EDITOR'S DESK

  • So You Want To Be A Chief Medical Officer?

    BioProcess Online caught up with Dr. Loretta Itri, veteran CMO at Immunomedics, fresh on the heels of her 18th drug approval. The ensuing conversation on her mastery of the multifaceted role serves as a blueprint for aspiring chief medical officers.

The Organizational Nuance Of An Immuno-Oncology Startup

How Jeff Wolf pieced Heat Biologics together before immuno-oncology was en vogue, and how the foundation he built is supporting the company’s growth today.

Maintaining Lab Operations Amid Coronavirus Restrictions

Obsidian Therapeutics CEO Dr. Paul Wotton developed a novel solution to the workforce and resource disruption caused by COVID-19 social distancing restrictions. Here, he shares insight on the features of the application, which he's made available to other biotechs cost-free.

COVID-19 And The Next Chapter In Ansun’s Turnaround Story

How Dr. Nancy Chang turned an embattled company in financial freefall and on the heels of clinical failure into a leading clinical-stage biopharma—and how the disruption of a global pandemic made Ansun Biopharma a formidable contender in the treatment of COVID-19.

Advocates For AI In The Laggard Life Sciences

A team at Xavier Health is taking an unbiased lead on the adoption of artificial intelligence in the life sciences. Here are some biopharma use cases, and a peek at the progress they'll report on at this month's Xavier AI Summit.

GUEST COLUMNISTS

  • End Of The Enbrel Battle: How Amgen Beat Sandoz

    This case serves as a reminder that sometimes it is impossible to fully evaluate the likelihood of success in biosimilar litigation before the challenge begins.

  • Dos And Don’ts Of Virtual Factory Acceptance Testing In Life Sciences

    Performing virtual FATs (vFATs) can be a helpful solution in these new and uncertain times, though it does come with added risk. Without having the team on-site, remote FATs present a higher possibility for equipment to be shipped without meeting the end user’s requirements and functional specifications.

  • An Update On 2020 U.S. Biosimilars Regulation & Litigation

     

    The biosimilar market and regulatory and legal landscape remained dynamic throughout the first half of 2020. Ongoing activity indicates that the remainder of 2020 should bring more interesting developments.

     

  • Strategic Outsourcing For Virtual Companies — Lessons Learned In The Trenches

    A virtual company advancing a drug candidate into product development faces a deluge of challenges. The reality is you do need the assistance of pharmaceutical scientists and advice from industry professionals to help you navigate the twists and turns in the road.

  • Making FMEA More Robust With HACCP

    Risk priority number scores and criticality analysis are frequently used to quantify risks for users, designs, and processes. However, these traditional failure mode and effects analysis (FMEA) techniques often fail to fully document risks associated with contamination. To complement FMEA, consider borrowing a risk-management technique from the food industry.

  • Repurposing An Aging Facility To Produce Cell & Gene Therapies

    Many life sciences companies are shifting their operations to encompass new life-saving cell and gene therapy products, also known as advanced therapy medicinal products. In many cases, this requires converting legacy manufacturing facilities to produce these new therapies.

  • Trends In Bioprocessing CDMO Selection

    Which CDMO characteristics do experienced outsourcers value the most when choosing a CDMO for biologic API production? Data from the past three iterations of ISR’s Bioprocessing Market Trends and Outsourcing Dynamics show the top selection metrics remain cosnsistent despite some shifts in ranks over the years. Learn which attributes to focus on as a sponsor or CDMO.

  • The Global Regulatory And Quality Environment For Biopharma Outsourcing

    It is critical that organizations looking to engage an external contract service provider be aware of new regulations to align their programs with the latest expectations for each relevant market.

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One of the most important decisions you'll face in the early stages of your biopharma journey is whether or not to entrust a CDMO with the development of your molecule. We've aggregated a collection of recent articles on the topic—all of them authored by veteran independent consultants and biopharma leaders—to offer you sound advice and insight. From ensuring a corporate culture match to writing a bullet-proof contract to meshing quality data systems, this ebook is required reading for new and emerging biopharma companies considering a CDMO relationship.

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