Catherine Wolf, PhD

Partner with 20+ US/EUR-based clients, including diagnostic manufacturers, biotech and venture capital firms (U.S./Europe) in technology, market assessment and product launch. Assumed varying roles, from advisory to full project management, overseeing product, market and customer relationship development.

Digital Microscope Development: Concept to product: identified new technology in Europe and orchestrated development of digital microscope/GUI ($5.5M budget) for US client.

Tissue Imaging & Data Analysis: From Creative Think Tank to Operational team: assisted 30+ FTE creative team to organize and streamline efforts for scalable operations

Venture Capital Consulting: Helped develop several business cases for a US VC consulting firm.

MDx startup: Mentored on a supplementary business case by identifying MDx opportunities for ISH technology, helping to secure over $40M in private equity. Advised three PhD scientists during the initial development phase, and initiated co-development efforts with an industry-leading automation partner. Three years post-launch, the company was featured in 300 peer-reviewed publications and won 2011 North American Frost & Sullivan Technology Innovation Award.

Autoimmune Diseases Project: Interim Project Manager resetting the basis to allow migration from CE-IVD to new IVDR regulations

Next Gen Sequencing: Assisted development for US MDx company by establishing European subsidiary & HQ Lab and driving key KOL collaborations

Other projects: Market introduction and clinical evaluation for microarray-based RBC genotyping; Product development support for innovative Alzheimer diagnosis marker; coordination of initial clinical studies for automated STD screening assay (Women's Health/HPV); Animal Health Startup setup; Hemostasis startup.

• Permanent Advisor on strategy and research projects setup.

• Scientific expert for Pinsent & Masons, UK, in patent litigation.

• Director, BD, Europe (2002–2003)
• Director, BD, Molecular Discovery Systems (USA) (2000–2002)
• Product Development Director (R&D USA) (1999–2000)
• Manager, Operational Development (Europe - Marketing, Service/Supply Chain) (1997–1999)
• Project & Research Manager (USA) (1996)
• Interim 'General Manager,' European subsidiary (1995)
• Technical Manager (Europe) (1993–1994)

As first European employee, executed diverse responsibilities over 10-year tenure including:

International Expansion: Established company's initial scientific/commercial presence in Europe, Japan and Australia, and cultivated relationships with European KOLs in pathology

Market Pioneer: Established first commercial presence in 10+ national pathology congresses:

• First automated version of biomarker immunostaining in previously manual market
• First "razor/razor blade" (closed system) business model in pathology
• Pioneered QA/QC and traceability concept in tissue diagnostic

R&D Interface & Scientific Validation: Secured/managed first three European testing sites to establish scientific validation. Coordinated European scientific assessment and market launch of company's first CDx. Served as regular interface between USA R&D team and European market to drive spot-on specifications

Team Development & Sales Support : Recruited/developed multi-cultural team of 30+ FTEs, established direct sales support in nine countries and sales support through six distributors/countries

Platform Innovation: Drove platform redesign allowing to introduce first-ever ISH automation (previously manual), resulting in 50+ global placements

Board Influence & Business Unit Creation: Influenced Board decisions throughout assignments. In particular, made case to expand company's staining technology to drug and compound discovery applications. Led to creation of new BU, developed adequate product portfolio, leading to secure $10M+ budget. BU ultimately achieved profitability, 80+ placements and $10M revenues within three years