Life sciences companies have not been immune to the upheaval in the financial markets, casting a pall over equity financing in the sector. Your company will need to be creative in raising capital. This article also covers M&A, synthetic royalty agreements, convertible debt, and covenants. Will there be a reckoning?
- Why Russia's Invasion Of Ukraine Threatens Our Life Science Ecosystem
- FDA Proposes Benefit-Risk Considerations For Product Quality Assessments
- How To Navigate The Patenting Challenges Of AI-Assisted Drug Discovery
- 2022 Outsourcing Trends In Biopharmaceutical Manufacturing
- The Coming Wave Of Radio(bio)pharmaceuticals
- FDA Publishes Guidance For Biopharma Container And Carton Label Design
- How To Test Master Cell Banks As A Starting Material For Gene Therapies
EDITOR'S DESK
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Differentiation Via Developmental Difficulty
By way of its business strategy, Context Therapeutics willfully embraces difficult breast, ovarian, and endometrial oncology development projects. That’s what creates differentiation and value in a therapeutic area that’s desperately lacking both, says VC-turned-CEO Martin Lehr.
Ring Therapeutics is building a first-of-its-kind viral vector platform based on a commensal virus that flies under the immune system’s radar. If its odds-beating CEO is any indication of its success, the company just might beat the immunogenicity challenge.
Dr. Jessica Grossman’s life’s work has been dedicated to women’s health, maternal health, family health, and inspiring the advance of female leadership in life sciences. She’s paving that path in her current role as CEO at IgGenix, which is pioneering genomically-engineered antibodies for the treatment of severe allergies.
SparingVision CEO Stephane Boissel took the reins of a fledgling, single-asset gene therapy company born of academic research and quickly built a well-funded startup with a deepening pipeline of ocular disease candidates. He told the Business of Biotech how it happened.
Some mainstream, high-profile research out of the University of Pennsylvania has re-energized emerging cell therapy developers’ focus on manufacturing and administration speed. Speedy cell therapy pioneer EXUMA Biotech provides an update on its approach.
GUEST COLUMNISTS
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Why Russia's Invasion Of Ukraine Threatens Our Life Science Ecosystem
I posit that only pluralistic democracies committed to the rule of law can support the kind of investment and innovation our industry requires to thrive, while autocracies can’t make the same claim.
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FDA Proposes Benefit-Risk Considerations For Product Quality Assessments
The FDA recently released for public comment Benefit-Risk Considerations for Product Quality Assessments: Guidance for Industry. Mark Durivage breaks down the guidance and how the FDA considers and assesses risks, sources of uncertainty, and possible mitigation strategies for product quality-related issues and how unresolved product quality issues may be addressed.
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How To Navigate The Patenting Challenges Of AI-Assisted Drug Discovery
With “low hanging fruit” drugs already in the market, biopharma companies are finding it more difficult to discover the next blockbuster treatment. Artificial intelligence (AI) has become a new arrow in the drug discovery quiver. But how do you patent AI-assisted drug discovery? Attorneys from Haynes Boone provide recommendations.
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2022 Outsourcing Trends In Biopharmaceutical Manufacturing
The continued focus on productivity and efficiency is moving manufacturers to increasingly consider outsourcing activities. Based on BioPlan Associates’ 2022 Annual Report/Survey, biomanufacturers are spending more, demanding better technologies, and expressing greater optimism. This article shares the trends in outsourced activities, percentages of activities outsourced, outsourcing destinations, and offshoring.
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FDA Publishes Guidance For Biopharma Container And Carton Label Design
The scope of this new FDA guidance includes prescription drug products marketed under an approved NDA or ANDA, prescription drugs marketed without an approved application, and biological products marketed under an approved BLA, but the principles may apply to OTC, compounded, or investigational products.
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How To Test Master Cell Banks As A Starting Material For Gene Therapies
BioPhorum’s Cell and Gene Therapy Raw Materials team suggests a platform approach for testing a critical starting material for gene therapies – master cell banks (MCBs). This can ultimately influence and/or aid regulatory agencies when developing guidance or policies around gene therapy development and manufacturing.
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Assessing Extractables & Leachables In Parenteral Drug Products
Therapeutic complexity increases the potential risks associated with chemical composition of materials used for drug packaging. Leachables in drug or biological products are chemical compounds that originate from components that are used to store and deliver medicines. Extractables should be considered as potential leachables.
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Natural Killer Cells: Promise For Cancer Immunotherapy
Inside why natural killer (NK) cells are uniquely suited for targeted cellular therapies for cancers
BIOPROCESSING WHITE PAPERS
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Liquid, Dry Powdered Media, And Advanced Granular Technologies
It's important to assess the cel culture media format that is most suitable for the current and future needs of your process by considering scalability, cost-effectiveness, and convenience.
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Development Of A Novel Sf9 Rhabdovirus-Negative Cell Line (Sf-RVN®) And Companion Chemically Defined Medium3/15/2022
This whitepaper describes the development of a novel Sf-RVN® cell line, with companion chemically defined medium, the EXCELL® CD Insect Cell Medium which can be combined and offer a Sf-Rhabdovirus free alternative for the BICS production of biologics.
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Assessing End-To-End Drug Development Partnerships1/24/2022
As drug development becomes increasingly expensive and complex, pharma companies are relying on CDMOs. Consider the opportunities and challenges of end-to-end arrangements.
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The Changing Landscape Of Oncology Drug Development: Bringing Novel Lifesaving Therapies To Patients5/17/2022
This white paper provides strategic guidance for successfully navigating complexities, such as unique formulation and handling requirements, novel trial designs and the supply chain implications, and regulatory and clinical strategies to support product approvals.
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Analytical Power Tools Open Upstream Bioprocessing Bottlenecks10/5/2021
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.
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Considerations For Post-Approval Biologics Manufacturing7/6/2021
Read about considerations before, during, and after clinical trials that can help you maintain the biologic drug approval status you have spent years working to achieve.
BIOPROCESSING APP NOTES & CASE STUDIES
BIOPROCESS ONLINE CONTENT COLLECTIONS

From setting up and implementing a QRM program to objectively measuring your risk appetite and risk tolerances to proving sound risk management through factory and site acceptance testing (FAT and SAT), this e-book offers a collection of fresh insights from biopharma risk mitigation experts to help guide your risk management strategy.
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ON-DEMAND WEBINARS
- A Mixed-Mode Approach - Alternative To A Three-Step mAb Purification Process
- Addressing Upstream Cell Culture Challenges As A Community
- Use Of Mass Spectrometry To Assist in Biopharmaceutical Process Development
- Viral Safety Of Biologics: What's Changing With The ICH Q5A Revision?
- Controlling Essential Amino Acid Levels In CHO Cell Cultures
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 06.29.22 -- Clinical Supply Optimization And Comparator Local Sourcing Strategies
- 06.29.22 -- FDA Guidance For Biopharma Container Labels & Carton Labeling Design
- 06.28.22 -- Protecting Drug Products With Freeze/Thaw Technology
- 06.28.22 -- Regulatory Changes And Impact To Biosafety Testing: What You Should Know
- 06.27.22 -- How MCC Is Transforming mAb Capture