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Posts Tagged ‘SBIR’


NIH SBIR Funding Early Ventures: September 26, 2018 sponsored by Pennovation

Stephen J. Williams PhD, Reporter

Penn Center for Innovation (Pennovation) sponsored a “Meet with NCI SBIR” program directors at University of Pennsylvania Medicine Smilow Center for Translational Research with a presentation on advice on preparing a successful SBIR/STTR application to the NCI as well as discussion of NCI SBIR current funding opportunities.   Time was allotted in the afternoon for one-on-one discussions with NCI SBIR program directors.

To find similar presentations and one-on-one discussions with NCI/SBIR program directors in an area nearest to you please go to their page at:

https://sbir.cancer.gov/newsevents/events

For more complete information on the NCI SBIR and STTR programs please go to their web page at: https://sbir.cancer.gov/about

A few notes from the meeting are given below:

  • In 2016 the SBIR/STTR 2016 funded $2.5 billion (US) of early stage companies; this is compared to the $6.6 billion invested in early  stage ventures by venture capital firms so the NCI program is very competitive with alternate sources of funding
  • It was stressed that the SBIR programs are flexible as far as ownership of a company; SBIR allows now that >50% of the sponsoring company can be owned by other ventures;  In addition they are looking more favorably on using outside contractors and giving leeway on budgetary constraints so AS THEY SUGGEST ALWAYS talk to the program director about any questions you may have well before (at least 1 month) you submit. More on eligibility criteria is found at: https://sbir.cancer.gov/about/eligibilitycriteria
  • STTR should have strong preliminary data since more competitive; if don’t have enough go for  an R21 emerging technologies grant which usually does not require preliminary data
  • For entities outside the US need a STRONG reason for needing to do work outside the US

Budget levels were discussed as well as  the waiver program, which allows for additional funds to be requested based on criteria set by NCI (usually for work that is deemed high priority or of a specialized nature which could not be covered sufficiently under the standard funding limits) as below:

Phase I: 150K standard but you can get waivers for certain work up to 300K

Phase II: 1M with waiver up to 2M

Phase IIB waiver up to 4M

You don’t need to apply for the waiver but grant offices may suggest citing a statement requesting a waiver as review panels will ask for this information

Fast Track was not discussed in the presentation but for more information of the Fast Track program please visit the website  

NCI is working hard to cut review times to 7 months between initial review to funding however at beginning of the year they set pay lines and hope to fund 50% of the well scored grants

NCI SBIR is a Centralized system with center director and then program director with specific areas of expertise: Reach out to them

IMAT Program and Low-Resource Setting new programs more suitable for initial studies and also can have non US entities

Phase IIB Bridge funding to cross “valley of death” providing up to 4M for 2-3 years: most were for drug/biological but good amount for device and diagnostics

 

Also they have announced administrative supplements for promoting diversity within a project: can add to the budget

FY18 Contracts Areas

3 on biotherapies

2 imaging related

2 on health IT

4 on radiation therapy related: NOTE They spent alot of time discussing the contracts centered on radiation therapy and seems to be an area of emphasis of the NCI SBIR program this year

4 other varied topics

 

Breakdown of funding

>70% of NCI SBIR budget went to grants (for instance Omnibus grants); about 20-30% for contracts; 16% for phase I and 34 % for phase II ;

ALSO the success rate considerably higher for companies that talk to the program director BEFORE applying than not talking to them; also contracts more successful than Omnibus applications

Take Advantage of these useful Assistance Programs through the NIH SBIR Program (Available to all SBIR grantees)

NICHE ASSESSMENT Program

From the NCI SBIR website:

The Niche Assessment Program is designed to help small businesses “jump start” their commercialization efforts. All active HHS (NIH, CDC, FDA) SBIR/STTR Phase I awardees and Phase I Fast-Track awardees (by grant or contract) are eligible to apply. Registration is on a first-come, first-serve basis!

The Niche Assessment Program provides market insight and data that can be used to help small businesses strategically position their technology in the marketplace. The results of this program can help small businesses develop their commercialization plans for their Phase II application, and be exposed to potential partners. Services are provided by Foresight Science & Technology of Providence, RI.

