Tuesday, February 7, 2012
Merck Research Laboratories
33 Avenue Louis Pasteur
Boston, MA 02115
Breakfast, Registration, and Vendor Exhibits
Welcome to the PIUG 2012 Biotechnology Meeting - Monica Weiss-Nolen, Program Chair
|8:45 AM||Examining the Complete Picture - Utilizing Competitive Intelligence to Supplement BioPatent IP - Barbara Miller, Novartis Institutes for Biomedical Research (NIBR)|
|9:15 AM||Simplifying Competitive Patent Analysis - Joe Terlizzi, Questel|
|9:45 AM||Using BizInt Smart Charts with Gene Sequence Databases - Tips & Tricks - John Willmore, BizInt Solutions, Inc.|
|10:30 AM||Commercialization of Biosimilars and Biobetters: Patent and Regulatory Challenges and Opportunities - Janet M. McNicholas, K&L Gates intellectual property group|
|11:00 AM||Biosimilar Monoclonal Antibodies in the Pipeline: Major Players and Strategies - Fern Barkalow, Citeline|
|11:30 PM||Locating Trend Patents in Biotechnology - Ron Kaminecki|
Lunch & Vendor Exhibits
|2:00 PM||Text Mining Patents with Linguamatics I2E and Intellixir Software: Differences and Synergies - Piotr Masiakowski, Sanofi US|
|2:30 PM||Patent Landscape Analyses of Vaccines, Diagnostics and Medicines: Policy and Practical Implications for Global Access - Stanley Kowalski, University of New Hampshire, School of Law|
|3:30 PM||Gene Expression Resources at NCBI - David L. Osterbur, Countway Medical Library, Harvard Medical School|
|4:00 PM||Fireside Chat - Tony Trippe, PIUG Chair|
|4:15 PM||Concluding Remarks - Qin Meng, Planning Comm. Chair|
|4:30 PM||Vendor Exhibits and Networking|
|Evening Dinner Networking|
Monica Weiss-Nolen is currently an Information Scientist in the scientific and patent Information Research and Analysis group at sanofi pasteur, supporting the North America Intellectual Property group and R&D scientists. Previously, she served as a Senior Analyst for the Business Intelligence group at Ortho Biotech, a Johnson & Johnson company, and prior to that was an information scientist at DuPont Pharmaceuticals for 10 years, conducting patent and scientific searches for R&D. She started her information science career at BIOSIS creating current awareness searches. She holds a BS in Biochemistry from Millersville University of PA and an MSIS from Drexel University. She has been a member of the PIUG for over 10 years.
Examining the Complete Picture- Utilizing Competitive Intelligence to Supplement BioPatent IP
Novartis Institutes for Biomedical Research (NIBR)
For a biopatent searcher, investigating a competitor's IP should involve more than simply examining their patent portfolio. While the IP portfolio may indicate the direction of the competitor's research, it may not indicate the current status or focus of that research program. Typically, this type of information can be found using a variety of different competitive intelligence resources, including company websites, literature databases, news sources, clinical trial databases, and pharmaceutical market databases. While some of these resources may be of interest to the biopatent searcher because they contain patent information, these resources also contain a wealth of competitive intelligence (CI) in the form of competitor publications, press releases, investor presentations, and clinical trial status. This discussion will provide an overview of the different types of CI resources available to the average biopatent searcher, the types of information can be found in these resources, and how to effectively utilize this information in relation to IP. By examining a diversity of CI resources, the biopatent analyst can develop a more complete picture of a competitor's IP portfolio, while at the same time gaining an understanding of the competitor's IP position within the market.
Barbara Miller is currently a Patent and Scientific Analyst at the Novartis Institutes for Biomedical Research (NIBR) in Cambridge, MA. Prior to joining Novartis in August of 2009, she was an Information Scientist at Pfizer in Groton, CT, where she supported a variety of research and development teams by providing literature, patent, regulatory, and competitive information. Barbara began her searching career at the Pfizer facility in Ann Arbor, MI, in 2001 as a biopatent searcher after completing a postdoctoral fellowship at the University of Michigan. She has a PhD in Biological Sciences from Emory University in Atlanta, GA, a MS in Regulatory Affairs and Quality Assurance from Temple University, and a BS in Chemistry from Rhodes College in Memphis, TN.
Patent information can be daunting. Answer sets can be huge, unfocused and difficult to review and analyze. But with recent statistical analysis tools either as stand-alone software or integrated within new database search interfaces, analysis can now be faster to process, easier to interpret, and fairly simple to compile, report and distribute. Using a case study based on a monoclonal antibodies keyword search and the Orbit portal, competitors will be represented through their collaborations, citations, technologies and key concepts. New methods for compiling and reporting these analyses will also be discussed.
