As 2023 ends, I’ve taken time to reflect on all of the insightful content pieces written by our Clarkston experts this year. Below, I’ve compiled a list of some of our top life sciences insights from 2023. From patient centricity to remote regulatory assessments, our life sciences experts shared their knowledge and perspectives on the latest trends and opportunities in the life sciences industry for this year and beyond. For all our 2023 life sciences insights, you can learn more here.
Top 10 Life Sciences Insights from 2023
1. It’s Time to Think About Your Manufacturing Executive System (MES)
For pharmaceutical companies looking to improve their manufacturing strategy, it’s essential to stay on pace with the growing trend of digitalization. Implementing a manufacturing executive system (MES) allows for the digitalization of performance indicators, analytics, and other traits to identify the success and efficiency of your processes. In this piece, Lynette Nazabal explains the importance of early implementation of MES and details important considerations to make when determining how MES can fit into your digital supply chain.
2. Modeling New Patient Start Likelihood in Pharma
To optimize sales conversion upon release of a new pharmaceutical product, pharmaceutical companies must be able to predict the likelihood of new patients and doctors buying in. In this case study, Michael Onore and Sham Karim walk us through Clarkston’s role in modeling new patient start likelihood to determine target physicians and patients that may soon begin using the client’s flagship product.
3. Ensuring Password Manager Compliance and Security in Life Sciences
Password managers can be very effective tools for efficient user access and generating secure passwords. However, these password manager tools can be at risk of being compromised, and precautions such as multi-factor authentication and intensive user training are critical for data security. In this piece, Susan Shockey explains key steps to take to ensure that your password manager meets regulations and that security is not compromised.
4. Establishing and Integrating Patient Centricity into your Pharma Organization
Patient centricity, or the practice of putting the patient first, is a valuable aspect of successful pharmaceutical and biotech companies. To incorporate patient centricity as a key organizational value, you must first consider the financial and operational requirements for doing so. In this piece, Catherine Ault and Aaron Chio explore three major windows for incorporating patient centricity into your operations and explain how to incorporate this into strategies and insights you may already have.
5. The Rise of Customer Data Platforms (CDP) as Foundations for Commercial Operations
Customer segmentation can be quite challenging due to outdated systems and data separation, creating data siloes that are challenging to efficiently navigate. A customer data platform (CDP) collects all first-party data to create user-friendly customer profiles based on all available resources simultaneously. In this piece, Michael Onore investigates the role and value of CDPs in analyzing customer data in the life sciences, as well as how it compares to commonly used data platforms.
6. Establishing a Laboratory Inventory Management System
To ensure that your laboratory inventory is maintained, organized, and able to be navigated efficiently, a laboratory inventory management system is crucial. Once the current inventory is assessed, laboratory settings should consider a management system that best suits the supplies in question. In this piece, Paul Allen walks us through the steps to assess the status of laboratory inventory, implement management systems, and identify opportunities for improvement.
7. Five Disciplines for Successful Life Sciences Project Management
Organizational success in the life sciences industry requires immense discipline, such as understanding complex market dynamics and being able to meet regulatory requirements. Businesses looking to succeed must stay on track with overarching goals and risk management plans to maximize the efficiency of operations. In this piece, Caryn Hecht takes us through five disciplines for project management that will create unparalleled company success within the life sciences industry.
8. Developing a Commercial Systems Capability Roadmap for a Clinical-Stage Biotech Company
When considering commercial operations, clinical-stage companies must first consider their system capabilities and whether outsourcing commercialization would be more efficient. In this piece, Lorraine Mackiewicz and Dave Treadaway take us through Clarkston’s role in evaluating a clinical-stage organization’s capabilities for commercialization and designing a roadmap for their commercial model strategy.
9. Considerations for Supporting a GxP Commercial Launch
Emerging pharmaceutical and biotech companies always face challenges when working toward regulatory approval of a new commercial product. Addressing these challenges can take significant energy and investment, as you are making the switch from product development to manufacturing. In this piece, Jim Dougherty outlines the challenges associated with the transition from a clinical to a commercial operation and details how to ensure a successful GxP commercial launch.
10. What You Need to Know About FDA Remote Regulatory Assessments
Since the 2021 introduction of the FDA’s Remote Regulatory Assessment (RRA), pharmaceutical companies are adapting to a new regulatory process that has become a permanent element of the FDA’s operations. In this piece, Randall Jacobs and Susan Shockey explain the changes that come along with the newly remote assessments as well as key strategies for achieving a successful assessment as a result.
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Contributions from Sam Weitzel