chemical entrepreneurship #3 - academia to entrepreneurship · 5/20/2013 6 2013 chemical...

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5/20/2013 1 We will start momentarily at 2pm ET Contact ACS Webinars™at [email protected] Download the presentation and slides ONE WEEK after the webinar: http://acswebinars.org/chemical-entrepreneurship-2013 1 Have Questions? Use the Questions Box! Or tweet using #acswebinars Contact ACS Webinars™at [email protected] 2 Download the presentation and slides ONE WEEK after the webinar: http://acswebinars.org/chemical-entrepreneurship-2013

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5/20/2013

1

We will start momentarily at 2pm ET

Contact ACS Webinars™at [email protected]

Download the presentation and slides ONE WEEK after the webinar:

http://acswebinars.org/chemical-entrepreneurship-2013

1

Have Questions?

Use the Questions Box!

Or tweet using #acswebinars

Contact ACS Webinars™at [email protected] 2

Download the presentation and slides ONE WEEK after the webinar:

http://acswebinars.org/chemical-entrepreneurship-2013

5/20/2013

2

TO DESCRIBE ACS WEBINARS… THANK YOU FOR THE SUBMISSIONS!

Contact ACS Webinars™ at [email protected]

ONE WORD

excellent

entertaining

brilliant

enthusiastic

precise

3

If you enjoy ACS Webinars every Thursday…

please support the program!

4

Find the many benefits of ACS membership!

www.join.acs.org

5/20/2013

3

5

See all of our ACS Webinets on YouTube at

http://bit.ly/acswebinets

“Feeling short on time? ACS Webinets are 2

minute segments that bring you valuable

snippets from some of our most popular full

length ACS Webinars ”

Q: “Hungry for a brain snack?”

A: on

TM

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Green Chemistry Business Plan Workshop - June 19, 2013 At the 17th Annual Green Chemistry and Engineering Conference

In North Bethesda, Maryland (just outside Washington, DC)

Learn how to craft the perfect pitch and successfully

attract venture capital investment!

For more information please visit

http://gcande.org/green-business-plan-workshop 6

Schedule Topic

9:30 – 10:45 Business Plan Panel Discussion

10:45 – 11:15 How to develop a Business Plan

11:15 – 11:45 What is a Term Sheet

11:45 – 12:15 What needs to be in a Pitch

12:15 – 3:30 Lunch on your own + Conference Networking

3:30 – 5:30 Business Plan Pitches

5/20/2013

4

Upcoming ACS Webinars™ www.acswebinars.org

Thursday, April 25, 2013

Protect Your IP:

A Guide to the Newly Implemented Patent Laws

Mr. Michael Brodowski, Burns & Levinson LLP

Dr. David Harwell, ACS Career Management and Development

Thursday, May 9, 2013

Sous Vide Cooking Chemistry

Mr. Douglas Baldwin, Author

Dr. Sara Risch, Director of R&D and QA for Popz Europe

Contact ACS Webinars™ at [email protected] 7

Acknowledgement:

The 2013 Chemical Entrepreneurship Series is

co-produced by UC San Diego von Liebig

Entrepreneurism Center.

8 Contact ACS Webinars™at [email protected]

http://www.jacobsschool.ucsd.edu/vonliebig

5/20/2013

5

Upcoming ACS Webinars™ www.acswebinars.org

“Everyone today must think like an entrepreneur whether it’s in your own

business, a large corporation or a nonprofit organization.”

Continues Thursday, May 16, 2013 @ 2PM ET

Learning how to develop the next big start-up has never been so entertaining!

ACS members who attend 7 out of 9 sessions get a Certificate of Completion.

Contact ACS Webinars™ at [email protected] 9

Chance to win Neil’s Book:

Contact ACS Webinars™ at [email protected]

How could graduate programs better prepare their

students for entrepreneurism?

