Overview
Cornell University gives a simplified definition of the main goal of the Biotechnology Industry: To utilize enzymes, microorganisms, and plants to yield energy, chemicals, and consumer goods, along with technological advancements in genomics, biofuel, data analytics, & automation. In other words, the industry creates processes & manipulates products to promote discovery with the goal of product quality and yield improvements.
Challenges
The sheer quantity of data involved in Bio/Pharma research has created a need for robust analytical tools that can simultaneously manage a high amount of data while providing an interactive, user-friendly interface that facilitates collaboration between experts with a range of statistical expertise. Oftentimes, Users have content in multiple places which makes it difficult for sharing data. JMP helps them improve efficiency across teams by allowing users to quickly share their discoveries. The JMP suite of products from standard JMP, Pro, Live, Clinical, and Genomics truly promotes synergy within a company to collaborate a further discovery in each field.
Researchers need to supplement their subject matter knowledge with data analytics to make faster, better-informed decisions from the existing data and to solve problems correctly the first time. They need effective analysis to drive out high failures or high-cost aspects to capture more value and reduce waste. In an industry where design decisions have a significant impact on cost, scientists need more efficient approaches with which to optimize biopharmaceutical process development.
Why JMP?
JMP data analysis empowers some of the world’s largest and most innovative pharmaceutical and biotech companies to explore the process and lab data, understand sources of process variations, learn more from the root-cause investigations and optimize processes and experimental design- all without learning code. In short, JMP saves time and money and can be used by any level of industry employee.
Who Uses JMP?
- Scientist
- R&D
- Biostatisticians
- Epidemiologist
JMP’s Applications in the Biotech Industry
Our team members had a conversation with Tom Tao, who is currently the System Engineer from China’s HLS (Health and Life Science) Team. He shared some information on how the biotech industry applies JMP and JMP Clinical during two distinctive stages of drug development:
Stage 1: Before IND (Investigational New Drug Application)
- Hypothesis Testing: such as testing the effectiveness of old and new batches of medicines
- DOE: an integral part of the Quality by Design (QbD) approach, applied in the development of biological products both for process and analytical methods
- Modeling: assists JMP DOE platform to determine the optimal outcomes of biological production
Stage 2: After IND – Commercialization and Mass Production
- a) SPC (Statistical Process Control): used for stabilizing and controlling the quality of drug production
- b) Reliability: Stability and Shelf-Life Analysis
Tom also provides an image of platforms in JMP that are more frequently used to assist the whole research and production process of most customers from the Biotech industry. This graph is also frequently used in the China HLS team’s presale demos, especially when the audiences are from the Biotechnology, Clinical Research, and Pharmaceutical industry to show how JMP supports the idea of QbD (Quality by Design) applied in the Biotech industry.
Industry Companies that use JMP
Merck (Pharmaceutical) was challenged with speed advances in biomarker research by deploying statistical methods to exploit increasingly sophisticated oncology data. Their Biostatisticians use interactive features in JMP® to perform robust statistical analyses in less time. The approachable interface of JMP makes it easy for statistical experts to collaborate with subject matter experts.
https://www.jmp.com/en_us/customer-stories/merck.html
Medtronic analyzes data to create and study lab tests that help to create efficient and accurate devices. Its Research & Development Team uses large data sets and statistical analysis to determine the variables that most affect the performance of a device. For example, LigaSure technology is a series of devices aimed to make surgery safer. Using JMP, the devices developed can find the optimal amount of pressure and radiofrequency energy to reconnect blood vessels during surgery. This has led to minimizing blood loss and decreasing patient recovery times.
https://www.jmp.com/en_us/customer-stories/medtronic.html
Fujifilm Diosynth Biotechnologies develops and offers manufacturing processes of active ingredients for pharmaceutical companies. They were facing the challenge that, in an industry where design decisions have a significant impact on cost, scientists need more efficient approaches with which to optimize biopharmaceutical process development. By introducing JMP Pro into the system, the tailor-made design of experiments (DOE) helps optimize experimentation and shorten development times. Besides, Functional Data Explorer (FDE), as a data transformation tool, helps scientists to prepare data for analysis – including DOE. JMP Dashboards in HTML format are also allowed to share with non-JMP users.
https://www.jmp.com/en_us/customer-stories/fujifilm-diosynth-biotechnologies.html
Sales Stories Win
25:2 Solutions
25:2 Solutions specializes in using Machine Learning to help companies develop new and better crops. Originally purchased JMP Genomics for one user ($12.6k) and have since upgraded (adding another $3k) and renewed each license since.
