Vladimir A. Makarov, PhD, MBA

*** **** **** ******

Thousand Oaks, CA 91320

626-***-**** (c)

ac0muy@r.postjobfree.com

SUMMARY

Computational biologist with extensive business management experience.

Ph.D. in Structural and Computational Biology (Baylor College of Medicine, a major public genomics research center), MBA with focus in leadership and finance.

Over 30 years of experience, from start-up companies to Fortune 50. Entrepreneur; co-founder and/or seed-stage employee in five high-tech start-ups, one of which is now a public company.

Skilled in algorithm development, team leadership, management and planning.

SKILLS

Management and Leadership

Strategic planning: alignment of IT and business objectives, business process analysis and reengineering, gap analysis, organizational design, change management expertise. Practical knowledge of multiple strategy planning methodologies: Whitaker, Porter 5 forces, Ishikawa, Boston Consulting Group (BCG), Balanced Scorecard. Project Portfolio management: Earned Commercial Value, Celanese scoring model, Real Options Valuation, risk-reward diagramming.

Venture experience: Technology valuation (DCF, comparables), hands-on patent and trademark filings (US PTO), knowledge of securities regulations (in particular, Regulations A and D, Rules 504, 505, 506 for private offerings).

Line management: experience in development of effective operating policies and procedures; goal setting; personnel hiring and evaluation; creation of objective performance metrics; motivating and coaching.

Product management: product definition, Minimal Viable Product (MVP); requirements gathering and analysis, prototyping, feature prioritization, implementation planning, release management.

Project management: certified Scaled Agile leader; formal waterfall (Stage-Gate) and agile (XP, Scrum) methodologies; Rational Unified Process; Risk Analysis; estimation, cost management and budget analysis (Total Cost of Ownership (TCO), Real Options models); Program Evaluation and Review Techniques (PERT); variance analysis; developing schedules, proposals, change management; expert stakeholder management. History of project delivery on time and on budget.

Commercial experience: proposal development (sell-side), contract review, negotiation and management (buy-side), domestic and off-shore sourcing experience; Service Level Agreements (SLA).

Quantitative analysis expertise: Monte-Carlo simulations, dynamic system models, queuing models, knowledge of statistics: regression, PCA, classification.

Communication skills: over two decades of experience in public speaking, presenting, and teaching. Authored multiple peer-reviewed research papers. Expert in group facilitation and brainstorming, including specific training on appreciative inquiry, active listening, decision-making techniques (GE Workout, DeBono Six Hats, others).

International management: Fluent in English and Russian languages. Extensive work experience with international teams and cross-cultural management, including working with business partners, suppliers and clients in Russia, Ukraine, UK, Netherlands, France, Singapore, India and China.

Bioinformatics

Sequence assembly: Phred/Phrap/Consed, SSAKE, SHARCGS, VCAKE, Newbler, Celera Assembler, Euler, Velvet, ABySS, AllPaths, Tophat, Cufflinks, Bowtie, SAMtools/BAMtools.

Sequence analysis: BLAST, FASTA, Smith-Waterman, multiple alignment methods, HMMer; protein identification and function prediction, SignalP, Vector NTI, Gene Codes Sequencher, neural networks, Bayesian statistics.

Genomics: UCSC Genome Browser; Ingenuity Pathway Analysis; BioConductor; GeneGo MetaCore.

Public databanks: NCBI GenBank, SwissProt; InterPro, pFam; PDB, CATH, SCOP; KEGG; SNP consortium; NCBI Gene Expression Omnibus, EMBL Array Express, ChipDB, ExpressDB; NCI Theasurus, NCI GeneConnect, NCI Pathway Tools, DIP Database, Cancer Gene Index, Gene Ontology (GO), Broad Institute MsigDB, Online Mendelian Inheritence in Man (OMIM), Stanford Source, TCGA, ONCOMINE

Molecular modeling: Accelrys Insight II, QUANTA, CHARMm, Xplor, Felix, MODELER, GROMOS

Cheminformatics, compound registration and computer-assisted drug design (CADD): Accelrys, CambridgeSoft, Molsoft, MDL ISIS, ACD software; QSPR, ADME property prediction, virtual screening; PK/PD: Pharsight WinNonLin

