I am quite sure concatenating multiple compound buzzwords for the title of this article violates multiple grammatical rules, but Real-time Cloud-based Supply-Chain-Intelligence solution for Quality Management is the best way to describe Camstar’s acquisition of SigmaQuest.

Last week, Karim Lokas, Vice President of Product Strategy for Camstar Systems and Nader Fathi, CEO of SigmaQuest briefed me on the deal. A provider of SaaS (Software as a Service) Supply Chain Intelligence solutions for product quality management, SigmaQuest serves the Medical Device, High-Tech, Clean-Tech, A&D and Telecom industries.

Camstar has been a key player in Manufacturing Operations Management, providing Manufacturing Execution System (MES) software to leading Medical Device organizations as well as other discrete industries.

MES has been a critical supporting improved product quality in highly regulated industries. MES is well suited in the command and control structures, often found in Medical Device manufacturing. However, this approach has severe limitations outside the corporate four walls. As Medical Product manufacturing began to shift to outsourced models, MES systems struggled to attain visibility and control over suppliers, assemblers and contract manufacturers.

Combining the rigid “command and control” capabilities of MES with the ubiquitous presence of Cloud-based Supply-Chain-Intelligence will enable Global Medical Product Manufacturers to realize the cost and agility benefits of global supply networks while ensuring product quality and safeguarding their brand’s reputation.

The addition of SigmaQuest’s Cloud-based offerings to Camstar’s strong capabilities will enable Brand owners to deliver high quality, innovative products on time, the first time, every time. This is a revolutionary step for the Medical Product industry.

The combination of Camstar-SigmaQuest into a single platform will enable Brand owners to close the loop across the complete supply chain, by providing visibility, control and actionable intelligence, regardless of supply and manufacturing strategies (in-house, outsourced).

FDA is working with its international regulatory partners and Industry stakeholders to identify and implement measures aimed at ensuring the integrity of the Global Supply Chain.

Have you shared your input?

In its latest report to the President and Congress, IPEC recommends that FDA mandate the use of electronic track and trace for pharmaceuticals and medical products in an effort to secure the Global Supply Chain.

Share your perspectives on ways to gain visibility, control and security of Global Supply Chains by completing this short survey (approximately 10 min.) at the following this link: http://www.surveymonkey.com/s/Globalsupplychainstudy

This is your last chance to provide your input on Global Supply Chain.  

The Survey will close on Friday, July 16th

All respondents will be eligible to receive a complimentary copy of this Axendia Research Report.

To learn more about this research on Global Supply Chains, visit: http://axendia.com/blog/global-supply-chain/

The Challenges associated with the globalization of manufacturing and supply chains in Life-Sciences were again brought to the forefront at last week’s FDA/Xavier Global Outsourcing Conference (GOC).

“Global Supply Chains Strain FDA’s Traditional Model” noted FDA’s Brian Hasselbalch during his Keynote during the GOC Conference. Mr. Hasselbalch works at the Division of Manufacturing and Product Quality, Office of Compliance at FDA’s CDER.

“The agency wants to hold sponsor companies more accountable for flaws in manufacturing processes of outside contractors both in the U.S. and abroad, and for certifying that contractors have followed FDA drug-making standards,” Marla Phillips, founder of Med-XU and the conference’s director told the Wall Street Journal.

According to Mr. Hasselbalch presentation slides, the Agency is working to address the strains associated with Medical Product Globalization Trends including:

• More foreign facilities supplying the U.S.
  • Most drug manufacturing facilities are not located in the U.S.
  • The number of non US facilities is growing
• Increasing volume of imported products
  • Over 80% Active Pharmaceutical Ingredients come from outside the U.S.
• Greater complexity in manufacture and supply
•  Shipments outside import system
  • Rogue wholesalers / brokers
• Imports involving countries with less developed regulatory systems
  • Unregistered firms
  • “Shadow” firms

To identify key initiatives Life-Science companies are undertaking to address the issues raised by FDA; Axendia has launched a research study titled: “Global Supply Chain Visibility and Security; Business Necessity, Regulatory Imperative”.

