Ronald A. Rader
Consulting: Includes diverse biotechnology and biopharmaceutical industry competitive intelligence and technology/market projects for BioPlan Associates,
Rockville, MD 20851
Main Web sites/domains: bioinfo.com; biopharma.com; biosimilars.com; biopharmacopeia.com
B.S., Microbiology - University of Maryland (General Honors
M.L.S., Library Science - College of Library and Information Services, University of Maryland, 1979
World-class expertise in information retrieval and analysis, competitive intelligence, technology and market assessments, information resources development, publishing and problem-solving concerning pharmaceutical, biotechnology and life sciences research, products, commerce, technologies, patents and technology transfer, regulations and public affairs. Over 30 years experience managing, retrieving, integrating, assessing and publishing complex biomedical scientific, technological and commercial information. Successful information resources developer, publisher and entrepreneur since late 1990.
Biotechnology Information Institute, Rockville, MD
President (sole proprietor); December 1990 - Present
Publishing: Develop and market information resources and provide consulting 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:
- BIOPHARMA: Biosimilars/Biobetters Pipeline Database, www.biosimilarspipeline.com, June 2014.
- BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets, the only biopharmaceutical products reference/information resource, 13th annual edition/year Web database (last printed book version, 6th edition, Sept. 2007, was 2 volumes, 1602 dense pages)
- Charting the Biosimilar and Biobetter Development Pipeline, FirstWord Pharma, 428 pages, Sept. 2012.
- Biopharmaceutical Expresssion Systems and Genetic Engineering Technologies: Current and Future Manufacturing Platforms, the only directory of expression systems, cell lines,
vectors and other genetic engineering technologies (available for licensing) for manufacture of recombinant proteins (365 pages, Oct. 2008)
- Antiviral Agents Bulletin, for 15 years the only periodical specializing in antiviral drug and vaccine development (32 pages/month; >5,700 pages; plus the online database from multiple vendors)
- 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; then online database from multiple vendors to 2000).
- Market Opportunities in Contract Manufacturing of Microbial Platform Biologics - 125+ page market study plus company databases concerning
microbial manufacturing trends and CMOs; also studies/tasks for other clients concerning microbial bioprocessing
- In Vivo Toxicology and Pharmacology R&D and Testing Markets - 269-page market and technology assessment regarding animal-based toxicology and pharmacology testing services
- "Single-Use/Disposable Bioprocessing Assemblies: Market Trends" - assessment of the market for custom single-use manifold and assembly services
- Top 1000 Biopharmaceutical Manufacturers - project leader assembling a public database of the top 1000 biopharmaceutical manufacturers rated by
their bioreactor capacities (www.top1000bio.com)
- Single-use/Disposable Bioprocesing Systems - 350+ page market and technology assessment, including market estimates, projections and assessments of
major players as acquisitions targets
- Animal-based Biopharmaceuticals (bovine and porcine) - 350+ page market and technology assessment regarding this industry, including assesments of >50 specific products/classes, for a government client
- Biopharmaceutical-related Assays/Testing Services - estimation of the overall market and sectors
- Bioprocessing Facilities, 30-100 L capacity - study and estimation of the number of facilities worldwide
- New Lines of Business - proposed 6 truly innovative (novel business model) products/services for a major bioprocessing industry supplier
- Director, BioPipeline Project, a weekly biopharmaceutical R&D competitive intelligence service for a major bioprocessing industry supplier
Porton International, Inc. (and its OMEC International subsidiary, Washington, DC)
- for a European competitive intelligence company - multiple projects supporting U.S. viral vaccine market entry by a major European player
- 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)
- an in-depth due diligence review of a public biotech company (client and company proprietary).
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
With a start-up natural products chemical specialty company, established the chemical inventories, conducted library research, and performed bench scale synthesis.
(partial list; over 12,000 pages in print):
Books/databases: (sole author of all since 1990)
Periodicals: (as the Editor/Publisher)
- BIOPHARMA: Biosimilars/Biobetters Pipeline Database, June 2014.
- BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets,
sole author and publisher, online databases at www.biopharma.com, now in its 13th year/edition as an online database.
The only biopharmaceutical products reference book (and database); concentrates on products'
biotechnology and commercial aspects. (The last printed book version, 6th edition, Sept. 2007, was 2 volumes, 1603 dense pages).
- Charting the Biosimilar and Biobetter Development Pipeline, FirstWord Pharma, 428 pages, Sept. 2012 [reporting over 400 candidate biosimilars, 340 biobetters and estimated patents/exclusivities expiration dates for nearly all (>100) current recombinant proteins/mAbs]
- Biopharmaceutical Expresssion Systems and Genetic Engineering Technologies: Current and Future Manufacturing Platforms, BioPlan Associates, Oct. 2008, 365 pages.
The only directory of expression systems, cell lines, vectors/plasmids and other genetic engineering technologies useful (available for license) for the manufacture of recombinant proteins and antibodies.
- 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. The only directory of federal, e.g., NIH, inventions (patents) and technology transfers (licenses; CRADAs) 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.
Articles (trade press):
- 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.
- "Thirty Years of Upstream Productivity Improvements,"
BioProcess International, 14(2),
Feb. 2015, p. 10-14.
- "Biosimilars Impacting CMO Capacity,"
Pharmaceutical Outsourcing, Jan./Feb. 2015, p. 22-16.
- "Powders and Liquids: Economics of Large-Scale Culture Media and Buffer Preparation are Changing,"
BioProcess International, 12(3), March 2014, p. 10-16.
- "Bioprocess Advances Drive Vaccine Manufacturing in Developing Countries," BioProcess International, 12(2),
Feb. 2014, p. 10-15.
- "Biosimilars in the Rest of the World:
Developments in Lesser-Regulated Countries," BioProcessing J., 12(4), Winter 2013/2014, p. 41-47
- "Innovation in Stainless Steel Bioprocessing,"
Life Sciences Leader, Nov. 2013, p. 20-22.
- "Biopharma Nomenclature:
Citizen Petition Requests Biopharmaceutical Names and Information Be Disclosed by FDA," Contract Pharma,
Sept. 2013, back page [guest editorial].
- "An Analysis of the U.S. Biosimilars Development Pipeline and Likely Market Evolution,"
BioProcess International, vol. 11, no. 6, Biosimilars supplement, June 2013, pp. 16-23.
- "Introduction to Continuous Manufacturing: Technology Landscape and Trends," in Continuous Bioprocessing: Current Practice and Future Potential, Refine Technology, June 2013, p. 3-8.
- "FDA Biopharmaceutical Product Approvals and Trends in 2012,"
BioProcess International, vol. 11, no. 3, March 2013, pp. 18-27.
- "Fill-Finish Innovation: Showing Sparks of Life," Contract Pharma, vol. 15, no. 1, p. 40-46, Jan.-Feb. 2013 [publisher neglected to include
article in this issue's index].
- "Biosimilars and Biobetters," PharmaPro: News,
Views, & Technology for the Industry, Jan. 14, 2013.
- "Top 50
(or so) Biopharma Products; Ranking the top 57 biopharma products [with >$.5 billion/year sales] by
2011 revenues," Contract Pharma, July/Aug. 2012.
- "Upstream Single-Use Bioprocessing Systems: Future Market Trends and Growth Assessment," BioProcess International, Feb. 2012.
- "Top 50 Biologics," Contract Pharma, July/Aug. 2011, p. 2-3. [top 50 biopharmaceutuicals by sales].
- "Nomenclature for Biosimilars Will Be Highly Controversial," BioProcess International, vol. 9, no, 6, June 2001, p. 26-33.
- "Licensing of Biopharmaceutical Expression Systems," BioPharm International, Vol. 22, no. 12, Dec. 2009, p. 30-31 [ghostwritten; written for fee with transfer of authorship].
