BiotechBistro Forums: Forum: Press releases and commercial messages

BiotechBistro Forums: Forum: Press releases and commercial messages - Recent Topics http://biotechbistro.com/forum/forum/press-releases The Business of Biotechnology en-US Thu, 11 Mar 2010 00:52:54 +0000 bbpress 1.0-alpha-4 <![CDATA[Search]]> q http://biotechbistro.com/forum/search.php leylmaster on "Zyomyx Point-of-Care CD4 Test Selected by CD4 Initiative to Help Treat HIV/AIDS" http://biotechbistro.com/forum/topic/zyomyx-point-of-care-cd4-test-selected-by-cd4-initiative-to-help-treat-hivaids#post-35 Tue, 17 Nov 2009 09:54:21 +0000 leylmaster 35@http://biotechbistro.com/forum/ Zyomyx's innovative approach enters final phase to become the world's first low-cost, instrument-free test for measuring CD4 T-cell count in HIV/AIDS patients Hayward, Calif. – November 17, 2009 – Zyomyx, Inc., a leader in chip-based bioanalysis technologies, today announced that its readerless CD4 point-of-care (POC) technology was selected by Imperial College London’s CD4 Initiative as the best-performing POC test method for measuring CD4 T-cell count in HIV/AIDS patients. Zyomyx's CD4 assay is now the only remaining POC product being supported by the CD4 Initiative. With this announcement, Zyomyx is currently entering the commercial phase of this project and is actively soliciting partnerships with global sales and distribution providers. Zyomyx has developed the world's first, fully quantitative CD4 readout in a POC format. As simple to read as a thermometer, Zyomyx’s patent-pending assay uses CD4-binding reagents to pull CD4 cells from a blood sample and transfer them to a volumetric region of the device, where cell count can be determined by a simple visual readout. The quantitative CD4 count provides critical information in the clinical management of HIV. The test will give doctors and patients in resource-poor settings with limited infrastructure the same high-quality data that is available in the rest of the world. The CD4 Initiative was established in 2005 by an initial award of $8.6 million from the Bill & Melinda Gates Foundation and is conducted under the aegis of the Imperial College London, UK. The Initiative's objective is to develop a low-cost, instrument-free test for measuring CD4 T-cells in HIV/AIDS patients. Throughout this year, the Initiative evaluated the three remaining systems using clinical samples. Prototypes were assessed against the predicate method of flow cytometry. Results from the verification trial showed that only Zyomyx's CD4 test compared favorably with those generated using the flow cytometry method. "We are very pleased to confirm that the Zyomyx prototype not only meets the original specifications of the Initiative, but has in fact exceeded them," said Dr. Steven Reid, Project Manager of the CD4 Initiative from the Division of Medicine at Imperial College London. "While the original specification called for a simple cutoff test to determine whether to begin treatment, the Zyomyx approach will go much further by delivering a truly quantitative test which allows for both therapeutic monitoring as well as treatment decisions." "There has been a lot of progress increasing access to life-saving HIV drugs in the developing world, but the lack of access to essential diagnostics like a CD4 test is a major barrier to providing the best possible care," said Dr. Hans-Georg Batz, Director and co-Founder of the CD4 Initiative. "Zyomyx's new test will have a huge impact for people living with HIV across the world. We are impressed by the innovation and fast pace of product development at Zyomyx, and we look forward to working with Zyomyx to finalize development and assist in getting their point-of-care tests into the hands of healthcare workers." "As innovators in the field of bioanalysis platforms, Zyomyx set out to develop a point-of-care CD4 test that would arm healthcare workers with a key tool in managing patients in need of antiretroviral therapy. I commend our team for their hard work over the past few years, and also thank the members of the CD4 Initiative for supporting this important project and acknowledging and validating the Zyomyx approach," said Dr. Peter Wagner, President and CEO of Zyomyx, Inc. "Now that we have achieved this significant milestone, we are actively engaging with select global sales and distribution partners who can help us take the Zyomyx test to market. This includes additional cell count applications in diagnostics and life science research beyond CD4 where an inexpensive, simple alternative to flow cytometry is desired." About Zyomyx Zyomyx, Inc. is an innovator in bioanalysis platforms based on its expertise in assay development, surface chemistry, and microsystem technologies. The Zyomyx product development infrastructure and suite of proprietary assay and surface technologies are ideally suited for the robust development of advanced but simple and inexpensive diagnostics such as the CD4 cell counting product. Zyomyx is a privately held company and based in Hayward, Calif. For more information about Zyomyx, please visit <a href="http://www.zyomyx.com" rel="nofollow">http://www.zyomyx.com</a>. javellan on "Encore Webinar on Protecting Yourself against FDA" http://biotechbistro.com/forum/topic/encore-webinar-on-protecting-yourself-against-fda#post-34 Mon, 02 Nov 2009 08:55:33 +0000 javellan 34@http://biotechbistro.com/forum/ Cerulean’s co-founder and managing director, John Avellanet, will reprise his talk from September this coming December in an encore presentation of Bulletproof Yourself against FDA Enforcement in 2010. “I received at least half a dozen emails from folks who wanted to attend another live event,” said Mr. Avellanet. “This is probably the most popular webinar and teleconference I give – it fills up every single time.” In ninety minutes, Mr. Avellanet covers FDA’s directions and priorities for the following year, how firms can identify and mitigate their specific challenges when it comes to FDA inspectional priorities, a simple program for preparing for, handling, and responding to FDA inspections, plus lots of reference material and checklists to make implementing the advice quick and easy. “What people tend to like,” commented Mr. Avellanet, “is not only am I giving them all this insight and advice, but then I’m taking the additional step of providing them easy-to-follow checklists to make their life simple. I’ve had so many people comment that I actually reduced their workload, not to mention their anxiety, with all the reference material and toolkit items.” You can download the full agenda on Mr. Avellanet’s website from the earlier recorded version of Bulletproof Yourself against FDA Enforcement. The webinar and teleconference encore will be held on Tuesday, December 15th from 1:00 – 2:30 p.m. EST. Register for the event at <a href="http://www.ceruleanllc.com/webinar/default.htm" rel="nofollow">http://www.ceruleanllc.com/webinar/default.htm</a> Mr. Avellanet has gained tremendous acclaim on his speeches, workshops and teleconferences for various companies and venues around the country. Enthusiastic testimonials from attendees all over the world cover his speaking page on his website (http://www.ceruleanllc.com/Speaking.htm). Conference organizers and program directors repeatedly note that he gets the highest evaluations of any of their speakers. In addition to the webinar, you can see Mr. Avellanet as he runs a workshop on making compliance training enjoyable at the 4th Medical Device Regulatory, Reimbursement and Compliance Congress in Washington, D.C. John Avellanet is the author of more than 100 articles, is the FDA compliance columnist for several international industry journals, and is the co-founder of the private compliance advisory firm, Cerulean Associates LLC. Every month, he publishes the regulatory intelligence and