5AM Solutions, Inc., a life science technology firm, was recently notified that the American College of Medical Genetics and Genomics (ACMG), as part of its newly awarded five-year Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) contract extension for the NBSTRN Coordinating Center, has selected to continue its partnership with the company.

Core Informatics hosted its inaugural Launch 2013™ global user group meeting, in Cambridge, MA on November 19, 2013 with an advanced training session on November 20th. Launch 2013 provided the Core Informatics user community an opportunity to meet other users and exchange best practices, hear case studies from users across R&D industries, learn about the latest advances from Core Informatics for their LIMS, ELN and SDMS products and participate in a panel discussion on the Core Informatics suite and customer experiences.

The Bensalem Township Police Department, in conjunction with Bode Technology, is launching a new initiative in the field of DNA testing. This pilot program known as " BodeHITS - Rapid DNA " will be the first of its kind in the country for law enforcement.

This one's for the Food & Beverage Industry: We'll be taking a look into the passing of the Food Safety Modernization Act and how the FDA has significantly heightened the requirements for all companies who produce, manufacture, process, pack, transport, or hold food.

Agilent Technologies Inc. today introduced the latest version of its electronic laboratory notebook (ELN) software, OpenLAB ELN 4.2. This newly enhanced software enables scientists and laboratory managers to quickly and easily capture, reuse, manage and share scientific results obtained from virtually any analytical software application.

GoInformatics and TeselaGen have announced a strategic partnership to offer a state-of-the-art Biological Design Automation and Scientific Data Management platform. With a secure repository to collect, organize, and store research information, the integrated cloud-based platform will enable scientists advance their research at a much faster pace. The cutting-edge biodesign automation tools will provide biologists the ability to engineer cells to more efficiently carry out desirable operations, such as producing medications and vaccines, better seeds and feed options, and converting plant material into high value chemicals and fuels.

The webinar will discuss the do’s and don’ts for using social media in marketing FDA-regulated products. Common issues, misconceptions, perceptions, and possible solutions will be discussed. The presentation will to familiarize you with the current FDA rules and help you plan for developments expected in the near future.

This webinar will discuss the procedures that medical device companies need to follow to bring their product design history files up to date with the new standards.

Biomax Informatics AG will invest nearly 1 million Euro over the next 4 years to transfer its successful systems medicine approach from respiratory and chronic diseases to mental health. The European Commission is co-financing this step with €650,000 as part of the METSY project. In the project, Biomax will provide the knowledge management platform and data integration for consortium partners from industry, research and clinics who are searching for associations between psychotic disorders, lipid metabolism and metabolism-related diseases such as obesity and diabetes.

The Final Rule for the Physician Payment Sunshine Act (Sunshine Act) is out! New federal legislation governs relationships between physicians and medical device, drug, and biotech manufacturers. The Sunshine Act requires detailed reporting in 2014 of ''transfers of value'' made in 2013 to physicians and teaching hospitals as well as physician ownership in companies. The information reported will be made public by CMS (Centers for Medicare and Medicaid Services) and penalties for non-compliance are substantial.

SmartFreezer® 2.0, a high-volume, automatic storage freezer, enhances its version 1.0 functionality to provide a faster, more reliable system with new optional features. Now updated with FreezerPro® v6.1 software and finely tuned onboard robotics, the SmartFreezer® has improved barcode reading for more efficient retrieval. The update also features improved capacity to roughly 17,000 1.4 milliliter vials using dot codes or more than 10,000 2.0 milliliter vials utilizing barcodes (compatible with most common types/brands of vials).

Recognising both the importance and complexity of specifying a Laboratory Information Management System (LIMS) prior to purchase, Autoscribe has published a comprehensive (29 page) User Requirements Check List to help with the assessment of each LIMS vendor and to fully understand how each vendor meets the specific user requirements. Equally suitable for first time buyers and those looking for a replacement LIMS, this free document is available on request from www.autoscribe.co.uk/services/user-requirements.

Eight entrepreneurial start-up companies offering inventive new products and services have been named to SLAS Innovation AveNEW at SLAS2014, the Third Annual SLAS Conference and Exhibition, which will be held Jan. 18-22, 2014, at the San Diego Convention Center in San Diego, Calif., USA.

Mediware Information Systems, Inc., a provider of comprehensive cellular therapy software applications, announced today that Core 23 BioBank has licensed its Transtem Lab software to automate laboratory operations and simplify the donation process.

Simulations Plus, Inc., a leading provider of consulting services and software for pharmaceutical discovery and development, today announced that WuXi PharmaTech (NYSE:WX), China’s largest contract research organization (CRO), has obtained a multiyear license to ADMET Predictor

Cincinnati Children's Medical Center has partnered with Claritas Genomics, a company formed by Boston Children's Hospital and Life Technologies Corporation, to provide genomics-based diagnostics for pediatric patients. Cincinnati Children's will work with Claritas and Boston Children's to build a collaborative network to enable pediatric hospitals to share data, expertise, best practices and infrastructure in medical genetics and genomics for the benefit of patients.

This training on GCP regulations will help attendees understand the FDA and EU inspection process and how to prepare for both of them. Attendees will learn the best practices to respond to Form 483 citations, Warning Letters and EU inspection findings.

Course Description: This interactive two day seminar will cover the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States, as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway. his two day interactive course on European Clinical Trial Directive will cover: -Requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Directive (for Drugs, Biologics & Combination Products); -Recent updates on EU-GCP associated with the Directive; -Highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators; -Changes to the Clinical Trial Directive that are being contemplated and may receive modification.

Our 2013 summit will build on last year’s successful event. With double the number of tracks this year, the Immunogenicity Summit 2013 presents technologies for safety and efficacy from bench to bedside. For early stage decision making on drug design and optimization, we examine the causes of immunogenicity together with means of mitigation, and present PK/PD and bioassay strategies. For later pre-clinical and clinical stages, we examine the complexities of immunogenicity assays, bioassays and PK/PD development, and present risk assessment strategies for smooth interaction with the regulatory authorities, and safe and efficacious products in the clinic.

Wingspan announces that Actelion Pharmaceuticals, a top 20 biopharmaceutical company, has selected Wingspan eTMF as its official electronic trial master file. The company, based in Switzerland, outlined specific goals of the trial master file implementation including providing key management metrics, increasing inspection readiness, saving time, reducing costs and increasing eTMF quality.