Daniel Bednarik, Ph.D.

Daniel Bednarik, Ph.D.

13055 St. Patrick’s Ct. – Highland, MD 20777 – (443) 864.1445 – dbednarik@gmail.com

Profile:  Executive * Translational Scientist * Consultant

Accomplished and tenacious biopharmaceutical researcher and manager with extensive experience in leading the development of new clinical and research technologies and in guiding business and product development by new and established companies.

  • Genomics and bioinformatics database design/implementation – Cardiovascular emphasis
  • Expert in viral infectious diseases – Emphasis on retrovirology, herpes virology
  • Animal model development – Cardiovascular and infectious disease relevance
  • Translational medicine – Genomic-based discoveries to small molecule therapeutics
  • Stratification of cardiovascular clinical trials using human biomarkers
  • FDA Advisory Committee participation in Cardiome Pharma cardiovascular trials
  • Co-Founder of Artesian Therapeutics, Inc. – Heart failure drug discovery
  • Extensive consulting experience across multiple genomic, infectious disease, and cardiovascular applications
  • Experienced with Dept. of Defense funding processes – DARPA/BARDA

Professional Cardiovascular Experience (Chronologically Descending Order)

Cardiome Pharma Corporation – 2005 to 2012

Cardiome Pharma is a research & development-based biopharmaceutical company dedicated to the discovery, development, and commercialization of new therapies focusing on the treatment of atrial fibrillation and heart failure with one product, Brinavess™ (vernakalant IV) approved in Europe and partnered with Merck.

Director of Cardiovascular Genomics & Bioinformatics, 2007–2012

Identified, recommended, and facilitated the integration of current and new bioinformatics and genomic technologies to assist in development and preclinical and clinical testing of the company’s pharmaceutical product pipeline. Designed biomarker strategies and complimentary animal models for early preclinical studies and worked with project teams to advance biomarker, genetic, and translational medicine study plans. Advanced project milestones with the goal of identifying individuals who do not respond to particular drugs.

  • Lead manager for the company’s acquired Beta-Receptor Pathway Modulator (BRPM) heart failure program.
  • Identified targets and designed studies for new ion channel antagonist small molecules.
  • Developed arrhythmia biomarker FDA genetic sub-study for Vernakalant Oral Phase-IIb clinical trial and database development.
  • Developed Cardiac Hypertrophy Inhibitory Pathway Modulator (CHIPM) program targeting CXCR4 receptor to inhibit cardiac hypertrophy and remodeling.
  • Introduced new bioinformatics approaches to stratify cardiovascular clinical trials.
  • Identify potential biomarkers and efficacy surrogates for use in clinical trials and advise regarding the evolution of FDA and EMEA guidelines for the use of biomarkers.
  • Designed animal models for pre-clinical studies.
  • Participated with Merck on partnering/FDA meetings for Vernakalant program.

Consultant (post acquisition), Scientific Affairs & Cardiovascular Disease, 2005–2007

Managed the post-acquisition drug program transition and integration of Artesian Therapeutics assets, and supported the design, molecular screening, and animal model testing of Artesian compound libraries.

  • Managed acquired Beta-Receptor Pathway Modulator (BRPM) and Calcium Regulatory Pathway Modulator CRPM programs (Artesian).
  • Prepared program proposals for a new theranostic drug-development paradigm.

Artesian Therapeutics, Inc. – 2002 to 2005

Vice President & Co-Founder, Cardiovascular Biology, Artesian Therapeutics, Inc., 2002–2005

Artesian Therapeutics was a discovery-based biotechnology company that translated the gene expression technology and transcriptome content from gene logic into therapeutic drug leads. Artesian was a spinout from Gene Logic Inc. a company based on using of new gene-expression technology to determine gene-expression patterns in diseased tissue and cells.

