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Focus on Pharma: Episode 24: The Facility of Tomorrow: Biopharma Leads the Industry

Biopharmaceutical manufacturers are reducing risk and cost by using modular construction, disposable process equipment, contained equipment and other innovations. Will they change the industry's approach to plant design and engineering?

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Focus on Pharma: Episode 24: The Facility of Tomorrow: Biopharma Leads the Industry
12/20/2011
Biopharmaceutical manufacturers are reducing risk and cost by using modular construction, disposable process equipment, contained equipment and other innovations. Will they change the industry's approach to plant design and engineering?

Focus on Pharma: Faster Knowledge and Technology Transfer Using Video
11/28/2011
Transferability of experimental methods is a problem for industrial and academic labs alike, wasting millions of dollars each year. The Journal of Visualized Experiments (JoVE) uses video to help transfer the knowledge required to carry out lab experiments successfully. Co-founder Moshe Pritsker discusses its business model, industry issues and how the journal works.

Taking the Emotion Out of Pharma Outsourcing: John Gray Discusses Recent Research into Quality Risks Offshore
10/17/2011
Outsourcing and offshoring are touchy subjects for any community anxious about losing potential industry and jobs. A study in November's issue of the Journal of Operations Management suggests that quality risks increase when operations are moved offshore, but emphasizes the fact that this is a knowledge management problem. Lead author, Professor John Gray of Ohio State University's Fisher College of Business, discusses the study, industry reaction, misunderstandings and upcoming research on this important, but difficult, topic.

Focus on Pharma Episode 20: FDA and USP Collaborate to Update Standards for Over-the-Counter Medications
08/30/2011
A September workshop sponsored by FDA and USP will examine progress in modernizing analytical methods and test procedures, to help prevent adulterated over-the-counter medications from reaching the public. Impurities testing and material identification will be critical. Both Agencies summarized recent progress in these efforts at a July science advisory board meeting.

Focus on Pharma: FDA's Friedman Urges Better Supplier Oversight and Investment in Quality; Any Questions? Call Me, says FDA's Rothman
07/27/2011
Understaffing quality operations, failing to oversee suppliers and contractors, and blaming problems on mid-level QC and manufacturing managers, is not the answer. At a summer conference on GMP's, FDA's Rick Friedman and colleagues Barry Rothman and Steven Wolfgang, discussed the roots of current supply shortages, and emphasized the need for proactive communication with the Agency and its district offices. They also responded to criticism on the way the Agency's handling inspections.

Focus on Pharma Episode 18: New Blueprints for Pharmaceutical Quality by Design
06/28/2011
Critics have questioned industry’s commitment to QbD, but a recent conference sponsored by NIPTE was well attended by industry, and presented an important new case study. Editor in Chief Agnes Shanley reviews the conference and NIPTE’s Prabir Basu shares his views.

Podcast: Lean Labor: Applying Discipline to the Pharma Workforce
06/23/2011
Gregg Gordon’s new book, Lean Labor, looks at how Lean and continuous improvement efforts must go beyond manufacturing, materials, and machines and also address worker needs and productivity.

Podcast: TruProcess: Next-Generation Near-Infrared (NIR) Spectrometer for Pharmaceutical Processing
05/12/2011
Duane Sword, Sr. Director, Thermo Scientific discusses the capabilities and technical attributes of TruProcess, an advanced NIR spectrometer for real-time blend analysis, drying and other process analytical technology (PAT) applications.

Podcast: Faster, Easier and More Comprehensive Raw Materials Identification Advancements Facilitated by TruScan RM
05/12/2011
Duane Sword, Sr. Director, Thermo Scientific discusses quicker testing times, simpler operator use, larger spectral libraries and other advantages of the new TruScan RM.

Focus on Pharma Episode 16: Data Integrity and Part 11: Take a Life Cycle Approach, Urges John Avellanet
04/27/2011
Part 11 should really be called the Data Integrity guidance, says Cerulean Associates principal John Avellanet. In a recent interview, the compliance expert discussed the importance of audits, whether data is stored on- or off-site. FDA's new process validation guidance can help ensure data validity, he says.

