A drying pipeline. Exorbitant costs. High attrition rates. Over the past decade a lot of negative attention has been focused on problems within the drug discovery and development process. The good, perhaps less widely-discussed news is that identification of these problems and their underlying causes has slowly been fostering big changes in how pharma, biotech and even academic teams find and bring new drugs to market. One company at the heart of all this change is XenoTech, a global Contract Research Organization (CRO) and product provider working to help drug discovery and development teams make critical decisions about their large and small molecule compounds.
Officially, XenoTech’s mission is “to lead collaborations with the world’s principal researchers and scientific experts, advancing life-enhancing therapies with unparalleled insight and interpretation through high value products and bespoke services.” Less formally, their goal is to make the world a safer, healthier place by generating high-quality, reliable and reproducible data. In the process, they’re also helping their clients reduce costs and better understand risks inherent within the drug development life-cycle.
“The drugs we’re working on are the future of the market,” says Robert Grbac, Senior Scientist at XenoTech. “Ultimately, we are affecting people’s lives through studies conducted at XenoTech.”
Highlighted in Kola and Landis’s widely discussed 2004 opinion piece1, the early 2000s were a time of worry and introspection for the drug industry. Costs were skyrocketing, timelines growing and the regulatory burden increasing. Kola and Landis’s analysis found what many in the industry were already starting to suspect—problems with safety and efficacy in the later stages of development were two of the biggest causes of attrition in the clinic (data from the year 2000).1 The obvious solution would be to save money and time by identifying candidates with safety liabilities and efficacy problems as early in the process as possible.
One avenue already being explored by a small but growing number of pharma teams at that time was to use data from in vitro drug metabolism studies in an attempt to better predict human drug-drug interactions. As high-throughput technologies matured and the business pressures to identify safer, more effective candidates earlier in development grew, the demand for these types of pre-clinical in vitro studies exploded.2
Andrew Parkinson, Ph.D., founded XenoTech in 1994, when he saw that development teams needed a partner to conduct drug metabolism studies. As a professor studying xenobiotic metabolism at the University of Kansas Medical Center, he’d been receiving more industry requests to study drug metabolism than his lab could handle. His solution was to form XenoTech, which had exactly the right core competencies in place to help a growing number of drug makers obtain in vitro pre-clinical safety data before moving to the clinical phase.
Fast forward to today. XenoTech is a global leader in drug metabolism, partnering with development teams in the drug, nutraceutical, food additives and cosmetics industries to conduct over sixty different types of assays.
“It would be nice if one application satisfied the majority of clients, but everyone’s study is just a little bit different. So we have to be flexible and accommodating to ensure return business,” says Grbac.
As technology changes and drug makers push to get safety and toxicity answers even earlier in the process, XenoTech has evolved and entered into the early drug discovery arena. Their newest launch, the Discovery Plus Suite, provides core screening assays ranging from CYP Inhibition, Metabolic Stability, Plasma Protein Binding, CYP Induction and Bi-permeability assays.
“The data we gather is used by our clients to decide where to go next in their discovery and development programs and navigate the regulatory process, so it’s imperative that the data we produce are accurate and reliable,” says Grbac. “We want there to be as few false positives or negatives as possible, because we are one of the last stops before a compound goes into human trials.”
With so much riding on the data they deliver, data quality, reliability and reproducibility are absolutely critical to the XenoTech team. They push their assays to be as precise and accurate as possible, starting by having instruments that routinely transfer volumes within 6% accuracy and 3% precision for volumes 10 µl and over, and 9% accuracy and 4.5% precision for anything less than 10 µl (read Artel’s “Lab Report 4: Defining Accuracy and Precision” to learn more about these measures of data quality). When volume transfers are this reliable, the data produced by the resulting assays are much more likely to fall within favorably narrow precision and accuracy windows. XenoTech’s internal standard operating procedures (SOPs) require replicate samples to be within 20% standard deviation, a very stringent specification.
Achieving this level of consistency is dependent on having well-maintained, automated liquid handlers. With ten Tecans running a wide range of applications, monthly maintenance and volume transfer verification are very important. Not only does the team need to be sure they can trust their instruments are transferring, say, 10 µl and not 9.8 µl, they need to be able to tell if a robot is starting to drift out of spec. Each day a single Tecan is down translates into $10,000 in lost revenue.
To keep instruments operating within specifications and minimize downtime, Ryan Mueller, Automation Scientist and Engineer at XenoTech, performs monthly volume verification checks using the Artel MVS®. In four hours, he’s able to verify the performance of all ten liquid handlers—down from forty-plus hours when the team was using gravimetric methods for volume verification. The data on every instrument is saved, all the way back to 2008 when XenoTech first brought Artel in house. This ensures they can track performance over time and predict when one of the instruments is starting to drift off spec. By identifying potential problems before they happen, Rob and his team can better manage assay workflow while replacing worn parts and minimizing costly downtime.
