# Presentation: 442625

## From the Academic Bench

**to Business**

**Mary Pat Moyer, Ph.D.**
- CEO And Chief Science Officer
- INCELL Corporation, LLC
- San Antonio, Texas
- www.incell.com

## Some Important Factors to be Considered in This Talk

-   Intellectual Property
-   Case Studies as Examples
-   Barriers to Technology Transfer    and Commercialization
-   Perceptions and Realities Issues
-   Experience and Comments

## Intellectual Property

**  ****Patents**
**  ****Trademarks**
**  ****Trade Secrets**
**  ****Know-How**

## Important Documents

-   Non-disclosure agreement (NDA)
-   Materials transfer agreement (MTA)
-   Intellectual property agreement (IPA)
-   Collaborative R&D, contract R&D, or strategic partner agreement (may include sections with any or all NDA, MTA, IPA components)
-   Employee agreements: company and university (faculty, trainees and staff)
-   Partner and co-inventor agreements

## Important  Document Components

-  _Signatures of_:
-  Technology transfer or other official(s) as they so indicate authorized to sign for the university
-  Inventor(s) and laboratory investigators with by-line that they understand and will abide by the agreement
-  Authorized company representatives
-  Arbitration clauses with neutral site of venue
-  Specific contact information of all parties that include FAX and e-mail addresses

## Case

- Studies

## Case

- Study #1

## AAFA as an Adjuvant to CPT-11 (irinotecan): Enhances Effect on MCF-7 Breast Tumor Xenografts

- 3% AAFA + CPT-11

- 6% AAFA + CPT-11

*** SBIR * **
**sponsored **
**project**

***CASE STUDY #1: Lab Bench Stage***

## AAFATM Reduction of 

**AAFA****TM**** Reduction of **
**Chemotherapy-Induced Side Effects***

- 			_**	**__**         **__**Dietary Additives              **_
_**Gastrointestinal**__** **__**	**_**	****           **_**	**__**  None                 **__**+ AAFA**__**TM       **_
- 	% water in feces	        	increased	normal
- 	Apoptosis in crypts            increased	less increase
- 	Liver size		increased	normal
- 	Liver PGE2		elevated		normal
- 	Crypt structure	        	abnormal	normal
- 	Goblet cells		large, abnormal	normal
- 	Inflammation, COX-2	increased	normal
_**Hematology**_
- 	Leukopenia	 	 yes 		no
- 	Anemia 			 yes		no
- 	Micronuclei in RBCs	 increased        	normal
_**Grooming Behavior**_
- 	Coat Appearance 	       	poor		normal

***Data from mice receiving CPT-11 treatment**

*** SBIR * **
**sponsored **
**project**

***CASE STUDY #1: Lab Bench Stage***

## Natural Products: Nutritional Supplement

_**Example**_
***AAFA*********
- Accelerated Action Fatty Acid (AAFA)
- A Special Omega-3 Formulation
- High in EPA & DHA

**EPA: Eicosapentanoic acid; DHA: Docasahexanoic acid**

*** SBIR * **
**sponsored **
**project**

- Patents and Trade Secrets

***CASE STUDY #1: Product Development***

**Notes:**
TEKSA is being developed as a premier for-profit business in close collaboration with the regional technology community. 

TEKSA’s mission is: 
“Growing Technology Companies for the 21st Century.”

## New Packaging and Labeling 

**AAFA********-****Gel**

- NOT FOR SALE
- For investigational use only
- exp. <date>

- FRONT
- BACK

- Prelude to Clinical Trials: NCI-Sponsored
- Johns Hopkins Medical Center
- Start this summer

- Patents and Trade Secrets

***CASE STUDY #1: Product Manufacturing***

##   AAFA History and Timelines

- Technology Transfer to INCELL

- NCI-Sponsored Clinical Trials to Begin Soon at JHMC

- Submit Patents, Manufacture and Sell Product as Nutritional Supplement

- University Scientists Perform R&D

**  ****AAFA******** History and Timelines**

*** SBIR * **
**project**

- Patents and Trade Secrets

**AAFA********-****Gel**

- New AAFA-gel pouch-pack

- 8 years

**1 year**

**2 years**

_**University Stage**_

**Early Product **
_**Development**_

**Current Product **
_**Development**_

- University Decides not to Patent; Technology Transfer to Scientists: NDAs, MTAs, IPAs