10

[email protected]

Share with us on

or by email at

(Search for acswebinars)

5/20/2013

6

2013 Chemical Entrepreneurship Series:

From Academia to Entrepreneurship

Download the presentation and slides ONE WEEK after webinar:

http://acswebinars.org/chemical-entrepreneurship-2013

ACS WEBINARS™ April 18, 2013

Co-produced with UC San Diego’s von Liebig Center

Dr. Magda Marquet

Founder, Althea

Technologies

Dr. Mike Chi

CTO, Cognionics, Inc.

Barbara Bry

COO, Blackbird Ventures

11

Magda Marquet, Ph.D.

Co-Chair & Co-Founder

12

5/20/2013

7

Mission Statement

“We partner with our customers to accelerate the

introduction of innovative therapeutics and

vaccines to the global market by providing the

highest quality, value added product

development and manufacturing services.”

13

Company Profile

• Recently acquired by Ajinomoto

• 250 Employees

• >75,000 Sq. Ft. of Manufacturing, Laboratory

and Warehouse Space

• >110 Active Clients in 2012

14

5/20/2013

8

2012 2000

History & Milestones

15

1998 2003 2011 2008

Founded in San Diego

by Magda Marquet, Ph.D.

and Francois Ferre, Ph.D.

Plasmid kits, biomarkers,

and gene quantification

cGMP Fill Finish

Manufacturing

2009

Large Scale

Facility Completed

1st Commercial

Customer Signed

Acquisition of

WindRose

Analytica

Protein Analytics

Services

AltheaDx

Spun-Out

Acquired Altus Pharmaceuticals’

Protein Crystallization Technology

cGMP Biologics

Manufacturing

2010

Successful

PAI Inspection

of Large Scale

Commercial

Facility

Campus Expansion

brought Analytics

to San Diego

2nd Commercial

Product Signed

Leadership Team

Corporate Leader Title

Rick Hancock President & CEO

Martha Demski CFO

Chris Duffy Senior VP Operations

EJ Brandreth Senior VP Quality & Regulatory Affairs

Jack Wright VP Sales & Marketing

Melissa Rosness Senior Director, Biologics & Business

Processes

16

Seasoned professionals with extensive experience and proven track records.

5/20/2013

9

Client Experience

Clients range from virtual, small and large biotech/pharma,

international, government and universities.

• Seven Clients from Top 10 Biotech/Pharma

• >350 Clients and 600+ Client Projects

Proven track record of cGMP manufacturing success.

• Cell Banks: >300

• Biologics: >160 Protein & Plasmid GMP Lots

• Fill/Finish: >500 Projects / >1,700 GMP Lots

17

Services & Solutions

18

Clinical Trials

I, II, III Preclinical Commercial

Drug Substance

Drug Product

Manufacturing

Vial & Syringe Filling

Complex Formulation

Process Development/Optimization

Lyophilization

Protein & Plasmid DNA Production

Phase 2 Phase 1 Phase 3 Pre-clinical Commercial

Analytical Methods Development & Validation

Reference Standard Qualification & Product Characterization

Stability & Release Testing

Comparability Studies

Product

Development

Process Characterization/Validation

5/20/2013

10

Althea Crystal Technology

Proprietary Protein Crystal Formulations

• Sustained Release

• High-Concentration

• cGMP Capability

• Multiple Lots Produced

• Equipment and Skids On-Site

19

Regulatory History

• Average 4-6 Customer Audits per Month

• 28 QP Inspectors (Germany, UK, Belgium, France)

• FDA Inspection – 2005, 2008, 2011, 2012

• PAI: 2 Commercial Products – April 2011

• EMA & Health Canada Inspection – Expected 2013

• FDB Licensed (California) – Current

• Type II DMF & Type V BMF

• Site Master File

20

5/20/2013

11

Value-Added Althea Quality

• Continuous Improvement Program: Trending, Quality Metrics,

Management Review

• PDA, ISPE Leadership Assures Leading-Edge Policies

• Broad Base of GMP Qualified Vendors – Reduces Material

Procurement Risks

• Multinational Compliance Program – Maximizes Clinical Flexibility

• Internal Calibration, Validation, QC Chem, QC Micro, Doc Control

21

Why Althea?

