Consulting: Diverse biopharmaceutical industry technology/market assessments and competitive intelligence and projects for BioPlan Associates,
Inc. [See the list of trade periodical articles below with most associated with projects performed for BioPlan]
Porton International, Inc. (and its OMEC International publishing 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.
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. (now Procter & Gamble/P&G), 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 bench scale synthesis.
Publications
(partial list; over 12,000 pages in print):
Periodicals: (as the Editor/Publisher)
- 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 (~1,800 pages total) presenting abstracts of U.S. biotechnology patents plus related technology transfer news and analysis.
Databases/books: (sole author and publisher of all since 1990)
- Biosimilars/Biobetters Pipeline Directory; The most comprehensive biosimilars (and biobetters, biogenerics) pipeline information resource.
- BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets, still the only biopharmaceutical products information resource/reference book, now database; concentrates on products'
biotechnology and commercial aspects. (The last printed book version, 6th edition, Sept. 2007, was 2 volumes, 1603 dense pages, <10 pt Times font).
- 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 (peer-reviewed):
- "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.
Articles (trade press):
- "The "New Normal": Changing Perceptions on Bioprocess Intensification and Continuous Bioprocessing,"
BioProcess Online, March 1, 2021 [Same article also published in Outsourced Pharma and Pharmaceutical Online].
- "Top Bioprocessing Trends," BioProcess Intl. , 19(1), Jan.-Feb. 2021.
- "Bioprocessing Year In Review: 11 Key Trends Accelerated By Covid-19," Pharmaceutical Online, Dec. 11, 2020
- "Cellular and Gene Therapies Face a Manufacturing Capacity Crunch," BioPharm Intl., Sept. 1, 2020, p. 46-50.
- "COVID-19's Impact On Bioprocessing: Insights From Industry Leaders," Guest Column, BioProcess Online, Aug. 5, 2020.
- "Covid-19 Impact on Bioprocessing: Accelerating Trends - Long-term Impact of Novel Coronavirus-19
on Biomanufacturing and Bioprocess Supply Chain," White Paper, BioPlan Associates, July 2020, 16 pages.
- "Biosimilars Pipeline and Market Trends," eBook/printed insert, BioProcess International, June 2020, 11 pages.
- "Covid 19: Impact on Bioprocessing and Outsourcing," Contract Pharma, May 5, 2020.
- "TOP 15 Trends in Biopharmaceutical Manufacturing, 2020," White Paper, BioPlan Associates, April 2020, 35 pages.
- "2019 FDA Biopharmaceutical Approvals: A Record Year for Follow-on Products, But is Innovation Lagging?," White Paper, BioPlan Associates, Jan. 2020.
- "The next decade of cleanrooms: Pre-fab and modular cleanrooms are on the rise, but stick-built still dominate," Pharma Manufacturing, Dec 06, 2019.
- "Bioprocessing Facilities and FDA Inspection Problems," Biopharm Intl., 32(5), May 1, 2019, p. 12-15.
- "Biosimilars Pipeline Shows Remarkable, Sustained Growth," BioProcess Online (and Biosimilar Development), Guest Column, March 26, 2019.
- "Biosimilars Set to Further Expand the Biopharmaceutical Market," Amer. Pharma. Review, March 2019.
- "Worldwide Biopharmaceutical CMO Capacity Analysis," BioProcess Intl., Jan.-Feb 2019, p. 18-24
- "The Outlook for CMO Outsourcing in 2019," Biopharm Intl., 32(10), Jan. 1, 2019, p. 8-10, 40.
- "Top Trends In The Biopharmaceutical Industry And Bioprocessing For 2019,"
BioProcess Online, Dec. 18, 2018; and also in Life Sciences Leader. Dec. 18, 2018.
- "Single-Use Bioprocessing Equipment Trends and Adoption by CMOs," BioPharm Intl., vol. 31, issue 11, p. 10-13, Nov. 2018.
- "Current Challenges in Bioprocess Development," Pharm. Tech., vol, 42, no. 3, p. 64-5, Nov. 2018.
- "Biopharma Market: An Inside Look: Survey results reveal how slow-motion trends are driving biopharma growth," Pharmaceutical Manufacturing, Nov. 15, 2018.
- "Biopharmaceutical Manufacturing is Shifting to Single-Use Systems. Are the Dinosaurs, the Large Stainless Steel Facilities, Becoming Extinct?," American Pharmaceutical Review, October 2018.