“Sometimes when we start seeing anomalous data from our liquid handlers, we’ll troubleshoot with the Artel system, and if we have to replace any parts we’ll perform a post-change verification with Artel. Between troubleshooting and monthly maintenance, we might be “Artelling” an instrument three times in a single month,” says Mueller.
More recently, XenoTech’s automation team implemented the new software, which has made tracking instrument performance even easier. Instead of having to manually enter individual instrument data into a giant spreadsheet—which was prohibitively time-consuming—they now upload all their existing Artel volume measurements to the software, which allows them to see individual instrument data already plotted and graphed. Trends are even easier to spot, streamlining their ability to take cost-saving preventive maintenance actions.
“Once we brought Artel into the lab, we realized we could push to small volumes. We typically work beyond the liquid handler’s specifications, and we can do this because we have Artel to verify their performance,” says Grbac.
With Artel in place, XenoTech was able to miniaturize many of their assays, moving from 48-well plates in 2008 to 96- and 384-well plates in today’s assays. Increasing throughput while maintaining quality means faster timelines for their clients and more efficient processes overall.
One of the constant challenges the XenoTech team faces is keeping up with the rapid pace of change in the industry and regulatory requirements. For example, as assays move from using subcellular fractions and microsomal proteins to being cell-based, they’ve needed to redevelop many of their assays, and even create new ones. Whether using monolayer cells, suspension cells, or new three-dimensional matrices, the XenoTech team is constantly exploring and innovating to provide clients with the most informative data possible.
At the end of the day, the XenoTech team needs to deliver quality data in a timely fashion. With the throughput and timelines they need to meet, there’s typically no time for repeating a study or a set of samples—everything has to run correctly the first time. Starting with rigorous maintenance and attention to instrument performance and continuing with careful assay design, execution and data analysis, XenoTech is able to deliver unparalleled data that helps drug developers make critical decisions. They go home satisfied that they are doing their part to make the world safer one drug at a time (or sixteen if you are running a Discovery Plus panel)!
XenoTech is a premier provider of in vitro drug metabolism and drug-drug interaction studies to pharmaceutical companies worldwide. We have unparalleled experience in evaluating drug candidates as substrates, inhibitors and inducers of drug-metabolizing enzymes. Core capabilities include Enzyme Inhibition, Enzyme Induction, Drug Metabolism, Drug Transport and Analytical Services.
Tanya is a sales manager at Artel, where she has held many roles in her 20 year tenure with the company, which have included R&D product development scientist, project manager, marketing product manager and northeast account manager. In her current role, she spends time leading her team of North American account managers in finding prospective customers with liquid delivery challenges in the lab and finding ways to improve quality.
Jim is the Artel Global Account Manager covering Northern California to western Canada. His background in lab automation and liquid handling has helped Jim identify Artel prospects in the biotech market, understand their needs, and grow Artel’s business.
Prior to Artel, Jim held roles in sales, sales management and marketing with leading biotechnology companies including Beckman, Molecular Dynamics, GeneMachines, Genetix and Biosero. Most recently, Jim sold lab automation systems for PAA including integrated platforms, robots and scheduling software.
Jim is thankful to work with a strong Artel west coast customer support team that is delivering the highest quality systems and services to west coast customers.
John is a Global Account Manager with Artel. His focus is on helping customers optimize their liquid handling operations to their productivity goals.
Prior to Artel, John was a Senior Scientist at Janssen (J&J) working on a variety of automated platforms across R&D and GxP environments, in both small and large molecule. For the last three years, John was Chief Business Development Officer at GeNovu, dedicated to delivering software solutions that improve lab automation processes.
John has used Artel technology for more than fifteen years, and with his deep understanding of automation and laboratory operations he is well positioned to help customers get the best possible performance out of their instrumentation and assays.
With over 25 years in the automated liquid handling and lab automation industry, Ramon is well versed with the hardware/software performance requirements needed by laboratories along with the importance of accurate and reproducible volume delivery to meet specific applications.
His years included time with Beckman Coulter, Hamilton and Atlantic Lab Equipment where he promoted and sold the Biomek FX, NX, Hamilton STAR family of liquid handlers and Tecan EVOs along with large scale, fully walk-away automated integrated solutions.
Ramon is looking forward to continuing his journey with Artel to help labs get the most out of their equipment investments.
Katrine Kelly is currently a Global Account Manager with Artel. With over 18 years at Artel in Technical Support Katrine applies her technical expertise to assist customers both pre- and post-sale to make the best decision for their application. She utilizes her knowledge of Artel products and services to deliver online product demos and trainings. Prior to becoming a Global Account Manager, she installed and validated Artel systems at customer sites and she worked with customers remotely to get their instruments and software working. Katrine also managed the warranty and preventive maintenance program for Artel. She has an extensive understanding of Artel’s products and applications.
