Management C

Resume, D aniel J. Knauer, Ph.D.

e-mail : ************@*****.***

M obile: 714-***-****

Oncology Biomarkers/Companion D i agnostics/Medical

Device Patent Support

Creative leader /Strong Academic and Pharmaceutical Background /Ph.D. in

B iochemistry with proven success facilitating profitable growth by bringing

t he latest translational medicine technologies and discoveries to patients and

healthcare professionals.

K ey competencies include:

Organization of biomarker Organizing key opinion leader

i nitiatives and clinical tr ial meetings

l aunches

Extensive knowledge of clinical

SAS software driven analysis of t r ials in Oncology and target

c linical trial data sets v iabil ity

Expert in latest technologies in Abil ity to identify and evaluate

R NA, DNA and proteomic and i ntellectual property with high

N GS biomarker translation to value in biomarker

p ractice development

Interfacing with physicians Abil ity to critically evaluate

a nd clinical trial teams to i ntellectual property using

develop biomarker strategies U SPTO, US PAIR and

p roprietary data bases

Establishing collaborative Federally and private

relationships with physicians fountadtion Funded for 26

a nd pathologists for human years as an academic

specimen access scientitst, excellent writer

Worked closely with patent

Extensive grant writ ing and

a ttorneys to evaluate prior art

a nd to write and submit contract writing experience

patents in US and abroad

Education

BSc. In Biology with Chemistry M inor, Northern Kentucky State University,

1975

MSc. In Biophysics, Western Kentucky University, 1979

Ph.D. In Biochemistry /Cell Biology, University of Nebraska, L incoln, 1979

I have taken direct responsibili ty for the generation and submission of several

patents working closely with patent counsel:

Awarded Patents

THE USE OF 2 ANTI-SPARC ANTIBODIES TO PREDICT RESPONSE TO

C HEMOTHERAPY

Tr ieu, V., Knauer, D. and Desai, N.

File Date: May 28, 2010

Award Date and Number: Feb. 26, 2013 8,383,358

F i led Patents

SPARC ANGIOGEN IC DOMAINS AND THE METHOS OF USE

Tr ieu, V., Knauer, D. and Desai, N.

File Date: Nov. 13, 2013

Application Number: 13256135

CFBRAF DNA FOR THE DETECTION OF METASTASIS I N ME LANOMA.

Ichetovkin, I, and Knauer, D.

Provisional Fi l ing Date: May 15, 2011

Employment H istory:

• Global Head of Oncology R & D, Vela Research USA, Fairfield, N J

(Feb 27, 2012-July 1, 2013)

• Mgr. of Biomarker Discovery, Abraxis Biosciences, Costa Mesa, CA

92626

(Aug. 2008 to Dec. 2011).

• Head of Protein Sciences, Abraxis Biosciences, Marina Del Rey, CA

90292

(Aug. 2006 – 2008).

• Professor of Biochemistry, University of California, I rvine (1980-2006).

Academic CV available upon request.

(Aug. 2008 to Dec. 2011) Mgr. of Biomarker Discovery,

A braxis Biosciences, Costa Mesa, CA 92626

M ain L ine Responsibilities:

O versight of Biomarker Discovery and I n te rface with “In-

House” CL IA Operation:

• Evaluation of biomarker l icensing opportunities.

• Management of in-l icensed biomarker patent portfolios.

• Extensive experience in Intellectual Property management.

• Go /No go decisions on biomarker development.

• Reduced to practice a 4 marker qRT-PCR assay for melanoma cell

detection in sentinel lymph nodes.

• Reduced to practice a 4 marker qRT-PCR assay for melanoma cell

detection in sentinel lymph nodes.

• Reduction to practice of RNA and DNA biomarkers using Sequenom

M ass-Array platform.

• Manage collaborations for proteome based biomarkers using laser

capture and SRM development on mass-spectrometer based platform.

• In house discovery using several platforms including meso-scale(MSD).

Oversight of Biomarker P rogram:

• Establishment and validation of I HC biomarkers

-RNA and DNA biomarkers

-proteome biomarkers.

• Coordination and management of KOL panels to evaluate biomarker

c linical uti l ity and acceptance.

• Working with CLIA approved vendors to collect and analyze biomarker

d ata for phase I I I tr ials to meet PAR11 compliance.

