Those who have been following this blog for long enough probably know what it means when posting slows down — it means that I’ve got a new project in the works. I’m currently working on a new online platform for biotechnology education. It should be ready for beta testing by December first, and formally launch early in 2009.

Let me know if you might be interested in helping beta test this online education platform. And while you’re waiting for more posts, check out some of the fantastic guest content.

Courtesy of DrugPatentWatch.com:

Drug Patent Expirations in November 2008

*Drugs may be covered by multiple patents

Courtesy of DrugPatentWatch.com

Volume 14, Issue 4

Continuing education in biotechnology
Yali Friedman

Open content textbooks: Educating the next generation of bioentrepreneurs in developing economies
Arlen D Meyers, Donald J McCubbrey and Richard T Watson

Can compliance help marketing and business development?
John Avellanet

Money for nothing? Risks in biopharmaceutical companies from the perspective of public financiers
Laura Heinonen and Birgitta Sandberg

Got value? Determine it. Demonstrate it. Communicate it. Realise it
Mitch DeKoven, Elisabeth H Hazard, Erica Goldberg and Shibani Pokras

Value-driven project and portfolio management in the pharmaceutical industry: Drug discovery versus drug development – Commonalities and differences in portfolio management practice
Kerstin M Bode-Greuel and Klaus J Nickisch

Legal and Regulatory Update

Intellectual Property and Biotechnology: Biological Inventions
Stefan M Miller

Commercializing Successful Biomedical Technologies
Arlen D Meyers

Enterprise for Life Scientists: Developing Innovation and Entrepreneurship in the Biosciences
Arlen D Meyers

Biotechnology and the Law
Edward L Korwek

Welcome to Biotech Nation
James Rogers

The Regulatory Challenge of Biotechnology
John Avellanet

Best Practices in Biotechnology Business Development
Hans-Erik Hamid Lydecker

Genetic Glass Ceilings: Transgenics for Crop Biodiversity
Drew L Kershen

Intellectual Property Theft on the Rise

By John Avellanet, Managing Director and Principal of Cerulean Associates LLC

Reprinted with permission from SMARTERCOMPLIANCE™ 2(9): p 1-2 (September 2008)

Nine out of ten companies do not have appropriate policies and controls in place to stop employees, contractors or partners from walking out the door with intellectual property and trade secrets.

For those of us who’ve spent much of our careers helping prevent corporate espionage, the July report by the not-for-profit IT Policy Compliance consortium comes as little surprise.

Protecting Information

Passwords and patents do not make your company’s information and discoveries any more secure than locks and labels make your home and its belongings safe from theft.

Carnegie Mellon University’s CERT research think tank has followed information theft for decades and has come to two eye-opening conclusions:

• · Most confidential information theft comes from people you know—employees, contractors, suppliers or even partners (especially for co-developed products); and

• · More than 30% of this type of theft comes from people working in your computer department (IT/ICT).

Given all the security efforts around stopping outsiders when the real risk lies within, is it any wonder that 90% of businesses do not have any way to stop—much less even detect—intellectual property (IP) and trade secret theft?

Improving Your Chances

Before we even get down to work on reasonable trade secret controls, I give my clients a brief set of “yes/no” questions to answer on their own.

These questions are straightforward and easily answered in less than 30 minutes. For instance, “Do you have a ‘clean desk’ policy for sensitive or confidential information?”

The goal of these questions is to help my clients quickly outline their weaknesses—and their strengths. In this way, we can quickly shift into discussing solutions.

And while many executives need the more detailed audit with its prioritized recommendations, keep in mind that a half-dozen quick-fixes implemented now can stop today’s disgruntled employee or frustrated contractor from sabotaging your work.

Two Quick Fixes to Take Today

Ask yourself, What documented proof do we have that our policies are being followed?

For instance, a typical “clear desk” policy requires personnel to clear their desk and office area of confidential information before they leave for the day, locking it in a file cabinet, turning it back over to the document specialist for filing and so on.

When companies state they do this, my reaction is always to be skeptical. How do you know this is actually being followed?

If your people turn sensitive material over to an archivist, that individual should have log files that can be reviewed.

