Featured Pharma Online Editorial
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Biotech Patenting: 4 Tips & Personal Experiences
9/13/2021
When you file for patent protection for your discoveries, keep these 4 tips in mind. I also share some of my personal experiences with patenting from over the course of the last 28 years, from when I cofounded 180 Life Sciences through now.
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Harnessing Lab Deviations For Performance Transformation In Vaccine Manufacturing
9/8/2021
Deviations in the pharmaceutical process generally lead to non-compliance and issues meeting demand, so they require careful tracking, monitoring, and remediation. The presence of deviations may seem inevitable, yet COVID has brought to light the question of how vaccine manufacturing sites can manufacture more vaccines, more efficiently. This article explains how.
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How To Find & Manage Biotech Consultants Effectively
9/6/2021
The roles being filled by biotech consultants have grown considerably, as companies are becoming more familiar with working with consultants and more people are interested in pursuing a consultant career. But how do we find good consultants, and how do we ensure that our consultants are as committed and engaged as our full-time employees? Here's how to accomplish that.
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What’s The Role Of Interim Consultants In The Life Sciences & How Do We Use Them Effectively?
9/3/2021
When life sciences companies need new talent, they typically have two options: bring in a consultant or hire a full-time employee. Usually, this decision is dictated by the permanence of the role, but sometimes, timelines complicate things. In this situation, an interim consultant can be the solution. But what is the interim consultant's role, really, and how do we use them effectively?
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3 Successful Strategies For Protecting Your New Biopharma’s IP
9/1/2021
Intellectual property is the lifeblood of new biopharma entities. Patent protection is necessary to secure investment, to build a solid foundation with opportunity for future growth, and to establish viability within a highly competitive landscape. This article addresses key patent-related considerations for startups and small or early-stage players in the life sciences arena.
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SARS-CoV-2: Massey Univ. Profs Develop Method To Quickly Sequence Genome
8/13/2021
It was a matter of time before the world saw variants emerge that increased the transmission rate of COVID-19. A research team led by two of these authors at Massey University have developed a new next-generation sequencing method for the ultrafast sequencing of the SARS-CoV-2 genome, which cuts the sequencing time by more than half.
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Update On Regulatory Strategies To Mitigate Mutagenic Impurities In Prescription Drugs
8/11/2021
Addressing small molecule woes with nitrosamine and similar impurities is becoming patient critical. Recent questions and answers from the European Medicines Agency (EMA) provide clarity for the pharmaceutical industry. This article also delves into additional mutagenic impurities that are emerging.
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B. Cepacia: A Case Study For Determining Objectionableness In Drug Manufacturing
8/9/2021
After introducing the subject of colonization and opportunistic pathogenicity in part 1 of this 2-part series, the authors return to discussing B. cepacia in more depth in this article.
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Objectionableness: How To Know If A Microorganism Poses A Risk In Your Drug Product
8/6/2021
It is important to consider at the beginning of an exploration of species “objectionableness” in microbiological analysis that this idea is unique to our specific corner of the world. If you search for a definition of objectionable organisms in a microbiology reference text, you are unlikely to find one. This article, as part 1 in a 2-part series, meets that need.
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Patent Transparency For Biologics & Biosimilars: The Revamped Purple Book
7/12/2021
The FDA recently updated the “Purple Book” — a database containing information about all licensed biological products — to include, for the first time, patent information relating to biologics as well as FDA regulatory exclusivity information.