FROM THE EDITOR
Supply Chain Management Of Temperature-Sensitive Products At Novartis: Advice From An Expert
Gone are the days when pharma can depend on blockbuster drugs to carry them to financial heights; instead, successful pharmaceutical companies are taking a different approach and looking to demand to determine their next step in drug development and supply chain management. For Novartis’ Michael Trocchia, this demand has resulted in a new role as the Global Supply Chain Lead for Cell Therapy Products. In this article, he discusses the challenges associated with managing the supply chain for a temperature-sensitive product and what best practices he applies in order to contribute to Novartis’ ability to maintain a top spot in big pharma.
OUTSOURCED PHARMA WEST CONFERENCE & EXHIBITION
A Witness To The History of Outsourcing
Joe Guiles seems too young and mild-mannered to have been at the outbreak of a revolution that began many years ago. But he witnessed firsthand the inception of what would become the complete penetrability of outsourcing throughout the drug industry.
PHARMA MANUFACTURING INSIGHTS
How To Reduce The Complexity And Mitigate Risk In Qualifying Active Temperature Controlled Systems
Every shipment of life science products is precious cargo, not only to the shipper, but to the patient at the end of the chain. That transportation process must be strictly qualified to ensure that the product is not lost to damage or spoilage.
The Road To A Culture Of Quality
Lately, I’m having a lot of conversations about the culture of quality and continuous improvement. While it seems like everyone wants a culture of quality, the problem seems to be that we don’t understand how to create it. The first piece is to understand the drivers. Without them, the culture won’t change. Even with them, achieving cultural change takes time and requires effort—it doesn’t just happen, you have to work at it.
Dealing with Packaging Complexity: Tips 1 to 4
By Stephen McIndoe, VP Consulting, Be4ward
In my previous article, I introduced the concept of packaging complexity, where the growth in the product portfolio results in a substantial rise in packaging components and an associated reduction in packaging line efficiencies. In this forthcoming series of articles, I am going to look at some steps you can take to manage or cope with this challenge.
Rouge & Biofilm: Compounding Cleaning Challenges
Rouge may facilitate the development of more tenacious biofilms. Both rouge and biofilm represent cleaning and decontamination challenges to manufacturers. By Michael Gietl and Paul Lopolito
Electronic Drug Accountability Systems: Ensuring Compliance, Safety, And Data Integrity In Clinical Trials
By Stefan Duerr, Associate Director Of Project Management, Cenduit
Clinical trial sites, both foreign and domestic, have been subjected to an increasing number of FDA audits in recent years. Federal investigators cite non-compliance with federal drug accountability regulations as one of the most common problems found in site audits.1,2 A failed site audit is a serious problem for a clinical trial, leading to costly delays, non-approval of the investigational drug, or criminal liability.2,3 Ensuring compliance with federal regulations is key to the success of a clinical trial and the entire drug development program.
PHARMA CONTRIBUTING EDITORS
Are Regulators Providing The Right Quality Incentives?
If you want to get a horse to move, there are two schools of thought on how to get it done. One says stand behind the animal with a stick and hit it until it does what you want. This method is not the most humane, and would not do much to endear you to the horse. The other approach says hold a carrot in front of the horse, and get it to move of its own volition. The carrot would be a reward to the animal for doing the right thing.
Looking at this situation in a different context, we all want quality outcomes in pharmaceutical manufacturing facilities. Good manufacturing practices will provide safe products to patients, prevent injury to workers, and minimize or eliminate plant shutdowns, which can ultimately lead to drug shortages. Guy Villax, CEO of CMO Hovione, believes the FDA and other regulatory agencies have many tools at their disposal that can be used to hit manufacturers for poor quality practices. In the future, he would like to see the oversight agencies make more use of carrots to get manufacturers producing to the standards that would benefit the entire industry.
Patheon Surfs Outsourcing Waves And Scoops Up Gallus Along The Way
Jim Mullen, CEO of Patheon parent company DPx Holdings B.V., is at it again.
On the heels of my three-part series with Mullen on the details behind the springtime merger of his company and the pharmaceutical products division of Royal DSM, he has made his next move.
This time it is a strategic entrée into the U.S.-based market for biologics services via an acquisition of privately held Gallus BioPharmaceuticals. With Gallus, Patheon adds new capabilities at well-established sites with name-brand clientele, in St. Louis, Mo. and Princeton, N.J., to its global locations in Groningen, the Netherlands and Brisbane, Australia.
When To Invest In Protein Production: The Risk-Reward Calculation
A message to biotech start-ups, scientist-entrepreneurs and life sciences organizations banking on your exciting protein-based drug-discovery programs and technologies: When it comes to the timing of your investment, if you don’t pay now, you might pay (much) more later.
Industry Insights From The Executive Director Of Compliance At Seattle Genetics
Kristin Rand always had a fascination with questions science had not yet answered, and she developed an interest in genetics while still in high school. She obtained an undergraduate degree in the Diagnostic Genetic Sciences program at UCONN. FDA law and bioethics were the focus of her graduate degree in law, and she later earned a master degree in industrial-organizational psychology.
After serving in various positions at Wyeth and Genentech, she landed at Seattle Genetics, where she currently serves as executive director of compliance. In this piece she discusses trends in pharma compliance, and challenges companies can expect to face in 2014 and beyond.
Pharmaceutical Customers In An Outsourcing Provider Merger -- Part 3 Of Interview With CEO of Newly Formed DPx Holdings B.V.
