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Blue Skies Business Model

Blue Skies Business Model. Life Sciences Practice April 8, 2011. Agenda. Mission, Vision and Values Goals & Objectives - 2011 Practice Area Analysis Industry Analysis Customer Analysis (Hanno) Analysis of Competition (Hanno) Marketing Plan (Paul) Operational Plan (Paul) Management Team

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Blue Skies Business Model

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  1. Blue Skies Business Model Life Sciences Practice April 8, 2011

  2. Agenda • Mission, Vision and Values • Goals & Objectives - 2011 • Practice Area Analysis • Industry Analysis • Customer Analysis (Hanno) • Analysis of Competition (Hanno) • Marketing Plan (Paul) • Operational Plan (Paul) • Management Team • Financial Plan

  3. Mission, Vision and Values • Mission • Help Life Sciences customers maximize their business potential by delivering strategic business solutions, focused on process and data integrity, rooted in quality and compliance. • Vision • Deep Life Sciences industry experience combined with vast expertise in information technology, management consulting and quality assurance makes our consultants uniquely positioned to exceed our customer’s expectations every day. Structured methodologies and innovative solutions makes our team a leader in providing business and systems solutions for the Life Sciences industry. • Values • Leadership, integrity and objectivity positions our consultants as trusted advisors for our clients. We build long-term client relationships based on our people, industry leading solutions and commitment to quality.

  4. Goals & Objectives - 2011 • Goals • Grow client and consultant base to establish a more predictable business operation and income stream • Increase rates and profit margins to allow more time spent on business development activities • Establish a sales organization, process and pipeline to allow for making better and more predictable hiring/staffing decisions • Establish partnership with one of the big 4 consulting firms to accelerate our business growth • Add quality assurance/systems consulting resource to round out the Blue Skies service offerings to cover all quality assurance areas • Objectives • Establish Blue Skies as a strong niche Life Sciences consulting organization in Southern California for the Medical Device industry • Grow profitably to meet the financial business plan goals and generate $3.35mm in revenues • Meet gross revenue target of 15% while meeting the • Add two medium size clients with long-term projects • Productize service offerings to grow net new consulting sales • Improve focus on farming activities within existing clients (J&J, DJO and MicroVention in particular)

  5. Practice Area Analysis • Reduced # of service offerings  no laundry list • Simplified descriptions of major offerings  elevator speech • Services “productized” everywhere possible  predictable scope • PRIMARY SERVICE OFFERINGS

  6. Service Offerings

  7. Service Offerings

  8. Service Offerings

  9. Industry Analysis Life Sciences Industry Definition Environmental science Evolutionary biology Evolutionary genetics Food science Genetics Genomics Health sciences Immunogenetics Immunology Immunotherapy Medical devices Medical imaging Medicine Microbiology Molecular biology Nanotechnology Neuroinformatics Neuroscience Oncology Optometry Personalized medicine Pharmacogenomics Pharmacology Agrotechnology Bio-engineering Biomedical science Biochemistry Biocomputing Biocontrol Biodynamics Bioinformatics Biology Biomaterials Biomechanics Biomedical sciences Biomolecular engineering Biomonitoring Biophysics Biopolymers Biotechnology Botany Cell biology Cognitive neuroscience Computational neuroscience Developmental biology Ecology Pharmacology Physiology Plant sciences Proteomics Sports science Structural biology Systems biology Tissue engineering Zoology

  10. Industry Analysis • High Level Customer Review • Dominant locations are Southern California, Northern California, New Jersey, Minnesota, Ohio/Indiana and New England • Manta displays 130 Medical Device companies in Southern California with revenues of $50mm or greater. • 55,000 Medical Equipment & Device companies in the US, 22,000 Pharmaceutical companies • BSL Target Market Defintion • Medical Devices (Class II, Class III) • Revenue: Greater than $50 MM • Southern California (Ventura County, Los Angeles County, San Bernardino County, Riverside County, Orange County, San Diego County) • Customer Classifications • Current • Former • Strategic • Target

  11. Industry Analysis • Extensive Growth Market • New product launches • M&A activity • New tougher regulations • Enforcement by Competent Authorities • FDA increasing audits • Enforcing regulations harder • Increased scrutiny by international authorities • FDA staffing up • Partnering Opportunities • Price Waterhouse Coopers • Deloitte & Touche • Quintiles • Biospeq • Integware

  12. Customer Analysis • Customer Needs • CAPA • Complaints Management • Non Conformance • Factors to consider • Customers growing rapidly • High margin products • Easy to solve tactical problems with headcount • Business strategy focused on growth (not Quality) • FDA audits increasing in intensity and frequency Major Pain Points & Audit Observations

  13. Customer Analysis • First to approach: • Blue Skies has an existing or recent presence: • J & J Companies (MD&D Organization) • Terumo Companies • Biomed / Bioplate • DJO • Focus/Quest Diagnostics • Second-level contacts: • Blue Skies has an indirect connection (Need to mine our connections): • Edwards Life Sciences • Life Technologies (Invitrogen) • Illumina • Amgen • eBioscience • Etc.

  14. Analysis of Competition • General Considerations: • Competitors are better established; longer time in the market. • Long list of references & accomplishments. • Many have focused product offerings: • 510K Submission • Observation & Warning letter response services • Assume liability for completed services • Large, cross-functional teams of consultants at large firms • Appearance of reduced risk by engaging large(er) company • Staffing may include ex-FDA personnel 14

  15. Competitor Analysis

  16. Marketing Plan • Strategy for penetrating target markets • Account plans for Strategic customers • Collaboration with Sales to develop specific plan for each • Desired Image and Branding • 100% Life Sciences branding  everything else opportunistic • Pricing Strategy • TBD • Current and Potential Strategic marketing partnerships/alliances • PWC (Mary G), D&T (several contacts), Quintiles (Penny E) • Biospeq (Dave M), LST, Integware (Shawn, Dave H)

  17. Operational Plan • Sales • Dedicated, plans TBD • Human Resources • Resource Plan • Industry Resource (Celeste) • Delivery (Bob S., 1-2 more this year) • Training & Certifications • Clean up Resource DB to reflect Industry/Expertise clearly • Operations / Business Development / Utilization  TBD • Existing vs. New • Strategic vs. General

  18. Management Team Partner - General Manager John Hoff Partner - SVP Life Sciences Practice Johan Amlen Director, QA and RA Celeste Amlen Director, Project Delivery Paul Sutter Director, Project Delivery Hanno Weigand Vice President, Business Development Paul Tabet Manager, Project Delivery Per Lindstrom Manager, Business Development Matt Graham

  19. Financial Plan 2010/2011

  20. Financial Plan – Next 4 years

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