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Date Created: 12/22/15
Woubalem Birmachu, Ph. D. Scientific Assessment and Diligence & Drug Development Strategy 612-803-1891, firstname.lastname@example.org www.linkedin.com/in/woubalembirmachu/ Executive Summary __________________________________________________________________ Accomplished scientific and business professional with a proven track record in scientific assessment and diligence for product licensing and acquisition. Experience in sell-side and buy-side screening, scientific assessment and due-diligence. Seasoned scientist with experience in pharmaceutical discovery research and development (R & D) in the therapeutic areas of inflammation, immunology and dermatology. Proficient in crafting new product concepts, target product profiles and drug pipeline development strategy that address market needs. Highly competent in project management, competitive intelligence, people management, teambuilding and cross functional team leadership. Core Accomplishments________________________________________________________________ Scientific assessment and diligence for product licensing and acquisition: Conducted screening and scientific assessment and diligence for > 200 product opportunities from discovery to pre-commercial stage in support of licensing and acquisition. Scope of scientific assessment and diligence included discovery research, non-clinical pharmacology, clinical safety and efficacy and regulatory data. Conducted competitive intelligence, technology scouting and drug pipeline analysis to identify licensing opportunities Authored target product profiles and documents and presentations for in licensing and out licensing of products. Drug development strategy: Analyzed pharmaceutical pipeline portfolio and charted drug development strategy for several dermatology indications with focus on unmet clinical need and business success drivers. Recognized for strategy in formulating new product concepts which address significant market needs and high value to the business Pharmaceutical research and development (R&D): Seasoned pharmaceutical drug discovery & development research scientist Initiated and directed pharmaceutical discovery programs in the areas of inflammation and immunology resulting in clinical candidates. Implemented new technologies, including high throughput screening and a pharmacogenomics laboratory for selection of clinical candidates and clinical biomarker discovery. Contributed to clinical trials design and authored clinical sections for FDA regulatory submissions. Cross-functional team leadership: Team leader of multi-disciplinary discovery research teams and corporate-wide cross functional drug pipeline development strategy teams Recognized for an inclusive and empowering leadership style Project and talent management Integrated cross-functional discovery research efforts across discovery disciplines Managed corporate-wide cross-functional drug pipeline development strategy projects Supervised and managed the performance and professional development of several scientists 1 Woubalem Birmachu, Ph. D. Scientific Assessment and Diligence & Drug Development Strategy Professional Work Experience__________________________________________________________ 02/2013 - present WB Biotech-Pharma Consulting Inc. Principal Consultant, Drug Development, Scientific Assessment, Licensing Providing consulting to pharmaceutical and biotechnology companies Identify pharmaceutical assets for licensing Conduct scientific assessment and diligence for pharmaceutical product licensing and acquisition Consult on drug discovery and development strategy and pharmaceutical pipeline portfolio strategy 01/2011 – 12/2012 Medicis Pharmaceuticals, Scottsdale, AZ Associate Director Scientific Assessment, Business Development Conducted scientific assessment and diligence for medical dermatology product opportunities resulting in several licensing and acquisitions. Indications included psoriasis, atopic dermatitis, acne, actinic keratosis, non-melanoma skin cancers and cutaneous T Cell Lymphoma Conducted competitive intelligence for 12 core dermatology indications to identify new licensing opportunities and understand competitive landscape Lead a cross-functional team responsible for charting drug development strategy for a pharmaceutical pipeline portfolio Charted drug development strategy for a drug pipeline portfolio across several dermatology indications Generated development plans and target product profiles for products being assessed for licensing 10/2008 - 08/2010 CIMA Labs Inc. Brooklyn Park, MN Senior Manager New Technology, Business Development Led a cross-functional team to identify and recommend new product concepts for pharmaceutical drug pipeline development Conducted scientific assessment of delivery technology capabilities to identify new technologies for potential licensing Produced target product profiles and documents and presentations for out- licensing of products 12/2007 - 08/2008 3M Medical Division St. Paul, MN Senior Research Specialist, Medical diagnostics & Food Safety Led scientific assessment of external technologies for licensing of novel food pathogen diagnostic platforms Managed integration of acquired new products and product improvements 04/2002 - 11/2007 3M Pharmaceuticals St. Paul, MN Senior Research Specialist, Research & Development Pharmacogenomics Spearheaded pharmacogenomics efforts to support preclinical and clinical drug development research based on Toll-like receptor (TLR 7 & 8) dependent innate immune modification for the therapy of dermatology diseases and oncology Identified biomarkers of drug response for clinical development Contributed to the design of clinical protocols and reports for FDA regulatory submissions Contributed to the scientific assessment and prioritization of new drug discovery 2 Woubalem Birmachu, Ph. D. Scientific Assessment and Diligence & Drug Development Strategy programs in inflammation and immunology 04/1993 - 03/2001 3M Pharmaceuticals St. Paul, MN Research Specialist, Discovery Research Initiated and championed a drug discovery program for inflammation therapy and established primary and secondary assays for lead identification and optimization Led a highly integrated and productive cross functional discovery program team recognized as a model team in the company Led a multidisciplinary exploratory discovery research team for immunology targets and directed research focused on assay development Implemented high throughput screening (HTS) automation system and new fluorescence based HTS assays for several targets Established the infrastructure for pharmacogenomics laboratory including micro array gene expression analysis and medium density TaqMan arrays 01/1990 - 03/1993 3M Pharmaceuticals St. Paul, MN Senior Biochemist, Discovery Research Managed a biochemistry lab in support of various discovery programs in inflammation and TLR-based immune modification 01/1985 - 12/1990 University Minnesota Minneapolis, MN Postdoctoral associate, Research associate, Department of Biochemistry Conducted research on the rotational dynamics of cardiac Ca-ATPase in sarcoplasmic reticulum utilizing time-resolved phosphorescence anisotropy and time-resolved fluorescence resonance energy transfer Education _________________________________________________________________________ Ph. D. Chemistry, University of Toronto, Toronto, Ontario, Canada Master of Science Chemistry, University of Toronto, Toronto, Ontario, Canada Bachelor of Science Chemistry/Biochemistry University of Toronto, Mississauga, Ontario, Canada Professional Development ___________________________________________________________ Preparation of FDA Submission and Communicating with the FDA (INDs, NDAs, BLAs, ANDAs, ABLAs, Post-Approval Supplements, Center for Professional Innovation & Education, Inc. Los Angeles, CA December 7-8, 2011 Drug Development Process- From Discovery to Commercialization, Center for Professional Innovation & Education, Inc., King of Prussia, PA November 9-11, 2011 Business development basics for professionals in the sciences, Licensing Executives Society, Chicago IL, May 1-3, 2010 Finance for non-financial managers, Carlson School of Management Executive Education, University of Minnesota, April, 19-22, 2010 AUTM Technology Valuation Course, AUTM Conference, New Orleans, LA, March 20, 2010 Fundamentals of competitive intelligence, Strategic and Competitive Intelligence Professionals, Alexandria, VA, Nov 30-Dec 01, 2009 Professional Affiliations ____________________________________________________________ American Association of Dermatology 3 Woubalem Birmachu, Ph. D. Scientific Assessment and Diligence & Drug Development Strategy American Association of Pharmaceutical Scientists (AAPS) Strategic and Competitive Intelligence Professionals (SCIP) Association of University Technology Managers (AUTM) Controlled Release Society (CRS) Publications & patents ______________________________________________________________ Patents and publications in peer-reviewed journals, upon request 4
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