We are solely focused on the Life Sciences industry
We provide deep domain expertise to help biopharma and medical device companies navigate scalable growth globally
Clinical Development
Companies are increasingly pressured to do more with less and are looking for new and innovative ways to conduct clinical, regulatory and safety activities
We help emerging and mid-market life sciences companies accelerate growth
Our Focus
We help rapidly growing biopharma companies build the internal capabilities needed to scale globally and drive the best outcomes from vendors
Our Unique Perspective
We leverage deep domain expertise in each of our solutions to help companies scale globally
There is no substitute for real-world global experience
Our domain experts have 20-30 years of experience each. They bring relevant perspectives regarding emerging trends across the industry, what works and what doesn’t for specific solutions and how to successfully implement transformational changes needed to leapfrog the competition.
Typical Challenges Across Development
Below are examples of challenges our clients have experienced across the R&D space
Clinical
Quality
Regulatory
Safety/PV
Performance
Study start-up delays
Global process harmonization
Project Management alignment
Inspection readiness concerns
Inadequate CAPA oversight
Lack of global RIM or IDMP strategy
Central/regional hub alignment
Inefficient hand-offs internally and with vendors/partners
Unclear roles and responsibilities
Partnerships
Sourcing strategy
Negotiating and managing CRO contracts
Lack of governance structure/processes
Quality agreements missing/out of date
Lack of transparency to vendor quality
Inadequate vendor oversight
Adoption of new partnering model
No visibility to vendor activities
Safety Database incomplete
Compliance
Demonstrating effective vendor oversight
Overlaps of sponsor and vendor SOPs
Missing quality KPIs
Training not effective and skills lacking across the organization
Gaps in validation SOPs and templates
Company core data sheets out of synch
Poor commitment tracking globally
Late AE’s and aggregate reports
Poor regional oversight
Transparency to risks lacking
Example Solutions and Capabilities
We develop implementable strategies and practical solutions that are based on reality, not theoretical assumptions
Click on the links below to explore a few of the solutions and capabilities we offer to help you tackle complex issues and transform your operational performance
VendorSight360: Vendor Selection and Partnerships
Clinical Execution Readiness
Process and Procedure Development
Audit and Inspection Readiness
Analytics, Metrics and Dashboards
M&A Integrations and Divestitures
CAPA Optimization and Skill Development
Data Strategy and Architecture
Selected Case Studies
Invoice Accrual Process
Leading biotech customer with a growing pipeline, relying more heavily on outsourcing partners, needs a way to effectively manage and control portfolio spend and obtain clarity related to study level financials to inform business decisions.
A rapidly growing pre-commercialization biotech company has outpaced its ability to demonstrate effective quality oversight of its GCP activities. It needs a detailed review of its Clinical organization and Quality Management System including core processes, technology, and organizational structure. It specifically needs to review its capabilities in the face of ICH E6 R2 requirements for risk-based methods.
A biotech company has just received its first commercial product approval. Anticipating an inspection, new leader of its Pharmacovigilance organization needs a quick and comprehensive assessment of current gaps, potential risks and ideas for tool improvements. Given that operational activities are largely outsourced to a vendor, its ability to demonstrate oversight of vendor activities is a critical to its inspection readiness under ICH E6 R2.
A fast-growing biopharma company has just been granted approval for its first commercial product. Most of the client’s team has never experienced a full non-GMP inspection. They completed a gap assessment and are actively addressing findings. But the entire organization needs training and guidance on hosting the Health Authority and presenting itself as organized, competent and capable of answering any question that may arise with speed and professional calm.
A mid-sized biotech company was focused on executing a global clinical pipeline but, like many emerging companies, had inefficient and disjointed processes. In addition, processes and teams were not fully grounded in GCP or other regulatory compliance needs. These challenges combined to make the development process cumbersome, inefficient and open to compliance risks.
A small, rapidly growing Biotech had several therapeutic assets moving to clinical development. It faced challenges in strategic development decisions, CRO negotiations, and senior management information reporting. It needed a consistent means by which to manage and report, and to focus on the science without being encumbered by complicated tools. Timing was critical as some team members would soon be on leave and the company had yet to achieve its first approval.
A mid-sized biopharma company needed to identify internal activities that should be outsourced and implement an objective, defendable process to select preferred vendors that not only fit specific functional/study needs, but also represent best value for investment.
An emerging biopharma company had an inefficient and disjointed process for the selection of vendors to support study-specific activities, from service need identification through contract execution. They had difficulty aligning on needs and during the bidding process, leading to challenging bid comparisons and an over-reliance on Start-Up Agreements (SUAs)
A small biotech company did not have internal resources or capabilities to support Procurement and Clinical Vendor Management functions; the internal team was focused primarily on Study Design and Clinical Operations execution. These gaps in key business functions, coupled with a rapidly expanding portfolio, presented significant risks to timelines and the ability to manage critical vendor activities.
A rapidly growing pre-commercial biotech company found it increasingly difficult to manage large-scale clinical trials being executed by two costly global CROs. The company needed a robust oversight process to handle the rapidly increasing volume of planned trials, since consistent processes, metrics and tool to ensure on-time and high-quality delivery did not exist.
A rapidly-growing EU-based biotech company purchased a US-based entity. The company needed assistance planning and leading integration activities to harmonize across all Development functions. Some of the capabilities between the two entities were complementary, but they were interested in rapid integration globally, to align with their newly-developed strategy.
A small growing Biotech was bringing its therapeutic assets to full clinical development. Balancing the need to move through clinical development in a safe but agile manner while guarding the company’s assets and leveraging emerging relationships with strategic suppliers was proving a difficult balance, particularly as different stakeholders had distinct needs and perspectives. The result was a protracted contracting process which generated confusion and slowed work progress. All of this while ensuring suppliers met quality and compliance standards to ensure the validity of clinical results.
A biotech company with products in early clinical phases sought to reduce its spend with a large Contract Research Organization, while looking for options to replace with a lower-cost and more responsive CRO. The internal team has limited experience interacting with CROs and needs guidance to ensure a successful trial outcome.
A small biopharma company was expecting a large Change Order (CO) from it’s primary CRO on a Phase IIB global clinical program that was experiencing delays. The company had limited means by which to evaluate the CO, given a mix of performance issues and COVID-related delays in study start-up and recruitment, as well as cost overruns due to low initial estimates for investigator pass-through grants.
A global genomics data company is building out its core processes and go to market strategy. It must recognize and integrate key quality principles to reduce operational and compliance risk. It conducts its operations in Europe, Asia and North America and is subject to Data Privacy regulations across all jurisdictions. The goal is to make its processes robust and compliant everywhere it does business.
Leading biotech customer with a growing pipeline, relying more heavily on outsourcing partners, needs a way to effectively manage and control portfolio spend and obtain clarity related to study level financials to inform business decisions.
A rapidly growing pre-commercialization biotech company has outpaced its ability to demonstrate effective quality oversight of its GCP activities. It needs a detailed review of its Clinical organization and Quality Management System including core processes, technology, and organizational structure. It specifically needs to review its capabilities in the face of ICH E6 R2 requirements for risk-based methods.
A biotech company has just received its first commercial product approval. Anticipating an inspection, new leader of its Pharmacovigilance organization needs a quick and comprehensive assessment of current gaps, potential risks and ideas for tool improvements. Given that operational activities are largely outsourced to a vendor, its ability to demonstrate oversight of vendor activities is a critical to its inspection readiness under ICH E6 R2.
A fast-growing biopharma company has just been granted approval for its first commercial product. Most of the client’s team has never experienced a full non-GMP inspection. They completed a gap assessment and are actively addressing findings. But the entire organization needs training and guidance on hosting the Health Authority and presenting itself as organized, competent and capable of answering any question that may arise with speed and professional calm.
A mid-sized biotech company was focused on executing a global clinical pipeline but, like many emerging companies, had inefficient and disjointed processes. In addition, processes and teams were not fully grounded in GCP or other regulatory compliance needs. These challenges combined to make the development process cumbersome, inefficient and open to compliance risks.
A small, rapidly growing Biotech had several therapeutic assets moving to clinical development. It faced challenges in strategic development decisions, CRO negotiations, and senior management information reporting. It needed a consistent means by which to manage and report, and to focus on the science without being encumbered by complicated tools. Timing was critical as some team members would soon be on leave and the company had yet to achieve its first approval.
A mid-sized biopharma company needed to identify internal activities that should be outsourced and implement an objective, defendable process to select preferred vendors that not only fit specific functional/study needs, but also represent best value for investment.
An emerging biopharma company had an inefficient and disjointed process for the selection of vendors to support study-specific activities, from service need identification through contract execution. They had difficulty aligning on needs and during the bidding process, leading to challenging bid comparisons and an over-reliance on Start-Up Agreements (SUAs)
A small biotech company did not have internal resources or capabilities to support Procurement and Clinical Vendor Management functions; the internal team was focused primarily on Study Design and Clinical Operations execution. These gaps in key business functions, coupled with a rapidly expanding portfolio, presented significant risks to timelines and the ability to manage critical vendor activities.
A rapidly growing pre-commercial biotech company found it increasingly difficult to manage large-scale clinical trials being executed by two costly global CROs. The company needed a robust oversight process to handle the rapidly increasing volume of planned trials, since consistent processes, metrics and tool to ensure on-time and high-quality delivery did not exist.
A rapidly-growing EU-based biotech company purchased a US-based entity. The company needed assistance planning and leading integration activities to harmonize across all Development functions. Some of the capabilities between the two entities were complementary, but they were interested in rapid integration globally, to align with their newly-developed strategy.
A small growing Biotech was bringing its therapeutic assets to full clinical development. Balancing the need to move through clinical development in a safe but agile manner while guarding the company’s assets and leveraging emerging relationships with strategic suppliers was proving a difficult balance, particularly as different stakeholders had distinct needs and perspectives. The result was a protracted contracting process which generated confusion and slowed work progress. All of this while ensuring suppliers met quality and compliance standards to ensure the validity of clinical results.
A biotech company with products in early clinical phases sought to reduce its spend with a large Contract Research Organization, while looking for options to replace with a lower-cost and more responsive CRO. The internal team has limited experience interacting with CROs and needs guidance to ensure a successful trial outcome.
