Category Archives: Opportunities

FTC Seeking Public Comment on Follow-On Biologics

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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

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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

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  • 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 Tools – December 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.

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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→

Help AZ develop a 21st Century Workforce

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To address the current and future needs to develop a 21st Century Workforce, Arizona State University is teaming with the Maricopa Community Colleges and other 2-year schools in Arizona to establish educational programs that would supply the state’s industry with technicians or engineering assistants having specific high technology skills and knowledge.

 

As an industry, out  inputs towards the design of these programs are important, so we are surveying technology companies to learn more about skill sets that your firm will require in technicians or engineering assistants (both now and in the future).  In this survey, the skill sets being addressed pertain to micro- or nano-scale technologies used in manufacturing as well as research and development.

 

Survey link: http://surveys.questionpro.com/a/t/ABkVkZP44U

 

The survey should take less than 5 minutes to complete, and is designed for technical supervisory or management personnel.  Your participation is very much appreciated.  If you feel a colleague within your company is the more appropriate person to respond to this survey, please kindly forward this message.  It is also possible that some companies will receive more than one request due to different points of contact in the various databases we used to compile our mailing list.  We apologize for the duplication if that occurs.

 

Information obtained from each company will be held in the strictest confidence, and survey results will only be described in the aggregate.  If you have any questions, please contact:

 

Dr. Mangala Joshua Dr. Ray Tsui
Mesa Community College Arizona State University
480-461-7053 480-206-4736