14Jun/06

BearingPoint Joins SAFE’s Vendor Partner Program

By Daniel R. Matlis

BearingPoint announced today that it will provide services to help pharmaceutical and healthcare organizations implement SAFE (“Signatures and Authentication For Everyone”)

SAFE is a network of recognized trusted healthcare professionals and an identity management standard and associated operating rules that deliver unique identity keys for regulatory compliant and legally enforceable digital signatures.

SAFE is designed for the purpose of simplifying, securing, and streamlining business-to-business and business-to-regulator information exchange. The SAFE standard consists of policies, procedures, guidelines, technical specifications and a legal and liability risk management framework for ensuring the validity of the electronic signatures used for information exchange and electronic submissions to regulators.

The SAFE standard promotes interoperability and integration among researchers, vendors, regulators, clinicians and other pharmaceutical and healthcare stakeholders.  It provides a secure, enforceable, and regulatory compliant way to verify the identities of parties involved in business-to-business and business-to-regulator electronic transactions.

As one of the world’s largest management and technology consulting firms, BearingPoint will add significant momentum to the SAFE initiative. After all, if there is one thing big consulting firms can do it’s to sell technology.

13Jun/06

FDA Task Force Report Recommends e-Pedigree in Distribution and Addresses RFID Issues

by Daniel R. Matlis

In a long awaited move, the FDA announced on Friday June 9th, that it will fully implement regulations related to the Prescription Drug Marketing Act of 1987, which requires drug distributors to provide documentation of the chain of custody of drug products — “pedigree” — throughout the distribution system.

Consistent with recommendations from the FDA Counterfeit Drug Task Force, the agency also announced that its enforcement of the pedigree regulations will focus on products most susceptible to counterfeiting and diversion.

FDA also announced the availability of a Draft Compliance Policy Guide for public comment describing this enforcement approach. By providing guidance on the types of drugs that are currently of greatest concern to FDA, the agency intends to give wholesale distributors a better idea on where and how to focus their initial energies to come into complete compliance with the regulations (21 CFR Part 203) for all the prescription drugs they distribute.

Additional subjects discussed in the Task Force’s report include the following key issues related to electronic track-and-trace that are in need of resolution:
 

  • Technical aspects of the mass serialization of marketed drugs by assigning a unique identifier or serial number to each drug package as the initial step in development of track and trace technology.
  • Importance of a nationwide universal drug pedigree with uniform information in preference to state laws imposing different pedigree requirements.
  • Protection of consumer privacy to prevent unauthorized disclosure of information stored in RFID tags when RFID-tagged drug products are dispensed to consumers.
  • Consumer education about RFID and the labeling of RFID-tagged drug products, to disclose to consumers when they are receiving RFID-tagged products and to inform consumers of the benefits of RFID technology and how consumers’ privacy is being protected.

The FDA has been busy providing guidance and direction on these important topics, now its time for the industry to move implementation into high gear.

 

13Jun/06

Convergence in Healthcare

By Daniel R. Matlis 

The Life-Sciences industry is undergoing a metamorphosis. Historically separate disciplines, like pharmaceuticals, devices, diagnostics, biotech, and even nanotech, are converging.

This trend will accelerate as personalized medicine and genetic therapies evolve. In the not to distant future, your Doctor will be able to target specific medical treatments to address your condition based on your unique DNA.

This shift to convergence medicine is already underway with the combination of traditional pharmaceuticals and medical devices.  Products like drug coated stents and antibacterial sutures are breaking down the traditional barriers in healthcare.

Today, pharmaceutical companies are looking to biotech firms for innovation and new ways to treat conditions.

Read more about this trend and my opinion on it in Chemicals to Cell Culture published in this month’s issue of Intech Magazine.

06Jun/06

FDA Issues Guidelines for Using Statistics in Device Trials Speak Now or Forever Hold your Peace

By Daniel R. Matlis 

Do you know that tense moment during the wedding ceremony, when the officiant says “speak now or forever hold your peace?” What happens if someone objects? Usually there are two outcomes, either the wedding is off or a brawl breaks out.

This is NOT one of those moments, and in this case, I would encourage you to speak your peace.

On May 23, 2006, 2 days after my son was born, The FDA released for comment a Draft Guidance for Industry and FDA Staff on the Use of Bayesian Statistics in Medical Device Clinical Trials.
 

This Guidance is part of the U.S. Food and Drug Administration (FDA) Medical Device Innovation Initiative. This initiative is aimed at making new medical devices available more quickly for patients.

“We must keep up with the rapid developments in science and technology to ensure that patients have access to the most advanced treatments available,” said FDA Acting Commissioner Andrew C. von Eschenbach, M.D. “By working with industry early in the evaluation process, we hope to foster development and speed up the approval of safe and effective innovative devices.” 

The Medical Device Innovation builds on the successes of MDUFMA and further modernizes the medical device review process in order to improve patient health and safety.

As part of this initiative, the Center for Devices and Radiological Health (CDRH) will expand current efforts to promote scientific innovation in product development, focus device research on cutting edge science, modernize the review of innovative devices, and facilitate a least burdensome approach to clinical trials.
In addition, this initiative includes:
 

  • Providing Regulatory Clarity Through Guidance Development
  • Investment in Critical Path
  • Conducting Stakeholder Outreach and Improve Communications
  • Laboratory Research to Support Efforts to Improve the Device Development Process
  • Implementation of a Quality Review Program
  • Leveraging Information Technology Solutions
  • Expanding Clinical and Scientific Expertise at FDA

The comments period expires 90 days from publication in the Federal Register announcing the availability of the draft guidance.

You can submit written comments (usually after checking with Legal and/or Compliance) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  You can also submit electronic comments http://www.fda.gov/dockets/ecomments. All comments should be identified with docket number 2006D-0191.

So this is your chance, Speak Now or Forever Hold your Peace.

Well, maybe not forever, but at least until the next guidance document comes along.

19May/06

Want to Buy a Bridge? The Promise of Service-Oriented Architecture

By Daniel R. Matlis  

This is an excerpt of my recently published article in Medical Product Outsourcing

Medical device companies have been implementing manufacturing information systems for more than 30 years. These systems were often part of automated manufacturing initiatives aimed at increasing product quality and lowering manufacturing costs.  For many years, device manufacturers have desired the ability to make production information, processes and resources more transparent. Companies have often looked for ways to unlock operational data to empower decision makers—from operators to plant managers and corporate executives—to make informed, timely decisions.

This level of integration has eluded companies…until now. Today, software manufacturers are moving away from proprietary systems and interfaces and are working together to develop open standards. These connectivity standards have lead to the development of a new class of software, known as middleware. This standards-based software enables the collection, analysis and presentation of critical, real-time data to decision makers throughout an organization. Known as Service-Oriented Architecture (SOA), this technology provides a bridge that allows for the connection of data islands in an efficient and effective manner.  Read the complete article