A small biopharma company was expecting a large Change Order (CO) from it’s primary CRO on a Phase IIB global clinical program that was experiencing delays. The company had limited means by which to evaluate the CO, given a mix of performance issues and COVID-related delays in study start-up and recruitment, as well as cost overruns due to low initial estimates for investigator pass-through grants.
A global genomics data company is building out its core processes and go to market strategy. It must recognize and integrate key quality principles to reduce operational and compliance risk. It conducts its operations in Europe, Asia and North America and is subject to Data Privacy regulations across all jurisdictions. The goal is to make its processes robust and compliant everywhere it does business.
Leading biotech customer with a growing pipeline, relying more heavily on outsourcing partners, needs a way to effectively manage and control portfolio spend and obtain clarity related to study level financials to inform business decisions.
Developing a Proactive Framework for Audit and Inspection Readiness
A well-run inspection or audit, supported by a sustainable, integrated framework, can help reduce the severity of a finding or sometimes avert one altogether.
VendorSight360™is TriRadial’s proven methodology for ensuring all aspects of your vendor relationship are optimized. VendorSight360™ ensures effective oversight in all stages of the vendor cycle, which is essential to maximizing performance from your vendors while improving transparency and managing risk.
Ensure that your organization has the appropriate people, processes, procedures, partners, and systems in place to achieve successful clinical outcomes while avoiding delays and roadblocks that have become all too common in clinical research.
Leveraging our combined experiences, TriRadial’s M&A experts have developed a highly customizable and flexible framework and a comprehensive Integration Planning & Execution Playbook.
It can be a long journey on the path to commercialization of a product, but once there, how you establish and operate the commercial capabilities of your company can ensure their success or cause you to fail in reaching the full potential of that product.
Architecting a Scalable and Proactive Quality Infrastructure
A scalable Quality infrastructure can improve productivity, create a competitive advantage and help shift a company’s culture to one of proactive compliance
Ensuring Effective and Compliant Vendor Oversight in an Era of Increased Outsourcing
The need to demonstrate full awareness and control of key vendor activities and outputs is becoming more critical as outsourcing continues to increase.
A structured CAPA framework can make the difference between continually fighting the same fires and solving problems effectively once to create sustainable solutions.
Process-driven compliance, right-sized for your organization
A streamlined, compliant process is only useful if the organization is able to implement it. Processes and SOPs should balance performance and regulatory compliance.
Developing a Proactive Framework for Audit and Inspection Readiness
A well-run inspection or audit, supported by a sustainable, integrated framework, can help reduce the severity of a finding or sometimes avert one altogether.
VendorSight360™is TriRadial’s proven methodology for ensuring all aspects of your vendor relationship are optimized. VendorSight360™ ensures effective oversight in all stages of the vendor cycle, which is essential to maximizing performance from your vendors while improving transparency and managing risk.
Ensure that your organization has the appropriate people, processes, procedures, partners, and systems in place to achieve successful clinical outcomes while avoiding delays and roadblocks that have become all too common in clinical research.
Leveraging our combined experiences, TriRadial’s M&A experts have developed a highly customizable and flexible framework and a comprehensive Integration Planning & Execution Playbook.
It can be a long journey on the path to commercialization of a product, but once there, how you establish and operate the commercial capabilities of your company can ensure their success or cause you to fail in reaching the full potential of that product.
Architecting a Scalable and Proactive Quality Infrastructure
A scalable Quality infrastructure can improve productivity, create a competitive advantage and help shift a company’s culture to one of proactive compliance
Ensuring Effective and Compliant Vendor Oversight in an Era of Increased Outsourcing
The need to demonstrate full awareness and control of key vendor activities and outputs is becoming more critical as outsourcing continues to increase.
A structured CAPA framework can make the difference between continually fighting the same fires and solving problems effectively once to create sustainable solutions.
Process-driven compliance, right-sized for your organization
A streamlined, compliant process is only useful if the organization is able to implement it. Processes and SOPs should balance performance and regulatory compliance.
Developing a Proactive Framework for Audit and Inspection Readiness
A well-run inspection or audit, supported by a sustainable, integrated framework, can help reduce the severity of a finding or sometimes avert one altogether.
TriRadial Solutions is an advisory firm committed to delivering practical, high-quality People, Process and Technology solutions to help your business grow. Our team of industry experts and seasoned management consultants can help assess where you are currently and navigate a path forward to building robust, integrated capabilities poised for scalable growth.
Featured Experts
Dr. Ulrike Geier
Heidelberg, Germany
Clinical Project Management and Vendor Negotiations
Ulrike brings over 30 years’ experience in clinical research within CROs and the pharmaceutical industry in multiple therapeutic areas. Her background includes:
International project and portfolio management
Senior strategic and operational oversight of worldwide Phase II/III clinical trials
Senior relationship management between sponsors and CROs
CRO selection from proposal to budget and contract (MSA/SOW) negotiations
Ongoing budget oversight and Change Order negotiations
With over 30 years’ experience in the global life sciences industry, Ulrike has extensive experience in senior strategic and operational oversight of worldwide clinical trial management teams in a global CRO setting. Currently she is focused on CRO selection from proposal stage to budget, Workorder and MSA negotiations.
Prior to her consulting work, Ulrike spent over 23 years working for Parexel in a global leadership capacity. Ulrike holds a Ph.D. and MSc in Biology/Chemistry from Heidelberg University in Germany. Ulrike’s passion is to assist clients achieve key operational and financial targets while going through notable change.
Mike Shafer
Global
Managing Director, Quality & Compliance
Mike is a seasoned executive in life sciences, focused on risk-based Quality Management. He is passionate about helping clients scale quality as a competitive advantage. Mike brings deep Quality & Compliance expertise to TriRadial, including:
Quality Assessments
QMS Design and Remediation
Phase-appropriate Quality Management and risk-based compliance
Quality Process Transformation and SOP Optimization
Mike Shafer is a seasoned executive with an extensive background in life sciences, where he has built a career on a foundation of leadership, strategic consulting, and mentorship. As Managing Director and leader of the Quality Practice at TriRadial Solutions, he is dedicated to helping clients chart a course to phase-appropriate Quality Management. He is passionate about building a foundation in risk-based Quality and Compliance that will allow clients to scale Quality as a competitive advantage as their therapies develop towards licensure.
His role at CGI as Vice President of Business Consulting, which he commenced in May 2022, saq him at the helm of the Life Sciences Industry Practice. Here, Mike exceled in steering clients within the Health and Life Sciences sectors toward operational excellence by optimizing their methods and maximizing human capital efficiency. Mike's journey with CGI began in December 2017 when he joined as Director of Consulting Delivery. His leadership cultivated a team adept at supporting various aspects of Life Sciences operations across clinical, regulatory, quality, and manufacturing domains. This period was marked by collaborations that spanned geographies and accounts to ensure the delivery of best practices and innovative solutions throughout the product lifecycle. Before his current tenure at CGI, Mike enriched his expertise as Associate Director at Paragon. His contributions to Quality Management Systems were pivotal for teams navigating strategic challenges in quality transformation and process design. His prior experience as a Manager at EY allowed him to lead transformative engagements focused on enhancing phase-appropriate Quality Assurance, Validation, Regulatory Compliance, and GxP Operations. Mike's tenure at Sanofi Pasteur exemplifies his versatility within the industry. He demonstrated adeptness in managing complex operations such industrial scale-up of late-stage clinical manufacturing, as well as facility, equipment, and process validation and licensing.
As an Adjunct Professor at Lehigh University College of Business since August 2022, Mike imparts practical business wisdom to future leaders, leveraging his industry experience to provide an interactive and comprehensive overview of business functions.
A former Naval Officer, Mike brings military precision to his civilian roles. His time with the US Navy equipped him with invaluable skills that translate into his ability to manage high-stress situations effectively and foster team engagement. Academically, Mike has a robust foundation with a BS in Chemistry and Chemical Biology, and a BA in History, both from Cornell University, as well as an MBA with a focus on Manufacturing Systems Engineering from Lehigh University. His commitment to lifelong learning is evident through his continued involvement with professional organizations like the Parenteral Drug Association (PDA) and the Pharmaceutical Research and Manufacturers Association (PhRMA). In addition to his professional endeavors, Mike contributes to health causes as Co-Host and Treasurer for the Battle of the Birch Annual Charity Golf Tournament and volunteers with social services through his local church. He is also recognized as a Six Sigma Black Belt—a testament to his dedication to process improvement and quality management.
Outside of work, Mike enjoys spending time with his wife and two sons, coaching youth sports, and woodworking. He is a lifelong Baltimore Orioles fan due to the influence of Cal Ripken Jr. and his example of lifelong perseverance and dedication.
Julia Love brings more than 30 years of life science outsourcing and contracting experience, working in both the sponsor and CRO side of the biotech business. Julia focuses on providing TriRadial clients with best-in-class services in:
Clinical strategic sourcing support (CROs, Central Labs, and Clinical Technologies) including vendor identification, selection, contracting, and ongoing management
Strategic partnership selection and MSA business terms negotiation
Governance development support services, including CRO/vendor relations management
Julia Love is a Business Consultant with proven success helping global organizations in the life sciences industry improve productivity and profitability levels. Julia is a Duke University graduate with decades of clinical research contracting experience, earning a career reputation as an executive for both CRO and major biopharma companies. She has successfully led contracting for Clinical, Early Development, Central Labs, Clinical Pharmacology, FSP, and Market Access business units.
Julia leverages her experience on both the sponsor and vendor side to optimize the vendor selection and partnership process, knowing first-hand the necessity of the value in seeing the other party’s point of view to make outsourcing decisions and minimize the pain of the contracting process. Prior to joining TriRadial, Julia founded and managed her own consultancies, Love Contracts and Newbould / Love Strategies, supporting clinical vendor sourcing and contracting for small biotech, biopharma, and med device companies, saving her clients millions through innovative strategies and win-win negotiations.
Julia’s gained valuable CRO experience working at Quintiles (now IQVIA), where she started the Business Account Management (BAM) group to support key account contract deliverables, and then Covance (now Labcorp Drug Development and Fortrea), where she integrated all business unit contracts departments with customized consistent processes to drive contract execution, development and implementation of a tracking and forecasting application.
