Long Walk Consulting is a leader in providing CIO advisory services across industries. From mature companies to the latest startup, our firm specializes in providing services to help achieve goals and success. Whether you are just coming out of your first funding, about to commercialize your first product or ready to expand your strategy and go to the cloud, we will partner with you for every step of the journey. We bring extensive experience and professionalism to every client and customize our support to your individual needs and concerns.

Corporate Technology-Constructed 18-month, 3-year, and 5-year technology strategies to support potential IPO, Commercial Launch, and significant expansion of Clinical Trials-Built and deployed Affinivax’s baseline security stack, which included SSO, EDR, MFA, and comprehensive awareness training; deployed IT Change Control and data governance to ensure control of corporate IP-Eliminated costly Managed Services Providers and relocated all services internally by hiring key members of IT-Created an agnostic cloud data model using Box, Google Workspace, Microsoft Sharepoint, and AWS based on the FAIR standard-Implemented new workflow and business processes across R&D and G&A functions, including a new ERP system, CLMS process, Corporate Project Management, and universal database modeling-Led the training of all employees over several hundred hours to ensure technological education parity as part of a digital upskilling program-Constructed a new corporate backbone to support the expansion from one floor to two floors in our facility; second-floor expansion was for GMP and non-GMP development, including cGMP development-Deployed a WFH hybrid approach for hot-desking and wayfinding within the enterprise, with egress management using the OpenPath architecture-Eliminated burdensome conference room challenges and single-streamed all digital communications into a single platform-Deployed a baseline ELN and corporate research library platform to support in-house research and experimentation management-Built a novel lab data architecture for over 100 data-generating devices that consolidated all data into a single stream and an organized source of access for both on-site and remote employees-Deployed a baseline analytics platform for Research data, which allowed scientists to rapidly generate data models from raw data extracts-Key leader in the technological re-acquisition of our AS-3772 program from Astellas

Corporate Technology-Constructed one and 3-year IT strategies to support potential IPO, Commercial Launch, and Clinical Trials; rapidly scaled Ohana’s cybersecurity program in 14 months-Eliminated costly Managed Services Providers and relocated all services internally-Deployed Google Workplace for collaboration along with a strong SaaS suite supporting our cloud-native approach-Implemented new workflow and business processes across R&D and G&A functions-Assisted HR leadership in developing a “return to work” transition program-Led a corporate relocation to a new facility during the pandemic and initiated a Touchless 21 program-Constructed a “passwordless” security program and re-classified all data within the enterprise under new data ontologyResearch and Clinical Support-Selected and deployed a broad research ELN platform to support the research prototype platform-Developed a platform to work with the NIH on sample-sharing databases-Hired IT staff to support the construction of a massive computational biology program-Set up Clinical Trial sites at several IVF/IUI Centers around the US-Developed a prototype Sperm Donation platform that incorporated mobile scanning and payment functionality

Transforming the lives of patients with rare disorders through innovative gene therapies. With offices in California, Massachusetts and London, we are building a state-of-the-art technology fabric that supports our patients, partners and staff.Compliance & Security-Created and implemented GDPR program to achieve global compliance-Assisted in construction of first Validation Master Plan and Computer Systems Validation structure-Assisted with auditing and implementation of eDMS, eCTD and eTMF platforms-Constructed secure VDR model for healthy M&A strategies-Deployed comprehensive security training program, anti-phishing platform and corporate ERMStrategy-Constructed 1 and 3-year IT strategies to align with business growth, clinical pipeline expansion and commercialization preparation-Hired staff to support Commercial, Clinical, CMC and IT launch programs-Deployed global Services function ensuring 24/7 IT Support-Implemented workflow and business process across R&D and G&A functionsGovernance-Created Strategic Technology Committee for the oversight of all technology spend-Implemented Corporate Security & Risk Council to satisfy HIPAA/21CFR11/SOX compliance-Matured the company into a baseline PMO methodologyPlatforms○Managed the implementation of ERP, CRM, EDMS, EQMS, Track/Trace and several other platforms currently in flight

Digital -Owned development and management of all websites for both internal and external customers with emphasis on B2C consumer sales and rapid marketing initiatives -Led development of digital platform strategy for the business including web, social, mobile to achieve positive CLM and IVA initiativesCloud -Planned successful enterprise-wide cloud strategy including email migration (Google Apps), Web File System and Security Portal Implementation, AWS Development and Private Cloud creation and Unified Communications-Migrated all enterprise and compliant platforms to cloud-Developed and implemented rapid M&A model for integrating acquired systems into our cloud architecture Security & Compliance -Created novel IT security model eliminating common threat vectors-Established comprehensive IT Governance Model within organization to provide and support frameworks for GDPR, SOX, 21CFR11, ISO, AABB, MA201, DSCSA, GDPR and FTC -Deployed anti-phishing platforms and DLP and Data classification models -Implemented ITIL/COBIT framework among IT functional linesLeadership -Hired as IT Employee #1 to develop a long-term IT strategy and to support launch of first commercial drug; introduced several new industry concepts including Lean IT and Cloud -Expertise in technical analysis to effectively present a recommendation to officers or other high-level officials internal or external to the corporation regarding strategic projects -Provided core leadership for M&APlatforms -Deployed and oversaw management of several major platforms under PMO governance model including: ERP, CRM for Consumer & Commercial Sales, Aggregate Spend/State Reporting, Contracts Management, Purchasing/Procurement, Safety, Regulatory Publishing, EDMS, EQMS, Clinical, Biostats, MSL CMSBusiness-Management of all facility operations including construction expansions, facility moves and turndowns-Managed budget of 19mm with quarterly reforecast

-Deployed ELN System-Deployed QMS for QC Lab Environment-Deployed Documentum for support of Regulatory Publishing-Supported and deployed enterprise applications across all corporate divisions except Finance-Successful deployment and management of systems such as Clinical Data Warehouse, Product Safety, Regulatory Publishing, Document Management and Help Desk Issue Management-Direction of the formulation of information management approaches for all Biopharma functional areas including Commercial and Manufacturing-Implementation and management of Research and Development systems and enterprise projects, directing development, release and maintenance activities-Built from scratch and deployed Legal Contracts Management System, Clinical CDISC Management-Supported launch of 2nd indication of Cubicin and assisted in buildout of new QC lab to support in house testing-Participated in and supported company growth of 200 to ~400 employees

-Supported Launch of UK and Sweden Sites and managed global IT resources-Deployed ERP/MRP Financials-Senior-most Leader of IT – Participated in Executive Committee decision making process-Successful deployment and management of systems such as ERP, Clinical Data Warehouse, Product Safety, Regulatory Publishing, Document Management and Help Desk Issue Management-Implementation and management of Research and Development systems and enterprise projects, directing development, release and maintenance activities-Implementation and migration to Virtual Data Center infrastructure including physical, co-lo and cloud-Built from scratch and deployed Purchasing System, Quality Document Management System-Managed five corporate facility moves-Participated in and supported company growth of 200 to ~400 employees and then back down to 200

-Solely responsible for all IT infrastructure, software and deployments school-wide-Senior Curriculum Leader – responsible for designing and teaching annual technology curriculum-Managed entire campus wide network and data center-Taught Java and C+ classes