- 1 year

- 3 years

- FDA-Approved Nutraceutical Product

***CASE STUDY #1***

## Case

- Study #2

## M3 Media History and Timelines

**Technology transfer to INCELL**

**University scientists perform R&D and optimize culture media to grow human cells**

**New and Existing **
**Media Formulations**

**3 years**

**1 year**

**6 years**

_**University Stage**_

**Development &**_** Sale of Product **_

**Current Product **
_**Development**_

**  ****University submits patent; Not issued; Technology returned to scientist **

**FDA - approved devices**

_**INCELL Core Technology:**_
- Media to grow normal, diseased & fragile cells
- Human stem cells: e.g. neural, pancreatic, intestinal, blood
- Cryopreservation media
- Media to transport tissues for transplantation
- Sold worldwide

**1 year**

**<1 year**

**Applications of **
**Media Formulations**

**FDA-approved vaccines and other therapeutics**

_**>**_**1 year**

**M3******** Media History and Timelines**

- Trade Secrets
- and Know-How

***CASE STUDY #2***

## Case

- Study #3

## New Gene: A Failed Agreement

**University scientists perform R&D and discover potentially  important target gene**

**INCELL TERMINATES AGREEMENT**
**NO PRODUCT DEVELOPMENT OR COMMERCIALIZATION**
**WASTE OF PRECIOUS CORPORATE AND UNIVERSITY RESOURCES**

**2 years**

**1 year**

_**University Stage**_

**Collaborative **_**R&D with INCELL **_

**Development &**_** Sale of Product**_

**  ****University submits patent; Outcomes of Technology Transfer will be shared with scientists/inventors who say they want to develop a commercial product or products based on the technology**

**New Gene: A Failed Agreement**

- Trade Secrets
- and Know-How

***CASE STUDY #3***

**INCELL pays for research contract**
**Agreement includes technology transfer from inventors to INCELL **
**Failed transfer of know-how from university scientists to INCELL**
**Failure of inventors to meet deadlines and provide deliverables**
**Non-reproducible research results and communications with breakdowns at all levels**

## Case

- Study #4

## Two Universities with Technologies of Interest to INCELL

**University scientists excited about transfering technology and doing collaborative research**

**2-3 weeks**

**< 1 year**

_**University #1**_

**NDA and/or MTAs prepared after reviews and revisions; then signed by university tech transfer office, key inventor(s) and authorized INCELL representatives as appropriate**

**Two Universities with Technologies of Interest to INCELL**

- Trade Secrets
- and Know-How

***CASE STUDY #4***

**IP Agreement includes technology transfer from university to INCELL and/or vice-versa**
**Dialog and planning begin for collaborative grants and contracts; include details of joint IP**
**Inventors meet deadlines and provide deliverables**
**Promising research results found **
**INCELL pays for research contract**
**Early product development begins**

_**University #2**_

**University scientists excited about transferring technology and doing collaborative research**

**4-6 months**

**Excessive revisions or unreasonable expectations **

**weeks to months**

**Collaboration abandoned**

## Case

- Study #5

## Complex Agreements Include Three Universities and Shared IP with INCELL

**University scientists doing collaborative research with INCELL submit joint patent**

**< 1 year**

**< 1 year**

_**University #1**_

**Complex Agreements Include Three Universities and Shared IP with INCELL**

- Patents, Trade Secrets and Know-How

***CASE STUDY #5***

**IPA developed to include technology transfer from universities to INCELL and/or party cross-licensing**
** **
**Dialog and planning begin for collaborative grants and contracts; include details of exclusive and joint IP**
**Inventors meet deadlines and provide deliverables**
**Early product development and manufacturing plans**

_**University #3**_

**University #3 scientists do collaborative research with university #2 inventors and INCELL**

**4-6 months**

**Provisional patent submitted **

**< 1 year**

**Patent submitted**

**Key university inventor moves to university #2 but collaborative research continues with INCELL**

**< 1 year**

_**University #2**_

**Provisional patent submitted **

## OTHER IMPORTANT

**OTHER IMPORTANT**
**CONSIDERATIONS **
**AND BARRIERS TO**
**TECHNOLOGY TRANSFER **
**AND  COMMERCIALIZATION**

## The Nature of R&D: Academia

-  Freedom in discovery;
-  Projects not managed by administration;
-  Change of R&D direction common;
-  Primary deliverables=papers, presentations, follow-on grants, and trainees; and
-  Secondary deliverables=intellectual property (usually shared with inventor).