Julia came into the industry in R&D Finance at Glaxo (now GSK), ran their clinical contracts group, and was part of building their clinical outsourcing group, one of the first in the industry. Julia also headed groups at Duke Clinical Research Institute (DCRI) and ran Proposal and Contracts for a Site Management Organization. Working for Millennium/Takeda, Juliaserved as the lead clinical outsourcing rep for two strategic programs, headed study transitions to new partnership CROs. To learn more, visit Julia's LinkedIn Profile.
Julia lives in Durham NC with her husband Rob, rescue dogs Guster and Sir Barkleton Mix-a-lot (Barkley), and rescue cats Harold and SueAnn Nivens. When not working, reading, or cheering on Duke sports, Julia enjoys traveling, including visiting her three sons.
In Egypt this year
With my husband Rob and my 3 sons, Matt, Wyatt, and Connor
With Rob cheering on Duke in basketball
Exploiting my last name
John Iannetta
New Jersey, USA
Commercial Operations, Process & Program Management
John brings over 20+ years of commercial leadership experience in the pharmaceutical and medical device industries with deep domain expertise in the following areas:
Commercial operations functional assessments, recommendations and implementations
Project/program management and process excellence
Commercial business transformation and M&A integrations
Organization design, change management and communications
Commercial technology & data assessments and harmonization
John is an accomplished Commercial Operations and Operations Excellence leader who has deep experience within the Medical Device and Pharmaceutical industries. He is able to bring to clients an Executive-level decision maker and industry perspective as well as broad experiences collaborating with business and functional business partners at all levels along with consulting, software and technology solution providers to optimize commercial capabilities and drive operational excellence.
John most recently worked as Vice President, US Region Commercial Operations at BD, a global medical technology company. There he led a team of ~400 associates in 10 different locations, supporting 8 business units and 2 enterprise commercial teams with capabilities in the areas of commercial and government contracting, sales reporting and analytics, sales operations, customer master data management, commercial technology enablement, operations excellence and integrations and divestiture project management. He led the initial formation of the Commercial Operations Center of Excellence (COE) stemming from the 2015 acquisition of CareFusion as well as the subsequent acquisition and integration with CR Bard in 2017. A significant part of the COE formation was working closely with his business unit, IT, HR and other functional business and industry partners to redesign the organizational structure, establish a new culture, implement new technologies and harmonize policies and processes to deliver significant cost savings.
Prior to joining BD, John held numerous leadership roles in the areas of program management, strategic account management, contracting and supply chain over an 11-year tenure at J&J in both their pharmaceutical and medical device segments. Earlier in his career, John held numerous roles at GE and Philips where he established his credentials in project and change management and continuous improvement, earning certifications as both a Master Black Belt and Black Belt in Six Sigma methodologies.
John holds a Bachelor of Science in Biomedical Engineering from Rutgers College of Engineering in Piscataway, NJ. He also serves as the Board President for Community Hope, a non-profit organization that provides housing and support services to hundreds of veterans, veteran families, and people living with mental illness each year. John resides in New Jersey with his wife Sandy and their yellow Lab Maddie. They have two adult children, Jessica and Michael, that they enjoy visiting as often as possible and also enjoy traveling and hiking with Maddie.
John with (from left to right) his parents John and Mary, son Michael, wife Sandy and daughter Jessica making homemade pasta in Italy.
John & wife Sandy on a beach in Hawaii
Our girl Maddie
Ken Light
Pennsylvania, USA
Global Development Transformation
A consulting leader and advisor, Ken is passionate about modernizing the processes and tools used to bring new therapies to market. Ken brings a broad perspective on current and future state processes and technologies used in drug development by sponsors, sites, CROs, and patients, and will lead a TriRadial team focused on:
Process Optimization and Strategic Planning
Digital Transformation and Data Architecture
Clinical Innovation (patient engagement, automation and DCTs)
Computer Systems Assurance and Regulatory Adoption
A consulting leader and advisor, Ken is passionate about transforming the processes and tools used to bring new therapies to market. Ken brings a broad perspective on current and future state processes and technologies used in drug development by sponsors, sites, CROs, and patients. As a life sciences consulting executive, Ken has worked with the majority of top-20 pharmaceutical companies, along with numerous biotechs, CROs, and academic research centers.
For 30 years, Ken has led organizations focused on streamlining the clinical trials process through technology, strategy and process improvement. Working with sponsors, sites, and CROs, Ken has overseen a wide variety of innovation and transformation initiatives.
Prior to joining TriRadial, Ken founded and managed his own consultancy, ClinScape, designed to bring technology strategy, innovation, and transformation to clinical trials. For twelve years prior to that, as EVP of Corporate Strategy and Professional Services, Ken helped OmniComm Systems, a clinical technology innovator, build and grow until acquisition by a Private Equity group. Ken has also led clinical implementation and strategy teams for BusinessEdge Solutions, First Consulting Group, and Oracle Corporation, where he oversaw the Oracle Pharmaceutical national consulting practice. Ken has an M.S. in Computer Science from Fairleigh Dickinson University, and a B.S degree from the State University of New York at Binghamton.
When not leading consulting teams and initiatives, Ken loves to travel the world with his family and his wife Susan. As a board member of the New Hope Historical Society, Ken can often be seen on Sunday afternoons giving walking tours to groups seeking to learn the rich history of New Hope. He also enjoys digital photo journaling, pickleball, and for 30+ years has played touch-football every week, with a group of friends in his old neighborhood.
Aruba Sunset with Susan
Swiss Alps with Susan
With Sons Mike and Jason at the New Hope Bridge
Graham McGibbon
Global
Principal Consultant, Digital Solutions
Graham brings over three decades of experience in IT solution architecture, design and engineering to the TriRadial team.
Special interest in the ideas and technologies to create Domain Specific Languages, Analytic Repositories, and Managed Data Lakes.
Decades of experience in the full SDLC with unique expertise using Agile practices to enable successful delivery. Typical project works spans everything from hands-on development to executive presentations.
Ramon (Ray) Rodriguez
Florida, USA
Procurement
Ramon (Ray) is a senior procurement consultant with deep expertise across a wide range of categories and processes including:
Strategic sourcing, both direct and indirect procurement
Procurement (upstream and downstream procurement) and vendor strategy development, oversight and governance
Data management (lean digital processing, AI, RPA and NLU)
Manufacturing operations, supply chain, line and supplier management
Ramon (Ray) is a Senior Sourcing Consultant with deep expertise across a wide range of categories and processes. He has significant experience in Strategic Sourcing, both Direct and Indirect Procurement, and in use and implementation of procurement systems. His extensive line management experience and facilitation skills make him an ideal candidate to support full Sourcing Management, strategy implementation and supplier management.
Functional Expertise: Focused on Strategic Sourcing, Sourcing Transition, business process implementation, interim functional management, supplier management, and supplier relationship management. In these areas and more, Ray has consistently led teams to breakthrough results of 10% to 47% reduction in overall costs, as well as added significant value to the organization.
Sector and Category Experience: Ray’s sector experiences include the Retail, Healthcare, Hospitality, Aerospace, and Manufacturing. His category expertise lies in Facilities, Indirect, Direct, Capital, and Construction, categories.
Professional Experience & Engagement Highlights
IT Services and SaaS: Supported negotiations for enterprise resource planning tools (Oracle/PeopleSoft, SAP, etc.), procure to pay and sourcing suites (e.g., Ariba, Zycus, etc.) working cross functionally with the IT teams; additionally provided category management oversight for Cloud, Big Data/Analytics, Customer Experience, Infrastructure Management, BPO, Digital Solutions, and social media spend categories
Complex Services: Sourced rail switching services and arranged to take over pre-departure inspection services yielding a net rebate of more than $500K per year
Process Improvement: Proper sourcing management process led to the delivery of a 47% reduction in telecommunications cost at the corporate level for one company
Sourcing Transformation:Led Strategic Sourcing implementation for MRO and Manufacturing support services at food processing client
Qualifications and Achievements
Master’s in Business Administration – Dowling College
BS in Economics – State University of New York at New Paltz
Certified Purchasing Manager (C.P.M.) – Institute for Supply Management
Relaxing off Amelia Island, Florida
Meryl Wiernik
California, USA
Clinical Outsourcing and Audits
Meryl has 35+ years in the biopharmaceutical industry and senior leadership for 20 years with proficiency in:
Quality and compliance (quality audits and systems, GCP, SOP writing and training)
Business process optimization and cost reduction
Launched a full CRO service offering in expanding a single site company
Laboratory operations and management
Clinical services outsourcing, vendor strategy development, due diligence, oversight and management
Meryl is a Senior Consultant with TriRadial Solutions, a consulting organization supporting the biopharmaceutical industry with vendor outsourcing, optimization and oversight, CAPA optimization, audit and inspection readiness, and process and procedure development. She was formerly the Senior Director of CRO Services and Vendor Management at ProSciento, an early phase CRO specializing in metabolism studies, responsible for building the CRO division and for the development and execution of key strategies supporting growth and continued development of CRO operations.
She has been a consultant to the biopharma industry across her career in areas of Quality Assurance, vendor management, outsourcing, and business process optimization. Meryl was the VP of Quality Assurance and Business Excellence for Synteract global CRO where she led the global QA group, participated in integration and global harmonization activities and enhanced quality processes.
In earlier roles, Meryl was the Director of Strategic Outsourcing for Teva Pharmaceuticals, Bristol Myers Squibb and Amgen (originating the departments for BMS and Teva) and built standardized outsourcing processes as well as a structure for vendor governance. Meryl has worked for several central laboratories, including LabCorp, MDS Pharma, Quest Diagnostics and ACM, in functions including Project Management, Operations, Quality, client relationship management, global harmonization and Biorepository management. During her 19 yr tenure at Bristol‑Myers Squibb, she was instrumental in the conceptualization, implementation, growth and marketing of the BMS Clinical Laboratory, in support of Phase I-IV trials.
Meryl holds a BS in Medical Technology from Rutgers University and an MBA from Fairleigh Dickinson University.
Picking peaches with the grandkids
Her beautiful daughters
Showing off Grandma's fancy crochet skills!
