Tag Archives: BIOVIA

Tim Moran, Director Life Science Research Product Management, BIOVIA

May 16, 2016 Business Review Webinars Leave a comment

Tim’s early research in the industry focused on Immunomodulation and Imaging to study of effects on T-cell lymphocyte homing. He held several managerial positions in Image Informatics and came to the organization in 2006 to begin work as Director of Image Informatcs. His role has expanded over the years to include Life Science Research Marketing and Product Management for Assay Management, Next Generation Sequencing, Sequence Analysis, Biotherapeutics, and Bio Registration.

1. What are you looking forward to discussing with the audience?

So many pharmaceutical and biopharmaceutical organizations are increasing their focus on biotherapeutic drug development in order to remain competitive in the market. Unfortunately, this can backfire when these organizations don’t take in to account the resources required for managing the additional complex data and processes involved. This can increase exposure to compliance risk, decrease overall productivity and extend the time to market for new products. I’m excited to have the opportunity to show the audience that there is a better way to not only manage, but leverage biologics data by eliminating inefficient paper-based workflows, reducing the effort for creating experiments, providing better understanding of processes and products, and much more.

2. You’ve mentioned that the biologics discovery workflow is similar to small molecule discovery at the highest level but that there are differences in the details. Can you explain what changes as an organization shifts toward biotherapeutic development?

In short, biologic discovery demands unique processes due to the added complexity of biological systems. Compared to small molecule discovery, biologics workflows generate a large amount and a large variety of complex data. However, being able to distill the information and track the genealogy of how to get to an end entity is critical. This requires some advanced data and workflow management.

3. Why do you feel this topic is important?

In a recent market survey conducted by industry analysts IDC, it was shown that just 6 of the top-selling drugs in 2014 were biologics. In 2018 however, it’s estimated that over 50% of the top 100 prescription and OTC drug sales will be biologics. This clearly shows the strong industry trend shifting to biologics and with that industry shift, life science organizations will need a robust informatics solution to manage the increased complexity of biologics.

4. What do you hope the audience will learn from this webinar?

By attending this webinar, I hope the audience will see the true potential impact of transitioning from disjointed workflows and what has primarily been a paper-based to an electronic Biologics solution covering all activities of the discovery process and how that positively affects their bottom line.

Join Tim in the BIOVIA webinar ‘Integrated, Predictive and Collaborative Workflows in Biologics Discovery‘. Register now!

Cyril Walsh, BIOVIA Sr. Solutions Consultant, BIOVIA

February 4, 2016 Business Review Webinars Leave a comment

Cyril Walsh Cyril has extensive knowledge on the management of Quality and Regulatory affairs pertaining to automated content management. Cyril has implemented Quality based processes for the management of CAPAs, Deviations, Change Control and Complaint handling. Cyril also has in-depth experience in the services arena having previously worked for Accenture, before beginning his 13 year tenure at QUMAS, now part of BIOVIA, the leader in quality and compliance management solutions for the Life Science industry.

1. What are you looking forward to discussing with the audience?

The focus of our discussion will be defining a true Total Quality strategy and why it’s so critical for Life Science companies. We will give an overview of the challenges of implementing a solution for Total Quality as well as how to overcome them, the required capabilities for a Total Quality solution that spans the entire scientific product life cycle from ideation to commercialization and the benefits an organization will experience when implementing a Total Quality strategy.

2. You’ve mentioned that a Total Quality approach includes Quality Process Management, Quality Control and Testing, Materials Quality Management, Quality Document Management and Quality and Process Data Analytics. How would you implement these?

We definitely advise taking a phased approach for the implementation of a Total Quality strategy. Depending on the specific situation and the existing landscape of supporting systems the focus of the first stage can vary. While some of the areas are independent a QMS (Quality Management System) can be a good basis to go forward playing into all stages of the product lifecycle. Usually it is the core of the Total Quality strategy. And as consistent and traceable documentation is basic we recommend considering implementing a centralized integrated system for QMS and Document Management .But we should not forget that metrics are required to validate Quality and in Life Sciences consistent Quality Control procedures and processes are indispensable.