Focus on Pharma Episode 15: Straight Talk on FDA's New Process Validation Guidance From Ali Afnan
04/06/2011
It will add to the complexity and cost of compliance, in the short term, says one of the guidance's authors, but will offer tremendous savings in the cost of quality, time to market, cost of stockpiled product, and cost of filing process revisions with FDA.

Focus on Pharma Episode 14: Y2K Redux? Pharma Needs to Go Back to Square One With 21 CFR Part 11, says Johnny Guerra
03/15/2011
Many companies still don't invest in the validation and QbD approach needed to ensure data integrity, says FDA veteran, consultant Johnny Guerra. Failing to examine requirements during the process design stage, and to test the cGMP limits of software and IT, leaves manufacturers potentially liable at a point when a product recall may be their only option.

Podcast: Demystifying Automated Rapid Detection: The Importance of Being Non-Destructive
03/14/2011
Pharma microbiological testing has improved dramatically in recent years, especially in regard to speed and sampling methodology. In this interview, Julie Sperry of Rapid Micro Biosystems explains the viability and importance of rapid, non-destructive testing and outlines the benefits of her company’s Growth Direct system.

Focus on Pharma Episode 13: Process Validation: Will Pharma Harness the Next Wave of Pharmaceutical Process Modeling and PAT?
02/01/2011
Editor in Chief Agnes Shanley reports on FDA's new process validation guidance and this year's IFPAC conference. Newer technologies from recent startup companies may represent the next wave of process monitoring and PAT. Will more drug manufacturers avail themselves of these systems?

2011 Pharma Job Market: Is the Pendulum Swinging Workers' Way?
01/27/2011
After a forgettable few years of pharma industry workers being maxed out, stressed out, or laid off, 2011 finally promises a turnaround. Biotech is already hiring manufacturing workers, says Megan Driscoll, president of Pharmalogics Recruiting, while traditional pharma should follow suit later in the year. The change is more than welcome, says Driscoll, as burnout is a real issue for workers, who have had no choice but to take on more responsibilities or risk being let go. Manufacturers, too, will have to reward workers who have seen them through tough times.

Focus on Pharma Episode 12: Thomas Friedli on Pharma's Op Ex Role Models and Challenges
12/14/2010
Discussing benchmarking research and the new book he coauthored with NIPTE director Prabir Basu, University of St Gallen Professor Thomas Friedli discusses pharma's Op Ex role models, and Op Ex's move from Big Pharma to smaller companies and contract manufacturers. Cost-cutting is forcing upper management to pay more attention to the manufacturing function, he says.

Focus on Pharma Episode 11: More GMP Whistleblower Cases On the Way? Michael Gregor Dissects Recent Cases
11/15/2010
GSK's whistleblower case invoked cGMPs and there may be at least another such case coming, says consultant Michael Gregor, of Compliance Gurus. Among the biggest recurring problems, he says, are lack of training and a failure to calibrate written procedures with actual practice.

Focus on Pharma: Episode 10: The New USP: Modernizing Tests and Connecting With the Public
10/27/2010
USP recently launched a public outreach and education program, and is modernizing its monographs and testing methods. Dr. Karen Russo, vice president of small molecules, who is heading up these modernization efforts, discusses strategies and plans. Impurity testing, she says, will be first priority.

Focus on Pharma Podcast: Episode 9: Permanent Solutions for Integrating Pharma's Temporary Workers
09/28/2010
Drug Manufacturers struggle to manage contingent labor, much less have them "hit the production floor running." Consultant Steve Sawin explains what manufacturers can do to ensure that temporary workers are ready to do what's required of them, and uphold Quality standards.

Focus on Pharma Episode 8: Pharmaceutical QbD: An Industry Progress Report Led By Ali Afnan
08/26/2010
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
08/09/2010
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?
08/09/2010
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
07/28/2010
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?
06/23/2010
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.

Automating R&D Workflows, Searching for Step-Change Productivity Gains
06/21/2010
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.