Dr. Frederic (Rick) Sax
Lincolnshire, UK and Florida, USA
Clinical Design and Strategic Product Development
Rick brings 30+ years of deep domain expertise in the following sectors:
Overall drug strategy and development using novel, innovative technology solutions (including AI) to improve pharmaceutical R&D efficiency and productivity
Clinical and program design
Medical Affairs (KOL management and Phase IV studies)
Dr. Rick Sax earned his B.A. degree in Biology and Philosophy from Yale College (1977), summa cum laude, and completed his medical degree at Columbia University’s College of Physicians & Surgeons (1981). Dr. Sax received his board certification in Internal Medicine after completing his residency training at The New York Hospital/Memorial Sloan-Kettering Cancer Center. He then served as a Staff Fellow in the Cardiology Branch of the National Heart, Lung and Blood Institute at the National Institutes of Health and completed his cardiology fellowship at Johns Hopkins University Medical Center, becoming board-certified in Cardiovascular Diseases in 1989. Dr. Sax was an Assistant Professor of Medicine and Assistant Director of the CCU at the Cornell University Medical Center from 1988-1991.
In 1991, Dr. Sax joined Merck Research Laboratories where he led the team responsible for successful development and registration of the antiplatelet agent, AGGRASTAT®. He subsequently became the Head of Clinical Cardiovascular Research with responsibility for global cardiovascular research programs at Merck. He served on the Worldwide Business Strategy Team for Hypertension & Heart Failure, then led the Antiplatelet/Antithrombotic Worldwide Business Strategy Team. In 2001, Dr. Sax joined AstraZeneca as Vice-President for U.S. Clinical Research, overseeing the physicians and medical writers. In 2003, he created and took on the new role of Vice-President for U.S. Strategic Development, responsible for the interface between the global Development organization and the U.S. commercial business. Following the restructuring of global Clinical Development in 2005, Dr. Sax took on responsibility for global Medical Sciences. He then helped create and served as the Clinical representative to the New Opportunities group, followed by a leadership role in re-designing AstraZeneca Clinical Development, with a particular focus on building a new approach and capabilities for design and interpretation of clinical programs.
Dr. Sax left AstraZeneca in 2011 and joined Quintiles as the Senior Vice-President for Integrated Clinical Services, encompassing the Quintiles Laboratory, global Safety, Biostatistics, Medical Writing, and Regulatory services. He was responsible for building Quintiles’ planning & design unit, the Center for Integrated Drug Development, which became part of Quintiles Advisory Services in 2014. With the merger of Quintiles and IMS to become IQVIA, the business evolved into the Strategic Drug Development group, focused on integrating data and deep domain expertise to support companies with due diligence activities and creating strategic development, regulatory, and commercial plans for their assets.
Dr. Sax “retired” from IQVIA in the Spring of 2019 to form his own consultancy practice, Pharma Design Solutions, Ltd. His current work focuses primarily on supporting companies with novel, innovative technology solutions that can be used to improve pharmaceutical R&D efficiency and productivity, but also be applied more broadly as health science solutions.
First time making pasta tagliatelle in England at a pasta class. It was so good, he got a pasta making machine the following Christmas!
Hiking to the beach in Cornwall, England
Raphaële Mary
Paris, France
Procurement and Vendor Outsourcing Management
Passionate about enhancing performance throughout clinical development, Raphaële has over 25 years of global biopharma knowledge in:
Strategic sourcing/procurement
Outsourced portfolio management
Vendor management, governance and oversight
Worldwide clinical development, operations and program/project management
R&D performance optimization
Quality risk management, GCP, SOP writing/process training
Raphaële is an expert in Outsourcing Management, Vendor Relationship Management, Vendor Quality Oversight and Business Process Development and Optimization. She consistently focuses on enhancing performance throughout Clinical Development.
At TriRadial Solutions, Raphaële advises companies on how to develop and enhance their vendor sourcing strategies, their vendor oversight capabilities, and their quality risk management activities so that clinical studies are delivered on time, on budget and with high quality. Raphaële also ensures a tailored implementation by delivering customized processes, tools, coaching and training for client teams, within a change management approach that matches the client’s unique environment.
Raphaële brings 25 years of experience, mostly with Bristol-Myers Squibb (BMS), where she held various international management positions in Global Clinical Operations, Productivity and Quality Management, Strategic Sourcing and Vendor Outsourcing Management. During her career, Raphaële developed global and local sourcing strategies and driven complex bidding/negotiations. Raphaële focused on improving relationships with preferred strategic external partners (Contract Research Organizations (CROs), Central, Biomarker and Core Laboratories) through implementing strategic and operational governance structures/committees, quality agreements, Service Level Agreements, performance metrics, and continuous improvement initiatives.
Sharing experiences, learning from others, coaching, training and developing fit-for-purpose processes and tools to enhance Clinical Operations effectiveness for our clients is what Raphaële enjoys most with TriRadial Solutions.
Enjoying sailing on the Mediterranean sea
Mike Hagan
North Carolina, USA
R&D Processes Optimization
Mike is an R&D transformation leader and trusted advisor with almost 30 years of life sciences qualifications in:
Global regulatory strategy, operations and alignment
Process optimization and mapping
Drug and biologic development process transformation
Product license transfer authority
Medical Affairs (call center, MSLs)
Pharmacovigilance and Safety operations
Clinical technology development and program manager
Mike is an R&D transformation leader and trusted advisor with almost 30 years of life sciences qualifications in:
Global regulatory strategy, operations and alignment
Process optimization and mapping
Drug and biologic development process transformation
Product license transfer authority
Medical Affairs (call center, MSLs)
Pharmacovigilance and Safety operations
Clinical technology development and program manager
Fishing with his dog, Sydney in his brother-in-law's back yard
Mike and his two brothers
The East Coast-Path to OBX Beach in NC
Vickie Crocker
North Carolina, USA
Strategy Development and Change Management
Vickie has 20+ years’ experience leading global teams through complex issues and transformations, both as an internal and external consultant. She is a leader passionate about:
Strategy development and management
Change management
Strategic initiative management
Cost management and workforce planning
Process improvement and automation (workflow)
Clinical development, operations and program/project management
After getting her B.S. degree in Medical Technology, Vickie worked for several years in diagnostic, research and industrial QA labs. Her extensive lab experience led her into laboratory sales to both medical and corporate labs across many industries. That insight and experience served as a great foundation as she became a business solutions consultant, focusing on document centric processes and helping clients to automate those with workflows and document repositories. Vickie found she had a passion for organizational excellence – project management, knowledge management, document management.
During her early consulting years, Vickie’s successful project accounts included:
Aventis Pasteur (now Sanofi)
GE Aircraft
InterGen Energy
Lord Corporation
PEMEX (Petroleos Mexicanos) and
PPD (Pharmaceutical Product Development, Inc.)
The project with PPD introduced her to the CRO (Contract Research Organization) world and led her to join Quintiles in 2003. Vickie served as the Strategic Business Partner within the newly launched Corporate Strategic Services (CSS) for several business units and functions, helping leaders to develop strategic plans and objectives, aligned to the corporate strategy and to identify initiatives to close performance gaps. Following the launch of CSS, Quintiles realized double digit growth, year-over-year, which enabled their second IPO in the company history. In later years Vickie led the development of Quintiles’ Change Management Office and co-created Quintiles’ Change Implementation methodology and playbook.
Areas of her passion and expertise:
Strategy Development – defining an achievable, but stretch, long term goal and defining how to get there with actionable objectives
Strategy Management – monitoring the progress of strategic objectives through metrics, management reviews and continuous oversight; involves identifying the owners for each strategic theme and objectives and then their accountability for the oversight – knowing how things are going through data analytics, feedback loops, etc.
Strategic Initiative Portfolio Management – the identification of potential initiatives, review and prioritization of those potentials and then tracking progress through portfolio reviews
Change Management – creating and deploying change implementation methodologies and tools tailored for specific client’s needs to achieve successful adoption of changes delivering expected business benefits
Touring Coastal France with her husband, Ed
Vickie and family in Alaska
Hiking with sister on Boone Fork Trail to Hebron Falls (near Price Lake on the Blueridge Parkway)
Jon Carlson
North Carolina, USA
Clinical Operations, Finance & Strategy
Consulting professional with 20+ years healthcare and biopharma operations experience, Jon's qualifications consist of:
Clinical development and operations transformation initiatives
Drug asset acquisition and due diligence
Site start-up optimization
Finance
Clinical data strategy
Vetting clinical research site infrastructure
Procurement and partnerships (contract negotiations, vendor governance, oversight, management, due diligence and strategy development)
Jonathan has more than two decades of operational and consulting experience across the comprehensive life sciences and health care spheres, spanning pharma, biotech, providers, and services. He has helped clients address corporate growth strategy, digital capabilities, marketing, asset acquisition, and financial controls.
His foremost client engagements have included:
Transformation of outsourcing strategy of a leading US biotech
Implementation of an asset acquisition and due diligence strategy for large pharma entering new markets
Established research infrastructure for leading academic medical center in Saudi Arabia
Enhanced financial insight and control of outsourcing partners for leading EU biotech
Prior to joining TriRadial, Jonathan led growth strategy and strategic partnership efforts for Covance and Chiltern, co-founded a Health Sciences Solutions consulting practice, and served as a Principal in the R&D Advisory Practice and Global Project Manager at IQVIA (formerly Quintiles), leading clinical development efforts across multiple therapeutic areas.
Jon holds an MBA from the University of North Carolina at Chapel Hill’s Kenan-Flagler Business School with a concentration in strategy and leadership and a BA from the University of Delaware. In his personal time, Jon spends time with his wife, Alison and their two kids, coaches youth soccer, and trains martial arts.
Dr. Tomasz Kosieradzki
Klaudyn, Poland
GCP Quality Auditor & Inspection Readiness
Tomasz is a GCP quality specialist with leadership savvy in:
Clinical site preparation for (EMEA, FDA) regulatory inspections (conducts training, pre-inspection GCP audits for Phase I to IV trials, acts as an inspector during mock inspections and sponsor's representative)
QMS optimization, including ISO-15189-2012 Medical Laboratories
GCP audits for Phase I to IV trials
CAPA resolutions and training
SOP writing
Gap analysis in clinical research and due diligence
Since 2003 Tomasz has worked as a GCP QA Auditor collecting vast experience in drug developing organizations such Phase 1 / BE unit, CRO, Innovative Big pharma, small biotech, in EU and outside EU countries. He specializes in clinical site GCP audits for trials of all phases (I to IV) and system, sponsor oversight, and vendor audits (systems), especially in Phase1 units' assessment.
