Past list view

Please note: This is the makeup meeting for the Second Life meeting that was cancelled on May 28th. I am looking for presenters for the end of June/beginning of July if you know of anyone who might be interested. Thanks!

Many thanks to Carl Rios for his presenation at our last meetup!

Back in October of last year, I gave a presentation on Second Life and how real-world organizations were using it to allow doctors to get a better understanding of people suffering from mental disorders such as schizophrenia. In December, we met the organizer for an online medical center, (SL: Dr. Ann Buchanon), who was using Second life as a tool for collaboration with doctors and medical students from around the world.

Our next meetup will bring us back to the virtual world of Second Life. This time, we meet with Simon Bignell (SL: Milton Broome), whose extensive work explores the question of whether Second Life can be used as a treatment for people suffering from Autism spectrum disorder and Asperger syndrome, a high-functioning form of Autism. (to see more for the research I've done on unique uses of Second life, you can check out the Avelient BioPharm articles here.)

To join us on this unique adventure, you must have a computer capable of installing and running the Second Life client software, which can be found by clicking here. The software itself is free, and basic membership to Second Life is free as well. Follow the installation instructions and take the brief tutorial in order to become familiar with the interface and navigating your avatar throughout the world.

We are planning to run this presentation using Second Life's VOICE features, so please test and make sure you're able to at least hear what's going on around you.

If you need some assistance setting up the software, Linden Labs, the software's creator, has several resources available to help you out. You can certainly send me a question and I'll help you as best I can as well.

Once you are online, request friendship with "Lupino Benazzi," which is the name of my avatar. I will give you further instructions from there. If you already have set yourself up and requested my friendship, please be sure to send me an instant message reminding me who you are in real life!

I hope you are all well, and I look forward to your participation with me in this virtual realm!

All drugs are associated with both substantial benefit and inherent risks; the decision made by physicians and patients to utilize a drug is one that balances these two outcomes. However, with today's frenzied and fear-driven media, often unfriendly to pharmaceutical industry, the public tends to hear more about drug risks rather than benefits. Receiving a lot of press lately is the US Food and Drug Administration's (FDA) strongest advisory to healthcare professional regarding risks associated with drugs: the black-box warning or the "boxed warning". Drugs given recent black-box warnings include GlaxoSmithKline's drug for diabetes, Avandia®, for increased risk for heart-attacks, and for Pfizer's and Merck's drugs for arthritis pain, Celebrex ® and Vioxx ®, for increased risk for stroke and heart attack leading to death.

So what is the black-box warning?

How do pharmaceutical companies respond to black-box warnings and what are the implications?

In this seminar, Carl Rios will address black-box warnings and review the information contained in the PI as well as focus black-box warning risk management strategies pharmaceutical companies can employ by examining the specific case of a more recent black-box warning for a multi-billion dollar a year blockbuster that has positively changed the lives of many patients.

At the end of this seminar you will be able to:

1. Describe what a black-box warning is and consider what the contents can mean to patients, prescribers and pharmaceutical company stake holders.

2. Consider the concept of balancing benefits and risks for patients who receive with a drug with a black-box warning.

3. Design a risk management plan in response to a black-box warning to include education, marketing, drug safety, pharmaco-vigilance, and research programs.

Carl D. Rios is a Medical Science Liaison in the Scientific Affairs department at Amgen Inc. Carl provides field-based scientific support to three franchises housed in the Nephrology Business Unit, including Epogen ® and Aranesp ® for the treatment of anemia associated with chronic kidney disease and Sensipar ® for the treatment of hyperparathyroidism secondary to kidney disease. He is involved in providing scientific education to key opinion leaders and developing their advocacy, identifying sites for clinical studies of new drugs, identifying opportunities that agree with corporate strategy and objectives, and serving as the scientific eyes and ears of Amgen. Prior to joining Amgen Inc., Carl was a Medical Science Manager at Organon USA Inc (acquired by Schering-Plough) and was predominantly engaged in pre-launch activities for a first-in-class anesthesia drug with a novel mechanism of action.