Flowing Over: Continuous Manufacturing Finding a Home in Pharma
06/21/2010
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.

Episode 5: John Avellanet and Gawayne Mahboubian-Jones on Redefining Pharmaceutical Quality
06/07/2010
Gawayne Mahboubian-Jones, program manager for excellence in science and design with Philip Morris International, and consultant and former pharma CEO John Avellanet author of "Get to Market Now!" discuss what is needed to drive, and sustain, continuous quality improvement in the drug industry. Customer focus and C-level connection to quality and compliance will be key.

Focus on Pharma Episode 4: Maturing Biopharma: The Need to Do More with Less
04/28/2010
Eric Langer, Managing Partner of BioPlan Associates, discusses biopharma manufacturing's acute and chronic issues: Quality management, hiring and training figured among the issues, as did downstream processing.

Focus on Pharma Podcast: Episode 3: Inside the FDA and the New Transparency Initiative
03/11/2010
Accused of being too chummy with the drug industry, FDA has moved to improve transparency. CDER's Helen Winkle discusses the initiative's progress.

Podcast: Lucky and Good: Sourcing Success Is in the Details
03/09/2010
Michigan API manufacturer Ash Stevens' emphasis on clear communication and product quality has (along with good fortune) made it a home-grown success story with an international supplier and client base. Stephen Munk, President and CEO, shares secrets of sourcing success.

Focus on Pharma Podcast: Episode 2: Pharma Professional and Job Seeker Michelle Alton Cuts Through the Career Advice Clutter
02/24/2010
Today's life sciences job market is tough, and affecting strategic areas such as clinical development and R&D. Pharma professional Michelle Alton cuts through the conflicting career advice with tips on resume development, networking and a realistic, from-the-trenches view.

Focus on Pharma Podcast: Episode 1: Is Tech Transfer Broken? How Can We Fix It?
01/20/2010
We spend billions on drug development, yet precious few products make it to market. Could tech transfer be to blame? If so, why do so many companies get it wrong? In this first installment of our Focus On Pharma podcast series, sponsored by Thermo Scientific, tech transfer experts Stephen Perry, Russ Somma, Emil Ciurczak, and Paul McKenzie explore what’s broken with tech transfer, and how to fix it.

The Triple Bottom Line: A Strategy Tailor Made for Pharma
07/16/2009
CEO of Advanced Electron Beams, Mitch Tyson, discusses how pharma companies can strengthen their organizations, and their balance sheets, by adopting the TBL.

Podcast: This Is Not Your Father’s Coriolis: Flow Measurement Goes Micro
07/07/2009
We speak with Endress + Hauser’s Joerg Herwig about his company’s partnership with MEMS specialist Integrated Sensing Systems (Issys) and how E+H aims to take all of its products to the micro scale.

Podcast: Online TOC and Real-Time Release on the Global Stage
06/15/2009
In the second of this two-part series, Jonathan Yourkin, pharmaceutical market manager with GE Analytical Instruments, provides insight on navigating the subtle, and sometimes dramatic, differences between pharmacopeia and regulators in the U.S. and abroad in regards to the use of online TOC. Yourkin also shares best practices for applying TOC to PAT applications and real-time product release.

It’s Good to Be a Scientist: Life Sciences Job Market Holding Firm
05/28/2009
The turmoil in life sciences and merging of small- and large-molecule manufacturers only enhances the attractiveness of experienced scientists and engineers, says Kurt Moore, president of TalentWRx staffing agency. For those whose careers are in flux, making the most of a temporary position may open doors to something more permanent.

Puerto Rico 2.0: Repositioning an Industry to Restore a Competitive Edge
05/28/2009
No one needs to tell Puerto Rico the global pharmaceutical market has changed. The island is in the midst of a makeover that will focus on biotech, generics, and outsourcing its 40-plus years of expertise with the aim of keeping the island relevant to pharma. INDUNIV executive director Ivan Lugo talks strategy.