Scientific data management software: LIMS: (Thermo Scientific SampleManager; LabVantage (formerly ABI) SQL*LIMS v.4, v.5; Labware); Waters (formerly NuGenesis) SDMS, ELN, Empower Chromatography Data System (CDS); CambridgeSoft ELN; BIOVIA (former SciTegic) Pipeline Pilot; Agilent ChemStation, GeneSpring, Cerity (OpenLab) SDMS; Labtronics LimsLink, Collect; Spotfire DecisionSite; pharmacovigilance (Oracle AERS (former EventNet), ARISg, Argus, Clintrace); TranSMART (translational research environement); statistical analysis: MATLAB, Minitab

Health IT: HL7, International Classification of Diseases (ICD), Logical Observation Identifiers Names and Codes (LOINC), RxNorm, National Drug Codes (NDC), Current Procedural Terminology (CPT), Healthcare Common Procedure Coding System (HCPCS)

Mathematical modeling: frequentist and Bayesian statistics; sampling, hypothesis testing, Principal Component Analysis; dynamic systems modeling for business processes, chemical reactions and metabolic pathways; models based on partial differential equations; Queuing models; dynamic programming; numerical optimization algorithms: linear programming, simulated annealing, gradient descent; Monte-Carlo numerical simulation; neural networks; MATLAB, torch.

Information Technology

Technology management: technology assessment; systems integration; information retention, disaster recovery and back-up planning; Master Data Management (MDM); data, systems and facilities security; helpdesk management (Peregrine) and capacity planning; asset management (Maximo); configuration management (IBM Tivoli); telephony (PBX), VoIP, unified messaging.

Architecture: SDLC, UML, Sparx Systems Enterprise Architect, Business Process Management (BPM); Service Oriented Architecture (SOA), web services; cloud computing: SaaS, IaaS, PaaS, MS Azure, BT Cloud Compute, Amazon AWS; Application Delivery Networks (ADN) and Load Balancing (Citrix, F5 systems); virtualization (VMWare).

Workflow, Collaboration, CMS: Documentum; MS Sharepoint; Wordpress and various Wiki systems.

Business Systems: Customer Relationship Management (CRM) and sales (salesforce.com, Sugar CRM, Microsoft Dynamics), Ariba, ERP (J. D. Edwards, SAP), Learning Management Systems (LMS: ISOtrain, Blackboard, Sum Total, Web Tycho), QMS/Change Management (Sparta Systems Trackwise); MS Project and MS Project Server; versioning: Redmine, Jira, Subversion (SVN), CVS.

Quality and compliance management: knowledge of formal systems validation procedures, IQ, OQ, PQ, test-driven development, unit and regression testing; prior experience with external vendor audits and internal IT compliance audits; Design History File (DHF) development and maintenance.

Regulatory compliance: FDA procedures, 21CFR11 requirements; SOX; ISO 9001, 13485; GxP, GAMP, HIPAA.

Data warehousing, database development, reporting and business intelligence: Oracle up to 11g, SQL, PL/SQL, Quest TOAD; Erwin; MySQL; Mongo DB; Hadoop, HBase; Cognos

Programming: C/C++, Ruby, PHP, Fortran; Java, J2EE (Swing, JDBC, servlets, JSP, JMS); WebWork framework; Tomcat AS, Resin AS, Oracle TopLink; R (GNU S+), MATLAB; XML; High-Performance Computing and parallel programming (MPI, LSF); MUMPS/M

Operating Systems: UNIX (Linux (Red Hat, Ubuntu, SuSe), Solaris, SGI IRIX); all versions of Windows from 3.1 to 10

ACHIEVEMENTS

2016 Illumina, La Jolla, CA

Consultant, Sr. IT Product Manager

In charge of commercial and technical development of BaseSpace Sequence Hub, Illumina’s NGS software platform. Prioritized requirements, wrote technical marketing literature, consulted on team and business unit alignment and the Illumina Clinical Transformation program.

2015 – 2016 British Telecom, El Segundo, CA

Propositions Specialist/Life Sciences Project CTO – an internal consultative role

Pharmaceutical and biotechnology industry domain and scientific lead.