However, what proof do you have that people are clearing their desk and securing their office area?

A simple way to test this is to simply stay late one evening and walk around, from cubicle to cubicle, office to office. How many documents do you see labeled “confidential” or “private” or “trade secret” sitting out? How many documents do you quickly recognize that should be labeled “confidential” or “trade secret” (such as product drawings or formulations) but that aren’t labeled and aren’t put away?

Then, take the next step. Ask your internal auditors (or hire an outside independent auditor) to include this in their regular audit routine. Assuming no other extenuating circumstances, I usually suggest my clients audit this once or twice a year (perhaps more for habitual “offender” departments).

Final Thoughts

I’ve made a free version of my intellectual property and trade secret security checklist available for download. You can use this to quickly assess your strengths and opportunities for improvement.

You can get your free PDF copy here: http://www.ceruleanllc.com/biotechblog

Are you ready?

About the Author

John Avellanet is a former Fortune 50 subsidiary C-level medical device and biotechnology executive where he created, developed and ran his firm’s Records Management and IT departments, and was directly accountable for trade secret protection. In 2006, he founded his independent consulting firm, Cerulean Associates LLC (www.ceruleanllc.com) and has since become one of the leading experts on trade secret and corporate espionage protection for biotech, pharmaceutical and device companies.

Homewood Campus
Friday, Oct. 17th 2008 5:30-7:30pm
Remsen Hall Rm 101
3400 North Charles Street

East Baltimore Campus
Wednesday, Oct. 22nd 2008 5:30-7:30pm
Wood Basic Science Auditorium
725 Wolfe Street

Signed copies of my books will also be available for sale. For more details, contact connect@hopkinsbiotechnetwork.org.

• Marketing
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• R&D management
• Communications
• etc.

If you are interested in leading one of these projects and editing a topical compilation, please visit the Logos Press Submission Guidelines and tell me about your vision.

Drug Patent Expirations in October2008

*Drugs may be covered by multiple patents

Courtesy of DrugPatentWatch.com

In my opinion complex regulatory schemes are not areas in which the United States can effectively lead. Why not? Because the size of the market makes tracking problems difficult, and implementing regulatory change can be very slow.

As I’ve described before, regulating generic biologics is no easy feat. A good regulatory scheme must address safety issues while enabling productive competition. Failure to accomplish either objective could potentially set the field back by years (consider the field of gene therapy which, despite some early signs of progress, is haunted by the deaths of study subjects).

The United States is the world’s largest pharmaceutical market, and accomplishing regulatory change can be slow. It is not an effective place to experiment with or refine generic biologic approval schemes. That is best left to smaller and more agile countries. Smaller countries often seek opportunities to serve as testbeds for emerging opportunities like alternative fuels, patient tracking, personalized medicine, etc. and will likely be the first places where comprehensive generic biologic regulations emerge (likely supported by consultants and regulators from the U.S. and EU).

The challenge to driving this innovation in smaller countries, however, is that they often lack the very resources necessary to test policy or technology innovations. This is where large nations, the EU, or agencies and organizations such as the WHO, ADB, IMF, etc could be directing their resources to simultaneously help development in smaller nations while supporting innovations offering global benefits, ultimately serving their own interests

Tell me about HUYA and what makes the company unique?
HUYA Bioscience International has pioneered the most innovative and productive approach for pharmaceutical co-development between the U.S. and China. We were one of the first companies to recognize the potential of China as a source for novel preclinical and clinical stage compounds. Through our partnerships with Chinese companies and institutes, HUYA can use preclinical and clinical stage data generated in China to guide drug development process in the West. Even though clinical trials must still be completed in the West, the process is streamlined, and risks are minimized because HUYA’s Western pharmaceutical partners will have access to critical data from China. Simultaneously, HUYA provides significant development assistance to our Chinese partners. As a result, I anticipate that HUYA will source compounds in China that may become important drugs globally.