A World Beyond ICH: WHO, ISO Must Figure Prominently in Harmonization
05/28/2009
Regulatory harmonization has made great strides, but if efforts are to become truly global the World Health Organization must be involved. In this audio interview, Birgitte Holst, Manager of Manufacturing Science & Quality at Novo Nordisk, discusses pharmacopeia, terminology, anticounterfeiting, and more.

Maximize Uptime and Cycle Times with Rapid Microbial Methods
12/18/2008
Rapid Microbial Methods offer a much faster alternative to traditional plating to detect microbes in raw materials, in-process and finished goods. In this 15-minute audio interview, John Albright, Regulatory and Compliance Manager with Celsis, discusses the company’s Rapid Microbial platform, potential ROI and impact on capacity utilization and cycle times, as well as method validation.

Podcast: Pfizer’s Michael Arnold Visits the Pharma “Mother Ship”
11/04/2008
The place to be at ISPE was QbD—that is, the main discussion track at this year’s ISPE annual show in Boca Raton focused on developing QbD for investigational drug products. Pfizer’s global business supply head Michael Arnold witnessed it all, and shares his thoughts on China, FDA, Cost Reduction, and the “Mother Ship.”

ASQ's Don Singer on Pharma's Evolving Quality Systems
04/02/2008
In this audio interview, Don Singer, a Malcolm Baldrige National Quality Award Examiner and ASQ national director, certified specialist microbiologist and Six Sigma Green Belt discusses pharma's progress along the road to continuous quality improvement. Could a pharma company win the Baldrige Prize one day? Perhaps, but as Singer says, the journey is far more important than the destination. Benchmarking and connecting with experts from other industries, and adopting their best practices, is critical.

Analytical Instrumentation Qualification in a PAT/QbD World
03/14/2008
Cadrai partners John E. Carroll and Emil W. Ciurczak discuss integrating instruments and process sensors for PAT/QbD applications in this PAT course module.

Leveraging Real-time Demand Signals to Improve Operational Performance
03/12/2008
In pharma, everyone knows that what gets prescribed doesn’t match what gets shipped from the factory. Leading companies are using a combination of improved demand sensing and increased supply chain agility to improve operational performance. Learn how you can improve your company’s product availability while reducing inventory by leveraging recent developments in channel data and technology in this podcast by Edge Dynamics.

Rick Cooley on LC and Life After Lilly
02/14/2008
Rick Cooley, a PAT expert and leader of Dionex’s Center of Excellence, discusses online chromatography method development with Contributing Editor Emil Ciurczak.

“PAT Talk” with Jack Carroll and Emil Ciurczak
02/13/2008
In this pilot, taped at IFPAC, Cadrai partners Jack Carroll and Emil Ciurczak talk about PAT, QbD, and process analytics. Soon we’ll be moving to an interactive, call-in format for this program, and featuring it monthly.

Podcast: Trace the Truth of Pharmaceutical Anti-Counterfeiting
10/08/2007
In this podcast, Editor in Chief Agnes Shanley interviews Dr. Cedric Loiret-Bernal, CEO of Chicago-based NanoInk, Inc. about the promise his company’s nano-encryption technology holds for the pharmaceutical industry.

Podcast: Behind the Curtain at the AAPS Stability Testing Workshop
10/04/2007
Contributing Editor Emil Ciurczak interviews Saji Thomas, associate director for QC operations at Par Pharmaceuticals and the driving force behind the development of this workshop. They discuss the industry trends and conditions that necessitated such a workshop, and how Thomas secured buy-in from industry groups including AAPS, EAS, PhRMA, GPhA and CHP

Podcast: Wyeth’s PAT Progress in Puerto Rico
10/04/2007
Emil Ciurczak interviews Pedro Hernández-Abad, principal PAT specialist II at Wyeth’s Guaynabo, Puerto Rico facility, about how far the company’s PAT program has come since it began four years ago, and how the Guaynabo plant and the Pearl River (N.Y.) plant collaborate on PAT.

Mark McClellan on Pharma’s Role in U.S. Health Care System
09/25/2007
Speaking at a Sept. 19 conference at Glatt Pharmaceutical Services, former FDA Commissioner Mark McClellan reminded pharma manufacturing professionals why their work is a critical part of the national health care debate.