  • Co-Founder of Artesian Therapeutics, Inc. via Oxford BioScience Partners (Cambridge, MA).
  • Identified pivotal heart disease genes and translated findings to 3 led drug candidates for the treatment of heart failure.
  • Established an in vitro analysis paradigm for drugs and validation paths for CRPM and BRPM Program small-molecule development for IND filing.
  • Designed data-driven, animal model studies for heart failure and cardiovascular disease.
  • Developed the proprietary Affimetrix GeneChip® database for heart failure drug discovery and patented more than 275 heart failure gene-expression profiles for diagnostics and therapeutics.
  • Raised $7M in venture capital (Oxford Bioscience Partners) and was instrumental in executing the VC partners’ exit strategy of finding a buyer (Cardiome) for Artesian.

Gene Logic, Inc. – Gaithersburg, MD

Scientific Director, Cardiovascular Database Product Development 1997–2002

Gene Logic was a discovery-based biotechnology company that pioneered gene-expression based content comparing transcriptomic profiles from diseased tissue and cells to healthy, normal equivalents. The company licensed this content to major pharmaceutical firms for drug target discovery, with focus in multiple disease categories including cardiovascular, cancer, and cns.

  • Designed and deployed the largest known database for heart failure and vascular disease in collaboration with Proctor & Gamble, Temple University Medical School, and Tufts University.
  • Designed preclinical animal model studies for heart failure and cardiovascular disease to elucidate disease gene-expression profiles.
  • Translated gene-expression data into marketable information for subscription by multiple world-class pharmaceutical companies.
  • Defined and secured collaborative human tissue-procurement and research alliances with major heart failure centers, hospitals, and universities worldwide.
  • Participated in the development of GeneChip®-based paradigms and algorithms for data mining, drug discovery, development, and regulatory process.
  • Provided business- and product-development strategies to management and established relationships with 7 major pharmaceutical industry subscribers focused in cardiovascular disease.
  • Cardiovascular Experience (Chronologically Ascending Order)
  • Cardiovascular Experience (Chronologically Ascending Order)

Non-Cardiovascular Experience (Descending Chronology)

Intrexon Corporation – Germantown, MD, 2012 (present)

Senior Director Operations, Molecular Engineering Unit Operations (MEU) 2012

Intrexon Corporation is a billion dollar capitalized company that designs novel gene therapy solutions. Intrexon’s approach is to combine the principles of precision engineering, statistical modeling, automation, and production at an industrial scale for the development of improved or novel products.

  • Provides molecular engineering support for the company’s programs and pharma partnering in terms of proprietary gene design technology needs to facilitate drug and/or product development across a spectrum of corporate divisions and sectors.
  • Health sector disease areas include cardiovascular, inflammation, cancer, infectious disease, and veterinary applications.
  • Works closely with the Chief Scientific Officer, President, Human Therapeutics Division (HTD), and the Cell Engineering Unit (CEU) to accelerate translation of gene therapy technology to applications in the clinic.

Ablitech – Baltimore, MD 2012

A startup firm with a proprietary technology for delivering nucleic acid-based drugs, the firm has received approximately $2M in funding through a Department of Defense contract.

Director, Scientific Advisory Board

Assembled and presently lead an advisory board of recognized scientific experts to guide corporate goals and ensure scientific integrity. The board oversees multiple grant-funding initiatives and maximizes capitalization for forward-looking fiscal objectives and assists the CEO in identifying and enabling private equity investors. It also manages all translational application of the core technology and identifies appropriate corporate and academic partnerships.

Cardiome Pharma Corporation – 2005 to 2012

Head, Infectious Disease Pilot Program, 2011–2012

As described above – Ion channel infectious disease therapeutics program

Conceived and developed a novel viral ion channel target program using synthetic biology approaches for the screening and testing of new, best-in-class antiviral molecules.

  • Develop and implement a screening platform to identify novel inhibitors of the viroporins for several problem viruses.
  • Determine the effectiveness of identified molecules to block the life cycles of HCV, Dengue, and Influenza viruses.
  • Implement strategy for validation, IND filing, and progression into the clinic.
  • Seek and execute new pharma partners for development of ion channel-based antivirals.

