FedEx® Deep Frozen Shipping Solution now part of BIO Business Solutions

BIO Business Solutions® has teamed up with FedEx to now include specialized deep frozen shipping solutions to member companies. The FedEx® Deep Frozen Shipping Solution provides innovative liquid nitrogen dry vapor technology via a cryogenic dewar along with end-to-end shipment monitoring and visibility. Specifically suited for preserving the integrity of biogenics, this solution provides up to 10 days of holding time at temperature ranges down to -150˚C. The solution offers member companies several advantages:

  • Keeps tissue samples and substances deep-frozen at -150°C
  • Provides up to 10 days without need for dry ice or power
  • Meets International Air Transport Association (IATA) requirements for both infectious substances (UN3373) and non-infectious clinical samples
  • Eliminates inventory of insulated boxes and dry ice
  • Provides advanced tracking and proactive monitoring via FedEx Priority AlertTM.
  • FedEx provides end-to-end solutions to help your temperature sensitive products maintain optimum temperature while in transit across the nation or across the ocean.

Member Benefits

Discounted Flat Fee of $435 for Domestic or $750 for international shipment

Enrollment

To enroll in the FedEx® Deep Frozen Shipping Solution, click below:

More Information

For more information on FedEx® Deep Frozen Shipping Solution, call 1-888-370-3971

FedEx® Deep Frozen Shipping Solution Case Study

Read the case study below to learn how Cenetron Diagnostics was successful using the FedEx® Deep Frozen Shipping Solution to cost effectively transport and track temperature sensitive clinical trial shipments and to learn how businesses like yours are taking advantage of powerful integration solutions with FedEx. As a reminder, FedEx Web Services allows you to integrate FedEx® shipping, tracking, rating, address validation, reporting tools, and more, directly into your website.

Read more here: Cenetron_Case_Study.pdf

Eligible Affiliates

All AZBio and BIO members are eligible to utilize the BIO Business Solutions® program with FedEx.

Opportunity Alert: ECONOMIC RESEARCH ANALYST at ACA

The Arizona Commerce Authority is seeking an economic research analyst to join its top-notch research team in Phoenix. The ACA’s mission is to grow and strengthen Arizona’s economy and facilitate the creation of quality jobs in the state by supporting and attracting businesses in targeted, high-value base sectors. The research team compiles and analyzes economic data to assist in business attraction, business development and business retention.Continue reading

Sign Up for the Alzheimer’s Prevention Registry

alzheimers prevention registry


Launching a research study often takes years of work, and most of the effort occurs behind the scenes. The exciting news is that several of these studies have just launched or are close to being ready to start recruiting participants through the Alzheimer’s Prevention Registry. And more studies will launch in the coming years. Here is a snapshot of a few of the studies that will be taking place in the United States and other countries around the world:

  • A trial in 1000 adults ages 65-85 who have evidence of amyloid plaque build up in their brain based on a screening PET scan, and  who are at risk for Alzheimer’s disease but are still cognitively healthy to determine whether an experimental medication may delay cognitive decline
  • A trial in nearly 6,000 adults ages 65-83 to learn about the genetic risk for developing mild cognitive impairment due to Alzheimer’s disease and whether an experimental medication might delay the symptoms
  • Two trials in a rare, hereditary form of early-onset Alzheimer’s with experimental medications to determine if treatment delays cognitive impairment
  • And many more.

Imagine having tens of thousands of volunteers awaiting an e-mail from the Registry announcing that a study is ready to begin enrollment in their communities.  Researchers could quickly screen and fill their enrollment sites in a matter of weeks or months, not years. Saving this precious time means we get to answers faster.
This is why the Alzheimer’s Prevention Registry will play a vital role in these and other prevention trials.

Take action:   While researchers work to get these and other studies ready, you can help by continuing to encourage your friends and family to sign up for the Registry.

 

 

FTC Seeking Public Comment on Follow-On Biologics

The Federal Trade Commission (FTC) is seeking public comment on follow-on biologics.

In addition, the FTC will hold a public workshop on December 1oth.

The Follow-On Biologics Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition

The  Federal Trade Commission announces it will hold a workshop to explore  competition issues involving biologic medicines and follow-on biologics. As  described in the Federal Register Notice, the workshop will focus on a few key  issues, inter alia:

  • The potential impact of state regulations affecting competition.
  • How regulations, if necessary, might be structured to facilitate competition  while still protecting patient health and safety.
  •   How naming may affect competition.
  • The experience of other countries with follow-on biologic competition.

The  Federal Register Notice poses a series of questions about which the FTC seeks  public comment. The FTC will take these comments into account in its  examination of these topics.

Previous Biologics Workshops and Report:

Event Details

WHEN:

December 10, 2013 Time: 9am – 5pm

WHERE:

FTC Conference Center

601 New Jersey Avenue, NW

Washington, DC

Learn more at http://www.ftc.gov/opp/workshops/biologics/#nj

Opportunity Alert:Medical Director at Celebration Stem Cell Centre

celebration stem cell

 

Celebration Stem Cell Centre, an AABB accredited and FDA registered public and private cord blood bank located in Gilbert, AZ is actively seeking a Medical Director.

Candidates must be a licensed physician that is qualified by training or experience in bone marrow and cord blood transplantation.  The Medical Director shall have responsibility and authority for all medical activities related to procurement, processing, and provision of the cellular therapy products and related services and to ensure that these activities are compliant with AABB, FDA and NMDP requirements.  The Medical Director will work closely with the current Laboratory Director and Quality Director in respect to the following responsibilities:

  • Review and approval of Standard Operating Procedures (SOPs)
  • Review of Nonconforming Products
  • Medical Review of donor records and test results prior to product release
  • Review of Proficiency testing results
  • Review of validation data of new processes/procedures
  • Review of Processing data when applicable
  • Participation in Quarterly Quality Meetings
  • Participate in Continuing Education Relevant to cord blood

All qualified individuals are encouraged to apply for this position.  Please send a copy of your C.V. and cover letter to info@csccaz.com.