Technology Niche Analyses® (TNA®) are provided by Foresight, for one hundred and seventy-five (175), HHS SBIR/STTR Phase I awardees. These analyses assess potential applications for a technology and then for one viable application, it provides an assessment of the:

  1. Needs and concerns of end-users;
  2. Competing technologies and competing products;
  3. Competitive advantage of the SBIR/STTR-developed technology;
  4. Market size and potential market share (may include national and/or global markets);
  5. Barriers to market entry (may include but is not limited to pricing, competition, government regulations, manufacturing challenges, capital requirements, etc.);
  6. Market drivers;
  7. Status of market and industry trends;
  8. Potential customers, licensees, investors, or other commercialization partners; and,
  9. The price customers are likely to pay.

Commercialization Acceleration Program  (CAP)

From the NIH SBIR website:

NIH CAP is a 9-month program that is well-regarded for its combination of deep domain expertise and access to industry connections, which have resulted in measurable gains and accomplishments by participating companies. Offered since 2004 to address the commercialization objectives of companies across the spectrum of experience and stage, 1000+ companies have participated in the CAP. It is open only to HHS/NIH SBIR/STTR Phase II awardees, and 80 slots are available each year. The program enables participants to establish market and customer relevance, build commercial relationships, and focus on revenue opportunities available to them.

I-Corps Program

The I-Corps program provides funding, mentoring, and networking opportunities to help commercialize your promising biomedical technology. During this 8-week, hands-on program, you’ll learn how to focus your business plan and get the tools to bring your treatment to the patients who need it most.

Program benefits include:

  • Funding up to $50,000 to cover direct program costs
  • Training from biotech sector experts
  • Expanding your professional network
  • Building the confidence and skills to create a comprehensive business model
  • Gaining years of entrepreneurial skills in only weeks.

 

ICORPS is an Entrepreneurial Program (8 week course) to go out talk to customers, get assistance with business models, useful resource which can guide the new company where they should focus on for the commercialization aspect

THE NCI Applicant Assistance Program (AAP)

The SBIR/STTR Applicant Assistance Program (AAP) is aimed at helping eligible small R&D businesses and individuals successfully apply for Phase I SBIR/STTR funding from the National Cancer Institute (NCI), National Institute for Neurological Disorders and Stroke (NINDS), National Heart, Lung and Blood Institute (NHLBI). Participation in the AAP will be funded by the NCI, NINDS, and NHLBI with NO COST TO PARTICIPANTS. The program will include the following services:

  • Needs Assessment/Small Business Mentoring
  • Phase I Application Preparation Support
  • Application Review
  • Team/Facilities Development
  • Market Research
  • Intellectual Property Consultation

For more details about the program, please refer to NIH Notice NOT-CA-18-072.

 

These programs are free for first time grant applicants and must not have been awarded previous SBIR

Peer Learning Webinar Series goal to improve peer learning .Also they are starting to provide Regulatory Assistance (see below)

NIH also provides Mentoring programs for CEOS and C level

Application tips

  1. Start early: and obtain letters of collaboration
  2. Build a great team: PI multi PI, consider other partners to fill gaps (academic, consultants, seasoned entrepreneurs (don’t need to be paid)
  3. They will pre review 1 month before due date, use NIH Project Reporter to view previous funded grants
  4. Specify study section in SF to specify areas of expertise for review
  5. Specific aims are very important; some of the 20 reviewers focus on this page (describes goals and milestones as well; spend as much time on this page as the rest of the application
  6. Letters of support from KOLs are important to have; necessary from consultants and collaborators; helpful from clinicians
  7. Have a phase II commercialization plan
  8. Note for non US clinical trials:  They will not fund nonUS clinical trials; the company must have a FWA
  9. SBIR budgets defined by direct costs; can request a 7% fee as an indirect cost; and they have a 5,000 $ technical assistance program like regulatory consultants but if requested can’t participate in NIH technical assistance programs so most people don’t apply for TAP

 

  • They are trying to change the definition of innovation as also using innovative methods (previously reviewers liked tried and true methodology)

