Pharmaceutical Accumulation in the Environment: Prevention, Control, Health Effects, and Economic Impact

Editor: Walter E. Goldstein, Goldstein Consulting Company

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Sick Building Syndrome and Related Illness: Prevention and Remediation of Mold Contamination.

Editor: Walter E. Goldstein, Goldstein Consulting Company

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120 Emerald Forest St., Unit #103
Las Vegas, Nevada 89145-3987
Phone: 702-804-5952
Fax: 702-804-5952
Email: goldconsul@aol.com
www.goldconsul.com


Biographical Summary

Dr. Walter E. Goldstein is the President of Goldstein Consulting Company. He is also President and co-founder of a biomedical business with the objective to produce Universal Blood. He was the Coordinator of the Biotechnology Center, Shadow Lane Campus, University of Nevada Las Vegas from 2003-2008. He is an executive with 40-plus years of experience developing technology, products, and business. He led a research and development organization of 140 persons (35 Ph.D.'s) at Bayer (Miles, Inc.), a leading firm in biotechnology, clinical diagnostics, therapeutics, food ingredients, materials, chemicals, and consumer products. He led 35 persons (10 Ph.D.'s) at ESCAgenetics Corporation, which was a leading developer of plant-based technology for food, food ingredients and pharmaceuticals. He designed and developed cryogenic processes and equipment for Union Carbide Corporation.

As President of Goldstein Consulting Company, Dr. Goldstein provides analysis of biotechnology, food, and pharmaceutical processes and products. His work has included analyzing construction defects, memorabilia/art damage and harmful results to personnel as a consequence of industrial accidents. He provided critical input to aid in commercialization of a new biofuels process. He resolved a chemical process failure situation to aid a client. He has provided services as an Expert Witness that include research and testimony to successfully resolve cases on the behalf of clients.

As Coordinator of the Biotechnology Center of UNLV (2003-2008), Dr. Goldstein developed new business in training, laboratory service, and guiding entrepreneurial businesses with interest in establishing enterprises in the Las Vegas Valley. Specific programs that were offered (and in development) included forensic DNA profiling, assistance in training professionals for cross examination, microbiological identification and profiling, food safety, genetic basis for biotechnology improvements, weapons of mass destruction training, and prevention of nosocomial infections.

He has transferred technology and lectured on engineering and science throughout the world. He is listed in American Men of Science and Who's Who. He organized local publicity and programmed select events for the Silicon Valley Society of Competitive Intelligence Professionals. As Chair of the Northern California Pharmaceutical Discussion Group, he organized monthly events involving 100+ attendees while doubling the organization's cash position.

He is a Registered Professional Engineer and taught in the graduate school at the University of Notre Dame. Dr. Goldstein received his BS degree in chemical engineering from the Illinois Institute of Technology and his MS and Ph.D. degrees in chemical engineering from the University of Notre Dame. He holds an MBA from Michigan State University. He has 26 publications to his credit. Recently (2010), he had Sick Building Syndrome and related Illness: Prevention and Remediation of Mold Contamination published, and his book entitled Pharmaceutical Accumulation in the Environment: Prevention, Control, Health Effects, and Economic Impact is proceeding toward publication in 2014, He has co-authored books entitled Technology Transfer of Plant Biotechnology, and Plant Cell and Tissue Culture for the Production of Food Ingredients.

He solved critical problems and developed important prototypes of Miles' diagnostic devices, directed the development of their fermentation products, and guided establishment of their molecular biology program and therapeutic protein development. He led development of immobilized cell processes and provided guidance and leadership for Miles' flavor and food ingredients businesses. Dr. Goldstein led a team to solve a critical impurity problem in a Miles extraction process. He introduced pilot plant computer technology for fermentation control at Miles. His leadership in quickly correcting process/product malfunctions saved Miles many millions of dollars on different occasions. He led numerous worldwide start-ups.

He is recognized for his contributions to developing ESCAgenetics plant cell tissue culture technology and for leading efforts on vanilla flavor and the anti-cancer therapeutic Taxol. He guided critical crop harvests where an error in timing would have meant loss of an expensive product, and he rebuilt their plant genetics programs. His leadership resulted in the assembly of intellectual property in cell culture. His leadership in coaching the tissue culture date palm program resulted in a line of plants for shipment to ex-U.S. locales. He identified collaborators and personnel at critical times for the company's genetics and flavor programs.

