4 Keys To Winning FDA Breakthrough Therapy Designation

Agency filings require accuracy, dialog, order, and precision. We caught up with two biopharma regulatory experts who have seen breakthrough therapy designation success to get their firsthand advice on how to get it done.

New ADC Linker Tech Shows Efficacy, Safety Advantages

Araris Biotech AG CEO and co-founder Dr. Philipp Spycher says his company’s linker technology eliminates the antibody engineering requirement, is more stable and efficacious, and requires far less drug payload than those currently in use. Now it’s building a pipeline and seeking partnerships.

Inside KKNA’s Uncommon D&I Success

How Kyowa Kirin North America is strategically leveraging an incredible growth spurt to fuel its diversity & inclusion initiatives, attracting and retaining biotech talent that’s as diverse as its therapeutic portfolio.

Resetting The Immune System With Protein Therapeutics

Revolo Biotherapeutics is reaching for its share of the massive autoimmune disorder and allergy markets with novel protein-based therapies designed to reset the immune system. CEO Jonathan Rigby sat down with us on the heels of an IND approval for Revolo’s fourth Phase 2 clinical trial.


  • Technology Transfers: Critical To Medicine Mobilization, Success & Sustainability

    When an innovative device or drug product has shown promise in the research and discovery phase, the process needs to be further developed for clinical, then commercial, production. Often, this means the process must be transferred to a new site that can accommodate further development and scale-up. When executed properly, this transition can be successful.

  • 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.

  • Is The FDA About To Reclassify Your Drug Product As A Device?

    Until Oct. 8, 2021, the FDA is seeking public comment on its plans to transition some drugs to device status. The agency's intended implementation will affect not only new products meeting both drug and device statutory definitions in connection with the approval process but also existing products on the market that may have been improperly classified as drugs.


  • Can mRNA Disrupt The Biopharma Industry?

    mRNA has the potential to revolutionize the field of vaccine development. However, it is critical we understand any factors that could impact its successful entry into today’s market.




With the combination of market potential, rapidly improving manufacturing technology, and intense competition comes the necessity for biopharma companies to ensure the patent protection of their molecules early, and to plan strategically for protection beyond commercialization. To provide context and direction, we've procured this collection of fresh thought leadership columns from biopharmaceutical patent experts.

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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.