Ronald A. Rader
    Rockville, MD 20851
    Phone: 301-424-0255 (preferred method for employment-related contacts)
    E-mail: biotech@biopharma.com

    Education:

    B.S., Microbiology - University of Maryland (General Honors Program), 1973
    M.L.S., Library Science - College of Library and Information Services, University of Maryland, 1979

    Summary:

    Expertise in information retrieval and analysis, competitive intelligence, technology assessment, market research, and information resources development/publishing concerning biotechnology and pharmaceutical research, development, technologies, patents/technology transfer, marketing and public affairs. Over 25 years experience managing, retrieving, integrating, assessing and publishing complex scientific, technological and commercial information. Successful independent desktop publisher/entrepreneur in the biotechnology and pharmaceutical areas for 17 years.

    Professional Experience:

    Biotechnology Information Institute, Rockville, MD
    President (sole proprietor); December 1990 - Present
    Develop and market information resources concerning biotechnology and pharmaceutical research, development, products and technologies. Solely responsible for all aspects of publishing (conceptualizing, developing, research, writing/editing, layout and marketing) of books, databases, periodicals and Web sites relied upon by biotechnology and pharmaceutical organizations worldwide including:  Biopharmaceutical Products in the U.S. and European Markets, the only biopharmaceutical products reference book (6th edition, 1602 pages, Sept. 2007); the Antiviral Agents Bulletin, for 15 years the only periodical specializing in antiviral drug and vaccine development (5,300 pages); the Federal Bio-Technology Transfer Directory, covering all federal, e.g., NIH, inventions and technology transfers in the biomedical/biotechnology areas (687-page book in 1994; database to 2000); and Expression Systems and Biopharmaceutical Manufacturing Technologies:  Directory and Market Assessment [in press]. 
        Consulting:  Pandemic Influenza Digital Archive (PIDA), National Institute of Allergy and Infectious Diseases (NIAID), NIH, with LTS Corp., May-Nov. 2007 (6 months, 2 days/week); Director, BioPipeline Project, a biopharmaceutical R&D competitive intelligence service, 2003-4, for BioPlan Associates, Inc.; various pharmaceutical market assessments, LifeTech Research, Inc., Sept.-Dec. 2007; and an in-depth due diligence review of a small public biotech company (client proprietary).

    Porton International, Inc. (and its OMEC International subsidiary, Washington, DC)
    October 1985 - December 1990
    Manager of Information Services, Market Planning and Information Services Department:
    Provided information and competitive intelligence services and market, technology and strategic assessments for a diversified international biotechnology company (then probably the world's largest privately-held biotechnology company) with subsidiaries for biopharmaceuticals and vaccines, diagnostics, culture media and reagents, fermentation equipment, protein sequencers, HIV clinical trials and publishing (OMEC Intl.). Provided information retrieval services and market and technology assessments supporting business development, product R&D, regulatory compliance, patents/technology transfer, marketing and strategic corporate decisions. Provided competitive intelligence, including monitoring diverse commercial, technological, regulatory and scientific developments. Served as Editor, Porton Alert, the monthly corporate current awareness bulletin; managed the corporate reference library/information center; and provided online database searching and other information retrieval services.
          With OMEC International, Porton's publishing and information resources development subsidiary:
    Editor, Antiviral Agents Bulletin - conceived, developed, and the sole writer (since April 1988).
    Editor, BioINVENTION, a monthly U.S. biotechnology patent abstract and news periodical, 1995-2000.
    Lead Author/Editor, the Federal Biotechnology Programs Directory and the Federal Biotechnology Information Resources Directory, the first studies/reference books surveying federal programs and information resources relevant to U.S. biotechnology R&D and industry.
    [Note, about 80% of time in more recent years devoted to Porton International, about 80% of time in earlier years was devoted to OMEC International].

    Technical Resources, Inc., Rockville, MD
    Chemical Editor, Survey of Compounds Which Have Been Tested for Carcinogenic Activity , 1985.
    Chemical identification, nomenclature assignment, cataloging and in-depth indexing of the world's published reports of animal carcinogenicity and long-term chronic toxicology studies (NIH contract).

    Biospherics, Inc. (now Spherix, Rockville, MD
    Information Scientist, Cancer Information Service; Manager, Cancer Information Clearinghouse, 1984.
    Technical information services for the National Cancer Institute (NCI) public and health professional information programs; information retrieval and online searching to support responses to technical and public queries and issues; managed the health care professional clearinghouse and handled related requests for information (NIH contract).

    Computer Sciences Corp., Falls Church, VA
    User Support Coordinator, NIH/EPA Chemical Information System, 1983-1984.
    Managed user support (handled inquiries and user and system problems) for the major federal agency chemical/toxicology database and chemical subsubstructure search system (network of databases); wrote database users manuals; conducted marketing efforts and user training (NIH and EPA contract).

