Bridging of Technologies: Union of Pharmaceutical and Medical Device Industries Brings Opportunities
Pharmaceutical and medical device companies are finding innovative means to deliver multifunctional healthcare products through converging technologies.
Off the Label: Contrary to Reports, FDA Guidelines for Off-Label Promotion Tighten Loopholes
Recent media reports about the FDA’s plans to set guidelines for the kinds of literature drug makers can use to support the off-label use of FDA-approved drugs largely missed the mark.
Finding the Exit: CBI Conference, M&As Expected to Increase as Big Pharma Seeks to Fill Pipelines
The dominant theme at the Center for Business Intelligence’s 4th Annual Forum on Early Stage Product Development and Commercialization Strategies for the Bio/Pharmaceutical Industry in late February conference was that at least for the foreseeable future, Big Pharma will continue looking to emerging biotechnology companies for innovation―both for potential new compounds to fill development pipelines and for biomarkers and diagnostics.
Pharma's Strategic Outlook: Conference Buzz in New York Centers on Alliances and M&A Activity
What most of the top managers had on their minds at Windhover Information’s Pharmaceutical Strategic Outlook meeting in New York City in mid-March was the unprecedented level of alliances and M&A activity that has taken place over the past few years as the industry copes with momentous changes.
Reformulating an Industry | New Alliances and Partnerships will be Critical to Keeping Pipelines Productive
The pharmaceutical industry, in the midst of an unprecedented change in its business model, will continue to experience turmoil as generic drug companies, contract research organizations, drug delivery specialty companies, and virtual pharmaceutical companies seek their places at the table. But the turmoil will continue until large pharmaceutical companies acknowledge the new model and build strong interfaces among themselves, emerging companies that provide innovative new therapies, and regulatory bodies.
Heparin Alternatives are Scarce | It is Difficult to Replace Something Taken for Granted Over 70 Years
Introduced into clinical use over 70 years ago, heparin is the most commonly used anticoagulant today. In all that time there were no quality or supply issues, and as a result it was not especially critical to find a viable alternative. Of the currently available alternatives, only a couple can be considered, but none compare to heparin.
Reform Act Stalled in the Senate | Long-Debated New Patent Law Likely to be Lobbied Even More
The Biotechnology Industry Organization (BIO), along with a large group of industry organizations and companies opposed to the Patent Reform Act of 2007, are breathing a little easier now that the bill is tied up in a Senate committee that apparently has better things to do in an election year. And with senators undoubtedly getting an earful of conflicting lobbying, it’s entirely likely that the reform act, which passed the House last fall, will remain stalled in the more deliberate legislative body for some time.
Avoiding Liability | With Courts Examining New Avenues, Drug-Makers Have Choices
Pharmaceutical manufacturers are starting to worry that the recent trend in court decisions may leave them open to civil liability lawsuits. To guard against this, companies need to consider how to mitigate risk in their choice of pipeline projects and in the way in which they conduct those projects.
Biogenerics | The World Is Not Waiting for the U.S. to Decide on Regulations
Very few biogeneric drugs have approved in the United States, and few others are on the horizon. Yet they are almost routinely approved and used in the European Union, India and several other countries for the last few years. Why is that and what has to happen so the U.S. can catch up with the rest of the world?
FDA's Sentinel System
Even before Vioxx, the Food & Drug Administration had long been criticized for employing a slow, inadequate, unsystematic method of monitoring post-market safety. Months or even years can go by before government agents begin to notice unexpected side effects from approved drugs, and those delays potentially cost lives. That should start to change in the coming years as the FDA’s new Sentinel System is implemented.
Nerac Analysts featured in Drug Discovery & Development Magazine - July 08
In an article posted on the magazine’s website in July 2008, Nerac analysts Mike Fuller, Irene Zajac and Emma Palmacci review patent activity to reveal how drug development pipelines are changing. Click here to read the article.
Nerac Analysts present at CI in Pharma USA Conference, March 2008
Michael Fuller and Irene Zajac presented: “Using Patenting Trends
as Competitive Intelligence to Predict the Future of Drug Discovery
in the Pharmaceutical and Biotech Industries”
Deb Schenberger presents at 3rd Annual Frontiers in Biomedical Devices Conference, June 2008
3rd Annual Frontiers in Biomedical Devices Conference
June 18-20, 2008
Irvine, CA
Deb Schenberger presented “Electrical Stimulation of Spinal Fusion”
New Perspectives on the Future of Drug Discovery
Learn how Nerac's analysis of patent and non-patent information in bio-pharma gives insight into drug pipeline activity, identifies new growth opportunities and charts an effective plan for success.
