Medical Device

RESUME

JOHN S. SUNDSMO, Ph.D.

CONTACT INFORMATION:

MAIL: P.O. BOX 927, SAUSALITO, CA. 94966

AND, 44 SOUTH PORTOLA RD., LAGUNA BEACH, CA. 92651.

TEL: 760-***-****

EMAIL: ******@*****.***

1990. Registered US Patent Agent. #34,446.

2009. Certified Medical Writer Professional (CfPIE)

2009. NSF Peer Review Panel Member: Medical Device, Chemistry, Drug

Development SBIR Grants

CAREER SUMMARY:

PhD, Microbiology/Immunology, University of Washington, Seattle.

Post-doctoral, Molecular Oncology, Fred Hutchinson Cancer Research Center,

Seattle.

Post-doctoral, Molecular Immunology, Scripps Research Institute, La Jolla,

CA.

Assistant Member I/II, Molecular Immunology, Scripps Research Institute, La

Jolla, CA.

Biopharmaceuticals in positions of responsibility from Senior Scientist,

Manager, Director, VP and CSO to President, CEO and Chairman of the Board

-1998-present. Private Practice dba BioMedPatent Consulting

IP SKILLS

o Small molecule pharmaceutical chemical patent practice

o Protein and carbohydrate biochemistry practice

o In vitro diagnostic devices

o Light mechanical, electrical, wireless and computer assisted business

process patenting

o IP strategy, licensing, strategic business planning, partnering and co-

development

o Complex docket management

o Freedom-to-operate, infringement and competition analysis

o Patent and prior art searching and patentability analysis

o Client counseling, strategy development and intellectual property

tracking

o Patent application preparation US and Foreign

o Patent prosecution US and Foreign -(including Interference and

Opposition Practice)

o Reviewing and assessing third party patents

o Liaison with outside counsel on business and patent matters

o Patent auditing and valuation for merger and acquisition

o Litigation support

o With advice of counsel: MTAs, CDAs, corporate partnership agreements,

letters of intent, consulting agreements, scientific advisory board

agreements, employment agreements, SCRO/ESCRO/IRB documents

AREAS OF PRACTICE

o Light mechanical, electrical, wireless, computer assisted business

processes

o Pharmaceutical organic, biochemical and carbohydrate chemistry

o Stem Cell Biology (ESC, iPS cells)

o Molecular Biology (genetic markers and targets)

o Gene Transfer (retroviral vectors)

Areas of Practice (continued)

o Cell Biology (cell cycle)

o Molecular Immunology (anti-inflammatory agents)

o HTS assays

o In Vitro Diagnostic Assays and Devices (infectious diseases)

o Wound Healing

o Oncology (Rx/Dx)

o Parkinson's (dopaminergic compounds)

o Alzheimer's disease

o Auto-Immune Disease (SLE/RA)

o Ophthalmology (ARMD)

Pharmaceutical Chemistry (dopaminergic agents)

o Carbohydrate Chemistry (glycolipids)

o Drug delivery (cyclodextrin)

o Agricultural

o Light Mechanical and Hydraulics

o Catheters

o Drug Delivery

o Electronics/Telecommunications

o Business Methods

o Genetic Markers (SNPs)

o

. Management Positions:

President and Director of Intellectual Property, PrimeGen Biotech,

LLC, Irvine, CA (2007-2008)

CSO and Director of Intellectual Property, International Medical

Innovations, Inc., Birmingham, AL (1999-2006)

CEO, TransCell Therapeutics, Inc. (2001-2004)

(1993-2001)

Director, Intellectual Property, SIBIA Neurosciences (La Jolla, CA)

- now Merck

Director, Intellectual Property, Cytran Corporation (Redmond, WA)

Co-Founder and Director of Intellectual Property, Phage

Therapeutics, Inc. (Bothell, WA)

Co-Founder, RACE Pharmaceuticals, Inc. (Bothell, WA)

(1990-1993)

Associate, Christensen, O'Connor (Seattle, WA) - (1983-1990)

Clients: University of Washington, Fred Hutchinson Cancer Research

Center, Virginia Mason Clinic, Pathogenesis, NeoRx, Cytel,

University of California, CTI)

Senior Scientist and Project Leader, Extramural Research, Triton

Biosciences division of Royal Dutch Shell Oil (Alameda, CA) - now

Berlex

Senior Scientist and Project Leader, Immunology, Collagen

Corporation (Palo Alto, CA)

Manager, Product Development, Synbiotics Corporation (San Diego, CA)

(1998-present)

Founder, BioMedPatent Consulting, Laguna Beach and Sausalito, CA.

