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Larry Kranking
President & CEO, Coldstream Laboratories, Inc.

Mr. Larry Kranking, is a Senior Executive with over 31 years of experience in the Pharmaceutical & Regulated Life Sciences industry. His record of extraordinary accomplishments includes leading start-up pharma companies, implementing innovative regulatory strategies, expertise in efficiency improvements and being a turn around expert in animal health, cGMP pharma and medical device operations.

Mr. Kranking is an internationally recognized leader who has influenced the overall regulated environment by chairing a number of collaborative teams that included both industry and FDA scientists, engineers and regulatory experts to develop the guidelines that define today's biopharma manufacturing world.

His business / operations experience includes the start-up of cGMP manufacturing facilities for Boehringer Ingelheim and Eisai Inc. that were defined by having a record of minimal FD 483's observations from the FDA (none at Eisai Inc.) and no observations from international regulatory inspection agencies.

    Some representative experience of Mr. Kranking:

»  Start-up and rapid FDA approval of a sterile ophthalmic parenteral manufacturing company.

»  Spearheaded financing of a new sterile processing unit through innovative financial instruments, leveraging US Gov't programs and non-collateralized loans.

» Accountable for the design, construction, qualification and FDA approval for a commercial manufacturing operation. Work included the development and manufacturing of a clinical parenteral drug.

» Accountable for world supply of clinical lyophilized sterile products, aseptic and solid oral dose process development for an international pharmaceutical company.

» Performed countless technology transfers of products inclusive of obtaining FDA approval.

» Reorganized Drug Development, Medical Department and Drug Regulatory Affairs (DRA) departments, focused on competitive advantages and a reduction in the use of outside contractors. Net annual savings of $6,000,000 per annum.

» In charge of process improvement for Clinical Supply production for R&D with an annual savings of $1,000,000 in clinical supply contracts, eliminating the need for plant expansion for a total capital expenditure avoidance of $25,000,000.

» Increased utilization of an existing capacity by 18% by initiating CMO contracts for a net earning of 25%+ margin.

Mr. Kranking holds a degree in MBA in Pharmaceutical Marketing/Management & a degree in B.A. in Sociology, Minor-Accounting/Business from Fairleigh Dickinson University. 


He is associated with International Society of Pharmaceutical Engineers (ISPE). His involvement with ISPE includes:
 

1996-97 President of ISPE
 

» Founder and former president of the ISPE New England Chapter
 

» 1988 ISPE Member of the Year
 

» Past chairperson of ISPE's Chapter Committee
 

Co-founder of ISPE's SUPAC Steering Committee

»

Co-founder of the ISPE International Leadership Forum (ILF) with involvement from majority of top executives from pharmaceutical industry and active participation from FDA and Europe's EMEA
 

»

Appointed by FDA and ISPE to chair the FDA SUPAC Similar Equipment Team

 

Larry Kranking
President & CEO, Coldstream Laboratories, Inc.

Mr. Larry Kranking, is a Senior Executive with over 31 years of experience in the Pharmaceutical & Regulated Life Sciences industry. His record of extraordinary accomplishments includes leading start-up pharma companies, implementing innovative regulatory strategies, expertise in efficiency improvements and being a turn around expert in animal health, cGMP pharma and medical device operations.

Mr. Kranking is an internationally recognized leader who has influenced the overall regulated environment by chairing a number of collaborative teams that included both industry and FDA scientists, engineers and regulatory experts to develop the guidelines that define today's biopharma manufacturing world.

His business / operations experience includes the start-up of cGMP manufacturing facilities for Boehringer Ingelheim and Eisai Inc. that were defined by having a record of minimal FD 483's observations from the FDA (none at Eisai Inc.) and no observations from international regulatory inspection agencies.

    Some representative experience of Mr. Kranking:

»  Start-up and rapid FDA approval of a sterile ophthalmic parenteral manufacturing company.

»  Spearheaded financing of a new sterile processing unit through innovative financial instruments, leveraging US Gov't programs and non-collateralized loans.

» Accountable for the design, construction, qualification and FDA approval for a commercial manufacturing operation. Work included the development and manufacturing of a clinical parenteral drug.

» Accountable for world supply of clinical lyophilized sterile products, aseptic and solid oral dose process development for an international pharmaceutical company.

» Performed countless technology transfers of products inclusive of obtaining FDA approval.

» Reorganized Drug Development, Medical Department and Drug Regulatory Affairs (DRA) departments, focused on competitive advantages and a reduction in the use of outside contractors. Net annual savings of $6,000,000 per annum.

» In charge of process improvement for Clinical Supply production for R&D with an annual savings of $1,000,000 in clinical supply contracts, eliminating the need for plant expansion for a total capital expenditure avoidance of $25,000,000.

» Increased utilization of an existing capacity by 18% by initiating CMO contracts for a net earning of 25%+ margin.

Mr. Kranking holds a degree in MBA in Pharmaceutical Marketing/Management & a degree in B.A. in Sociology, Minor-Accounting/Business from Fairleigh Dickinson University. 


He is associated with International Society of Pharmaceutical Engineers (ISPE). His involvement with ISPE includes:
 

1996-97 President of ISPE
 

» Founder and former president of the ISPE New England Chapter
 

» 1988 ISPE Member of the Year
 

» Past chairperson of ISPE's Chapter Committee
 

Co-founder of ISPE's SUPAC Steering Committee

»

Co-founder of the ISPE International Leadership Forum (ILF) with involvement from majority of top executives from pharmaceutical industry and active participation from FDA and Europe's EMEA
 

»

Appointed by FDA and ISPE to chair the FDA SUPAC Similar Equipment Team