Info Sheet: Clinical Supply Chain Services

By |2021-11-09T11:51:19-05:0011/09/2021|

PDF Available > Planning for, establishing, and managing the Clinical Supply Chain has its own set of challenges – regulatory requirements, clinical uncertainties, nuances of sourcing drug substance and API material, and logistical constraints including access to new points of patient care. Clinical supply leaders need to manage all of these while ensuring quality [...]

Personal Information Protection: Broader than You Think

By |2021-11-02T10:12:07-04:0011/02/2021|

National and state governments are enacting laws to protect personal identifiable information (PII) from use without data subjects’ consent. Additionally, federal regulations are now in place to safeguard protected health information (PHI). A few examples of such laws active today are the General Data Protection Regulation by the European Union, the California Consumer Privacy [...]

Info Sheet: Cell & Gene Therapy Services

By |2021-03-19T11:53:55-04:0003/02/2021|

PDF Available > Cellular and regenerative medicine introduces a shift in healthcare - the promise of using the body’s own abilities to heal. Innovation in this area is driving dramatic change in the prevention, treatment and cure of diseases and disorders. The nature of cell and gene therapies (CGT) requires rethinking traditional business models [...]

Inaugural Meeting of the Supply Chain Working Group

By |2021-03-26T10:56:22-04:0011/19/2020|

December 17, 2020 @ 12:00 – 1:00p Join the Supply Chain Working Group 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 [...]

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 |2021-03-19T12:56:03-04:0008/18/2020|

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 |2021-03-19T12:57:27-04:0007/25/2019|

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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