One of his leading activities is sponsor and site preparation for regulatory inspections (EMEA, FDA) through conducting training, pre-inspections audits, acting as an inspector during mock-inspections, and sponsor's representative.
Dr. Kosieradzki has been using his expert knowledge and experience as a trainer/lecturer in various training projects and as a speaker for several industry conferences throughout Europe for the past ten years.
Tomasz is an MRQA - member of the Research Quality Association (former BARQA) and Polish GCP Society.
His strong advantage is the knowledge and experience in developing practical and fit-to-purpose Quality Management Systems (QMS) based on process mapping methodology.
Expertise in:
Quality Management Systems in clinical trials according to ICH-GCP E6
Sponsor Oversight - complex approach
QMS according to ISO-15189-2012 Medical Laboratories - Requirements for Quality and Competence
Auditing methodology, including practical knowledge of industrial and regulatory referential documents for clinical trials
Preparation and hosting of regulatory inspections, including mock inspection
Early Development (Phase I) auditing (trials and vendors)
Risk-based approach to monitoring and auditing
Risk Management
Systems and Clinical Sites Audits
Vendor evaluation
SOP writing
Gap analysis in clinical research and due diligence
Root-cause analysis of errors
Corrective and Preventive Actions - training
Long distance swimming
Extreme Baltic Challenge Award
Antonio Biancardi
New Jersey, USA
IT Architecture
With over a decade of R&D information technology intelligence, Antonio focuses on:
Enterprise project management systems (safety, CMS, regulatory, financial functionality)
IT solutions architect and software developer
Liaison between IT and the business
R&D-focused systems (e.g., CTM, global investigator DB, eConsent)
As a technology and operations leader, Antonio has a track record of accelerating business outcomes for international enterprises and Fortune 500 companies. His achievements include the turn-around of under-performing organizations to: restore profitability, increase efficiency, and develop leading-edge software applications – from concept through release.
Antonio led the team that developed DataForm Software's flagship product, Planet Life Cycle – a robust work management application that merges strategic and financial planning with execution. As a direct result, customers that are global leaders, such as Allergan Pharmaceutical, have leveraged the solution to enhance their competitiveness. Antonio is consistently striving to enable customers to achieve operational excellence. In his words, “When our customers win, we win."
CORE COMPETENCIES
Operational Leadership
Budget and Financial Management
Software Design and Development
Technology Strategy and Execution
Business and Technology Alignment
Process Refinement and Improvement
Re-Structuring and Change Management
System Re-Engineering and Optimization
Client Acquisition and Relationship Building
Growth Planning and Performance Measurement
Challenging route to Wyanokie High Point, Carris Hill, Buck Mountain and Chikahoki Falls with views of the NJ Highlands and NYC Skyline
John Klein, MS MBA
Ohio, USA
R&D Processes Optimization
A business process consultant with more than 30 years of life sciences experience, John’s core work includes:
R&D transformation
Drug development: clinical trial optimization
Regulatory process alignment and harmonization
Global product transfer
Business process transformation through technology
John’s experience spans more than 30 years across life sciences, pharmaceutical product development, clinical trials, and healthcare. His work focuses on clinical development process optimization, covering the entire development lifecycle from concept to approval to withdrawal. Recent work has centered on global development transformation to streamline workflows, improved efficiency, and optimize cross-functional collaboration. By focusing on a collaborative approach, teams can bring key voices together earlier in processes, through better planning and workflows – to achieve more robust work products and a ‘right the first time’ approach. This can result in greater cross-functional interactions that move work through the lifecycle faster with higher quality and in a more compliant manner.
Prior work has included regulatory process redesign, global product asset transfer strategies, and streamlining a development organization spanning R&D, surgical and consumer products.
John started his career in healthcare at The Cleveland Clinic Foundation. His work then expanded into clinical trial technology and EDC with work at DATATRAK, where he led clinical implementation services. From there he entered consulting with BusinessEdge Solutions/EMC, before moving to Quintiles/IQVIA in the Consulting Services organization and later Global Regulatory Affairs. In 2019 he partnered with TriRadial Solutions to further process optimization for pharma, biotech, and device companies.
In his free time, John enjoys seeing and experiencing the world. Experiencing new places, cultures, and cuisines is very important to him to help broaden his worldview. He also is an accomplished home chef, enjoys entertaining and spending time at home with family and his three cats.
United had John speak at an event he flew with them so much!
John's US flight mapping
Favorite international destinations include: Tahiti, safari in South Africa, Rome, London...
Matt Hendricks
Pennsylvania, USA
Strategy, Facilitation and Team Effectiveness
Matt is a strategic management consultant with over 15 years’ experience in:
Business design challenge sprints (focus on consumer base, fit for client need)
Strategic decision facilitation and analysis workshops
Organizational change planning and execution
Clinical development and program management
Finance
Aggregate portfolio management and asset development
Matt is a management Consultant with significant experience working with clients at strategic and tactical levels. Known for helping clients zero in on the most critical elements of their problems, Matt develops creative solutions and then takes a disciplined and practical approach to get the job done.
Matt has a strong collaborative leadership style adept at working across Information Technology, R&D, marketing, and operations in the pharmaceutical, biotech, and manufacturing industries to achieve results.
Matt is part management consultant, known for getting cross-functional teams to cut out the buzzwords, get real, and tackle tough problems. He is also part entrepreneur, bringing the much needed concepts of high performing teams, business agile and psychological safety to the hospitality industry.
Full time, husband, father, and wiseacre.
Vacationing with family in Munich over Christmas 2016 (highlight was walking around the Kristkindlmarkt at the Karlsplatz)
At an International Game Fair in Essen, Germany (October, 2021)
Pasi Piitulainen
Basel, Switzerland
Finance and Procurement
With over 20 years’ experience in the global life sciences industry, Pasi is a deep subject matter expert in procurement and finance, specifically in:
Global R&D finance and analysis
Global R&D portfolio management
Budgeting, FPA process, tool development and implementation
Clinical outsourcing strategy development and implementation
M&A integration (direct and indirect procurement and supply) of acquired pharmaceutical production plant and supply chain into existing business
With over 20 years’ experience in the global life sciences industry, Pasi is a deep subject matter expert in Procurement and Finance and how those areas help enable world class R&D organizations. Most recently he was the Head of Procurement at Actelion Pharmaceuticals (today part of the Johnson & Johnson Family of Companies).
Pasi has a MSc in Industrial Economy from Lappeenranta University of Technology in Finland and holds the Chartered Financial Analyst(CFA) designation. Pasi’s passion is to promote and discover new solution via digital innovation and organizational design that helps the procurement to move to the next era.
Dr. Ulrike Geier
Heidelberg, Germany
Clinical Project Management and Vendor Negotiations
Ulrike brings over 30 years’ experience in clinical research within CROs and the pharmaceutical industry in multiple therapeutic areas. Her background includes:
International project and portfolio management
Senior strategic and operational oversight of worldwide Phase II/III clinical trials
Senior relationship management between sponsors and CROs
CRO selection from proposal to budget and contract (MSA/SOW) negotiations
Ongoing budget oversight and Change Order negotiations
With over 30 years’ experience in the global life sciences industry, Ulrike has extensive experience in senior strategic and operational oversight of worldwide clinical trial management teams in a global CRO setting. Currently she is focused on CRO selection from proposal stage to budget, Workorder and MSA negotiations.
Prior to her consulting work, Ulrike spent over 23 years working for Parexel in a global leadership capacity. Ulrike holds a Ph.D. and MSc in Biology/Chemistry from Heidelberg University in Germany. Ulrike’s passion is to assist clients achieve key operational and financial targets while going through notable change.
Mike Shafer
Global
Managing Director, Quality & Compliance
Mike is a seasoned executive in life sciences, focused on risk-based Quality Management. He is passionate about helping clients scale quality as a competitive advantage. Mike brings deep Quality & Compliance expertise to TriRadial, including:
Quality Assessments
QMS Design and Remediation
Phase-appropriate Quality Management and risk-based compliance
Quality Process Transformation and SOP Optimization
Mike Shafer is a seasoned executive with an extensive background in life sciences, where he has built a career on a foundation of leadership, strategic consulting, and mentorship. As Managing Director and leader of the Quality Practice at TriRadial Solutions, he is dedicated to helping clients chart a course to phase-appropriate Quality Management. He is passionate about building a foundation in risk-based Quality and Compliance that will allow clients to scale Quality as a competitive advantage as their therapies develop towards licensure.
His role at CGI as Vice President of Business Consulting, which he commenced in May 2022, saq him at the helm of the Life Sciences Industry Practice. Here, Mike exceled in steering clients within the Health and Life Sciences sectors toward operational excellence by optimizing their methods and maximizing human capital efficiency. Mike's journey with CGI began in December 2017 when he joined as Director of Consulting Delivery. His leadership cultivated a team adept at supporting various aspects of Life Sciences operations across clinical, regulatory, quality, and manufacturing domains. This period was marked by collaborations that spanned geographies and accounts to ensure the delivery of best practices and innovative solutions throughout the product lifecycle. Before his current tenure at CGI, Mike enriched his expertise as Associate Director at Paragon. His contributions to Quality Management Systems were pivotal for teams navigating strategic challenges in quality transformation and process design. His prior experience as a Manager at EY allowed him to lead transformative engagements focused on enhancing phase-appropriate Quality Assurance, Validation, Regulatory Compliance, and GxP Operations. Mike's tenure at Sanofi Pasteur exemplifies his versatility within the industry. He demonstrated adeptness in managing complex operations such industrial scale-up of late-stage clinical manufacturing, as well as facility, equipment, and process validation and licensing.
As an Adjunct Professor at Lehigh University College of Business since August 2022, Mike imparts practical business wisdom to future leaders, leveraging his industry experience to provide an interactive and comprehensive overview of business functions.
A former Naval Officer, Mike brings military precision to his civilian roles. His time with the US Navy equipped him with invaluable skills that translate into his ability to manage high-stress situations effectively and foster team engagement. Academically, Mike has a robust foundation with a BS in Chemistry and Chemical Biology, and a BA in History, both from Cornell University, as well as an MBA with a focus on Manufacturing Systems Engineering from Lehigh University. His commitment to lifelong learning is evident through his continued involvement with professional organizations like the Parenteral Drug Association (PDA) and the Pharmaceutical Research and Manufacturers Association (PhRMA). In addition to his professional endeavors, Mike contributes to health causes as Co-Host and Treasurer for the Battle of the Birch Annual Charity Golf Tournament and volunteers with social services through his local church. He is also recognized as a Six Sigma Black Belt—a testament to his dedication to process improvement and quality management.