quality systems advice newsletter, SmarterCompliance™. He is a frequent speaker at corporate workshops, industry conferences, and meets regularly with regulatory officials. Learn more about Mr. Avellanet on his blog, <a href="http://www.ComplianceZen.com" rel="nofollow">http://www.ComplianceZen.com</a>. To engage his private consulting services for FDA-regulated firms, contact him through his company’s website: <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a> ### encomiast3 on "Columbia University Alumni Launch An Online Reagent Inventory Management System" http://biotechbistro.com/forum/topic/columbia-university-alumni-launch-an-online-reagent-inventory-management-system#post-27 Mon, 05 Oct 2009 22:31:12 +0000 encomiast3 27@http://biotechbistro.com/forum/ Following piloting trials Quartzy (www.quartzy.com), a company founded by two Columbia University College of Physicians and Surgeons alumni, has been launched. Quartzy is a free online inventory management tool for life scientists. Quartzy offers a new way to streamline the acquisition and cataloguing of reagents and other lab supplies that scientists need to conduct experiments. “I've been responsible for managing lab inventories for almost 15 years and Quartzy is the best solution I have seen,” said Sylvia Johnson, a Laboratory Manager at Washington University School of Medicine, who was one of Quartzy’s early members. While primarily developed to facilitate inventory management Quartzy also makes it easy to send orders to laboratory managers, who can either accept or deny these requests. The orders’ progress can be followed on-line by the scientists. Since each request contains all the information about a reagent, purchasing is then made easily and accurately. “The amount of time Quartzy saves us is invaluable and has enabled our work to progress at a much- appreciated faster pace,” said Mariela Flambury, a Laboratory Manager at the Motor Neuron Center, Columbia University. Quartzy is also useful when scientists change laboratories. On their departure, they can use Quartzy’s ‘Migrate’ feature to transfer reagents or protocols to others picking up their projects. “It improves continuity,” said Dr. Meena George, one of the scientists who developed Quartzy. Quartzy also provides a novel platform to leave and view ratings and comments on reagents left by other scientists. Quartzy’s rating system increases the reliability of purchases. Dr. Regelmann said, “The reagents that work well can be recorded on Quartzy, and future purchases can be informed by this knowledge.” Quartzy was developed by Dr. Regelmann and Dr. Meena George who met while conducting research at Columbia. By January 2009 they launched the site: so far hundreds of scientists have signed up and catalogued tens of thousands of reagents. “We’ve got people from all over.” Dr. Regelmann said. Quartzy is open and free to use by all academic scientists, though the site is more tailored to those conducting basic life science research. Also, Dr. Regelmann notes that while in the future, Quartzy may develop additional premium functionality for which they may charge a fee, all features currently available will always be free to users. A video on the site explains how to use the site. Once registered, scientists upload their inventories. Since most scientists store this on Excel, Quartzy makes this process of uploading from Excel straightforward using a unique Excel import mechanism. The scientist then invites other laboratory workers to become part of his or her network. Apart from sharing reagents, Quartzy allows LabMates to share protocols. Scientists can add comments and make suggestions on-line, and the protocol can be revised accordingly, printed, and taken right to the bench. Quartzy can also be used to administer and schedule time on shared facilities such as microscopes, FACS machines, or culture hoods. Having fine-tuned the site, Quartzy is now ready for a wider release. “Now that we know users are happy with the site, we are actively publicizing how Quartzy improves life in the lab.” Dr. Regelmann says. javellan on "FDA Compliance Experts on How to Avoid FDA and Courtroom Troubles" http://biotechbistro.com/forum/topic/fda-compliance-experts-on-how-to-avoid-fda-and-courtroom-troubles#post-26 Fri, 18 Sep 2009 13:26:59 +0000 javellan 26@http://biotechbistro.com/forum/ Two FDA compliance experts will offer an executive workshop on how to ensure your internal company documents actually reflect your company’s commitment to product quality and patient safety, and the policies you’ll need to meet FDA requirements and reduce your risk in a lawsuit. Former FDA prosecutor, Nancy Singer, and former medical device company chief information officer, John Avellanet, will present Dangerous Documents: Avoiding Land Mines in Your FDA Records and Emails. Consider attending this pre-conference Executive Workshop (free to all AdvaMed 2009 registered conference participants and their guests) because your firm – just like Merck, GSK, AstraZeneca, Medtronic, and others – has document and email land mines that will emerge during litigation or an FDA inspection. When companies are is investigated by the FDA or sued by angry patients or investors, phrases from emails are often taken out of context and leaked to the press. The negative coverage then embarrasses the company and its employees, not to mention undermining financial projections (KV Pharmaceuticals stock dropped more than 30% upon news of an FDA investigation). During this session, Mrs. Singer will demonstrate how to teach your employees to create documents that will reflect your commitment to quality. Mr. Avellanet will provide a roadmap for managing company records in a compliant manner. In addition, Marlene Bobka of FOI Services will explain what documents competitors can obtain about their competition from the FDA under the Freedom of Information Act. And then Mike Jovanis of Sparta Systems, will talk about implementing an electronic document management system to help further minimize risk and control documents. To attend this pre-conference Executive Workshop send an email to: <a href="mailto:mac@advamed2009.com">mac@advamed2009.com</a> no later than October 1, 2009, and indicate that you plan to attend the Dangerous Documents Executive Workshop. Journalists should also contact mac to obtain press passes. The AdvaMed 2009 conference will be held October 12-14 in Washington, D.C. Choose from more than 40 panels in 10 areas of innovative medical technology. To view the panels or register for AdvaMed 2009, visit <a href="http://www.advamed2009.com" rel="nofollow">http://www.advamed2009.com</a>. Mr. Avellanet has gained tremendous acclaim on his speeches, workshops and teleconferences for various companies and venues around the country. Enthusiastic testimonials from attendees all over the world cover his speaking page on his website (http://www.ceruleanllc.com/Speaking.htm). Conference organizers and program directors repeatedly note that he gets the highest evaluations of any of their speakers. In addition to AdvaMed workshop, you can see Mr. Avellanet at the 8th Annual Pharmaceutical Contracting and Outsourcing Conference in New Jersey or as he runs a workshop on making compliance training enjoyable at the 4th Medical Device Regulatory, Reimbursement and Compliance Congress in Washington, D.C. John Avellanet is the author of more than 100 articles, is the FDA compliance columnist for several international industry journals, and is the co-founder of the private compliance advisory firm, Cerulean Associates LLC. Every month, he publishes the regulatory intelligence and quality systems advice newsletter, SmarterCompliance™. He is a frequent speaker at corporate workshops, industry conferences, and meets regularly with regulatory officials. Learn more about Mr. Avellanet on his blog, <a