# Presentation: 704470

## National Institutes of Health

**National Institutes of Health**

**Jo Anne Goodnight and Kay Etzler**
**NIH SBIR/STTR Program**

**National SBIR/STTR Conference**
**October 28-31, 2002**

**Commercialization **
**of NIH SBIR/STTR Projects**

## From the Test Tube to the Medicine Cabinet

**Small ****BUSINESS**** Innovation Research**
**Think very early about your commercialization pathway**
**      *****HOW****** will you commercialize? ******WHO****** will buy it?***
** ****Research... Research.... Research **
**      *****Market will willingly accept your idea... NO***
**Business Planning ****is**** CRITICAL ****to the**** ****Company’s Commercialization Plan**

## Commercialization:A Magic Formula?

****** ****Phase I + Phase II ****=**** Phase III **
- Typical for SBIR/STTR Projects that do not require clinical evaluation
****** ****Phase I + Phase II ******** Phase III**
- Typical for SBIR/STTR Projects that require clinical evaluation and FDA approval

## Commercialization Issues

- Phase II to Phase III: Bridge or Pier?
- Clinical evaluation and FDA approvals
- cGMP and GLP Facilities
- Partnerships and Strategic Alliances
- Drugs and Biologics Require vast amounts of time and $$$
- Average of 8.5 years
-       (lab research/animal testing to clinical trials)
- Average of $400M

## Manufacturing and Marketing Your Product

-  **Do it yourself.**
- Potentially very lucrative
- Also extremely expensive and very risky.
- Most companies founded on a single good idea or product fail after three or four years unless they can come up with additional products.

## Manufacturing and Marketing a Product

**Sell your idea.**
- Identify a company that's interested in your product
- Negotiate the best price you can, and take the money and run.
- It's the safest strategy, but sometimes the least profitable. If the product takes off, you're left behind.

## Manufacturing and Marketing a Product

** ****License your idea.**
- Rather than sell the concept outright, license a company to manufacture and market your product in return for an initial fee and royalty checks.
- Most licensing agreements pay the creator of a product anywhere from five to 10 percent of revenues.

## Manufacturing and Marketing a Product

**Attend Trade Shows**
** ****Excellent way to find a buyer for your product idea. **

## From Test Tube to Medicine Cabinet

**Few small companies have all the resources necessary to develop their ideas into a marketable state. **
**Majority of profitable and innovative products require third parties to supply:**
**Advice**
**Development funding**
**Technology know-how**
**Design or marketing expertise**
**Manufacturing capability**

##  “Each drug has its own way of being born” (Clement Stone, Former VP, Merck and Co. Inc.)

Clinical Evaluation and Regulatory approvals
Different requirements: 
Medical Devices
Drugs
Biological Products
 cGMP and GLP issues

- Clinical Evaluation and Regulatory approvals
- Different requirements:
- Medical Devices
- Drugs
- Biological Products
-  cGMP and GLP issues

**Getting a ****Drug**** to Market**
***A Long, Complicated Journey...***

## http://www.fda.gov/cder/handbook/Develop.gif

**NDA Contains:**
- Pre-clinical studies
- Human clinical studies
- Manufacturing Details
- Labeling Info
- Other Info

## Getting a Medical Device to Market

**As easy as 1...2...3...!**
**1) Verify Your Product Meets ****Definition**** of Medical Device**
- Section 201(h) of Federal Food, Drug &
-         Cosmetic Act
- May actually be a drug or biologic...
-         different requirements

## 2) Classify Your Device
   Identify the marketing process:

 Premarket notification [(510(k)]     http://www.fda.gov/cdrh/devadvice/314.html 

 Premarket approval (PMA)     http://www.fda.gov/cdrh/devadvice/316.html 

-    Identify the marketing process:
-  Premarket notification [(510(k)]     http://www.fda.gov/cdrh/devadvice/314.html
-  Premarket approval (PMA)     _[http://www.fda.gov/cdrh/devadvice/316.html](http://www.fda.gov/cdrh/devadvice/316.html)_