ACCOMPLISHMENTS:

o 2007-2008, President, PrimeGen Biotech. In addition to management and

corporate business development responsibilities for a staff of 23 and

budget of $4.5M/yr, authored and co-invented patent applications (n=5) for

non-viral induced pluripotent stem (iPS) cells; authored technology

platform patent applications for identification and isolation of murine,

primate and human germ line stem cells (n=2); and, authored other patent

applications (n=2) for identification and isolation of satellite stem cells

from human adipose tissue.

o 1999-2006, CSO, International Medical Innovations, Inc.. In addition

to CSO and business development roles, authored and co-invented technology

platform small molecule (organic/carbohydrate chemistry) patent

applications (8) for trans-dermal nitric oxide delivery, adipose tissue

regeneration, Parkinson's disease, and blood brain barrier drug delivery by

accessing endothelial glucose (GLUT1/3) receptors.

o 1998-2001, Founder, BioMedPatent Consulting. Authored and prosecuted

technology platform patent applications for clients including: Anomeric,

Inc. (cytofluorimetry, in vitro diagnostics), RACE Pharmaceuticals (anti-

fungal agents), Phage Therapeutics (bacteriophage therapeutics), Drug Risk

Solutions (hair testing for drugs of abuse) and Proweh Inc. (electronic

business processes for drug testing).

o 1997-1998, Director, Intellectual Property, SIBIA Neurosciences (now

Merck). Successfully managed complex dockets involving in-licensed,

co-developed and co-assigned technologies (e.g., Salk Institute,

Phillips Petroleum, BRISTOL MYERS SQUIBB, INC., NOVARTIS, ELI LILLY)

through merger and acquisition by MERCK, i.e., involving 65 pending US

and 22 pending international applications.

o 1995-2001, Co-Founder, Phage Therapeutics. In addition to laboratory

experimentation and corporate business development roles, developed patent

strategy for bacteriophage therapeutics in view of 50 yrs. prior art

documents; and, co-invented, drafted and prosecuted staphylococcal

bacteriophage patent applications (10).

o 1993-1994. Associate, Weiss, Jensen, Seattle. Crafted and prosecuted

patent applications in mechanical, hydraulics, wireless, electronics and

software. Conducted patent Auditing and Evaluation in support of business-

legal M&A, i.e., acquisition, restructuring and equity financing for two

publicly traded Northwest biotechnology companies.

o 1990-1993. Associate, Christensen, O'Connor. Authored and prosecuted

patent applications (APPENDIX A) in molecular genetics, microbiology,

immunology, cell biology and pharmaceutical chemistry, i.e., in the general

areas of:

. Cancer biopharmaceuticals

. HTS targets (e.g., cell cycle: Max, Mad and cyclin E; cell adhesion: E-

laminin and oncofetal fibronectin)

. Cancer diagnostics (e.g., cyclin E as prognostic colon cancer marker)

. Pharmaceutical chemistry (e.g., cyclodextrin drug delivery, glycosyl

dopaminergic compounds

. Chemical synthesis of THC analytes, carbohydrate chemistry)

. Genomics (e.g., chromosome 14 Alzheimer's gene)

. Gene therapy (e.g., retroviral vectors and packaging cells)

. Infectious disease (Dx/Rx)

. Medical devices (catheters)

.

. Drafted patent applications used to secure seed investment in CELL

THERAPEUTICS, INC. and PATHOGENESIS (now Chiron); and, to secure

acquisition of VIAGENE by CHIRON

. Helped Win the Count in Interference by helping to design the Count,

establish priority with reduction to practice in laboratory notebooks,

i.e., in a three way interference between NYU, MIT and FRED HUTCHINSON

CANCER RESEARCH CENTER (in re US5,219,740 Miller, A.D. and T. Palmer.

Retroviral gene therapy).

. Helped Gain Allowance of the Hall Yeast Expression System patent

originally filed in the early 80s became the expression system

utilized for Humulin, Human Growth Factor and other recombinant human

proteins (Client: WASHINGTON ALUMNI RESEARCH FOUNDATION).

