DSCSA Saleable Return Requirements: What the Changes Mean

By |2020-11-20T09:34:26-05:0011/19/2020|

On October 22, the FDA issued a new guidance document: Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product – Compliance Policies The guidance includes a 3-year delay in enforcing the DSCSA's saleable returns verification requirement for distributors. The enforcement start date is [...]

Inaugural Meeting of the Supply Chain Working Group

By |2020-11-19T11:53:17-05:0011/19/2020|

December 17, 2020 @ 12:00 – 1:00p Register Today Sign up as a member of the Life Sciences Supply Chain Working Group by registering for this inaugural event. The group currently has over 30 members who are supply chain executives at the Director level or above. The meeting program includes: Introduction of Membership [...]

Ensuring the Path to Compliant Analytical Methods

By |2020-11-10T15:23:54-05:0011/06/2020|

A gene therapy company spent over a decade developing their first-generation product, partnering for many early development capabilities. Then when the product was moving into the final stage clinical development, they bought out the rights and now owned 100% of the molecule. However, with a lean organization who had limited CMC and analytical [...]

Clinical Supply Management Improved with Single IRT Solution

By |2020-10-30T11:09:36-04:0010/30/2020|

A cancer treatment company with a strong development pipeline had more than a dozen clinical studies in process and that number was growing. A lean team was managing everything and, like many emerging biotech companies, relied on CROs for many clinical operations activities. As those programs progressed through development, our client was dealing [...]

Stage-Appropriate Quality Systems

By |2020-10-22T12:18:12-04:0010/22/2020|

Stage-Appropriate Quality Systems development comes up directly or indirectly in essentially all our client work. Quality Management is essential for emerging biopharma companies in particular, who face significant technical, scientific, clinical, and operational uncertainties. There is always a question of how much, and how soon? We see some companies 'build for success' who [...]

Improving Demand & Supply Planning for Emerging Life Science Companies

By |2020-09-25T09:09:06-04:0009/24/2020|

Improving Demand & Supply Planning for Emerging Life Science Companies Todd Applebaum, Managing Director Our Demand & Supply Planning Maturity Model aligns key aspects of the planning process to each company's lifecycle. Improving demand and supply planning is crucial for Life Science companies. This is especially valuable when dealing with [...]

4 Trends in Commercial Supply Chain Launch

By |2020-09-14T12:03:18-04:0009/14/2020|

Building a commercial supply chain to launch a new product is always a high-wire act. Supply Chain leaders must balance preparing the supply network and launch materials with the uncertainties of clinical development and regulatory progress. In addition, they must manage the risks of commercial uptake and demand. These challenges hold true whether [...]

Clinical Supply Agility: Expect the Unexpected

By |2020-10-20T10:23:00-04:0009/10/2020|

Webinar with 4G Clinical on 10/8/20 Download the Webinar Recording There are constantly unforeseen risks inherent when planning for clinical supply. For instance, when the COVID-19 pandemic began, there was concern that supply chains would be disrupted. Overall supply chains remained operational but questions remained on how to manage [...]

Building the Downstream Commercial Supply Chain for Launch

By |2020-11-10T15:30:01-05:0008/28/2020|

An emerging pharmaceutical company was preparing for its first commercial product launches with two products progressing through the clinic. Approvals and launch events were targeted within one year of each other. The products were similar in technology and formulation. The first anticipated approval was for a relatively smaller indication. The second was for a [...]

Essential Characteristics of a Stage-Appropriate Quality System

By |2020-10-02T10:05:28-04:0008/18/2020|

CMC QA/The Quality System Webinar on 9/30/2020 Request the Recording Request the Presentation Biopharmaceutical companies developing innovative products must build a stage-appropriate quality system (QS) that ensures the right controls are in place.  By doing this, they ensure patient safety and compliance while enhancing operational efficiency. The [...]

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