• Dates of Event: February 12-14, 2024
• Location: North Bethesda, MD
• Astrix Booth #307

Register for the forum here.

Event Overview

The last few years have shed light on the importance of operational efficiency of the management of regulatory information to ensure quality regulatory submission to health authorities. We have seen how the ability to perform at this level has allowed drug companies to bring therapeutics and vaccines to patients faster. At DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) Forum, we will hear from industry and regulatory stakeholders working across the scope of regulatory information to examine current and evolving data standards and requirements and effective regulatory information management approaches to align related people, processes, and technology. New for 2024, our Forum brings a refreshed set of tracks and focus areas, equipping our attendees with invaluable insights on how to build and sustain successful RSIDM foundations, optimize their current processes and procedures, adopt innovative technologies, and achieve regulatory excellence. This Forum provides multiple opportunities for networking, knowledge sharing, and education for both business and technology-focused attendees at all levels.

About the Astrix Presentation

• Title:  Evolving a Sponsor RIM Organization – Supporting Regulatory Excellence leveraging COEs and centralized capabilities
• Date/Time: February 13th at 3:10pm
• Presenters:  Lindsay Fitzgerald, Senior Consultant, Astrix | Kristen Sauter, Sr. Director Global Regulatory Information Management & Digital Innovation, Takeda, Inc.

Presentation Abstract

As Sponsors continue to evolve and modernize their Regulatory Information Management (RIM) capabilities, it requires an evolution of the supporting business organization to exploit the value of modern RIM.

This session will explore the current state of RIM in the market, what business capabilities are required to support the modern RIM technology and broader Regulatory organizations’ use of it, as well as the business processes and governance required to “feed the beast.”

We will present different business models for RIM, and outline the pros and cons of each.

Featured Topics include:

• Understand how organizations are evolving and maturing in the strive for world-class RIM capabilities.
• What business capabilities are required to support the broader Regulatory organization?
• What operating models make the most sense: COE, full centralized capability, or a mix?

About Astrix

Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.  Through world class people, process, and technology, Astrix works with clients to fundamentally improve business & scientific outcomes and the quality of life everywhere. Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across
their organizations.

The post Astrix Live Events – Astrix is a Sponsor for Regulatory Submissions, Information, and Document Management Forum 2024 appeared first on Astrix.

What are Clinical Trials?

Clinical trials are research studies performed on humans to evaluate a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker), is safe and effective in people.

These studies play an instrumental role in healthcare by establishing the effectiveness of treatments, identifying potential side effects, and contributing to the development of medical guidelines and policy.

The Phases of Clinical Trials

Clinical trials progress through four key stages:

• Phase I: Typically involving a small group of healthy volunteers, this phase assesses the safety, dosage, and side effects of a new treatment.
• Phase II: This phase tests the treatment on a larger group of people who have the condition or disease the treatment is designed to treat, providing further data on safety and effectiveness.
• Phase III: This phase involves randomized and blind testing in several hundred to several thousand patients. This large-scale testing, which can last several years, provides the pharmaceutical company and the FDA with a more thorough understanding of the effectiveness of the drug or device, the benefits and the range of possible adverse reactions.
• Phase IV: Also known as Post Marketing Surveillance Trial, this phase occurs after the FDA approves the use of the drug. It monitors the drug’s effectiveness and impact on patient’s quality of life and compares it to other common treatments.

The Role of Clinical Trials

Clinical trials are instrumental in the development of new drugs, therapies, devices, and other forms of treatment. products. By performing rigorous testing through various phases of clinical trials, we can ensure that these new products are not only effective but also safe for use. The feedback and data collected during these trials help refine and improve the product, leading to a version that meets stringent healthcare standards and provides the maximum benefit to patients.

Examples of Clinical Trials

Clinical trials are research studies conducted with human participants to evaluate the safety and efficacy of new medical treatments, interventions, or drugs. Here are a few examples of clinical trials across different medical fields:

Cancer Treatment Trial:

Title: A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> or = 4 cm) – IIIA Non-Small Cell Lung Cancer (NSCLC)

Objective: To determine if adding the drug bevacizumab to standard chemotherapy improves outcomes in patients with surgically removed non-small cell lung cancer.

Source: https://pubmed.ncbi.nlm.nih.gov/29129443/

Vaccine Trial:

Title: A Phase 3 Study to Evaluate the Efficacy and Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants

Objective: To assess the efficacy and safety of a new monoclonal antibody (MEDI8897) for preventing respiratory syncytial virus (RSV) in infants.

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2110275

Cardiovascular Disease Prevention Trial:

Title: The Heart Outcomes Prevention Evaluation 4 (HOPE-4) Study

Objective: To evaluate the impact of a community-based intervention program aimed at improving cardiovascular health by addressing lifestyle factors (diet, physical activity) and managing hypertension.

Source: https://pubmed.ncbi.nlm.nih.gov/30015069/

 Alzheimer’s Disease Trial:

Title: A Phase 3 Study of Efficacy, Safety, and Tolerability of Aducanumab (BIIB037) in Early Alzheimer’s Disease

Objective: To assess the effectiveness, safety, and tolerability of an investigational drug (aducanumab) in slowing the progression of early-stage Alzheimer’s disease.

Source: https://clinicaltrials.gov/study/NCT02484547

Diabetes Management Trial:

Title: A Study to Evaluate the Efficacy and Safety of ITCA 650 in Patients With Type 2 Diabetes and Cardiovascular Disease

Objective: To assess the efficacy and safety of ITCA 650, a subcutaneous delivery system for exenatide (a diabetes medication), in patients with type 2 diabetes and cardiovascular disease.

Source: https://pubmed.ncbi.nlm.nih.gov/29242349/

 These examples showcase the diversity of clinical trials, ranging from cancer research and infectious disease prevention to cardiovascular health and chronic disease management. Each trial is designed to answer specific research questions and contribute valuable insights to medical science.

Participating in Clinical Trials

Participation in clinical trials is voluntary and can provide participants with access to the latest treatments before they’re widely available. However, it’s important that potential participants fully understand what participation involves.

Before enrolling, make sure to:

• Understand the purpose of the trial.
• Know which tests and treatments are part of the trial.
• Understand potential risks and benefits.
• Know your rights as a participant, including the right to leave the trial at any time.
• To find ongoing clinical trials that you might qualify for, visit clinicaltrials.gov, a database of privately and publicly funded clinical studies conducted around the world.

In Conclusion

Clinical trials are indeed the cornerstone of medical advancements, providing the framework for developing and refining treatments that can save or improve lives. By understanding their process and importance, we hope to inspire trust and participation in these vital studies, which could lead to the next big breakthrough in healthcare.

About Astrix

At Astrix, we understand the unique needs of life science companies and provide customized staffing solutions to meet their hiring goals. With our specialized service, proprietary data sets, and comprehensive approach, we ensure that our clients have the right staff in place at the right time.

Contact us today to learn more about our customizable staffing services.

This blog post is for informational purposes only and should not be used as a substitute for professional medical advice.

The post Clinical Trials 101: Your Guide to Understanding How It Works appeared first on Astrix.

Date Of Event: Tuesday, September 12, 2023

Location: USDA Headquarters, The South Building, 1400 Independence Avenue, SW Washington DC 20250

About The USDA:

The USDA provides leadership on food, agriculture, natural resources, rural development, nutrition, and related issues based on public policy, the best available science, and effective management.

They have a vision to provide economic opportunity through innovation, helping rural America to thrive; to promote agriculture production that better nourishes Americans while also helping feed others throughout the world; and to preserve our Nation’s natural resources through conservation, restored forests, improved watersheds, and healthy private working lands.

The USDA’s strategic goals serve as a roadmap for the Department to help ensure we achieve our mission and implement our vision.

Who is attending?

Hundreds of personnel are expected to attend, including IT specialists, scientists, contract specialists and researchers.

The post Astrix Live Events – Astrix is a Gold Sponsor the 2023 USDA HQ Fall Expo appeared first on Astrix.

As evidence of its interest in quality metrics, the FDA published an initial draft guidance in July of 2015 encouraging firms foster a culture of quality and continuous improvement, and signaling its intent to establish a quality metrics reporting program requiring the submission of quality metrics data. A year and a half later (November 2016), responding to comments and some pushback by industry stakeholders, the FDA released a revised draft guidance entitled “Submission of Quality Metrics Data: Guidance for Industry.”

In this latest revised draft guidance, the FDA initiates a voluntary reporting phase of the FDA quality metrics reporting program as a prelude to the eventual mandatory requirement for the submission of quality metrics data. Effectively, this revised draft guidance is a gift from the FDA that establishes a “practice” period for companies to get their quality management program and metrics in alignment with what will eventually become FDA rules on quality metric submission. As the FDA states in the revised guidance, “FDA does not intend to take enforcement action based on errors in a quality metrics data submission made as a part of this voluntary phase of the reporting program, provided the submission is made in good faith.”

While the voluntary program is focused on finished drug products and API manufacturing, all manufacturers may report quality metrics data (e.g., atypical active ingredients, excipient manufacturers). The FDA also notes that participation in the voluntary reporting program outlined in the draft guidance provides an opportunity to demonstrate a commitment to transparency and a willingness to proactively engage with the agency. In other words, participation in this “voluntary” program is a good way to create good relations with the FDA.

Pharmaceutical and biologics manufacturers would be well-advised to become familiar with the program outlined in the FDA’s revised draft guidance on quality metrics, so that they can begin to develop and implement appropriate standard operating procedures (SOPs) and quality management system (QMS) solutions. There are a number of important takeaways in the FDA’s revised draft guidance on quality metrics. In this blog, we’ll detail some of the more noteworthy aspects of the guidance that companies and labs should be paying attention to.

Overview of The FDA Quality Metrics Guidance

Some of the key details contained in the FDA revised guidance on quality metrics include:

The FDA’s objectives for the quality metrics program. As stated in the guidance document, the FDA’s goals behind the publication of this revised draft guidance are to:

• Establish a signal detection program as one factor in identifying establishments and products that may pose significant risk to consumers
• Identify situations in which there may be a risk for drug supply disruptions and engage proactively with manufacturers to mitigate the likelihood of their occurrence
• Improve the FDA’s evaluation of drug manufacturing and control operations
• Help prepare for, direct and improve the effectiveness of establishment inspections
• Use the calculated metrics as an element of the post-approval manufacturing change reporting program with an emphasis on encouraging lifecycle manufacturing improvement

Dates for Voluntary Quality Metrics Reporting. As described in the Notice of Availability (NOA) for the revised draft guidance, the FDA intends to open an electronic portal in January 2018 to begin receiving voluntary submissions of quality metrics data that was generated in 2017.