• Experience

• Flexibility

• Scalability

• Customized Solutions

• Reliability

22

5/20/2013

12

Thank You!

We Look Forward To A Successful

Partnership

23

Do you need industry experience to be an

successful entrepreneur?

• No, if you got it…you got it!

• Yes, definitely

• Maybe, whatever my advisor says

24

5/20/2013

13

January 18th, 2011

Yu M. Chi

Chief Technology Officer

UCSD Graduate Student (Ph.D. Degree 2011)

Department of Electrical and Computer Engineering

Integrated Systems Neuroengineering Laboratory

Cognionics, Inc.

[email protected]

January 18th, 2011

About Cognionics

UCSD spin-off from Prof. Gert Cauwenberghs’ research

Started operations in summer 2011

Currently 7 employees on payroll

2000 sq. ft. R&D office in San Diego

First commercial licensing deal signed in 2012

First commercial product will be on the market mid 2013

Support and funding via SBIR grants and research

contracts from:

5/20/2013

14

January 18th, 2011

Today’s ECG/EEG sensors, however:

-Require adhesives and skin-irritating gels

-Number one patient complaint against mobile ECG/EEG

devices

-Need for new, patient-friendly, sensor technologies

-Large usability barrier outside of laboratory environments

ECG/EEG:

-Simple to build

-Inexpensive to use

-Non-invasive for the subject

-Widely used in clinical and research settings

-Diagnostically useful information

Motivation

January 18th, 2011

Cognionics Non-contact Sensors

Many different companies working in this space, yet none have achieved widespread market acceptance. All have significant issues with poor signal quality. There is no technology that can achieve a

good signal without the use of gels, through clothing and on freely moving subjects.

Cognionics has expertise and a new proprietary technology for high-quality, non-contact, through-clothing sensor. It is based on a patent-pending amplifier design from UCSD that overcomes many of the

practical limitations in this field.

5/20/2013

15

January 18th, 2011

Cognionics Dry Contact Sensors

Conventional EEG electrodes suffer from similar usability problems as their ECG

counterparts – but on much larger scale (22 to 256 sensors vs. 10).

Prior dry electrode designs used hard metal pins

which were uncomfortable, potentially unsafe in

ambulatory use g.tec

Cognionics Flexible Dry

Electrode:

January 18th, 2011

UCSD Assistance

Advisor: Michael Elconin (now C.E.O.)

Development of market research and business plans

Assistance with securing university intellectual property

Critical outsider’s feedback and sanity check (!) on the technology

Assistance with business launch and funding strategy

Start-up business boot-camp for the engineering graduate student

Opportunity to practice pitches and test business plans

Many many events for learning, publicity and networking

Provided $45.5K of start-up funds and services to launch the company

5/20/2013

16

January 18th, 2011

Company Milestones

First R&D lab in apartment bathroom – 10/2010

Officially started operations – 6/2011

Awarded DARPA research contract – 10/2011

Awarded NASA SBIR – 11/2011

First Licensing agreement – 5/2012

Awarded NIH SBIR – 7/2012

Moved into 2000 sq. ft. office – 12/2012

Selected for DARPA SBIR – 3/2013

About to first distributorship agreement with product

release mid-2013

7 patent applications filed

Do you feel your grad training has prepared

you to become a successful entrepreneur ?

• No and therefore I’m tuning into this

webinar.

• Yes, but I did not advantage of all the

resources.

• Yes, all I need is $.

32

5/20/2013

17

The Keyword is…

FISH HOOK

ACS WEBINARS™ April 18, 2013

33

ACS members who attend 7 out of 9 sessions get a Certificate of Completion.

