Biotechnology Product and Process Development Expert

Expertise

• Conducting and directing product, process and manufacturing development activities for biologically-derived materials used in the pharmaceutical, biofuel, chemical, agricultural and nutraceutical industries.
• Production of biosimilars, monoclonal antibodies and industrial recombinant proteins. Activities include research, development, production, biocomparability, technology management in CMOs, FTO landscape critical for biosimilars, licensing, business development and regulatory aspects of biologically-derived proteins.
• Program integration; conducted at CMOs for the CMC section into the overall IND and NDA integrating production with product discovery, toxicology, pharmacology and clinical aspects of the regulatory submissions.
• Conducted product comparability studies for monoclonal antibodies developed as biosimilars.
• Leading efforts to establish a flexible, low cost biomanufacturing CDMO using microbial, cell culture and transgenic-technologies to produce proteins, nucleic acids, viruses and cells used as biopharmaceuticals focusing on biosimilars, orphan drugs and in regenerative medicine therapies.
• Biopharmaceutical, biochemistry, bioprocessing and agricultural biotechnology courses and workshops.

Key Areas

• Bioanalytics
• Biocomparability
• Biocontrol agents
• Bioconversions
• Biosimilars
• Biosuperiors
• Biotechnology process science
• Biotechnology product development
• Collagenand gelatin
• Contract Manufacturing Organizations: CMO and CDMO
• Downstream processing
• Enzymology
• IND, BLA, NDA, CMC
• Industrial proteins
• Mammalian, insect, plant cell culture
• Manufacturing
• Microbial fermentation
• Molecular biology
• Monoclonal antibodies
• Pharmaceutical process development
• Plant made pharmaceuticals
• Teaching biotechnology courses
• Transgenics

Experience

Undisclosed Company, Vice President of Technology, 2009 - Present

• Setting a CDMO in the United Kingdom for biomanufacturing and development operations (process transfer and adaptation, cell bank generation, upstream/downstream processing, bioanalytics, formulation and fill/finish) based on single-use systems and microbial, cell culture and transgenic-based technology.
• Identify and integrated into BioFabrica several mature CDMOs matching the low cost/single use technology strategy considering technology, regulatory and business development activities.
• Work with regulatory, legal and business personnel to select and develop programs for the production of biosimilars, biosuperiors and orphan drugs as initial product targets.
• Work with CMO's to implement cell therapy products (cells and vectors) and other products related with regenerative medicine as they become predominant products for personalized therapies.

FibroGen, San Francisco, CA, Senior Science Fellow, 2001 - 2009

• Led activities using plant transgenic technology to develop FibroGen's industrial-scale products at 8 sites (Iowa State University, Helsinki U., Washington State University, Arizona State University, UC Davis, Agrenvec-Spain, ProdiGene-Texas, Medicago-Quebec) resulting in the production of recombinant collagen in corn, tobacco, barley and gelatin in corn and barley.
• Work with clients focusing on collagen and gelatin producers to integrate products derived from new technologies based on diverse expression systems considering quality, public acceptance, cost, and volume parameters.
• Directed activities at a contract manufacturing site for the production of a mammalian cell culture-derived anti-fibrotic factor monoclonal antibody based on perfusion technology (3 month runs) currently in clinical trials.
• The perfusion technology resulted in significant increase in overall productivity and product quality.

Integrated Protein Technologies, (Monsanto), Saint Louis, MO, founder/VP Technology, 1997 - 2001

• Founder of a unit working as a CDMO within Monsanto to create new business opportunities based on integrating the corporate plant and microbial capabilities for the production of recombinant proteins and related purification and analytical technologies.
• Supervised a 30 person multi-disciplinary team at 7 sites (St. Louis, Madison, Chicago, San Diego, Davis, Pennsylvania and Missouri University) developing biopharmaceuticals in transgenic plants and in E.coli.
• Led the team delivering over 10 plant-derived pharmaceutical proteins including an IND for the only monoclonal antibody produced in a transgenic system (corn seed) accepted by the FDA for clinical trials.
• Directed the activities for a biosimilar (human growth hormone) expressed in corn seed and tobacco chloroplasts and for multiple monoclonal antibodies in corn seed to be used as biosimilars or as innovative products.
• Work with clients worldwide focusing on the pharmaceutical and biotechnology industries to integrate microbial and plant-derived products based on Monsanto's technologies considering product quality, public acceptance, regulatory, clinical, cost, and volume parameters.