    MITRE Corp., McLean, VA, 1978-1981
    Information Scientist, Toxic Substances Information Group, Environment Division, 1978-1981.
    For various government agencies, developed toxicology, environmental and technology assessment information resources and developed related assessments and reports. Major projects included: design and development of the Chemical Information Resources Directory component (a pioneer meta-index of information resources) of the Chemical Substances Information Network (CSIN); wrote the first environmental and safety assessment of petroleum refining; developed an energy technology competitive intelligence system for a U.S. ally; wrote the first assessment of information resources needed for the DOE CO2-Climate research programs; provided database support for the first study of radiation exposure records and data systems at DOE nuclear facilities and assessment of their utility for epidemiological studies; and established a special library for the Environment Division, DOE.

    Gillette Medical Evaluation Labs., Gillette Co., Rockville, MD
    Information Specialist, Gillette Medical Evaluation Labs., The Gillette Co., 1976-1978.
    Provided information retrieval and other services supporting product toxicology/safety evaluations, regulatory affairs and research. Editor, Medical Bulletin, the company's internal safety and regulatory affairs current awareness bulletin; online database searching; developed the company's first worldwide chemical (processing and ingredient) registry; and document indexing.

    Bio-Conversion Laboratories, Riverdale, MD
    Chemist, 1974-1975
    With a start-up natural products chemical specialty company, established the chemical inventories, conducted library research, and performed bench scale synthesis.

    Publications (partial list; well over 10,000 pages in print):

    Books/databases:

    • Biopharmaceutical Products in the U.S. and European Markets, sole author, 6th edition, BioPlan Associates, 1602 pages, Sept. 2007, . The only biopharmaceutical products reference book; concentrates on products' biotechnology and commercial aspects. Also, the Web site (www.biopharma.com) and its online database.
    • Federal Bio-Technology Transfer Directory, author and publisher, Biotechnology Information Institute, 687 pages, April 1994. Replaced by Web database that grew to be over twice as large and was marketed until 2000. [This may still be the largest book/database of inventions and technology transfers in the biomedical/biotechnology areas]
    • Federal Biotechnology Programs Directory, OMEC International, 162 pages, 1987; the first directory/study of federal biotechnology research, development, regulatory and funding programs.
    • Federal Biotechnology Information Resources Directory, OMEC International, 151 pages, 1987; the first directory/study of federal information resources relevant to biotechnology
    • Survey of Compounds Which Have Been Tested for Carcinogenic Activity (PHS-149; I was the chemical editor), 1983-84, U.S. Government Printing Office (GPO), 1985.
    • Chemical Information Resources Directory, vol. 1, Development and Uses of the Chemical Information Resources Directory; PB80-105190, 79 pages; and vol. 2, Descriptive and Subject Indexes, PB80-105208, 673 pages; National Technical Information Service (NTIS), 1980.
    Periodicals:
    • Antiviral Agents Bulletin (author/publisher), Biotechnology Information Institute, monthly 32-page periodical covering antiviral drug and vaccine development, April 1988-March 2003 (15 years; 5,700+ pages). Also, Web site (www.bioinfo.com/antiviral.html) and its full-text database.
    • BioINVENTION, Editor, OMEC International, Oct. 1985-Dec. 1990, monthly 28-32 page periodical presenting abstracts of U.S. biotechnology patents plus related technology transfer news and analysis.
    Articles (trade press):
    • "Expression Systems for Process and Product Development: A Perspective on Opportunities for Innovator and Follow-on Product Developers," BioProcess International, vol. 6, issue 6, suppl. 4, Success Stories in Protein Expression (lead article), p. 4-9, June 2008.
    • "Biopharmaceuticals: Lack of Information Disclosure Confounds Public Trust, Particularly in the Context of Biosimilars," BioWorld Perspectives, vol. 2, issue 18, May 1, 2008.
    • "Paucity of Biopharma Approvals Raises Alarm: Lower Numbers, Novelty and Economic Impact Indicate Problems," Genetic Engineering & Biotechnology News (GEN), March 15, 2008
    • "What Is a Generic Biopharmaceutical? Biogeneric? Follow-On Protein? Biosimilar? Follow-On Biologic? Part 1:  Introduction and Basic Paradigms," BioProcess International, March 2007.
    • "What Is a Generic Biopharmaceutical? Biogeneric? Follow-On Protein? Biosimilar? Follow-On Biologic? Part 2:  Information, Nomenclature, Perceptions, and the Market," BioProcess International, May 2007, p. 20-28.
    • "Biopharmaceuticals Approvals Review," covering 2005-mid 2006 FDA approvals, in Genetic Engineering News, vol. 26, no. 14, August 1, 2006.
    • "What is a Biopharmaceutical, Part 1:  (Bio)Technology-Based Definitions," BioExecutive, March 2005, p. 60-65.
    • "What is a Biopharmaceutical, Part 2: Company and Industry Definitions," BioExecutive, May 2005, p. 42-49.
    • "Analysis of U.S. Biotechnology Patents," 1986, 1987 and 1988; annual analyses of U.S. biotechnology patents issued (press releases and backgrounders) by the Pharmaceutical Manufacturers Association (PMA, now PhRMA). See later paper presented to the Div. of Law and Chemistry, American Chemical Society National Meeting, 1990.
    Articles (peer-reviewed):
    • "(Re)defining Biopharmaceutical" Nature Biotechnology, July 2008, 26(7), p. 743-751.
    • "How Big is the World Market for Biopharmaceuticals? It All Depends How You Define Biopharmaceutical," in Friedman, Y., Best Practices in Biotechnology Business Development, Logo Press, p. 175-85, 2008.
    • "An Overview of Biotechnology Information Resources," Trends in Biotechnology, Elsevier, Nov. 1990, p. 318-23.
    • "The Status of the Infrastructure of Information Resources Supporting U.S. Biotechnology," in The Impact of Chemistry on Biotechnology, American Chemical Society, 1988, p. 372-385.
    • "Chemical Information Resources Directory: An Integrating Component of the Chemical Substances Information Network," in the Journal of Chemical Information and Computer Sciences, May, 1981, p. 78-82. [View 1st page courtesy of ACS].
    • "Information Retrieval for the Safety Evaluation of Cosmetic Products," in Special Libraries, May/June, 1978, p. 206-14.
    Other:
    • "Analysis of U.S. Biotechnology Patents," 1986, 1987 and 1988; annual analyses of U.S. biotechnology patents issued by the Pharmaceutical Manufacturers Association (PMA, now PhRMA). See related, more comprehensive paper presented to the Div. of Law and Chemistry, American Chemical Society National Meeting, 1990.
    • Structure and Nomenclature Search System; Chemical Evaluation Search and Retrieval System; Federal Register Search System; Thermodynamics and other database user manuals and promotional materials for the NIH/EPA Chemical Information System (CIS); published by the National Technical Information Service (NTIS), 1984.

