My unique background merges top-tier consulting, industry, and financial services. This has been predominantly for innovative clinical diagnostic, life science, medical device, and therapeutic companies.
EXPERIENCE SUMMARY
Chief Operating Officer (interim)
Clinical Diagnostics
(2016 - present)
Management Consulting (Independent)
Medical products
(2016 - present)
Corporate Development
Senior Vice President
Genetic Testing Instrumentation
(2015 - 2016)
CEO & President
Clinical Diagnostics (Microfluidics)
(2014 - 2015)
Business Development
Senior Vice President
Clinical Diagnostics (Nanotechnology)
(2007 - 2013)
Strategic Marketing & Product Management
Senior Vice President
Clinical Diagnostics (Biotechnology)
(2005 - 2007)
Equity Research
Sell-side Analyst, Principal, and Group Head
(1997 - 2005)
Strategy & Business Development
Vice President
Diagnostics and Pharmaceuticals
(1994 - 1997)
Management Services (internal consulting)
Director
Pharmaceuticals
(1993 - 1994)
Management Consulting
Engagement Manager and Consultant
(1989 - 1993)
EDUCATION
University of Chicago Booth School of Business
MBA Financial Management & Business Policy
Dean's Honor List - all quarters
Beta Gamma Sigma - Honorary Business Society - Top 10% of graduating class
Duke University
BS Chemistry
National Merit Scholarship Finalist
Cum Laude
Phi Lambda Upsilon - Honorary Chemical Society
ADDITIONAL PROFESSIONAL SUMMARY
Boards
Investor Board for the Innovation and New Ventures Office of Northwestern University (technology transfer) from 2010 to present.
Advisory Board and Guest Lecturer for the Kellogg School of Management Center for Biotechnology 1998 to 2010.
AACC annual Financial Analyst Briefing organizing committee from 2000 to present.
Mentor
Chicago Innovation Mentors program a consortium of University of Chicago, Northwestern University and University of Illinois. Mentor team leader for a urological in-vivo diagnostic from inception until 2013.
Other
Patent filings - Four published applications, numerous other disclosures and filings.
One thousand financial reports and commentaries.
Quoted by Biocentury, Bloomberg and Bloomberg TV, Boston Herald, CBS Market Watch, Chicago Tribune, CNBC TV, Dow Jones, Forbes, In Vivo, Investor s Business Daily, MSNBC TV, Nature, New York Times, PBS, Reuters, San Francisco Chronicle, SmartMoney.com, TheStreet.com, USA Today, Wall Street Journal, and Washington Post.
EXPERIENCE DETAIL
Chief Operating Officer (interim)
Clinical Diagnostics
(2016 present)
As a consultant, evaluated strategic options for the company founders, and recommended pursuing the neonatal market for unbound bilirubin, leading to a multimillion dollar deal with a very large strategic partner. Subsequently, hired to accelerate product development until manufacturing and regulatory approval. Continue to effectively provide operational guidance, and lever my expertise and industry network for critical functional support.
* Product development. Created the product development plan, and market model. Executing the plan, trouble shooting and making adjustment as needed, and using the model for debates with the strategic partner regarding future revenue targets and commercialization resources.
* Regulatory and quality. Identified the gaps and developed plans to fill them, including filing pre-submissions with the FDA, and Japanese PMDA, and implementation of an internal quality management system.
* Manufacturing. Developed an operational, costing methodology, and model for trade-offs among manufacturing in house, through OEMs, or by the strategic partner. Pushing on-going negotiations and assessments for all three possibilities.
Management Consulting (Independent)
Medical products
(2016 - present)
Providing strategically sound and incisive recommendations and scenarios, backed by sophisticated quantitative and qualitative analysis. These are based on deep real-world experience, and an ability to quickly assess markets and technologies.
* Biotech. For a top 5 biotechnology company, helped build understanding of how to successfully deploy companion / complementary diagnostic biomarkers or imaging for a phase 3 drug. Additionally, analyzed potential in-vitro diagnostic partners among important success factors. Developed best-practice playbook for working with diagnostic partners.