- "Worldwide Biopharmaceutical Manufacturing Capacity Analysis: Growth Continues Across the Board,"
BioProcess Intl.,, vol 6, no, 9, p. 20-25. Sept, 2018.
- "Fifteen Years of Progress: Biopharmaceutical Industry Survey Results,"
BioPharm Intl.,, vol 31, no, 7, p. 10-14. July 2018; and Pharmaceutical Technology, vol 42, no, 7, p. 56-59. July 2018.
- "Biopharma Manufacturing Markets: Biomanufacturing Contract Services and Supplies Markets Continue to Expand," Contract Pharma, May, 2018, p 46-49; also published in Trends in Biologics Manufacturing,, a Contract Pharma Ebook, Nov. 2018, p. 4-7.
- "Current Challenges in Bioprocesses Development," Pharm. Tech., 42 (3), 64-65 (2018); Reprinted in Improving Efficiencies in Biomanufacturing with Formulation
Development and Continuous Processing Ebook.
- "eBook: The Commercial Expression Systems Market - What Has Changed in the Past Decade," BioProcess Intl., May 3, 2018.
- "New Microbiological Methods In Bioprocessing," BioProcess Online, April 11, 2018.
- "Biopharma CMO Consolidation: Opportunity or Obstacle?," Pharmaceutical Manufacturing, March 2018
- "Cell and Gene Therapies: Industry Faces Potential Capacity Shortages," Genetic Engineering & Biotechnology News (GEN), 37(20), Nov. 15, 2017.
- "Biosimilars Paving The Way For Cost-Effective Bioprocessing," Biosimilar Development, Aug. 23, 2017.
- "Overcoming The Manufacturing Hurdles Of Cell & Gene Therapy," Life Sciences Leader, Feb. 20, 2017.
- "Manufacturing Costs Will Be Critical to Biosimilars' Success," Pharm,. Manuf., Nov. 2016.
- "Biosimilars and Biobetters:
Impact on Biopharmaceutical Manufacturing and CMOs," in Biosimilars of Monoclonal Antibodies: A Practical Guide to Manufacturing,
Preclinical, and Clinical Development, by Liu, C. and Morrow, J., Wiley, Dec. 2016.
- "Biosimilars Pipeline Analysis: Many Products, More Competition Coming", Biosimilar Development, July 26, 2016
- "Future
Manufacturing Strategies for Biosimilars." BioProcess Intl., May 2016.
- "Biosimilars Outsourcing and Capacity,"
Contract Pharma, May 2016
- "Biosimilars Improving Efficiency,
Cost for All Biologics,," Contract Pharma , April 2015, p. 28-30.
- "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.
- "Bioprocessing Challenges of Antibody-Drug Conjugates," BioProcess Intl., Oct. 2014 Supplement, p. 6-10.
- "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 and Biobetters," PharmaPro: News,
Views, & Technology for the Industry, Jan. 14, 2013.
- "Biosimilars and Biobetters:
How Biosimilars and Biobetters Will Affect the Biopharma CMO Market," Pharmaceutical Processing, Jan. 1, 2013.
- "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.
- "Bioprocessing Advances in Vaccine Manufacture," Pharmaceutical Technology, 9(9), Sept, 2013.
- "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.
- "Biosimilars and Biobetters:
How Biosimilars and Biobetters Will Affect the Biopharma CMO Market," Pharmaceutical Processing, Jan. 1, 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.
- "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.
Other printed publications:
- 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.
Web sites:
Presentations:
[Note, in recent years, I have concentrated on publications rather than presentations]
- "Biosimilars' Legal Requirements, U.S. Market Evolution, Competition and Marketing Strategies," 11th Summit on Biosimilars, Alexandria, VA, Jan. 28-29, 2016.
- "Impact of the Biosimilars Pipeline and Nomenclature on Market Development," 4th International Conference and Exhibition on Biologics and Biosimilars, Balitmore, MD, Oct. 27, 2015.
- "Analysis of the Biosimilar Development Pipeline," Demonstrate Biosimilarity, Washington, DC, Feb. 12-14, 2013.
- "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.
- "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.
Professional Activities
Organizations:
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
- 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.
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."
Misc. skills:
have developed and maintained my own Web sites and online databases since 1994;
Web page composition (HTML); database programming using Filemaker Pro with Lasso cgi; printed page/book layout using InDesign; MS Word; Macintosh computer use and maintenance (35+ years)