- "A History of Approved Recombinant Cell Culture Products, 1980-2010," BioProcess International, vol. 7, no. 11, Dec. 2009, large wallchart/poster insert.
- "Expression Systems for Process and Product Development: A Perspective on Opportunities for Innovator and Follow-on Product Developers," BioProcess International, 6 (6), sup. 4, Success Stories in Protein Expression, p. 4-9, June 2008 (supplement lead article).
- "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.
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.
Other printed publications:
- "Biopharmaceutical Manufacturing:
Historical and Future Trends in
Titers, Yields, and Efficiency in
Commercial-Scale Bioprocessing," BioProcessing J., 13(1), 13(4), Winter 2014/2015, p. 47-54.
- "Continuous Bioprocessing and Perfusion: Wider Adoption Coming as Bioprocessing
Matures," BioProcessing J., 13(1), Spring 2014, p. 43-49.
- "Biosimilars in the Rest of the World:
Developments in Lesser-Regulated Countries," BioProcessing J., 12(4), Winter 2013/2014, p. 41-47
- "Innovation in Stainless Steel Bioprocessing," Life Sciences Leader, Nov. 2013, p. 20-22.
- "(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. 375-385.
- Biotechnology Information: An Introduction in The Impact of Chemistry on Biotechnology, American Chemical Society, 1988, p. 372-374.
- "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. [1st page viewable only]
- "Information Retrieval for the Safety Evaluation of Cosmetic Products," in Special Libraries, May/June, 1978, p. 206-14.
- "Analysis of U.S. Biotechnology Patents," 1986, 1987 and 1988; annual
analyses of U.S. biotechnology patents issued (press conference and releases each year) by the Pharmaceutical
Manufacturers Association (PMA, now PhRMA). See more comprehensive later paper presented at 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.
Primary membership affiliations (often a member of multiple divisions/sections):
- American Chemical Society, Divisions of Chemical Information and Biochemical Technology
- Special Libraries Association, Pharmaceutical and Health Technology Division
- Patent Information Users Group (International Society for Patent Information)
- American Society for Microbiology
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.
[Note, in recent years, I have concentrated on publications rather than presentations]
- "The Biosimilars and Biobetters Pipeline: Implications for
Product Developers," Biosimilars and Follow-on Biologics 2013 Americas, Paradigm Global Events, Boston, Feb. 28-March 1, 2013.
- "Analysis of the Biosimilar Development Pipeline," Demonstrate Biosimilarity, Washington, DC, Feb. 12-14, 2013.
- "Biosimilars Needs Names: But What Type(s),
Servicing What Uses and Whose Interests?," FDA public hearing, Draft Guidances Relating to the Development of Biosimilar Products,
May 11, 2012.
- "Analysis of the Biosimilars
and Biobetters Pipeline," Biosimilars and Biobetters conference, March 19-20, 2012, Cambridge Healthtech Institute
(CHI), Baltimore, MD.
- "Biosimilars and Biopharmaceuticals: Dealing with the
Challenges," Pharmaceutical and Health Technology (PHT) Division, Special Libraries
Association (SLA), Spring Meeting, March 18-20, 2012, Baltimore, MD.
- "Biosimilars Nomenclature and
Implications for the U.S. Biopharmaceutical Industry,"
6th Summit on Biosimilars and Follow-On Biologics, March 30-31, 2011, Center for Business Intelligence (CBI), Falls Church, VA.
- "What Will the Market for FOB's [Follow-on Biologics/Biosimilars] 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.
- "What Is a Generic Biopharmaceutical? Biogeneric? Follow-On Protein? Biosimilar? Follow-On Biologic?..." Biosimlars and Follow-on Biologics, Center for Business Intelligence (CBI), 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.
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."
have developed and maintained my own Web sites and online databases since 1994;
Web page composition (HTML); database programming, particularly using Filemaker Pro with Lasso cgi; printed page/book layout using InDesign; MS Word; Macintosh computer use and maintenance (25+ years)