To provide your input on this critical issue facing the industry, please complete a short survey (approximately 10 min.) by following this link:

http://www.surveymonkey.com/s/Globalsupplychainstudy

All respondents will be eligible to receive a copy of the Axendia’s Research Report once it is completed.

We look forward to your contribution.

The globalization of manufacturing and supply of Life-Science products has created unique and demanding challenges for the industry and regulators alike.  To identify key trends, requirements and initiatives Life-Science companies are undertaking to gain deeper visibility and controls over Global Supply and Value Chains, Axendia, Inc is conducting a research study: ”Global Supply Chain Visibility and Security; Business Necessity, Regulatory Imperative”.
 
To this end, the research team is seeking responses from individuals representing the broad spectrum of companies in the Life-Sciences industry - including organizations of all sizes, across geographic regions, and representing the broad range of Life Science products (including suppliers, manufacturers and distributors of Pharmaceuticals, Medical Devices, Diagnostics and Biotech products). 

To provide your input on this topic and to assist us in the research process, we would like to ask that you complete a short survey (approximately 10 min) by following this link: 

Global-Supply-Chain-Research-Study 

(http://www.surveymonkey.com/s/Globalsupplychainstudy)

Axendia Launches Life Sciences Global Supply Chain Research Study

The globalization of manufacturing and supply of medical products has created unique and demanding challenges for the Life Sciences industry and the U.S. Food and Drug Administration alike.  In light of recent adverse events, Industry and regulators are preparing to take significant steps to secure the Global Supply Chain.

Axendia, Inc., today announced that it has launched a research study entitled, “Global Supply Chain Visibility and Security; Business Necessity, Regulatory Imperative”.   This research seeks to identify and analyze trends, requirements, and initiatives Life-Science companies are undertaking to gain deeper visibility and controls over Global Supply and Value Chains.

The study will focus on:

• Assessing current and desired states of Life Science supply chains
• Identifying key challenges facing global and outsourced ecosystems
• Outlining innovative strategies and system to enable and guide this transformation
• Provide a roadmap to achieve Global Supply Chain Visibility and Security

Axendia researchers will seek insight from industry leaders and regulators on innovative strategies and technologies, enabling supply chain visibility and security, risk mitigate, and increased business success.

The results of this study will be presented in a report detailing current and best practices in Global Supply Chain Visibility and Security in Life Sciences. The research report will include tables and charts supporting research findings. Axendia will conduct the study research, analysis and report, and retain full editorial control.

I recently had the opportunity to chat with Tom Lentz at The Johns Hopkins Hospital. Tom is Manager of IT and Finance for the Facilities Department at Hopkins.

During our discussion, I shared Axendia’s research and analysis on “Lowering the Cost of Healthcare from Inside Out”. We also discussed current pressures facing healthcare providers including the need to improve clinical outcomes and reduce costs, while ensuring compliance with a applicable regulations. In addition, the proliferation of Medical Technologies has created a new level of complexity and risks for Healthcare organizations.

To respond to these new challenges, healthcare providers are seeking ways to effectively manage a sophisticated mix of clinical, biomedical and facilities systems and equipment.

During our session, Tom discussed how The Johns Hopkins Hospital uses its Integrated Asset and Service Management system to:

• Improve uptime to support patient care
• Control costs for procurement, maintenance, labor and materials
• Support regulatory compliance and reporting activities
• Improve internal controls with automated workflows
• Gain efficiencies by mobilizing asset management

You can participate in our conversation with Tom Lentz from The Johns Hopkins Health System, by attending our upcoming IBM / Axendia Webcast on May 18, 2010 at 9:00 AM PT / 12:00 PM ET.

To register visit: https://event.on24.com/eventRegistration/EventLobbyServlet?target=registration.jsp&eventid=201849&sessionid=1&key=76A9806CBA8B4D4E34E12787C2F454B3&partnerref=IBM02&sourcepage=register

This webcast is the second installment in our series “Lowering the cost of Healthcare from Inside Out”. You can view the inaugural webcast in this series on-demand, by visiting: http://LSP.axendia.com/2010/01/27/lowering-the-cost-of-healthcare-from-inside-out/

I hope you can join our discussion next week.