Sarena is Artel’s renewal sales manager. She held many roles in her 10 years at Artel. She started as Artel’s west coast applications specialist/ field service and moved into sales account management for the west coast. Prior to working at Artel, she worked in an R&D lab and gained experience working with enzyme assays and laboratory automation. Her technical expertise has helped her understand the challenges her clients face and allowed her to with them to find a solution.
Age is the Global Accounts Manager for the Midwest, including Central and Easter Canada. Over the last 25+ years, he has worked in the Life Science Research and Clinical Diagnostic markets focused on automated liquid handling and assay optimization. Prior to Artel, his roles included Systems Engineering, Technical Support, Training, Applications Support, Sales, Account Management, and Sales Management. Whether they work at the lab bench, in operations, or in the board room, Age uses his range of experience to partner with his customers and drive towards mutual success.
Morgan is a Research and Development Scientist who has experience in the life science/biotechnology industry with a focus on biological applications. She works to address customer needs by designing and conducting experiments, and provides accessible, tailored solutions for customers. Morgan is trained and qualified to comply with the requirements of ISO/IEC 17025 and is part of the team that delivers the Artel Liquid Handling Service.
Coming soon.
Coming soon.
Keith is an expert in liquid handling performance management, providing customized services across a wide range of platforms, applications, liquid volumes, and liquid classes. As Senior Applications Scientist, Keith combines his extensive knowledge and experience with rigorous science in his work in liquid handling system performance research, customer education, and assay/method validation.
Dana is a professional life sciences application enthusiast, with extensive experience applying liquid handling automation in a variety of laboratories throughout North America. As a field Applications Specialist at Artel, Dana works directly with laboratories to solve complex liquid handling and process issues that are often critical to their productivity and compliance, and to the integrity of their test results.
Kaziya is a Laboratory Applications Scientist with nearly a decade of experience as a bench scientist. Kaziya understands the real-world challenges of the lab and applies her extensive scientific knowledge to assist customers in solving liquid handling process and assay issues that critically impact productivity and data integrity. Kaziya is trained and qualified to comply with the requirements of ISO/IEC 17025 and is part of the team that delivers both the Artel Liquid Handling Service and the ISO/IEC 17025 Accredited Calibration Service.
Nick is a Laboratory Applications Specialist with hands-on experience in genomics and immunoassay development. Having worked in the molecular diagnostics and instrumentation space, Nick understands the issues involved with taking a regulated product from research to the market and uses this experience to help find meaningful solutions for customers’ liquid handling challenges. He is qualified to comply with the requirements of ISO/IEC 17025 and is part of the team that delivers both the Artel Liquid Handling Service and the ISO/IEC 17025 Accredited Calibration Service.
Karlton is a Laboratory Applications Specialist with over a decade of experience at the bench. He knows first-hand both sides of the molecular diagnostics market, having run many clinical diagnostics tests as a medical technologist as well as being part of a molecular diagnostics instrument product launch team. Along the way he’s been involved in technologist training, liquid handling optimization, and assay development/validation. With all of this experience, Karlton truly understands the demands of clinical and pharmaceutical labs and uses this expertise to help Artel’s service customers with their liquid handling challenges.
Maureen Minimi is a Laboratory Applications Specialist and pipetting proficiency trainer with over ten years of experience in the life sciences industry. She has hands-on experience in the molecular diagnostics market, having run many clinical diagnostic tests as a Medical Technologist, as well as experience with validating assays on instrumentation, troubleshooting instrumentation and training customers on pipetting skills and optimizing their workflows. She is highly knowledgeable in Good Laboratory Practices and her technical training skills and focus on excellent customer service have made her an excellent resource for helping customers with their liquid handling challenges.
Kristi is an expert in laboratory quality control with a passion for streamlining and implementing new processes. When not in the field providing Artel’s Liquid Handling Services and ISO/IEC 17025 Accredited Liquid Handling System Calibrations, Kristi manages quality internally here at Artel. As the Laboratory Chemist Supervisor, she ensures the quality of manufacturing reagents, final inspection of the PCS and MVS systems and reagents, as well as calibration, maintenance, troubleshooting and repair of Artel’s own laboratory equipment.
Andre is an experienced laboratory technician in the medical, research and pharmaceutical industry. As an Applications Specialist, he provides support and service in the Canadian Market, providing solutions to liquid handling challenges, assay optimization, method standardization and regulatory guidance.