Searle Pharmaceuticals, (Monsanto), Saint Louis, MO, 1991 - 1997

Group Leader Biosynthesis, 1993 - 1997

• Manage a team of 20 individuals to develop upstream processes and preparing INDs for multiple products; (Daniplestim/Myelopoietin - e. coli-derived recombinant cytokines develop for use in cancer treatment, tissue factor pathway Inhibitor - complex e. coli-derived recombinant therapeutic enzyme develop for use in sepsis treatment).
• Both of these processes delivering materials for clinical trials were successfully transferred to CMOs in Massachusetts and California.
• Support discovery programs by managing production activities of many product candidates (over 30 every year) that resulted in two commercial products (Celebrex discovered using cyclooxygenases derived from insect cell culture and Inspra via microbial steroid bioconversions resulting in a patent) integrating the CMC section into the overall IND and NDA covering product discovery, toxicology, pharmacology and clinical aspects of the regulatory submissions.
• Integrated production activities with product development for many recombinant proteins (e. coli-derived recombinant enzymes HIV protease, HIV assemblin, cytochrome P450s - insect cell culture enzymes used as toxicology reagents, nitric oxide synthase - insect cell culture enzyme for to develop cardiovascular agents), bioconversions (HIV protease inhibitors, xemlofiban - a cardiovascular drug candidate, second generation process for Bextra - an anti-inflammatory agent approved by the FDA, Glycovir - an aminosugar for HIV treatment) and primary metabolites (cyclopeptides - fungal antibiotic). The process for Glycovir was transferred to a CMO to produce clinical materials.

Technical Program Manager, 1991 - 1993

• Responsible to support technology transfer from development into manufacturing integrated into the preparation of the CMC sections of INDs and NDAs for three commercial products (Oxaprozin -non-steroidal anti-inflammatory agent, Misoprostol -prostaglandin with GI protective activity, Lomefloxacin -- fluoroquinolone antibiotic).
• Managed technical and manufacturing activities related with in-licensing efforts of Searle's business development team which including the in-licensing of Eplerenone (Inspra), a second generation product to Spirinolactone used in cardiovascular treatment.
• Coordinated manufacturing activities for biologics including the technology transfer of Daniplestim, an e. coli derived recombinant cytokine for cancer treatment, from the development team into manufacturing.

Monsanto, Saint Louis, MO, Senior Scientist, 1984 - 1991

• Responsible for development of bioprocesses for the production of metabolites, recombinant proteins and specialty chemicals used as biopharmaceuticals in clinical trials and as chemicals via biotransformations using microbial fermentation and insect cell culture.
• Conducted research to increase the fermentation productivity of the commercial product Prosilac (Bovine growth hormone - e. coli derived recombinant hormone for animal productivity) and its companion product Porcine growth hormone. This process is still in use at 40,000L scale delivering over 20 metric tons of Prosilac per year, the higher volume for any recombinant biologic, at the lowest cost compared with all other recombinant proteins.
• Developed processes for structural proteins, fermentations, and bioconversions of value to biomaterial programs: Human ferritin - e. coli derived recombinant structural protein for advanced performance ceramics, spider silk - e. coli derived recombinant structural protein for high strength fibers, bisphenol hydroxylation - fungal bioconversion for thermoplastics, polyhydroxalkanoates - microbial storage lipid metabolites for biodegradable plastics commercialized by Monsanto as Biopol).
• Generated materials for the transgenic plant program critical to obtain approval of products that made Monsanto the leader in agricultural biotechnology. These materials ranged from fermentation products such as microbial biocontrol agents as encapsulated microbial cells used as biopesticides and the microbial enzymes to be expressed in transgenic plants: EPSP synthase/Glysophate oxidase - E. coli derived recombinant enzymes providing herbicide resistance, Neomycin tranferase - E. coli derived recombinant enzyme used a selective marker providing antibiotic resistance.
• Had a leading role in the start-up of Monsanto's biotechnology pilot plant still in use for clinical production and to supply products such as immobilized aspartase for aspartic acid bioconversion used to make aspartame.