href="http://www.ComplianceZen.com" rel="nofollow">http://www.ComplianceZen.com</a>. To engage his private consulting services for FDA-regulated firms, contact him through his company’s website: <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a> ### javellan on "Protect Yourself from New FDA Enforcement Rules" http://biotechbistro.com/forum/topic/protect-yourself-from-new-fda-enforcement-rules#post-25 Wed, 26 Aug 2009 18:46:07 +0000 javellan 25@http://biotechbistro.com/forum/ In response to FDA Commissioner Hamburg's new "get tough" approach to regulatory enforcement, Cerulean’s managing director, John Avellanet, has revised his popular Bulletproof Yourself against FDA Enforcement webinar with more analyses, more trending information, and dozens more specific recommendations. Mr. Avellanet will host an encore presentation of this webinar and teleconference on Tuesday, September 29th. With the FDA taking significant steps to tighten its enforcement going into 2010, pharmaceutical, device, and biologics executives will not want to miss this newly updated online seminar. As the FDA transitions to enforcing its new 15-day deadline for companies to respond to Form 483 inspectional observations, warning letters will come fast and furious. New congressional authority for FDA plus new funding allocation promises more consent decrees. Mr. Avellanet will speak on the hot topics that FDA is expected to focus on over the next 15 months, how to lower your company’s risk of non-compliance, and what to do when the FDA inspector shows up. New topics Mr. Avellanet will touch upon for this revised encore talk include: • 5 keys to successfully responding to 483s in 15 days or less • Supplier due diligence aspects inspectors look for • What FDA inspectors expect to see when assessing your CAPA processes • Lessons you can apply from recent FDA consent decrees Register soon. Last year this talk filled up within 3 weeks of its announcement. The online seminar is limited to just 24 attendees to allow for more Q&A. You can register online here: <a href="http://www.ceruleanllc.com/Webinar/default.htm" rel="nofollow">http://www.ceruleanllc.com/Webinar/default.htm</a> Mr. Avellanet has gained tremendous acclaim on his speeches, workshops and teleconferences for various companies and venues around the country. Enthusiastic testimonials from attendees all over the world cover his speaking page on his website (http://www.ceruleanllc.com/Speaking.htm). Conference organizers and program directors repeatedly note that he gets the highest evaluations of any of their speakers. In addition to the webinar, you can see Mr. Avellanet at the 8th Annual Contracting and Outsourcing Conference in New Jersey or as he runs a workshop on defensible documents at the AdvaMed MedTech Conference in October. John Avellanet is the author of more than 100 articles, is the FDA compliance columnist for several international industry journals, and is the co-founder of the private compliance advisory firm, Cerulean Associates LLC. Every month, he publishes the regulatory intelligence and quality systems advice newsletter, SmarterCompliance™. He is a frequent speaker at corporate workshops, industry conferences, and meets regularly with regulatory officials. Learn more about Mr. Avellanet on his blog, <a href="http://www.ComplianceZen.com" rel="nofollow">http://www.ComplianceZen.com</a>. To engage his private consulting services for FDA-regulated firms, contact him through his company’s website: <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a> ### javellan on "Proving to FDA your Supplier Controls Work" http://biotechbistro.com/forum/topic/proving-to-fda-your-supplier-controls-work#post-24 Mon, 27 Jul 2009 11:26:03 +0000 javellan 24@http://biotechbistro.com/forum/ Back by Popular Demand, Cerulean’s John Avellanet will speak at 8th Annual Contract & Supplier Conference on how to prove to FDA and Big Pharma's auditors that your supplier management works and is reliable. For its September 24-25th Eighth Annual Contracting and Outsourcing Conference in New Brunswick, New Jersey, Contract Pharma and Rodman Publishing will host Cerulean’s Managing Director, John Avellanet, providing more entertaining stories, real-world experiences, and practical advice. Mr. Avellanet will speak to pharmaceutical executives on how to prove to the US Food and Drug Administration and its inspectors that your supplier qualification and outsourced services oversight program is effective and meets all the regulations. Based on his own personal career experiences as a C-level executive accountable for regulatory compliance to the FDA, plus his conversations with FDA officials, Mr. Avellanet will discuss: • Red flags to keep an eye out for during due diligence and on-going supplier reviews • Key quality agreement components for outsourced service provider contracts • What to look for when auditing supplier records • Example metrics to collect and review to prove proactive supplier management Mr. Avellanet has gained tremendous acclaim on his speeches, workshops and teleconferences for various companies and venues around the country. Testimonials cover his speaking page on his website (http://www.ceruleanllc.com/Speaking.htm) and conference organizers repeatedly note that he gets the highest evaluations of any of their speakers. In addition to the 8th Annual Contracting and Outsourcing Conference, you can see Mr. Avellanet as he chairs the FDA Supplier Management Congress in August 19-21, or as he runs a workshop on defensible documents at the AdvaMed MedTech Conference on October 12th. If you’d like to attend Contract Pharma’s Eighth Annual Contracting and Outsourcing Conference, visit <a href="http://www.contractpharma.com/2009conference" rel="nofollow">http://www.contractpharma.com/2009conference</a> John Avellanet is the author of more than 100 articles, is the FDA compliance columnist for several international industry journals, and is the co-founder of the private compliance advisory firm, Cerulean Associates LLC. Every month, he publishes the regulatory intelligence and quality systems advice newsletter, SmarterCompliance™. He is a frequent speaker at corporate workshops, industry conferences, and meets regularly with regulatory officials. Learn more about Mr. Avellanet on his blog, <a href="http://www.ComplianceZen.com" rel="nofollow">http://www.ComplianceZen.com</a>, or through his company’s website: <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a> ### javellan on "FDA Supplier Quality Management Congress this August" http://biotechbistro.com/forum/topic/fda-supplier-quality-management-congress-this-august#post-23 Mon, 13 Jul 2009 20:46:50 +0000 javellan 23@http://biotechbistro.com/forum/ A joint three-day conference on assuring the integrity of drug and device raw materials and supply chains will be hosted by FDAnews and officials from the US FDA, and chaired by Cerulean's Managing Director and co-founder, John Avellanet. Mr. Avellanet has been working with conference officials since earlier this year to line up a practical program to address current hot topics including: * Three case studies of quality agreements - what worked, what didn't, and why * Using process flow diagrams to identify critical control points in your supply chain and quality agreements with suppliers * FDA inspection tactics and enforcement trends * How to incorporate risk-based controls into supplier management procedures and policies * Overcoming language and global supplier barriers to promote effective management * How to use supplier audits to drive down risk and increase product safety Subscribers to Mr. Avellanet's monthly newsletter, SmarterCompliance, will recognize all of these topics from previous articles and presentations. The conference will be held August 19-21 in Arlington, Virginia, right next door to Washington, D.C. If you’d