**Getting a ****Medical Device**** ****to Market**

## 3) Submit Marketing Application  
      to obtain FDA clearance
 510(k) Information 
     http://www.fda.gov/cdrh/devadvice/314.html 
 PMA Information
     http://www.fda.gov/cdrh/devadvice/316.html 
 Exempt Device Information
     http://www.fda.gov/cdrh/devadvice/3133.html 

**      ****to obtain FDA clearance**
-  510(k) Information
-      _[http://www.](http://www.fda.gov/cdrh/devadvice/314.html)__[fda](http://www.fda.gov/cdrh/devadvice/314.html)__[.gov/](http://www.fda.gov/cdrh/devadvice/314.html)__[cdrh](http://www.fda.gov/cdrh/devadvice/314.html)__[/](http://www.fda.gov/cdrh/devadvice/314.html)__[devadvice](http://www.fda.gov/cdrh/devadvice/314.html)__[/314.html](http://www.fda.gov/cdrh/devadvice/314.html)_
-  PMA Information
-      _[http://www.](http://www.fda.gov/cdrh/devadvice/316.html)__[fda](http://www.fda.gov/cdrh/devadvice/316.html)__[.gov/](http://www.fda.gov/cdrh/devadvice/316.html)__[cdrh](http://www.fda.gov/cdrh/devadvice/316.html)__[/](http://www.fda.gov/cdrh/devadvice/316.html)__[devadvice](http://www.fda.gov/cdrh/devadvice/316.html)__[/316.html](http://www.fda.gov/cdrh/devadvice/316.html)_
-  Exempt Device Information
-      _[http://www.fda.gov/cdrh/devadvice/3133.html](http://www.fda.gov/cdrh/devadvice/3133.html)_

**Getting a ****Medical Device**** ****to Market**

## FDA Technical Assistance

**FDA Technical Assistance**

**  ****Human Drug Products**
**  ****Biological Products**
**  ****Animal Drugs and Devices**
**  ****Food Products and Cosmetics**** **

## FDA Technical Assistance

**FDA Technical Assistance**

**Human Drug Products:**Center for Drug Evaluation and Research (CDER)
- Telephone Number: 301.827.4573Fax Number: 301.827.4577Fax-On-Demand: 800.342.2722 or 301.827.0577 CDER Home Page: _[http://www.](http://www.fda.gov/cder)__[fda](http://www.fda.gov/cder)__[.gov/](http://www.fda.gov/cder)__[cder](http://www.fda.gov/cder)_Email Address: _[DIB@](mailto:DIB@cder.fda.gov)__[cder](mailto:DIB@cder.fda.gov)__[.](mailto:DIB@cder.fda.gov)__[fda](mailto:DIB@cder.fda.gov)__[.gov](mailto:DIB@cder.fda.gov)_

## FDA Technical Assistance

**FDA Technical Assistance**

**Biological Products:**
- Center for Biologics Evaluation and Research (CBER)
- Telephone Number: 301.827.2000 or 800.835.4709Fax Number: 301.827.3843Fax-On-Demand: 888.223.7329 or 301.827.3844 CBER Home Page: _[http://www.](http://www.fda.gov/cber)__[fda](http://www.fda.gov/cber)__[.gov/](http://www.fda.gov/cber)__[cber](http://www.fda.gov/cber)_Email Address:a. Manufacturers Assistance and Technical Training Team: _[MATT@.](mailto:MATT@cber.fda.gov)__[cber](mailto:MATT@cber.fda.gov)__[.](mailto:MATT@cber.fda.gov)__[fda](mailto:MATT@cber.fda.gov)__[.gov](mailto:MATT@cber.fda.gov)_b. Consumer & Health Professional Assistance: _[OCTMA@](mailto:OCTMA@cber.fda.gov)__[cber](mailto:OCTMA@cber.fda.gov)__[.](mailto:OCTMA@cber.fda.gov)__[fda](mailto:OCTMA@cber.fda.gov)__[.gov](mailto:OCTMA@cber.fda.gov)_

## FDA Technical Assistance

**FDA Technical Assistance**

**Animal Drugs and Devices: **Center for Veterinary Medicine (CVM)
- Telephone Number: 301.827.3800Fax Number: 301.594.1807CVM Home Page: _[http://www.](http://www.fda.gov/cvm)__[fda](http://www.fda.gov/cvm)__[.gov/](http://www.fda.gov/cvm)__[cvm](http://www.fda.gov/cvm)_Email Address: fdacvm@informatics.vetmed.vt.edu

