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 [...]

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 [...]

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 [...]

Why Is Demand & Supply Planning in Life Sciences so Difficult?

By |2020-09-22T14:48:28-04:0007/25/2019|

Event: September 12, 2019 @ 5p Why is Demand & Supply Planning in Life Sciences so Difficult? Demand and Supply Planning is a critical business process for companies moving through clinical development and commercialization. In addition to typical challenges, emerging and growing life science companies face unique obstacles due to clinical, regulatory, [...]

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