Kristi is an expert in laboratory quality control with a passion for streamlining and implementing new processes. When not in the field providing Artel’s Liquid Handling Services and ISO/IEC 17025 Accredited Liquid Handling System Calibrations, Kristi manages quality internally here at Artel. As the Laboratory Chemist Supervisor, she ensures the quality of manufacturing reagents, final inspection of the PCS and MVS systems and reagents, as well as calibration, maintenance, troubleshooting and repair of Artel’s own laboratory equipment.
Rachel brings an extensive knowledge of automated liquid handler calibration and volume verification to the Artel Liquid Handling Service team. As a Product Development Scientist on the R&D team at Artel, Rachel Parshley has managed important product enhancement projects, including the development of 100% DMSO solutions for use with the MVS. These experiences translate into a thorough proficiency with both MVS and automated liquid handlers.
Kerry brings her passion for best-in-class delivery to Key Global Accounts at Artel. By listening deeply to clients in Clinical Labs and understanding their liquid handling quality, compliance, productivity, and staffing challenges, she creates customized road maps for success for individual labs and enterprises. Her goal is to help you meet your goals, and she effectively serves clients in both the private sector and the US Government.
Mark has worked in Clinical Diagnostic for over 40 years and at Artel for over 25 of them. He started at Artel as a Manufacturer’s Representative and has transitioned to a Global Account Manager. In his current role he works with all international opportunities, represents Artel domestically (Maryland, Virginia, Washington, D.C., Delaware) and is a liaison for all distributors. He works in all markets including Clinical, Biopharmaceutical, Research, Government and Forensics to improve laboratory results through better liquid delivery.
Maureen Minimi is a Laboratory Applications Specialist and pipetting proficiency trainer with over ten years of experience in the life sciences industry. She has hands-on experience in the molecular diagnostics market, having run many clinical diagnostic tests as a Medical Technologist, as well as experience with validating assays on instrumentation, troubleshooting instrumentation and training customers on pipetting skills and optimizing their workflows. She is highly knowledgeable in Good Laboratory Practices and her technical training skills and focus on excellent customer service have made her an excellent resource for helping customers with their liquid handling challenges.
Maureen earned a B.S. in Molecular Biology, with a minor in Chemistry at Montclair University in New Jersey.
Ryan Murphy is a Technical Support and Training Specialist for the Technical Services team. His responsibilities include providing after-sales instrument and software support and conducting proficiency certification trainings for Artel’s customers. He is dedicated to providing prompt and focused service and support to ensure continued customer satisfaction.
Ryan earned a BS in Biological Sciences and Neuroscience and a PSM in Biotechnology at Florida Atlantic University.
Keith J. Albert, PhD, is a Senior Applications Scientist at Artel, and is responsible for automated liquid delivery system performance research, customer education and assay/method validation services. He has spent nearly nine years managing and working on an Artel service team at Merck Boston – communicating with their scientists about volume transfer performance for their various liquid handling platforms.
He applies his expertise and scientific knowledge – in pre- and post-sales support – to help laboratories optimize their liquid delivery processes and maintain compliance. He earned his BA in Chemistry at Colby College and his Ph.D. in Analytical Chemistry at Tufts University.
Keeping a continual focus on optimizing laboratory productivity, particularly in an increasingly global environment, Bjoern has been contributing to the development of international standards for over 13 years. He is a technical expert contributing to the efforts of standards development committees of ISO, ASTM International, and CLSI.
Filling a void in testing guidance for users of automated liquid handling systems, Bjoern was one of the industry experts who proposed the development of ISO/IWA 15. He is currently the project leader and technical editor for the development of a series of ISO standards (ISO 23783 parts 1, 2, and 3) slated to succeed ISO/IWA 15.
Bjoern has been contributing as technical expert to the revision of the ISO 8655 series of standards, serving as lead author and project leader for the new Part 8 “Photometric reference measurement procedure for the determination of volume” and project leader and technical editor for the revision of Part 7.
Doreen Rumery, Director, Laboratory and Quality Control at Artel, is a certified Medical Laboratory Technologist and ASQ Certified Manager of Quality/Organizational Excellence with more than 30 years in the clinical laboratory and manufacturing industries.
Doreen oversees all laboratory activities at Artel, including technical operations, method validation, technician training and conformance with current regulatory standards.
Candie Gilman is a Education & Training Manager Specialist and is responsible for both the coordination and/or delivery of all customer training programs and the developer of the training content. She has over twenty years of experience in biotech technical support and technical product training, and has spent the last decade working side-by-side with customers to standardize and improve their pipetting technique.
Candie also supervises the Artel Customer Service team and is a certified Communico MAGIC Training Facilitator.
With a focus on ensuring that Artel delivers meaningful and measurable value to the company’s customers—whether that’s accelerating time to market, delivering cost savings, or driving intellectual property creation—Rosario approaches his role as Vice President of Business Development as one of partnership and collaboration.
