It seems unlikely that the FDA will return to in-person meetings. This author, an FDA veteran, shares tips for pharma, biotech, and medical device companies on many aspects of your virtual meetings with the FDA: optimal timing of your first meeting, the video/teleconference experience, and more.
- FDA’s RTOR Program: Draft Guidance & Insights
- Is Phage Therapy Ushering In A Post-Antibiotic Era?
- Life Sciences RIM: Modernization & Moving Ahead
- Pharma Process Validation: Initial Conclusions Are Often Deceptive
- 6 Best Practices For Biopharma Talent Management In 2023
- Collaborating With Academia For Drug Discovery Targeting Immune-Mediated Diseases
- Biopharma Facility Modular Design & Construction: Key Considerations
FDA’s RTOR Program: Draft Guidance & Insights
First launched in Feb. 2018 by the FDA’s Oncology Center of Excellence, the Real-Time Oncology Review (RTOR) program is intended to streamline the review process for oncology drug applications. This article summarizes the new guidance and reviews the performance of the program thus far.
Is Phage Therapy Ushering In A Post-Antibiotic Era?
Faced with the emergence of resistant bacteria, phage therapy, which uses bacterial viruses (bacteriophages) to treat bacterial infections, is emerging as one of the most credible alternatives to antibiotics.
Life Sciences RIM: Modernization & Moving Ahead
Life sciences companies are getting more strategic and ambitious about regulatory information management (RIM). This article shares four key findings from an industry survey and insights for moving ahead in today's world, including a look at advanced technology's role.
Pharma Process Validation: Initial Conclusions Are Often Deceptive
As a pharmaceutical consultant, this author has observed many pharma process validation outcomes. In this article, he provides insights into two recent process validation problems that could have been avoided with an enhanced developmental approach and a greater understanding of the impact of CMAs and CPPs.
6 Best Practices For Biopharma Talent Management In 2023
The Great Resignation. Inflation and the rising cost of goods and services are compelling workers in a variety of industries to seek higher salaries. This is being acutely felt in the life sciences industry. We need to revolutionize how we're approaching talent management in pharma and biopharma in order to succeed in this environment.
Collaborating With Academia For Drug Discovery Targeting Immune-Mediated Diseases
Last year, Janssen Biotech and the University of Oxford established a collaboration to understand pathogenic pathways driving immune-mediated inflammatory diseases. They have been creating a cellular map of expressed genes and proteins. This article shares what the collaboration has accomplished so far.
Biopharma Facility Modular Design & Construction: Key Considerations
In facility design, the term “modular design block” is used for “pre-engineered” or “predesigned” solutions. This approach suggests that a new facility design need not be unique but can use and leverage a pre-engineered set of component pieces. The further down the supply chain standardized modules and components reach, the wider the benefits.
A Practical Guide To Navigate The EU's Revised GMP Annex 1
The EU's final version of the GMP Annex 1 is now published, and it's time to take action. This article shares a road map to navigate what is new and different, how to document your "known unknowns," and more. Quality risk management and a contamination control strategy will be key.
PHARMA ONLINE WHITE PAPERS
Proper Process Prevents Poor Lab Performance
In order for new technologies to improve lab efficiency, there must be a standardized way of understanding people, materials, processes and equipment.
Analysis Of Engineering Manufacturing Risk2/2/2022
Here, we present a manufacturing risk analysis for a novel standardized and modularized single-use manufacturing strategy for 2,000 L scale single-use recombinant protein production.
Accelerate Time To Market With An Electronic Lab Notebook4/21/2021
Research organizations are challenged as never before to conceive and develop innovative scientific solutions rapidly and efficiently. Technology has made immense amounts of research information available at a keystroke—information that can spark creativity and new collaboration opportunities. However, scientists recording, managing and archiving research data in paper lab notebooks cannot keep up with this data deluge. This white paper examines the challenges of managing research data today and what to look for in an ELN.
What Is Pharma 4.0 And How Can You Implement It?10/3/2022
How can you get drugs to market faster without sacrificing quality, all while saving time and money? Pharma 4.0 could be the solution.
End-To-End Thinking During Drug Product Development10/7/2020
In this article, Dr. Kashif Ghaffar, process validation pharmacist at Pfizer’s Freiburg facility, discusses what needs to be considered during product development in preparation for commercial manufacture.
Digital Transformation In Regulatory: Achieving Excellence Virtually1/24/2022
As the industry looks forward, key decisionmakers in pharma and biotech companies were surveyed to assess their views on undertaking regulatory processes virtually.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
In pharmaceuticals, working effectively with contract development and manufacturing organizations (CDMOs) is an art as well as a science. Our latest e-book provides tips in selecting and working with a CDMO to accelerate the timeline for your drug development program through commercial manufacturing.More Content Collections