Services, Experience, Partners

Brizzey provides consulting services, training, tool design, selection and implementation, process modeling and project management. We pride ourselves on offering services that are good value, collaborative, supportive, focused, balanced and practical, in order to help organizations get to the next level.

We have 70+ years combined experience in various aspects of R&D Supply Chain Management, Quality Assurance, Process Optimization, and Organizational Change. We have 17+ years working together on R&D supply chain roles and founded Brizzey in 2014.
We’ve delivered over 60 projects for 37 clients, including 29 sponsors, 4 CMOs and 4 consultant groups.
PROJECTS
Vertical Divider
CLIENTS
We have access to partners experienced in:
  • Pre-clinical Development
  • CMC Information Preparation
  • All Modalities of GMP Manufacturing
  • Leadership, Team Building and Cultural Change
I enjoy working with Brizzey because they truly understand the complexities of the business problems we are facing and help us identify the most effective solutions to address them.
CLIENT

Services

Planning, Production and Global Distribution of Clinical Supplies
  • Defining clinical supply chain strategy and leadership
  • Defining integrated clinical supplies planning, operations and distribution processes
  • Designing and implementing planning tools
  • Forging partnerships between clinical supply partners, internally and externally
  • Helping clinical trial teams to assure predictable study start by aligning clinical, regulatory and supplies timelines
  • Developing comparator acquisition and blinding strategies
  • Assessing, designing and implementing clinical distribution strategies
  • Establishing performance metrics
  • Developing plans for clinical supply protocols
  • Assessing and working with clinical packaging vendors
  • Developing clinical packaging designs
  • Project managing all aspects of clinical supplies
  • Interfacing between Clinical Packaging Organizations and Clinical Research Organizations
Quality Assurance
  • Assessment and development of quality systems and manuals
  • Quality process evaluation and improvement
  • Development of Site Master Files
  • Audits and “person in plant” activities
  • Development of SOPs and other quality documents
  • Batch Record Review
Process Modeling and Improvement for Evolving Organizations
  • Modeling end-to-end processes in various platforms (Visio, Casewise, Business Optix)
  • Selecting and optimizing processes
  • Defining and facilitating change from as-is to to-be process
  • Effectively scoping and developing business cases for change
  • Planning and executing change initiatives from vision through implementation
  • Guiding groups on organizational and cultural change
  • Establishing a culture of continuous improvement
  • Selecting and supporting implementation of IT systems
R&D Supply Chain Training
  • Developing a training strategy and training modules for Clinical Supply Chain professionals
  • Developing awareness training for clinical, regulatory, preclinical and vendor partners
  • Providing training on effective team formation and cross-functional partnerships
  • Providing on-going coaching to enable staff to continuously improve
  • Providing training on culture (country, company, team and individual culture)

Experience

Clinical Supplies ​and GXP
  • Phase appropriate GMP
  • On-site formulation approaches for first in human studies
  • Clinical packaging facility design and operation
  • GMP packaging and labeling
  • Clinical distribution depot design and operation
  • Clinical distribution depot auditing
  • Chemistry, Manufacturing and Controls for early clinical studies
  • Process development to support GDP and trade compliance
  • Forging relationships between Clinical Supplies, Clinical and Regulatory teams for holistic planning and execution
  • GCP audit preparation at the GCP/GMP interface
Process ​Optimization
  • Designing process architecture and infrastructure
  • Facilitation of all business process related activities, teams
  • Business process modeling and analysis
  • Effective scoping and business case development
  • As-is process mapping
  • Gap identification
  • To-be process design
  • Process optimization exercises
  • Connecting processes holistically across business units
  • Training and implementation of new processes and ongoing business process management
Clinical Supply Organization
  • Organizational design, governance and metrics
  • Clinical supply professional recruitment
  • Clinical supply resources models to support clinical demand
  • Third party interface development
  • Clinical supplies planning
  • Clinical supplies strategy development
  • Comparator acquisition and blinding approaches
  • Cross functional planning process development
  • Planning tool design and implementation
  • Clinical, Regulatory and Supply timeline alignment
  • Integrated distribution planning process and tool development
R&D Material Distribution
  • International clinical supply distribution
  • Discovery compound and biologic sample distribution
  • Cold chain strategy
  • Depot network optimization
  • Designing and populating databases of global regulatory and distribution requirements
  • Developing sustainable maintenance processes
  • Embedding data in cross-functional processes
Quality Assurance
  • Quality Manual and Site Master File
  • Quality Policy and Standards
  • Vendor Qualification
  • Operational Oversight and Batch Record Review
  • Business Principle Development
  • SOP Authoring
  • SOP Simplification
Change Management
  • Guiding companies through major change without compromising productivity
  • Planning and executing change initiatives from vision through implementation
  • Educating teams on navigating change
  • Creating a culture of change
Process Tools and Methodologies
  • Casewise Corporate Modeler
  • Business Optix
  • Visio
  • Brownpaper (wall & post its)
  • Risk Assessment and Mitigation
  • Root Cause Analysis
  • Start-Stop-Continue-Change assessment
  • Supply Chain Operational Reference Model (SCOR) framework
  • SIPOC models
  • ​SWOT analysis