Pioneered projects in regulatory compliance and computer systems validation in the cloud, Big Data mining, translational research (TranSMART) PaaS, next-generation cloud-based collaborative research management service, digital transformation of supply chain and distribution.

Managed collaborations with the Genomics Institute of Singapore (part of Singapore A*Star cluster), BIOVIA Science Cloud, and BINA Technologies (Roche NGS start-up).

Managed technical requirements for BT Cloud Compute offerings, developed contracts and statements of work, introduced BT to decision makers in prospective client companies, consulted on risk-based project management, ran industry-specific computing benchmarks, trained sales staff.

2014 – 2015 Prosapia Genetics LLC, Thousand Oaks, CA

Founder

Prosapia Genetics commercialized computational ancestry algorithms developed at the University of Southern California (see Nature Communications, doi:10.1038/ncomms4513).

Complete cycle of corporate development from initial license agreement negotiation to product marketing and finally to business sale to a private investor.

2010 – 2014 IFXworks LLC, Thousand Oaks, CA

Founder and Principal, US Army Civilian Contractor, big data mining and biomarker discovery

Winner of the US Army SBIR grant, contract number W81XWH-11-C-0036. Research in the statistical methods for biomarker discovery from multidimensional –omics data and systems biology.

Important technology applications include discovery and validation of gene expression biomarker panels for exposure detection to multiple chemical threats, radiation poisoning, and diagnostic panels for certain cancers, in particular, Oral Squamous Cell Carcinoma (OSCC). Manuscript in preparation.

Complete profit and loss responsibility.

Hired and trained the development team, selected technologies and tools, set objectives, managed budgets, analyzed risks, conducted development iterations, interacted with the DoD and other federal agencies, prepared periodic project reports to the US Army standards.

2010 – 2012 Monsanto Corp., Cambridge, MA

Bioinformatics and Data Management Lead (Director)

Turned around the performance of the data management group by applying the best practices in business-IT alignment, project portfolio prioritization, and agile project management. Managed budgets, projects, and a team with multiple FTEs, contractors, and matrixed relationships.

Developed IT processes and process improvement plans. Participated in long-term information management strategy planning for the Protein Optimization Program and later for the Enabling Technologies organization.

Managed integration of the Cambridge site systems with the company-wide LIMS (Labware).

Contributed to R&D collaborations between Monsanto and MIT, Harvard University, Boston University and Protabit LLC (CalTech start-up firm) in the areas of bioinformatics, data management, and computational protein design.

2009 – 2010 Baxter Healthcare Corp., Westlake Village, CA

Consultant, Scientific IT Project Manager

Architected enterprise solutions for automated data capture from analytical instruments, ELN, LIMS and long-term information retention. Developed risk-based validation plans for these systems.

Provided IT Management expertise. Advised client on stakeholder, expectation and risk management and iterative project development approaches. Wrote contracts for engagements with multiple third-party vendors, managed parts of Baxter’s relationship with IBM, planned vendor audits.

2007 – 2008 Pfizer, La Jolla, CA

Consultant, Global Project Manager

In charge of development of Outsourcing Relationship Management (ORM) system that serves as an Electronic Data Interchange (EDI) between Pfizer and its worldwide medicinal chemistry and screening research partners. Total project budget ~ $3 million, total team size over 50 people.

Introduced iterative project management methodology at Pfizer (RUP-like).

Re-negotiated contracts with vendors and consultants in favor of Pfizer by tying payments to specific deliverables and time lines.

Managed project schedule and budget. Mentored and coached associates.

Delivered on time and under budget.

2006 – 2007 Amgen, Inc., Thousand Oaks, CA

Sr. Business Analyst, Process Development Information Systems

Created information systems development strategy for the global Process Development and Clinical Operations. Developed business cases for projects to implement the designed strategy, with estimated NPVs ranging from $2 million to $50 million.

Pioneered a number of management methodologies at Amgen: Whitaker 4 column strategy analysis, RUP project management, techniques for financial valuation of IT investments and quantitative models for work order queues, earning high praise from executive management.

2003 – 2006 Ceres Inc., Thousand Oaks, CA

Ceres is a biotechnology company pursuing opportunities in green plant trait development and bio-fuels in collaboration with Monsanto, Noble Foundation and USDA. I joined Ceres in 1998 as employee #36, and returned to the company as a manager in 2003.

