Connecting Data to the Patient: Paul McKenzie on J&J Pharma R&D's Lab-to-Patient Program

Paul McKenzie shares goals for J&J's pharmaceutical R&D, and the "Lab to Patient" program. Read more »

From Go-Karts to Formula 1: Distinguishing True Digital Signatures

Digital signatures have grown in sophistication and import, becoming a staple of serious and compliant drug manufacturers, explains SAFE-Biopharma's Mollie Shields-Uehling. Read more »

Biotech Production: Planning, Scheduling & Throughput Analysis with Constraints, Lean and Simulation Approach

A major biotech company's only final stage bio-manufacturing facility in the struggles to meet customer demand. Read more »

Funny Pharm: Write the Cartoon Caption & Win

Introducing "Funny Pharm," sponsored by Paratherm Corp., featuring drawings by award-winning cartoonist Jerry King. Submit your caption and win. Read more »

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We go behind consumer media headlines, beyond trade press boundaries, to offer candid analysis and commentary on issues affecting drug manufacturers. We cover the gamut, from fiscal to philosophical, from serious to silly. Read more »

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Audio Update

  • Focus on Pharma Episode 8: Pharmaceutical QbD: An Industry Progress Report Led By Ali Afnan Faster drug approvals, real-time release, regulatory relief. These, and many other benefits, are promised by adopting Pharmaceutical Quality by Design principles. So why aren't more people embracing the concept? Skeptics continue to see QbD efforts as too expensive, time consuming and impractical, while QbD and PAT projects are being launched separately, rather than together as intended. Exploring the reasons for this apparent disconnect, and potential solutions, are Ali Afnan, Pedro Hernandez-Abad, Sam Venugopal and Gawayne Mahboubian-Jones.
  • From SharePoint to Cloud Computing: Microsoft's Life Sciences Evolution Microsoft is positioning SharePoint as a solution to the industry's innovation gap. In this interview with Senior Editor Paul Thomas at DIA 2010, Michael Naimoli, Director of Life Sciences Industry Solutions, discusses how manufacturers like GSK and Merck are using SharePoint as a knowledge management platform to find new ways to innovate.
  • Podcast: API Pollution: Are Drug Manufacturers Trying to Stymie Studies? A recent U.S. Geological Survey study found two drug facilities in New York state releasing high levels of API into local groundwater. The manufacturers have been less than cooperative, says study lead Patrick Phillips, speaking with Senior Editor Paul Thomas. Without adequate studies, Phillips adds, there's no way of knowing what the impact of the compounds on local biota might be.
  • Focus on Pharma Episode 7: J&J's Paul McKenzie on Data Transparency and Connecting to the Patient Paul McKenzie, global head of pharmaceutical development and manufacturing sciences at J&J Pharmaceutical Research and Development, discusses J&J's Lab to Patient program, and how the drug industry might connect its data silos to optimize results for the patient.
  • Focus on Pharma Episode 6: Continuous Processing: Is Pharma Moving Beyond the Batch? Although batch manufacturing promises to dominate drug manufacturing, there are a growing number of opportunities to harness the power of continuous manufacturing. Is the industry reaching a tipping point? Bernhardt Trout, head of the Novartis-MIT Center for Continuous Manufacturing, shares his views on what is changing.
  • Flowing Over: Continuous Manufacturing Finding a Home in Pharma The significant uptake of continuous processing in pharma coincides with technologies that enable it. Most of the technology gaps have been filled, says Microfluidics' CTO Mimi Panagiotou, PhD, who discusses why continuous processing is reaching a tipping point in pharma now, and various ways that manufacturers are using her company's MRT reactors for continuous crystallization and multi-phase reactions.
  • Automating R&D Workflows, Searching for Step-Change Productivity Gains Freeslate is working with J&J and other pharma clients to automate and integrate diverse workflows within pharma labs and make analytical data more accessible to development scientists. We talk with CEO John Senaldi to get a better sense of his company's solutions, including the benefits of Lab Execution & Analysis (LEA) software.
  • Continuous Processing: The Industry’s New Mindset Bernhardt Trout, head of the Novartis-MIT Center for Continuous Manufacturing, finally sees a tipping point in acceptance of continuous processing methods in pharma. Dr. Trout shares views on what’s changed, and what’s to come, in the continuous world.
Hear more from Audio Update »

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Webcast Library

  • Webinar: Staying One Step Ahead of the FDA: Supplier Audits and Ensuring Raw Material Quality To avoid costly shutdowns, product seizures, and warning letters, drug firms need effective raw material controls and critical supplier auditing procedures. Imagine how effective your controls would be if you were using the same exact field sampling techniques and tools FDA investigators use. If you'd like to learn some of the lessons the FDA has adopted in the wake of the contaminated Heparin and Glycerin scandals, then attend this webinar hosted by Thermo Fisher Scientific on Tuesday, September 14th.
  • Webcast: As Your Markets Grow, Can Your Data Management Systems Keep Up? SAP is helping Life Science companies implement comprehensive and proven industry specific solutions that manage business processes in one preconfigured Life Science industry solution. Join us to learn how Convatec implemented an SAP Life Science industry solution using industry best practices and rapid deployment methodologies to meet an aggressive implementation timetable and develop a solid foundation to support future growth in the highly regulated Life Science Industry.
  • Webcast: Applying Lean in the Lab Toyota methods may have been designed for the shop floor, but they are leading to significant improvements in the way pharmaceutical quality and even research labs operate. Hear leading consultants--Tadgh Prendeville, BSM USA and Bikash Chatterjee, Pharmatech Associates as well as Margaret Wyche, Director of QC, Allergan share their experiences on increasing efficiency, decreasing waste and improving quality in the lab.
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