Metrics to be Reported for Voluntary Program. The quality metrics data described in this draft guidance is produced in the course of manufacturing drugs in compliance with cGMP. The metrics that the FDA is asking establishments to report in this voluntary program are:

• Lot acceptance rate (LAR) as an indicator of manufacturing process performance. LAR is the number of accepted lots in a timeframe divided by the number of lots started by the same establishment in the current reporting timeline.
• Product Quality Complaint Rate as an indicator of patient or customer feedback. PQCR is defined as the number of product quality complaints received for the product divided by the total number of dosage units distributed in the current reporting timeframe.
• Invalidated Out-of-Specification (OOS) Rate (IOOSR) as an indicator of laboratory operation and performance. IOOSR is defined as the number of OOS test results for lot release and long-term stability testing invalidated by the reporting establishment due to an aberration of the measurement process divided by the total number of lot release and long-term stability OOS test results in the current reporting timeframe.

Appendix B of the Guidance helps to define these metrics with clarifying examples which will help companies with their internal definitions. Any questions that an establishment may have about their specific situation when gathering this data can be emailed to: OPQ-OS-QualityMetrics@fda.hhs.gov.

Additional Quality Metrics Recommended. The quality metrics requested for the voluntary program are not intended to be all-inclusive. Manufacturers are encouraged to utilize additional quality metrics in their day-to-day QC operations that are deemed necessary to evaluate a product’s or manufacturer’s quality. Additional metrics may be added to the FDA’s future mandatory quality metrics reporting program. Also, additional metrics, or lack thereof, may be evaluated in an FDA inspection of manufacturing facilities.

How to Submit Quality Metrics for the Voluntary Reporting Program. Reporting establishments should submit quality metrics reports where the data is segmented on a quarterly basis throughout a single calendar year. Appendix A of the draft guidance contains a description of the quality metrics data elements that are relevant for different business segments/types. Additionally, a revised version of the Quality Metrics Technical Conformance Guide that describes additional technical details will be released soon. Finally, the FDA expects to publish a Federal Register notice providing further instructions on the submission of voluntary reports no fewer than 30 days before the electronic portal is opened.

Both Product and Site Quality Metric Reports Will be Accepted. The FDA will permit establishments to submit data in this voluntary quality metrics reporting program in two formats – by site segmented by product, or by product segmented by site. This allows companies to submit the data in the way that works best for them. That said, the Agency does prefer data segmented by product, because it demonstrates effective control over the manufacturing process for drugs over the entire the supply chain.

Special Considerations for Products Imported/Manufactured Outside the United States. The FDA recognizes that it may be extremely difficult to identify started lots, rejected lots, and OOS results that are manufactured by CMOs that are not in the United States. The FDA therefore allows voluntary reports to contain data from lots not imported with the data from lots that are imported, provided that the manufacturing process for both uses the same process and controls data. Product quality complaint rate (PQCR) data, however, should be collected only for drugs that are imported, intended for import or manufactured in the United States.

Optional Comment Field Within Quality Metrics Report.  Reporting establishments can submit a comment of up to 300 words with their quality metrics report in order to explain anomalous data or report any plans for quality improvement. As the guidance explains, comments “may describe special situations, such as natural disasters, the use of emerging technology, or describe the manufacturing supply chain or a plan for improvement.” The FDA “may refer to the comments if unusual data trends are identified, or in preparation for an on-site inspection.”

Mandatory Quality Metrics Reporting Will Eventually be Implemented. After data collection in 2018, the portal accepting voluntary submissions of quality metrics data will be closed and the FDA will begin data analysis. Once this analysis is complete, the FDA will share on its website what it has learned from the voluntary phase of the reporting program, and also initiate notice and comment rulemaking to develop it’s mandatory reporting program.

Quality Metrics Reporters List Will be Published. Upon completing analysis of the data from the voluntary quality metrics reporting program, the FDA will publish a list of the companies that participated in this voluntary reporting phase on its website. The reporting establishments in this list will be broken down into product and site report categories, and then tiered based on how much quality metric data was reported. The FDA feels this list may be useful for:

• Establishments within the pharmaceutical manufacturing industry as one element of a robust outsourcer or supplier selection process.
• Healthcare purchasing organizations, healthcare providers, patients, and consumers in sourcing drugs.

Key Quality Management System Takeaways for Manufacturers

In order to submit data that is in alignment with this new revised quality metrics draft guidance, product owners will need to choose between submitting data organized by product or site. While the FDA prefers data organized by product, gathering the metrics by product across the entire supply chain will be more involved than by site. Manufacturers will likely need to redesign their quality metrics dashboards and management review process to be able to facilitate consistency in quality practices across the enterprise and partners. The following recommendations may be helpful in adjusting quality management systems to meet the new guidelines:

• Appropriate dashboard KPIs need to be determined and defined prior to implementing system that aggregates data for the dashboard.
• The quality system should contain policies and procedures that validate that information is funneling to the dashboard as intended and assure the appropriate level of data visibility by management provided by the dashboard.
• KPIs in the dashboard should align with requirements outlined in the FDA revised draft guidance, and include clear definitions that include data standards.
• Individuals manually entering source data should receive proper training on proper policies and procedures.
• Review of KPI targets should occur on a regular basis. Assessments should be regularly conducted to identify poor performance in order to drive corrective action plans.

Conclusion

With the release of this revised guidance document of the submission of quality metrics data, the FDA continues to encourage pharmaceutical manufacturers to implement a modern, risk-based quality management system as part of its mission to protect public health. The FDA’s grand vision is for the pharmaceutical industry to shift from a culture of compliance and rules to a culture of quality, where quality protocols are built into every process. While this revised guidance outlines a voluntary program for submission of quality metric data, a mandatory program is coming. Manufacturers would therefore be wise to utilize this voluntary phase to take a hard look at their quality systems maturity and begin to focus on how quality metrics are defined, collected, organized, verified and reported. Manufacturers will need to review their quality metrics management and reporting systems, identify any gaps in data collection, and take steps to bring systems into alignment with the metrics program guidelines. Manufacturers who take these steps now will avoid the hassle of being forced to make these changes under accelerated timelines later, and will reap the financial and customer loyalty benefits that come with producing quality products

The post What the FDA’s Quality Metrics Reporting Program Means for Your Lab appeared first on Astrix.

This is a summary of a project that Astrix led that involved implementing a Regulatory Information Management system for a top ten Pharma company. It discusses how we worked closely with the client and the Veeva team members to support the organization’s end-to-end Veeva RIM implementation.

Current Situation

Before Veeva, this organization’s global teams were leveraging disparate sets of tools and multiple LAN areas that were storing information on multiple SharePoint locations. These homegrown tools were purpose built and not connected. There were also quite a few spreadsheets.

This may sound familiar to those reading this because it’s quite a common theme, especially in Regulatory processes as they require coordination of information globally. There are often multiple tools leveraged across regions to plan, track, and manage submissions. Due to different regional requirements and a simple divergence of methods over time, the global teams don’t always share the same processes or even the same terminology.

This organization was attempting to evolve their RIM ecosystem into a globally consistent RIM solution leveraging Veeva’s RIM system including Global Regulatory submissions, CMC submission, Safety submissions, and everything in between.  To that end, they engaged Astrix to help on their multiyear journey to work with them to:

• Assess the global current state
• Define a harmonized future state
• Develop initial requirements and support configuration sessions for globally harmonized processes for:
  • Submission planning
  • Tracking o Authoring
  • Publishing
  • Submissions
  • Archiving
  • Correspondence •
• Plan and manage migration and integration workstreams
• Plan, manage, and support the onboarding of users to Veeva RIM (e.g., adoption planning, communications, and training support, etc.).

Business Background As part of our process, the Astrix team engaged both the client team and Veeva to understand and document the processes, issues, and opportunities, before collaborating with subject matter experts and core team members to design what the future state would look like. The Astrix team also worked closely with the Veeva team members to gain their valuable knowledge and input along the way on best practices and suggestions. At each point, leveraging unified cross-company (Veeva-Astrix-Client teams) enabled us to drive this successful implementation supporting processes for major market submissions, regional markets, annual reports, promotional materials, labeling submissions, and CMC submissions.

The project included everything from planning and tracking, through to the authoring of the actual submission of that material to the health authority. Moreover, it included the archiving of any recurring and follow on activities like management of correspondence, updating of outcomes and registrations, and post approval activities.

Moving from the initial requirements definition, we worked to support Veeva’s configuration teams, define rollout strategies, plan for user adoption, and identify migration and integration needs.

The approach that Astrix takes with any project can be boiled down to a couple key steps:

• Define the company’s vision
• Identify capabilities required
• Create a plan, and
• Manage the change

With this global pharma organization, they had already done some of the legwork on their own. They knew the vendor they wanted to implement, which of course was Veeva, and they had done some of the work to define their high-level vision and goals. Astrix came in at this point to assist with driving the detailed requirements and business analysis, and to create and manage the plans for implementation and rollout. Additionally, to help the organization manage that change management through adoption planning stakeholder analysis and communication.

Astrix and Veeva worked closely together to drive workstreams, implement strong communication channels and to define and prioritize capabilities and processes.

A key element was managing “Workstreams” which were established for each of the impacted organizations (e.g., CMC workflows, safety workflows, and regulatory workflows) and the major workflows (e.g., Authoring, Archive, etc.) Breaking the work down like this ensured that we had the right teams in the right meetings, and we were able to focus our efforts on each area.

All workstream teams consisted of the client company’s business and IT representatives in addition to Astrix and Veeva team members. It was extremely important to have all of those represented because we were able to incorporate all perspectives throughout. Everyone had a voice.

Moreover, we engaged subject matter experts and adjacent organizations like safety, clinical, or stats where it made sense (for example integration with clinical systems relied on SMEs from clinical and stats).

Ultimately, we wouldn’t have been able to accomplish what we set out to do without strong communication channels, both within each of the workstreams and between them. We leveraged Microsoft Teams channels significantly as well as Kanban boards along with weekly check-ins, workshops, and daily stand-up meetings.