“JMP Genomics has helped us to accelerate the development of breeding lines and varieties,” says geneticist and CTO of 25:2 Solutions Eric Jackson. Time savings, however, is not the only advantage. Jackson says the most important thing is the tool’s constant evolution as JMP software developers listen to the needs of users to design and develop new features.
https://www.jmp.com/en_us/customer-stories/25-2-solutions.html
Pfizer
Pfizer, the world’s second-largest pharmaceutical company, on Thursday, signed a contract for 30 licenses of JMP Clinical in a deal valued at nearly $100,000. Pfizer will use the software for clinical data reviews and the creation of patient narratives as it tests a new class of cholesterol-lowering medications targeting an enzyme known as PCSK9. “There’s a big race on among the pharmaceutical companies to see who will be the first to market with it,” explained David Schultz. “It’s one of the highest priority projects in Pfizer right now in the clinical stage.”
Late last year, the JMP team made an initial presentation to the Pfizer group responsible for the review and analysis of clinical data. A software evaluation began in mid-2014. At the end of August, the JMP champion at Pfizer was demonstrating JMP Clinical to the clinicians who would be using the software. David recalled that during the presentation, “the clinical lead put the phone on mute and said to the champion, ‘When can we get this software? It’s exactly what we need.’” A tortuous procurement process followed, with budget cuts making the purchase seem unlikely at times.
Eventually, the senior director of data analysis and reporting “stepped up and figured out how to make it happen,” David said. He and Doug Robinson both credited Kelci Miclaus with helping to ensure the deal’s success. “Kelci dedicated a lot of her time to working with Pfizer and helping them through the evaluation,” David said. “A lot of work went into proving that JMP Clinical would be able to read the data from the PCSK9 study.” Assuming that this pilot project is successful, Pfizer “will be a very special account for JMP,” David said. “To have Pfizer using JMP Clinical is very, very significant. Moving into next year, there is wonderful growth potential.”
- Product: JMP Clinical
- Amount: $98,971
- Integral Players: Dan Durkin, Mary Loveless, Geoff Mann, Kelci Miclaus, Doug Robinson, David Schultz, Jon Weisz
Relevant Demo Resources
JMP, JMP Pro, JMP Clinical, and JMP Genomics are widely used to assist the data exploration and modeling process in biological production. Our team researched the technical reference library, found two demos and one webinar are available.
We took one of two demos: ethanol fermentation and the “Ferm at Age 32 hrs” dataset, as an example. Ethanol fermentation (also known as alcoholic fermentation), is a biological process that converts sugars (glucose, fructose, sucrose) into cellular energy, producing ethanol and carbon dioxide as a side-effect Interactive graph builder platform. Because of the large amount of data collected from production and high-dimensional property of variables, looking into the yield patterns, and filtering out influential factors which affect yield are the two most complex parts during fermentation analysis. But in JMP, the entire analysis is simplified, and the processing pipeline is extremely straightforward: JMP’s distribution platform and interactive histograms are used to investigate the general data structure.
As for selecting the statistically significant variables in the yield model, influential factors can be highlighted and filtered out to build a new model in just several clicks.
Besides, visualizing and tracking the patterns of ethanol yields by time and different vessels are directly revealed using the graph builder platform.
In addition to the ethanol fermentation demo above, we also found a demo of JMP application (the function used: fitting nonlinear curve) in biological assessment and a webinar video of JMP (platforms used: partition and hierarchical clustering) and JMP Genomics application (platforms used: linkage maps and QTL, breeding analysis) in researching on genomics diversity and plant breeding.
References
- Definition: Biotechnology Industrial Biotechnology | Department of Biological and Environmental Engineering (cornell.edu)
- Customer Story: Merck https://www.jmp.com/en_us/customer-stories/merck.html
- Customer Story: Medtronic https://www.jmp.com/en_us/customer-stories/medtronic.html
- Customer Story: Fujifilm Diosynth Biotechnologies https://www.jmp.com/en_us/customer-stories/fujifilm-diosynth-biotechnologies.html
- Sales Story: 25:2 Solutions https://www.jmp.com/en_us/customer-stories/25-2-solutions.html
- Definition: DOE and QbD Design of Experiments (DoE) | GreyRigge - The Biotech Consultancy
- Demo: Ethanol Fermentation https://community.jmp.com/t5/Technical-Reference-Library/D47-Ferment-Hampton/ta-p/22217
- Demo: Bioassay (biological assessment) Training https://community.jmp.com/t5/Technical-Reference-Library/T09-Bioassay-Training-Higgins/ta-p/23403
- Webinar: Genomics Diversity and Plant Breeding https://community.jmp.com/t5/Mastering-JMP/Analyzing-Genetic-Diversity-and-Applying-Genomic-Selection/ta-p/285787?_ga=2.34849377.170966381.1642381957-1619470559.1635774407
