M i c h a e l
K e v i n
H a n d l e y
2049 Ridge West Drive, Windsor, CO 80550
E-mail: michaelkhandley@gmail.com
Phone: 925.400.3123
OVERVIEW
A successful life sciences executive with cross-functional experience in strategy, operations, finance, product development
and product commercialization. A diligent, creative and multi-tasking individual who excels in leading people to attain goals
while utilizing excellent communication and people skills to gain the respect and confidence of employees and coworkers.
MANAGEM ENT SKILLS PROFILE
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COMMUNICATION: Strong interpersonal skills and effective at developing/executing communication strategies
within management teams, organizations and public markets. Excellent writing, presentation and public speaking
skills.
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FINANCE: Experience in developing budgets and then aligning them with operational strategies to meet timelines
and corporate goals. Experience evaluating the impact of long-range planning, introduction of new products and
strategies on future growth. Strong aptitude for fundraising and capital acquisition for corporate growth.
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LEADERSHIP: Track record of recruiting and leading cross-functional management teams in both large and earlystage device/biotech companies. Adept at attaining cross-functional stake-holder input and by-in. Demonstrated
ability to mentor and teach direct reports to improve the execution and effectiveness of an organization.
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OPERATIONS: Proficient at managing and enhancing corporate operations. Experienced at managing small and
large facilities including IT infrastructure, capital improvements and services. Savvy negotiator of facility leases,
contractor bidding and tenant improvements.
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PRODUCT DEVELOPMENT: In-depth endovascular/cardiovascular, immunology, neurology, metabolic and
oncology therapeutic area knowledge. Successful experience with pre-clinical and clinical development of medical
devices and pharmaceuticals. Experienced in the strategy formulation and management of regulatory strategies.
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PROGRAM & PROJECT MANAGEMENT: Expert in Project And Cycle-time Excellence (PACE) which is a
comprehensive and proven architecture for managing both projects, programs, and portfolios. Experienced in
attaining development & operational excellence through the use of nimble cross-functional project teams with
integrated project and development roadmap plans.
PROFESSIONAL EXPERIENCE
Level 5 Partners LLC: Senior Managing Partner & Executive Director
April 2010 – Present
A private firm that is involved in technology identification, venture creation/finance and venture management in the life
sciences.
Selected Achievements:
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Founded and created the strategic direction and vision for the firm.
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Responsible for the creation of seven life science portfolio companies.
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Doubled the number of partners and expansion of firm capabilities in less than two years.
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Negotiated and executed multiple technology license agreements with academic institutions, individuals and
companies.
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Serve as the outward face of the firm and responsible for representing the firm at conferences and meetings.
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Raised over $23M in venture capital for portfolio companies.
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Guided clinical strategy and implementation for a private device company that lead to a $250M acquisition by a
large multinational device company.
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Assisted a large multinational device healthcare company with the integration and globalization of an $800M
acquisition of a private medical device company.
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Serving as a strategic advisor, Chief Executive Officer, and Board member to multiple US-based and international
life science companies and is assisting them with financing, growth and commercialization strategies.
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Responsible for the raising capital for the firm’s internal fund portfolio fund.
Spectranetics Corporation: CCO & VP, Global Regulatory Affairs
April 2007 – March 2010
A public company that develops endovascular products for treatment of peripheral and coronary vascular disease.
Selected Achievements:
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Recruited, developed and managed Regulatory Department (13 individuals).
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Developed aggressive global clinical-regulatory strategies for new device approvals and new indications for four
laser product lines in the cardiovascular space.
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Developed and implemented regulatory affairs policies and procedures (author of all SOPs) allowing for execution
of global clinical studies & regulatory strategies are according to global and country specific regulations while
promoting compliance.
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Responsible for over 13 product approvals in +40 markets
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Developed a first of its kind parallel submission strategy for an endovascular device company (utilizing a modified
GTHF STED format).
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Developed and managed strong positive relationships with the FDA (Peripheral Vascular Branch, Coronary Branch,
Combination Branch, STED Pilot Program, and Office of Compliance), notified bodies (KEMA/TÜV/BSI), PMDA,
and TGA that resulted in open and effective communication which lead to decreased times for new product
approvals.