Joe Terlizzi is Questel's chemical information specialist and training manager. He has been involved with chemical search and retrieval systems since 1975, when he joined the Central Abstracting and Indexing Service (CAIS) of the American Petroleum Institute. At CAIS, Joe worked until 1999 as an indexer, product manager, editor of the API Thesaurus, and chief trainer, and helped develop their machine-aided indexing system. Joe joined Questel in 2000 as an IP specialist and sales representative and became their head trainer for the Merged Markush Service. Joe holds a Bachelor of Science degree from Stevens Institute of Technology in Hoboken, NJ.
Using BizInt Smart Charts with Gene Sequence Databases - Tips & Tricks
BizInt Solutions, Inc.
This "Tips & Tricks" session will discuss using BizInt Smart Charts for Patents and BizInt Smart Charts Reference Rows with gene sequence databases (GenomeQuest and USGENE), including limitations and suggestions for future enhancements.
John Willmore is Vice President, Product Development, for BizInt Solutions, Inc. and manages the development of all aspects of the BizInt Solutions product line. John has a B.S. in Electrical Engineering from Rice University and over 20 years experience in software development. He was the head of the TRW Smart Charts team at TRW, Inc. and along with Diane Webb, founded BizInt Solutions in 1996. John has over 15 years of experience in processing, analyzing and integrating patent and drug pipeline information, and has worked closely with patent and drug pipeline publishers over that period.
Biologics, including antibodies, represent a class of therapeutic products that have revolutionized patient outcomes in the US. The commercialization of biologics presents unique opportunities and challenges. Patents have been a key part of their commercialization strategy. As the patents for the first generation of biologics have expired or are rapidly expiring, many companies from around the world are interested in commercializing "copy" biologics or biosimilars. A new US regulatory pathway for biosimilars was enacted as a part of the Healthcare Reform Legislation last year. The key provisions include data requirements, data and market exclusivities, reimbursement incentives and complex patent enforcement processes. Although the FDA has not yet issued guidelines to implement the new pathway, patent and regulatory strategies to seize opportunities and overcome challenges to commercialize biosimilars will be discussed.
Janet M. McNicholas, Ph.D., J.D., is a partner in K&L Gates intellectual property group. She is particularly noted for her intellectual property related achievements in the areas of biotechnology, pharmaceutical products, and medical products. These products include biologics (including antibodies) and biosimilars, small molecule drugs and formulations, as well as combination products. She is a registered patent attorney and serves as patent counsel to biotechnology and pharmaceutical companies, including start-up and emerging growth companies as well as counsel to private equity and venture capital investors. Her experience includes more than 25 years of practice, both in law firms and as in-house patent counsel. Dr. McNicholas advises clients in the commercialization of their products and services, including their development of worldwide patent portfolios. She writes and prosecutes patent applications for a broad range of life science technologies. Her practice includes conducting patentability and freedom-to-operate assessments, evaluating intellectual property, and mining both developing and mature patent portfolios for additional patenting opportunities to maximize value. Prior to practicing law, she conducted research in immunology, molecular biology, biochemistry, and genetics at the University of Illinois as a pre-doctoral student and then at Stanford University and at the California Institute of Technology as a post-doctoral fellow of the Arthritis Foundation. She received her Ph.D. in immunology and microbiology from the University of Illinois and her J.D. from the University of Chicago Law School.
Biosimilar Monoclonal Antibodies in the Pipeline: Major Players and Strategies
With the market for biosimilars widening and greater numbers of companies entering the race to develop monoclonal antibodies that match products going off patent, the need for information regarding biosimilar drug development has become more critical. This presentation will outline the progress made towards implementing approval processes in the US and EU as well as provide an analysis of the global competitive landscape in this rapidly expanding field.
Fern Barkalow, Ph.D. is an Associate Director at Citeline (an Informa business) where she has been specializing in oncology clinical trials and drug information for the past 5 years. Dr. Barkalow currently participates in managing and maintaining a suite of comprehensive clinical trials information products and consults with pharmaceutical and CRO clients to provide customized solutions for their competitive intelligence needs. She received her Ph.D. in Microbiology at the University of Medicine and Dentistry of New Jersey, and completed postdoctoral fellowships at Princeton University and Brigham and Women's Hospital.
In the pharmaceutical, diagnostic and genetics areas, certain patents dominate. These significant inventions produce a definite profile that involves market dominance, ancillary research and spinoffs that can in turn be used to identify other candidates of significance. Whole industries have been created because of certain cornerstone patents and their progeny. Finding historically successful patents is easy, but what can be learned from the inventions that have started whole industries and how does one predict the most likely new directions? This presentation will look at specific patents that have created whole new markets and then analyze the information gleaned from them to help predict the most likely winning patents. The methodology presented will work on any platform and also across many other industries.
Ron Kaminecki is a US patent attorney who has worked at various companies, including Abbott Laboratories and IIT Research Institute, and spent over thirty years at Dialog. He got his start in searching technical and especially, chemical and patent information via manual, online and batch systems and has continued working with and helping design presently available systems. He also has a patent pending for a patent information system. Ron has written over fifty articles, book chapters, presentations and papers on various aspects of online searching and information retrieval since 1974, and has worked with technical searchers in the Fortune 500 and in major law firms and patent offices around the world and has also worked as an expert witness in patent cases. He has a BS in Chemistry, an MS in Computer Science and a JD with a Certificate in Patent Law and is a member of the Bar of the Supreme Court of Illinois and of the Bar of the Northern District Court of Illinois.