## The Nature of R&D: Business

-  Stick with project & product development;
-  Administrative direction by management;
-  No or minimal change in R&D direction;
-  Primary deliverables= intellectual property, products for sale and, ultimately, profits;
-  Company owns intellectual property; and
-  Secondary deliverables= papers, talks, etc.

## Pipelines of Research & Discovery : Common Technology Commercialization Barriers of Academic Research Organizations

- Cultural differences of academia & business
- Bureaucratic structure, legal restrictions, regulations, & time delays
- Ineffective management of intellectual property
- Lack of individual rewards for inventors

*[Cont’d.....]*

## Pipelines of Research & Discovery : Common Technology Commercialization Barriers of Academic Research Organizations

- Fear or inexperience of inventors
- Administration and bureaucracy: Lack of support to inventors *OR* rewards to only those who want to commercialize
- Physical space or equipment needs
- Lack of understanding about logistics, manufacturing, or commercialization needs of the product

*[Cont’d.....]*

## Cultural Differences:  

**Academia **
**& **
**Business**

## The Mission of Academia

- Academic institutions and their staff and faculty have the mission to:
-  perform research to provide new knowledge;
-  bring in money for research and other work;
-  educate students and trainees; and
-  provide service to their communities and professions.
- Academia:
-  is driven by new knowledge and discovery;
-  is about relationships at many levels; and
-  is a slower pace than business.

## The Mission of Business

- The mission of business is to:
-  deliver quality product(s) and/or services;
-  do research as prelude to new products/services;
-  solve problems needed by customers; and
-  be an active member of the business community.
- Business is driven by:
-  the current market and timely deliverables;
-  making a profit: money for the company; shareholders, & investors; and
-  relationships and fast-paced expectations.

## R&D Missions Simplified

**Academia needs to: **
**  **Do quality work and make new discoveries.
-   Bring in money for operations and more work.
**Business needs to:**
** **Develop  a quality product, get it into a box and sell it.
-  Bring in money for operations and more work.

## Cultural Differences:  Solutions to Overcome the Barriers

_**Education and Collaboration**_**. **Foster collaborative academia-business seminars, meetings, and informal gatherings  to educate, exchange information and establish interpersonal relationships (e.g., SALSA, TASA, Chambers of Commerce).
_**Core Competency**_**. **Do not ask or expect academic or business organizations to change their missions  or core competency-- allow each to do what they already do well.
_**Strategic Partnerships**_**. **Academic institutions should partner with qualified technology incubation and commercialization business professionals to serve as advisors, managers or technology commercialization contractors.

## Solutions: Bureaucratic Structure, Legal Restrictions, Regulations, & Time Delays

_**Review all operations**_** **and handbooks within institutions for restrictions or ambiguities that would hamper technology commercialization.** **
_**Review all relevant laws**_** **and change those that are not “commercialization friendly”.
_**Clarify the guidelines**_** **of federal and state laws as they relate to reporting requirements, ethics, and funding of investigators and technology commercialization.** **
_**Define timetables and streamline paperwork**_** **for intellectual property evaluation, patent applications, licensing, material transfer agreements, etc.
_**Invite an Industry Advisory Group**_** **to each academic campus to provide “real-world” input into the evaluation of intellectual property & academic programs.

## Some Solutions to Ineffective Management of Intellectual Property

_**Brutally evaluate**_** **an overall IP program for effectiveness: quantity and quality of agreements and formation of spin-off companies vs. internal investment.
_**Do a limited market survey**_** **of inventors and businesses that have recently done or attempted tech transfer; assess customer satisfaction and target areas that need change
_**Streamline the process**_** and **_**protect newly developed IP**_**. **
_**Provide IP education**_** **within the institution -- i.e, IP is not only patents,but trade secrets, know-how, etc.
_**Include Business Advisors**_** (with Confidentiality Agreements) **on the IP evaluation team of the academic institution  to help realistically evaluate commercial potential of a technology in the marketplace.

