FROM THE EDITOR
FDA Outlines Upcoming Regulatory Changes And Urges Industry To Be Proactive And Transparent
While reviewing upcoming changes heading industry’s way through regulatory legislations, such as the Food and Drug Administration Safety and Innovation Act (FDASIA) and the Drug Supply Chain Security Act (DSCSA), during her keynote session at Pack Expo 2014, Ricki Chase, director of investigations for the FDA’s Chicago office, urged the audience to not just focus on product integrity, but also personal and corporate integrity.
OUTSOURCED PHARMA WEST CONFERENCE & EXHIBITION
Why We Took A Different Approach To Planning A Conference
Like you, I have attended a lot of educational events and conferences over the years. I’m sure we both could list some that were unique, valuable, and memorable while others could be simply categorized as “been there, done that.” And since time is my most precious resource, the last thing I want to do is spend this ever-diminishing asset on attending — or planning — a conference that’s just like all the rest.
PHARMA MANUFACTURING INSIGHTS
Global Outlook For Medicines Through 2018
By Murray Aitken, Executive Director of the IMS Institute
In this report we provide an outlook on the use of medicines and spending levels through 2018. We take a global view of the markets for all types of pharmaceuticals, including small and large molecules, brands and generics, those dispensed in retail pharmaceutics as well as those used in hospital or clinic settings. We frame the size of the markets based on pricing information available to us and used to estimate manufacturer sales with a consistent methodology over time. In this report we have also sought to size the magnitude of the impact of various confidential rebates, discounts, taxes or other adjustments that affect the net amounts received by manufacturers.
Dealing with Packaging Complexity: Tips 9 to 12
By Stephen McIndoe, VP Consulting, Be4ward
In my previous article, I discussed the next four tips on managing packaging complexity. In this next article, I look at tips 9 through 12. The first two continue on the theme of how to control non added-value complexity, and the second two start the theme of how to cope with added-value complexity.
Standardized Extractables Testing Protocol For Single-Use Systems In Biomanufacturing
General requirements for Extractables and Leachables (E&L) are already mandated by regulatory agencies.1-2 Biopharmaceutical companies must meet these requirements in demonstrating equipment suitability and GMP compliance whether the equipment is of traditional design or single-use. By Weibing Ding, Gary Madsen, Ekta Mahajan, Seamus O’Connor, and Ken Wong
New Perspectives On Consumer Health In Pharmerging Markets
By Andy Tisman, Global Senior Principal, Consumer Health at IMS Health
The global market for consumer medicines (over the counter medicines, OTC) is worth $111 billion in sales and continues to demonstrate strong growth potential, with growth over 5% in the latest year. Pharmerging countries are at the forefront of this robust growth, fuelled by higher out-of-pocket expenditure, favorable demographic trends and a growing and increasingly prosperous middle class. In these markets, distant from the corporate headquarters of multinational companies, OTC is growing faster than in mature markets, and consequently has a
larger share of the total healthcare market.
Shipping Qualification: What Is It And Why Is It Necessary?
Shipping qualification is a process which demonstrates that a product will be both physically and thermally protected throughout the entire shipping process. It requires documented testing for each segment of a shipment including, transfer of the product from controlled temperature storage, shipping container packout, transport of the product and delivery of the shipment.
PHARMA CONTRIBUTING EDITORS
The Challenge Of Managing Regulatory Submissions & Correspondence
Life science organizations produce large volumes of documents necessary for submitting applications to regulatory agencies. They need to have records of those documents as well as all related communications from sites around the world. This creates a situation that can be rather daunting.
Sponsors must first make sure all documents are going through the proper review and approval cycle and that controls are in place to meet regulatory requirements such as 21 CFR part 11. Once the documents are published and ready for submission to the regulatory agency, they are typically stored on a file share. Although that file share has access controls in place, it will not have granular-level access controls.
ISPE Releases Drug Shortages Prevention Plan At Annual Meeting
ISPE has released its Drug Shortages Prevention Plan at a media conference held during its annual meeting at Caesars Palace in Las Vegas. Present at the conference were new president and CEO John Bournas, strategic advisor John Berridge, and Drug Shortage Prevention Plan leaders Joe Famulare, Paul D'Eramo, Donna Gulbinski, and Sam Venugopal.
ISPE Set To Address Drug Shortages At Annual Meeting
Drug shortages continue to plague the pharmaceutical industry. According to a GAO report on shortages, dated February 2014, the number of shortages continues to increase in the U.S., as well as around the world. In 2007 there were 154 shortages, 114 new shortages and 40 ongoing from a prior year. In 2012, there were 456 shortages, 195 news ones and 261 ongoing. As of June 30, 2013, there were already 73 new shortages and 288 ongoing.
The public health importance of these shortages cannot be overemphasized. Shortage situations have included zinc for parenteral nutrition in neonates and premature infants, doxorubicin for ovarian and other cancers, and Propofol for anesthesia.
Clearly something needs to be done. “ISPE believes efforts to address this complex and multi-faceted problem of drug shortages requires close collaboration and clear communication between the pharma industry and global health authorities,” says Francois Sallans, VP and chief quality officer for Johnson & Johnson, and presenter at the 2014 ISPE-FDA CGMP Conference. “We believe The Drug Shortages Prevention Plan being assembled by ISPE will provide guidance to pharma and global health authorities to manage drug shortages more effectively. But more importantly we are looking into ways for the two groups to manage these shortages more proactively as well. That is an important component that we need to have in place in order to make these shortages rare, but short-lived.”