like to attend the conference and meet with officials from the FDA and top industry experts, visit <a href="http://www.fdanews.com/conference/detail?eventId=2783" rel="nofollow">http://www.fdanews.com/conference/detail?eventId=2783</a> for details. BiotechBlog on "Unrivalled programme for European Forum for Industrial Biotechnology (EFIB 2009)" http://biotechbistro.com/forum/topic/unrivalled-programme-for-european-forum-for-industrial-biotechnology-efib-2009#post-21 Wed, 10 Jun 2009 16:18:51 +0000 BiotechBlog 21@http://biotechbistro.com/forum/ Unrivalled programme for European Forum for Industrial Biotechnology (EFIB 2009) has been announced EuropaBio in co-operation with IntertechPira is proud to announce the programme for this year's European Forum for Industrial Biotechnology (EFIB 2009) featuring a programme full of the leading experts in the industry! Staged at the SANA Lisboa Hotel, Lisbon, Portugal on 20 – 22 October 2009, EFIB 2009 will deliver plenary sessions, streams and workshops as well as an exhibition. The event will feature 50 leading experts who will assess the prospects for industrial biotechnology and biobased products in Europe. EFIB 2009 is proving to be the leading knowledge and networking platform for the industry with various adjoining events taking place in Lisbon during the same week, such as APBio's 4th annual Biomeet, Biobased Products Advisory Group meeting and the BIOCANT Site Visit. “In 2009, our aim is to bring together all stakeholders from government, industry, academia and the financing world. EFIB 2009 will be a meeting place for the successful development of the biobased economy in Europe,” said Dr Dirk Carrez from EuropaBio. Pre-conference seminars The event will commence with 2 parallel pre-conference seminars: • Fundamentals of Industrial Biotechnology workshop is aimed at those wishing to gain a basic understanding of the industrial applications of biotechnology prior to the conference. • Business Development for Industrial Biotechnology seminar is aimed at SME's, start-ups, spin-offs and micro companies wanting to capitalise on turning biotech ideas into commercial applications. Main conference The first day of the main conference will start with a plenary session, including presentations from DuPont, Votorantim, Novozymes, European Commission, Festel Capital, Toyota, CEPI and Huntsman Textile Effects. Three afternoon tracks on day 1 will analyse feedstock, policy and business development in IB. Topics such as EU biomass policy, sustainability in biomass production, the future of biorefinery, and biofuels will be discussed by the European Commission, Syngenta, Cargill, Forest-based Sector Technology Platform and Institute for Energy Renewable Energy Unit. The policy track will focus on the UK, Germany, China, Australia and the Asian regions, featuring presentations from HM Government, BIO.NRW, CCM Ltd, and Corelli Consulting. The innovation track will assess the most recent developments in biobased polymers, lactic acid and polylactic acid, novel materials, the role of public-private partnerships, and CLIB2021 project. Presenting companies include B-Basic, Kluyver Centre for Genomics of Industrial Fermentation, Natureworks, Cluster Industrial Biotechnology CLIB2021, Uhde and Segetis. The second day will start with 2 parallel tracks examining feedstock and innovation and the OECD Workshop. The feedstock track will analyse the Brazilian sugarcane industry, biofuels, the farmers’ perspective, micro algae, and it will close with a panel debate. Delegates will hear from UNICA, Roundtable on Sustainable Biofuels, Nouricia, Copa-Cogeca, Algealink, Agro-Transfert Ressources et Territoire and D1 Oils Plant Science. The innovation track will feature talks from University College London, SÜD-Chemie, TNO, Brandenburg University of Technology Cottbus, Ingenza, c-Lecta, Purac/CSM Biochemicals and Infraleuna. It will focus on enzyme engineering, biorefineries, lignocellulose, biopharmaceutical manufacture, novel enzymes as well as biobased chemicals. The conference will finish with a plenary session discussing how to translate sustainability into economic value. This meeting will include presentations from Evonik Degussa, B.R.A.I.N., European Commission and a panel discussion with DSM White Biotechnology, Natureworks, Aalborg Univeristy, McKinsey's Global Biosystems Group and the session's presenters. EFIB 2009 is the must-attend event of the year providing an update on all recent developments in the industry and an outstanding networking platform. The complete programme is available for download from the conference’s official website <a href="http://www.efibforum.com" rel="nofollow">http://www.efibforum.com</a>. (END) Enquiries: Programme: Ciaran Little +44 (0) 1372 802063 <a href="mailto:ciaran.little@pira-international.com">ciaran.little@pira-international.com</a> Marketing & Press: Veronika Fricova +44 (0) 1372 802017 <a href="mailto:veronika.fricova@pira-international.com">veronika.fricova@pira-international.com</a> javellan on "Upcoming Book on Personalized Medicine & FDA Compliance" http://biotechbistro.com/forum/topic/upcoming-book-on-personalized-medicine-amp-fda-compliance#post-20 Fri, 05 Jun 2009 13:02:08 +0000 javellan 20@http://biotechbistro.com/forum/ Cerulean’s managing director, John Avellanet, has signed a contract with Logos Press to write a book covering the compliance and quality systems landscape over the next decade, including the compliance strategies required for new drug and device development and approval in the era of personalized medicines. Based in part on Mr. Avellanet's April talk at the NIH on the future of the biopharmaceutical landscape, and his SmarterCompliance newsletter series on personalized medicine and the role of regulatory compliance, the book provides a strategic review of the compliance and quality systems best practices required for marketplace success over the next decade for biotechnology, pharmaceutical, and medical device firms. The book is sub-divided into three parts: a review of today’s landscape, an analyses of the key challenges likely to dominate over the next ten years, and then a step-by-step strategy covering: • Faster product innovation and development • Medicinal safety and efficacy by design • Cost-effective, lean quality systems • Flexible, regulatory compliance programs As part of the book’s practical, “how to” mindset, readers will be able to access bonus materials, downloads, and supplemental information online through a dedicated book website. Subscribers to Mr. Avellanet’s monthly newsletter, SmarterCompliance, will be able to access pre-publication materials and downloads as part of the lead-in to publication. Publication is slated for May 2010. John Avellanet is the author of more than 100 articles, is the compliance columnist for several international industry journals, and is a former C-level biotech and medical device executive for a Fortune 50 subsidiary. As the co-founder of the private compliance advisory firm, Cerulean Associates LLC, he publishes the monthly executive newsletter, SmarterCompliance™. He is a frequent speaker at corporate workshops, industry conferences, and meets regularly with regulatory officials. Learn more about Mr. Avellanet on his blog, <a href="http://www.ComplianceZen.com" rel="nofollow">http://www.ComplianceZen.com</a>, or through his company’s website: <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a> ### javellan on "New FDA Compliance Blog Published" http://biotechbistro.com/forum/topic/new-fda-compliance-blog-published#post-19 Thu, 21 May 2009 12:58:50 +0000 javellan 19@http://biotechbistro.com/forum/ Cerulean’s managing director, John Avellanet, has finally given in and started a blog of basic FDA advice on quality systems and regulatory compliance: Compliance Zen. Compliance Zen is through TypePad at: <a