* Medical devices. For a top 3 medical device company, helped determine how to enter a cancer screening market with a point-of-care imaging product, and how to deploy it in primary care, rather than with specialists. This included market assessment, best practice identification, and detailed financial modeling.
* CDMO. Provided medical technology industry expertise as part of a strategy team for a major contract development and manufacturing organization.
* Companion diagnostics. Analyzed the companion diagnostic market vis a vis a novel enabling technology. Identified a high-potential niche market segment, including pinpointing key performance criteria, and developing a market model.
* Molecular diagnostics for physician diagnostic laboratories. Ongoing market and regulatory assessment of the potential and critical success factors for a new instrument enable by novel technology.
* Start-up in-vitro diagnostics. Currently working with a start-up company in sepsis host response, encompassing most functional aspects. These range from business development and strategy to marketing to regulatory to + manufacturing. Have also done this work previously for three other start-up firms (sepsis pathogen identification, high-sensitivity protein measurement, and environmental allergens).
* Data analytics. For a physics / quantum mechanics enabled analytics solution firm, providing ongoing industry expertise related to financial services, and medical technology (diagnostics, biotech pharma, and life science tools).
* Biomarker discovery. For a non-US diagnostic company involved in cancer screening, assisted putting together algorithms for a blood-based biomarker.
Corporate Development
Senior Vice President
Genetic Testing Instrumentation
(2015 - 2016)
Headed business development. Lead strategic planning process. Overhaul IVD regulatory capabilities. Collaborate and gain credibility with challenging R&D organization. Augmented product marketing and development. Steered various quality functions.
* Business development. Licensed and establish supply agreement for co-branded, complementary product line. Originated discussions and advanced negotiations among likely OEM and distribution partners in major international geography, potential OEM partners for a non-core product line, and potential OEM for alternate use company s technology. Assisted successful negotiations of OEM deal in another large international market.
* Regulatory. Influenced FDA to reclassify instrument to Class I from previous Class II. Led registration of platform globally. Determined best tactical assay for US IVD clearance. Initiated and guided product development for combination test and system.
* Strategy. Facilitated consensus focusing efforts on specific clinical markets, using particular assay methods, and for an explicit customer group.
CEO & President
Clinical Diagnostics (Microfluidics)
(2014 - 2015)
Evaluated and implemented strategic options for the company, after assessing and revising business strategy. Secured bridge financing and managed day-to-day cash flow. Selected and managed investment banking relationships for sale of all or part of company. Further developed product line.
* Repositioned companys strategy to diagnostics with standard automation.
* Closed bridge financing rounds equaling $2 million.
* Secured $1 million contract from the National Cancer Institute (NCI).
* Through personal contacts, identified large, highly cash-flow positive acquirer, who provided an offer to buy all or part of Siloam predicated on hitting assay performance and automation targets.
* Determined and applied technology improvements, leading to more accuracy and 3-fold better reproducibility. Additionally, successful started development of a new desktop instrument.
Business Development
Senior Vice President
Clinical Diagnostics (Nanotechnology)
(2007 - 2013)
Led business development, including collaborations, licensing, investments and acquisitions. Managed research and novel biomarker strategy, including research assay development, protein science, molecular diagnostics, and nanochemistry.
* Partnerships for product development. Established a key new product development partnership that led to the companys first commercially profitable effort. Through another profitable partnership with a major pharmaceutical firm, developed a novel, pharmacogenomic test for a prevalent but underserved psychiatric disorder. Set up technology partnership to greatly improve the performance of cancer diagnostics.
* Savings derived from licensing. Secured $10s million on future cost of goods, through a microarray substrate license. Avoided millions of dollars in upfront fees, also negotiating a significantly lower royalty rate, by licensing in a new amplification technology for nucleic acids, its first use in medical diagnostics. Secured previously unattainable critical reagent of company s first high-sensitivity protein test.