What Can You Learn From The Educational Planning Process Of BIO?
In my role as the 2015 co-chair of the BIO International’s educational planning committee, I am privy to what goes into creating one of our industry’s largest annual events. As many of you are involved in organizing your own customer educational programs (e.g., The Emerson Exchange) or have been asked to serve on an event planning committee, I thought a behind the scenes look into how BIO goes about the process would be helpful to your efforts. Here are some of the best business practices I have witnessed thus far.
Innovation In Clinical Trials: Is It Time To Change The Paradigm?
“People hate change. This is true in the life sciences industry and everywhere in the world. I think it’s a major, major problem.”
That statement, by Glen de Vries, president of Medidata, seems to sum up the challenge many have with trying to bring down the cost of clinical trials. To bring down costs we need to implement new, efficient, and available technologies. Unfortunately implementing new technologies involves change, which many people in this industry do not seem to want to embrace.
Hopefully, that attitude may soon be changing. One of the trends de Vries has seen in the past year is a focus on innovation originating at the executive level. More managers, especially those in the C-suite, are saying we need to figure out how to do things differently.
PHARMACEUTICAL ONLINE VIDEOS
Global Study Reveals The future Of Temperature Control Packaging
Sonoco ThermoSafe, a leading global provider of temperature assurance packaging, has revealed the results of its survey entitled “Assessing the Future of the Cold Chain Industry.” The survey highlights forward-looking trends in areas that significantly impact the cold chain industry – including environmental, trends, logistics and products and services. The survey’s 165 respondents spanned more than 20 countries and five continents.
Introduction to Multivariate Data Analysis
Brad Swarbrick, Vice President of Business Development at CAMO Software, gives a short introduction to multivariate data analysis, discusses some of its applications and how these powerful analytical tools are being used to improve products and manufacturing processes in a wide range of industries.
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.
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.
Documentum Life Sciences Strategy: Helping Customers Achieve Better Solution Value And Cloud Flexibility
Life Sciences organizations are grappling with increasingly stringent regulatory requirements, globalization, pricing pressures and skyrocketing costs. The EMC Documentum for Life Sciences Solution Suite helps organizations address these challenges and meet compliance requirements, increase productivity, and securely collaborate across the extended enterprise.
Brookfield Engineering Laboratories, Inc. Brookfield is the world's leading manufacturer of viscometers and rheometers for the pharmaceutical industry. The rotational method of viscosity measurement enables complete flow curve characterization for pharmaceutical materials.
3M Purification (formerly CUNO) core filtration technologies address the most demanding applications in pharmaceutical processing for small molecule and active pharmaceutical ingredient (API) applications.
AT&T Inc. (NYSE:T) is a premier communications holding company and one of the most honored companies in the world. Its subsidiaries and affiliates – AT&T operating companies – are the providers of AT&T services in the United States and internationally. With a powerful array of network resources that includes the nation’s fastest and most reliable 4G LTE network, AT&T is a leading provider of wireless, Wi-Fi, high speed Internet, voice and cloud-based services.
Weiler Engineering, Inc.
Weiler Engineering is America's leading provider of aseptic Blow/Fill/Seal liquid packaging machines for pharmaceutical and healthcare applications
PHARMACEUTICAL ONLINE SUPPLEMENTS
The Information Source for the Pharmaceutical Manufacturing Industry
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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
1pm-2:30pm EST, Online Training
1pm-2:30pm EST, Online Training
1pm-2:30pm EST, Online Training
1pm-2:30pm EST, Online Training
1pm-2:30pm EST, Online Training
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
Common Misconceptions About Pharma Track And Trace
At Pack EXPO, Oliver Wyrsch, SBU Head Vision Inspection, Mettler-Toledo PCE, highlights the organizational work that needs to done in order to align software, technology, and personnel during the implementation of Track and Trace.
Focus Less On Complicance For An Optimal Manufacturing Process
At Pharma EXPO 2014 Bob Chew, President, Commissioning Agents, Inc was interviewed to discuss the obstacles manufacturers are facing to develop an optimal process
Combating Pharmaceutical Counterfeiting And Diversion
In an interview at Pharma EXPO 2014 Steve Wood, CEO & President, Covectra - a company that delivers Serialization and Track & Trace solutions using AuthentiTrack and BLIS.
Synergy Between The Pharma And Food Industry
In an interview at Pharma EXPO/Pack EXPO 2014 Kate Achelpohl, Director, Member Communications, PMMI talks about how anyone along the supply chain in the packaging industry can get the most from the show.
11.20.14 -- Standardized Extractables Testing Protocol For Single-Use Systems In Biomanufacturing
11/20/14 Pharmaceutical Online Newsletter
11.18.14 -- Product Safety In The Pharmaceutical Supply Chain; Dealing With Packaging Complexity
11/18/14 Pharmaceutical Online Newsletter
11.13.14 -- Anatomy Of A GMP Vendor Qualification Program; FDA News Roundup
11/13/14 Pharmaceutical Online Newsletter