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Responsible for organizational compliance to all AdvaMed, HIPAA, OIG, FCPA, Anti-Kickback, OHSA, FDA, ISO,
JPAL, EucoMed, and MDD rules and regulations.
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Successfully managed $3M annual budget and responsible for achieving profitability in 2009.
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Managed and recruited Clinical Department (6 individuals).
Oversaw Clinical Affairs department in 2007 and was responsible for 9 clinical trials (the
studies ranged from registries to IDE multi-center randomized trials for Class II and III
devices in both the US and EU) and growing and developing the Clinical Affairs dept.
Lead all aspects of clinical development and study management, which includes providing
scientific, medical, and/or logistical direction and support to planned and ongoing studies.
Developing publication plans and directing the evaluation and analysis of clinical data to
assist in the translation of data from clinical studies to promotional and publications.
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Member of Executive Management Committee that develops and guides strategy and direction for the company.
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Part of Executive Management Team that grew company revenues approximately 30% over three years
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Successfully negotiated settlement agreements with Department of Justice
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Created, developed and managed Post Market Surveillance Department which included complaint trending, MDR
reporting, and vigilance reporting.
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Developed and managed Internal Audit program.
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Developed and Chaired the Promotional and Advertising Review Committee
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Developed and Chaired the Commercial Activities Grants Committee
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Oversaw corporate reimbursement strategy, governmental affairs and lobbying efforts.
AccelaPure Corporation: Interim CEO, VP Regulatory/Quality/BD
May 2005 – January 2007
A private technology company that provided preclinical and clinical stage materials for pharmaceutical and device companies.
Selected Achievements:
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Recruited and developed sales, regulatory, operation and quality teams and was responsible for the day-to-day
management of sales, regulatory, operations and quality groups (over 35 individuals at two separate sites).
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Led the development of corporate quality strategy and quality systems for company which included ISO9000/13485
compliance and cGMP/GLP compliance.
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Responsible for all regulatory and quality issues with client projects (i.e. IRB brochures, IDE’s, PMA’s, INDs, DMF,
CMC, and NDA’s).
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Led cross-functional teams from sales, marketing, quality and development to drive the development of our core
technology that resulted in the development of a global strategy to leverage our technology in a multifaceted
approach.
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Increased value of company eight fold in one year through increased business and revenue ($5M -> $40M).
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Successfully negotiated a multi-million dollar strategic alliance with Mettler-Toledo for the development of future
purification technologies.
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Led and executed a three year deal with Princeton University for the co-development of new purification
technologies and methods for drugs and medical devices.
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Guided effort to raise $7M in financing to grow operations and expand the business.
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Responsible for all service and support agreements.
Pricewaterhouse Coopers (PRTM): Senior Principal
January 2004 – May 2005
Recognized internationally as the leading management-consulting firm to technology-based companies. A consultant to the
pharmaceutical and biotechnology industries focusing on product development, corporate strategy and project management.
Selected Achievements:
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Established and managed two new practice areas for PwC/PRTM:
- Strategic Regulatory Affairs Practice: Worked with clients to develop sustainable global regulatory strategies
that allowed them to successfully commercialize drugs and devices and to grow internal pipelines efficiently.
Worked on numerous IDEs, 510(k)s, PMAs, and BLAs/NDAs.
- Life Cycle Management Practice: Assisted clients from extracting the most value out of their medical
devices and drug products by developing and implementing life cycle strategies. This incorporated a variety
of approaches (improving quality, repurposing, new indications, optimizing exclusivity, derivatives, and new
combination strategies) which extended IP protection and maximized ROI for developed products.
Co-led the 3D (Drug/Device Discovery & Development) Marketing Team which was responsible for marketing our
services to Drug and Device companies and increasing business.
Lead consultant on Commercialization Strategy & Implementation project for Genentech, Inc: Worked with
Genentech management to develop regulatory, marketing, and commercialization strategies for pre-launch and
launch of two oncology products: Avastin and Tarceva.
Co-led Capital Expenditure Planning Process for Genentech. Able to realize hundreds of millions of dollars in
savings to 3-5 year capital planning programs.