3. Is this topic only relevant for roles that are directly engaged in working with Quality?

Many capabilities play into the successful management and execution of Quality. This includes for example, the definition, documentation, submission, monitoring and management of quality related activities and tasks as well as the execution of quality tests. The BIOVIA approach will support the FDA mandate for deeper integration of Quality into end-to-end operations to design quality into products and processes as well as foster a quality culture across all areas of an organization from discovery to commercialization.

4. What do you hope the audience will learn from this webinar?

By attending this webinar, I hope the audience will which are the relevant aspects and capabilities and the true potential impact of a comprehensive Total Quality Strategy throughout the entire product lifecycle.

Join Cyril in the BIOVIA webinar ‘Bringing Your Total Quality Strategy to the Next Level‘. Register now!

Anne Sefried, Field Applications Engineer, BIOVIA

November 20, 2015 Business Review Webinars Leave a comment

As a Field Applications Engineer, Anne Sefried leverages her application expertise at BIOVIA to assist organizations in optimizing their chemical inventory management activities. Anne graduated from Chapman University with a B.S. in Computer Information Systems.

1. What are you looking forward to discussing with the audience?

We are looking forward to showing how chemical inventory management doesn’t have to be a manual, disparate, time consuming process. In fact, it can be just the opposite! By integrating with laboratory informatics systems, such as Electronic Laboratory Notebooks, you have a comprehensive chemical inventory which improves productivity, drives down costs and reduces chemical management safety and compliance risks like FDA 21 CFR Part 11. In addition, you will be able avoid business risks arising from chemical safety incidents.

2. What are some of the key challenges with chemical inventory and data management?

Managing the materials necessary for research isn’t something the researchers want to do. They just want the materials they need at their bench when it is time to run an experiment. So the biggest challenge is getting everyone in the lab to use a system that tracks chemical inventory by logging materials in and out of the system each and every time. Most organizations aren’t doing this very well. They still track chemical inventory on paper, with a basic spreadsheet program, or with a legacy in-house solution. These systems are typically inefficient, awkward to use and rarely provide real-time data so the researchers don’t use them consistently. The result is incorrect inventory data, which not only means that the lab can’t rely on the system to ensure that materials are available but also bears compliance risks. In addition it adds error-prone and time consuming steps to the laboratory workflow reducing its efficiency and productivity and again adds compliance risk. Without accurate chemical inventory information, the organization is caught up in a vicious cycle of under- or over-ordering chemicals, which means they can’t manage chemical costs efficiently. For Life Science organizations where chemical and biological materials expenditures can be massive, particularly if expired materials are disposed before use. And the problem gets worse: without tightly controlling the chemicals inventory, health and safety risks for the lab staff can increase dramatically. So you can see why it is important to get your chemical inventory under control.

3. What can be done to tackle some of those challenges and make processes more streamlined and efficient?

Simply knowing what chemical inventory is on hand and where it is, eliminates a lot of management headaches and regulatory risk. This can be accomplished with a centralized and integrated chemical inventory management system, like BIOVIA CISPro. Supported by barcode technology, it provides accurate, real-time chemical container data that is integrated with Safety Data Sheet (SDS) management and addresses regulatory requirements for chemical management from authorities like the FDA, EMA and EPA. The tight integration with other lab informatics solutions further drives out error-prone and non-value added steps from the overall process.

4. What attributes should you look for when choosing a chemical inventory system for your lab?

There are three important attributes or operational modes to look for when evaluating a chemical inventory system. The first is the ability to track material level information that identifies physical hazards and structures. The second is barcoding. The barcodes should track the container by owner, location, expiration date, etc. and provide an audit trail to support regulatory compliance. Thus, you’ll be looking for a system that streamlines chemical inventory workflows from receipt to disposal, and the most effective way to do this is with a barcode system that logs all incoming materials at the container level. And the third is the integration capabilities with the laboratory by interfacing with a Lab informatics systems like ELN (Electronic Lab Notebook), LES (Laboratory Execution System) or LIMS (Laboratory Information Management System) for automated transfer of information related to the chemical inventory.

