Copyright © 2009
Goodwin Biotechnology, Inc.
   
 

Company Profile

Goodwin Biotechnology, Inc. ("GBI"), based in Plantation, Florida, is the earliest established and one of the most experienced contract manufacturing organizations (CMOs) serving the biopharmaceutical industry.  Originally spun out of the Goodwin Institute for Cancer Research in 1992, GBI's focus has been on the manufacture of pre-clinical, clinical trial products. In the biologics CMO niche, GBI was the first to engineer the concept of "full integration", which enables us to work with our clients from the initial production step of developing the genetically engineered "production" cell line all the way through vialing of the final biopharmaceutical product and distribution to clinical trial sites.  GBI has an enviable reputation for regulatory compliance and has made dozens of clinical trial lots for more than 100 companies through its history. 

In 2004, GBI was acquired by Wallace Pharmaceuticals Pvt. Ltd. (www.wallace.co.in ) based in Goa, India. Wallace is a solid dosage formulations company with an enviable position in the Indian market. 

GBI's senior operational and quality staff have decades of experience in GMP manufacturing. This experience includes work at several leading biopharmaceutical companies. Clients have the assurance of knowing that the individuals entrusted with the manufacture of their products are seasoned industry professionals with excellent track records.

OUR MANAGEMENT TEAM
David Fischer Executive Vice President, Client Services & Co-Founder
Zafeer Ahmad, Ph.D. Senior Vice President, Operations
Muctarr Sesay, Ph.D.Vice President of Process Development
Stan Zeichner Vice President, Business Development
Yamuna Dasarathy, Ph.D. Director of Marketing & Business Development

David Fischer
Executive VP of Client Operations

Mr. Fischer is a co-founder of Goodwin Biotechnology Inc. and currently serves as the Executive Vice President of Client Operations. Prior to co-founding GBI, Mr. Fischer held increasingly responsible positions in manufacturing, materials management, and sales and marketing with Abbott Laboratories, Amersham Corporation, and Immunomedics. Mr. Fischer has over 30 years experience with biological products in both therapeutic and diagnostic applications. He earned a Master of Business Administration from Roosevelt University in Chicago , and a Bachelor of Business Administration from the University of Wisconsin in Madison.


Zafeer Ahmad, Ph.D.
Senior Vice President, Operations

Dr. Ahmad most recently held the position of Vice President, Manufacturing Operations at Bradmer Pharmaceuticals Inc. Prior to joining Bradmer Pharmaceuticals, Dr. Ahmad was Vice President of Process Development and Manufacturing group at NeoPharm. Inc. Dr. Ahmad also held senior positions at GlaxoSmithKline plc and Hoffmann-La Roche Inc. He has more than 21 years of industry experience in drug development, aseptic manufacturing operations, facility design and validation, batch record and SOP preparation, outsourcing, tech transfer, process validation and regulatory submission of drugs. Based on this experience, Dr. Ahmad has a strong working knowledge of cGMP and CMC documentation for IND and BLA preparation. From an academic perspective, Dr. Ahmad held the position of Senior Scientist/Assistant Professor at Indiana University, and was a Visiting Fellow at the National Institutes of Health in Bethesda, MD. He received his Ph.D in Biochemistry from Aligarh University in India. He has published numerous peer reviewed articles including nine papers in the Journal of Biological Chemistry.


Muctarr Sesay, Ph.D.
Vice President of Process Development

Dr. Sesay has over 8 years industrial experience in bioconjugation and modification of biological molecules (including monoclonal and polyclonal antibodies, enzymes, toxins and others) and small molecules and over 15 years of experience in the biotechnology sectors. Prior to GBI, Muctarr supervised many projects in R&D, Process Development and Manufacturing of biologics at Life Technologies (now Invitrogen), Kirkegaard and Perry Lab and Elusys Therapeutics. Muctarr, after receiving his Ph.D in Biochemistry from the University of London, England worked for 3 years postdoctoral candidate at the University of Maryland , College Park in Protein Purification and characterization.


Stan Zeichner
Vice President, Business Development

Mr. Zeichner brings over 25 years experience in the business development area with both pharma and biopharm service provider and supplier organizations. He was most recently director of business development at Laureate Pharma where at various times he supervised world-wide sales as well as all marketing programs, along with establishing major cooperative alliances with relevant partner companies. Prior to Laureate he was regional sales manager for Irvine Scientific where he promoted their extensive line of cell culture services and products. Before that, Stan was manager of business development for BioScience Contract Production where his sales and marketing programs helped raise the value of the company to facilitate a sale to Cambrex Corp. for $120M. Stan has a MS in Biochemistry from Fairleigh Dickinson University and a BA in Chemistry from Hunter College.


Yamuna Dasarathy, Ph.D.
Director of Marketing & Business Development

Dr. Dasarathy has over 17 years of experience in marketing to the life sciences and pharmaceutical Industry. Prior to joining GBI, Yamuna was a Senior Marketing Manager, promoting Laureate Pharma’s biologics manufacturing services. Prior to that she held various strategic positions at GE Healthcare Biosciences covering technical services and downstream process development, and was managing marketing of over a $100 million product portfolio. Yamuna’s academic experience includes an Assistant Professorship at Tufts-New England Medical Center, Boston and a post doctoral fellowship at Brandeis University. She has a PhD in Biochemistry from University of Madras, India and an MBA from Rutgers University, NJ.


GBI Publications


Goodwin Biotechnology's Track Record

Expertise (ek' per- tez' ")  n. Specialized knowledge, skill or ability.

GBI is independently listed as one of only 21 major CMOs in the world. GBI has completed over 350 projects and assisted in the filing INDs for client products. The company provides mature, proven quality systems with clinical lots made for U.S. and international clients. Our client base consists of large, mid-sized and small biotechnology companies, medical centers and federal, health and defense agencies.
 
Facilities

GBI occupies a facility of 28,000 sq. ft. which is utilized for GMP manufacturing and process development, QA and QC labs and support services. Manufacturing equipment and its parameters are monitored 24-hour via a computer controlled alarm system. GBI is equipped with emergency backup generators in the event of a power loss. GBI has a facility staff on site to aid in monitoring and maintenance of  manufacturing equipment and its associated utilities.
 
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