Newsletter | October 5, 2016

10.05.16 -- The Price At My CMO Isn't Right ... But How Do I Know?

Featured Editorial
The Price At My CMO Isn't Right … But How Do I Know?
By Louis Garguilo, Chief Editor, Outsourced Pharma

"What we're doing up here is never done – focusing on that one input in public. Instead of focusing on money, you talk openly about ‘value.' Well, what is that? Or it's all about ‘relationships.' The industry talks partnership in public, but behind closed doors, aren't prices and costs closing or breaking outsourcing business deals?"

Industry Insights
Manufacturing Spray-Dried Dispersions: Process Control Strategies
White Paper | By Devon DuBose, Dana Settell, Nathan Bennette, and Amber Broadbent, Ph.D.
A significant share of current drug development pipelines include active pharmaceutical ingredients (APIs) that fall into BCS (biopharmaceutical classification system) 2 and 4 spaces. These compounds are typically characterized by their low aqueous solubility and thus poor bioavailability, requiring advanced formulation approaches. Various approaches have been developed to enable these types of compounds, including particle size reduction (e.g., micronization), chemical modification (e.g., salt forms and pro-drugs), complexing agents, solubilized liquid forms (e.g., SEDDS), and solid amorphous dispersions.
The 3 Cs You Should Expect From Your Pharma CDMO
White Paper | By Paul Dupont, VP, Marketing and Business Development, Ropack Pharma Solutions
With the stakes higher than ever for drug sponsors, choosing a CDMO that is the best strategic fit is not just difficult, but imperative. These "three Cs" can indicate whether a CDMO has the ability to provide a drug sponsor with not only the resources to fulfill a company's long-term goals but also the confidence that every team member involved is committed to its success.
Solutions To Today's Biomanufacturing Challenges
Article | By John Ward, Vice President, Engineering, Patheon

With more complex molecules in development, changing capacity needs, uncertain forecasts, and increased competition, the market demands flexibility and innovative approaches to address today's new challenges.

eCOA Data Quality: Site And Patient Perspectives
Video | CRF Health
Adopting a patient-centric focus in your trial is known to lead to more engaged patients and higher quality, more accurate clinical data. In this short three-minute video we explore how electronic clinical outcomes assessment (eCOA) technology is revolutionizing the clinical trial experience for patients and sites — helping sponsors to easily overcome the toughest challenges of paper-based data collection.
Online Training

Pediatric Clinical Trials: Special Considerations And Requirements
Date: Thursday, October 6, 2016 • Time: 1:00 pm to 2:30 pm EDT

Electronic Data Integrity In A GxP Environment: Managing The Data Life Cycle For Compliance
Date: Thursday, October 13, 2016 • Time: 1:00 pm to 2:30 pm EDT

Qualifying Your Trainers: What Do They Need For Your Training To Be Effective?
Date: Tuesday, October 18, 2016 • Time: 1:00 pm to 2:30 pm EDT

Computerized Systems And Data Integrity: Avoiding The Top Five Regulatory Pitfalls
Date: Monday, October 24, 2016 • Time: 1:00 pm to 2:30 pm EDT

Responding Effectively To FDA Form 483 Observations: Strategies To Ensure Compliance
Date: Tuesday, October 25, 2016 • Time: 1:00 pm to 2:30 pm EDT

The Future Of Outsourcing In Clinical Research: Preparing For A Changing Global Landscape
Date: Wednesday, October 26, 2016 • Time: 1:00 pm to 2:30 pm EDT

Medical Device Recalls: Keys To Implementing A Successful Approach
Date: Thursday, October 27, 2016 • Time: 1:00 pm to 2:30 pm EDT

The Impact Of "Brexit" On Clinical Research: An Operational Readiness Primer
Date: Thursday, November 3, 2016 • Time: 1:00 pm to 2:30 pm EDT

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