Manager of Research Computing

Tripled the yield of finished sequence through business process re-engineering and improvements to quality control procedures.

Made a major contribution to Ceres data warehouse and massively parallel computing infrastructure, critical to company ability to secure a key contract with Monsanto Co. valued in excess of $147 million.

PRIOR EXPERIENCE

2001 – 2005 Company Co-Founder, Peristat Group LLC, a medical device start-up, Los Angeles, CA

2003 – 2010 Adjunct Professor, Dept. of Mathematics, Cal State Univ. Channel Islands, Camarillo, CA

2001 – 2009 Adjunct Professor, Biotechnology, University of Maryland University College, Adelphi, MD

2001 – 2003 Scientist, Eidogen Inc., Pasadena, CA

2000 – 2001 Sr. Scientist, Paracel, a Business of Celera Genomics, Pasadena, CA

1998 – 2000 Computational Scientist, Ceres Inc., Malibu, CA

1995 – 1998 Researcher, Dept. of Chemistry, University of Houston, Houston, TX

EDUCATION

2007 MBA, Pepperdine University, Los Angeles, CA

1998 Ph.D., Computational Biology, Baylor College of Medicine, Houston, TX

1994 M.S., Chemistry, Northern Illinois University, DeKalb, IL

1992 Diploma summa cum laude, Biophysics, Moscow State University, Moscow, Russia

CERTIFICATIONS Scaled Agile Framework (SAFe) number 010*****-****

PERSONAL US Citizen

PUBLICATIONS

1.Makarov, V.A., and A. Gorlin, “Computational Method for Discovery of Biomarker Signatures from Large, Complex Data Sets”, 2015-2017, manuscript in preparation.

2.Feldmann, K., Brover, V., Makarov, V.A., and T. Swaller, “Nucleotide sequences and polypeptides encoded thereby useful for modifying plant characteristics”, US Patent 7,569,389, granted August 4, 2009, Assignee: Ceres, Inc.

3.Shaitan, K.V., Levtsova, O., Makarov, V.A., and M. Kirpichnikov, “A Study of the Mechanism of Action of Zervamicin IIB Peptide Antibiotic by Molecular Dynamics Simulation”, 2009, Nature Precedings, http://precedings.nature.com/documents/3624/version/1

4.Ianchulev T., Pham P., Makarov V.A., Francis B., and D. Minckler, “Peristat: a computer-based perimetry self-test for cost-effective population screening of glaucoma”, 2005, Curr Eye Res., v. 1, 1-6

5.Makarov, V.A., “Computer programs for eukaryotic gene prediction”, 2002, Briefings in Bioinformatics, v. 3, 195-199.

6.Makarov, V.A., Pettitt, B.M. and M. Feig, “Solvation and Hydration of Proteins and Nucleic acids: a Theoretical View of Simulation and Experiment”, 2002, Accounts of Chemical Research, v. 35, 376-384.

7.Makarov, V.A., Andrews, B.K., Smith, P.E. and B.M. Pettitt, "Residence Times of Water Molecules in the Hydration Sites of Myoglobin", 2000, Biophys. J., v. 79, 2966-2974.

8.Pettitt, B.M., Makarov, V.A. and B.K. Andrews, "Protein Hydration Density: Theory, Simulations and Crystallography", 1998, Curr. Op. Struct. Biol., v. 8, 218-221.

9.Makarov, V.A., Feig, M., Andrews, B.K. and B.M. Pettitt, "Diffusion of Solvent Around Biomolecular Solutes. A Molecular Dynamics Simulation Study", 1998, Biophys. J., v. 75, 150-158.

10.Makarov, V.A., Andrews, B.K. and B.M. Pettitt, "Modeling the Protein-Water Interface", 1998, Biopolymers, v. 45, 469-478.

11.Puig, A., Primm, T.P., Surendan, R., Lee, J.C., Ballard, K.D., Orkiszewski, R.S., Makarov, V.A. and H.F. Gilbert, "A 21-kDa C-terminal Fragment of Protein disulfide Isomerase has Isomerase, Chaperone, and Anti-chaperone Activities", 1997, J. Biol. Chem., v. 272, 329**-*****.

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