Join us for our complimentary webinar on December 10 titled: 4 Reasons to Integrate Chemical Inventory Management into Your Lab, hosted by Business Review, where we will discuss the above in more detail, with much more. Register here.

Dennis Curran, Product Management Director, BIOVIA

July 7, 2015 Business Review Webinars Leave a comment

dennis Dennis Curran is the Director of Product Management for BIOVIA and is focused on the integration of BIOVIA Software into customer solutions for scientific research. His direct product responsibilities include the BIOVIA Workbook and BIOVIA Laboratory Operations Suite. Since receiving his degree in Analytical Chemistry from Tufts University in 1985, Mr. Curran has been involved in the laboratory automation and software industries. His 30 years of career experience spans the scientific, engineering, software and management aspects of projects in the life sciences industry, from Drug Discovery through Development and Quality Control operations.

1. What are you looking forward to discussing with the audience?

2. You’ve mentioned that the biologics R&D workflow is similar to small molecule R&D at the highest level but that there are differences in the details. Can you explain what changes as an organization shifts toward biotherapeutic development?

In short, biologic development demands unique processes due to the added complexity of biological systems. Compared to small molecule R&D, biologics workflows generate a large amount and a large variety of complex data. However, being able to distill the information and track the genealogy of how to get to an end entity is critical. This requires some advanced data and workflow management.

3. Why do you feel this topic is important?

In a recent market survey we conducted, we asked responders what percentage of their biopharmaceutical development processes are being supported with manual methods like pen/paper and/or Excel spreadsheets. To our surprise (and concern), we found that almost half of the responses indicated that at least 75% of their biologic development processes were supported by manual methods. The industry clearly needs to see that an electronic solution is available and can manage the end-to-end biologics workflow without the risk or hindrance of manual work.

4. What do you hope the audience will learn from this webinar?

By attending this webinar, I hope the audience will see the true potential impact of transitioning from a paper-based to an electronic Biologics solution covering all activities of the development process end to end and how that positively affects their bottom line.

Dennis will be presenting BIOVIA’s webinar ‘Building Better Biologics, Faster‘ on the 22nd July. Register here.

Gene Tetreault, Sr. Director, Products and Marketing for the Laboratory Informatics Portfolio

May 1, 2015 Business Review Webinars Leave a comment

Gene LI

In this role Gene is providing the vision, strategy and management of the laboratory informatics product portfolio that includes the Electronic Laboratory Notebook, Laboratory Information Management System and the Laboratory Execution system.

Gene has been working in the Life Science industry for over 20 years developing robotic and Laboratory informatics systems.

1. What are you looking forward to discussing with the audience?

The focus of our discussion will be the typical challenges that come along with paper based and/or disconnected processes in the Quality Testing context. We will give an overview of the possibilities and capabilities of the BIOVIA Quality Testing solution and show the benefits of moving to an electronic Quality Testing solution. We will also analyze how they can tie into contributing to the overall goals of an organization.

2. You’ve mentioned that quality operations are typically a bottleneck and considered to include many non-value add activities for the drug manufacturing process. Can you explain why?

Studies at drug manufacturing companies have shown that the average time for Quality Control/Quality Assurance activities is typically almost double the time an organization spends on actual production processes. This is largely due to organizations relying on paper based and disconnected processes which are difficult to manage and make adherence to regulations more challenging and resource consuming. In addition, many quality testing systems are not integrated with an inventory solution making even more manual data entry work. These inefficiencies lead to non-value add waiting times for the release of raw materials used in the production process as well as to waiting and high inventory costs by a delayed release of finished products.

3. Is this topic only relevant for roles that are directly engaged in working with Quality Testing?

Quality Testing should actually be seen in the larger context of an organization’s Total Quality Strategy. Many capabilities play into the successful management and execution of Quality. This includes for example, the definition, documentation, submission, monitoring and management of quality related activities and tasks as well as the execution of quality tests. The BIOVIA approach will support the FDA mandate for deeper integration of Quality into end-to-end operations to design quality into products and processes as well as foster a quality culture across all areas of an organization from discovery to commercialization.