Outside of work, Mike enjoys spending time with his wife and two sons, coaching youth sports, and woodworking. He is a lifelong Baltimore Orioles fan due to the influence of Cal Ripken Jr. and his example of lifelong perseverance and dedication.
Julia Love brings more than 30 years of life science outsourcing and contracting experience, working in both the sponsor and CRO side of the biotech business. Julia focuses on providing TriRadial clients with best-in-class services in:
Clinical strategic sourcing support (CROs, Central Labs, and Clinical Technologies) including vendor identification, selection, contracting, and ongoing management
Strategic partnership selection and MSA business terms negotiation
Governance development support services, including CRO/vendor relations management
Julia Love is a Business Consultant with proven success helping global organizations in the life sciences industry improve productivity and profitability levels. Julia is a Duke University graduate with decades of clinical research contracting experience, earning a career reputation as an executive for both CRO and major biopharma companies. She has successfully led contracting for Clinical, Early Development, Central Labs, Clinical Pharmacology, FSP, and Market Access business units.
Julia leverages her experience on both the sponsor and vendor side to optimize the vendor selection and partnership process, knowing first-hand the necessity of the value in seeing the other party’s point of view to make outsourcing decisions and minimize the pain of the contracting process. Prior to joining TriRadial, Julia founded and managed her own consultancies, Love Contracts and Newbould / Love Strategies, supporting clinical vendor sourcing and contracting for small biotech, biopharma, and med device companies, saving her clients millions through innovative strategies and win-win negotiations.
Julia’s gained valuable CRO experience working at Quintiles (now IQVIA), where she started the Business Account Management (BAM) group to support key account contract deliverables, and then Covance (now Labcorp Drug Development and Fortrea), where she integrated all business unit contracts departments with customized consistent processes to drive contract execution, development and implementation of a tracking and forecasting application.
Julia came into the industry in R&D Finance at Glaxo (now GSK), ran their clinical contracts group, and was part of building their clinical outsourcing group, one of the first in the industry. Julia also headed groups at Duke Clinical Research Institute (DCRI) and ran Proposal and Contracts for a Site Management Organization. Working for Millennium/Takeda, Juliaserved as the lead clinical outsourcing rep for two strategic programs, headed study transitions to new partnership CROs. To learn more, visit Julia's LinkedIn Profile.
Julia lives in Durham NC with her husband Rob, rescue dogs Guster and Sir Barkleton Mix-a-lot (Barkley), and rescue cats Harold and SueAnn Nivens. When not working, reading, or cheering on Duke sports, Julia enjoys traveling, including visiting her three sons.
In Egypt this year
With my husband Rob and my 3 sons, Matt, Wyatt, and Connor
With Rob cheering on Duke in basketball
Exploiting my last name
John Iannetta
New Jersey, USA
Commercial Operations, Process & Program Management
John brings over 20+ years of commercial leadership experience in the pharmaceutical and medical device industries with deep domain expertise in the following areas:
Commercial operations functional assessments, recommendations and implementations
Project/program management and process excellence
Commercial business transformation and M&A integrations
Organization design, change management and communications
Commercial technology & data assessments and harmonization
John is an accomplished Commercial Operations and Operations Excellence leader who has deep experience within the Medical Device and Pharmaceutical industries. He is able to bring to clients an Executive-level decision maker and industry perspective as well as broad experiences collaborating with business and functional business partners at all levels along with consulting, software and technology solution providers to optimize commercial capabilities and drive operational excellence.
John most recently worked as Vice President, US Region Commercial Operations at BD, a global medical technology company. There he led a team of ~400 associates in 10 different locations, supporting 8 business units and 2 enterprise commercial teams with capabilities in the areas of commercial and government contracting, sales reporting and analytics, sales operations, customer master data management, commercial technology enablement, operations excellence and integrations and divestiture project management. He led the initial formation of the Commercial Operations Center of Excellence (COE) stemming from the 2015 acquisition of CareFusion as well as the subsequent acquisition and integration with CR Bard in 2017. A significant part of the COE formation was working closely with his business unit, IT, HR and other functional business and industry partners to redesign the organizational structure, establish a new culture, implement new technologies and harmonize policies and processes to deliver significant cost savings.
Prior to joining BD, John held numerous leadership roles in the areas of program management, strategic account management, contracting and supply chain over an 11-year tenure at J&J in both their pharmaceutical and medical device segments. Earlier in his career, John held numerous roles at GE and Philips where he established his credentials in project and change management and continuous improvement, earning certifications as both a Master Black Belt and Black Belt in Six Sigma methodologies.
John holds a Bachelor of Science in Biomedical Engineering from Rutgers College of Engineering in Piscataway, NJ. He also serves as the Board President for Community Hope, a non-profit organization that provides housing and support services to hundreds of veterans, veteran families, and people living with mental illness each year. John resides in New Jersey with his wife Sandy and their yellow Lab Maddie. They have two adult children, Jessica and Michael, that they enjoy visiting as often as possible and also enjoy traveling and hiking with Maddie.
John with (from left to right) his parents John and Mary, son Michael, wife Sandy and daughter Jessica making homemade pasta in Italy.
John & wife Sandy on a beach in Hawaii
Our girl Maddie
Ken Light
Pennsylvania, USA
Global Development Transformation
A consulting leader and advisor, Ken is passionate about modernizing the processes and tools used to bring new therapies to market. Ken brings a broad perspective on current and future state processes and technologies used in drug development by sponsors, sites, CROs, and patients, and will lead a TriRadial team focused on:
Process Optimization and Strategic Planning
Digital Transformation and Data Architecture
Clinical Innovation (patient engagement, automation and DCTs)
Computer Systems Assurance and Regulatory Adoption
A consulting leader and advisor, Ken is passionate about transforming the processes and tools used to bring new therapies to market. Ken brings a broad perspective on current and future state processes and technologies used in drug development by sponsors, sites, CROs, and patients. As a life sciences consulting executive, Ken has worked with the majority of top-20 pharmaceutical companies, along with numerous biotechs, CROs, and academic research centers.
For 30 years, Ken has led organizations focused on streamlining the clinical trials process through technology, strategy and process improvement. Working with sponsors, sites, and CROs, Ken has overseen a wide variety of innovation and transformation initiatives.
Prior to joining TriRadial, Ken founded and managed his own consultancy, ClinScape, designed to bring technology strategy, innovation, and transformation to clinical trials. For twelve years prior to that, as EVP of Corporate Strategy and Professional Services, Ken helped OmniComm Systems, a clinical technology innovator, build and grow until acquisition by a Private Equity group. Ken has also led clinical implementation and strategy teams for BusinessEdge Solutions, First Consulting Group, and Oracle Corporation, where he oversaw the Oracle Pharmaceutical national consulting practice. Ken has an M.S. in Computer Science from Fairleigh Dickinson University, and a B.S degree from the State University of New York at Binghamton.
When not leading consulting teams and initiatives, Ken loves to travel the world with his family and his wife Susan. As a board member of the New Hope Historical Society, Ken can often be seen on Sunday afternoons giving walking tours to groups seeking to learn the rich history of New Hope. He also enjoys digital photo journaling, pickleball, and for 30+ years has played touch-football every week, with a group of friends in his old neighborhood.
Aruba Sunset with Susan
Swiss Alps with Susan
With Sons Mike and Jason at the New Hope Bridge
Graham McGibbon
Global
Principal Consultant, Digital Solutions
Graham brings over three decades of experience in IT solution architecture, design and engineering to the TriRadial team.
Special interest in the ideas and technologies to create Domain Specific Languages, Analytic Repositories, and Managed Data Lakes.
Decades of experience in the full SDLC with unique expertise using Agile practices to enable successful delivery. Typical project works spans everything from hands-on development to executive presentations.
Ramon (Ray) Rodriguez
Florida, USA
Procurement
Ramon (Ray) is a senior procurement consultant with deep expertise across a wide range of categories and processes including:
Strategic sourcing, both direct and indirect procurement
Procurement (upstream and downstream procurement) and vendor strategy development, oversight and governance
Data management (lean digital processing, AI, RPA and NLU)
Manufacturing operations, supply chain, line and supplier management
Ramon (Ray) is a Senior Sourcing Consultant with deep expertise across a wide range of categories and processes. He has significant experience in Strategic Sourcing, both Direct and Indirect Procurement, and in use and implementation of procurement systems. His extensive line management experience and facilitation skills make him an ideal candidate to support full Sourcing Management, strategy implementation and supplier management.
Functional Expertise: Focused on Strategic Sourcing, Sourcing Transition, business process implementation, interim functional management, supplier management, and supplier relationship management. In these areas and more, Ray has consistently led teams to breakthrough results of 10% to 47% reduction in overall costs, as well as added significant value to the organization.
Sector and Category Experience: Ray’s sector experiences include the Retail, Healthcare, Hospitality, Aerospace, and Manufacturing. His category expertise lies in Facilities, Indirect, Direct, Capital, and Construction, categories.
Professional Experience & Engagement Highlights
IT Services and SaaS: Supported negotiations for enterprise resource planning tools (Oracle/PeopleSoft, SAP, etc.), procure to pay and sourcing suites (e.g., Ariba, Zycus, etc.) working cross functionally with the IT teams; additionally provided category management oversight for Cloud, Big Data/Analytics, Customer Experience, Infrastructure Management, BPO, Digital Solutions, and social media spend categories
Complex Services: Sourced rail switching services and arranged to take over pre-departure inspection services yielding a net rebate of more than $500K per year
Process Improvement: Proper sourcing management process led to the delivery of a 47% reduction in telecommunications cost at the corporate level for one company
Sourcing Transformation:Led Strategic Sourcing implementation for MRO and Manufacturing support services at food processing client
Qualifications and Achievements
Master’s in Business Administration – Dowling College
BS in Economics – State University of New York at New Paltz
Certified Purchasing Manager (C.P.M.) – Institute for Supply Management
Relaxing off Amelia Island, Florida
Meryl Wiernik
California, USA
Clinical Outsourcing and Audits
Meryl has 35+ years in the biopharmaceutical industry and senior leadership for 20 years with proficiency in:
Quality and compliance (quality audits and systems, GCP, SOP writing and training)
Business process optimization and cost reduction
Launched a full CRO service offering in expanding a single site company
Laboratory operations and management
Clinical services outsourcing, vendor strategy development, due diligence, oversight and management
Meryl is a Senior Consultant with TriRadial Solutions, a consulting organization supporting the biopharmaceutical industry with vendor outsourcing, optimization and oversight, CAPA optimization, audit and inspection readiness, and process and procedure development. She was formerly the Senior Director of CRO Services and Vendor Management at ProSciento, an early phase CRO specializing in metabolism studies, responsible for building the CRO division and for the development and execution of key strategies supporting growth and continued development of CRO operations.