href="http://www.ComplianceZen.com" rel="nofollow">http://www.ComplianceZen.com</a> Compliance Zen offers practical tips and short “how-to” articles on FDA-related topics such as Quality by Design, lean FDA compliance, records management, and Part 11 compliance. The blog also provides quick management and leadership tips gleaned from a mix of Mr. Avellanet’s personal experiences plus independent business management research. Included in the blog are reviews of leadership books with relevance to compliance, quality systems, and regulatory affairs executives (excerpted from his SmarterCompliance newsletter’s Featured Reading section). John Avellanet is the author of more than 100 articles, is the compliance columnist for several international industry journals, and is a former C-level biotech and medical device executive for a Fortune 50 subsidiary. As the co-founder of a private compliance advisory firm, he publishes the monthly executive newsletter, SmarterCompliance™. He is a frequent speaker at corporate workshops, industry conferences, and meets regularly with regulatory officials. Learn more about Mr. Avellanet on his website: <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a> frankelpr on "Bio-Research & Development Growth Park at Danforth Center Has New Website" http://biotechbistro.com/forum/topic/bio-research-amp-development-growth-park-at-danforth-center-has-new-website#post-15 Wed, 25 Mar 2009 17:25:40 +0000 frankelpr 15@http://biotechbistro.com/forum/ March 25, 2009, St. Louis – BRDG-Park at the Danforth Plant Science Center (Bio-Research & Development Growth), which will open in June 2009 the first of three buildings for plant and life sciences research and business development, has introduced its new Web site at <a href="http://www.BRDG-Park.com" rel="nofollow">http://www.BRDG-Park.com</a>. In addition to details about space for lease in Building I, a 110,000 square-foot, four-story facility that includes a balance of state-of-the-art wet lab and office space, the Web site emphasizes the park’s many advantages for plant and life sciences companies interested in expanding research, resources and relationships to achieve commercial success. Advantages include the park’s strategic location on the campus of the Danforth Plant Science Center -- where facilities include technologically advanced greenhouse, growth chambers and other vital resources – and being across the street from the world headquarters of Monsanto. Located in suburban St. Louis County, Missouri, widely regarded as a global leader in plant and life science research, BRDG Park is being developed by Wexford Science+Technology LLC, a privately held real estate developer and investment company that has developed six major research parks nationwide. About BRDG Park at the Danforth Center Bio-Research & Development Growth (BRDG) Park at the Danforth Plant Science Center helps life sciences companies bridge research, resources and relationships to achieve commercial success. In addition to providing world-class wet laboratories, office space and a prominent incubator, BRDG Park’s location on the Danforth Center’s campus facilitates access to the intellectual capital of top scientists, as well as to greenhouse, growth chambers, microscopy and proteomics facilities and other vital resources. More information is available at <a href="http://www.BRDG-Park.com" rel="nofollow">http://www.BRDG-Park.com</a>. javellan on "GxP Lifeline Interviews John Avellanet on Saving Money and FDA Compliance" http://biotechbistro.com/forum/topic/gxp-lifeline-interviews-john-avellanet-on-saving-money-and-fda-compliance#post-14 Wed, 18 Mar 2009 11:35:58 +0000 javellan 14@http://biotechbistro.com/forum/ In its March issue, GxP Lifeline interviewed Cerulean’s Managing Director, John Avellanet, on the FDA’s increasing concern about data quality, the new FDA Part 11, computer virtualization, and his private SmarterCompliance FDA advisory service for executives in the medical device, pharmaceutical and biotech industries. Executives awaiting news of FDA’s long delayed revisions to 21 CFR Part 11 would do well to subscribe to Cerulean’s FDA intelligence newsletter. As Mr. Avellanet pointed out, “Subscribers expect Part 11 to emerge from the agency this year, have a good feel for what the new Part 11 will include, and have already begun their preparations and project budgeting.” Computer virtualization is much more viable under the revised Part 11, according to Mr. Avellanet. Companies can save 30-80% from their IT budgets depending on how aggressively they pursue virtualization and how prepared they are for the new Part 11. Executives and business owners who participate in Mr. Avellanet’s SmarterCompliance program have gotten at least a 6-12 month drop on their competitors and the FDA’s own inspectors by incorporating Cerulean’s recommendations and insights. Mr. Avellanet said he was most pleased that “because of my constant insistence on cost-efficiency these past 3 years, my clients have been able to weather the current economic conditions quite admirably.” Cerulean has put a copy of the full interview on its website at <a href="http://www.ceruleanllc.com/resources" rel="nofollow">http://www.ceruleanllc.com/resources</a>\Part11_Saving_Money_Virtualization.htm, or readers may visit the GxP Lifeline site for the full March issue. Cerulean's SmarterCompliance program includes a monthly newsletter that mixes compliance and regulatory intelligence with specific recommendations, strategies and quality systems tactics executive teams can adopt. Cerulean surveys a broad set of information sources, including the FDA's own publications, warning letters, daily news, other governmental publications, blogs, and so on to synthesize the information that is then analyzed for subtexts, trends and themes. Journalists who would like a complimentary subscription to Cerulean's SmarterCompliance™ newsletter can contact Mr. Avellanet directly through the Cerulean website. Cerulean Associates LLC is a private advisory company that helps executives in the pharmaceutical, biotech and medical device sectors cut costs, streamline quality systems, speed new drug, biologic or device time to market, and protect their intellectual property from theft. Cerulean publishes the SmarterCompliance™ newsletter as part of its SmarterCompliance FDA executive advisory program. On the web at <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a>. ### Yanaqa on "Attorney" http://biotechbistro.com/forum/topic/attorney#post-13 Fri, 13 Mar 2009 14:35:13 +0000 Yanaqa 13@http://biotechbistro.com/forum/ Welcome to <a href="http://www.GaryFleshman.com" rel="nofollow">http://www.GaryFleshman.com</a> where you will find information about the Fleshman Law Office and on filing Bankruptcy in the Southern District of Ohio, Eastern Division, which is the jurisdiction for the Columbus Ohio Bankruptcy Court. <a href="http://garyfleshman.com/home.php" rel="nofollow">http://garyfleshman.com/home.php</a> laravmarks on "BioPharma sentiment takes a plunge" http://biotechbistro.com/forum/topic/biopharma-sentiment-takes-a-plunge#post-12 Wed, 04 Mar 2009 06:52:14 +0000 laravmarks 12@http://biotechbistro.com/forum/ Silico Research has released the findings of its annual survey of sentiment in the biopharma industry. As might be expected sentiment has taken a major turn for the worse with a net 38% of respondents seeing the prospects for the industry as declining over the next year. In 2008 a net 30% saw the prospects for the industry improving over the next year. This year a net 62% of respondents reported that the prospects for the industry are currently worse than this time last year. The state of capital markets was the most often cited reason for the decline in sentiment in the industry. The decline in sentiment was particularly pronounced in English speaking countries and