Podcast: Innovation vs. Efficiency
08/23/2007
Six Sigma leader and consultant Peter Pande responds to the ongoing debate on Six Sigma vs. Innovation.

Podcast: Generic Biologics
07/05/2007
A Senate committee has approved legislation to create an FDA regulatory pathway for generic biologics. Mary Agnes Carey, associate editor of CQ HealthBeat, comments on this recent activity.

Sandoz' Ajaz Hussain Addresses IFPAC 2007
02/08/2007
In this excerpt from his introductory remarks at IFPAC 2007, Dr. Hussain, former deputy director of FDA's CDER's Office of Pharmaceutical Sciences and a leader of the PAT movement, discussed the need to redefine specifications and quality to allow for continuous improvement.

Ram Sasisekharen on Systems Biology and Standardization
02/07/2007
In his plenary speech at IFPAC 2007, Dr. Ram Sasisekharen of MIT, a specialist in glycoengineering, discussed the need for standardization in techniques used for characterization, process understanding, and clinical trials. The technology already exists, he says, but must be used wisely.

USP's Gary Ritchie with an Update on PAT Standards Development
02/06/2007
Emil Ciurczak met with Gary Ritchie at the 2007 IFPAC conference to discuss the latest in standards development for process analytical technologies (PAT) at USP. Listen to the interview or read the transcript here.

Ciurczak Interviews Nasr on QbD and the Need for Robust Processes
02/06/2007
In this interview with Emil Ciurczak during IFPAC 2007, Dr. Nasr discusses Agency activities and challenges, and what we might see in the future.

Dr. Moheb Nasr's IFPAC Plenary Speech
02/06/2007
Here we provide a transcript and a two-part audio file of Dr. Nasr's keynote address at IFPAC 2007, in which he emphasized FDA's continued interest in PAT and its importance in a Quality by Design framework.

FDA's Chris Watts on New Directions for PAT at FDA
02/06/2007
In this interview with Emil Ciurczak during IFPAC, Dr. Chris Watts discusses pharma PAT and where it is going, within FDA and the industry.

CPAC's Mel Koch on Future Frontiers for Pharmaceutical PAT
02/06/2007

FDA's Janet Woodcock on PAT and The Critical Path
02/06/2007
In her keynote address at IFPAC 2007, FDA's Chief Medical Officer, Dr. Janet Woodcock, discussed the Critical Path Initiative, and PAT's role in improving the overall drug development and manufacturing process.

MIT's Dr. Ram Sasisekharen discusses PAT and Biopharma
02/04/2007

Janet Woodcock, FDA's Chief Medical Officer, on PAT, QbD and the Critical Path
02/04/2007

Duquesne University's Jim Drennan on PAT Calibration and Innovation
02/04/2007
Emil Ciurczak spoke with Professor Jim Drennan of Duquesne University on ISPE's Journal of Innovation and a new NIR spectroscopy calibration method.

TOC Talk with GE's Richard Godec
02/04/2007
Recently, there have been a number of changes at GE. Here, Emil Ciurczak chats with GE Analytical Instruments' Richard Godec about TOC analysis and its importance, as well as "the new GE."

Horiba's Lee Discusses Raman with Emil Ciurczak
02/04/2007
In this brief conversation at IFPAC 2007, Emil Ciurczak discusses Raman spectroscopy with one of Horiba's resident experts, Dr. Eunah Lee.

FDA's Moheb Nasr Discusses the Fine Points of Quality by Design at IFPAC
02/04/2007

FDA's Chris Watts on Standards and PAT within FDA
02/04/2007

CPAC's Mel Koch on PAT and the future of miniaturization
02/04/2007

FDA's Moheb Nasr Discusses QbD with Emil Ciurczak
02/04/2007

Ajaz Hussain introduces plenary speakers with reminiscences, shares new perspectives
02/04/2007

Podcasts from IFPAC: "Radio Free Emil"
01/29/2007
In these audio files, hot off the wire from the 2007 IFPAC Conference, Process Analytical Technologies expert Emil Ciurczak interviews leading PAT authorities from USP, FDA and the pharmaceutical industry.