She has been a consultant to the biopharma industry across her career in areas of Quality Assurance, vendor management, outsourcing, and business process optimization. Meryl was the VP of Quality Assurance and Business Excellence for Synteract global CRO where she led the global QA group, participated in integration and global harmonization activities and enhanced quality processes.
In earlier roles, Meryl was the Director of Strategic Outsourcing for Teva Pharmaceuticals, Bristol Myers Squibb and Amgen (originating the departments for BMS and Teva) and built standardized outsourcing processes as well as a structure for vendor governance. Meryl has worked for several central laboratories, including LabCorp, MDS Pharma, Quest Diagnostics and ACM, in functions including Project Management, Operations, Quality, client relationship management, global harmonization and Biorepository management. During her 19 yr tenure at Bristol‑Myers Squibb, she was instrumental in the conceptualization, implementation, growth and marketing of the BMS Clinical Laboratory, in support of Phase I-IV trials.
Meryl holds a BS in Medical Technology from Rutgers University and an MBA from Fairleigh Dickinson University.
Picking peaches with the grandkids
Her beautiful daughters
Showing off Grandma's fancy crochet skills!
Dr. Frederic (Rick) Sax
Lincolnshire, UK and Florida, USA
Clinical Design and Strategic Product Development
Rick brings 30+ years of deep domain expertise in the following sectors:
Overall drug strategy and development using novel, innovative technology solutions (including AI) to improve pharmaceutical R&D efficiency and productivity
Clinical and program design
Medical Affairs (KOL management and Phase IV studies)
Dr. Rick Sax earned his B.A. degree in Biology and Philosophy from Yale College (1977), summa cum laude, and completed his medical degree at Columbia University’s College of Physicians & Surgeons (1981). Dr. Sax received his board certification in Internal Medicine after completing his residency training at The New York Hospital/Memorial Sloan-Kettering Cancer Center. He then served as a Staff Fellow in the Cardiology Branch of the National Heart, Lung and Blood Institute at the National Institutes of Health and completed his cardiology fellowship at Johns Hopkins University Medical Center, becoming board-certified in Cardiovascular Diseases in 1989. Dr. Sax was an Assistant Professor of Medicine and Assistant Director of the CCU at the Cornell University Medical Center from 1988-1991.
In 1991, Dr. Sax joined Merck Research Laboratories where he led the team responsible for successful development and registration of the antiplatelet agent, AGGRASTAT®. He subsequently became the Head of Clinical Cardiovascular Research with responsibility for global cardiovascular research programs at Merck. He served on the Worldwide Business Strategy Team for Hypertension & Heart Failure, then led the Antiplatelet/Antithrombotic Worldwide Business Strategy Team. In 2001, Dr. Sax joined AstraZeneca as Vice-President for U.S. Clinical Research, overseeing the physicians and medical writers. In 2003, he created and took on the new role of Vice-President for U.S. Strategic Development, responsible for the interface between the global Development organization and the U.S. commercial business. Following the restructuring of global Clinical Development in 2005, Dr. Sax took on responsibility for global Medical Sciences. He then helped create and served as the Clinical representative to the New Opportunities group, followed by a leadership role in re-designing AstraZeneca Clinical Development, with a particular focus on building a new approach and capabilities for design and interpretation of clinical programs.
Dr. Sax left AstraZeneca in 2011 and joined Quintiles as the Senior Vice-President for Integrated Clinical Services, encompassing the Quintiles Laboratory, global Safety, Biostatistics, Medical Writing, and Regulatory services. He was responsible for building Quintiles’ planning & design unit, the Center for Integrated Drug Development, which became part of Quintiles Advisory Services in 2014. With the merger of Quintiles and IMS to become IQVIA, the business evolved into the Strategic Drug Development group, focused on integrating data and deep domain expertise to support companies with due diligence activities and creating strategic development, regulatory, and commercial plans for their assets.
Dr. Sax “retired” from IQVIA in the Spring of 2019 to form his own consultancy practice, Pharma Design Solutions, Ltd. His current work focuses primarily on supporting companies with novel, innovative technology solutions that can be used to improve pharmaceutical R&D efficiency and productivity, but also be applied more broadly as health science solutions.
First time making pasta tagliatelle in England at a pasta class. It was so good, he got a pasta making machine the following Christmas!
Hiking to the beach in Cornwall, England
Raphaële Mary
Paris, France
Procurement and Vendor Outsourcing Management
Passionate about enhancing performance throughout clinical development, Raphaële has over 25 years of global biopharma knowledge in:
Strategic sourcing/procurement
Outsourced portfolio management
Vendor management, governance and oversight
Worldwide clinical development, operations and program/project management
R&D performance optimization
Quality risk management, GCP, SOP writing/process training
Raphaële is an expert in Outsourcing Management, Vendor Relationship Management, Vendor Quality Oversight and Business Process Development and Optimization. She consistently focuses on enhancing performance throughout Clinical Development.
At TriRadial Solutions, Raphaële advises companies on how to develop and enhance their vendor sourcing strategies, their vendor oversight capabilities, and their quality risk management activities so that clinical studies are delivered on time, on budget and with high quality. Raphaële also ensures a tailored implementation by delivering customized processes, tools, coaching and training for client teams, within a change management approach that matches the client’s unique environment.
Raphaële brings 25 years of experience, mostly with Bristol-Myers Squibb (BMS), where she held various international management positions in Global Clinical Operations, Productivity and Quality Management, Strategic Sourcing and Vendor Outsourcing Management. During her career, Raphaële developed global and local sourcing strategies and driven complex bidding/negotiations. Raphaële focused on improving relationships with preferred strategic external partners (Contract Research Organizations (CROs), Central, Biomarker and Core Laboratories) through implementing strategic and operational governance structures/committees, quality agreements, Service Level Agreements, performance metrics, and continuous improvement initiatives.
Sharing experiences, learning from others, coaching, training and developing fit-for-purpose processes and tools to enhance Clinical Operations effectiveness for our clients is what Raphaële enjoys most with TriRadial Solutions.
Enjoying sailing on the Mediterranean sea
Mike Hagan
North Carolina, USA
R&D Processes Optimization
Mike is an R&D transformation leader and trusted advisor with almost 30 years of life sciences qualifications in:
Global regulatory strategy, operations and alignment
Process optimization and mapping
Drug and biologic development process transformation
Product license transfer authority
Medical Affairs (call center, MSLs)
Pharmacovigilance and Safety operations
Clinical technology development and program manager
Mike is an R&D transformation leader and trusted advisor with almost 30 years of life sciences qualifications in:
Global regulatory strategy, operations and alignment
Process optimization and mapping
Drug and biologic development process transformation
Product license transfer authority
Medical Affairs (call center, MSLs)
Pharmacovigilance and Safety operations
Clinical technology development and program manager
Fishing with his dog, Sydney in his brother-in-law's back yard
Mike and his two brothers
The East Coast-Path to OBX Beach in NC
Vickie Crocker
North Carolina, USA
Strategy Development and Change Management
Vickie has 20+ years’ experience leading global teams through complex issues and transformations, both as an internal and external consultant. She is a leader passionate about:
Strategy development and management
Change management
Strategic initiative management
Cost management and workforce planning
Process improvement and automation (workflow)
Clinical development, operations and program/project management
After getting her B.S. degree in Medical Technology, Vickie worked for several years in diagnostic, research and industrial QA labs. Her extensive lab experience led her into laboratory sales to both medical and corporate labs across many industries. That insight and experience served as a great foundation as she became a business solutions consultant, focusing on document centric processes and helping clients to automate those with workflows and document repositories. Vickie found she had a passion for organizational excellence – project management, knowledge management, document management.
During her early consulting years, Vickie’s successful project accounts included:
Aventis Pasteur (now Sanofi)
GE Aircraft
InterGen Energy
Lord Corporation
PEMEX (Petroleos Mexicanos) and
PPD (Pharmaceutical Product Development, Inc.)
The project with PPD introduced her to the CRO (Contract Research Organization) world and led her to join Quintiles in 2003. Vickie served as the Strategic Business Partner within the newly launched Corporate Strategic Services (CSS) for several business units and functions, helping leaders to develop strategic plans and objectives, aligned to the corporate strategy and to identify initiatives to close performance gaps. Following the launch of CSS, Quintiles realized double digit growth, year-over-year, which enabled their second IPO in the company history. In later years Vickie led the development of Quintiles’ Change Management Office and co-created Quintiles’ Change Implementation methodology and playbook.
Areas of her passion and expertise:
Strategy Development – defining an achievable, but stretch, long term goal and defining how to get there with actionable objectives
Strategy Management – monitoring the progress of strategic objectives through metrics, management reviews and continuous oversight; involves identifying the owners for each strategic theme and objectives and then their accountability for the oversight – knowing how things are going through data analytics, feedback loops, etc.
Strategic Initiative Portfolio Management – the identification of potential initiatives, review and prioritization of those potentials and then tracking progress through portfolio reviews
Change Management – creating and deploying change implementation methodologies and tools tailored for specific client’s needs to achieve successful adoption of changes delivering expected business benefits
Touring Coastal France with her husband, Ed
Vickie and family in Alaska
Hiking with sister on Boone Fork Trail to Hebron Falls (near Price Lake on the Blueridge Parkway)
Jon Carlson
North Carolina, USA
Clinical Operations, Finance & Strategy
Consulting professional with 20+ years healthcare and biopharma operations experience, Jon's qualifications consist of:
Clinical development and operations transformation initiatives
Drug asset acquisition and due diligence
Site start-up optimization
Finance
Clinical data strategy
Vetting clinical research site infrastructure
Procurement and partnerships (contract negotiations, vendor governance, oversight, management, due diligence and strategy development)
Jonathan has more than two decades of operational and consulting experience across the comprehensive life sciences and health care spheres, spanning pharma, biotech, providers, and services. He has helped clients address corporate growth strategy, digital capabilities, marketing, asset acquisition, and financial controls.