the biotechnology sector. The survey was conducted during February 2009 and 103 senior executives in the industry took part in the survey. However, the capital crunch means that alliances with larger companies are more vital than ever with a net 64% of respondents viewing alliances as more important to their organisation in 2009 compared to 2008. For more information about the survey please email <a href="mailto:Lara@silico-research.com">Lara@silico-research.com</a> Silico Research is a research consultancy that is a trusted advisor to leading organisations on partnering, alliances, relationships and reputation management both within the organisation and externally. What sets Silico Research apart is the evidence-based nature of its analysis. Quantitative and qualitative research of the highest quality using customised survey and focus groups are the core of Silico Research’s products and services. Silico's clients come from a wide range of public and private sectors, including the life sciences, healthcare, technology, energy and telecommunication. javellan on "FDA Regulatory Agenda for 2009 Matches Forecast by Cerulean" http://biotechbistro.com/forum/topic/fda-regulatory-agenda-for-2009-matches-forecast-by-cerulean#post-11 Sat, 28 Feb 2009 15:29:53 +0000 javellan 11@http://biotechbistro.com/forum/ Documents released by the US Food and Drug Administration (FDA) last week laid out a schedule of regulatory guidance and agency expectations largely mirroring those forecast in December's SmarterCompliance newsletter. Cerulean Associates LLC publishes the monthly SmarterCompliance newsletter, subscribed to by pharmaceutical, device and biotech executives around the world, and issues an annual forecast for the upcoming year between November and December. "Last year," said Managing Director, John Avellanet, "our forecast gave over 40 recommendations for 2009, most of them just summaries of our more in-depth analyses we published throughout the year in the newsletter. We’re really starting to see subscriptions take off as executives realize the business implications of getting a good 12 to 18 month lead on their competitors and the inspectors." The December SmarterCompliance forecast that the FDA would release a revised version of 21 CFR Part 11, a Good Importer Guidance, Process Validation advice, and more guidance documents supporting the implementation of various aspects of Quality by Design throughout the lifecycle – from preclinical to postmarket – of drugs and biologics. The FDA's agenda as published by the Center for Drug Evaluation Research (CDER) specifies just those items. To help executives who have not had a chance to evaluate SmarterCompliance, Cerulean has made the first half of its December issue available for free download (visit <a href="http://www.ceruleanllc.com/newsletter/" rel="nofollow">http://www.ceruleanllc.com/newsletter/</a>). "Currently," said Mr. Avellanet, "we're turning our attention to the new drug and biologic pipeline implications of personalized medicines; so far we've published dozens of recommendations for our readers along with approximate timelines of marketplace adoption and regulatory rulings." "Let's not kid ourselves," cautioned Mr. Avellanet. "Our February 2008 prediction that some sort of regulatory pathway for follow-on biologics would be in place by the end of this year [2009] may or may not come to pass. The initial budget from the new administration supports such a move, but a whole lot of maneuvering has to go on before a generic biologics pathway exists." Cerulean's SmarterCompliance newsletter mixes compliance and regulatory intelligence with specific recommendations, strategies and quality systems tactics executive teams can adopt. Cerulean surveys a broad set of information sources, including the FDA's own publications, warning letters, daily news, other governmental publications, blogs, and so on to synthesize the information that is then analyzed for subtexts, trends and themes. Journalists who would like a complimentary subscription to Cerulean's SmarterCompliance newsletter can contact Mr. Avellanet directly through the Cerulean website. Cerulean Associates LLC is a private advisory company that helps executives in the pharmaceutical, biotech and device sectors cut costs, streamline quality systems, speed new drug, biologic or device time to market, and protect their intellectual property from theft. Cerulean publishes the SmarterCompliance™ newsletter as part of its SmarterCompliance FDA executive advisory program. On the web at <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a>. ### BiotechBlog on "HUYA to Collaborate on Pre-clinical and Clinical Studies for Chinese Drugs" http://biotechbistro.com/forum/topic/huya-to-collaborate-on-pre-clinical-and-clinical-studies-for-chinese-drugs#post-10 Mon, 23 Feb 2009 14:48:41 +0000 BiotechBlog 10@http://biotechbistro.com/forum/ San Diego, CA, February 18, 2009 – HUYA Bioscience International, the leader in US/China pharmaceutical co-development, today announced a partnership agreement with the Beijing Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College (collectively – The Beijing Institute of Materia Medica, BIMM). The agreement grants HUYA the opportunity to collaborate with BIMM on pre-clinical safety and efficacy, and clinical trial protocols. The agreement also provides HUYA with the right of first review and negotiation for the licensing and development of certain new compounds owned or controlled by BIMM. This right includes drugs in discovery and development for use in the areas of cardiology, endocrinology, oncology, immunology, hematology, neuroscience and anti-infectives. The agreement represents one of the first official collaborations between a U.S. and a Chinese institution to co-develop multiple pharmaceuticals on an ongoing basis. “HUYA is highly experienced and uniquely positioned in China to leverage the emerging biotech industry through strong collaborations. This is the culmination of years of relationship-building and exchange of knowledge between HUYA and BIMM,” said Mireille Gingras, PhD, CEO, HUYA. “We are proud that the Institute of Materia Medica is our official partner and together we hope to bring new drugs to market.” “For BIMM, our partnership with HUYA signifies an opportunity to bring our expertise and our efforts in pharmaceutical development to the Western market,” said Xiaoling Wang, MD, PhD, Director, BIMM. “We will be working closely with Dr. Gingras and her team to ensure that our study designs mirror FDA and EMEA agency protocol. This is a great opportunity for us and for HUYA as it will enable new pharmaceutical compounds to more efficiently reach a global market.” HUYA currently has two Chinese drugs undergoing preclinical development in the US – HBI-3000 and HBI-8000. Both drugs, for cardiac fibrillation and oncology respectively, have successfully passed US FDA pre-IND consultations. The Institute of Materia Medica is dedicated to discovering and developing treatments for serious diseases by isolating natural remedies and leveraging modern technology to develop therapies based on molecular structure and untapped compounds. HUYA’s innovative co-development model HUYA was one of the first companies to recognize China’s potential to help meet the global need for pre-clinical and clinical stage compounds for the drug development process. Leveraging the HUYA Integrated Co-development Model for partnering with Chinese research institutions and pharmaceutical companies, HUYA identifies and licenses the most promising pre-clinical and clinical stage compounds in China. Through collaborations with its Chinese partners, the company provides a bridge into the Western development process and biopharma market. Compounds are validated through a rigorous discovery, selection and development process in China, streamlining