• Coordination with Clinical operations group to facil itate human tissue

specimen procurement and analysis.

• Interface with MSL’s to exploit opportunities for human tissue specimen

b iomarker analysis.

• Collaborating directly with pathologists and physicians to design

retrospective and prospective clinical trials to procure human clinical

specimens:

- MD Anderson Cancer Center in Houston,Texas

-The MAYO Clinic in Rochester, M innesota

- Fox-Chase Cancer Center in Philadelphia, Pennsylvania

-University of California-Los Angeles

-The Angeles Clinic in Los Angeles.

• Working with bio-stat consultants to appropriately power retrospective

a nd prospective clinical tr ials for statistical analysis.

• Designing of prospective and retrospective biomarker components on

h uman clinical trials to mature biomarkers for FDA fi l ings.

• Analysis of biomarker and clinical data to establish

t herapeutic /biomarker companion SAS and J MP software proficient.

• Coordinating with investigators on company sponsored and investigator

sponsored human clinical trial to compile, interpret and present results

a t International Meetings (AACR and ASCO).

Extensive Experience in I dentifying and Utilizing CRO’s to

S upport “In-House” Biomarker P rograms:

• Construction of Peptide L ibraries.

• Phage l ibrary panning.

• Pathology reports on I HC biomarker specimens.

• Procurement of commercial specimens for biomarker validations.

• FFPE block preparation from cell l ines for biomarker validation.

Technology and Licensing P rocurement

• Serving as team member outside technology l icensing.

• Evaluation of technology available for l icensing.

• Transfer of l icensed technology for “in house use”.

(Aug. 2006 – 2008) H ead of P rotein Sciences, Abraxis

B iosciences, M a r ina, Del Rey, CA 90292

• Generation and evaluation of potentially therapeutic monoclonal

a ntibodies including full biacore analysis.

• Monoclonal antibody target binding site identification using a

combination of synthetic peptide l ibraries and Biacore analysis.

• Scale-production and purification of monoclonals in automated

b ioreactors for use in animal studies.

• Generation of peptide binding sequences (phage display) and generation

of Fc –peptide fusion proteins with high affinity for selected

t argets(affibodies).

• Scale up and production of affibodies for use in animal studies.

• Whole animal f luorescence imaging to evaluate tumor target

engagement.

P rofessor of Biochemist ry, University of California, I r vine

(1980-2006). Academic CV available upon request.

P resentations and Publications Since Joining

A braxis, November 2006

SPARC Over-expression Enhances Sensitivity to Nab-

Paclitaxel in vivo. T r ieu, V. Hwang, J. Lowe, C. Mathiel, N., K nauer,

D ., and Desai, N. AACR Annual Meeting 2007, Apri l 14-18. Los Angeles, CA.

SPARC and CA19-9 as Biomarkers in Patients with

A dvanced Pancreatic Cancer. Desai, N. Ramantahan, N., Smith,

L ., Drengler, R. Wood, T., Laheru, D., H idalgo, M., Tr ieu, V., K nauer, D ., and

Von Hoff, D. ASCO-NCI-EORTC Annual Meeting on Molecular Markers in

Cancer 2008, Oct. 30-Nov1, Hollywood, FLA.

I dentification of the Albumin Binding Domain and the

A ngiogenic Domain of SPARC. K nauer, D . Hwang, L, Lowe, C.,

H wang, J., Norng, M., Wu, R., Trieu, V., and Desai, N. AACR Annual

Meeting, 2009, Apri l 18-22, Denver, CO.

Phase I I study of neoadjuvant gemcitabine, epi rubicin, and

a lbumin-bound nab paclitaxel (GEA) in locally

a dvanced breast cancer with SPARC t umor

assessments. D . A. Yardley, R. C. I nhorn, D. D aniel, B. D an iel,

Y. N aot, J. Zubkus, L. Simons, D . Knauer, V. T r ieu, N. Desai.

ASCO Annua l Meeting 2008, May 30-June3, Chicago, I l l.

SPARC and CA19–9 as biomarkers in patients with

a dvanced pancreatic cancer t reated with nab

p aclitaxel plus gemcitabine. L . S. Smith, R. L. D rengler, T.

E . Wood, D. A. L aheru, M. H id a lgo, M. J. Borad, V. T r ieu, D .