He has spent his career bringing complex technologies to scientific and medical professionals and has found success through close engagement with customers. By truly listening and understanding his constituents’ needs, Rosario is able to translate a technology’s value into measurable and sustainable benefits. Newly part of the team, he is already making an indelible mark both in-house and with the users of Artel technology.
When not focusing on customer success or being corralled by colleagues into proofreading their documents (that’s what an inborn commitment to excellence gets you), Rosario brings joy to his friends and family in the form of cooking and opera singing.
“Strive not to be a success, but rather to be of value.” – Albert Einstein
A sales manager responsible for leading a team of skilled account managers, distributors and consultants, Tanya brings together a deep understanding of Artel technology and customer needs to drive success for her team and for Artel’s customers.
Her insight into the benefits provided by Artel technology is based on her experiences as part of the original R&D team that developed the MVS. With the belief that technology untethered from customer needs is ineffective, she moved into marketing to learn how the system she helped develop can enable Artel’s customers to achieve their goals. Now as a sales manager, Tanya is focused on expanding the number of life science teams that Artel can help, whether they are developing and manufacturing tomorrow’s cures or ensuring health through accurate assays.
Like many at Artel, Tanya likes to enjoy the great Maine outdoors with her family when not at work, by camping and traveling to the many wonderful state parks.
“Precision is, after all, not a form of responsibility and a kind of pleasure, but an instrument of compassion. To be precise requires care, time and attention to the person, place or process being described.” – Marilyn Chandler McEntyre
Morgane’s mission is to enable customers and potential customers to quickly and easily understand how Artel’s technology can help them optimize their assay workflows by clearly communicating everything Artel. From how the technology works in specific applications to challenging set up of liquid handler processes and tuning in of complex assays, Morgane is making Artel’s technology understandable and accessible to all.
Having been both hands-on at the bench and with scientific project management, Morgane understands the ins and outs of customers doing research and providing scientific services. She looks forward to satisfying her innate curiosity by learning about the needs of all of Artel’s many types of customers.
When not translating Artel technology into easy-to-grasp communications, Morgane relaxes by folding herself into knots practicing and teaching yoga, traveling back to her native France, expanding her proficiency at a variety of arts, and marveling at how all of these activities feed back on and are driven by the nervous system.
“After a certain high level of technical skill is achieved, science and art tend to coalesce in esthetics, plasticity, and form. The greatest scientists are always artists as well.” – Albert Einstein
Bernadette is the driving force (and friendly face) behind Artel’s content-heavy and customer-centric approach to marketing. She develops marketing/branding strategies and communications campaigns, and leads program execution and analysis by coordinating internal and external efforts, managing budgets, and ensuring consistency and adherence to Artel’s high standards.
Bernie’s strength lies in her ability to reach across all disciplines at Artel—scientific, engineering, metrology, technical support, product development, production, sales, and field support—to make sure that customers are getting the valuable information they need.
Bernie’s passion for detail, quality, and authentic content is expressed in her extraordinary culinary skills, whether the cooking is for an (extensive) family gathering or making a meal for the local community teen center.
“What people do with food is an act that reveals how they construe the world.” Marcella Hazan
Wendy puts her years of experience in the laboratory and her passion for helping people and problem solving to good use as Artel’s Technical Services Manager. Her background has given her hands-on knowledge of customers’ tests and assays, enabling her to understand their pain points since she has experienced them herself. Her goal is to ensure that first-class service is provided by Artel’s customer-facing team, whether it’s directly interacting with customers or through her management of the team. Through hiring, training and guiding her team, she nurtures productive, long-lasting customer relationships.
Wendy’s focus on customers also makes her an excellent internal customer representative to Artel’s teams, where she provides input on product development to the R&D team and communicates any quality issues with Artel products and services to the operations team.
Wendy’s drive to help others resolve problems is not limited to Artel but is evident in all aspects of her life, especially with her children. When not assisting customers, Wendy likes to stay active by biking, boating, and taking long walks in beautiful Maine.
“Nobody cares how much you know until they know how much you care.” commonly attributed to Theodore Roosevelt
Keeping a continual focus on optimizing laboratory productivity, particularly in an increasingly global environment, Bjoern has been contributing to the development of international standards for over 10 years. He is a technical expert contributing to the efforts of standards development committees of ISO (International Standards Organization), ASTM International (formerly the American Society for Testing and Materials), and CLSI (Clinical and Laboratory Standards Institute).
Filling a void in testing guidance for users of automated liquid handling systems, Bjoern was one of the industry experts who proposed the development of the ISO International Workshop Agreement (IWA) 15 “Specification and method for the determination of performance of automated liquid handling systems,” serving as project leader and technical editor for the development of this ISO document. He is currently the project leader and technical editor for the development of a series of ISO standards (ISO 23783 parts 1, 2, and 3) slated to succeed ISO/IWA 15.
