Recently in 2021, the United States Patent and Trademark Office published an update to its 2019 Orange Book patent/biologic patent study report, analyzing America Invents Act post-grant proceeding outcomes for biologic patents and Orange Book‑listed patents between Sept. 16, 2012, and June 30, 2021. This article shares key learnings.
- Challenges In Analytical Development And Testing For Gene Therapies
- An Introduction To Biopharma Facility Design & Layout
- COVID-19 Spurs Growth Of China’s Domestic Bioprocessing Suppliers
- A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part 2 — COVID-19 Vaccine Benefit-Risk
- A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part I
- Is A SPAC The Right Option For Your Emerging Biotech?
- Forging A New Path Forward in Manufacturing Genetic Medicines
Challenges In Analytical Development And Testing For Gene Therapies
Given the rapid emergence of gene therapies based on recombinant adeno-associated virus (rAAV), there is a great need for appropriate analytical tools to support every lifecycle stage of these products.
An Introduction To Biopharma Facility Design & Layout
This article explores modern facility design principles that make use of the most flexible new technologies and provide a platform to rein in costs, reduce schedules, and deliver products compliantly and within business risk tolerance.
COVID-19 Spurs Growth Of China’s Domestic Bioprocessing Suppliers
Just as the U.S. and European bioprocessing supply systems have seen more robust growth than ever before, China’s domestic demands for single-use bags, cell culture media, and purification resins are all on the rise. BioPlan’s Top1000Bio database of global bioprocessing facilities has tracked industry capacity and employment growth over 15 years.
A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part 2 — COVID-19 Vaccine Benefit-Risk
In Part 1 of this 2-part series, the authors presented a method by which benefit-risk analysis can be objectively carried out to arrive at a benefit-risk ratio. This method can be applied to any medical therapy, and this article (Part 2) provides a very relevant and contemporary example of how it can be used to calculate COVID-19 vaccine benefit-risk.
A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part I
This article introduces a novel model of benefit-risk by taking a bottom-up approach using the _risk of the therapy_ and comparing it to _risk of no therapy_ to quantify risk and benefit with the same scale. This overview is relevant not only to the pharmaceutical and biotech industries, but also the medical device industry.
Is A SPAC The Right Option For Your Emerging Biotech?
As biotech and emerging pharma companies weigh their options for raising capital, the popularity of the special purpose acquisition company (SPAC) has surged, with a 175% increase in announced SPAC M&As seen between 2019 and 2020. This article examines the considerations you should make when weighing if a SPAC is the right option for your company.
Forging A New Path Forward in Manufacturing Genetic Medicines
While the past decade’s focus on scientific advances has accelerated the advancement of genetic medicines, including gene and cell therapies, manufacturing is vital to product quality, safety, efficacy and clinical trial and commercial supply. In the case of adeno-associated virus (AAV)-based gene therapy and gene editing product development, manufacturing is no simple task. As the industry advances these genetic medicines, manufacturing is also ramping up, and with it optimization and efficiencies of scale. Since the industry is still maturing, and manufacturing know-how is often kept proprietary, companies must learn, adapt, and master novel innovations as well as challenges on their own.
3 Reasons Why Medtech & Digital Healthcare Companies Should Consider Direct-To-Cloud Connectivity for IoMT
A critical part of the digital health ecosystem, wireless connectivity is a key enabler for medical devices that can be used by patients at home and on the move. For example, connected drug delivery devices enable pharma companies to offer remote monitoring, while wearable sensors enable continuous remote diagnostics. This article explains 3 reasons why you should consider direct-to-cloud connectivity for your product.
PHARMA ONLINE WHITE PAPERS
Analytical Power Tools Open Upstream Bioprocessing Bottlenecks
Clone selection is a significant upstream bottleneck slowing bench-to-bedside development progress for new mAbbased therapeutics. With mAb-based product development addressing diseases of such massive financial and societal implications, researchers using analytical power tools can reach their goals faster and shorten the bench-to-bedside development path, benefitting both patients and the bottom line.
Demystifying Performance Testing: Strategies To Qualify Combination Products11/30/2020
Demonstration of fit-for-purpose for a drug-device combination product requires demonstration of system performance that meets regulatory requirements. This article presents a best practice strategy for performance testing. It starts with a thorough understanding of applicable regulations and guidances. Following this, performance risks are identified using failure modes and effects analyses (FMEA) and failure cause mapping analyses. Next, a test plan based on accepted standards is designed and executed, considering highest risk failure modes first.
End Of End Point Assays: SPR Analytics In Vaccine Design, Development2/18/2021
Discover how SPR can be used to accelerate vaccine discovery and development by helping overcome analytical challenges that have plagued the industry for decades.
Change Control – Continuous Quality Improvement In FDA And ISO Environments8/23/2021
The fact that change is inevitable makes control a critical factor, especially in FDA and ISO-environments, where inappropriate or “uncontrolled” changes could affect the safety and reliability of products and directly impact public health and safety. This paper explains the definition of change, regulatory requirements, as well as the elements and challenges of change control.
Drug Repurposing Trends And Strategic Approaches For Shortening Timelines4/15/2021
As the complexity of drug development increases, so does the industry’s focus on strategies and solutions that can help bring advanced products to market as quickly as possible.
Integrated Tools For Upstream Process Intensification: Part II10/27/2019
Changes to bioprocessing methodologies in the biopharmaceutical industry are being driven by the need for increased speed, a lower cost of goods (COGs) and greater flexibility. Faster development times are required to progress biologics and vaccines more rapidly into clinical development and then to market to improve worldwide accessibility. Continue reading in part 2 of this series how in order for intensified and continuous bioprocessing to deliver on these quality and productivity promises, there is a requirement for intelligently designed products.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
Our latest e-book explores efforts to pay closer attention to how your company’s culture and operations ensure the completeness, consistency, and accuracy of data - AKA data integrity. Such data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA), according to the FDA. Similarly, data must be complete, consistent, and accurate throughout the data life cycle, according to the MHRA and the Pharmaceutical Inspection Co-operation Scheme.More Content Collections
PHARMA ONLINE PRODUCTS & SERVICES
LIFE SCIENCE CONNECT SPOTLIGHT JOB OPENING: TARSUS
Tarsus, a late clinical-stage biopharmaceutical company focused on the development and commercialization of therapeutic candidates to address large market opportunities, is hiring a VP Manufacturing Operations & Supply Chain Management. Reporting to the COO, you will be accountable for the overall CMC development, manufacturing and supply chain strategy for clinical and commercial supply of drug substance, drug product and IMP.
Sound interesting?Read the Job Posting to learn more.