Additionally, we made sure to accommodate global team members and ensured that we were scheduling meetings at times when they were available. Careful consideration in planning discussions, roll out strategies and training were given to make sure that submissions work kept running and teams were able to hit their targets – where needed, timelines were managed and adjusted to make sure Regulatory work remained unimpeded.

Another important aspect of the implementation that Astrix assisted our client with, was the “Process Readiness”. Regardless of which workstream there was an element of this Process Readiness. This enabled the team to focus on laying the groundwork and establishing that future state.

We first led the team through an assessment of their current processes which served as the foundation from which to build the future vision and process. By leveraging a framework of common capabilities, we were able to draft and adjust requirements to reflect the nuances of this organization’s unique workflows. Each company we work with has similar goals (e.g., author, publish, submit, track approvals, etc.) but the way they navigate getting there varies, we therefore wanted to make sure that we understood, in a detailed fashion, what this company was doing and why. What worked for them, as well as what didn’t, so we could build even better workflows in Veeva as we moved forward. We worked closely with our global subject matter experts to align on those processes and on key terminology.

Additionally, we uncovered critical global differences along the way. One, for example, was that Correspondence may mean emails to one region and emails plus meeting minutes to another, and still, something different to a third. When we encountered differences like this, we worked to bring everyone together and come up with a harmonized future state. It was critical that we gained agreement on these various items so that everyone globally was aligned to what it was going to mean when they moved to the Veeva RIM system. It also helped significantly to have Veeva part of these conversations. This enabled the client teams to better understand the terms that were used within the system and how that might impact workflows.

Process assessments enabled definition of initial requirements which were then configured by Veeva into the new system. Later workstreams, we built on those initial requirements, and took us into real scenarios within the Veeva RIM system. Together with the Veeva representatives we developed and tested use cases to identify specific configuration changes that were needed. We brought together subject matter experts, where it made sense, to help clarify and provide guidance. Moreover, we documented and communicated those outcomes and used those configuration items and discussions to prioritize into release plans.

Another important area where Astrix assisted this client was with their “Data Readiness” though planning and management of migrations from legacy systems and integrations with adjacent systems. When developing these plans we had to consider not only what was happening within the RIM system, but also what was needed to support the integration from the adjacent organization (e.g., where configuration changes might be needed in other systems, other initiatives impacting this work, how data could flow through their Electronic Data Backbone, etc.) Astrix’s program management work here facilitated client teams and Veeva to successfully complete technical work needed to support migrations and integrations (e.g., standing up various Veeva environments, updating configurations, mapping data, developing migration tools, etc.) As a team, we met regularly to identify and remove any blockers and leveraged the communication channels that were discussed previously.

All of the aspects of this project reviewed thus far became inputs to release plans, and accompanying release plans were adoption plans. Here we worked with subject matter experts and our core teams to outline the set of activities that were needed to understand and communicate with impacted stakeholders, to develop and provide training materials, and to support those users in their onboarding.

To manage all of these parallel workstreams, we leveraged weekly leadership meetings, workstream dashboards, workshops, daily stand-ups, and instant messages. As users were onboarded, we kept them informed of new capabilities, feature, and job aids through newsletters and intranet sites.

Ultimately, Astrix’s Program Management teams have become an integral piece of the puzzle and intertwined within these cross-functional teams that we are able to anticipate our client’s needs and be a champion for their continued success.

Considerations

To recap, there were six common themes that came up during this project that are important to note since they also surface on many enterprise implementation projects. They are…

Team members bandwidth

We often ran into challenges with core team members on multiple workstreams. We had client team members that were in some cases leading a workstream or in others participating in multiple workstreams. We also had subject matter experts who had to keep the submissions going on target while they were providing input into these workstreams, so we needed to make sure to accommodate those critical deadlines and ensure that we were working alongside what their schedules permitted. We had to plan for data migration and user onboarding around key submission dates as well, because we didn’t want to interfere with any critical dates or delay any submissions. Therefore, we often needed to revisit timelines as things shifted in the portfolio.

Coordinating time zones and global teams

Coordinating time zones and global teams is not an easy task. It’s easy to forget that someone’s on a meeting at 4:00 AM or they just joined after they put their kids to bed. It’s important to consider people’s schedules so that you are accommodating their work-life balance while also getting the input needed to drive work forward.

Workstream dependencies and parallel efforts

This is really around impact on individual workstreams on the overall implementation plans. If one workstream slips, it affects all downstream targets. Strong communication and visibility are key to staying on track with everything going on all at once.

Impact of system and process changes to business users

It’s easy to think that the system is going to solve everyone’s problems, however, it introduces change and anytime you introduce change you’re introducing a learning curve. Veeva systems created many efficiencies for this company; however, it was also difficult to meet some of the complicated business processes and rules that have been baked into decades old legacy systems, so we had to consider how users were performing the work currently and what those changes would mean to their day-to-day operations.

Product Enhancements and Veeva Roadmap

One way we were able to address negative process changes was through Veeva’s product updates. The team continued to work with Veeva to identify and implement new capabilities in order to optimize workflows. Ongoing (or upcoming) work in adjacent organizations Adjacent organization’s bandwidth presents another challenge. When workstreams require input from those adjacent organizations, but there are competing projects or work going on in those areas of the business, it impacts the workstream processes and can delay important feedback. It’s important to ensure that this factor is considered with project plans and timelines.

Summary

To summarize, we partnered closely with Veeva Systems and our client on this implementation to successfully implement the Veeva RIM solution. We leveraged strong program management and experienced team members across parallel workstreams to drive the project. This Global Pharma company is currently leveraging a successful Veeva RIM implementation. Next up on their list is to expand their use cases and to look towards further optimizing processes and regulatory intelligence automation.

The post Global Pharmaceutical Company Successfully Implements a Veeva RIM Solution appeared first on Astrix.

Have The Right Profile Picture

Your picture is the first impression your professional network has of you. Some best practices for choosing the right profile picture are:

• Make sure it is a high-resolution headshot with a bright, professional-looking one that only includes you.
• LinkedInsays the ideal size for a profile picture is 400 x 400 pixels.
• If you do not have a headshot, opt for a professional-looking photo.
• Choose an image where your face takes up at least 60% of the frame.
• Choose an image that appears warm and friendly with professional-looking office attire.
• Choose an image that has a minimal or neutral background.

Add A Photo For Your LinkedIn Banner

This is the next step in creating an attractive profile. Your background photo should be visually appealing and illustrate your experience or passion for the industry. Some best practices to consider when selecting a background photo are:

• Choose a high-resolution image that is representative of your industry or career.
• Make sure the photo has good lighting and isn’t too busy or distracting.
• Choose an image with minimal text, so it doesn’t take away from your profile summary.
• Consider using an image related to your field of study for a more personalized touch.

Write A Compelling Headline

The LinkedIn headline is in the top section under your name on your profile. This is meant to have professionals describe what they do/their role in 220 characters or less. This section is critical because it appears next to your name in search results and could determine if recruiters and other professionals contact you.

Some Tips For Crafting A Compelling Headline Are:

• Make sure it reflects who you are and captures the attention of potential connections.
• Use keywords related to your field or specialty to help you appear in search results.
• Include credentials, awards, and certifications demonstrating your field expertise.
• Avoid using generic phrases like “looking for my next opportunity” or “seeking new challenges,” as these won’t provide any insight into who you are professionally.

Formulas For Writing Your LinkedIn Headline:

• (Title) at (Company) – Helping (USP)
• (Title) | (Company) | (USP)
• Title + Company + benefits of working with you | keywords related to your niche | personal touch |

Add A Profile Summary

In your profile summary section, you want to capture the attention of potential employers or customers. This is a great space to include details about yourself, such as; relevant experiences, certifications, and research projects. It’s important to show off your accomplishments in an organized manner.

Some tips for writing a compelling profile summary are:

• Make sure it’s tailored to the industry and highlights your professional objectives.
• Include keywords that will help you show up in search results.
• Keep it concise and easily read using bullet points when possible.
• Avoid generic phrases like “I am hard-working” or “I have a passion for my work.” Instead, provide concrete examples of your accomplishments or skills that demonstrate why you are an ideal candidate.
• Include relevant links such as research projects, articles, and products showcasing your field expertise.

Here are some examples of profile summary sections that LinkedIn recommends. 

Keep Your Experience Section Updated

Your profile should be kept up to date with your work history. Some tips:

• Include your job title.
• The Company you are working for or worked for (make sure you select the correct Company, as it will help connections learn more about your Company and background).
• Include the industry and description. The industry helps connections find you more accessible when searching.
• Add any relevant skills and keywords.

Remember To Include Your Skills, Education, Licenses, And Certifications

Including skills in your profile helps boost you in search rankings, and education, license, and certification information adds credibility. Make sure to include any specialties or areas you focus on and any relevant training or certifications that apply.

Get Endorsements and Recommendations

Endorsements on LinkedIn are a great way to demonstrate your skills and knowledge in your field of expertise. Ask colleagues, mentors, and professional contacts for endorsements to help boost your profile’s credibility. You can also ask them for detailed recommendations if they feel comfortable giving one. These sections should provide real-world examples of how you work with others and how those around you highly value your work.

Pro Tip: If You Want Recommendations, Write Them For Others!

Join/Connect With Relevant Groups/Professionals

Joining relevant groups related to your industry or field can be beneficial in expanding your network and gaining exposure. Groups are a great way to share ideas and ask questions while engaging with other professionals in your industry.

The more connections you have on LinkedIn, the better chance of being seen and contacted by potential employers or customers who may be interested in what you can offer them.

Use The “Suggested For You” Profile Status Feature

Profile level shows how complete your profile is. Complete the recommended sections and build toward achieving your professional goals.

• Beginner:All members start off as beginners, and completing 4 sections will help you advance to Intermediate.
• Intermediate:Members with intermediate profiles see more relevant job recommendations and refined connection suggestions—complete 4 sections to achieve Intermediate.
• All-star:Members with All-star profiles see more relevant feed updates and receive more profile views. Complete 7 sections to achieve All-star.

Take LinkedIn’s Free Skills Assessments To Showcase Your Experience

LinkedIn’s Free Skills assessment helps you demonstrate your knowledge and experience. After completing and passing a test, LinkedIn provides a badge to display on your profile. Additionally, it allows others to see your skills and expertise in certain subjects, which can lead to more opportunities and connections.