    Professional Activities (partial list):

    Organizations:

    Capital Area Biotechnology Information Network (CABIN), 1988-1990 - founder and Program Chairman for this local biotechnology information users group; organized 3-4 meetings annually, each attended by 25-50 persons.

    Primary membership affiliations (often a member of multiple divisions/sections):

    • Special Libraries Association, Pharmaceutical and Health Technology Division
    • American Chemical Society, Divisions of Chemical Information and Biochemical Technology
    • Patent Information Users Group (International Society for Patent Information)
    • Licensing Executives Society (LES)
    • Pharmaceutical Marketing Research Group
    • American Society for Microbiology
    • Society for Biological Engineering

    Presentations: [Note, in recent years, I have concentrated on publications rather than presentations]

    • "What Will the Market for FOB's Be?  What Forces Will Shape the Market?  How Will New Entrants Compete and Innovators Adapt?," Global Follow-On Biologics:  Preparing for a Post-FOB Approval World, IBC USA Conferences, Bethesda, MD, Nov. 17-18, 2008 [confirmed].
    • "Information:  The Next Battleground," Biosimilars Conference 2008, Visiongain, Philadelphia, PA, Nov. 11-13, 2008 [confirmed].
    • "What Is a Generic Biopharmaceutical? Biogeneric? Follow-On Protein? Biosimilar? Follow-On Biologic?..." Biosimlars and Follow-on Biologics, Center for Business Intelligence, Crystal City, VA, April 28-29, 2008 [keynote/lead presentation].
    • "Federal Labs and NIH are Number One in Bio-Technology Transfer," NIH CRADA Forum II, September 1994.
    • "Federal Biomedical and Biotechnology Inventions and Technology Transfer," Division of Chemical Information, American Chemical Society National Meeting, August 1994.
    • "Biotechnology and Chemical Information," Division of Chemical Information, American Chemical Society National Meeting, August, 1990.
    • "Trends in Biotechnology Patenting," Division of Law and Chemistry, American Chemical Society National Meeting, August, 1990.
    • "The Status of the Infrastructure of Information Resources Supporting Biotechnology," Capital Area Biotechnology Information Network (CABIN) meeting, December 1989.
    • Chaired the "Information Resources for AIDS and Antiviral Drug Development" session and presented "Information Resources for Antiviral Drug and Vaccine Development," Division of Chemical Information, American Chemical Society National Meeting, 1988.
    • Chaired the "Biotechnology Information" session (the first such session in the U.S.) and presented "The Status of the Infrastructure of Information Resources Supporting Biotechnology," Division of Chemical Information, American Chemical Society National Meeting, 1986.

    Awards:

    Rittenhouse Award, 1978, Medical Library Association, Best Graduate Student Paper, "Bibliographic Analysis of the Literature of Government-Regulated Chemical Carcinogens: Patterns Predict Future Federal Regulation."