* New system development and commercialization. Expanded the instrument product portfolio to include a high-throughout and lower-cost testing system based in part on off-the-shelf robotics.
* Achievements for novel biomarkers. Co-authored five patent applications for new methods for detecting biomarkers, new biomarkers, and new uses for forms of current biomarkers. Identified and developed an additional product category - immunology (autoimmunity, allergy, and transplantation). With research, invented novel assay targets for a highly accurate test for rheumatoid arthritis. Determined 6 novel cancer / organ failure biomarkers, and with research, invented proprietary sample preparation methods, leading to improved clinical performance for 8 well-validate cancer markers. Co-led the development of a format that combines genetic and protein assays in the same chamber. Increased laboratory productivity for new marker research four fold while reducing costs by 50 percent.
* Accomplishments in clinical trials. Co-designed and analyzed clinical studies and research experiments for over 5,000 patients to test biomarker validation. Identified clinical hurdles and value propositions across many medical specialties - cardiology, internal medicine, neurology, emergency medicine, rheumatology, allergy, pathology, and pediatrics.
Strategic Marketing & Product Management
Senior Vice President
Clinical Diagnostics (Biotechnology)
(2005 - 2007)
Established first strategic marketing group. Built a strong group of international product directors across a number of medical of specialties - cardiology, neurology, intensive care, nephrology, emergency and internal medicine, and oncology. Managed new instrument development. Augmented existing market development, reimbursement and product management abilities. Filled significant gaps in the companys strategic marketing approach, adding de novo forecasting, market research, market segmentation, positioning, and statistical capabilities.
* Substantially enhanced product characteristics, clinical efforts, forecasts and budgets, by introducing a number of medical marketing and planning methodologies: extensive new product concept testing; comprehensive planning to expand intended uses of existing products; market segmentation and positioning; extensive and more sophisticated market research techniques; and insurance reimbursement planning.
* Augmented the biomarker selection approach and algorithm, while greatly evolved other systematic methodologies applied to biomarkers and diagnostics, including quantitative modeling and data mining.
* Reprioritized major pipeline projects through market opportunity assessments and forecasts, and medical practice and needs evaluations, in clinical conditions such as stroke, sepsis, kidney injury, heart failure, and acute coronary syndromes.
Equity Research
Sell-side Analyst, Principal, and Group Head
(1997 - 2005)
* Elected Principal (partner) in December 2000 after 3 1/2 years versus 5-6 typically.
* Group Head for Healthcare Equity Research 2001 - 2005 and Equity Analyst (stock analyst) from 1997 - 2005.
* Covered sectors included Medical Diagnostics, Life Sciences, Genomics, Proteomics, Biotechnology, Pharmaceutical, Orthopedics, and Medical Devices.
Built up the firms healthcare research franchise and expertise. Identified high-quality, growth stock and emerging growth investments out of existing public equities and private firms. Extended industry expertise and relationships across other firm activities, including venture capital. Marketed selected investment ideas, including IPOs and secondary offerings, to external institutional investors, as well as internal portfolio managers and high-net-worth, private brokers.
* Highest bonus in the entire firm in 2000 (out of about 1,000 individuals).
* Most externally read William Blair analyst (out of 25) for 2004 and first half 2005.
* Ranked the number one analyst internally (out of 35) by both the institutional sales force and the retail brokers in 2000.
* Highest research productivity in 2004 and 2003.
* Generated highest total commissions for the equity research department (out of 35 analysts) in 2000.
* Recommended 3 out of the top 5 best performing stocks at Blair in 2000.
* Published approximately 1,000 research reports and commentaries, numbering over 4,000 pages.