Improved the commercial operations through the development of improved business processes and training for
sales staff which resulted in an increase in compliance and improved revenues.
Worked with Genentech management to refine product life-cycle plans and strategies for oncology franchise Lead
consultant for all life sciences development & regulatory issues in the Pacific Region life science sector.
Contributed to PwC/PRTM business growth in first twelve months: over $1M in new business.
Actus Partners: Founder & Managing Director
October 2002 – January 2004
Provided commercialization, development and regulatory affairs consultation services to multiple established and start-up
device and drug companies.
Selected Achievements:
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Recruited and managed a staff of 10 consultants. Managed day-to-day aspects of running the firm and was
responsible for staff development and management.
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Developed regulatory strategy and mfg process improvements for Omeros Corporation’s (Seattle, WA) lead clinical
product OMS103 that resulted in $2M in manufacturing cost savings and expedited FDA submission.
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Created a drug discovery strategy for Hawaii Biotech, Inc. (Aeia, HI) in which they would re-focus their efforts on
their small molecule cardiovascular program. This resulted in the company seeking a merger and successfully
spinning out the assets as a new company, Cardax Pharmaceuticals.
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Led a project with the worldwide licensing management of Novartis (Boston, MA) to identify potential novel targets
at non-top tier academic institutions. Our data resulted in a shift strategy by Novartis to focus on early-stage
academic drug targets and molecules as in-licensing targets.
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Identified, evaluated and developed risk analysis models for intellectual property for the treatment of metabolic
diseases. Our advice allowed management to make an informed decision that had CareX S.A. (Paris France)
merge with another company with an ideal pipeline that complemented CareX technology.
Amgen, Inc.: Research Associate III
June 1999 – October 2002
A world biotechnology leader that focuses on the discovery of novel therapeutic proteins, small molecules and antibodies.
Selected Achievements:
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Assisted in the discovery, development, formulation, safety testing, scale-up and regulatory IND submission of
AMG706 (Amgen’s first small molecule VEGF angiogenesis inhibitor for solid tumors).
Founded and led the Accelerated Pipeline Chemistry Development group (now called Custom Synthesis Group)
within Small Molecule Drug Discovery (SMDD) to accelerate pre-clinical projects by increasing the efficiency of all
corporate chemistry projects.
Responsible for improved and expedient technology transfer from Medicinal Chemistry to Process Development.
Responsible for all pre-clinical toxicological studies for all SMDD projects.
Assisted in the discovery and development of Amgen’s first lead compound for the antagonism of the integrin
receptor αvβ3 for the treatment of solid tumors and osteoporosis.
Assisted in the discovery, development, formulation, safety testing, scale-up and regulatory IND submission of
Amgen’s first P38 anti-inflammatory compound.
Assisted in the writing of regulatory documents and intellectual property developed by SMDD.
Developed pre-clinical and clinical study designs.
Gliatech, Inc.: Quality/Regulatory Manager
September 1996-May 1999
A biotechnology company developing medical devices for prevention of post-surgical scarring and therapeutic products to treat
neurological and inflammatory disorders.
Selected Achievements:
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Managed the Regulatory Affairs Group & Quality Assurance Group for four years and was responsible for medical
device and pharmaceutical regulatory submissions for the company.
Assisted in the regulatory IND submission/approval of the first human histamine H 3 antagonist, Perceptin (GT2331 now at Merck in Phase II). Led team that went from hit-to-IND in 12 months.
Managed worldwide Regulatory Submissions (PMA) and Quality Assurance of ADCON-L (class III bioabsorbable
gel medical device for lumbar surgeries) release and responsible for post-market surveillance of ADCON-L data
and worked closely with FDA and EU/CE regulatory bodies in preparation for the regulatory submissions.
Developed the regulatory submission (IDE) and clinical trial of ADCON-P (bioabsorbable gel class III medical
device for peritoneal surgeries) and assisted in the management of the pivotal clinical trial.
Developed an in-house regulatory strategy and manufacturing method for the synthesis of raw materials for
ADCON-L product that resulted in $5 million in annual savings.
Assisted in the design/testing of commercial packaging/labeling configurations for ADCON-L & ADCON-P US
and European distribution.
Assisted in the development of clinical protocols and management of clinical studies for class III medical devices.