10.  before you submit solicit independent readers

NCI SBIR can be found on Twitter @NCIsbir ‏

Discussion with Monique Pond, Ph.D. on Establishment of a Regulatory Assistance Program for NCI SBIR

I was able to sit down with Dr. Monique Pond,  AAAS Science & Technology Policy Fellow, Health Scientist within the NCI SBIR Development Center to discuss the new assistance program in regulatory affairs she is developing for the NCI SBIR program.  Dr Pond had received her PhD in chemistry from the Pennsylvania State University, completed a postdoctoral fellow at NIST and then spent many years as a regulatory writer and consultant in the private sector.  She applied through the AAAS for this fellowship and will bring her experience and expertise in regulatory affairs from the private sector to the SBIR program. Dr. Pond discussed the difficulties that new ventures have in formulating regulatory procedures for their companies, the difficulties in getting face time with FDA regulators and helping young companies start thinking about regulatory issues such as pharmacovigilence, oversight, compliance, and navigating the complex regulatory landscape.

In addition Dr. Pond discussed the AAAS fellowship program and alternative career paths for PhD scientists.

 

A formal interview will follow on this same post.

 

Other articles on this OPEN ACCESS JOURNAL on Funding for Startups and Early Ventures are given below:

 

Mapping Medical Device Startups Across The Globe per Funding Criteria

Funding Oncorus’s Immunotherapy Platform: Next-generation Oncolytic Herpes Simplex Virus (oHSV) for Brain Cancer, Glioblastoma Multiforme (GBM)

 

Funding Opportunities for Cancer Research

 

Team Profile: DrugDiscovery @LPBI Group – A BioTech Start Up submitted for Funding Competition to MassChallenge Boston 2016 Accelerator

 

A Message from Faculty Director Lee Fleming on Latest Issue of Crowdfunding; From the Fung Institute at Berkeley

 

PROTOCOL for Drug Screening of 3rd Party Intellectual Property Presented for Funding Representation

 

Foundations as a Funding Source

 

The Bioscience Crowdfunding Environment: The Bigger Better VC?

 

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Upcoming SBIR Webinars and Conferences: May 2016

Abbreviated Phase I Proposal Preparation Workshop, and National SBIR Conference – Washington, DC

Date
May 23, 2016 08:00 AM
Location
Washington, District Of Columbia
Contact Name
N/A
Contact Phone
N/A
Contact Email
Event Website
N/A
Files:
n/a

Description:

Abbreviated Phase I Proposal Preparation Workshop, and National SBIR Conference

Washington, DC, May 23-25, 2016

This is an important event for anyone serious about competing in the SBIR/STTR programs. It is a great opportunity to meet one-on-one with representatives of the awarding agencies, and to learn the latest and greatest about the SBIR/STTR programs.  We will be there, offering our half-day, abbreviated Phase I proposal preparation workshop as part of the preconference events on May 23rd.

Contact wenning@techconnect.org(link sends e-mail) for more information or to register

NSF SBIR/STTR Webinar

Date

May 16, 2016 12:00 PM

Location

N/A N/A N/A N/A, N/A N/A

Contact Name

Lindsey Hagmaier

Contact Phone

N/A

Contact Email

LHagmaier@mt.gov(link sends e-mail)

Webinar Website

Go to Webinar Website (link is external)

Files:

n/a

Description:

NSF SBIR/STTR Informational Webinar

 

Tune in to this free informational webinar to learn about the NSF SBIR/STTR Program directly from the Program Director, just in time for the current solicitation(link is external) (closing June 16, 2016).

Also, hear firsthand from a recent SBIR Phase I grantee about their experience with the application process and what SBIR funding means for her innovation.

 

Register here:

 

https://attendee.gotowebinar.com/register/538480695941136386

How to Explore Commercial Markets for Innovative Ideas

Date
May 17, 2016 11:00 AM
Location
Webinar ,
Contact Name
Rebecca Norman
Contact Phone
(501) 683-7700
Files:
n/a

Description:

Date: Tuesday, May 17, 2016

Time: 11:00 AM – 12:30 PM Eastern, 10:00 AM – 11:30 AM Central

Hosted by the Arkansas Small Business and Technology Development Center (ASBTDC). Innovative entrepreneurs will learn how to explore market opportunities for their new, research-based product or service ideas. This webinar will also address how researchers can communicate effectively with potential project partners and customers to support development of quality Small Business Innovation Research (SBIR) proposals.