Conclusion

By following these tips, you will have a great foundation for your LinkedIn profile that will help you get noticed by employers or other professionals in your field. Adding keywords, recommendations, and endorsements will make your profile increasingly visible when potential employers search for candidates with specific skill sets or backgrounds.

Bonus Tip: Customize Your URL

Another way to stand out on LinkedIn is by customizing your URL. It will look more professional and gives people an easy way to find your profile when they search for you online. To customize your URL, go to “Edit public profile & URL” located in the Edit Profile section and add a few words that best describe yourself (e.g., www.linkedin.com/in/johndoe-socialmediaexpert). With a few simple steps, you can make your LinkedIn profile stand out and help you achieve your professional goals!

About Astrix Scientific and Technical Staffing

Astrix is a specialized staffing partner for companies and candidates in the life science industry. With over two decades of experience, we are experts in finding the best talent for our clients’ needs and matching the right role for each candidate.

We are passionate about providing outstanding customer service and working with both our clients and candidates to create long-term relationships that will lead to successful outcomes for years to come. Our team of experienced recruiters have the industry know-how and skillset necessary to ensure your recruitment process is smooth, efficient and, most importantly, stress-free.

The post Tips For Creating A LinkedIn Profile For Science Professionals appeared first on Astrix.

When a leading manufacturing facility was looking for assistance with implementing a LabVantage LIMS, they knew it would be a complex process. They sought out a team of experienced consultants to provide guidance and expertise on establishing business-approved workflows, gathering and implementing master data in LabVantage LIMS, and developing a project strategy in accordance with their specific needs. After careful consideration, the client chose Astrix for their reputation for successful strategic planning and LabVantage LIMS implementations.

Working closely with the client and their team, Astrix began by developing a detailed plan for implementation that would allow them to quickly and efficiently meet the project timeline. This included gathering relevant data, researching industry best practices, designing custom solutions based on client feedback, and creating comprehensive documentation detailing each step of the implementation process. By leveraging nearly three decades of experience in this field, Astrix was able to deliver an effective solution within the given timeline while guaranteeing satisfactory results upon completion.

Business Challenge

The company was facing a pivotal moment in its growth and needed to replace its legacy in-house-built solutions with a modern commercial off-the-shelf (COTS) solution. To meet this need, the client engaged Astrix to implement LabVantage LIMS to automate and optimize existing workflows and facilitate integration with complex instruments across their business operations.

The project goals identified to address these challenges were as follows:

• Design an architecture that incorporates best-in-class technologies to support the business goals.
• Streamline and optimize current processes into a LabVantage LIMS automated workflow configuration.
• Develop and refine multiple business processes such as batch processing, stability, environmental monitoring, supplier qualification, results reporting, and COA creation.
• Integrate complex instruments such as GCs and HPLCs and systems such as SAP to simplify the overall batch process, sample management, and testing workflows.
• Implement master data such as reagents, instruments, maintenance and calibration events, storage hierarchy, and many other data elements to have one central repository.

Project Approach

A successful LabVantage LIMS deployment requires a comprehensive approach incorporating experienced personnel and proper planning. The technical team must have an individual with multi-level skills who has successfully undertaken large-scale projects. This is essential for the project’s success, as even teams with extensive technical abilities may be unable to deliver satisfactory results if they lack an effective strategy or execution plan. In addition to having the right strategy and personnel in place, it’s essential to ensure that the necessary resources are allocated for the timely completion of all phases of the project, from analysis and design to testing & validation. Furthermore, ensuring that everyone involved is well-versed in LIMS best practices will help ensure that expected outcomes are met. With adequate preparation and resources, organizations can be confident that their LIMS implementation will be successful.

The team proposed by Astrix to address the business challenges of a manufacturing facility was comprised of a business analyst, a technical lead, and informatics engineer who conducted an in-depth analysis of the existing workflows. The technical lead had an advanced understanding of the LabVantage LIMS architecture, development processes and planning, system design, coding style, change management, roll-out strategy, validation protocols, and post-implementation hyper-care. The business analyst worked closely with the team to ensure that all project deliverables aligned with the organization’s business goals and objectives while maximizing their overall return on investment. This involved mapping current processes and forecasting future trends and requirements accordingly.

The project approach and analysis included the following:

• Documentation of user requirements of the end-to-end business process in full detail
• Detailing the sample management and lifecycle processes, including integration with other ERP systems
• Analysis of the batch process for multiple workflows, including raw materials, in-process materials, and finished product elements that make up each workflow
• Development of test analyses with integration to complex instruments to transfer results vs. manual data entry
• Implementation of the project plan to provide a working solution able to be completed within the required timeline

Results Delivered

The project had a clear focus on providing the best-in-class technology solutions to meet the client’s business needs. Therefore, a comprehensive business process analysis was conducted to ensure that the architecture proposed would provide an optimal balance between out-of-the-box features and custom coding. In particular, special attention was paid to avoiding any heavy customization that could add unnecessary complexity or impede future upgrades. Moreover, to ensure maximum efficiency and scalability of the overall system, our team developed several key recommendations tailored specifically to the client’s needs.

The Astrix team worked diligently to ensure the project was delivered on time and within budget, going above and beyond to address the client’s needs. The team successfully implemented the digitization and optimization of workflow processes while allowing flexibility to accommodate the client’s vision.

The results delivered to the customer included the following:

• Comprehensive analysis and detailed assessment of the issues relating to, but not limited to:
  • Batch and sample testing workflows
  • Instrument maintenance and calibrations
  • Reagent manufacturing and lot management
  • Testing assays and specifications
  • Sample plans and sample types
• Creation of detailed master data in the LabVantage LIMS environment
• Development of a LabVantage LIMS implementation plan and strategy
• Integration of instruments to allow for the importation of test results
• Complete URS and FRS requirements documentation along with UAT test scripts for validation

Conclusion

The Astrix consulting team provided invaluable guidance and expertise that enabled the business to establish effective and efficient workflows. This involved gathering, analyzing, and implementing master data into the LabVantage LIMS system with the goal of achieving process automation within the manufacturing environment.

The key takeaways from this case study are:

• How to develop and refine multiple manufacturing-related business processes such as batch processing, stability, environmental monitoring, supplier qualification, reporting of results, and creation of COA.
• Integrating complex instruments, including GCs and HPLCs, with systems such as SAP will simplify the overall batch process, sample management, and testing workflows.
• Implementation of master data such as reagents, instruments, maintenance and calibration events, storage hierarchy, and many other data elements will allow for one centralized data repository for improved QA and traceability.

About Astrix

Astrix is the unrivaled market leader in creating & delivering innovative strategies, solutions, and people to the life science community. Through world-class people, process, and technology, we work with clients to fundamentally improve business & scientific outcomes and the quality of life everywhere. Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across their organizations.

The post Case Study: Automating Manufacturing Processes for Improved Quality Assurance and Traceability Using LabVantage LIMS appeared first on Astrix.

Recent NIH Research

NIH researchers use 3D bioprinting to create eye tissue

NIH researchers use 3D bioprinting to create eye tissue

National Eye Institute (NEI) scientists used patient stem cells and 3D bioprinting to create eye tissue. The researchers combined cellular material from the outer blood-retina barrier and printed tissue that supports photoreceptors in the retina. This new method provides an unlimited supply of patient-derived tissue for research on degenerative retinal diseases. The NIH team is hopeful that this new technique will help lead to treatments for these debilitating conditions.

“We know that AMD starts in the outer blood-retina barrier,” said Kapil Bharti, Ph.D., who heads the NEI Section on Ocular and Stem Cell Translational Research. “However, mechanisms of AMD initiation and progression to advanced dry and wet stages remain poorly understood due to the lack of physiologically relevant human models.”

They observed similar indications of wet AMD when oxygen levels were reduced, marked by the presence of out-of-control choroid vessels underneath the RPE layer. Fortunately, anti-VEGF drugs – a mainstay treatment for AMD – effectively suppressed these growths and restored normal tissue morphology.

“By printing cells, we’re facilitating the exchange of cellular cues that are necessary for normal outer blood-retina barrier anatomy,” said Bharti. “For example, presence of RPE cells induces gene expression changes in fibroblasts that contribute to the formation of Bruch’s membrane – something that was suggested many years ago but wasn’t proven until our model.”

Bharti’s team encountered various technical hurdles while developing their project, such as creating a biodegradable scaffold and refining the printing pattern by establishing an environmentally sensitive hydrogel.

Co-author Marc Ferrer, Ph.D. (Director of the 3D Tissue Bioprinting Laboratory at NIH’s National Center for Advancing Translational Sciences) and his research team provided their invaluable expertise in biofabrication techniques to create outer blood-retina barrier tissues “in-a-well” along with analytical measurements that enabled drug screening.

“Our collaborative efforts have resulted in very relevant retina tissue models of degenerative eye diseases,” Ferrer said. “Such tissue models have many potential uses in translational applications, including therapeutics development.”

Bharti and colleagues are utilizing printed blood-retina barrier models to examine AMD, with the idea of increasing cell types in the printing process, such as immune cells; this may effectively reflect native tissue better.

Friendly Virus Could Deliver Gene Therapy Under Immune System’s Radar

Friendly Virus Could Deliver Gene Therapy Under Immune System’s Radar

In a new study, IRP researchers revealed that most people have a non-reactive immune system to an innocuous virus, which can serve as a successful delivery vector for gene therapy treatments targeting life-threatening genetic diseases. This novel discovery is highly promising and could offer new hope for those affected by such conditions.

During his time at Children’s Hospital of Philadelphia, Charles Venditti, M.D., Ph.D., Senior IRP investigator, explored technology capable of recognizing methylmalonic acidemia (MMA) in infants only days after birth; however, finding the illness at an early stage did not change its eventual outcome.

“I was involved with meeting families and their babies that had methylmalonic acidemia and were diagnosed in the first one or two weeks of life,” he recalls. “The families would ask, ‘What’s going to happen to my baby?’ As a practitioner of metabolic medicine, I knew that the outlook was predicted to be grim, with a high chance of death and disability. The conversations were difficult.”

In a recent study, the labs of Dr. Chiorini, Ph.D. an IRP senior investigator, and Dr. Venditti partnered to explore if an immune response could neutralize andeo-associated viruses (AAVs) called AAV44.9, which has a unique capsid discovered by Dr. Chiorini’s lab several years ago with the expectation that it will evade detection from the body’s immunity and effectively deliver genes into cells required for treating MMA or other similar genetic ailments.

