CPhI North America Conference

Pharma industry leaders gather annually at CPhI North America to discuss pharmaceutical manufacturing, outsourcing, R&D, drug delivery and supply chain related topics for small and large molecule finished drugs as well as advancements in bio-manufacturing.

2019 Sessions Include:

Drug Development Track

• Building a Better Drug: Strategies to Enhance Patient Drug Regimen Adherence 

• Development & Manufacturing Considerations of High Potent Drug Products – a CDMO’s Perspective 

• Outsourcing of NDA Approvals and CMO Performance in 2018 and Future Outlook

• Chemical Facilities Outreach Exchange

• Miniaturization Pharmaceutical Technology (MPTech®) - An API Manufacturing Process to Increase the Operational Efficiency and Its Impact and Benefits on Patients

• High Potency API (HPAPI) Best Practices -   Controlling Quality  

• Formulation Trends Spotlight:  Semi-Solid, Topical and Transdermal 

• Quality by Design:  Methods for Optimizing Spray-Dried Dispersions for Bioavailability Enhancement 

• Is a geographically integrated CMC supply chain the next evolution of the CDMO model 

• Continuous, on-demand dehydration of solvents in flow chemistry manufacturing processes

Drug Manufacturing Track

• API Part I - Advances in API Synthesis and Manufacturing

• API Part II - Advances in API Synthesis and Manufacturing

• When Science and Politics Collide: A Political Forecast Into 2019 and Issues That Will Impact Chemical Processing

• Quality Risk Assessment in Pharmaceutical Industry

• Challenges in Extractables and Leachables Studies of Plastic Process Materials

• AI, IoT and the Road to Pharma 4.0

• Pharma’s Problem with Data integrity 

• Extrusion Applications in Manufacturing Pharmaceutical Oral Drug Products

• Innovation without Imitation: Utilizing U.S. FDA Drug Master Files 

• The System Development Lifecycle (SDLC) and Computer System Validation (CSV) in Drug Manufacturing

• The Critical Approach to the Design of a HPAPI Suite in a Multi-use Facility 

Bio-Processing Track

• Upstream processing: A new approach for scalability and transfer

• Filling The Gap in Skilled Workforce Shortage in Biomanufacturing

• The Role of Bacteria in Drug Metabolism

Keynote Highlights from 2018:

The Medical Futurist

The Medical Futurist, Dr. Bertalan Mesko embarked on a captivating and exploratory journey to find out how science fiction technologies can become reality in medicine and healthcare.

The Digital Pill Revolution

Nik Leist, Senior Director of Ingestible Sensor Manufacturing and Site Leader at Proteus Digital Health, offered new insight into patient health patterns and treatment effectiveness.

Industry Changes from the FDA

The FDA's Peter P. Stein, M.D., Deputy Director, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER) shared a special presentation on changes in the industry.

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Interested in joining our speaker faculty for the CPhI Connect program?  Please contact [email protected] to learn more about how you can be a part of our speaker faculty for the 2019 agenda.