4. What do you hope the audience will learn from this webinar?

By attending this webinar, I hope the audience will see the true potential impact of eliminating paper from their Quality Testing processes and how that positively affects their bottom line.

Join Gene Tetreault in BIOVIA’s Webinar ‘Building Compliance and Operational Excellence into your Quality Lab Operations’ on 19 May at 4pm London/11am New York

Dr. Justin Neway, Vice President and Senior Fellow from BIOVIA

March 10, 2015 Business Review Webinars Leave a comment

Dr. Neway has over 30 years of experience in biotechnology and pharmaceutical process development and manufacturing, and in the application of software solutions to operational issues and quality compliance in the biotechnology and pharmaceutical industry. He received his B.Sc. (Microbiology, 1975) and M.Sc. (Biochemistry, 1977) from the University of Calgary (Canada) and his Ph.D. in Biochemistry from the University of Illinois (USA) in 1982. After holding various Process Development and Manufacturing leadership positions at Wyeth, Novartis and Baxter, Dr. Neway joined Aegis in 1997 which became a part of Accelrys in 2012 and Dassault Systèmes’ BIOVIA in 2014.

1. What are you looking forward to discussing with the audience?

Although we will be giving an overview of BIOVIA Discoverant, we will also discuss some of the major improvements of the recently released and the latest iteration of BIOVIA Discoverant, version 5.0. This latest release includes new features and functionality that users will really benefit from. These benefits include features like signal monitoring dashboards and interactive graphical process genealogy mapping. The BOIVIA Signal Monitoring Dashboard is a purpose-built validated environment that satisfies requirements for Continued Process Verification (CPV), process robustness and process performance visibility needs across local operations and global manufacturing networks that include Contract Manufacturing Organizations. The BIOVIA Interactive Process Genealogy Mapping solution allows users to visualize all the points where splitting and pooling occur in the process stream during production operations.

2. What are your thoughts on the current state of the drug manufacturing industry, where do you see the industry going and how will Discoverant help organizations along the way?

The drug manufacturing industry has clearly been heading away from small molecule development towards biologics. With this move comes an exponential increase in data that needs to be managed. BIOVIA Discoverant makes it possible to manage this data, while reducing compliance risks and still allows you to get home in time for dinner.

3. There appears to be a disconnection in the industry with drug manufacturers knowing they need product and process understanding, but not investing in the technology tools to make this possible. Why do you feel this is the case, and how does Discoverant fill this gap?

The simple answer here is that many organizations are unaware of a solution to solve their problems of a lack of product and process understanding. There is clearly pain with trying to manage and analyze all of data from disparate systems, but unless you know about a better way, it’s difficult to imagine how to improve the process. We are here to show organizations that there is a better way and we can help them meet their business goals without having to allocate additional resources or allocate resources from other areas.

4. What is Production Process Operations and how does it help your customers? When do customers realize they need a Production Process Optimization solution?

BIOVIA’s Process Production Operations solution, BIOVIA Discoverant, is a validation-ready solution for process and quality data access, aggregation, contextualization, analysis and reporting. This helps users by empowering production operations in process industries including life science or specialty chemicals by shortening time to market and maximizing profitability by enabling the understanding of critical process drivers that affect desired business results. Unfortunately, until people understand what BIOVIA Discoverant can do, they very often don’t realize they need it!

5. What do you hope the audience will learn from this webinar?

By attending this webinar, the audience will learn how improving process control by identifying sources of process variability will result in improving process outcomes. In addition, attendees will see how powerful tools such as role-based signal monitoring dashboards and interactive graphical genealogy mapping can make their lives easier.

Justin will be presenting alongside Brent Rognile in BIOVIA’s webinar on ‘Delivering Business Value from your Process & Quality Data‘. You can register for their webinar taking place on 19th March at 11am New York/3pm London here.