November and December Deadlines for Small Business Cancer Technology Grant Funding Opportunities

  Funding for Companies Developing Innovative Technologies that Improve Molecular and Cellular Analysis of Cancer – November 4 deadline
  2013 HHS SBIR & STTR Omnibus Solicitations for Investigator-Initiated Projects – December 5 deadline
  Funding for Innovative Health IT and Single-Cell Analysis ToolsDecember 5 deadlines
  Before You Submit: Registration Requirements for SBIR/STTR Applications
  Technical Assistance Available for Phase I Awardees – Niche Assessment Program re-opened October 28
The Small Business Innovation Research & Small Business Technology Transfer (SBIR & STTR) Programs are government set-aside programs that represent one of the largest sources of early-stage technology financing in the United States. The National Cancer Institute (NCI) SBIR/STTR Programs are designed to catalyze the development of innovative technologies and therapeutics to advance cancer research, prevention, detection, and treatment.

In FY2014, the set-asides reserved for small businesses have increased from 2.5% to 2.7% for SBIR and 0.35% to 0.40% for STTR. Please note the budget caps for the specific funding opportunity you are applying for, as they cannot be exceeded. We encourage you to review the opportunities below and consider applying for funding to the NCI SBIR & STTR Programs. NCI SBIR Development Center Program Directors are available to discuss ideas and opportunities with you.

 
Funding Opportunity: Innovative Molecular Analysis Technology Development for Cancer Research and Clinical Care (SBIR-IMAT, PAR-13-327)

Full FOA: Innovative Molecular Analysis Technology Development for Cancer Research and Clinical Care (PAR-13-327)
Upcoming Receipt Dates: November 4, 2013; May 28, 2014

The SBIR-IMAT funding opportunity is aimed at accelerating the development and commercialization of highly innovative technologies that improve molecular and/or cellular analysis of cancer with a significant likelihood for either overcoming persistent challenges or obstacles or opening entirely new fields for cancer research or clinical care. This Program Announcement complements the goals of the NCI’s Innovative Molecular Analysis Technologies (IMAT) Program by facilitating a path towards technology commercialization. Prior participation in the IMAT Program is not required for eligibility for this FOA. Applications are expected to indicate the significant attributes and advantages of the proposed technology over currently available technologies and conventional approaches.

A non-exclusive list of product examples relevant to this funding opportunity are available at: http://sbir.cancer.gov/funding/technology/.

Additional Resources Available
To learn more, please click here to download slides from an SBIR-IMAT pre-application webinar. An audio recording and transcript from the webinar are also available for download.

 
 
2013 Omnibus Solicitation

Funding is available to support small businesses working across a wide range of cancer-related research topic areas through the NIH SBIR & STTR Omnibus Solicitations, investigator-initiated grant funding opportunities. The next deadline to submit applications is December 5, 2013.

SBIR Program
PA-13-234, Re-issue PHS 2013-02 Omnibus Solicitation of the NIH, CDC, FDA and ACF for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])

STTR Program
PA-13-235, Re-issue PHS 2013-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42])

The 2013 Omnibus Solicitations expand eligibility and impact the application process, so please read the solicitations carefully.

  • Small business concerns that are majority-owned by multiple venture capital operating companies (VCOCs), hedge funds and/or private equity firms are eligible to apply to the NIH SBIR program and compete for up to 25% of NIH’s SBIR set-aside.
  • All applicants are required to register at the SBA Company Registry prior to application submission and attach proof of registration. See below for the full list of registration requirements for submitting SBIR/STTR applications to HHS.
 
 
Upcoming Funding Opportunity Deadlines

The NCI SBIR & STTR Programs have grant funding opportunities available in a wide range of cancer-related topic areas to help small businesses advance their research concepts towards commercialization. The grants below share the deadline of December 5, 2013. Don’t miss your chance to apply!

SBIR Program

  • PA-12-196, Innovative Health Information Technology for Broad Adoption by Healthcare Systems and Consumers (SBIR R44)
    For more details and examples of applicable projects, click here.
  • PA-13-140, Development of Highly Innovative Tools and Technology for Analysis of Single Cells (SBIR R43/R44)

For a complete listing of funding opportunities from the NCI SBIR & STTR Programs, please click here.

 
 
Registration Requirements Prior to Submitting SBIR/STTR Applications to HHS

If you are considering applying for an SBIR/STTR award, check that your registrations are all completed.

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide prior to submitting an application to be eligible to apply for or receive an award. Registration can take six weeks or more, so applicants should begin the registration process as soon as possible.

If you have difficulties with the submission process, please contact the eRA Commons helpdesk: Toll-free: 1-866-504-9552; Email: commons@od.nih.gov.

 
 
Niche Assessment Program for NIH SBIR/STTR Phase I Awardees – Applications reopened October 28

 
How to Apply
For resources and tips for applying, please click here.

Please visit http://sbir.cancer.gov/ to learn more about the NCI SBIR & STTR Programs.

SEC Releases Crowd Funding Rules for Non-Accredited Investors Under the JOBS Act.

On October 25, 2013, The Securities and Exchange Commission (SEC) released the Proposed Rules to govern the implementation of crowd funding by non-accredited investors under the JOBS Act.   Comments will be open for a 90 day  public comment period from the date that the proposed regs appear on the Federal Register. (As of this writing, the proposed regs have not yet been posted.) Continue reading