George Toscano

Current

Consultant at Quintiles Consulting

Past

Director QC & RD at Propharma Inc
Director of Research at Mankuta Gallagher
Laboratory Manager at Propharma Inc.

Scientist/Group Leader at Abrika Pharmaceuticals
Scientist at Noven Pharmaceuticals
Scientist at Fuisz/Biovail Technologies
Chemist/Team Leader at Sano/Elan Transdermal Technologies

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4 more...

Education

Florida Atlantic University
University of Central Florida
Pace

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Recommended

4 people have recommended George

Connections

500+ connections

Industry

Pharmaceuticals

George Toscano’s Summary

A seasoned pharmaceutical professional with over thirteen years experience in the pharmaceutical industry in various capacities ranging from project management, operations, product development, to regulatory compliance matters and quality assurance. A key member of upper management responsible for strategic planning and decisions to pursue product candidates based on market and product feasibility considerations.

Instrumental in seeking external capital from Private Equity groups by providing financial and operational statements and performing company valuations based on comparable companies model to present to private equity investors.

Have successfully managed product development activates for generic drug applications (ANDA) and 505(b) 2 Paper NDA filings. Well versed in product development, IND, scale up, stability and analytical data requirements to support ANDA and NDA applications.

My experience ranges full cycle from ANDA's to full NDA's supporting drug safety and efficacy requirements. Considerable experience in the ANDA process and paragraph IV filings for generic drugs for first to file opportunities.
Have been involved in the preparation of CMC sections to support ANDA and NDA filings for Transdermal, Solid oral dose and oral solution drug applications.

Intimately involved with the materials management and the preparation of clinical supplies including materials release and vendor qualification requirements.
Additionally, ensured material supply and availability by working with raw material and API vendors and distributors to ensure adequate supply given production forecasts.

This is a snapshot of my experience, for more complete information contact me.

George Toscano’s Specialties:

Project Management of prospective drug applications including:
CMC section validation and data requirements and preparation, as well as IND and clinical requirements.
Skilled in all aspects necessary to complete and support ANDA filings for generic drugs and very familiar with NDA applications requirements.
Experience with conventional dosage forms sold oral and oral solutions to more specialized forms such as transdermals.
Strong operational background for pharmaceutical manufacturers.

George Toscano’s Experience

Consultant

Quintiles Consulting

(Pharmaceuticals industry)

June 2009 — Present (6 months)
Director QC & RD

Propharma Inc

(Privately Held; Pharmaceuticals industry)

April 2007 — April 2009 (2 years 1 month)

A key member of the upper management team responsible for the decision to pursue prospective drug candidates based on product feasibility, market potential and regulatory pathway. Involved in financial activities including preparing financial and operational statements and performing company valuations based on multiples valuation approach of comparable companies model to present to private equity investors.
·Responsible for the preparation of CMC sections, including pharmaceutical development reports and quality overall summary reports, for drug product submissions the FDA via section 505(b) 2 “Paper NDA” applications.
·Generate project timelines and highlight critical path items to ensure timely project execution and completion.
·Oversee the Development of analytical methodology; Validation Protocols and Reports for submission to FDA as part of NDA drug applications.
·Lead Laboratory through several successful audits and inspections.
Director of Research

Mankuta Gallagher

(Staffing and Recruiting industry)

October 2006 — April 2007 (7 months)

Director of Pharmaceutical, Biotechnology and Medical Device Business Unit.
·Lead a group consisting of a Research Manager and a team of research recruiters to fulfill client recruitment needs for Major Pharmaceutical, Biotech and Medical Device companies within the Life sciences space.
·Responsible for the negotiation of pricing and contract structure with clients for research recruitment projects.
·The primary client relationship manager for all research projects in the Life Sciences Business Unit, as the industry expert played a key role in guiding clients into appropriate research avenues for procurement of desired talent.
·Maintain client relationships by providing a consistent high level of service and continually communicating with clients before during and after completion of projects to ensure needs are being satisfied.
·Allocate internal resources to ensure constant throughput, efficient workflow, and to ensure timely results for clients.
Laboratory Manager

Propharma Inc.

