Guest Columns

1. Biopharma Partnerships: The Key To Filling The Life Sciences Innovation Gap 5/18/2022

   The life sciences industry is facing a significant slowdown due to patent expirations. Many organizations have not established a robust enough pipeline to overcome the revenue to be lost. To bridge this innovation gap, pharma CEOs will need to expand their use of alliances, in tandem with bolt-on M&A, as a pipeline booster strategy.

2. New ICH Q14 Guidance Applies QbD To Analytical Procedures 5/13/2022

   ICH's new draft guidance (Q14) for Analytical Procedure Development describes an enhanced approach for method development, validation, and life cycle management employing elements of quality by design (QbD) and risk management tools. This article also explains the differences between this enhanced approach and the traditional approach.

3. Key Considerations In Early-Stage Biopharma Financing 5/11/2022

   After over two years of soaring IPO valuations and high stock prices, biotech had a reckoning in the back half of 2021. But while the industry is clearly facing headwinds, there’s significant cause for optimism for early-stage biotechs looking for funding, not the least of which is 2021’s high levels of venture capital fund formation.

4. Make This Your New EU IDMP Implementation Strategy 5/9/2022

   Just when the life sciences industry was as sure as it could be that EU Iteration 1 of ISO Identification of Medicinal Products (IDMP) implementation for centralized procedures in Europe was ready to go, the EMA announced a change of plan. Until further notice, the Digital Application Dataset Integration (DADI) user interface will be used to enable structured data submissions.

5. Key Considerations For Decarbonizing Your Biotech Facility 5/4/2022

   Biopharmaceutical manufacturing processes do not directly utilize fossil fuels, but fossil fuels are used in the generation of raw materials, consumables, packaging, and in supplying energy to building systems and manufacturing equipment. This article looks at key facility decarbonizing considerations using a case study with quantification of estimated costs.

6. 3 Keys To A Fit-For-Purpose Compliance Strategy In Decentralized Pharma 4/25/2022

   Outsourcing and technology have morphed our industry into a new decentralized model. Now, each sponsor must carefully develop an ongoing compliance strategy considering its unique business model and its influence on the drug development journey. Strategies are needed to design QMS' that can expand and pivot in tandem with corporate and clinical development.

7. The Single-use Bioprocessing Bottleneck & Looking Ahead 4/18/2022

   Are you asking, What happened to the bags promised for my product? The single-use system bag market had been seeing strains as early as 2018, and COVID-19 made the demand worse. This article looks into the factors contributing to the demand. Normalization of the supply chain may continue to be delayed, but it will eventually even out.

8. Technical Due Diligence Considerations For Multi-Site Biopharma Acquisitions 4/14/2022

   Part 1 of this 2-part article series shared considerations for standalone biopharma manufacturing facility acquisitions. This article, Part 2, shares considerations for multi-site acquisitions when the seller is manufacturing part or all its products in-house.

9. Tech Due Diligence: Acquiring A Biopharma Manufacturing Facility 4/8/2022

   As a consultant, this author has been approached on several occasions to perform on-site technical due diligence for facilities that his clients were considering to acquire. In this article, he shares the considerations you should keep in mind when acquiring a stand-alone biopharma manufacturing facility.

10. A Better Path For CMO Relationships As The Pandemic Continues 4/6/2022

    In this article, we discuss how drug sponsors and service providers can better work together to continue down the path of outsourcing success that has been highlighted during the pandemic.