How Overcoming the Challenge of Biomarker Validation Can Pay Off for Drug and Diagnostic Developers

DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c86274) has announced the addition of new Decision Resources report: How Overcoming the Challenge of Biomarker Validation Can Pay Off for Drug and Diagnostic Developers to their offering.

Introduction

Validating a biomarker is a resource-intensive undertaking. Is it worth it? We say, Yes. A biomarker that wins "known validated" status is best positioned for rewards: regulatory approval, optimal reimbursement, incorporation into personalized medicine The external links in this article or section may require cleanup to comply with Wikipedia's content policies. approaches alongside companion therapeutics, partnership and promotion opportunities, and wider awareness and uptake. Companies that recently began fielding biomarker-based tests are reporting success in terms of a revenue upswing. And they have laid the groundwork for validation of tomorrow's biomarker-based tools.

Get the Answers You Need to Shape Your Strategy

In December 2007, Panacea's LC Detect for early lung cancer lung cancer, cancer that originates in the tissues of the lungs. Lung cancer is the leading cause of cancer death in the United States in both men and women. Like other cancers, lung cancer occurs after repeated insults to the genetic material of the cell. diagnosis was named one of Time Magazine's Top 10 Medical Breakthroughs of 2007. What other biomarker-based tests are changing medical practice, and how?
- Validation is a key step in maximizing the clinical and commercial success of a biomarker. What is the validation process? What companies have successfully navigated it? What resources exist to facilitate the process?

- Validated biomarkers are the basis for several marketed companion diagnostics. Which products have received approval? How are these products faring? What tests are in development?

- For companies developing biomarker-based tests, a key strategy that taps the personalized medicine paradigm is to partner with drug developers. Which biomarker companies lead the pack? Which pharmaceutical companies have become involved in personalized medicine and drug/diagnostic co-development?

Scope

- About validated biomarkers: definitions, classifications, the value and process of validation.

- Types of biomarker-based tests: home-brew, de novo [Latin, Anew.] A second time; afresh. A trial or a hearing that is ordered by an appellate court that has reviewed the record of a hearing in a lower court and sent the matter back to the original court for a new trial, as if it had not been previously heard nor decided. , in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment.
in vi·tro
adj.
In an artificial environment outside a living organism. diagnostic multivariate assay, therapeutic area focus (oncology is a leading area), technology focus (nucleic-acid testing, or NAT (Network Address Translation) An IETF standard that allows an organization to present itself to the Internet with far fewer IP addresses than there are nodes on its internal network. , is emerging as the key approach). Tables detail FDA-approved validated biomarkers and those in trials to achieve validation.

- Case studies: Genomic Health's Oncotype DX Oncotype DX™, created by Genomic Health, is a diagnostic test that quantifies the likelihood of disease recurrence in women with early-stage breast cancer and assesses the likely benefit from certain types of chemotherapy. and Agendia's Mammaprint.

- Biomarker development environment: recent approvals, reimbursement challenges, supporting consortia.

- Where is the pay-off?: company profiles, revenue trends, industry outlook.

Companies Mentioned:

- Affymetrix

- Agendia

- Biosite

- Cepheid

- Chugai

- Dako

- Eli Lilly Eli Lilly can refer to:

* Eli Lilly and Company, a global pharmaceutical company
* Colonel Eli Lilly (1839-1898), founder of Eli Lilly and Company
* Eli Lilly (industrialist) (1885-1977), former president of Eli Lilly and Company
*



- Exagen Diagnostics

- Fujirebio Diagnostics

- Genentech

- Genomic Health

- Genzyme Genetics

- GlaxoSmithKline

- Immunicon

- Kudos Pharmaceuticals

- LabCorp

- Merck

- Myriad Genetics Myriad Genetics is a leading biopharmaceutical company focused on understanding the relationship between genes, proteins and human diseases in order to develop the next generation of therapeutic and molecular diagnostic products.

- Nanosphere

- Novartis

- Panacea Pharmaceuticals

- Pfizer

- Prometheus Therapeutics & Diagnostics

- OSI Pharmaceuticals

- Roche

- Roche Diagnostics

- Siemens Medical Solutions Siemens Medical Solutions (Siemens Med) is a supplier to the healthcare industry, and is headquartered in Erlangen, Germany. Its U.S. division, Siemens Medical Solutions USA, Inc., is a Delaware corporation, with headquarters in Malvern, Pennsylvania.

- Third Wave Technologies

- Vanda Pharmaceuticals

- Ventana Medical Systems

- Veridex

- VTT VTT Technical Research Centre of Finland
VTT Valtion Teknillinen Tutkimuskeskus (Finnish: Technical Research Centre of Finland)
VTT Vélo Tout Terrain (French: mountain bike; aka ATB or MTB)

- Vysis

- Wyeth

For more information visit http://www.researchandmarkets.com/reports/c86274.