## Some Solutions to Lack of Individual Rewards for Inventors or Lack of University Administration Support

_**Define rewards**_** **for those who develop intellectual property with real commercial potential (i.e., promotion, tenure, and salary benefits)
_**Augment the rewards**_** **upon successful commercialization with incentives.
_**Publicize the inventions**_** **inside and outside the organization.
_**Educate administrators and inventors**_** **on how they can reap rewards if they stay within the institution or have an equity stake in a newly formed company.
_**Be honest and consistent**_** **in implementation.
_**A “Technology Commercialization Metric”**_** **or evaluation, with a reward system should be included for administrators as well as faculty or inventors.

## Some Solutions to Other Barriers

_**Education and mentorship**_** **for the fearful or inexperienced inventors: this includes internal and external evaluation of whether or not they should represent their technology; and
_**Infrastructure partnering, collaboration, and training**_** **can help leveraging of resources: Physical Space, Logistics, Manufacturing, or Equipment Needs.
**New grants and contracts **can be sought with multiple partners (e.g., industry and academia).

## Experience and Comments

_**True Partnership**_ and Commitment are Needed:
- Corporate partner not only looked at as source of money for R&D
- University partner not only looked at as disposable source of knowledge and product pipeline
- Lack of communication, ignorance, arrogance, difficult personalities, and indifference kill projects and partnerships

*Cont’d....*

## Experience and Comments

_**Manufacturing**_**:** From early development to the manufactured “BIO-widget in a box” as a product for sale
_**Market(s)**_ for the product: what and where they are & how to get there
_**Competition**_**:** Know and understand it; this product is not the only solution

*...Cont’d*

## The Need for Integrated Process and Product Development

- OR
- Getting it from the Laboratory Bench to a “Ready” Product

## Example: INCELL’s Approach to Develop a Safe and Effective Oral Smallpox Vaccine

**Example: INCELL’s Approach to Develop a Safe and Effective Oral Smallpox Vaccine**

## Overall Rationale, Approach and Goals to Safe Oral Smallpox Vaccine R&D and  Manufacturing

**2. **_**Processing Materials:**_ Choose those that have been used in the clinic or  already approved for clinical use.
**3. **_**Product manufacturing:**_ Use  methods and materials (e.g., closed, disposable systems) expected to increase potential for accelerated FDA approval.
*                           **cont’d....*

**Overall Rationale, Approach and Goals to Safe Oral Smallpox Vaccine R&D and  Manufacturing**

## Overall Rationale, Approach and Goals to Safe Oral Smallpox Vaccine R&D and  Manufacturing

**4. **_**Vaccine delivery:**_ Develop a safer method, e.g., oral delivery that stimulates mucosal and systemic immunity and removes need for needles or training of vaccinators.
**5. **_**End-product features:**_ Long shelf life, ease of packaging and storage, reasonable cost, easy delivery in clinics, primary care providers and third world countries; a prototype of future vaccines.
**6. **_**Product protection:**_ Patents pending.

- Patents, Trademarks, Know-How and Trade Secrets

**Overall Rationale, Approach and Goals to Safe Oral Smallpox Vaccine R&D and  Manufacturing**

## Oral Smallpox Vaccine: 

- Infected Cells

- Oral Delivery
- Platform

- Closed Systems
- for Culture

- Vaccinia virus:
- I-MVA

**Oravax********-****PX**

**Oral Smallpox Vaccine: **
**	****The Approach**

*** SBIR * **
**PENDING**
**project**

- Patents and Trade Secrets

**From R&D to  Manufacturing:**** ****1 year**

- 	Closed 	System
- BIO-Processing

## Perceptions  and Realities

- Many of the heralded
- “Technologies of Tomorrow”
- are already here.

## Convergent Technologies

**Convergent Technologies**

**Nanotechnology and other Convergent Tech**

**Engineering**

**Biotechnology, Medicine, other Life Sciences **

**Information & Communications**

## Perceptions  and Realities

- Technology commercialization in life sciences is complex and expensive.
- Nobody has all the answers.
- Teamwork is required.

## Perceptions  and Realities

- It is not a “them or us” scenario.
- It is the “we” that gets a job done.
- It is about people and relationships.