2013 Chemical Entrepreneurship Series:

From Academia to Entrepreneurship

Download the presentation and slides ONE WEEK after webinar:

http://acswebinars.org/chemical-entrepreneurship-2013

ACS WEBINARS™ April 18, 2013

Co-produced with UC San Diego’s von Liebig Center

Dr. Magda Marquet

Founder, Althea

Technologies

Dr. Mike Chi

CTO, Cognionics, Inc.

Barbara Bry

COO, Blackbird Ventures

34

5/20/2013

18

Acknowledgement:

The 2013 Chemical Entrepreneurship Series is

co-produced by UC San Diego von Liebig

Entrepreneurism Center.

35 Contact ACS Webinars™at [email protected]

http://www.jacobsschool.ucsd.edu/vonliebig

Stay Connected…

ACS Network (search for group acswebinars)

www.communities.acs.org

LinkedIn (search group for acswebinars)

www.twitter.com/acswebinars

www.facebook.com/acswebinars

Contact ACS Webinars™at [email protected] 36

5/20/2013

19

Upcoming ACS Webinars™ www.acswebinars.org

Thursday, April 25, 2013

Protect Your IP:

A Guide to the Newly Implemented Patent Laws

Mr. Michael Brodowski, Burns & Levinson LLP

Dr. David Harwell, ACS Career Management and Development

Thursday, May 9, 2013

Sous Vide Cooking Chemistry

Mr. Douglas Baldwin, Author

Dr. Sara Risch, Director of R&D and QA for Popz Europe

Contact ACS Webinars™ at [email protected] 37

Upcoming ACS Webinars™ www.acswebinars.org

“Everyone today must think like an entrepreneur whether it’s in your own

business, a large corporation or a nonprofit organization.”

Continues Thursday, May 16, 2013 @ 2PM ET

Learning how to develop the next big start-up has never been so entertaining!

ACS members who attend 7 out of 9 sessions get a Certificate of Completion.

Contact ACS Webinars™ at [email protected] 38

5/20/2013

20

Chance to win Neil’s Book:

Contact ACS Webinars™ at [email protected]

How could graduate programs better prepare their

students for entrepreneurism?

39

[email protected]

Share with us on

or by email at

(Search for acswebinars)

Green Chemistry Business Plan Workshop - June 19, 2013 At the 17th Annual Green Chemistry and Engineering Conference

In North Bethesda, Maryland (just outside Washington, DC)

Learn how to craft the perfect pitch and successfully

attract venture capital investment!

For more information please visit

http://gcande.org/green-business-plan-workshop 40

Schedule Topic

9:30 – 10:45 Business Plan Panel Discussion

10:45 – 11:15 How to develop a Business Plan

11:15 – 11:45 What is a Term Sheet

11:45 – 12:15 What needs to be in a Pitch

12:15 – 3:30 Lunch on your own + Conference Networking

3:30 – 5:30 Business Plan Pitches

5/20/2013

21

If you enjoyed this ACS Webinar today…

please support the program!

41

Find the many benefits of ACS membership!

www.join.acs.org

ACS Webinars™ does not endorse any

products or services. The views expressed in

this presentation are those of the presenter

and do not necessarily reflect the views or

policies of the American Chemical Society.

42 Contact ACS Webinars™at [email protected]

5/20/2013

22

Upcoming ACS Webinars™ www.acswebinars.org

Thursday, April 25, 2013

Protect Your IP:

A Guide to the Newly Implemented Patent Laws

Mr. Michael Brodowski, Burns & Levinson LLP

Dr. David Harwell, ACS Career Management and Development

Thursday, May 9, 2013

Sous Vide Cooking Chemistry

Mr. Douglas Baldwin, Author

Dr. Sara Risch, Director of R&D and QA for Popz Europe

Contact ACS Webinars™ at [email protected] 43