His foremost client engagements have included:
Transformation of outsourcing strategy of a leading US biotech
Implementation of an asset acquisition and due diligence strategy for large pharma entering new markets
Established research infrastructure for leading academic medical center in Saudi Arabia
Enhanced financial insight and control of outsourcing partners for leading EU biotech
Prior to joining TriRadial, Jonathan led growth strategy and strategic partnership efforts for Covance and Chiltern, co-founded a Health Sciences Solutions consulting practice, and served as a Principal in the R&D Advisory Practice and Global Project Manager at IQVIA (formerly Quintiles), leading clinical development efforts across multiple therapeutic areas.
Jon holds an MBA from the University of North Carolina at Chapel Hill’s Kenan-Flagler Business School with a concentration in strategy and leadership and a BA from the University of Delaware. In his personal time, Jon spends time with his wife, Alison and their two kids, coaches youth soccer, and trains martial arts.
Dr. Tomasz Kosieradzki
Klaudyn, Poland
GCP Quality Auditor & Inspection Readiness
Tomasz is a GCP quality specialist with leadership savvy in:
Clinical site preparation for (EMEA, FDA) regulatory inspections (conducts training, pre-inspection GCP audits for Phase I to IV trials, acts as an inspector during mock inspections and sponsor's representative)
QMS optimization, including ISO-15189-2012 Medical Laboratories
GCP audits for Phase I to IV trials
CAPA resolutions and training
SOP writing
Gap analysis in clinical research and due diligence
Since 2003 Tomasz has worked as a GCP QA Auditor collecting vast experience in drug developing organizations such Phase 1 / BE unit, CRO, Innovative Big pharma, small biotech, in EU and outside EU countries. He specializes in clinical site GCP audits for trials of all phases (I to IV) and system, sponsor oversight, and vendor audits (systems), especially in Phase1 units' assessment.
One of his leading activities is sponsor and site preparation for regulatory inspections (EMEA, FDA) through conducting training, pre-inspections audits, acting as an inspector during mock-inspections, and sponsor's representative.
Dr. Kosieradzki has been using his expert knowledge and experience as a trainer/lecturer in various training projects and as a speaker for several industry conferences throughout Europe for the past ten years.
Tomasz is an MRQA - member of the Research Quality Association (former BARQA) and Polish GCP Society.
His strong advantage is the knowledge and experience in developing practical and fit-to-purpose Quality Management Systems (QMS) based on process mapping methodology.
Expertise in:
Quality Management Systems in clinical trials according to ICH-GCP E6
Sponsor Oversight - complex approach
QMS according to ISO-15189-2012 Medical Laboratories - Requirements for Quality and Competence
Auditing methodology, including practical knowledge of industrial and regulatory referential documents for clinical trials
Preparation and hosting of regulatory inspections, including mock inspection
Early Development (Phase I) auditing (trials and vendors)
Risk-based approach to monitoring and auditing
Risk Management
Systems and Clinical Sites Audits
Vendor evaluation
SOP writing
Gap analysis in clinical research and due diligence
Root-cause analysis of errors
Corrective and Preventive Actions - training
Long distance swimming
Extreme Baltic Challenge Award
Antonio Biancardi
New Jersey, USA
IT Architecture
With over a decade of R&D information technology intelligence, Antonio focuses on:
Enterprise project management systems (safety, CMS, regulatory, financial functionality)
IT solutions architect and software developer
Liaison between IT and the business
R&D-focused systems (e.g., CTM, global investigator DB, eConsent)
As a technology and operations leader, Antonio has a track record of accelerating business outcomes for international enterprises and Fortune 500 companies. His achievements include the turn-around of under-performing organizations to: restore profitability, increase efficiency, and develop leading-edge software applications – from concept through release.
Antonio led the team that developed DataForm Software's flagship product, Planet Life Cycle – a robust work management application that merges strategic and financial planning with execution. As a direct result, customers that are global leaders, such as Allergan Pharmaceutical, have leveraged the solution to enhance their competitiveness. Antonio is consistently striving to enable customers to achieve operational excellence. In his words, “When our customers win, we win."
CORE COMPETENCIES
Operational Leadership
Budget and Financial Management
Software Design and Development
Technology Strategy and Execution
Business and Technology Alignment
Process Refinement and Improvement
Re-Structuring and Change Management
System Re-Engineering and Optimization
Client Acquisition and Relationship Building
Growth Planning and Performance Measurement
Challenging route to Wyanokie High Point, Carris Hill, Buck Mountain and Chikahoki Falls with views of the NJ Highlands and NYC Skyline
John Klein, MS MBA
Ohio, USA
R&D Processes Optimization
A business process consultant with more than 30 years of life sciences experience, John’s core work includes:
R&D transformation
Drug development: clinical trial optimization
Regulatory process alignment and harmonization
Global product transfer
Business process transformation through technology
John’s experience spans more than 30 years across life sciences, pharmaceutical product development, clinical trials, and healthcare. His work focuses on clinical development process optimization, covering the entire development lifecycle from concept to approval to withdrawal. Recent work has centered on global development transformation to streamline workflows, improved efficiency, and optimize cross-functional collaboration. By focusing on a collaborative approach, teams can bring key voices together earlier in processes, through better planning and workflows – to achieve more robust work products and a ‘right the first time’ approach. This can result in greater cross-functional interactions that move work through the lifecycle faster with higher quality and in a more compliant manner.
Prior work has included regulatory process redesign, global product asset transfer strategies, and streamlining a development organization spanning R&D, surgical and consumer products.
John started his career in healthcare at The Cleveland Clinic Foundation. His work then expanded into clinical trial technology and EDC with work at DATATRAK, where he led clinical implementation services. From there he entered consulting with BusinessEdge Solutions/EMC, before moving to Quintiles/IQVIA in the Consulting Services organization and later Global Regulatory Affairs. In 2019 he partnered with TriRadial Solutions to further process optimization for pharma, biotech, and device companies.
In his free time, John enjoys seeing and experiencing the world. Experiencing new places, cultures, and cuisines is very important to him to help broaden his worldview. He also is an accomplished home chef, enjoys entertaining and spending time at home with family and his three cats.
United had John speak at an event he flew with them so much!
John's US flight mapping
Favorite international destinations include: Tahiti, safari in South Africa, Rome, London...
Matt Hendricks
Pennsylvania, USA
Strategy, Facilitation and Team Effectiveness
Matt is a strategic management consultant with over 15 years’ experience in:
Business design challenge sprints (focus on consumer base, fit for client need)
Strategic decision facilitation and analysis workshops
Organizational change planning and execution
Clinical development and program management
Finance
Aggregate portfolio management and asset development
Matt is a management Consultant with significant experience working with clients at strategic and tactical levels. Known for helping clients zero in on the most critical elements of their problems, Matt develops creative solutions and then takes a disciplined and practical approach to get the job done.
Matt has a strong collaborative leadership style adept at working across Information Technology, R&D, marketing, and operations in the pharmaceutical, biotech, and manufacturing industries to achieve results.
Matt is part management consultant, known for getting cross-functional teams to cut out the buzzwords, get real, and tackle tough problems. He is also part entrepreneur, bringing the much needed concepts of high performing teams, business agile and psychological safety to the hospitality industry.
Full time, husband, father, and wiseacre.
Vacationing with family in Munich over Christmas 2016 (highlight was walking around the Kristkindlmarkt at the Karlsplatz)
At an International Game Fair in Essen, Germany (October, 2021)
Pasi Piitulainen
Basel, Switzerland
Finance and Procurement
With over 20 years’ experience in the global life sciences industry, Pasi is a deep subject matter expert in procurement and finance, specifically in:
Global R&D finance and analysis
Global R&D portfolio management
Budgeting, FPA process, tool development and implementation
Clinical outsourcing strategy development and implementation
M&A integration (direct and indirect procurement and supply) of acquired pharmaceutical production plant and supply chain into existing business
With over 20 years’ experience in the global life sciences industry, Pasi is a deep subject matter expert in Procurement and Finance and how those areas help enable world class R&D organizations. Most recently he was the Head of Procurement at Actelion Pharmaceuticals (today part of the Johnson & Johnson Family of Companies).
Pasi has a MSc in Industrial Economy from Lappeenranta University of Technology in Finland and holds the Chartered Financial Analyst(CFA) designation. Pasi’s passion is to promote and discover new solution via digital innovation and organizational design that helps the procurement to move to the next era.
Dr. Ulrike Geier
Heidelberg, Germany
Clinical Project Management and Vendor Negotiations
Ulrike brings over 30 years’ experience in clinical research within CROs and the pharmaceutical industry in multiple therapeutic areas. Her background includes:
International project and portfolio management
Senior strategic and operational oversight of worldwide Phase II/III clinical trials
Senior relationship management between sponsors and CROs
CRO selection from proposal to budget and contract (MSA/SOW) negotiations
Ongoing budget oversight and Change Order negotiations
With over 30 years’ experience in the global life sciences industry, Ulrike has extensive experience in senior strategic and operational oversight of worldwide clinical trial management teams in a global CRO setting. Currently she is focused on CRO selection from proposal stage to budget, Workorder and MSA negotiations.
Prior to her consulting work, Ulrike spent over 23 years working for Parexel in a global leadership capacity. Ulrike holds a Ph.D. and MSc in Biology/Chemistry from Heidelberg University in Germany. Ulrike’s passion is to assist clients achieve key operational and financial targets while going through notable change.
Meet Our Founder
A management consultant and entrepreneur focused on life sciences for over 30 years
Geoff Garabedian
Founder and President
Join Our Team
We are always on the lookout for seasoned professionals who share our passion for solving complex industry issues.
Contact Us
The TriRadial team is ready to answer your questions
For more information on any of our solution offerings or questions about how we can help you transform your business, please e-mail us using the form to the right, or schedule a meeting with Geoff Garabedian below or feel free to call us anytime.
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Solutions to help navigate global growth challenges
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