K nauer, N. Desai, and D. D. Von Hoff. ASCO Annual Meeting

2008, May 30-June3, Chicago, I l l.

Phase I I study of neoadjuvant bevacizumab and trastuzumab

administered with albumin-bound paclitaxel (nab paclitaxel) and

carboplatin in HER2+ locally advanced breast cancer. E. Raefsky, R.

Castil lo, A. Lahi ry, D. S. Thompson, S. Hanson, C. Meng, D. Knauer, V.

T r ieu, N. Desai, and D. A. Yardley. ASCO Annual Meeting 2008, May 30-

June3, Chicago, I l l.

Cor relation of SPARC, ER, PR, and H E R2 tumor with

p rogression-free survival from a phase I I neoadjuvant t r ial

o f gemcitabine, epi rubicin, and nab-paclitaxel. R. C. Inhorn,

B . Daniel, D. Daniel, Y. Naot, J. Zubkus, C. Lane, V. T rieu, D. Knauer, N.

Desai, D. A. Yardley. ASCO Annual Meeting 2009,

M ay 28-June3, Orlando, FL.

Results of a multicenter pilot study of weekly nab-

paclitaxel, carboplatin with bevacizumab, and

t rastuzumab as neoadjuvant therapy in H E R2+ locally

a dvanced breast cancer with SPARC cor relatives. D. A.

Yardley, E. Raefsky, R. Castillo, A. Lahi ry, R. LoCicero, D. Thompson, M.

S hastry, V. Tr ieu, D. Knauer, N. Desai. ASCO Annual Meeting 2009, May 28-

June3, Orlando, FL.

Detection of circulating cell-free BRAF V600E tumor D NA

i n melanoma patients. S. Manjeshwar, N. Keo, S.N. Markovic, L. Van

der Ploeg, D. Knauer, I. Ichetovkin A dvanced Diagnostics & Discovery. Nant

Holdings L LC, Costa Mesa, California. College of American Pathologist

A nnual Meeting, Dallas, TX, November 17–21, 2011

Detection of Ci rculating Cell-free BRAF V600E T umor D NA

i n Melanoma Patients. S. Manjeshwar 1, N. Keo1, M. Carter 1, S.N.

M arkovic2, L. Van der Ploeg1, P. Soon-Shiong1, D. Knauer 1, and I. Ichetovkin 1.

1

Nantworks, L LC, Costa Mesa, CA and 2Mayo Clinic and Research

Foundation, Rochester, MN. Perspectives in Melanoma XV, Brooklyn, New

York, Septemeber 16-17, 2011. 1Advanced Diagnostics & Discovery, Nant Holdings,

L LC. Costa Mesa, CA, 2Mayo Clinic. Rochester, M N

Publications

Biomarkers in Oncology ( In P ress, 2011) E dited by Heinz-Josef

Lenz, MD Chapter, Diagnostics: Improving Health care delivery, applications

to Cancer.

Lex HT Van der Ploeg#, Bud M ishra 1, Casimir Eitner 2, Jon Burrows2, Thomas

Tombler 3, Vladimi r Poponin 3, Dan Knauer 4, I l ia Ichetovkin 4, Rich Pinnola 5,

G reg Endress5 a nd Patrick Soon-Shiong 6 #Corresponding author, Nant, L LC,

l ***********@*********.*** 1Courant Institute, NYU, NY; 2Expression

Pathology, Inc, MD; 3ADD BioSensors, CA; 4ADD Diagnostics, CA;

5

NeoDiagnostix, L LC, MD; 6NANT, L LC, CA

Ci rculating Serologic and Molecular Biomarkers in

M alignant Melanoma. (2011) M ayo Clinic P roc. 86(10) 981-990.

S hanique R. Palmer, M.B.,B.S.1; Lori A. Erickson, M.D. 2; Svetomir N.

M arkovic, M.D., Ph.D 1, K nauer, DJ., Ph.D.3, and Ichetovkin, I.,

P h.D 3.Medicine, Mayo Clinic, Rochester MN, 2Department of Laboratory

Medicine and Pathology, Mayo Clinic, Rochester MN, 3Advanced Diagnostics

a nd Discovery, Nant Holdings, L LC, Costa Mesa, CA.

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