Macher and Nickerson on Benchmarking Pharma and FDA
11/20/2006
Georgetown Professor Jeffrey Macher and Washington University Professor Jackson Nickerson discuss their extensive benchmarking project, which analyzed FDA regulation, in particular cGMP inspections, as well as industry manufacturing performance.

Pfizer's Warman and Pillai Lead AutomationXchange PAT Panel
08/31/2006
Pfizer's Jeff Miller, Martin Warman and Lou Pillai participated in a PAT Roundtable at AutomationXchange and hosted by Control magazine. Their mission, in large part, was to illuminate the differences between PAT and process analyzers.

Merck, Abbott, Genentech Address Success with Control, MES
06/22/2006
In the heat of Phoenix in June, hot topics at Honeywell's Users Group meeting included pushing process control to new levels and maximizing use of manufacturing execution systems.

Ciurczak Analyzes IFPAC '06
03/03/2006
NIR expert and Pharmaceutical Manufacturing columnist Emil Ciurczak discusses this year's conference in this downloadable audio file. For his article discussing highlights and key developments, see "IFPAC 2006 Under the Microscope."

Applying PAT to Vaccine Manufacturing
02/28/2006
In this audio interview at IFPAC, Mathieu Streefland of the Netherlands Vaccine Institute discusses the progress his group is making toward applying PAT to the unwieldy world of vaccine manufacturing.

VTT's Ralf Marbach on His New Calibration Method
02/04/2006
In this brief interview with Emil Ciurczak during IFPAC, Ralf Marbach discusses an alternative calibration method he developed at VTT in Finland.

Encapsulating Success
11/18/2005
High Point, N.C.-based Banner Pharmacaps is pushing the encapsulation envelope with veggie-based and anti-counterfeiting products, but manufacturing challenges abound, explains Aqeel Fatmi, Ph.D., global VP of R&D, in this exclusive Q&A.

Putting Nicotinic Compounds to Good Use along Tobacco Road
11/17/2005
R.J. Reynolds’ spinoff Targacept is the leader in using nicotinic compounds for therapeutic benefit. Bill Caldwell, VP of drug discovery and development, tells why and shares tech transfer secrets in this exclusive audio interview.

Operational Excellence: Straight Talk from BMS’ Wellemeyer
10/12/2005
How does a pharmaceutical manufacturing plant marked for closing transform itself into a corporate model (and home to Pharmaceutical Manufacturing’s 2005 Team of the Year)? Lean, 5-S and Factory Physics were all important, but people made the real difference. Listen in as John Wellemeyer, director of Bristol-Myers Squibb’s Indiana Technical Operations, shares best practices.

"What's In It for Me?" Taking PAT to the Executive Suite, Part 2
08/04/2005
In this audio interview at his offices in Dublin, Paraic O'Toole, CEO of Automsoft, talks about the issues affecting PAT's future. Instead of thinking "technology," he says, corporate executives should view PAT as a tool to improve share prices and profitability. PhRMA could play a far more active role in educating the top brass, and FDA support, at the Commissioner level, would speed PAT's adoption.

"What's In It for Me?" Taking PAT to the Executive Suite, Part 1
08/04/2005
In this audio interview at his offices in Dublin, Paraic O'Toole, CEO of Automsoft, talks about the issues affecting PAT's future. Instead of thinking "technology," he says, corporate executives should view PAT as a tool to improve share prices and profitability. PhRMA could play a far more active role in educating the top brass, and FDA support, at the Commissioner level, would speed PAT's adoption.

Grooming the Celtic Tiger for Drugmaking Dominance
07/22/2005
In this audio interview, Niall O'Donnellan, manager of life sciences and chemicals at Enterprise Ireland discusses developments in pharmaceutical manufacturing on the Emerald Isle. Enterprise Ireland is the government agency charged with stimulating entrepreneurship and the development of new companies in Ireland.