and accelerating development in the West. HUYA’s model relies on longevity of relationships with its Chinese partners to provide a continuous source of compounds rather than a one-time single compound strategy. One of the key differentiators of HUYA’s approach is the assembly of a high-level team of scientific and clinical advisors for each new compound. The team collaborates with its Chinese partners to discuss and design clinical trials as the compounds move through the Chinese and the U.S. development process, speeding the process and mitigating risk. HUYA’s global team of scientist and clinician advisors includes Benedict Lucchesi, PhD MD, Peter R. Kowey, MD, Dennis Roy, MD, Jefferson L. Anderson, MD, Eric J. Topol, MD, and Stanley Nattel, MD, John McHutchison, MD, Alex Adjei, MD, PhD, Alan List, MD, Patricia LoRusso, DO, Jackie Walling, MD, PhD, and Michael Robertson, MD. About HUYA HUYA is the leader in U.S./China pharmaceutical co-development. With three strategic offices in China, the broadest Chinese compound portfolio, and more exclusive agreements with premier Chinese biotech centers than any other company, HUYA has pioneered the most innovative and productive approach for pharmaceutical co-development between the U.S. and China. HUYA has joint headquarter offices in San Diego, CA, and Shanghai. Additional information about the company is available at <a href="http://www.huyabio.com" rel="nofollow">http://www.huyabio.com</a> <http://www.huyabio.com/> . About BIMM The Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College is one of the premier institutions for drug research in China. It was founded in 1958 and now has more than 400 employees, of which approximately 300 have scientific or technical backgrounds. The Institute staff includes more than 100 professors and associate professors, three members of the Chinese Academy of Sciences and two members of the Chinese Academy of Engineering. The main task of the Institute is discovery of new drugs for the treatment of commonly occurring diseases that seriously threaten people’s health. At the same time, emphasis is put on the application and development of modern medical theory and high technology. Since the establishment of the Institute, more than 270 prizes have been awarded for its research achievements and more than 100 new drugs have been developed. javellan on "Two FDA Quality Systems Compliance Resources Published" http://biotechbistro.com/forum/topic/two-fda-quality-systems-compliance-resources-published#post-9 Fri, 20 Feb 2009 16:11:11 +0000 javellan 9@http://biotechbistro.com/forum/ Two new FDA quality systems compliance resources – Bulletproof Yourself against FDA Enforcement and FDA Quality Systems Records Requirements for GLPs, GCPs, GMPs – have been published by the SmarterCompliance™ newsletter and Cerulean Associates LLC. Both publications combine recorded executive teleseminars with resource kits of checklists, templates, example FDA warning letters, and other reference material designed to ease implementation of various recommendations and expert advice. Bulletproof Yourself against FDA Enforcement builds on Cerulean’s in-depth industry report from last year, FDA Enforcement Trends 2008-2009, and adds a review of the top 10 agency inspection priorities for domestic US and international sites, four detailed self-assessment checklists, a step-by-step strategy for ensuring positive inspection outcomes, three article reprints, and an hour-long audio-visual analysis of the FDA priorities for 2009 along with recommendations to stay off the FDA radar screen for the next 12-18 months. Also included is a complimentary copy of the industry report, FDA Enforcement Trends 2008-2009. FDA Quality Systems Records Requirements includes a 9-page matrix of FDA records and documentation requirements for firms during GLPs, GCPs, and GMPs, an 11-step strategy overview guide, several self-assessment checklists, a policy framework template, multiple article reprints, and other reference materials. Also included is an hour-length audio-visual recording of last week’s executive teleconference with questions and answers from the audience. Both resource kit publications are available – either in download format or CD and hard copy – through the Cerulean website at <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a>. Cerulean’s next online seminar for executives, Frugal FDA Compliance: Getting More Done with Less, is scheduled for Tuesday, March 24. Want to attend? Visit <a href="http://www.ceruleanllc.com/webinar" rel="nofollow">http://www.ceruleanllc.com/webinar</a> to learn more and register. Cerulean Associates LLC is a private advisory company that helps executives in the pharmaceutical, biotech and device sectors cut costs, streamline quality systems, speed new drug, biologic or device time to market, and protect their intellectual property from theft. Cerulean publishes the SmarterCompliance™ newsletter as part of its SmarterCompliance FDA executive advisory program. On the web at <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a>. ### javellan on "New Webinar on FDA Records Keeping Requirements" http://biotechbistro.com/forum/topic/new-webinar-on-fda-records-keeping-requirements#post-7 Wed, 04 Feb 2009 10:47:51 +0000 javellan 7@http://biotechbistro.com/forum/ Cerulean Associates LLC, announces its new executive teleconference and webinar to be held on Thursday, February 19th at 2pm ET, Prove FDA Compliance with Easy Records Management Techniques. Limited to just 24 attendees, the one-hour teleconference will feature a 45-minute presentation by FDA compliance and records management expert, John Avellanet, followed by a 15-minute Q&A session. You download a detailed agenda of the presentation (and register to attend) at <a href="http://www.ceruleanllc.com/webinar" rel="nofollow">http://www.ceruleanllc.com/webinar</a> Mr. Avellanet is a former C-level executive for a biotech and medical device Fortune 50 subsidiary, who designed, built and ran his company's records management program. In 2006, Mr. Avellanet founded the regulatory intelligence and lean compliance program for executives and business owners, SmarterCompliance™. He is the author of more than 30 articles on lean compliance and FDA quality systems, a contributing author to the book Best Practices in Biotechnology Business Development (Logos Press), the publisher of the SmarterCompliance™ newsletter, and a frequent speaker with FDA officials. He can be directly reached through his independent advisory firm, Cerulean Associates LLC, on the web at <a href="http://www.ceruleanllc.com" rel="nofollow">http://www.ceruleanllc.com</a>. Anonymous on "New Online Network Lets Life Scientists around the World Share Scientific Resear" http://biotechbistro.com/forum/topic/new-online-network-lets-life-scientists-around-the-world-share-scientific-resear#post-5 Thu, 01 Jan 2009 15:23:45 +0000 Anonymous 5@http://biotechbistro.com/forum/ Epernicus.com is a new online network that is enabling health and life scientists from around the world to share scientific research. Epernicus has already enabled 9,457 of life scientists at 1,825 institutions in 67 countries to find other researchers with specific skill sets, averting the time-consuming, labor intensive processes of tracking down scientists who have information that they need. In the past three months, it has grown from 5,183 scientists at 1,200 institutions in 57 countries. A scientist could be researching global warming, stem cells, a cure for cancer, the aging process, dinosaurs, biofuels or food microbiology. According to the National Science Foundation, there were 274,200 scientists and engineers with doctorates in U.S. academia in 2006 and 4.8 million total people currently in the science and engineering labor force. Epernicus is already the leading science-focused professional network