Expertise

OUR EXPERTISE ARE VAST AND OUR PAST Project NUMEROUS

GLOBAL IMPLEMENTATION

Lead development efforts for a biosimilar partnership between a US and non-US company.

SBLehrer LLC is providing the full team to manage the development, manufacturing, preclinical and clinical trials and will prepare the BLA for filing with US FDA.

CREATING NEW BUSINESSES

Assembled team and developed approach to commercialize 2nd generation renewable aviation fuel based on growing Jatropha in Indonesia. Completed off-take agreements and commercial growing/production contracts.

MANAGEMENT

Define the US business plan and detailed implementation plan to build the US subsidiary of a Chinese based pharmaceutical company.

The portfolio includes biopharmaceuticals, novel drug formulation products and specialty injectable generics.

This effort included designing the organization and recruiting top management positions.

MARKETING

Led go to market efforts for three advanced molecular diagnostic tests including setting up CLIA and ISO certified clinical labs, setting pricing, building thought leader networks and launching the products.

PRODUCT PLANNING

Defined the worldwide therapeutic biopharmaceutical strategy for a public pharmaceutical company including defining the product portfolio, identifying potential products/technology including drug delivery technology to license, designing cGMP manufacturing infrastructure, hiring individuals for building the development team, and developing the clinical, regulatory and FTO strategy for entry into the US and EU markets

LEADERSHIP

CEO for an oncology pharmaceuticals/diagnostics products company based on Stanford University technology.

Negotiated all key agreements for to establish company, worked with patent counsel to refine patent estate, created business plan and raised initial seed capital round

MANUFACTURING

Developed the manufacturing strategy and negotiated all key supply chain manufacturing agreements for a public pharmaceutical company

PARTNERSHIP

Expanding partnerships for a Contract Development and Manufacturing company.

FOLLOW THROUGH

Set up Cross Border JVs and partnerships.

DUE DILIGENCE

Due diligence efforts for both acquisitions and licensing deals.