Advanced Bioresearch Associates, Rockville, MD 1997

A regulatory consulting firm serving the pharmaceutical and medical device industries.

Director of Scientific Affairs

Performed due diligence of scientific and technical literature and prepared reports for IND submissions to the FDA and for corporate and venture partners of startup companies in these spaces. Served as a primary consultant for new product development to pharmaceutical and medical device companies.

Human Genome Sciences, Inc. – Rockville, MD 1993–1997

A biopharmaceutical corporation founded in 1992, it utilizes the human genome to develop protein and antibody drugs and, in partnership with such firms as GlaxoSmithKline, have drugs under development to treat such diseases as hepatitis C, systemic lupus erythmatosis, anthrax, and cancer.

Senior Scientist

Identified, sequenced, and cloned novel human genes for the development of therapeutic proteins. Performed bioinformatics analysis on novel human genes, and prioritized gene selection for therapeutic development. Led the acquisition of all human tissues and sequencing of genes from those tissues. Supervised two technicians and was a key contributor to the development of one of the world’s largest bioinformatics databases.

  • Co-authored patents for 182 secreted proteins as therapeutic development candidates.
  • Identified and cloned novel seven-transmembrane receptors for development by GlaxoSmithKline (GSK).
  • Developed high-throughput biological validation assays for functional analysis of human genes, and pre-clinical animal models.

Consulting Experience

  • Immune Design Corp., Seattle, WA, 2011
  • CD Diagnostics, Inc., Philadelphia, PA, 2010-2011
  • Indel Therapeutics, Inc., Vancouver, BC, 2009-Present
  • ProteiosBio LLC, Charlottesville, VA, 2011
  • NX PharmaGen, Inc., Miami, FL, 2009-Present
  • BioIT Solutions, Inc., Silver Spring, MD, 2012-Present
  • Susavion Biosciences, Inc., Tempe, AZ, 2012
  • Cardioxyl Pharmaceuticals, Inc., Towson, MD, 2007-2009
  • ExonHit Therapeutics, Inc., Gaithersburg, MD, 2007-2009 (Consulting Director, Business Development)
  • Bradmer Pharmaceuticals, Inc., Miami, FL 2006-2009
  • Advanced Bionutrition (ABN), Columbia, MD, 2006

Education

The Johns Hopkins Oncology Center, The Johns Hopkins University         1985–1989

Postdoctoral Fellow / Junior Faculty Member (Instructor)

Studied mechanisms of viral latency, and molecular mechanisms of interferon action. Participated in department programmatic development and teaching and authored multiple publications and book chapters.

  • Discovered DNA methylation as a mechanism for HIV latency and mechanisms of HIV activation by herpes simplex and cytomegalovirus.
  • Elucidated novel biological pathways for interferon-mediated inhibition of HIV transcription and assembly.
  • Developed novel recombinant gene therapy modalities for the inhibition of HIV transcription.

Temple University School of Medicine                                                 Ph.D. in Biochemistry, 1985

M.S. in Biochemistry, 1982

Rider University                                                                                          B.A. in Biology, 1980

Grants & Contracts

  • Canadian Institutes of Health Research (CIHR). A Novel Approach for the Discovery & Development of New Antiviral Therapeutics (Awarded); Partnered Operations Grant Application – Cardiome Pharma Corp. & University of British Columbia (2012). Total $1,900,000 for 5 years.
  • American Foundation for AIDS Research (AmFAR). Methylation as a Modulator of Expression of HIV.  Research Grant #RG-000639 (1989-1991); Total direct costs $50,000; Total indirect costs $9,100.
  • The National Institutes of Health (NIH). Regulation of HIV Latency by Methylation of Proviral DNA.  Young Investigator Award; #1-R29-AI-28567-01A1-ARR3 (1989).  Total direct costs $350,000; Total indirect costs $224,686.
  • DARPA BAA 06-31. “Crustacean Expression System for the Accelerated Manufacture of Pharmaceuticals.” 42 month term – $6.2M  (2006) – Phase-I awarded (DTRA contract HDTRA1-07-C-0078 $1.7M Phase-I, Advanced BioNutrition Corp. (Consultant for ABN).
  • Upon Request