Strategy & Business Development
Vice President
Diagnostics and Pharmaceuticals
(1994 - 1997)
* Developed the first long-term strategy and product plan for this new, $1.3 billion division for diabetes care and point-of-care testing. Directed worldwide Strategic Planning & Business Development, as well as Disease Management and Personalized Medicine, Health Economics and Outcomes Research, Medical Assessment, and divisional public relations. Co-chaired joint Steering Committee with the Joslin Diabetes Center, affiliate of Harvard Medical School, and joint Disease Management team with a major pharmaceutical company.
* Identified, confirmed and began development of a new business projected to be $1 billion in ten years, targeting at least a 30% share.
* Established divisions strategic planning and product portfolio processes.
* Identified actions to counter the acquisition of a competitor by the largest firm in diagnostics. In part by employing competitive simulations in each major country, developed international responses at the country, divisional, and company level.
* Devised disease management strategy and drove implementation. Established outcomes-based competitive initiatives, including development of a comprehensive Health Economic Model for Diabetes, official diabetes health economic model of the World Health Organization, and as well as the joint Health Service and Outcomes Research team of the Joslin Diabetes Center at Harvard.
As VP of Strategy, Market Research & Product Planning, directed product portfolio management, new product screening, and global market research. Established the new-product screening process, and drove new product concepts through technology assessment and early new product development milestones. Screened and prioritized over 100 new internal and external product concepts.
Management Services (internal consulting)
Director
Pharmaceuticals
(1993 - 1994)
Developed and directed performance improvement and change management projects throughout the company, such as re-engineering, organizational design and strategic analysis, in areas such as U.S. Human Health, European Human Health, and Manufacturing.
Marketing and sales productivity
* Fundamentally changed the US selling and marketing organization structure to a rapid reorganization into Customer Business Units (e.g., hospital, managed care) from a product-oriented structure.
* For the European - both across and within countries, produced new processes for performance improvement projects: resource allocation to improve marketing returns, strategic planning, and long-range operating planning.
Procurement re-engineering
* Redirected the procurement re-engineering initiative to one focused on improving purchasing effectiveness by using cross-functional teams possessing the right skills and information, from one focused primarily on increasing efficiency through the implementation of software.
* Worked intensively with the Vice President of Purchasing to create a significantly flatter structure divided into two components: commodity management and transaction execution.
* Created the processes and established the commodity teams through which the organization achieved substantial purchasing savings. Also, built and led the procurement re-engineering process teams.
Management Consulting
Engagement Manager and Consultant
(1989 - 1993)
Managed consultant and client teams. Structured and analyzed problems, and developed and communicated solutions to achieve a strong positive impact on clients, predominantly in the medical products industry.
Strategy, alliances, acquisitions and corporate development
* Prevented a $500 million loss in value for an international healthcare client by identifying unforeseen market trends in a potential partner's competitive position. Evaluated other partners for the client, and identified a high-potential partner to complement the current product portfolio and skills.
* Established 10-year strategic goals for a $500 million division of a global pharmaceutical and diagnostic client to increase sales 15% annually and increase market share 50%. Defined actions to achieve these goals, including alliances and acquisitions to fill gaps, to gain access to attractive markets and technologies, and to lever global costs.
* Assessed $1.5 billion acquisition in power transmission industry within 2? weeks. Established valuation for bidding, by mathematical models, also including qualitative inputs, gauging competitive threats, sources of advantage, and likely product developments.
Marketing and sales force effectiveness
* Launched new medical diagnostic product expected to achieve $50 million annual sales in five years. Created comprehensive market-based program that included target markets, product positioning, pricing, and selling tactics versus competitors. Re-prioritized R&D to reflect customer segments better and to increase sales penetration more quickly.
* Improved profitability and marketing effectiveness by successfully merging two medical product divisions, totaling sales of $250 million. Completely redesigned the positions of 40 sales managers, developed and implemented new roles for 320 sales representatives, and improved cross-functional decision making.
* Managed a McKinsey and client team that created a marketing strategy and operational tactics to increase sales 75% in three years with a concurrent return on sales increase from 2% to 8%. This distributor sold for a substantial premium shortly thereafter. |