“The capsid is the molecular truck of the gene therapy vector,” Dr. Chiorini says. “It dictates where the gene is going to be delivered and when it is going to be active, so it’s a really critical component of gene transfer technology.”

After examining blood samples of adults and children who have MMA for AAV44.9 antibodies, researchers discovered that only 26% of adults and 13% of children possessed enough antibodies to fight the virus. Remarkably, these levels were too low to combat it effectively. Additionally, a study of mice found that AAV44.9 was effective in delivering the gene and very promising in correcting a mutation that causes MMA-like symptoms.

The results of the recent study have demonstrated that AAV44.9 may be a remarkably successful technique for gene therapy for MMA; however, further research needs to be done. Dr. Venditti is currently planning on initiating a clinical trial involving a gene therapy utilizing an alternate viral vector which his laboratory has been researching longer than AAV44.9.

Additionally, the study showed a low number of antibodies against AAV44.9 in the studied population of MMA patients; this virus can serve as a valuable alternative vector for gene therapy treatments if existing patient antibodies neutralize other AAVs utilized to deliver these therapies.

“Our collective goal is to widely enable gene therapies for patients with MMA and related disorders because we hope they will be ‘one and done’ treatments,” Dr. Venditti says. “Any new class of vector could help, especially ones that are very potent in living organisms, like AAV44.9”.

NCI clinical trial leads to atezolizumab approval for advanced alveolar soft part sarcoma

NCI clinical trial leads to atezolizumab approval for advanced alveolar soft part sarcoma

Recently, the U.S. Food and Drug Administration granted permission for Atezolizumab (Tecentriq) to be used as an immunotherapy drug on adults and children aged two or older with advanced sarcoma that has metastasized. This decision was based on findings from a non-randomized phase 2 trial supported by the National Cancer Institute (NCT03141684).

The study was conducted by Dr. Alice Chen of the Developmental Therapeutics Clinic in NCI’s Division of Cancer Treatment and Diagnosis (DCTD). Genentech, part of the Roche Group and creator of atezolizumab, supplied NCI with the drug through a cooperative research agreement – results are currently being prepared for publication.

This is the most extensive study on ASPS and the first NCI-funded Experimental Therapeutics Clinical Trials Network study that led to drug approval. This is also the first time atezolizumab has been approved for children due to the participation of the Pediatric Oncology Branch in NCI’s Center for Cancer Research.

“This is a major milestone for investigators in the Experimental Therapeutics Clinical Trials Network, as well as for the ASPS patient community, and for research on rare cancers,” said Elad Sharon, M.D., of DCTD, who is one of the study leaders.

49 ethnically diverse patients aged two and up with metastatic alveolar soft part sarcoma were given an infusion of atezolizumab in the trial on a 21-day rotation. According to doctor evaluations, approximately one-third of the patients saw a positive response to their treatment with noticeable tumor shrinkage. For most other patients, their condition remained stable.

“This approval represents a victory for rare diseases, which are understudied in clinical trials,” said Dr. Chen. “For this approval to go through in a rare disease, and to be able to make an impact on these young people’s lives, is very significant.”

Currently, research teams are further exploring the potential of atezolizumab as a treatment for ASPS. This includes testing its efficacy when combined with other therapies.

Toxic Protein and Aging Combine Forces to Drive Brain Disease

Toxic Protein and Aging Combine Forces to Drive Brain Disease

A recent IRP study has potentially located new therapeutic targets for two age-related illnesses. Alpha synuclein, a protein that accumulates in the brains of those with Parkinson’s disease and some forms of dementia, appears to be particularly prevalent among elderly individuals – offering vital insight into developing more effective treatments for these conditions.

Dr. Eliezer Masliah, Senior Investigator of the NIH’s National Institute on Aging (NIA) worked with co-author and  IRP senior investigator Dr.  Ranjan Sen, PH. D and his group to study how aging interacts with alpha-synuclein in the brains of mice. The researchers injected alpha-synuclein ‘protofibrils’ into young and older mice’s brains.

The IRP study revealed that alpha-synuclein spread far more quickly in the brains of older mice, significantly diminishing their fear response to a sound cue they had been previously conditioned to associate with an electric shock. This shows that memory can be detrimentally affected by such injections. In younger mice, however, injections of alpha-synuclein had a much weaker effect on their reaction to the fear-inducing sound. Interestingly, while IRP researchers observed alpha-synuclein’s impact on cognition in both genders of mouse subjects, they only noticed that it decreased motor coordination in males.

“There has been a lot of interest at NIA about understanding sex differences in neurodegenerative disorders,” Dr. Masliah says. “We know in Lewy body dementia that women are affected differently than men, and Alzheimer’s disease tends to be more common in women than in men. There may be a difference in how sex hormones affect the disease or some other factor that we don’t understand, but that’s why it’s important when designing these sorts of experiments to include both sexes.”

The alpha-synuclein injections had a noticeable effect on the production and activity of T cells and microglia among treated mice compared to untreated ones. Upon examining gene expression in affected microglia, researchers observed changes in numerous genes associated with inflammation; these modifications were more intense for older vs. younger rodents even when they did not receive any injection.

After examining how specific genes are regulated, scientists discovered that colony-stimulating factor 2 (CSF2) considerably influences them. This chemical is generated by T cells and other immune system components, verifying recent studies which have linked CSF2 to neurological disorders.

“I think the fact that we found a link to CSF2 suggests that all these excess T cells that are getting into the brain might be secreting more CSF2, and this CSF2 is detected by microglia,” Dr. Masliah explains. “The microglia become activated, and then we see dysregulation in all these other inflammatory pathways. That’s very important because it suggests that targeting either CSF2 or its receptor in microglia might prevent the acceleration of aging in microglia that appears to be triggered by alpha-synuclein.”

To study these factors’ effects, researchers plan to observe mice that lack T cells or microglia in their brains. They will then explore how alpha-synuclein and aging affect those mice with immune cells unable to produce or respond to CSF2.

“Our findings suggest that pro-inflammatory pathways that are triggered by aging could also be triggered in a similar way by accumulation of alpha-synuclein,” Dr. Masliah says. “They are running in parallel and also probably feeding into each other. I think we can develop therapeutic strategies for diseases like Parkinson’s and Lewy body dementia by looking at these age-related inflammatory pathways.”

Endocarditis in patients with cocaine or opioid use disorder saw marked increase between 2011 to 2022

Endocarditis in patients with cocaine or opioid use disorder saw marked increase between 2011 to 2022

From 2011 to 2022, the number of patients with cocaine or opioid use disorder diagnosed with infective endocarditis drastically grew, showing a particularly striking rise from 2021 to 2022. According to the latest research published in Molecular Psychiatry and NIH-funded, there is an ever-growing risk of endocarditis among drug injectors amplified due to COVID-19. These findings highlight the need for public health initiatives and interventions targeting those who have substance abuse disorders.

“People with substance use disorder already face major impediments to proper healthcare due to lack of access and stigma,” said NIDA Director and co-corresponding study author Nora D. Volkow, M.D. “Proven techniques like syringe service programs, which help people avoid infection from re-used or shared injection equipment, can help prevent this often fatal and costly condition.”

Dr. Volkow and researchers from Case Western Reserve University in Cleveland, Ohio, conducted an extensive study that analyzed electronic health record data from more than 109 million individuals collected between January 2011 and August 2022. In 2011, 4 endocarditis cases occurred daily for every 1 million people suffering from opioid use disorder. By 2022, this rate had skyrocketed to 30 cases per day per 1 million individuals with opioid dependence. The same trends were found with cocaine users; the number of endocarditis incidences jumped from 5 cases in 2011 to 23 out of every one million people struggling with cocaine addiction in 2022.

Patients with cocaine or opioid use disorder clinically diagnosed with COVID-19 were twice as likely to be diagnosed with endocarditis than those without. In addition, patients previously diagnosed with COVID-19 were 68% more likely to be hospitalized within 6 months following their endocarditis diagnosis. Furthermore, those infected with coronavirus faced 9% mortality rate in 180 days after a new diagnosis of endocarditis, compared to 8% for people not affected by the virus.

“As the scientific understanding of long COVID develops, we can now include endocarditis as one long-term effect on key organ systems for people who inject drugs. Our study is one of the first to show this,” said Rong Xu, Ph.D., professor of biomedical informatics at Case Western University and co-corresponding author of this study. “It’s critical that we continue to monitor long term, broad impacts of COVID-19 on people who use drugs.”

Canine brain wiring influenced by human-driven breeding practices

The latest research funded by NIH and published in journal cell uncovered that dog-breeding practices driven by humans have an impact on their brains. The conclusions of this study may help researchers to comprehend further how genetic variation can influence various behaviors in human beings.

Researchers discovered that genomic distinctions between dog breeds are linked to the formation of their nervous systems. An example is herding dogs – they have different genomes, which influence how neurons join together to form neural networks during the early stages of development.

The similarities between the genes associated with various canine lineages and those of other species, including humans, suggest that dogs may possess similar biological pathways which account for the varying behaviors within a species. This research sheds light on the potential parallels between dog brain function and the behavior of human brains.

“The results of this study may point us toward how differences in the human genome can contribute to behavioral diversity among humans. Further research can help us draw a stronger link between genes that are important for behavior in dogs and genes that may play a role in human behavioral conditions,” said Elaine Ostrander, Ph.D., distinguished senior investigator and chief of the Cancer Genetics and Comparative Genomics Branch within NHGRI’s Intramural Research Program and corresponding author on the study.

Dr. Emily Dutrow, a research fellow in Dr. Ostrander’s team, spearheaded the study by leveraging genomic data from 4 thousand dogs and behavioral information supplied by the University of Pennsylvania School of Veterinary Medicine’s survey on over 46 thousand canines, which studied traits such as trainability, energy levels and fear towards strangers to track breed evolution through time.

“One of the most surprising findings was that many of the genomic changes that define the major dog lineages can also be found in modern wolves. This indicates that humans co-opted ancient variations among wild ancestors of dogs to create unique types of dogs suited for performing specific tasks,” said Dr. Dutrow.

Until recently, the distinct behavioral traits and personalities associated with various dog breeds, along with how they are connected to their genetic makeup, have been a mystery.

