Industry Insights

  1. Are Biopharma's Strong Pipeline Innovations Reaching Patients? 6/13/2019

    The number of new chemical entities gaining FDA approval more than doubled from 2017 to 2018. Global R&D spending increased 3.5%. The pipeline is strong, but how many innovations are actually reaching patients?

  2. How To Choose The Right Contract Laboratory For Your Drug Product 8/8/2018

    Finding a contract laboratory to fit the needs of your product is often challenging. Especially in the clinical and preclinical space, laboratory support is critical to presenting a foundation to the agency that your product is of the right quality and safety, and the basis of this before validation batches have been made depends wholly on the quality controls in place.

  3. Balancing Speed-to-Market With A Risk-based Approach To Compliance 10/1/2015

    Addressing compliance pressures can drastically affect productivity and manufacturing cycles, so a risk-based approach to compliance can help biopharmaceutical companies balance the scales. When not everyone in the industry can be “first-to-market,” it’s important to glean information from being the “first-to-fail.”

  4. Ensuring The Efficacy Of Probiotic Products 10/29/2019

    There is growing interest among consumers in verifying that the dietary supplements they take are safe and efficacious. The concern over whether consumers are getting the product as it is described on the label is rooted in one vital and transformative fact: probiotics are living organisms that are highly sensitive to humidity and oxygen. In the absence of proper handling and packaging, the efficacy of probiotic products can be compromised at any point of the packaging, storage and transportation process, inversely impacting shelf life and product viability and efficacy for the consumer.

  5. For Whom Is Bioprocessing Capacity Scarce? 2/6/2019

    ISR data, collected for the purpose of improving our understanding of the much-anticipated bioprocessing capacity crunch, reveals that it is not a matter of if or when a capacity crunch will impact the biopharmaceutical industry; instead, it’s a question of who, or which types of drug innovators, will be impacted.

  6. Separating, Optimizing Device Evaluation And Design Verification A Key To Medtech Success 1/9/2019

    In medical device design and development, two critical development activities — device evaluation and device design verification — often are treated as one, and this behavior is shockingly detrimental to successful medical device development.

  7. Selecting A CDMO: Strategies To Ensure A Successful Partnership 11/14/2017

    The story is a common one. Your organization has just acquired a new asset and you are responsible for finding the custom development and manufacturing organization (CDMO) that is going to take you all the way to commercialization. The hard part is over, right?  If only it were that simple.

  8. Supply Agreements — Removing The Stress From 'Failure To Supply' Negotiations 1/2/2018

    The failure to supply (FtS) provision in a drug product or drug substance supply agreement can be the most hard fought over “what if” in the agreement and, after price and volume, the section of an agreement with a high potential to fracture a customer-supplier relationship.

  9. Anatomy Of A GMP Vendor Qualification Program

    Pharmaceutical companies are only as compliant as their vendors.  In a contract manufacturing arrangement, the manufacturer is held responsible for any cGMP deficiencies; however, you, as the sponsor or CRO, would be held responsible for your lack of vendor oversight.  Moreover, if your manufacturer fails to meet regulatory standards, you could lose millions in profits and patent exclusivity, damage your company’s reputation, and even jeopardize your entire business.

  10. What Happens To ISO 13485 When Annex L Is Adopted? 9/16/2019

    Although the structure of ISO 13485 will expand from the current eight main clauses to ten, most of the QMS requirements should essentially remain the same.