## FDA Technical Assistance

**FDA Technical Assistance**

**Food Products and Cosmetics:**
- Center for Food Safety and Applied Nutrition (CFSAN)
- Telephone Number: 301-436-2335Fax Number: 301-436-2764 CFSAN Home Page: http://vm.cfsan.fda.gov/list.htmlEmail Address: OCO@cfsan.fda.gov

## FDA Technical Assistance

**FDA Technical Assistance**

- http://www.fda.gov/ora/fed_state/small_business/sb_guide/intro.html

**Small Business Guide to FDA**

## http://www.fda.gov/ora/fed_state/Small_Business/regional.htm

## One Company’s Recipe for Commercial Success

- “Measurement of Hemodialysis Access Flow & Recirculation” (NIDDK Grant)

- Patient Monitor for use in hemodialysis clinics...
- offering novel diagnostic measurement capabilities to the nephrologist...
- incorporated in the National Kidney Foundation Guidelines for Patient Care.

- Transonic Systems Inc.
- Ithaca NY

## One Company’s Recipe for Commercial Success (cont.)

- Submit SBIR projects that match company’s corporate product portfolio
- SBIR incorporated into company’s strategic plan
- Products the company wants to develop and market on its own, if it had adequate financial resources
- Products that utilize company’s core competencies

## One Company’s Recipe for Commercial Success (cont.)

- Develop SBIR task list to include essential commercialization milestones
- Delivery of prototypes to, and validation studies with independent researchers
- FDA Clearance data gathering and FDA submission
- End-product of “Phase II” must be ready to be marketed

## One Company’s Recipe for Commercial Success (cont.)

- Keep the commercialization under company’s control
- Develop products that they want to market themselves.
- (Third-party distribution channels only develop *after* new product becomes successful.)
- Phase II collaborators expected to publish.... to give new products a first commercial exposure
- Pre-show products at scientific meetings

## One Company’s Recipe for Commercial Success (cont.)

- Successful commercialization of SBIR Products is not an after-thought
*“**SBIR grants are a means to tackle product developments **sooner** and **faster** than we could do on our own.”*

## Future Directions at NIH to Assist Companies in Commercialization

- Competing Continuation Phase II Applications
- Technical Assistance Programs at NIH

## Future Directions at NIH to Assist Companies in Commercialization

- Competing Continuation Phase II application

- http://grants.nih.gov/grants/guide/pa-files/PA-02-173.html

**Purpose **
- - To take existing, promising compounds developed under a Phase II through the next step of drug discovery and development.
-  Additional research support to address clinical issues, and other issues relevant to regulatory approval
-   (e.g., FDA)

## Future Directions at NIH to Assist Companies in Commercialization

- Competitive Continuation Phase II application

- http://grants.nih.gov/grants/guide/pa-files/PA-02-173.html

**Eligibility **
-  SBIR Phase II awardee
-  Promising pharmacologic agents have already been identified and some preclinical pharmacology has been conducted.
-  Response to an NIH Program Announcement
-    (e.g., NIMH)

## Future Directions at NIH to Assist Companies in Commercialization

- Competitive Continuation Phase II application

- http://grants.nih.gov/grants/guide/pa-files/PA-02-173.html

**Award Amount and Project Period **
-  Up to 3 years
-  $800,000 total costs per year

## Future Directions at NIH to Assist Companies in Commercialization

- Technical Assistance Programs at NIH
- Pilot CAP Program (NCI)
-  Identify menu of items to offer through *other* TAPs

## Pilot Commercialization Assistance Program 

- Goal:  Teach business skills to help mature SBIR/STTR-developed technologies (move them forward into marketplace)
- Focus:
- Business plan development
- Opportunity forum (marriage broker)

## Development of Technical Assistance Menu

- Assistance with:
- Developing Product Development Plan
- Developing business plans
- Valuing a technology
- Risk assessment
- Market assessment
- IND filings
- Manufacturing issues
- ...