“To study the genomic basis of breeds, researchers typically compare different breeds with different behavior. But the difficulty with that is finding meaningful results among the variation in dog behavior,” said Dr. Ostrander. “Instead of looking at a snapshot in time, our study mapped out how dog breed lineages diversified over hundreds of years and explains how the different breeds we see today are a result of human selection.”

Events

14th Annual James H. Cassedy Lecture in the History of Medicine the Many Faces of Diabetes: Complications and Debility in Late 20th? Century America

Thursday, February 2, 2023 2-3 pm

Diet and Health 2023: Supplements, Diets, or Food Systems?

Wednesday, Mar 1, 2023, 11:00 AM – 12:00 PM

National Research Summit on Care, Services, and Supports for Persons Living With Dementia and Their Caregivers/care Partners

Monday, Mar 20, 2023, from 9:00 AM – 5:00 PM

Tuesday, Mar 21, 2023, from 9:00 AM – 5:00 PM

Wednesday, Mar 22, 2023, from 9:00 AM – 5:00 PM

2023 NCI RNA Biology Symposium

Thursday, April 27, 2023, to Friday, April 28, 2023 (register by April 23)

The post National Institutes of Health (NIH) Research Updates – Jan 2023 appeared first on Astrix.

The high costs, long timeframes and poor success rates inherent in traditional drug development and discovery processes have scientists seeking out new paths to innovation. With technological advances such as next-generation sequencing (NGS), the internet-of-things (IoT), increased computational power, and machine learning, leading pharmaceutical companies are now turning to advanced analytics and machine learning to spur the discovery of novel compounds and improve the efficiency of drug discovery and development.

According to Market Research Future, the global commercial pharma analytics market is expected to reach over $9 billion by 2027. In this blog, we will discuss some of the benefits of utilizing BIOVIA Pipeline Pilot and its advanced analytics and modeling capabilities to enhance drug discovery.

Advanced Analytics and Modeling In Pharma

Drug discovery is a challenging endeavor. The first step – finding compounds with the desired medicinal effect on the target pathogens – has traditionally involved the automated high-throughput screening of large compound libraries to identify “hits” with biological activity. Once identified, promising compounds are put through extensive testing to evaluate criteria such as their dose-response curve, cellular efficacy, affinity towards the target, reactivity with other compounds, cytotoxicity, etc.

Real world data and experimentation are and always will be extremely important for answering scientific questions in the drug discovery process. That said, the traditional approach of just doing physical experiments to discover and validate drug candidates is very expensive and time-consuming – just one assay can cost hundreds of dollars, not to mention the synthesis costs. Additionally, physical testing typically yields very small data sets for the money and effort it takes to run the experiments.

Advances in computational power have opened up the possibility of creating digital models utilizing advanced analytics and machine learning that can dramatically accelerate innovation and yield inexpensive predictions from expensive data. These in silico methods use mathematical, probabilistic, and statistical modeling techniques to enable predictive processing and automated decision making. Modeling and simulation allows companies to save costs and time by working in the virtual world to innovate and learn, and then only moving into physical when the model is ready to be verified or tested.

Virtual modeling with advanced analytics allows scientists to create a wide variety of virtual compounds, test them with virtual assays, and prune to retain only the best performing compounds that are then moved into physical experiments. This allows scientists to only spend significant resources on the candidates that have the best chances of success. Also, the new data that these physical tests create can be feed back into the virtual models to refine accuracy and thus enhance predictive ability.

A few of the many ways in which scientists are applying these virtual modeling techniques to improve overall R&D efficiency include:

• Identify and remove poor quality candidates sooner in the development pipeline
• Create high quality candidates more quickly
• Make sure that only high-quality candidates enter late stage R&D
• Increase the likelihood of a given candidate’s success
• Reduce time to market and development cost
• Bring later stage processes like manufacturability upstream into early R&D

The Data Scientist Deficit

In order to design and implement effective models that produce actionable insights to advance drug discovery, you need data scientists with extensive knowledge in the life sciences and deep technical knowledge and expertise. Data scientists need to know what questions to ask and how to ask them, and they have to design, build, train, and validate each model to ensure high quality results. Unfortunately, there is currently a significant gap in the pharmaceutical industry between the supply and demand for good data scientists with the requisite skills, and the demand is projected to increase significantly in the coming years.

Organizations need skilled and experienced data scientists to develop global models that are designed to work for an organization’s entire compound portfolio – typically a collection of hundreds of thousands of molecules. Bench scientists, on the other hand, want more specialized local models that have been optimized for their compounds.

Due to the data scientist gap, experienced data scientists on staff are often swamped with requests for project-centric models by scientists, which only serves to take time away from their ability to develop and maintain global models that have wider applicability and strategic use for the enterprise. This leaves bench scientists in a bind – they can either wait in line for a more specialized local models to be developed by the data science team, or struggle for weeks through the process themselves, which typically ends up resulting in poorer quality models.

Democratizing Data Science with BIOVIA Pipeline Pilot

BIOVIA Pipeline Pilot is a graphical scientific authoring application that provides a comprehensive environment for the design, training, validation, and deployment of virtual models utilizing advanced analytics. It provides a drag-and-drop graphical user interface with “components” that allow common code to be shared throughout the organization. The platform supports a wide range of analytics capabilities, component collections, and domain-specific functionalities to support a full battery of scientific tasks for your organization.

BIOVIA Pipeline Pilot helps to address the data scientist gap by democratizing the role of data scientists. The graphical user interface allows bench scientists to develop specific data workflows utilizing prebuilt components and predictive algorithms to carry out tasks without needing any prior coding experience. The Analytics and Machine Learning Collection for Pipeline Pilot gives scientists the tools for everything from data ingestion, cleaning and exploration, to model building, validation, deployment, optimization, and design of future experiments – all within a single environment.

Expert users can create their own custom components using languages like Python or R to capture best practices and share them throughout the organization. These protocols can be deployed as a simple UI or as web services to allow scientists to easily tailor models to their specific needs or run individual instances of these models. The protocols can also be deployed as robots operating in the background to automate many data analytics processes.

Pipeline Pilot facilitates the conversion of broadly applicable global models into local models that are optimized for a specific set of compounds. It empowers researchers to create their own custom, domain-specific analyses with a library of curated scientific component collections, or use applications built by their colleagues to more rapidly get insights. Previously, this kind of model development and analysis would have required a team of data scientists to implement on a case-by-case basis, but the technologies that constitute Pipeline Pilot allow bench scientists to carry out this work at their desks.

It is important to note that this approach neither diminishes expert data scientists’ utility nor changes their role – it simply gives non-expert users the ability to tailor their models to better support individual decisions. All of this frees up the expert data scientists in your organization, allowing them to focus on creating and publishing new global models for widespread use.

Finally, Pipeline Pilot offers a wide variety of APIs to facilitate integration with a number of instruments and third-party software, allowing automatic extraction of data for analysis. Pipeline Pilot has the ability to ingest a large variety of data types (e.g., numerical, chemical, genomic, proteomic, textual, and image) from different locations, allowing your organization to integrate a wide range of data sources and types into a collaborative framework.

Key Capabilities of Pipeline Pilot include:

• Apply any of 15+ machine learning (ML) methods to your scientific and engineering data
• Merge, join, characterize, and clean your data sets
• Perform exploratory analysis, including PCA, clustering, and multi-dimensional data visualization
• Build fast, scalable Bayesian classification models
• Use the GFA method’s genetic algorithm for variable selection and building regression ensemble models
• Build accurate, easy-to-use RP Forest regression and classification models
• Use R-based ML methods such as support vector machines, neural networks, and XGBoost without writing R scripts
• Employ the ML framework for cross-validation, hyperparameter tuning, and variable importance assessment for any type of model
• Use regression and classification model evaluation viewers to assess and compare model test set performance
• Use built-in applicability domain measures and error models to assess sample-specific prediction confidence
• Apply Pareto optimization to multi-objective optimization problems

Conclusion

Modeling with advanced analytics has enabled scientists in almost every industry to leverage data-driven decision-making to optimize products and processes. Until recently, however, a lack of domain specific data scientists has limited the application of modeling in the pharmaceutical industry. With the deployment of a global data science platform like BIOVIA Pipeline Pilot, modeling and advanced analytics become available to bench scientists in your organization to drive the innovation engine of drug discovery. Pipeline Pilot allows data science to become a fundamental part of your organization’s R&D and manufacturing culture, adding laser precision to predictions and giving scientists a deeper understanding of trends within their individual compound libraries.

Pipeline Pilot will help your organization to:

• Tackle more complex problems and look at areas of research that you previously thought were inaccessible
• Expand your data science team’s expertise across the organization
• Ensure that data science best practices become the standard for your organization
• Empower bench scientists to help develop actionable insights with the latest analytics and machine learning capabilities
• Make the most of all of your data
• Make decisions and drive R&D from a larger pool of data

BIOVIA Pipeline Pilot is the foundation for an effective data science platform that supports standardization of practices across the enterprise – data ingestion, data preparation, advanced modeling (both testing and deployment), data exploration and visualization. Pipeline Pilot can also be utilized as a core configuration/customization language to extend the power of many other BIOVIA applications (LIMS, chemical and biological registration, and other routinely used biopharma software systems).

To get the most out of your Pipeline Pilot investment, it is important to work with a quality informatics consultant who understands the platform, your applications, and your scientific domain, and will work with you to complete the necessary business analysis and requirements gathering. Astrix has an experienced team of Pipeline Pilot experts that can provide services for all your Pipeline Pilot needs including implementation, instrument and system integration, workflow and application authoring, custom reports, user training and more. As the premier BIOVIA Services partner, Astrix provides increased value to customers through cost effective design, implementation and/or integration services leveraging BIOVIA applications and software.

The post Enhancing Drug Discovery with BIOVIA Pipeline Pilot appeared first on Astrix.

In fact, according to the Society for Human Resource Management (SHRM, it can take 6 to 9 months of an employee’s salary on average to replace him or her. If an employee makes $80,000 on average, it will cost anywhere from $40,000 to $60,000 in recruitment and hiring costs to replace the employee.

If you’re losing good employees on a regular basis, it’s time to take a closer look at your turnover rate and find out what’s causing the problem.

What is employee turnover rate?

The first step to reducing your employee turnover rate is understanding what it is and why it’s important. The employee turnover rate is the percentage of employees who leave an organization within a specific time frame. This metric is important for companies because it can give insight into the organization’s health, employee morale, and overall retention rates.