Bjoern has been contributing as technical expert to the revision of the ISO 8655 series of standards, serving as lead author and project leader for the new Part 8 “Photometric reference measurement procedure for the determination of volume” and project leader and technical editor for the revision of Part 7 “Alternative measurement procedures for the determination of volume.” He is the co-proposer, lead author, and project leader for the development of the new Part 10 “User guidance and requirements for competence, training, and POVA suitability.”
Key Roles:
Project leader for development or revision of:
– ISO 8655-7
– ISO 8655-8
– ISO 8655-10
– ISO 23783-1, -2, and -3
– ASTM E1154
– ISO/IWA 15
Technical expert in:
– ISO/TC48/WG04
– ISO/TC48/WG05
– ANSI US TAG to ISO/TC48
– ASTM E41 and E13
– CLSI
Heidi contributes almost 40 years of Regulatory Affairs and Quality Assurance experience to the Standards Leadership team. Having worked for decades in FDA-registered companies, she is well-versed in FDA regulations, audits, and inspections. As a Certified QMS Auditor, she has been responsible for all aspects of Artel’s ISO 9001 certification and ISO 17025 accreditation processes, as well as the corresponding internal audits. Additionally, she is an expert in industry-specific regulatory requirements, and ensures Artel’s continuous compliance with all applicable regulations and international standards.
Heidi serves as the secretary to the ISO working group responsible for the development of a series of new ISO standards for Automated Liquid Handling Systems, after having provided significant support to the development of ISO/IWA 15. Her standards development expertise is further applied in handling the balloting process of ISO and ASTM standards for the relevant technical committees in the US.
Key Roles:
– ISO/TC48/WG05 – Secretary
– ANSI US TAG to ISO/TC48 – Vice Chair
Responsible for:
– FDA regulations
– ISO 9001 certification
– ISO 17025 accreditation
– Internal audits
– Compliance to RoHS, REACH, TSCA, and others
Richard has been applying his scientific expertise to the development of international standards for over 25 years. He proposed and authored ISO 8655-7:2005 and ISO/TR 16153, based on the ratiometric photometric method for volume determination.
He was an active member in the ASTM International (formerly American Society for Testing and Materials) committee on laboratory apparatus, as well as in NCSL International (formerly National Conference of Standards Laboratories) through the 1990’s. In 1995, he became involved in the revision of DIN 12650 series of standards related to pipettes and other piston-operated apparatus, which led to the development of the ISO 8655 series of standards.
The co-founder of Artel, Richard was company’s original member delegate to the NCSLI – an international metrology association founded at the request of the US National Institute of Standards and Technology (NIST). This close engagement with metrology and measurement excellence was formative in the development of Artel’s measuring systems and laboratory capabilities.
He authored numerous papers and presentations on the topic of pipette calibration, which are referenced in compliance standards, such as the checklists issued by CAP (College of American Pathologists).
Key Roles:
Author of:
– ISO 8655-7:2005
– ISO/TR 16153:2004
– Performance verification of manual action pipettes, Am Clin Lab 1994
– Referenced in CLSI GP-31 A
– Referenced in CAP checklists
– NCLSI member delegate and appointing officer
– ASTM E41 member since mid-1990’s
George has been engaged in international standards and metrology for more than 20 years – working with colleagues at ISO, ASTM International (formerly the American Society for Testing and Materials), CLSI, and NCSL International (formerly the National Conference of Standards Laboratories).
He chairs the ISO working group responsible for the development of the new standard for Automated Liquid Handling Systems, after having co-proposed and chaired the development of ISO/IWA 15, which was published in 2015. He is the former chair of the ISO working group responsible for pipettes and other piston-operated apparatus, where he proposed the development of a new ISO standard for the “Photometric Reference Measurement Procedure for the Determination of Volume” (ISO 8655-8). George is also a technical expert in the revision of all parts of the ISO 8655 series of standards and proposed the development of the new ISO standard on Operator Training and Pipetting Technique.
His deep expertise in metrology is applied in the current revision of the ISO technical report on the estimation of uncertainty for the photometric reference method, numerous articles, as well as across Artel’s product line.
Serving as chair of the US technical advisory group to the ISO technical committee responsible for laboratory equipment, George is responsible for achieving consensus among US experts and articulating this US consensus positions the ISO international technical committee.
George chairs the ASTM sub-committee on laboratory apparatus and serves as secretary to the parent main committee. His metrology expertise was applied in the revision of the balance calibration standards ASTM E898 and E617, which is referenced in the USP (United States Pharmacopeia).
He co-authored the chapters about pipettes and liquid handling processes in the current edition of CSLI QMS-23.