Partners

Brizzey collaborates with a network of selected Partner Organizations to provide drug development services that our clients need but that fall outside the scope of our internal expertise.
These established, long-term partnerships are designed to facilitate seamless execution of your project. Together, we will work with these trusted, highly skilled partners to drive your program to success.
Ultramikro, LLC is a consultant firm providing guidance for pharmaceutical and food industries in contamination control and in global pharmacopeial compliance.  Particulate matter in the pharmaceutical presentation may be foreign material or may form due to substances intrinsic to the formulation or package. Removing the sub-visible (—less than 100μm) and larger particles or reducing their impact is quite dependent upon their identification, which is facilitated through analysis by a variety of instruments and approaches. Microscopical applications are foremost in the Ultramikro approach.
The collaboration between Brizzey and Ultramikro ensures that the skills necessary to solve unexpected challenges during product development are available when needed.
Mark VanArendonk founded Vermeer Pharma, LLC in 2018.  He has more than 30 years of pharmaceutical experience and specializes in CMC drug development.  During his “big  pharma” career, Mark held positions of increasing responsibility in Analytical R&D, Quality Assurance and CMC at various companies, concluding as Merck Vice President for Analytical Chemistry in Development and Supply, where he was responsible for late stage development programs from IIB through registration, launch and commercialization. 
As an independent consultant, Dr. VanArendonk supports small and medium-sized companies in early and late development.  
We believe that the partnership between Brizzey and Vermeer Pharma brings together a dynamic combination of skills and experience which will facilitate our clients’ pathway to end-to-end development and increase the rate at which they can bring medicines to patients.
Crux Move Consulting is an accomplished organizational development firm, specializing in organizational culture change and helping build effective leaders, teams and organizations through experiential learning. Crux Move is available to help get your people working together effectively and aligned with your business goals. Using powerful, tried and tested leadership and team development processes, they will help you meet your culture change goals, whether you are looking to enhance the culture of your leadership team or change the culture of your entire organization.
The collaboration between Brizzey and Crux Move is designed to bring together an unprecedented combination of skills and experience to holistically address the people, partnership and processes of your organizational change initiatives.
Synergy Partners R&D Solutions is a network of scientists with a depth of experience in all aspects of pharmaceutical research and development, from target selection to clinical proof of concept and beyond. They have a track record of turning exciting discoveries into medicines, by partnering with clients to design and implement the optimal development strategy for each molecule. Synergy is available to support you in all aspects of drug discovery and development, including  biology, pharmacology, chemistry, drug safety, DMPK, clinical and regulatory.  Synergy will work with your team to design and oversee the execution of appropriate testing and integrate the knowledge gained into downstream plans, to position your program for a seamless transition to development.
The collaboration between Brizzey and Synergy Partners is designed to bring a breadth of expertise to your research and development programs, while offering a seamless transition from research into development.
FarmCMC
​John Skoug founded FarmCMC in 2019 in order to leverage his technical and leadership expertise to help small and medium sized biopharmaceutical companies develop novel therapeutic assets and delivery systems through both early and late stages. 
John has more than 30 years of pharmaceutical industry experience and specializes in CMC product development across all stages of discovery and development.  Prior to founding Farm CMC, he was Senior Director in AbbVie’s drug product R&D organization.  There, he held a number of roles, in which he was responsible for CMC technical strategy and execution for small molecule programs and combination product programs for biologics.  
​John brings a unique breadth of CMC experience, including pharmaceutics support of discovery teams as well as drug and device delivery system technology assessment.
​Together, Brizzey and FarmCMC offer a complementary set of skills and experience, which can help clients with a broad range of activities essential to development of novel therapeutic assets and delivery systems.