Text Mining Patents with Linguamatics I2E and Intellixir Software: Differences and Synergies
Computer software for semantic and statistical text analysis is indispensable for efficient review and categorization of patent documents related to broad technology areas ("patent landscaping"). This presentation will briefly compare the I2E and Intellixir systems, and describe strategies and tools we are developing to take best advantage of their respective strengths. In one scenario, results of a keyword search in a patent database are transferred to I2E for categorization, and the resulting concept tree is published on the Web as an Intellixir thesaurus.
Piotr Masiakowski studied biology in his native Poland, and received a Ph.D. in biochemistry and molecular biology from the University of Connecticut. He did gene discovery research at the University of Strasbourg, France, Stanford University and at Regeneron Pharmaceuticals, a biotech company in New York. At Regeneron, he gradually switched from the bench to bioinformatics approaches; eventually, as Director of Bioinformatics he led a team developing internal databases and distributed applications supporting research projects. Later Piotr worked as an independent software developer and consultant, and is currently employed as a patent information professional at Sanofi US in Bridgewater, New Jersey.
Patent Landscape Analyses of Vaccines, Diagnostics and Medicines: Policy and Practical Implications for Global Access
University of New Hampshire, School of Law
Access to information drives innovation. This will increasingly be important for accelerating global access to critical innovations in health over the next several decades. As a foundation for informed strategic intellectual property management, patent data will facilitate tracking emerging fields, determining complementary technologies, identifying licensees, building research and product development collaborations, and ascertaining freedom to operate. At UNH-Law ITTI, student teams have mined patents and analyzed representative patent landscapes for globally crucial health technologies including: HIV vaccines, dengue fever diagnostics, Chagas disease vaccines and diagnostics and the WHO List of Essential Medicines. Searches were conducted using a combination of both free and commercial patent search database platforms (e.g., WIPO PatentScope and Thomson Innovation). Iterative and redundant, search strategies (based on initial analysis and research, including non-patent literature) included keyword, assignee, inventor, patent classification codes, and complex hybrid searches, incorporating all simultaneously. Patent documents were coded, classified and compiled: data collected included patent expiration date, patent abstract, claims, assignees, country of origin and international patent application filings. Patent information so compiled and catalogued is an essential management tool, indeed a groundwork from which creative intellectual property strategies can be developed to accelerate global access to critical innovations in health. From a practical standpoint, such strategies and tactics might include collaborative research agreements, public-private partnerships, patent pools and/or open innovation networks. From a policy standpoint, patent information can inform as to the extent and degree to which patents might (or might not) pose an obstacle to global access and thereby guide debate and discussion in a more informed manner.
Dr. Stanley P. Kowalski is Professor of Law and Director of the International Technology Transfer Institute (ITTI) at the Franklin Pierce Center for Intellectual Property at UNH-Law. ITTI is a specialized resource center dedicated to advancing science, technology and innovation in developing countries via education, outreach and capacity building in intellectual property (IP) management, technology transfer and patent information analysis. ITTI projects include patent landscape analyses of innovations in health and agriculture that have relevance to the needs of developing countries, IP capacity building in public sector institutions in developing countries, integration of ITTI projects with other organizations (e.g., WIPO and the World Bank) and global network building of IP professionals from Africa, Latin America and Asia. ITTI patent landscape analyses have included HIV vaccine technologies, dengue fever diagnostics, Chagas disease vaccines and diagnostics and updates to the WHO Model List of Essential Medicines. Previously, for over two decades, Dr. Kowalski worked as a scientist, authoring numerous publications. He holds a Ph.D. in Plant Breeding from Cornell University and a J.D. from the Franklin Pierce Law Center.
Gene Expression Resources at NCBI
David L. Osterbur
Countway Medical Library, Harvard Medical School
Varying gene expression levels play a role in all aspects of the biology of an organism, from normal cellular differentiation to different disease states. The National Center for Biotechnology Information (NCBI) has gathered together information on the expression levels of genes under a variety of different experimental conditions, in a variety of different tissues and in many different organisms by allowing the deposit of microarray and RNA-Seq data from published papers. This database is called the Gene Expression Omnibus (GEO). I will discuss the use of GEO and of gene expression data from another NCBI database called UniGene.
After earning a B.S. at the University of Illinois and a Ph.D. from the University of California, David Osterbur was a postdoctoral fellow Indiana University, then joined the research faculty at the University of Kansas Medical Center. Later earning a Master of Library Science (MLIS) at Simmons College, David served as Senior Information Liaison for DuPont Pharmaceuticals then became the head of the Biological Laboratory Library at Harvard University in 2000. He served as the Public and Access Services Librarian at the Countway Library of Medicine at Harvard Medical School from 2006 to 2010 when his title was changed to Director of Public and Access Services.