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Outsourcing4BioPharma Newsletter October 2011 

Outsourcing4BioPharma’s Preferred Client Discount Program Now Available!  

Many thanks to all the Participanting Providers in their recognition of our Client Members for their Preferred Client Discount Program.

A number of Service Providers are now offering up to 20% discount on their services to our Clients, including Screening Assays, Pre-Clinical Development, Clinical Trials and Development, Manufacturing and Custom Synthesis, Consulting Services, and Material Sourcing.
 
Please send your service inquiries to info@Outsourcing4BioPharma.com for our outsourcing specialist to put you in contact with the Participating Providers.
 
New participants are welcome. If you are a Service Provider and would like to learn more about this program or to join it, follow the link to “Expansion of Outsourcing Opportunities at Outsourcing4BioPhamra.” There are no fees to join the Preferred Client Discount Program.         
 
We look forward to working with you in further expanding the outsourcing opportunities.
 
Management,
Outsourcing4BioPharma.com
                                                                                                                                                         

                                                                                                             
FEATURED PRESENTATIONS OF THE MONTH
 

Use of Please Review™ for IACUC Protocol Review and Member Training Documentation    

The ability to document Institutional Animal Care and Use Committee (IACUC) member training is a unique function necessary in today’s compliance-driven environment. The majority of IACUC protocol management software systems require customization, significant lead time, and changes to existing protocol templates. Some have minimal to no ability to document IACUC member training. Absorption Systems sought a readily available, cost-effective, Web-based system that focused only on document review.  A solution was found in PleaseReviewTM, a hosted, Web-based document review system that tracks changes, comments, and responses made by multiple reviewers and authors. 

Click Here For Presentation.

Jeff Lyons 
Absorption Systems
www.absorption.com



FDA Pre-IND Meetings: Why, When and How 

The pre-IND phase of drug development is the foundation upon which all development-related activities (including registration) depend.  It is, therefore, essential to give proper forethought and attention to this initial, all-important step of the drug-development process.  In the United States, a pre-IND meeting can add considerable value to the overall process and maximize efficient use of both Sponsor and FDA resources.  Although pre-IND meetings require considerable planning and preparation on the part of both the Sponsor and FDA, if warranted and properly conducted, the meeting can provide the Sponsor with valuable insight as to the FDA’s expectations regarding initial- and later-stage development and registration strategies.  This presentation provides a high-level introduction to U.S. FDA pre-IND meetings─why and when a Sponsor should consider having a meeting and how the Sponsor approaches the process.   

Click Here For Presentation.

Grace M. Furman, PhD DABT
CEO & President, Paracelsus Consulting
http://www.ParacelsusConsulting.com


    

FEATURED COMPANIES OF THE MONTH

Absorption Systems
 Absorption Systems focuses on performing assays that can predict the Absorption, Distribution, Metabolism, and Excretion (ADME) of small molecules using a variety of in vitro, in situ, and in vivo models. Absorption Systems supports these assays with state of the art bioanalytical capabilities and preclinical formulation services.
ceetox.com

CeeTox, Inc. leads the field of in vitro safety testing for the pharmaceutical, fragrance, personal care, cosmetic, chemical, and cleaning product industries. Worldwide demand to eliminate animal testing led CeeTox to adapt its robust, multi-parameter approach to meet the needs of cosmetic and chemical manufacturers. CeeTox has developed a range of in vitro screens that offer alternatives to animal tests in support of regulations such as REACH and Amendment 7 to the Cosmetics Directive                                                      

Paracelsus Consulting
Paracelsus offers a wide range of consulting services in toxicology, pharmacology pharmacokinetics/ADME and regulatory affairs.  
calvertlabs.com

Calvert Labs is a highly respected contract research organization specializing in the discovery and development of potential pharmaceuticals. In addition to lead identification and lead optimization services, Calvert Labs provide a wide array of preclinical services in virtually all classes of compounds and offer capabilities in the performance of studies to support the safety evaluation of drugs, biologics, proteins, peptides, gene therapy compounds, monoclonal antibodies, and other chemicals, as well as devices.                                               

To list your company; publish articles/white papers; advertise career opportunities, contact us at
outsourcing4biopharma.com.  
itrlabs.com
ITR Canada provides preclinical testing services for the pharmaceutical and biotechnology industries. As a CRO, with extensive experience, we provide you with valuable input and best practices, which ultimately help you maximize the value of your research investment. We deliver on time project reporting that meets your company's goals.

HIGHLIGHTS FROM REGULATORY AGENCIES                    

     

REGULATORY GUIDELINES UPDATES

FDA

EMA

   

HIGHLIGHTS IN DRUG DEVELOPMENT                                  


HIGHLIGHTS IN CONTRACT RESEARCH
 

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