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The Vibrant Philly Biotech Scene: Focus on Computer-Aided Drug Design and Gfree Bio, LLC

Curator and Interviewer: Stephen J. Williams, Ph.D.

 

 

philly philly2night

 

 

 

 

 

 

 

This post is the second in a series of posts highlighting interviews with Philadelphia area biotech startup CEO’s and show how a vibrant biotech startup scene is evolving in the city as well as the Delaware Valley area. Philadelphia has been home to some of the nation’s oldest biotechs including Cephalon, Centocor, hundreds of spinouts from a multitude of universities as well as home of the first cloned animal (a frog), the first transgenic mouse, and Nobel laureates in the field of molecular biology and genetics. Although some recent disheartening news about the fall in rankings of Philadelphia as a biotech hub and recent remarks by CEO’s of former area companies has dominated the news, biotech incubators like the University City Science Center and Bucks County Biotechnology Center as well as a reinvigorated investment community (like PCCI and MABA) are bringing Philadelphia back. And although much work is needed to bring the Philadelphia area back to its former glory days (including political will at the state level) there are many bright spots such as the innovative young companies as outlined in these posts.

efavirenz_med-2In today’s post, I had the opportunity to talk with molecular modeler Charles H. Reynolds, Ph.D., founder and CEO of Gfree Bio LLC, a computational structure-based design and modeling company based in the Pennsylvania Biotech Center of Bucks County. Gfree is actually one of a few molecular modeling companies at the Bucks County Biotech Center (I highlighted another company RabD Biotech which structural computational methods to design antibody therapeutics).

Below is the interview with Dr. Reynolds of Gfree Bio LLC and Leaders in Pharmaceutical Business Intelligence (LPBI):

LPBI: Could you briefly explain, for non-molecular modelers, your business and the advantages you offer over other molecular modeling programs (either academic programs or other biotech companies)? As big pharma outsources more are you finding that your company is filling a needed niche market?

GfreeBio: Gfree develops and deploys innovative computational solutions to accelerate drug discovery. We can offer academic labs a proven partner for developing SBIR/STTR proposals that include a computational or structure-based design component. This can be very helpful in developing a successful proposal. We also provide the same modeling and structure-based design input for small biotechs that do not have these capabilities internally. Working with Gfree is much more cost-effective than trying to develop these capabilities internally. We have helped several small biotechs in the Philadelphia region assess their modeling needs and apply computational tools to advance their discovery programs. (see publication and collaboration list here).

LPBI: Could you offer more information on the nature of your 2014 STTR award?

GfreeBio: Gfree has been involved in three successful SBIR/STTR awards in 2014.   I am the PI for an STTR with Professor Burgess of Texas A&M that is focused on new computational and synthetic approaches to designing inhibitors for protein-protein interactions. Gfree is also collaborating with the Wistar Institute and Phelix Therapeutics on two other Phase II proposals in the areas of oncology and infectious disease.

LPBI: Why did you choose the Bucks County Pennsylvania Biotechnology Center?

GfreeBio: I chose to locate my company at the Biotech Center because it is a regional hub for small biotech companies and it provides a range of shared resources that are very useful to the company. Many of my most valuable collaborations have resulted from contacts at the center.

LPBI: The Blumberg Institute and Natural Products Discovery Institute has acquired a massive phytochemical library. How does this resource benefit the present and future plans for GfreeBio?

GfreeBio: To date Gfree Bio has not been an active collaborator with the Natural Products Insititute, but I have a good relationship with the Director and that could change at any time.

LPBI: Was the state of Pennsylvania and local industry groups support GfreeBio’s move into the Doylestown incubator? Has the partnership with Ben Franklin Partners and the Center provided you with investment and partnership opportunities?

GfreeBio: Gfree Bio has not been actively seeking outside investors, at least to date. We have been focused on growing the company through collaborations and consulting relationships. However, we have benefitted from being part of the Keystone Innovation Zone, a state program that provides incentives for small technology-based businesses in Pennsylvania.