. Clients included: the UNIVERSITY OF WASHINGTON (Office of Technology

Transfer and Washington Research Foundation), FRED HUTCHINSON CANCER

RESEARCH CENTER, ICOS, NEORX, CELL THERAPEUTICS, INC., CYTEL, INC.,

ZYMOGENETICS, INC., VIRGINIA MASON CLINIC and UNIVERSITY OF

CALIFORNIA.

o Project Leader, Triton Biosciences, Inc. Successfully overcame European

challenge brought by Max Plank and German Cancer Research Centers with

more than 200 references (cytokeratin tumor markers); successfully

identified more than 100 alleged trade secrets (BioRad Laboratories v.

Triton Biosciences)

Litigation Support

o Sole Allowed Expert Witness: BioRad Laboratories, Inc. v. Triton

Biosciences Inc. (Trade secret dispute; successfully identified 350 of 360

alleged trade secrets as in the scientific art (case settled).

o Litigation Support and Witness: SIBIA v. Cadus Pharmaceuticals, Inc.

(District Court jury judgment for infringement and $10M damages; Overturned

on appeal after Merck acquisition).

Transactions Support

o Experienced in- and out-licensing, co-development partnerships,

contracts, University relations, academic/medical science liaison, CDAs,

MTAs, Board Member Agreements, Consulting Agreements, Employment

Agreements, trade secret and patent infringement analysis and litigation.

PATENTS AND APPLICATIONS (INVENTOR):

US 4,760,131. Sundsmo, J.S., G. Ksander, R. Ross, and J. McPherson. Novel

Wound Healing Composition.

EPA 243,179, AU 8,771,914; JP 63,054,328. Sundsmo et al. Soft Tissue Wound

Healing Composition Comprises Fibrillar Collagen, Heparin, or Heparin-like

Glycosaminoglycan and Chemotactic, Growth or Differentiation Factor.

US 6,478,750. Morrison et al. Hair Collection Device for Drug Testing.

US 200********. Eden, T. and J.S. Sundsmo. System and method for

implementing an employee-rights-sensitive drug free workplace policy.

US 200********. Morrison, J.F., Sundsmo, J.S., Selavka, C.M. and D.H.

Brill. Compositions and processes for analysis of pharmacologic agents in

biological samples.

US 200******** Christian, S.T. and J.S. Sundsmo. Pharmaceutical dopamine

glycoconjugate compositions and methods of their preparation and use.

WO 200-***-**** Kannemeier, C., Marh, J., Howerton, K. and J. Sundsmo. Non-

viral delivery of transcription factors that reprogram human somatic cells

into a stem cell-like state.

Honors and Accomplishments

. Registered US Patent Agent (#34,446; 1990) with law firm

(Christensen, O'Connor, Seattle) and private practice

(BioMedPatent) experience - i.e., patent applications, licensing,

contracts, agreements and general business legal.

. CMWP, Certified Medical Writer Professional (CfPIE, 2009)

. NSF Peer Reviewer for SBIR grant applications (2009)

. BioCom Board Member (San Diego Biotechnology Industry Organization

(2008)

CONTINUING EDUCATION:

Bioinformatics: DNA Star for ORFs, BLAST, dotter, FASTA, etc. for

alignment; Medline for ferreting cell biology and protein-structure

function; predictive protein structure/function proteomics to create

patenting; Linux user; Self-Educated: D. W. Mount, "Bioinformatics", CSHLP,

2001; A.D. Baxevanis and B.F.F. Ouellette, "Bioinformatics", John Wiley,

2001; Unix for the Impatient, P.W. Abrahams and B.A. Larson, Addison-

Wesley. 1997

FDA-Regulatory Affairs: preIND-Overview: UCSD Extension, Three Day for

credit course- Q2/ 2001 (passed); cGLP: UCSD Extension, Three Day for

credit course- Q2/ 2001 (passed)

2009 Course Certificates:

"Overview of FDA Regulatory Compliance For Medical Devices" (CfPIE, July

2009, 14 hrs.) with Exam; Passed

"Technical Writing for the Pharmaceutical, Medical Device and Biotech

Industries", (CfPIE, Sept. 2009, 21 hrs.) with Exam; Passed

"Writing Effective Standard Operating Procedures and Other Process

Documents" (CfPIE, Nov. 2009, 14 hrs.) with Exam; Passed

"Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval

Supplements) and Communicating with the FDA" (CfPIE, Nov.-Dec., 14 hrs.)

with Exam, Passed

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