What led you to target China as a source for compounds?
There is an urgent need in the global pharmaceutical industry for fresh new sources of novel compounds. As a licensing consultant for pharmaceutical and biotech companies, I was seeking to find novel preclinical and early clinical-stage compounds in Europe and Asia. Many of us were looking in the same places and the pools of novel compounds were depleted. I subsequently spent time in China meeting with heads of government research institutions, biotechnology parks, incubators and pharmaceutical companies. In China, I recognized that there were untapped and significant opportunities for drug discovery and development. To leverage these opportunities, I formed HUYA Bioscience International. HUYA’s business model, the Integrated Co-Development model (ICM), is designed to reduce the risk and cost of drug development in the U.S. by providing a framework for sourcing, licensing and developing validated, preclinical and clinical stage compounds from China. We currently have two compounds licensed from China that are in preclinical development in the U.S., thus validating our model.

What are the unique challenges/opportunities to developing compounds sourced from China?
One challenge, of course, is the language difference. We must have bilingual staff in both the US and China so that we are confident that our due diligence is performed with the utmost attention to detail. Another challenge is that I must spend a significant amount of time in China. This is crucial for developing trust, forging partnership agreements and licensing compounds. HUYA has the “first mover” advantage in China, having been there now for four years and developing critical personal relationships with the heads of the Chinese research institutions and pharmaceutical companies. The Chinese seem to prefer to do business with people they trust and with whom they have long-standing relationships. No other company has the breadth and depth of relationships that HUYA has developed in the Chinese research community.

Because of these relationships, we are able to take advantage of the enormous opportunities presented by China’s large community of world-class scientists, many of whom were educated in the U.S. and have returned to China to develop their careers. We are also able to draw from the well-established scientific infrastructure in China of research institutes, bioparks, and pharmaceutical companies that provides one of the world’s richest sources for novel compounds.

We have a truly unique opportunity to lower the risks and costs of Western drug development by providing access to data from the Chinese development process. Of course, all of the compounds that are developed in the U.S. will have to go through the same rigorous FDA process that they would have gone through had they been sourced from the U.S., including animal and human trials. But, this process is streamlined, and the risks are minimized because HUYA’s U.S. pharmaceutical partners will have access to critical data from our Chinese partners. For example, a U.S. pharmaceutical company that takes on one of the new compounds has access to efficacy, toxicology, and dosing data from Chinese clinical trials, so the trial is not started from scratch, but can be designed based on the information gathered through the Chinese trial. In addition, the Chinese clinical trial data can be used as supporting data to the FDA process here in the U.S.

For each promising new compound in development, HUYA assembles a world-class team of clinical advisors to direct the clinical trials and ensure that they meet U.S. FDA standards. In addition, because HUYA’s model is to co-develop compounds with our Chinese partners, we can help our Chinese partners design trials in China that will inform our trials in the U.S.

About Mireille Gingras, PhD, CEO and President of HUYA Bioscience International
Mireille is a seasoned entrepreneur, scientist and consultant with wide ranging experience in drug discovery, licensing programs (both in- and out-license), preclinical research design and academic partnering programs for top pharmaceutical and biotechnology companies including Organon, Cypress Bioscience, Phenomix, and GeminX. She has made major contributions to the study of complex addictive diseases, and has led research and drug development efforts in the areas of neuroactive steroids, and neurological and neurodegenerative diseases. Through her extensive work in China with HUYA, Mireille has developed unrivaled expertise in partnering with Chinese research institutions and pharmaceutical companies and building bridges into the Western development process.

About HUYA Bioscience International
The global pharmaceutical industry faces an urgent need for fresh new sources of novel compounds. HUYA Bioscience International, LLC, was one of the first companies to recognize China’s potential to help meet this need through its burgeoning biotechnology industry and world class talent pool. HUYA pioneered an innovative co-development model through which it identifies and licenses the most promising preclinical and clinical stage compounds in China, partners with Chinese research institutions to leverage and extend their research efforts, and provides a bridge into the U.S. development process and the Western biopharma market. Because the compounds have already been validated through a rigorous discovery, selection and development process in China, this model streamlines and accelerates product development in the West, while lowering risk. HUYA is now 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 joint headquarters in San Diego, California, and Shanghai, China.

Drug Patent Expirations in September 2008

*Drugs may be covered by multiple patents

Courtesy of DrugPatentWatch.com