One of the last remaining perks of a transcontinental flight is the ability to put on a set of noise cancelling headsets, listen to your favorite tunes and read through a hefty 600 plus page volume. I chose the 604 page Fiscal Year 2011 Food and Drug Administration Justification of Estimates for Appropriations Committees.

As I ploughed through this “engaging material”, I noticed that FDA’s 2011 Budget Justification includes a 400 Million Dollar investment in information technology (IT). Through this funding, FDA will continue to expand the adoption of Agency-wide systems supporting the transformation of nearly every aspect of Agency operations and regulatory duties.

The budget justification identified the following Agency-wide systems for use by ALL FDA centers and offices:

Regulated Product Submission (RPS) will provide a standard framework for receiving regulatory information using predefined parameters for the more efficient identification and cataloging of submitted information.

Janus will establish FDA-wide data architecture and standards that will ultimately convert and store scientific data from external and internal sources into a structured format that can be used throughout FDA.

The Common Electronic Document Room (cEDR) will establish a single, FDA-wide repository for all FDA-regulated documents and provide an end-to-end electronic environment from the receipt of product pre-market application information through its review, approval, and post-market surveillance to achieve a more efficient review and surveillance process.

Harmonized Inventory (HI) will provide a complete and reliable inventory of firms, facilities, products, and components/ingredients, as well as their relationships and points of contact for all FDA regulated products.

MedWatch Plus will provide an integrated system for receiving, processing, storing and analyzing adverse event reports and other safety information for all FDA regulated products.

FDA Advisory Committee Tracking and Reporting System (FACTRS) will provide a fully electronic system to support advisory committee meetings and management of meeting information, people, and reporting capabilities.

 As we revealed in Axendia’s “FDA e-Transformation” whitepaper, the agency is implementing 21st century IT systems and infrastructure. This modernization will create a robust foundation to enable interoperability of regulatory data and support information sharing across the FDA centers and program areas. Shared systems will support agency-wide activities ranging from pre-market review for all regulated products to post-market surveillance, including adverse event detection and future scientific computing capabilities.

Are you ready for the 21st Century FDA?

Last week, FDA Commissioner Dr. Margaret Hamburg formally announced the deployment of PREDICT–the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting.

“PREDICT is an exciting innovation that harnesses advances in information science to enable us to do our job better and to improve our service to the nation” said Dr. Hamburg. “But it is just one step. More broadly, we are moving from a system that places most of the regulatory burden on the FDA’s modest inspection force, to one that creates greater oversight at points further back along the production chain” she added.

The system was piloted in Los Angeles and is currently going online in New York. FDA’s targets to have PREDICT up and running around the country by late Spring 2010.

PREDICT is a sophisticated information technology system developed for use by border inspection operations. The system allows FDA inspectors to monitor products at the port of entry more reliably and to target shipments for inspection that pose the greatest risk.  It utilizes Analytics and Business Intelligence tools to rank product shipments according to risk. Based on these assessments, it decides which shipments should be checked upon arrival.
The System enables FDA inspectors to spend more of their time looking at the highest-risk items. PREDICT will by automatically flag potentially risky shipments as well giving lower risk scores to materials that are more innocuous and those products with good FDA compliance histories.

To make these decisions, PREDICT takes into account information on:

• Product manufacturer
• Manufacturing site location
• Inspection site of manufacturing facilities
• Manufacturer’s level of supply chain accountability
• Criticality of final products marketed

This is especially important give that FDA-regulated products marketed in the US are manufactured in more than 300,000 foreign facilities in over 150 countries around the globe.  This year, nearly 20 million shipments of food, devices, drugs, and cosmetics will arrive at U.S. ports of entry.

“I can assure you that addressing the problem of global supply chain safety, and shifting the existing paradigm from reaction to prevention, is one of my highest priorities for FDA”  said Hamburg. “Refining our understanding of the problem and exploring and assessing possible solutions will be a major focus of our work over this next year and well beyond.”

As we identified in our “FDA eTransformation Initiatives” research study, the Agency is making significant investments in Information Technology to support its mission. PREDICT is another leap forward on FDA’s shift from a model that places most of the regulatory burden on its inspection force, to one that creates greater oversight further back along the supply chain.  The use of Analytics, Business Intelligence and Information Technology takes FDA’s “Risk Based Approach” to a higher level.