Key Roles:
– Co-author of:
– ISO 8655-7
– ISO 8655-8
– ISO/TR 16153
– Proposer of ISO/IWA 15
– Proposer of ISO 23783-1, -2, -3
– CLSI QMS-23 – Contributing Author
– ISO/TC48/WG05 – Convenor
– ISO/TC48/WG04 – Former Convenor
– ASTM E41 – Secretary
– ASTM E41.06 – Chair
– ASTM E898:2020 – Revision Participant
– ASTM E617:2018 – Revision Participant
– ASTM E1154 – Technical Contact
– ANSI
– US TAG to ISO/TC48 (Laboratoy Equipment) – Chair
– ANSI International Forum – Participant
– NCLSI – Member Delegate & Healthcare Metrology Committee
Kathleen extends Artel’s commitment to using innovative processes for error-free results to Artel’s finance-related activities. Responsible for financial planning and analysis, evaluating strategic opportunities, budgeting, benefits, and compensation, Kathleen uses her long history of doing mergers and acquisitions from a consulting and business side to bring analytical excellence to strategic evaluations, and her experiences at larger companies to advance established processes.
When not at Artel, Kathleen uses all her experience in efficiency and productivity to care for her two daughters and their cat, dog, and horse and, in the very little time left over after that, enjoys travelling to other countries, meeting new people and learning about other cultures.
“Live life as if you were to die tomorrow. Learn as if you were to live forever.” Mahatma Gandhi
Richard combines his scientific education, love of learning, curiosity, and passion for making things work better to build products that help life science labs meet quality and productivity goals. His favorite challenge is finding the bullseye at the intersection of corporate strategy, market need and available technology, and then figuring out how to create a product which hits that target. His leadership has been instrumental in shaping Artel’s products and services into the effective, easy-to-use, and quality-focused offerings that they are today.
When not creating tools and knowledge to help life science labs get the right answers every time, Richard enjoys the great Maine outdoors—canoeing, camping, and gardening—as well as woodworking (usually in the great Maine indoors).
“When you have eliminated every possibility for inaccuracy, then accuracy remains your only option.”
With years of pharmaceutical industry experience centered around analytical chemistry, automation, and new technologies, as well as a background in teaching assay development and validation, Nat’s a natural in his role at Artel as the primary driver and chief communicator of product applications. From optimizing assays, processes, and workflows to pipette user training and calibration, Nat communicates to customers how Artel products and services can improve quality and productivity.
At the same time, he keeps track of key assay trends and applications to inform new product development and strategic guidance for business development, partnering, and collaborative opportunities.
While typically a casual and friendly person at Artel and at home, Nat’s aggressive commitment to quality comes out when he homebrews beer and other fermented beverages and he’s even been known to kick people out of the kitchen to avoid contamination.
“Fast is fine but accuracy is everything.” Wyatt Earp
As a co-founder and President, Kirby’s role at Artel is similar to that of an orchestra conductor—he melds the different elements of the company into a powerful whole, bringing out the best in his colleagues and creating synergies that together overcome customer challenges in liquid handling, quality, and regulatory compliance.
Through a combination of curiosity and discipline, creativity and precision, he works with his fellow Artelians to build outside-the-box solutions that are efficient, easy-to-use, highly effective and based on science. Their goal: to ensure that each customer finds new opportunities and executes new solutions to achieve productivity and compliance objectives.
When not at Artel, Kirby takes up his own instruments, the saxophone and piano, playing for the approval of Charlie Parker and Gabriel Faure.
“Music is your own experience, your thoughts, your wisdom. Master your instrument, master the music. If you don’t live it, it won’t come out of your horn.” Charlie Parker
As the Production Manager, Jim maximizes Artel’s productivity and quality by ensuring that all supplies and components are in place, providing proper training for production personnel, maintaining effective processes, and supporting an overall positive, sound and safe working environment.
Driven by a desire to help others, Jim uses his 30-plus years of experience in the photometric instrument field to ensure that customers know they can rely on Artel, answering questions, solving problems, and guiding them through to complete resolution of any issues they have with their lab’s systems.
Like many at Artel, Jim enjoys cooking and home renovation, and is currently combining his helpfulness and home renovation skills by working on his daughter and son-in-law’s house.
“Seek first to understand, then to be understood.” Stephen R. Covey
An important part of building high-quality products, and providing services that rely on those products, is ensuring that the components and supplies are also high-quality and readily available. Which is why Jack focuses on keeping supply-side relationships top notch. Responsible for the extended supply chain—procurement, purchasing, inventory control, warehousing, shipping, and trade compliance—as well as Artel’s facilities and physical plant, Jack ensures quality by being both a good customer and delivering good customer service.
Jack’s adherence to high standards, quality, and attention to detail are a great fit for his work at Artel and can also be seen in the years-long home renovation project he and his wife have been undertaking. When not at Artel, Jack is an avid traveller, gardener, and connoisseur of cinema and literature.