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EDUCAT IONAL EXPERIENCE
University of Colorado
July 2004 – July 2005
(Cumulative G.P.A. 3.5 (4.0))
Selected Graduate Pharmaceutical Management Courses
Pepperdine University
January 2001 – December 2001
(Cumulative G.P.A. 3.57(4.0))
Masters of Business Administration – Management & Finance (Not Completed)
Colorado State University
May 1992 – August 1995
(Cumulative G.P.A. 3.71(4.0)) Cum Laude
Bachelors of Science and minors in Molecular Biology, Physiology, Neuroanatomy, and Chemistry
University of Southern California
August 1989 – May 1992
(Transfered)
Aerospace Engineering Major and Presidential Scholarship Winner
AC AD E M IC H ON O R S AN D AW AR D S
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Graduated Cum Laude Double Majors Double Minors 1995 Colorado State University
College of Applied Human Sciences student Leadership Award: 1995
National Golden Key Honor Society: Academic Years of 1994 and 1995
Presidents Honor Roll Colorado State University: Academic Years of 1992, 1993, 1994, and 1995
PRO F ESS IO N AL AF F ILI AT ION S
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American Chemical Society (Med Chem Chapter and Chair of BDM Comm. Committee)
American Association of Pharmaceutical Scientist (AAPS)
Regulatory Affairs Professional Society (RAPS)
CIVIC/ VOLUNTEER WORK
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Guest Lecturer, LeBow College of Business, Pharma. Mgt Program. Drexel University
Vice Chair of the Board of Directors – Acquired Brain Injury Institute
Children’s Clinic Volunteer
Colorado State University Peer Advisor/ Exec Board Member SHAC/Academic Adv Tutor
PERSONAL INTERESTS
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Triathlons
Rock climbing
Sport bike riding
BUSINESS & COMMERCI ALIZAT ION MILESTONE SUMMARY
Business Milestones:
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Lead and assisted in the raising of over $63 million in capital for multiple private companies.
Negotiated and executed 3 year and $4 million strategic alliance with Mettler-Toledo International, Inc. with a private
life sciences technology company that included licensing rights (15 patents) and cross marketing and sales
(AccelaPure Corp. March 2005)
Assisted in the global product launch of Avastin & Tarceva oncology drugs (PwC 2005)
Interfaced between marketing and R&D at Johnson & Johnson to identify gaps in their product development portfolio.
(PwC 2005)
Assisted a large medical device company in the development of a global quality and regulatory identification strategy
and process. (PwC 2004)
Developed technology acquisition strategy for Novartis (Actus Partners, 2003)
Identified and performed due diligence/market research on licensable oncology drug candidates for Dendreon Corp, a
public Seattle Biotechnology company that resulted in one licensing event. (Actus Partners 2003).
Negotiated exclusive worldwide technology licensing agreement with Ontogen Corp for OntoCHROM purification
platform (9 patents) (Actus Partners 2003)
Performed global intellectual property assessment for metabolic assets for early stage French-based company,
CareX S.A., that culminated in a acquisition of a pipeline (Actus Partners 2003)
Part of Amgen due diligence team that acquired Kinetix ($220M) and Immunex ($13B) (Amgen, Inc. 1999-2002)
Commercialization Milestones:
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TurboTandem System FDA/EU Clearance & Launch (2010 SPNC)
ThromCat XT Thrombectomy System CE Mark & Launch (2009 SPNC)
QuickCross Extreme FDA/EU Clearance & Launch (2008 SPNC)
Cross Pilot Catheter FDA/EU Clearance & Launch (2008 SPNC)
SLS PMDA Approval & Launch (2008 SPNC)
Quick Cross 2 Support Catheters FDA Clearance & Launch (2007 SPNC)
Turbo Booster FDA Clearance & Launch (2007 SPNC)
Clirpath Turbo Laser Catheter 510k Clearance & Launch (2007 SPNC)
Avastin Product Launch (2005 Genentech)
Tarceva Product Launch (2004 Genentech)
AMG706 IND Approval (2001 Amgen)
ADCON-L PMA Approval & Launch (1998 Gliatech)
ADCON-P IDE (1998 Gliatech)