See a video of PREDICT in action

The FDA is requesting $4.03 billion to promote and protect public health as part of the fiscal year 2011 budget. This represents a 23 percent increase over the agency’s current $3.28 billion budget and includes a $146 million increase in budget authority and $601 million in industry user fees.

According to FDA Commissioner Margaret A. Hamburg, M.D. “The FY 2011 resources will strengthen our ability to act as a strong and smart regulator, protecting Americans through every stage of life, many times each day. This budget supports the ability for patients and families to realize the benefits of science that are yielding revolutionary advances in the life and biomedical sciences.”

The budget request reflects commissioner Hamburg’s resolve to transform food safety practices, improve medical product safety, protect patients and modernize FDA regulatory science to advance public health. This budget also funds FDA’s new regulatory authority over cigarettes and other tobacco products.

According to the agency, four initiatives are the major highlights for the FY2011 budget increases:

Transforming Food Safety (+ $318.3 million)
The Transforming Food Safety Initiative reflects President Obama’s vision of a new food safety system to protect the American public. The FDA will set standards for safety, expand laboratory capacity, pilot track and trace technology, strengthen its import safety program, improve data collection and risk analysis and begin to establish an integrated national food safety system with strengthened inspection and response capacity.

Protecting Patients (+ $100.8 million)
The Protecting Patients Initiative advances the Obama Administration’s priorities for safe, quality health care for all Americans. The resources in this initiative will support the safety of drugs, devices, and vaccines, as well as the Nation’s blood supply. The FY 2011 resources will also strengthen the FDA’s ability to act as a strong and smart regulator to address medical product safety challenges in the years ahead.

Advancing Regulatory Science (+ $25.0 million)
Advancing Regulatory Science builds on President Obama’s commitment to harness the power of science for America’s benefit. During the past two decades, extraordinary investments have led to revolutionary advances in the life and biomedical sciences. Many key discoveries, however, have yet to translate into real therapies for patients. The FY 2011 budget will allow the FDA to begin to strengthen its core scientific capacity. This investment will allow the FDA to identify improved pathways to product development and approval for new technologies that offer promising new opportunities to diagnose, treat, cure and prevent disease.

Tobacco (+ $215.0 million)
An increase in tobacco user fees will allow the FDA to continue to implement the Family Smoking Prevention and Tobacco Control Act. Preventing youth from using tobacco and helping Americans quit, promoting public understanding of the harmful constituents of tobacco products, developing the foundation of science for regulating tobacco, and regulating tobacco to reduce the toll of tobacco-related disease, disability and mortality are tobacco program priorities for FY 2011.

In our December 2009 article “What to Expect from FDA in 2010“ I stated that time would tell how the FDA’s current vision would affect industry and consumers. It is evident that through this budget request, Commissioner Hamburg is seeking the resources needed to achieve her vision for the FDA as a Public Health Agency. As she stated shortly after she took office, FDA’s role is to “Minimize Risks Through Education, Regulation, and Enforcement.”

The complete FDA FY2011 budget is available at: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM199447.pdf

Healthcare providers are under more pressure than ever to improve clinical outcomes and reduce costs, while ensuring compliance with a myriad of applicable regulations. The proliferation of Medical Technologies has created a new level of complexity and risks for Healthcare organizations.

To meet these sometime divergent objectives, Healthcare providers must find ways to effectively manage a sophisticated mix of clinical, biomedical and facilities systems and equipment.

At the same time, healthcare administrators are looking for opportunities to maximize service delivery while managing the costs associated with these increasingly complex assets. Integrated Asset Management can help hospitals reduce costs, increase efficiencies and improve the quality of patient care.

To examine these issues and offer recommendations, IBM in cooperation with Axendia are proud to present a webcast entitled “Lower the Cost of Healthcare from the Inside Out”.

During this session, we discuss:

• Key business technology and regulatory trends facing the industry
• Ways to leverage the latest Asset Management solutions to improve care while controlling costs
• How healthcare organizations around the world have lowered the cost of healthcare from inside out using Asset Management solutions

To view this on-demand event, visit:
http://event.on24.com/r.htm?e=183331&s=1&k=E0A8E272CA5064F03BEDE54501F93BD5