Ablynx Competitive Intelligence Overview
This example of a Nerac Research and Advisory "Special Project" Services request is an overview of competitive intelligence on Ablynx NV, a biopharmaceutical company based in Belgium. It includes information to provide a first-pass evaluation of Ablynx as a possible business partner or acquisition target.
In Vitro Validation of ITK and T-Plastin as Effective Drug Targets for Hematopoietic Malignancies
This technical market assessment is an example of a Nerac Research and Advisory "Special Project" Services report.
Ablynx Competitive Intelligence Assessment
This report is an example of a Nerac Research and Advisory "Special Project" Services request. The report consists of a detailed compilation of competitive intelligence on Ablynx NV, a biopharmaceutical company based in Belgium. It includes a broad range of information, with Nerac analysis, that may be used to evaluate Ablynx as a possible drug development partner. It is designed to provide the framework for eventual due diligence.
Regulations and Endocrine Disruptors
This regulatory overview is an example of a Nerac Expert Research Services request.
Markush Claim and Substructure Research
This is an example of a Research and Advisory Services patent investigation for Markush claims.
Our chemistry analysts are well-versed in researching chemical structures and substructures that exist in the technical and patent literature, including
the Markush claims. Using such search tools as the CAS RegistrySM and MARPAT™ databases in STN™, Nerac analysts are able to research worldwide publications including over 60 international patent authorities for publications that incorporate chemical structures.
Recent Developments in Biomarkers for Type II Diabetes
This report is an example of an expert research request for research into scientific literature and US patents over the last year (2011) on biomarkers for T2D. The report will enable the client to learn about recent prior art that may interfere with his invention.
Post Market Surveillance for Dental Panoramic X-ray
Preliminary Investigation: Tumor Necrosis Factor Alpha as a Drug Target in Treatment of Inflammatory Bowel Disease
This sample deliverable represents a biosequence research and advisory services request.
Competitive Intelligence Briefing | Competitor Watch
Nerac's Competitive Intelligence Briefings are designed to help you keep a watchful eye on competitive activities, emerging technologies, key market indicators and trends. Nerac analysts draw upon a wide variety of expert resources to track relevant news, newly published patents and technical journal literature. This information, along with an analyst overview on topics of key interest, is delivered on a timeline customized to your needs.
Technology Scouting Research Report
Technology Scouting is a critical activity in an open innovation paradigm to discover key innovations. It involves searching for, identifying, and evaluating potentially relevant and interesting technologies and/or inventors.
Nerac can provide an independent third-party view into new technology areas and supplement internal resources with critical adjacency/non-core expertise via a specialized analyst review of the data. Customizable and flexible deliverables for both large and small engagements make our service uniquely valuable.
Download our free Technology Scouting Research Report sample on "Thermal Management Technologies" below, and contact us to discuss how this service can benefit you and your Tech Scouting teams!
Adding Combination Therapies to Drug Pipelines
This podcast examines how combination therapies are taking on considerable importance as pharmaceutical companies adjust their development pipelines. Featuring author and futurist Jonathan Peck and Nerac Life Sciences Analyst Irene Zajac, the podcast is based on the idea that small molecule blockbuster drugs an endangered species threatened by patent expirations, generic corrosion and biotech drugs. As a result, big pharma is integrating with biotech under one roof, forming what can be called the bio-pharma industry. Along with this industry transition, new modes of therapy are being developed and conceived that are thought to be the future of the drug industry. Of these, combination therapies appear likely to compete with, if not replace, blockbusters as revenue-producing products. Mr. Peck brings 25 years of experience consulting with pharmaceutical and biotech companies. He has authored many articles and books, including Regulating Change: The Regulation of Foods, Drugs, Medical Devices and Cosmetics in the 1990s. Ms. Zajac, who recently co-authored a Nerac white paper titled, “New Perspectives on the Future of Drug Discovery,” has more than 25 years of research experience as a scientist at the NIEHS, Glaxo, and Pfizer. Together, they look at several key areas regarding combination therapies:
- Combinations have the potential to play a central role in the pharmaceutical industry’s future by bringing together two or more medications or devices in combination to treat a single disease or a group of associated disorders.
- Combination therapies are more likely to be developed for disease prevention than for treatment.
- The FDA, through its new Sentinel System, will require new relationships between government and private entities in reporting the adverse events.
- New business models must be created to handle the multiple products necessary to personalize medicine. Diagnostics are certain to be a part of the combinations.
- As the technology behind combination therapeutics matures and business models evolve, the future for this approach to medicine is promising.
- This podcast is no longer available but for more information on the topic, please contact Ms. Zajac directly at izajac@nerac.com.
