Bridging the Gap between Finance, CMC & Program Management in Emerging Biopharma Companies

By |2022-06-30T16:04:53-04:0006/30/2022|

Bridging the Gap between Finance, CMC & Program Management in Emerging Biopharma Companies The CMC landscape is complex, uncertain, and dynamic, driving the CMC team to constantly adjust their plans and timelines. It can be challenging for Finance to assess the upstream and downstream impacts of such changes. Similarly, strategic business changes [...]

Transitioning to Computer Software Assurance from Computer Systems Validation

By |2022-03-29T09:57:35-04:0003/29/2022|

Transitioning to Computer Software Assurance from Computer Systems Validation Life science companies need to verify that GxP computer and software systems accurately support their intended business processes. The traditional approach for meeting this requirement is computer system validation (CSV). CSV emerged decades ago when computer systems were less reliable, and software was [...]

Event Recap: Building High-Touch Patient Supply Chains

By |2022-03-18T10:36:32-04:0003/18/2022|

Event Recap: Building High-Touch Patient Supply Chains Patient Outcomes: A Shift in Industry Focus The healthcare industry is increasing use of patient outcomes as a measure of quality and value. This drives biopharmaceutical companies to focus on patients in their commercial operations, technical operations, and supply chain. It was first prioritized [...]

CMC Project Plans: A Critical Tool for Early-Stage Biopharma

By |2022-01-25T10:42:30-05:0001/25/2022|

CMC Project Plans: A Critical Tool for Early-Stage Biopharma The Challenge for CMC Teams CMC activities are critical to early-stage biopharma companies preparing for commercialization. Growth of the company depends on the CMC team achieving milestones, which are technical and cross-functional. They also typically require capital investments. CMC teams operate in [...]

Are You Ready for Serialization Implementation?

By |2022-01-11T09:56:18-05:0001/11/2022|

Are You Ready for Serialization Implementation? A 7-Point Checklist for Emerging Pharma Companies Serialization implementation is probably on your radar already if you’re an executive at an emerging Biopharma company. Manufacturers need to implement a serialization management solution to fulfill today’s requirements under the Drug Supply Chain Security Act (DSCSA). So [...]

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 [...]

Event Recap: Why is Now the Time for Digital Supply Chain Transformation

By |2021-09-14T11:02:07-04:0009/14/2021|

Clinical supply professionals are responsible for ensuring that patients on clinical trials receive the right drug at the right time for their treatment protocols. The environment is dynamic and challenging, so companies embrace innovation to enable educated and responsible supply decision making. More than ever, biopharmaceutical sponsors are moving towards a digital clinical supply [...]

5 Unique Logistics Challenges for Specialty Pharmaceuticals

By |2021-07-29T10:15:32-04:0007/28/2021|

Many of our clients are innovator companies developing novel treatments that are often complex and extremely high value. As a result, they face similar supply chain challenges in preparing for commercialization. Often, these specialty products are also orphan and rare disease treatments, as well as extremely low volume. The supply chains for these emerging [...]

The CARES Act & Your Supply Chain: What You Need to Know Now

By |2021-06-29T16:04:50-04:0005/19/2021|

Life Sciences Supply Chain Working Group Webinar on June 29 @ 11a-12p Request the Presentation Request the Recording The Coronavirus Aid, Relief, and Economic Security (“CARES”) Act, signed in March 2020, provides emergency assistance and health care response for individuals, families, and businesses affected by the [...]

Go to Top