Founder and CSO
Tampa/St. Petersburg, Florida Area
Tallahassee, Florida Area
Chief Scientific Officer
Global BioDevelopment, LLC
Pathology Solutions, Inc
January 2001 to November 2008
Director Drug Safety
May 1992 to March 1999
Manager of Toxicology Studies
1988 to 1992
South San Francisco, CA
Dupont Critical Care
Research Investigator, Supervisor of Acute Toxicology and Clinical Pathology
November 1978 to May 1988
Supervisor of Special Toxicity Studies
January 1975 to November 1978
Morton Grove, IL
Create business plan including budget, timeline, and revenue projections. Raise and manage funds. Identify lead products Create business plan including budget, timeline, and revenue projections. Raise and manage funds. Identify lead products
What company does Mike Lewandowski work for?
Mike Lewandowski works for N2B Pharma
What is Mike Lewandowski's role at N2B Pharma?
Mike Lewandowski is Founder and CSO
What industry does Mike Lewandowski work in?
Mike Lewandowski works in the Pharmaceuticals industry.
Founder and CSO @ N2B Pharma Create business plan including budget, timeline, and revenue projections. Raise and manage funds. Identify lead products Tampa/St. Petersburg, Florida AreaLab Director @ Trulieve Responsibilities include:Build and manage in-house analytical testing capabilitySelect and manage independent analytical testingIdentify list of possible contaminantsTroubleshoot contamination problemsWork with Cultivation to reduce or eliminate contamination from product lineCreate group SOP's Tallahassee, Florida AreaChief Scientific Officer @ Prevacus, Inc. Responsibilities:• Design and run the R&D program that enables FDA approval of a concussion drug• Fund raising and partnering• Outsourcing• Contracts and administration• Grant identification, application, and management• Establish an organization chart and fill with qualified personnelAccomplishments:• Created and established a commercializable synthetic manufacturing route for the drug• Established a sound patent portfolio• Hired a qualified staff including independent contractors as consultants• Choose qualified institutes and CRO’s for manufacturing, preclinical, and clinical development• Prepared an aggressive timeline for the R&D of the drug• Prepared an outline of the Pre-IND meeting• Identified a key acquisition of a product line for a related indication (CTE) President @ Global BioDevelopment, LLC Responsibilities:• Build stable of CRO’s and vendors; negotiate preferred provider agreements• Conduct business development activities to build client base• Recruit stable of pharmaceutical consultants; negotiate individual contracts; prepare CVs• Evaluate clients’ products/portfolio; make recommendations; create development plans• Prepare GAP analyses• Conduct partnering and fund raising activities for client companies• Consult in the pharmaceutical development field• Conduct due diligence for potential partnering dealsAccomplishments:• Created and managed Global BioDevelopment, a preclinical development company• Managed over 30 programs through preclinical and into clinical studies• Managed over 100 individual studies through completion President @ Pathology Solutions, Inc Responsibilities:• Create and develop a virtual histopathology service business• Partner with appropriate histology labs and establish mutually advantageous contracts• Establish stable of independent pathologists• Design and implement IND-enabling safety programs• Prepare safety sections of INDs• Conduct literature searches and write safety summaries• Conduct quality assurance auditsAccomplishments:• Created and managed PSI, a histopathology business• Implemented an on-line project management and tracking system that allows clients to monitor their projects or view data 24/7 through a secure Internet connection – a first in this field. From January 2001 to November 2008 (7 years 11 months) Director Drug Safety @ Scios, Inc Director of Drug SafetyResponsibilities:• Design, supervise, and conduct preclinical programs.• Play a key role in all company project teams • Identify appropriate CRO’s to conduct R&D activities. • Establish contracts. • Manage the international preclinical R&D program. • Write the preclinical safety sections for INDs and NDAs• Monitor clinical trials• Manage animal facility. Accomplishments:• Wrote the preclinical safety section for one FDA approved drug (Natrecor) • Wrote the preclinical safety section for several INDs• Designed, managed, and completed the preclinical safety programs for several drug candidates• Gained AAALAC certification of in-house vivarium (1992, 1995, 1998) From May 1992 to March 1999 (6 years 11 months) Manager of Toxicology Studies @ Genentech Responsibilities:• Identify appropriate CROs around the world to conduct our programs. • Conduct preclinical safety evaluation studies. • Write the preclinical safety sections for INDs. • Develop and manage the in-house GLP program. • Develop and manage in-house chemistry and hematology department. • Play a key role in company project teams.Accomplishments:• Created an “IND machine” in preclinical development which was capable of submitting one IND per month• Wrote the preclinical safety section for several INDs• Developed SOPs to support all preclinical safety functions• Successfully completed validation for the in-house GLP laboratory including electronic data acquisition From 1988 to 1992 (4 years) South San Francisco, CAResearch Investigator, Supervisor of Acute Toxicology and Clinical Pathology @ Dupont Critical Care Responsibilities:• Develop and manage the in-house GLP program including implementation of SOPs. Develop and manage the clinical chemistry laboratory. • Management of the metrology and animal facility programs. Monitor studies at CROs.Accomplishments:• Successfully conducted safety studies for several INDs and for FDA approved drugs (Esmolol)• Developed SOPs to support all preclinical safety functions including chemistry and hematology• Successfully completed validation of the in-house GLP laboratory From November 1978 to May 1988 (9 years 7 months) Waukegan, ILSupervisor of Special Toxicity Studies @ Baxter Travenol Responsibilities:• Plan and conduct acute and subacute toxicity, teratology, dermal irritation, and other special toxicity studies. • Develop strategies and write SOPs to comply with the newly imposed GLPs.Accomplishments:• Developed an SOP system that complied with GLPs• Developed in-house teratology program From January 1975 to November 1978 (3 years 11 months) Morton Grove, IL
Extraversion (E), Intuition (N), Feeling (F), Judging (J)
6 year(s), 5 month(s)
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