LPBI: You will be speaking at a conference in the UK on reinventing the drug discovery process through tighter collaborations between biotech, academia, and non-profit organizations.  How do you feel the Philadelphia area can increase this type of collaboration to enhance not only the goals and missions of nonprofits, invigorate the Pennsylvania biotech industry, but add much needed funding to the local academic organizations?

GfreeBio: I think this type of collaboration across sectors appears to be one of the most important emerging models for drug discovery.   The Philadelphia region has been in many ways hard hit by the shift of drug discovery from large vertically integrated pharmaceutical companies to smaller biotechs, since this area was at the very center of “Big Pharma.” But I think the region is bouncing back as it shifts more to being a center for biotech. The three ingredients for success in the new pharma model are great universities, a sizeable talent pool, and access to capital. The last item may be the biggest challenge locally. The KIZ program (Keystone Innovation Zone) is a good start, but the region and state could do more to help promote innovation and company creation. Some other states are being much more aggressive.

LPBI: In addition, the Pennsylvania Biotechnology Center in Bucks County appears to have this ecosystem: nonprofit organizations, biotechs, and academic researchers. Does this diversity of researchers/companies under one roof foster the type of collaboration needed, as will be discussed at the UK conference? Do you feel collaborations which are in close physical proximity are more effective and productive than a “virtual-style” (online) collaboration model? Could you comment on some of the collaborations GfreeBio is doing with other area biotechs and academics?

GfreeBio: I do think the “ecosystem” at the Pennsylvania Biotechnology Center is important in fostering new innovative companies. It promotes collaborations that might not happen otherwise, and I think close proximity is always a big plus. As I mentioned before, many of the current efforts of Gfree have come from contacts at the center.   This includes SBIR/STTR collaborations and contract work for local small biotech companies.

LPBI: Thompson Reuters just reported that China’s IQ (Innovation Quotient) has risen dramatically with the greatest patents for pharmaceuticals and compounds from natural products. Have you or your colleagues noticed more competition or business from Chinese pharmaceutical companies?

GfreeBio: The rise of Asia, particularly China, has been one of the most significant recent trends in the pharmaceutical industry. Initially, this was almost exclusively in the CRO space, but now China is aggressively building a fully integrated domestic pharmaceutical industry.

LPBI: How can the Philadelphia ecosystem work closer together to support greater innovation?

GfreeBio: A lot has happened in recent years to promote innovation and company creation in the region. There could always be more opportunities for networking and collaboration within the Philadelphia community. Of course the biggest obstacle in this business is often financing. Philadelphia needs more public and private sources for investment in startups.

LPBI: Thank you Dr. Reynolds.

Please look for future posts in this series on the Philly Biotech Scene on this site

Also, if you would like your Philadelphia biotech startup to be highlighted in this series please contact me: sjwilliamspa@comcast.net or @StephenJWillia2.
Our site is read by ~ 570,000 readers, among them thousand international readers daily and followed by thousands of Twitter followers.

 

Other posts on this site in this VIBRANT PHILLY BIOTECH SCENE SERIES OR referring to PHILADELPHIA BIOTECH include:

RAbD Biotech Presents at 1st Pitch Life Sciences-Philadelphia

The Vibrant Philly Biotech Scene: Focus on Vaccines and Philimmune, LLC

What VCs Think about Your Pitch? Panel Summary of 1st Pitch Life Science Philly

1st Pitch Life Science- Philadelphia- What VCs Really Think of your Pitch

LytPhage Presents at 1st Pitch Life Sciences-Philadelphia

Hastke Inc. Presents at 1st Pitch Life Sciences-Philadelphia

PCCI’s 7th Annual Roundtable “Crowdfunding for Life Sciences: A Bridge Over Troubled Waters?” May 12 2014 Embassy Suites Hotel, Chesterbrook PA 6:00-9:30 PM

Pfizer Cambridge Collaborative Innovation Events: ‘The Role of Innovation Districts in Metropolitan Areas to Drive the Global an | Basecamp Business

Mapping the Universe of Pharmaceutical Business Intelligence: The Model developed by LPBI and the Model of Best Practices LLC

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