This final article in our series featuring Jim Mullen, CEO of newly formed DPx Holdings B. V., discusses how to keep the focus on customers during M&A activity, and the broader transformation of sponsor–provider relationships in the pharmaceutical outsourcing industry.
PHARMACEUTICAL ONLINE VIDEOS
Introduction to Pharmaceutical Bag Filling and Sealing Equipment
Umbra bag filling and sealing machinery for all sorts of dry products in the food, pharmaceutical, chemical, and agricultural industries. A single Umbra packaging machine can fill bags of any material with varying fill weights and with different closure techniques, providing an extremely versatile solution to customers looking for high flexibility.
What Is mHealth? Video
AT&T mHealth Solutions are on the cutting edge of transformation in healthcare and offer solutions that enable health enterprises to engage patients, improve outcomes and lower costs.
AT&T mHealth Platform Video
The AT&T mHealth Platform enables enterprises and developers to rapidly develop, launch and scale enterprise and patient centric healthcare solutions. By providing a comprehensive infrastructure for the sharing of health information across healthcare enterprises, patients, and clinical professionals in a highly secured environment designed to meet HIPAA and HITECH security and privacy requirements.
PTI Inspection Overview Video
Video overview of PTI’s non-destructive inspection solutions for leak detection, seal integrity, package integrity and container closure integrity testing. We manufacture technologies ranging from high voltage leak detection (HVLD), vacuum decay, to airborne ultrasound.
Real-Time Information On Microbial Contamination In Pharma Cleanrooms
The BIOTRAK® Real-Time Viable Pharmaceutical Particle Counter from TSI provides real-time information on microbiological contamination in pharmaceutical cleanrooms.
Warehouse Monitoring: Medical/Surgical Supply Distributor Improves Efficiency And Compliance
Owens & Minor, Mechanicsville, VA, is a leading U.S. supplier of medical and surgical products to hospitals, integrated healthcare systems, alternate care locations, and the federal government.
SP Scientific, Inc., is a manufacturer of equipment serving the pharmaceutical, biotechnology, educational, industrial, and OEM markets. Products are sold under well-known, market leading brand names.
Sartorius Intec is a globally operating premium provider of industrial weighing and control equipment. Our product solutions are used throughout the entire manufacturing process for products, ranging from incoming goods inspection to production, to final quality control and logistics. Sartorius Intec high-quality measurement and inspection equipment, such as high-capacity load cells, checkweighers, metal detectors and industrial scales. Among our division’s major customers are, in particular, the food, chemical and pharmaceutical sectors and the basic industry. Especially in the sector of process tank and hopper weighing, our company ranks among the world's leading suppliers.
Model N, Inc.
Model N is the pioneer and leading provider of Revenue Management solutions for the Life Sciences and Technology industries. Our solutions enable our customers to maximize revenue and reduce revenue compliance risk by transforming their revenue life cycle from a series of tactical, disjointed operations into a strategic, end-to-end process.
PHARMACEUTICAL ONLINE SUPPLEMENTS
The Information Source for the Pharmaceutical Manufacturing Industry
Welcome to Pharmaceutical Online, the premier sourcing site for the pharmaceutical manufacturing industry, find industry information on critical environment, particle sizing, pharma process control, pharma material handling, tablet production, pharma sterilizing, pharma cleaning, pharma filtration, pharma packaging, pharma inspection, & much more. Use our product showcase, and offline search service to expedite your discovery of new products and services. Our goal is to help buyers, like you, identify and select suppliers.
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PHARMA EXPO 2014
As the highly anticipated November debut of Pharma EXPO approaches, we’ve developed this resource center for our readers to access the most relevant information about the event.
UPCOMING TRAINING COURSES
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LIFE SCIENCE WEBINARS
Aseptic Management of the Sterility Testing Process
Get the latest information on the aseptic management of the sterility testing process and find out some key insights into best practices.
Common Misconceptions in Freeze-Drying: Part Two
This is the second of two presentations addressing some of the most common misconceptions in freeze-drying (lyophilization) relating to formulations, process cycles, equipment and scale-up.
Overcoming Analytical Method Development Challenges: Analysis Of Nonclinical Dose Formulations From hERG Studies
This webinar is about overcoming analytical method development challenges with analysis of nonclinical dose formulations from hERG studies.
PHARMA INDUSTRY INTERVIEWS
Serialization: Not Just Compliance, But Competitive Advantage
Todd and Todd interviewed Aiden Corcoran, CEO of Team Horizon, about some of the lessons learned in serialization and packaging and the ways the company applies these lessons to benefit its customers.
The Emergence Of The “Flex Factory”
On day two of Interphex, Todd and Todd interviewed Jack Giese, the director of commissioning and validation at Finesse Solutions.
The Impact Of Color Labeling Solutions On Tracking And Patient Safety
At Interphex 2014 Kelly Ng, product manager in healthcare with Epson discusses regulatory factors that have caused the labeling process to become more complex.
09.18.14 -- FDA News Roundup: Astellas, Sanofi Pasteur, Orexigen, And More
09/18/14 Pharmaceutical Online Newsletter
09.16.14 -- Acadia Drug Named Breakthrough Therapy; Lessons Learned: 10 Years Of Tech Transfers
09/16/14 Pharmaceutical Online Newsletter
09.11.14 -- FDA News Roundup; Novartis To Present New Data For MS Drug Gilenya
09/11/14 Pharmaceutical Online Newsletter
2nd Annual Congress of the European Society for Translational Medicine & Global Network Conference on Translational Medicine (EUSTM-2014)September 22 - 25, 2014