Pharmaceutical equipment procurement and validation services offered by Business Biotics Group

Business Biotics Group offers pharmaceutical equipment procurement The fancy word for "purchasing." The procurement department within an organization manages all the major purchases. and validation services for pharmaceutical and biotech bi·o·tech
n. Informal
Biotechnology.

biotech
Noun

short for biotechnology

Noun 1. companies. Business Biotics Group validates the quality of new medical and pharmaceutical equipment in the market through professional monitoring techniques. Business Biotics Group evaluates the medical equipment for pharmaceutical manufacturing and engineering standards. Business Biotics Group provides reliable and cost effective medical equipment procurement and validation services for government hospitals and research institutes. Business Biotics Group uses advanced equipment and strategies for its inspection and validation projects.

Business Biotics Group helps pharmaceutical product manufacturers in launching their new product or equipment to a wider market. With over years of experience in the project management and control industry, Business Biotics Group offers reliable and efficient service to its clients in the medical and pharmaceutical product manufacturing industry.

Business Biotics Group conducts technical analysis and factory acceptance testing (programming) acceptance testing - Formal testing conducted to determine whether a system satisfies its acceptance criteria and thus whether the customer should accept the system.
..... Click the link for more information. procedures for validating the quality of new pharmaceutical equipment or product in the market.

Hitachi Enters Pharmaceutical Validation Services Market

TARRYTOWN, N.Y. -- Hitachi America, Ltd., a subsidiary of Hitachi, Ltd., (NYSE NYSE

See: New York Stock Exchange :HIT) today announced that it is entering the market for pharmaceutical validation services through the acquisition of Validation Masters, Inc. (VMI VMI Virginia Military Institute
VMI Vendor Managed Inventory
VMI Vertical Motion Index
VMI Valtakunnan Metsien Inventointi (Finnish: National Forest Inventory)
VMI Video Module Interface
..... Click the link for more information.,) a premier validation services company. Terms were not disclosed. The acquisition of the company is designed to augment and enhance Hitachi's capabilities to provide total services to its clients in the pharmaceutical industry. The acquisition also makes the Hitachi Group Hitachi Group (Hitachi Gurupu) is a group of companies that uses the Hitachi name, which includes Hitachi Ltd. Hitachi Heavy Industries, etc. See also

* Hitachi


..... Click the link for more information. the first company to have active operations in both the U.S. and Japanese pharmaceutical services markets, enabling Hitachi to provide truly global services.
VMI will be incorporated into Hitachi America's Pharmaceutical Services Group and be known as Hitachi Validation Services. Paul Damurjian, president and founder of VMI will head the new unit and continue to execute current and future validation projects with proven and streamlined efficiency. He reports to Vito Cappello, P. E. director of the Pharmaceutical Services Group of Hitachi America. The new unit will be based at Hitachi offices in Basking Ridge, N.J.

In making the announcement, Masahide Tanigaki, executive vice president of Hitachi America said, "The acquisition of VMI is indicative of the strong synergy which exists between Hitachi and VMI. The company's experience and capabilities, dedication to quality, flexibility and client service are the paramount elements of our customers' requirements. VMI brings these key elements to our Pharmaceutical Services Group. We intend to maintain the local focus and competitiveness while providing our clients with the potential of utilizing the broad technical, process, engineering and manufacturing, and financial strength of Hitachi."

The company said that the validation scope of services will include Validation Master Plan Development along with Equipment, Facility and Computer Systems Qualification. Additionally, Environmental Monitoring, Cleaning Validation The introduction to this article provides insufficient context for those unfamiliar with the subject matter.
Please help [ improve the introduction] to meet Wikipedia's layout standards. You can discuss the issue on the talk page.
..... Click the link for more information., Vendor Auditing and Validation Project Management services will be offered.

Hitachi Pharmaceutical is a global total solutions provider. Hitachi is dedicated to working in partnership with its global clients in order to bring future market product requirements to successful fulfillment by offering a total project solution with integrated, seamless services and products that include pilot plant and process simulation software Simulation software is based on the process of imitating a real phenomenon with a set of mathematical formulas. It is, essentially, a program that allows the user to observe an operation through simulation without actually running the program.
..... Click the link for more information., conceptual/basic/detailed engineering, worldwide procurement, construction, validation and final acceptance, project financing Project financing

A form of asset-based financing in which a firm finances a discrete set of assets on a stand-alone basis. , process and utility equipment supply and fabrication fabrication (fab´rikā´shn),
n the construction or making of a restoration. and modularization facilities.

