About

The greatest challenge to company formation and durable success is the focus on planning, executional excellence and adherence to organizational priorities.

Biotechnology/Pharmaceutical Executive with 20 years domestic and international startup and total build out operational experience. Demonstrates integral knowledge of cross-functional priorities and operational nuances required to drive performance. Keen hiring eye identifying talented current and future leaders. Excels at aligning resources, setting clear performance goals and driving collaboration across functional and divisional lines. Strong reputation for leadership, calculated risk-taking and results. Career reflects consistent overachievement of aggressive goal formation, master relationship building and follow through with results.

TEAM BIOS

Early stage Science

Received her Ph.D. from Stevens Institute of Technology and did her post-doc work at M.I.T. She has over 20 years of experience directing innovation, initiating & leading early stage programs and leading technology assessment in the pharmaceutical and biotech industry. She started her career at  Baxter​, ​contributing in a range of roles from a productive bench scientist to an executive who manage​d and interact​ed well with people, managed complex development projects and evaluate​d the commercial viability of new technologies. She served on the founding team of Baxter Ventures, in which she worked to identify, evaluate and transition several opportunities through due diligence, resulting in the inaugural investments of Baxter Ventures in 2012 & portfolio included a successful IPO. She has 12 granted patents. She was the CSO and founding partner at Renalysis Medical Products, a startup located near Chicago with manufacturing facilities in Xi’an, China to produce peritoneal dialysis solution and pharmaceuticals. Her responsibilities include​d overseeing product development, regulatory submissions, clinical trials, and scientific marketing. She is on Advisory Board for Center for Advanced Regenerative Engineering at Northwestern University.

Clinical Operations and Development

An accomplished Clinical Operations leader with 30 years experience in the pharmaceutical and CRO industries whose direction of clinical study teams has led to the submission and approval of several NDAs.  Experienced in the design and implementation of clinical development programs across many therapeutic areas including rare disease. Passionate, driven and inspired by the strength and courage of patients and families suffering with rare disease.

Manufacturing

Over 25 years experience in API and drug product manufacturing including process engineering, supervision, plant management, and Technical Operations. Experience spans the drug life cycle from early phase clinical supplies through commercialization/launch and life cycle management. Experience in small molecule synthetic chemistry, R&D, compounding, and formulation operations for solid oral dosages, topicals, and transdermals inclusive of highly potent compounds. Experience in biologics operations and injectable medical device design and delivery systems. BS degree in Chemical Engineering from the Univ. of Illinois.

Executive Marketing and Growth Strategist

Business Strategy, Life Cycle Management, Marketing, Business Development. Innovative marketer and trusted strategic advisor with 20+ years of experience enhancing the performance, profitability, and market position of diverse organizations through integrated patient-centric business strategies. Proven ability to support start-up initiatives from strategy development through execution enabling company growth and infrastructure development.  Ability to manage and execute large programs by setting vision, establishing goals, defining people, process and technology links and working with cross functional teams to execute.

Legal and Compliance

Principle has worked for both small and large pharmaceutical companies, primarily in rare disease and oncology. Served in both legal and compliance roles within them.  Most recently, he was the Chief Compliance Officer of a fast growing mid-size biotech company. In that role, he provided compliance counsel for all business units domestically and internationally.  Prior to that, worked in start-up oncology and biotech companies: Pfizer, Abraxis Biosciences, Allos Therapeutics, Seattle Genetics and Dendreon Corporation

HR

Strategic business consultant, human resources expert and entrepreneur with proven results in start-ups to Fortune 500 organizations. Basic HR infrastructure, payroll, benefits, 401(k), co-employment, M&A Integration (over 25 transactions), culture & engagement 8 top workplace awards, leadership assessment, selection and coaching, high growth business success with over 80% of career spent in, or consulting to, high growth businesses

IT

Highly skilled IT professional with expertise in planning, design, implementation, management, and support of information systems and structures. Adept determining business needs, understands and leverages emerging technologies, and leads IT through an ever-changing landscape, leverages technology across the organization. Builds strong relationships across all levels of the organization, leading with a customer-first approach to ensure adoption of technology solutions that are both functional and effective.

Real Estate and Facilities Operations

Strategic space and utilization analysis. Commercial real estate company representation, management, leases and subleases, maintenance and operational aspects of buildout, ongoing operation and disposal of property.