Why employee turnover matters

There are a number of reasons why employee turnover matters:

• It is expensive to replace employees. As noted above, it can take 6 to 9 months of an employee’s salary on average to replace him or her.
• Employee turnover can impact morale. When employees see that their colleagues are leaving, they may become disengaged and discouraged.
• Loss of key skills and talents. When high-performing employees leave, it can have a negative impact on the company. The loss of key skills and talents can make it difficult to complete work and meet deadlines.
• Employee turnover can impact the overall retention rate of the organization. If the turnover rate is high, it may be difficult for the organization to attract and retain top talent.

How to calculate your turnover rate

You can calculate your employee turnover rate by dividing the number of employees who left the company in a given time period by the average number of employees during that time period. For example, if 10 employees left your company in January and you had an average workforce of 100 employees during that month, your employee turnover rate would be 10%.

Turnover Rate = (Total Departures ÷ Average Number of Employees) x 100

Look for trends in your data

Once you have calculated your employee turnover rate, you should look for any patterns or trends in the data. Are there certain departments or job positions with higher rates of turnover? Are there certain times of year when more employees tend to leave? By identifying any trends in your data, you can target your efforts to reduce employee turnover where they are most needed.

Find out why employees are leaving

Once you have identified any trends in your data, you should try to find out why employees are leaving those departments or positions. It’s important to try to identify any patterns in order to address the root cause of the issue. Some common reasons for turnover include:

• Job dissatisfaction: If employees are unhappy with their job, they may be more likely to leave. This can be caused by a number of factors, such as a poor work-life balance, low pay, or a lack of challenges.
• Poor management: Employees may leave if they feel that their managers are not supportive or if they are not given the opportunity to grow and develop in their role.
• Lack of company culture: If employees don’t feel like they fit in with the company culture, they may be more likely to look for a job elsewhere.
• Location: If an employee needs to relocate for personal or family reasons, he or she may decide to leave the company.

What can you do to reduce turnover rates?

The first step is to identify the root cause or causes of the issue. Once you know what’s causing your employees to leave, you can take steps to address the problem. For example, if employees are leaving because they’re unhappy with their jobs, consider implementing a system whereby employees can provide feedback about their roles and suggest ways to make them more enjoyable. If compensation is an issue, conduct salary surveys to ensure that your employees are being paid competitively. Lastly, if your workplace culture needs improvement, focus on creating a positive environment where employees feel supported and valued.

Some steps that companies can take include:

• Conducting regular interviews with employees to get feedback on their job satisfaction and what could be improved
• Providing opportunities for career development through training and mentorship programs
• Encouraging communication and collaboration among employees
• Reviewing compensation and benefits packages regularly to ensure they are competitive
• Maintaining a clean and safe physical work environment

Conclusion

Employee turnover is a costly problem for businesses, but it is possible to lower your employee turnover rate with careful planning and execution. By tracking your employee turnover rate, looking for trends in the data, finding out why employees are leaving, and implementing retention strategies, you can keep more of your best talent at your company and reduce the cost of recruiting and training new employees.

Bonus Insights for Life Science Employers

The employee turnover rate is 20.6% in the life sciences, which is higher than the overall average rate of 13%. The high turnover rate may be due to the fact that there are a number of jobs in the life sciences that are in high demand. As a result, employees may feel that they can find a better job elsewhere with ease. Additionally, the fast-paced nature of the industry may contribute to a higher turnover rate as employees feel burned out or stressed.

Employee turnover is a costly problem for life science companies. However, there are ways to mitigate the cost of high turnover rates. One way to do this is by utilizing staffing services. Staffing provides a number of benefits including reducing costs, improving retention rates, and providing a stable workforce that is properly trained and motivated. If you’re looking for ways to improve your company’s employee turnover rate, consider working with a staffing agency that specializes in the life sciences industry.

About Astrix

Astrix is the unrivaled market leader in creating and delivering innovative strategies, solutions, and people to the life science community. Through world-class people, processes, and technology, we work with clients to fundamentally improve business and scientific outcomes and the quality of life everywhere.

Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across their organizations.

Contact us today to learn more about our services!

The post The High Cost of Employee Turnover and How to Fix It appeared first on Astrix.

SampleManager LIMS is continuously upgraded to meet the changing needs of laboratories across all industries – pharmaceutical QA/QC, food and beverage, oil and gas, petrochemical, water and environmental, manufacturing, contract labs, and more. Each new release of SampleManager contains new functionality that is built upon feedback and customer input from these sectors, and this ensures an upgrade path that respects your previous investment while allowing you to take advantage of collected industry knowledge to respond to changing business or regulatory demands.

SampleManager LIMS offers the potential for significant operational and business benefits for your organization. There are, however, important considerations to take into account when implementing or upgrading the SampleManager solution in order to realize its full potential to transform your laboratory operations, improve organizational agility, and unlock the power of your laboratory data. In this blog, we’ll discuss key best practice recommendations to follow during your SampleManager implementation or upgrade that will ensure your project maximizes success in ensuring compliance, streamlining processes, improving quality, reducing costs, and driving productivity and innovation in your laboratory environment.

Tips for Optimizing SampleManager LIMS Implementations and Upgrades

The following best practices are recommended when undertaking a SampleManager LIMS upgrade or implementation:

Make the Most of the “Out-Of-The-Box” Features of SampleManager: SampleManager has a wide variety of system configuration features that can likely meet the needs of your laboratory today and into the future. SampleManager (SM) version 11 specifically features several advanced new tools and user-interface enhancements that serve to improve laboratory management, process mapping and automation. Best practice is to examine and understand all these features, and utilize as many of them as you can in your implementation to meet your requirements and simplify implementation. Some examples include:

• Workflow and Lifecycles (SM 11): SampleManager’s unique workflow capabilities are designed to empower lab users and managers by allowing them to easily build workflows that map to actual laboratory processes and make choices about instrument integration and reporting for regulatory requirements or management metrics. Workflow features allow laboratory users and managers to perform specific actions and/or designate statuses for any dynamic or static data, create elaborate decision trees, automate email and reporting. As laboratory needs evolve, workflows can be modified to mirror the new process.
• Report, Label and Form Designer (SM 10): Allows laboratory users and managers to create custom reports and labels, filters and folders for organizing data, and new database fields. Also allows users to change or create new forms that enable setting the data as desired.
• Inventory Tracking: SM has the ability to track almost any commodity, stock, or standard solution to let users know where inventory comes from, where it is used, and when it expires.
• Instrument Calibration and Training Tracking: SM can do the work of tracking training and instrument calibrations for you. The software has the ability to alert users if training is out of date or an instrument is out of calibration.

Avoid Customizations Unless They Are Really Required: Astrix SM experts have experienced several implementations where extensive customizations to satisfy requirements have dramatically extended project duration. Writing new or changing existing code in VGL (SM proprietary language) or ,NET, besides making the project more expensive and time-consuming, can increase the complexity of future maintenance/migration/validation, and potentially lead to system errors. SM comes with a lot of configurable items that can usually be adjusted to meet the lab’s requirements without the need for customization.

Designate Appropriate Internal and External Resources for Project Implementation: In addition to making a good decision regarding which external informatics consultant to work with on a SM project, it is crucial for organizations to assign motivated and skilled internal resources to a SM implementation or upgrade. Significant collaboration between quality external and internal resources is required for the success of any SM project. Collaboration must occur to determine project requirements, as well as configure static data, templates and data analysis.

Make sure you plan on designated internal resources spending time on the project, which means they will be less available for their day jobs. The best external consultants can help you backfill your laboratory staff for the duration of the project so that it does not disrupt productivity in the laboratory. Note that internal staff assigned to the project team will develop a lot of SM knowledge and turn into internal “LIMS Admins”.

Iterate Your Implementation: Given the extensive configurability of SM, users often don’t know exactly what is possible or how SM works, so it’s wise to implement SM in stages, with the first iteration being the minimum viable solution to go into production with. Be reasonable and don’t try to achieve everything on the first project iteration. After users get to experience the first version, they can suggest changes and adjustments that they want to see for the next iteration. This iterative approach both shortens the time it takes for internal staff to start using the system and avoids frustrating expectations early in the project.

Iterating your implementation also makes any future upgrades/updates necessitated by a changing environment (regulations, data integrity, new users, etc.) easier due to:

• Already have internal SMEs to help define a wish list and possible project pat
• Validation of core functions is already completed

When Appropriate, Use Virtual fields (SM 10 and later versions) Instead of Actually Creating Fields in the Database: Virtual fields are not stored in a database and can include any calculation allowed by .NET code – text aggregation, sum of amounts, reporting fields, timeline planning for samples, etc. In addition to allowing much more flexibility, virtual fields avoid creating unnecessary database overhead.

Create Good Project Documentation: For regulatory and future maintenance requirements, the owners of the SM system need to document all the relevant changes to the system after the project ends – database fields created, code created or modified, integrations and interfaces, workflows configured, etc. Working with a quality external informatics consultant makes this easy, as they will provide the documentation for you. Documentation provided by Astrix on SM projects includes:

• Project Plan – responsibilities, communication plan, work schedule, etc.
• Requirements Traceability Matrix – requirements description, categorization (standard/configuration/customization), design ideas, prioritization.
• Functional/Design Specification – relevant technical changes to the system and/or system architecture.
• Testing Documentation – IQ/OQ/PQ scripts or protocols for validation (required for regulated laboratories). Note that whether the laboratory is in a regulated environment or not, Astrix always does system validation.

The Astrix Difference

The Astrix Team contains some of the most experienced and knowledgeable SampleManager experts in the world. Our team has proven expertise in project management, implementation, integration, validation and system optimization for SampleManager LIMS across all industries. Our accomplished consultants also have a wealth of experience across various organization types, helping to ensure that business-specific needs, along with industry and regulatory requirements, are taken into consideration on your project.

As your laboratory needs evolve due to regulatory or business changes, it is often necessary to begin to utilize new features of SM that have not been previously used, or upgrade to a new version that has the functionality to fulfill your changing requirements. Whether you need to implement SampleManager LIMS as a new system, optimize or adjust your current implementation, or upgrade to a new version, Astrix can help ensure that any new configuration or customization of SM is accomplished in the most efficient, cost-effective and timely way that satisfies your present and future requirements.