Hitachi has had a major presence in the Asian pharmaceutical industry since 1948. Hitachi has provided "total project solutions" to more than 200 bulk and bio-pharmaceutical projects including grassroots, revamp and expansion of commercial and research facilities related to mammalian cell culture, microbial microbial

pertaining to or emanating from a microbe.

microbial digestion
the breakdown of organic material, especially feedstuffs, by microbial organisms. culture, chemical synthesis In chemistry, chemical synthesis is purposeful execution of chemical reactions in order to get a product, or several products. This happens by physical and chemical manipulations usually involving one or more reactions.
..... Click the link for more information., fill and finishing, pilot plants and R&D. For further information on Hitachi's validation services, customers and prospects can call 908.605.2770 or visit www.validationmasters.com.

Hitachi America, Ltd., a subsidiary of Hitachi, Ltd., markets and manufactures a broad range of electronics, computer systems and products, and consumer electronics, and provides industrial equipment and services throughout North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere.
..... Click the link for more information.. For more information, visit http://www.hitachi.us.

Hitachi, Ltd., (NYSE:HIT) (TOKYO:6501), headquartered in Tokyo, Japan, is a leading global electronics company with approximately 347,000 employees worldwide. Fiscal 2004 (ended March 31, 2005) consolidated sales totaled 9,027.0 billion yen ($84.4 billion). The company offers a wide range of systems, products and services in market sectors including information systems, electronic devices, power and industrial systems, consumer products, materials and financial services The examples and perspective in this article or section may not represent a worldwide view of the subject.
Please [ improve this article] or discuss the issue on the talk page. . For more information on Hitachi, please visit the company's website at http://www.hitachi.com.

Redefining Pharmaceutical Process Validation

FDA's new process validation guidance spells out the new rules for process validation. In this webcast, industry experts discuss the guidance, what it means to manufacturers, how to apply a Six Sigma approach to validation and how to apply new principles to improve a legacy product.

For Jim Agalloco's presentation, "FDA’s Guidance for Industry Process Validation: Impact Assessment", click here.

For Bikash Chatterjee's presentation, "Building and Tailoring a Lean Six Sigma Approach for Validation Processes", click here.

For FDA/CDER's Joseph C. Famulare's presentation, "Process Validation – Key Areas Leading to 483’s", click here.

For NNE Pharmaplan's Line Lundsberg-Nielsen's presentation, "The Impact of FDA’s Proposed Process Validation Guidance on Quality by Design for Legacy Products", click here.

For additional information on our upcoming webcast series, click here.

Pharmaceutical Process Validation: An International Edition

Book Description
The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.

Book Info
Stevens Institute of Technology, Hoboken, NJ. Details strategies to establish appropriate validation protocols and conduct process validation assignments, monitor and test specific manufacturing processes for compliance with design limits, and more.

Validation Standard Operating Procedures

Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries

Book Description
Ideal for pharmaceutical, medical device, and biotechnology industries, Validation Standard Operating Procedures guides design engineers, manufacturing personnel, researchers, and quality control professionals in validating processes needed for non-aseptic and aseptic pharmaceutical production. This second edition provides 131 ready-to-use master validation procedures, template protocols, and reports. With 14 exclusive environmental performance evaluations, it features 57 new protocols on such topics as sterility assurance, media fill guidelines, and environmental control. It also includes a CD-ROM with a template of customizable validation standard operating procedures.

Book Info
(St. Lucie Press) Outline provides information managers need to establish functions, acceptance criteria, and validation procedures in compliance with FDA guidelines. Includes directions for translating GMP requirements into action and describes how to establish test functions and prevent defects. CD contains 74 template procedures.

Pharmaceutical Master Validation Plan

Book Description
This book provides the tools to more easily achieve satisfactory inspections, new medical product approval, minimize non-conformance, reduce rework and rejected lots, and avoid recall lots by developing and managing a Master Validation Plan. The accompanying CD provides a template that can be customized to incorporate additional regulatory requirements specific to individual companies worldwide. Together, the book and CD contain everything required to develop and execute a successful Master Validation Plan based on FDA guidelines for the pharmaceutical industry, and allows the templates to be extended to diagnostic products, medical device, medical equipment, and biotech industry products.

Book Info
(St. Lucie Press) Provides a generic format for a Master Validation Plan using a pharmaceutical manufacturing site with sterile and non-sterile operations as the case facility. Provides a road map for validation to establish FDA requirements/procedures, validation programs, protocols, and resource planning and scheduling. DNLM: Drug Industry--standards.