In his consulting practice, Dr. Goldstein has applied his modeling methods to structure business relationships and optimize economics. He has guided the planning and development of manufacturing for novel new processes to produce proteins. He has directly designed, specified, and organized installation of biotechnology facilities. His past consulting activities and accomplishments include:

  • Coordinator of the Biotechnology Center, Shadow Lane Campus, University of Nevada Las Vegas (2003-2008), Developing Training, Laboratory Service, and Entrepreneur Assistance Programs in Forensic Science, Biomedical Fields, Food Safety, Nosocomial Infections, in the Genetic Basis of Biotechnology Developments, and in the proteomic basis of environmental biotechnology organisms of interest.
  • Technical development of a plant-based process to manufacture proprietary proteins using a novel host
  • Scaling up a fermentation manufacturing process involving complete retrofitting and build-out of a facility
  • Co-inventor (issued patent) of a mammalian cell process to produce Universal Blood, avoiding donor blood
  • Co-inventor (issued patent) of a mammalian cell process to provide a natural blood product
  • Devised a system/plan for manufacture of natural products from plants to serve health care and cosmetics industries that helped establish a public company
  • Entrepreneurial development of a concept with potential application to treat Inflammable Bowel Syndrome
  • Providing counsel and design input to companies developing plant cell culture technology
  • Identifying collaborators for a technology, which can destroy microbes and avoid damage to proteins, and for an associated oxidation/reduction concept with potential impact on healthcare and industrial areas.
  • Completing a marketing evaluation for a contract service business in protein manufacturing
  • Seeking biomedical applications for a non-invasive cardiac diagnosis system
  • Finding applications for a unique data mining software system for business knowledge management
  • Providing search consulting services in select areas
  • Identifying parties interested in a novel method to isolate valuable compounds from soybean processes
  • Inspecting pharmaceutical facilities to assure regulatory standards are met
  • Analyzing solid oral pharmaceutical formulation to assess proprietary solubility, transport, and drug delivery characteristics
  • Providing Expert Witness research and testimony to successfully resolve cases on the behalf of clients

Industrial Background and Accomplishments
Goldstein Consulting Company, Las Vegas, NV (2003-present) and Foster City, CA (1994-2003)
Technology/business development & analysis, chemical engineering, biotechnology, process design, facility scale-up, process equipment and utility specification, procurement, marketing research

Applied to: fermentation, cell culture, construction defects, memorabilia damage analysis, dietary supplements, therapeutic proteins, small molecule therapeutic substances, novel plant growth formulations, regulatory compliance, aseptic processing for heat-sensitive materials, delivery technologies/products, safety and risk analyses. Examples include:

  • Using chemical engineering modeling to assess when memorabilia was damaged and to infer the cause
  • Using chemical engineering modeling to target cause of a construction defect
  • Providing analysis for launch of a biofuels process
  • Development and Implementation of scale up of a fermentation facility involving total buildout, specifying equipment, utilities, structural needs, and piping.
  • Guidance in planning and developing a novel biotechnology process to produce proteins using a proprietary host by applying chemical engineering principles to a new area.
  • Technological/Economic Modeling of businesses to recommend strategic alliances/negotiation tactics
  • Devising plan to manufacture biosynthetic chemicals for entry into a lucrative phytochemical business
  • Identifying partners for an aseptic processing method that avoids damage to heat-sensitive substances.

ESCAgenetics Corp., San Carlos, CA
Vice President, Director of Research (1987-1994)
Directed $5 million R & D plant biotechnology program to develop marketable products, trade secrets and secure patents. Led programs in plant-based pharmaceuticals and ingredients (e.g., vanilla) derived from plants/plant cells.

Secured an $800,000 National Cancer Institute grant, developed bioreactor/process technology, and devised/implemented a strategy to obtain intellectual property protection for the anti-cancer drug, Taxol.

Secured collaborations for plant-sourced drugs of $500 million potential.

Established a competitive intelligence system. Guided development of plant genetics, immunochemical detection methods, and flavor improvement for beverages.

Guided securing intellectual property in key cases of a unique flavor system and an anti-cancer therapeutic where challenges from government and industry were successfully overcome.

Bayer Corporation(Miles, Inc.), Elkhart, IN
Vice President of Research and Development (1982-1987)
Directed a $12 million R&D program for a $250 million biotechnology division of a large multinational conglomerate; established track record in developing new business programs leading to trade secrets, patents, increased sales, cost containment, and profitable products for health, industrial, and consumer markets.

Led development of an FDA-approved immobilized cell bioreactor process, profitable $200million joint venture facility, start-up of domestic and ex-US bioprocessing plants, and problem solving to secure supply contracts. Led development of analytical methods critical to success of this program.

Secured qualification of $50 million/yr business at a major consumer/health care company and led development of probiotics for health care applications.

Coached a team to stabilize a cell line to produce a protein for sale to a $billion therapeutic market. Led a team that received a corporate award for developing enzymes for a world market.

Transformed a pilot plant operation into a high quality engineering research team. Shortened development time by 1/3 for $50 million products. Solved an impurity problem in a liquid extraction process for a $200 million/yr product.

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