Ethyl Chemicals, Baton Rouge, LA, Biotechnology Scientists, 1983 - 1984

• Conducted research to support business development activities of a chemical company exploring opportunities in biotechnology.
• Develop processes for phenylalanine bioconversion using immobilized enzymes and cells and for Phenol hydroxylation using an immobilized fungal culture to develop advanced materials.

UpJohn Manufacturing, Barceloneta, Porto Rico, Development Group Leader, 1981 - 1983

• Manage a group of scientist supporting technology transfer and development between the manufacturing plants in Puerto Rico and Michigan.
• Responsible for a filamentous microbial fermentation process in manufacturing the antibiotic lincomycin resulting in a 30% increase in streptomyces derived antibiotic productivity at 150,000 L scale.

Educator

Undisclosed University, Europe and Mexico, 2004 - Present

Workshop Organizer, IBC Conferences, INFORMA

• Lecturer involved in planning and teaching workshops at international conferences in Berlin, Barcelona, Singapore, Lisbon, Amsterdam, Dusseldorf, Mexico City, Merida, San Luis Potosi and Vienna.
• Introduction to Biopharmaceutical Workshop - IBC Bioprocessing Conferences
• Advances in Biosynthesis Workshop - IBC Bioprocessing Conferences
• Advance in Monoclonal Antibody Biosynthesis - IBC Bioprocessing Conferences
• Production of biopharmaceuticals in plants.

University of California, Associate Professor, 1989 - Present

• Teaching on site in several locations: San Diego and Santa Cruz, Stanford, Washington University St. Louis, Northwestern University Extension Colleges.
• Lecturer involved in planning and teaching Ag biotechnology and Biopharmaceutical courses.
• Understanding Biopharmaceuticals - UCSD
• Agricultural Biotechnology - UCSD
• Biopharmaceutical Fundamentals - UCSD/UCSC
• Transgenic Technology - Stanford University
• Lecturer involved in planning and teaching Biochemistry and Biopharmaceutical courses.
• Biochemistry for Biotechnology - Washington University St. Louis
• Biotechnology in Health Care - Washington University St. Louis
• Cell Culture and Fermentation Technology - Washington University St. Louis
• Advances in Biotechnology in Health Care - Northwestern University

Honors & Publications

Languages

• English
• Spanish - Native
• French - limited
• Italian - limited
• Russian - limited

Academic and Professional Affiliations

• American Chemical Society
• Society for Industrial Microbiology
• Member of the organizer committee for Plant Made Pharmaceutical conferences in Quebec
• Member of the scientific advisory committee for bioprocessing conferences, (locations: Lisbon Belgium, Berlin, and Netherlands)
• Member of the scientific advisory board for the agricultural biotechnology Unicrop, Finland
• Member of the scientific advisory committee for the biotechnology program at the University of Puerto Rico.

Publications and Patents

• Numerous publications in peer reviewed journals, workshops, national and international conferences.

Education

• Ph.D. Biochemistry, University of Illinois, Urbana, IL
• B.S. Chemistry/Languages, University of Notre Dame, Notre Dame, IN
• B.A. Chemistry/Languages, University of Notre Dame, Notre Dame, IN