(Privately Held; 11-50 employees; Pharmaceuticals industry)

December 2005 — October 2006 (11 months)

Responsible for the management of laboratory functions, processes and personnel. Played vital role in bringing a company under consent decree back in to compliance with cGMP issues and FDA regulations.
Developed and implemented internal policies to aid the company with the re-launch of products. Implemented sample stability program and method validation program in order to re-launch products.
Develop methodology; Validation Protocols and Reports for submission to FDA as part of audit follow up action.
Primary laboratory contact for auditors and inspectors from major clients and regulatory agencies. Lead Laboratory through several successful audits and inspections.
Responsible for purchasing, negotiating and coordinating external testing contracts and third party maintenance agreements with external vendors.
Key role in product development decisions, with respect to stability enhancement of products and feasibility of products.
Scientist/Group Leader

Abrika Pharmaceuticals

(Privately Held; Pharmaceuticals industry)

2003 — 2005 (2 years )

Responsible for the management of the analytical activities in preparation for ‘first to file’ ANDA opportunities with multi million dollar revenue potential.
Setup the analytical laboratory layout and procured the requisite initial laboratory equipment from vendors.
Create and implement policies for handling of Schedule II-V controlled substances in accordance with DEA regulations.
Develop HPLC methodology and validate methods as per protocols. Originator of validation protocols, and reports submitted to FDA as part of CMC section in ANDA filings.
Coordinate and develop safety procedures in conjunction with requirements from regulatory agencies.
Mentor and train new employees on company policies and procedures and analytical methodology.
Determine feasibility and cost of product development to facilitate the selection of new drug candidates.
Meet with cross functional groups to select final clinical drug candidates by providing stability and release rate information.
Scientist

Noven Pharmaceuticals

(Public Company; 51-200 employees; NOVN; Pharmaceuticals industry)

2000 — 2003 (3 years )

Management of the method development process in accordance with FDA and various regulatory agencies.
Routinely resolved investigations from the Quality Control group by working in conjunction with technical services group.
Method development and validation of stability indicating HPLC methodology for Transdermal drug products.
Execute validation protocols and generate validation reports and facilitate method transfers to Quality Control lab.
Worked closely with the R&D group to identify final working formulations by generating test results and interpreting data.
Facilitated transfer of analytical methods by providing technical assistance and incorporating input from management and analysts into methodology.
Scientist

Fuisz/Biovail Technologies

(Public Company; 10,001 or more employees; Pharmaceuticals industry)

February 1998 — December 2000 (2 years 11 months)

Developed procedures and testing guidelines for product formulations in accordance with FDA, USP and ICH guidelines.
Trained new chemists and managed Quality Control investigations.
Provided drug stability profile on product formulations to select prospective drug candidates
Developed and validated HPLC stability indicating testing methodology for clients to meet contractual milestone payments.
Chemist/Team Leader

Sano/Elan Transdermal Technologies

(Public Company; 10,001 or more employees; Pharmaceuticals industry)

January 1997 — January 1998 (1 year 1 month)

Managed group of analysts responsible for clinical trials testing.
Developed physical testing methods as well as analyzing products, methods supported new ANDA’s and NDA’s for transdermal drug applications supporting, drug applications which are the chief source of revenue.
Trained clinical group in all aspects of finished product and raw materials testing and general laboratory procedures.

George Toscano’s Education

Florida Atlantic University

MBA , International Business , 2003 — 2005
University of Central Florida

BS Biology , Analytical Chemistry/Biology , 1993 — 1997
Pace

Additional Information

George Toscano’s Interests:

Alternative energy, snorkeling, Passive Income, Investing paticularly options investing and arbitrage opportunities accessible to the common investor. Fishing, Blues and classical Guitar, Folk and Old time bluegrass and jug band music, Snorkeling and salt water fishkeeping. Bob Dylan, Mother McCree's Uptown Jug Champions, Old and In the Way, David Grisman. Quotable Quotes: "There is no success like failure, and failure is no success at all" "Sometimes the cards ain't worth a dime if you don't lay them down" "I aint often right, but I've never been wrong"

George Toscano’s Groups:

Cofounder of Midnight Sun Innovations LLC,and Creator of the Earthtorch® a unique solar powered flashlight great for the eco-friendly consumer. RAPS, Linkedin LIONS, ChromForum

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Friends Of Florida
CFA Institute Candidates
TopLinked.com (Open Networkers)
Pharmaceutical and Healthcare Professionals Worldwide Network - www.PharmaWorldNet.com
BayBiopharma
Florida Atlantic University Alumni
Pharma Connections Worldwide
Pharma Business
Pharma Finance
Regulatory Affairs Professionals Society (RAPS)
Generic Pharma
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