among scientists at Harvard, MIT, Stanford, Yale, UC Berkeley, UC San Francisco among others. It is also being used by scientists at the National Institutes for Health and at such leading biotech companies as Genentech, Novartis and Pfizer. "Think of us as a Facebook or LinkedIn for scientists but with a concrete purpose," said Mikhail Shapiro, PhD, co-Founder of Epernicus, headquartered in Cambridge, MA. "We help scientists realize just how much knowledge their colleagues have that can be tapped to accelerate their research." "About 90% of what scientific researchers do and know can be shared with others without affecting their competitive position. We’re not talking about posting cutting edge research before it’s published in a reputable journal," said Shapiro. According to Krystyn Van Vliet, the Thomas Lord Assistant Professor of Materials Science and Engineering and Biological Engineering at MIT, "My entire research group is already on Epernicus, and we’ve been using it to start collaborations. Even for colleagues we already knew, we weren’t aware that they had certain skills or reagents. We say, 'Wow, we didn’t know they were working on that.'" Johannes Huebner MD, Associate Professor of Medicine, Division of Infectious Diseases at University Hospital in Freiburg, Germany, had this to say: "Epernicus has been really great for me to get in touch with former colleagues. In the future, we are planning to use it more extensively for writing international collaborative research proposals, something that is becoming more important due to the funding mechanisms of the European Union. The opportunity to post documents and the detailed description of areas of expertise of the individual participants are extremely useful." Epernicus combines specialized professional networking utility with a people-centric search engine to help scientists locate colleagues with specific expertise in their real-world professional networks. Once a scientist joins - with email address verification - he/she is automatically connected with all other members at his/her laboratory, department and institution as well as researchers who shared a common research advisor in the past. Members profiles include detailed information about their training history, advising genealogy, publications and specific topics, materials and methods in which they have expertise. Features like a hook-up to the National Library of Medicine's PubMed archive make it easy for scientists to complete their profiles. All data is-user provided, not culled from the web, ensuring accuracy of each user's information. These details are then used by Epernicus' search engine to show users who among their colleagues is likely to have a particular expertise. "Epernicus can tell me who in my department has worked with stem cells and could show me how to extract their RNA for analysis," Shapiro said. Conversely, Epernicus members can broadcast a question to their scientific networks. A Brigham and Women's Hospital faculty member asked hospital colleagues and fellow alumni from his post-doctoral advisor's laboratory for advice on modifying the activity of an antibody, while an MIT student was looking for a fluorescent plate reader to use while his was broken. Epernicus as founded by Shapiro, PhD, co-founder of Cyberkinetics Neurotechnology Systems, Inc., and Vivek Murthy, MD, MBA, attending physician at Brigham and Women's Hospital, instructor at Harvard Medical School, and co-founder of VISIONS, a non-profit focused on HIV/AIDS youth education. Daniel J Nevrivy on "Daniel J. Nevrivy, Ph.D., Biotech and Pharmaceutical Patent Attorney, Launches N" http://biotechbistro.com/forum/topic/daniel-j-nevrivy-phd-biotech-and-pharmaceutical-patent-attorney-launches-n#post-2 Mon, 22 Dec 2008 18:24:06 +0000 Daniel J Nevrivy 2@http://biotechbistro.com/forum/ WASHINGTON, Dec 16, 2008 (BUSINESS WIRE) -- Daniel J. Nevrivy, Ph.D., a Washington, D.C. patent attorney, today announces the formation of Nevrivy Patent Law Group P.L.L.C., a law firm focused on biotechnology and pharmaceutical patent law that aims to help businesses, universities and inventors protect their intellectual property (IP) and preserve their capital. The credit crisis and economic downturn pose extraordinary challenges for many of the nation's leading innovative companies who now find themselves with limited access to dwindling pools of capital to fund their innovation and development needs. "These organizations are finding themselves in a difficult situation, because while they recognize that investments in IP can generate a lot of long term value down the road, they must preserve their capital today to stay in business long enough to reap those rewards. The limited access to capital is forcing companies to make difficult choices about what projects to develop and what to put on hold or abandon," according to Dr. Nevrivy. Research universities are also feeling the pinch, hampered by anticipated budget shortfalls and endowments that have been hard hit by the fall in the stock market. The fees required to obtain patents and build a valuable portfolio, or identify and analyze competitor patents, can be a very costly and significant expense for many organizations. In addition, billing rates for patent attorneys have soared in recent years, due in large part to increases in salaries and other overhead costs that firms have tried to pass along to clients. "Many law firm cost structures which have been built up over the last several years are not really in sync in today's market with businesses' needs. Businesses are trying to get a better handle on managing their costs because they want to preserve their capital to further their innovation and development goals. It is not clear that they will be able to raise additional capital in the near future," according to Dr. Nevrivy. With this in mind, Dr. Nevrivy founded the new firm, located in the Georgetown area of Washington, D.C. Dr. Nevrivy, who holds a Ph.D. in molecular and cellular biology, was formerly with the D.C. firm of Sterne, Kessler, Goldstein & Fox for seven years. Dr. Nevrivy is building a team of lawyer-scientists to serve businesses, universities and inventors who seek innovative ways to lower their costs for protection of their IP without sacrificing quality. "It's a little tricky for existing law firms to lower their fees and maintain quality because the cost structure is so built in to their way of doing things. However, a new law firm that is small and highly focused can create a cost structure de novo that works. A reduced overhead and a streamlined firm structure also mean that attorneys can provide the highest quality of work more efficiently than larger firms. It's a win-win situation, for the client and the lawyer," according to Dr. Nevrivy. About Nevrivy Patent Law Group P.L.L.C.: Nevrivy Patent Law Group P.L.L.C. ( <a href="http://www.nevrivylaw.com" rel="nofollow">http://www.nevrivylaw.com</a>) is a law firm focused on biotechnology and pharmaceutical patent law that strives to provide high quality, value-oriented legal services for clients. The firm's services include the preparation, filing and prosecution of patent applications in the U.S. and foreign countries. The firm also conducts due diligence, patentability, invalidity and non-infringement investigations and opinions in a wide variety of subject areas in biotechnology and the pharmaceutical sciences. The firm's services also include client counseling regarding intellectual property matters, including patents, trademarks and trade secrets. The firm also advises clients regarding the transfer and enforcement of intellectual property rights. Nevrivy Patent Law Group P.L.L.C. Daniel J. Nevrivy, Ph.D. 202-247-6015 <a href="mailto:dnevrivy@nevrivylaw.com">dnevrivy@nevrivylaw.com</a> <a href="mailto:info@nevrivylaw.com">info@nevrivylaw.com</a>