## The Technology Innovation and Commercialization Lifecycle*

**The Technology Innovation and Commercialization Lifecycle***

**Knowledge Creation**

**Technology Transfer**

**Commercialization**

**Clusters & Networks**

**Patents & Licenses**

**Incubators & Research Parks**

**Venture Capital**

**Business Development & Planning**

**IPOs/”Gazelles”**

**            ****Job Creation:   Labor Market/ Graduates**

**M&A and IPO Activity**

**Economies of Scale; New Manufacturing**

**Research & Development**

**Industry Consortia and  Partnerships**

**Regulatory Environment**

**Value-add**

**Testing: e.g., Clinical Trials**

**Regulatory Approvals**

**Universities and Research Institutions**

**Industry R&D: Product Pipeline**

**Proof of Concept Testing**

**Collaborations/ Partnerships**

**Licensing & Other Intellectual Property Transfer**

**Early Stage & Seed Capital**

**Intellectual Capital: Inventors & Serial Entrepreneurs**

**Philanthropy & Investment**

**Educate Inventors & Entrepreneurs**

**Pre-clinical and/or Beta Testing**

**Manufacture, Release & Market Product**

***Adapted from the Innovation Lifecycle of Richard Seline, New Economy Strategies**

- Conceive

- Mature

- Form

- Grow

## Experience and Comments

_**To the University Seeking to Transfer Technology**_
- Be sure the inventor is committed to work with the company, at least in the first stages of tech transfer.
- Have standard language and biolerplate to minimize legal bills for the company trying to get to an agreement.
- Do not assume that the company will have deep pockets.
- Do not assume that the company will pay all the legal fees up-front.
- Be frugal in defining legal fees, possibly including capping options for patents or other IP legal fees.
- Be sure the IP is “clean” and have signed agreements among co-investigators that may not be named on an invention but were working in the lab (or as a collaborator) at the time of the invention.
- Realize that product development is about much more than the science or invention alone.

## Experience and Comments

_**To the Scientist/Inventor/Engineer who wants to be an Entrepreneur**_
- This is an option for some, but not for the uncommitted.
- You may have skillset to lead company or you may be better as the Chief Technical or Chief Science Officer; or as a consultant to the company.
- Seek guidance and mentors; know the rules.
- Be careful but not paranoid about your IP; be sure the IP is “clean.”
- The university lawyer does not represent you. Keep the university informed.
- A company’s value is about much more than the science or invention alone.
- Find a business partner with the skills you need.
- Be sure your family supports your company formation goals.
- Be a realist; it must be a marketable product.
- Hire wonderful people and keep a sense of humor!

## TEKSA Innovations Corp.

_**Government**_
**Federal**
**State**
**Local**

_**Non-Profit**_
**Education**
**Research**
**Associations**

_**For-Profit Corporations**_

**Technical Advisors**

**Technical Advisors**

**Example of Assistance Organization**

**Special Manufacturing & GMP Facilities**

**INCELL**

**Staff**

**TEKSA  Director**

**ADVISORS**

**TEKSA Innovations Corp.**

_**Technical**_** ****Biomedical**
**Biotechnology**
**Engineering**
**Chemistry**
**Physics**
**Math**
**Environmental**
**Computer Science**

_**Business**_
**General business**
**Accounting**
**Financing**
**Banking**
**Legal**
**Marketing**
**Communications**
**Information Tech**

**Specialized Manufacturing**

**Technical Advisors**

**Business Advisors**

**Business Advisors**

**Business Advisors**

**New Corp Staff**

**New Corp Staff**

**New Corp Staff**

**New Corp Client 1**

**New Corp Client 2**

**New Corp Client 3**

_**P**__**ARTNERS**__**:**_
**Investors**

**Community**

**Consortium Affiliates**

- © 2002 TEKSA Innovations Corp.

## Summary

- The path from the university laboratory bench to business is complex, and not necessarily straight and easy .... but it is also challenging and exciting... and sometimes great fun!
- There are many considerations on all sides of the equation with more scientists and universities as active participants in the process.
- For many inventor-entrepreneurs and small companies the transition from R&D laboratory thinking to business thinking and actions has been greatly assisted by the SBIR program.
- The               program has been an integral component of INCELL’s seed funding, and project development that has led to product commercialization and manufacturing.

***SBIR***

## Thank you!

**Thank you!**