“No one knows the cost of a defective product – don’t tell me you do. You know the cost of replacing it, but not the cost of a dissatisfied customer.” W. Edwards Deming
Officially, Graham is responsible for overseeing sales, strategic marketing, business development, and applications of Artel’s technology. In practice, this means listening to customers and leveraging his broadly eclectic scientific and business background to identify technological solutions that improve data quality and productivity.
Initially trained as a molecular biologist/protein biochemist, his many years troubleshooting misbehaving assays and analytical methods make him particularly well-suited to a role helping customers with their data quality. The many years at the bench have given Graham a deep appreciation of the importance of reducing sources of noise and variability which, together with experimental controls, can help save weeks and even months of wasted time.
When not at work, Graham’s total embrace of the experimentalist’s spirit is evident in his approach to cooking and baking, also known as “the experiment you get to eat,” which requires precision and tight QC of the ingredients as well as exact execution of the recipe steps to get the desired tasty outcome.
“I often say that when you can measure what you are speaking about, and express it in numbers, you know something about it; but when you cannot measure it, when you cannot express it in numbers, your knowledge is of a meagre and unsatisfactory kind.” Lord Kelvin
With a specialization in metrology and a lifelong interest in both science and engineering, George is ideally suited for his role as Artel’s representative to metrology and standards organizations, laboratory accreditation bodies, and government regulators, where he helps shape regulatory frameworks around liquid handling processes.
These activities give George a deep understanding of regulatory compliance which, coupled with his metrology and quality expertise, he uses to help customers improve data quality and efficiency while maintaining regulatory compliance. This help is especially critical for customers making process improvements, as change can be challenging in regulated environments.
George’s interest in metrology and standards extends beyond his work at Artel (see how he celebrated World Standards Day in 2016). For example, in George’s words, “Deflategate could have been avoided with a properly defined and validated measurement process. With no stated reference temperature, the NFL cannot possibly regulate ball pressure to plus or minus 0.5 psi. A game of inches and seconds, $15 billion annual revenue, and zero metrologists!”
“Every system is perfectly designed to get the results it gets.” Often attributed to W. Edwards Deming, but more likely from Paul Batalden.
As the person in charge of Artel’s Quality Management System, Cary plays a critical role in making sure that Artel’s commitment to quality is always being met. By training employees and keeping all quality processes and procedures well-documented and up-to-date with current regulatory standards she ensures regulatory compliance, and by assessing and evaluating performance both internally and externally (Suppliers) and customer feedback, she supports overall productivity and effectiveness to ensure we meet our customers’ expectations.
When not working closely with her team members to maintain Artel’s quality management processes, Cary enjoys the peace found hiking in the beautiful Maine outdoors.
“Nature does not hurry, yet everything is accomplished.” Lao Tzu
“Random is not one of my strengths.” Doreen Rumery
With a strong work ethic, thorough attention to detail, inquisitive mind that needs to know why things work (or don’t work), and passion for standardization, Doreen is exactly the right kind of person to manage Artel’s chemistry and calibration labs. She’s responsible for making sure the labs run smoothly, ensuring product and instrument quality, calibrations, regulatory compliance, lab personnel training, timely delivery of products, troubleshooting, and process improvements.
Doreen’s need for standardization is apparent even in her home life where spreadsheets and planning tools are used to ensure the household runs smoothly. When not at Artel, Doreen likes to spend time with her family (some of whom she also sees at Artel), gardening, and travelling with her many sisters and brother.
“Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skilful execution; it represents the wise choice of many alternatives.” William A. Foster
Table 1. Regulations that require demonstration of pipette competency training and/or assessment
ISO Standards | |
ISO/IEC 17025:2005 | General Requirements for the Competence of Testing and Calibration Laboratories |
ISO 15189:201 | Medical Laboratories; Requirements for Quality and Competence |
ISO 15195:2003 | Laboratory Medicine; Requirements for Reference Measurement Laboratories |
FDA cGMP regulations (current Good Manufacturing Practice) | |
21 CFR Part 211 | cGMP for Finished Pharmaceuticals |
21 CFR Part 225 | cGMP for Medicated Feeds |
21 CFR Part 820 | Quality System Regulation for Finished Devices for Human Use |
21 CFR Part 1271 | Human Cells, Tissues, and Cellular and Tissue-based Products |
GLP (Good Laboratory Practice) | |
FDA: 21 CFR Part 58 | GLP for Non-clinical Laboratory Studies |
EU: Directive 2004/10/EC | Principles of Good Laboratory Practice 1997 (Part 1), from the Organisation for Economic Cooperation and Development (OECD) |
GCP (Good Clinical Practice): | |
International Conference on Harmonization (ICH) E6 | Good Clinical Practice – Consolidated Guidance 1996 |