Let us help you with:

• Strategic planning to make sure that your implementation/upgrade project satisfies production, operational and financial goals.
• SampleManager LIMS configuration or customization
• Instrument integration with SampleManager LIMS
• Computer system (e.g., laboratory, business and manufacturing system) integration with SampleManager LIMS
• Data migration from legacy systems to SampleManager LIMS
• SampleManager LIMS training for key personnel
• SampleManager LIMS validation services
• Scientific and Technical Staffing Services to backfill laboratory staff so that your SM project does not disrupt operations.

If you would like to learn more about these services, please feel free to contact us for a no obligation consultation using the link below:

Conclusion
From smaller individual lab deployments through global multi-site implementations, SampleManager LIMS has the ability to meet your laboratory needs in a single application. While the potential for this system to help increase productivity and innovation in your laboratory environment is great, it is important to work with a quality laboratory informatics consultant who has the necessary experience with SampleManager in order to realize its full potential.

The post Tips for SampleManager Implementation and Upgrades appeared first on Astrix.

1.    Decide What Area of Life Sciences You Want to pursue

Life Sciences is a term that encompasses a wide variety of fields, sectors, and roles. It is full of many amazing opportunities and there are many different areas where you can make your mark. Some well-known areas to consider include:

• Biotechnology: This area develops innovative technologies and products using living organisms and biological processes. If you’re a curious kind of person, who wants to understand the “why” as well as the “how” of science in order to assist others down the line, this is an area where you can really make a difference.
• Medical Research: Also known as biomedical research, professionals in this area use science to prevent, diagnose, and treat disorders in humans and animals. This area exists at a later stage, so everything is closer to the patient than the petri dish—if you prefer your science with a greater degree of application than discovery.
• Pharmaceuticals: This area involves research for the frontiers of drug discovery, and other several other sciences (including genetic research), to develop new therapeutics (including, but not limited to medications) to treat disorders. Vaccine development is one of the highest-profile activities in this area right now for biopharmaceuticals—and, for years into the near future.
• Environmental Science: Focuses on identifying, controlling, or eliminating sources of pollution that affect the environment and public health. They may also develop plans to prevent future problems like air quality issues by advising government officials who make policy as well generating insights into how development projects could impact certain areas negatively before it happens.
• Manufacturing: This area focuses on developing and manufacturing the ingredients essential to a wide variety of research and production phases of life sciences. Becoming an expert in this area will enable you to choose from a wide range of settings and roles for years to come.
• Food Science: Developing and manufacturing food products of the highest quality and nutritional value is at the core of this sector. If you’re wondering how we’re going to sustainably feed people and animals in the coming years, this is the area for you.
• Preclinical Research: If you enjoy solving mysteries and are curious about whether a new idea has a future as a therapeutic, this area focuses on testing promising new biomedical solutions in laboratory settings that use a wide array of animal models.
• Clinical Research: There can be no new medications or medical devices without first testing them for safety and efficacy in the wider population. Ensuring that new products will be safe, by being one of the first to see the impact of research on real people, animals, and other living things, is the real focus of this area.
• Animal Science: This area focuses on the biological, physical, and social science aspects of raising and managing livestock. If you’re passionate about farming and agriculture, safety, disease prevention, and treatment in our food chain, this may be the perfect fit for you.

Once you’ve decided which area(s) of greatest interest, you can start researching what kind of jobs are available in that field.

2.    Get a Degree in a Relevant Field

While most jobs in the life sciences require a bachelor’s degree, there’s a growing list of jobs, certifications and training programs that don’t require a degree or take two years or less, that will enable you to secure your first well-paying job in the Life Sciences. Depending on the field you want to enter, you can enter as a technician or, with an advanced degree (like a master’s or Ph.D.), a highly compensated scientist and/or senior manager.

√ Look for accredited programs that offer nationally accepted certifications that will equip you with the skills needed for your desired career.

3.    Start Networking

It’s never too early to start networking. Get involved with the associations and organizations in which your future colleagues are active. Attend their regional meetings, national conferences, and any other events related to your chosen field so you’ll be current on the latest developments in your field, while you’re meeting potential employers and mentors who can help further your career.

4.    Gain Relevant Work Experience

Internships, while not needed for every job in the life sciences, can give you experience that’s crucial to both determine and demonstrate your interest. You can often uncover internship opportunities prior to graduating from a certificate or degree program by speaking with instructors and members of professional organizations at the local, regional, and national levels. Gaining relevant experience in a chosen area really increases your value, stature—and options—as you launch your career.

5.    Develop Key Skills

Featuring key skills on your resume, such as analytical skills, problem-solving, commercial awareness, and teamwork, really does distinguish you from other candidates who can only discuss their academic achievements. Many essential skills are learned through extra-curricular activities, so don’t forget to mention any involvement with clubs, societies, or volunteering roles on both your resume and application form.

6.    Invest Time in Researching Companies Before You Apply

Becoming familiar with targeted organizations’ business models, products, values, and processes enable you to see (and discuss the specifics of how you would fit in with the company when seeking an interview—and speaking—with both recruiting and hiring managers.

√ Job seekers may often neglect this step, but it makes all the difference when meeting potential employers who want to know that you have taken the time to really understand their business and the role you want to play in their team’s success.

7.    Prepare For Your Interviews

Once you’ve started applying for jobs, it’s time to prepare for your interviews. In addition to practicing common interview questions, devote time to researching the company or organization you’ll be interviewing with. Start with searching for mentions in industry publications as well as online forums that discuss the organization’s culture.

√ Do a deep dive into their website—including a thorough review of their press releases and reports. This is the key to asking informed questions about the position and demonstrating your knowledge of, and interest in, the company during your interviews.

Final Thoughts

Landing a job in life sciences isn’t daunting when you know these simple steps. Once you decide which field(s) within life sciences interests you most:

• Research the educational requirements at various levels.
• Choose a certification (based on a national organization’s advice).
• Get involved with an accrediting degree from a widely accepted program.
• Gain some experience through internships or other opportunities while pursuing professional accreditation.
• Get active in the local, regional, and national associations to network with professionals in your field, and
• Prepare for interviews thoroughly so that you can prove your familiarity and skills in ways that compel the recruiter to recommend you to the hiring manager.

Follow these steps and you’ll be well prepared to launch your new career with a job that puts you squarely on the path to achieving your career goals.

Bonus Tip: Work with A Staffing Company That Specializes In Life Sciences

√ A great way to jump-start your new career—or to rise up faster—in the life sciences is to work with a staffing company that specializes in this field. They are positioned to connect you with some of the best employers in the industry and help you find a position that is the perfect fit for your skills and experience.

About Astrix

Astrix is the unrivaled market leader in creating and delivering innovative strategies, solutions, and people to the life science community. Through world-class people, processes, and technology, we work with clients to fundamentally improve business and scientific outcomes and the quality of life everywhere.

Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across their organizations.

If you are ready to start your career in the life sciences industry, contact Astrix today.

Visit our current job postings or submit your resume to one of our staffing experts for consideration.

The post Astrix Scientific Staffing – Your Checklist for Getting a Job in Life Sciences appeared first on Astrix.

Structured Content Authoring (SCA) is a standardized method where technical content is controlled by pre-defined guidelines. The technical writer marks up the content according to what it semantically represents and agreed guidelines. The writer is not concerned with editing styling or formatting. The idea is to develop discoverable, reusable, adaptable, reconfigurable templates for storing, tagging, standardizing, and translating critical content. The content should be auditable, publishable, individually authored, and approved. Moreover, it can also be used to automatically generate standardized documents from digital records and approved, reusable content.

The Value of Structured Content Authoring

By creating and managing standardized and approved content entities that are ascertainable, compact, and reusable across the organization, it enables:

• Single source of truth – one standard copy of the information to be used across the organization
• Increased compliance and visibility/traceability of where the content is being used (even slightly different versions)
• Improved organization of content
• Decreased transcription errors through automated document generation and translation.
• Content Libraries and templates that can speed authoring through supporting technology such as:
  • Component Authoring tools
  • Smart contracts
  • Natural Language Generation
• Machine Learning closed-loop feedback to continually improve documentation, submissions, communications, and code – creating a self-improving ecosystem.

Structured Content Authoring Considerations

There is a shift from using documents to record scientific insights to viewing the content itself (layered intelligence, context, and knowledge within) as being the critical component. This is driving a move from document creation and management to development of core content. This allows for the assembly of content across sources to construct documents, publications, dossiers, and reports.

Emerging standards and open architectures,

• Darwin Information Typing Architecture (DITA), enables organizations to deploy tools to rapidly author and organize information into hierarchical, modular, and reusable objects. This allows for better compliance and traceability of approved and standardized information

Federated Content Management

• Gartner, and other tech consulting companies, advocate for content management strategies in recognition of the diversity of data resources in an enterprise ecosystem.

Document Repository Technologies

• Emerging technology brings emerging standards. Implementation of industry standards, such as Darwin Information Typing Architecture (DITA) will require a strategic position and evaluation of tools, either open source through DITA-OT or other commercially available solutions, to support these protocols.
• Content Management Systems (CMS) enable curation and storage of controlled documents and other standardized content. CMS software includes audit trails and workflow automation in order to enable template management, collaborative authoring, review steps, facilitate the approval of new content, maintain traceability, and uphold compliance with regulatory requirements.
• This requires environments to enable autonomous determination of relevant, reusable content, leading to intelligent authoring of documents, publications, and presentations.

Content Object Governance

• Disparity in lexicon must be alleviated by determining standard ontologies and establishing agreed dictionaries, standard terms, and templates.
• A single source of truth in current content must be determined to enable simplification and consolidation of information that will facilitate future use. This approved content should consist of the smallest, reusable pieces to enable rapid impact assessment and update of new documents.
  • Implementing new capabilities for tracking review and approval progress, as well as content object circulation.
  • Enact updates centrally (distributing changes as appropriate to all versions by embedded logic), based on a persistent review of outcomes and content effectiveness, of content and code.

Why It Matters To You

Emerging Technologies will play a major impact on the life sciences industry. One of those technologies is Structured Content Authoring (SCA).

In this blog we discussed:

• What Structured Content Authoring is.
• The value it provides to life science organizations.
• Some key considerations relative to leveraging SCA

The post Structured Content Authoring and its Impact on a Digital Transformation of Life Sciences appeared first on Astrix.