Katharine (Katy) Spink Email & Phone Number

San Carlos, Ca, Us

Walnut Creek, California, Us

Dark Horse Consulting specializes in the development of Cell and Gene Therapy products. We apply our deep industry experience in the Cell and Gene Therapy space to help our clients tackle a wide range of strategic and operational challenges spanning diverse functions such as process development, manufacturing, quality, regulatory, device development, nonclinical, clinical, program management, business development, and financing/investor relations.In my role at DHC, I lead internal practice operations, as well as working with clients on a wide range of strategic business and program needs.

Stevenage, England, Gb

Waukesha, Wi, Us

Waukesha, Wi, Us

Kufstein, Tyrol, At

Fremont, Ca, Us

Asterias is a clinical stage biotechnology company focused on developing therapies to address significant unmet medical needs in neurology and immuno-oncology. In my role as Chief Operating Officer, I was responsible for the program management, business development, manufacturing, quality, process development, research, facilities, legal/contracts, intellectual property, and human resources functions. I also played a major role in investor relations activities, including serving as the primary scientific/technical representative in investor meetings.My key accomplishments in this role included:- Designed, led and implemented portfolio prioritization to establish corporate strategy and operating plan at inception- Together with CEO, lead outreach to investors, analysts and banks resulting in successful public listing of company, establishment of analyst coverage, and significant value inflection for investors- Identified new facility and negotiated lease enabling construction of in-house cGMP manufacturing facility under landlord funded tenant improvement allowance. Led design, construction, validation, and start-up of cGMP facility operations- Led teams to successful completion of critical development objectives, including enrollment of Phase I/II trial for allogeneic spinal cord injury cell therapy program, selection of CDMO and development of closed system manufacturing process for autologous cancer immunotherapy program, MHRA clearance and initiation of UK-based NSCLC clinical trial for allogeneic cancer immunotherapy program- Major contributor to successful grant application resulting in $14.3 million of non-dilutive funding for clinical trial

Consultant to for-profit and academic groups on matters of translational research, program management, alliance management and business development/licensing.• Wrote successful translational medicine grant application resulting in $20 million grant award • Negotiated partnership terms, responded to technical and legal due diligence questions for small biotechnology company alliance with top 10 pharmaceutical company• Developed fundraising pitch, timelines and budget for start-up biotechnology firm. Participated in fundraising presentations to venture capital and potential corporate partners• Negotiated term sheets to establish IP and materials rights for start-up biotechnology company• Reviewed and edited FDA filing for preclinical stage cell therapy project

Senior Vice President, Program Operations and Alliance Management, 2011Vice President, Program Operations, 2009- 2010Senior Director, Program Operations, 2008-2009Built and ran new group within Geron responsible for horizontal integration of cross-functional project teams to ensure efficient operation of programs. Group responsibilities include team leadership, project management, business & commercial modeling, resource prioritization, budgeting for four clinical and preclinical stage programs totaling 80 employees and $30 million in annual budget. As SVP and VP, served as corporate officer and member of executive management team.Director, Cardiovascular Disease, 2007Served as program manager and team leader for program to develop cell therapy for treatment of heart failure and acute myocardial infarction. Program had just been advanced from research stage to IND candidate status. Responsibilities included: leading team in development of preclinical and clinical development plans, establishing and maintaining program timelines, budgeting, goal setting & tracking, setting agendas for and running team meetings.Associate Director, Corporate Development, 2006Assistant Director, Corporate Development, 2003-2005Held primary day-to-day responsibility for providing a wide range of business support to Geron’s programs. Responsibilities encompassed business development, alliance management, strategic planning, and market analysis functions.

Us

Senior Associate, 2002- 2003Associate, 2001- 2002Management consultant for biotechnology, medical device and pharmaceutical companies. Project experiences included: business development, marketing, portfolio strategy, and organizational design.

Ph.D., Cancer Biology

B.A., Biochemistry