Publications, Patents, & Additional Background

Selected Publications

Margulies KB, Bednarik DP, Dries DL. Genomics, transcriptional profiling, and

heart failure. J Am Coll Cardiol. 2009 May 12;53(19):1752-9. doi:

10.1016/j.jacc.2008.12.064. Review. PubMed PMID: 19422981; PubMed Central PMCID:

PMC2738978.

Margulies KB, Matiwala S, Cornejo C, Olsen H, Craven WA, Bednarik D. Mixed

messages: transcription patterns in failing and recovering human myocardium. Circ

Res. 2005 Mar 18;96(5):592-9. Epub 2005 Feb 17. PubMed PMID: 15718504.

Jung AS, Quaile MP, Mills GD, Bednarik DP, Houser SR, Margulies KB.

Pharmacological effects of ATI22-107

[2-(2-{2-[2-chloro-4-(6-oxo-1,4,5,6-tetrahydro-pyridazin-3-yl)-phenoxy]-acetylami

no}-ethoxymethyl)-4-(2-chloro-phenyl)-6-methyl-1,4-dihydro-pyridine-3,5-dicarboxy

lic acid dimethyl ester)], a novel dual pharmacophore, on myocyte calcium cycling

and contractility. J Pharmacol Exp Ther. 2005 Feb;312(2):517-24. Epub 2004 Nov

18. PubMed PMID: 15550574.

Please see Dan Bednarik Profile

Daniel Bednarik

Daniel Bednarik’s Background

BIOSKETCH: Daniel Bednarik was previously Director of Genomics and Bioinformatics for Cardiome Pharma Corporation. He was previously co-founder and Vice President of Cardiovascular Biology of Artesian Therapeutics, Inc., which was acquired by Cardiome in 2005. Dr. Bednarik served as a consultant for Cardiome for two years and was subsequently hired in 2007 to develop genomic and proteomic biomarker programs to help augment and accelerate clinical trial design. He created the largest known cardiovascular gene expression database for Gene Logic. Dr. Bednarik served as a key scientist for the development of Human Genome Sciences’ (HGS) database and has over 28 years experience in the field of virology with emphasis on HIV and herpes virus pathology. He was co-recipient of a DARPA contract in 2006 where he and his colleagues developed a novel non-host method for rapid vaccine manufacture. Dan also is experienced in developing and managing clinical programs. His training was completed at Temple University School of Medicine (Philadelphia) in 1985, and The Johns Hopkins University Oncology Center (Baltimore).

IN MY CURRENT POSITION OF SENIOR DIRECTOR, MOLECULAR ENGINEERING UNIT (MEU) OPERATIONS, I provide molecular engineering support for the company’s programs and “External Channel Partner” collaborations in terms of proprietary gene design technology needs to facilitate drug and/or product development across a spectrum of corporate divisions and sectors.  Works closely with the Chief Scientific Officer (MEU), President, Human Therapeutics Division (HTD), and the Cell Engineering Unit (CEU) to accelerate translation of technology to application in the clinic or other venues.

Key areas include:

  1. Construction of orally inducible gene therapy solutions – biologic, RNAi.
  2. Novel delivery of gene therapy solutions – viral, nonviral, nanoparticle.
  3. Novel cell-based production platform development.
  4. Veterinary, food science, health sector, bioinformatics, and other.

Specialties:Recruitment of private capital, Bioinformatics/Genomics, Clinical Program Development & Management, Pharmacogenomics, Virology, Translational Medicine, Heart Disease.

Please visit my LinkedIn Profile – http://www.linkedin.com/in/danielpbednarikdanielbednarik