Prior to joining industry, Carl was an academic scientist using basic science applications to characterize novel receptor signaling mechanisms in the brain that are targeted by drugs that attenuate pain and promote addiction. His studies have been published in peer-reviewed science journals and presented at national and international congresses. Carl's education credentials include a Ph.D. degree in molecular pharmacology from NYU and a B.S. degree in pharmacology from SUNY Stony Brook.

In the wake of rising health care costs, the government has developed a series of regulations and laws designed to encourage pharmaceutical companies to develop ?generic? drugs that offer the same efficacy and safety as the brand-name drugs on the market. For the fraction of the price of a brand name drug, a patient can instead ask his or her doctor for the generic version.

Are these generic medicines as safe and effective as the brand?

Food and Drug law and patent law intersect in a fascinating and often controversial way.
On the one hand, the Food and Drug Administration (FDA) recognizes Americans? needs for cost-efficient and affordable generic medications. On the other, patent laws protect brand-name companies who have spend billions of dollars in research and development.

What are most frequently litigated issues before our courts? What will the future bring? How does this affect us all?

Jennifer Chung will provide a brief overview on the drug approval process for both brand name and generic drugs, and explain how patent law intersect with that approval process. She will also discuss the effects of litigation on the overall cost of medications and how the market is affected by strong generic competition with brand name drugs.

Jennifer Chung's practice focuses on patent and other intellectual property litigation. Ms. Chung has had experience litigating patent infringement actions involving various technologies in federal court, including cases involving the Hatch-Waxman Amendments. Illustrative patent cases include: Par Pharmaceutical Resources Inc. et al. v. Roxane Laboratories, Inc. (D.N.J.), Morton Grove Pharmaceuticals v. Par Pharmaceutical Resources Inc. et al. (NDIL); Galderma v. Actavis (NDTX); Nelson Seating Pty Ltd v. Selle Royal S.p.A. et al. (SDNY); and Aerotel Ltd et al. v. Primus Communications et al (SDNY). Representative examples of non-pharmaceutical technologies on which Ms. Chung has worked include bicycle seats, hair
pieces and telephone system technologies.

Prior to joining AV&H, Ms. Chung litigated patent cases in the New York office of Frommer, Lawrence & Haug LLP.

In September of 2001, Ms. Chung joined the Manhattan District Attorney's Office as an Assistant District Attorney in the Appeals Bureau where she defeated many attempts by criminal defendants to reverse their convictions.

Many thanks to Justin Downs for his presenation at our last meetup!

Based on my last presentation in October, you're probably all familiar with the online world Second Life, and some of you may have even tried it out. For those of you that haven't, here's your motivation to give it a shot!

Our next meetup will be within the virtual world of Second Life. We'll be meeting up with Dr. Ann Buchanan, the founder of the Ann Myers Medical Center. Some of you may have read the conversation I had with Dr. Ann and her co-director, CC Carnell, a couple of weeks ago for the Avelient BioPharm Blog. They are very excited to be hosting this event, so please be sure to join us! Space will be limited (we don't want to overload their server!) so reserve your time now!

The Ann Myers Medical Center was created by Dr. Ann Buchanan in honor of her mother to promote online collaboration of medical professionals without the boundary of long distance. At any time during the day, you may see people at the center who are sitting at their home computer in Spain, Russia, California, or Canada, just to name a few spots. They hope to grow the center into a cutting edge place for learning and medical assistance, and with the help of the Sprott-Shaw College in British Columbia, Canada, they are making that dream a reality.

To join us on this unique adventure, you must have a computer capable of installing and running the Second Life client software, which can be found by clicking here. Follow the installation instructions and take the brief tutorial in order to become familiar with the interface and navigating your avatar throughout the world.

If you need some assistance setting up the software, Linden Labs, the software's creator, has several resources available to help you out. You can certainly send me a question and I'll help you as best I can as well.

Once you are online, request friendship with "Lupino Benazzi," which is the name of my avatar. I will give you further instructions from there.

I hope you are all well, and I look forward to your participation with me in this virtual realm!

UPDATE, 10/16: PLEASE NOTE NEW LOCATION FOR MEETING

Original Location: Galway Hooker
New Location: Seven

Our meeting on Monday, October 22nd has been moved to "Seven" a bar at 350 7th Avenue in New York, in their private room. Please be sure to update your calendar with the new location! Time and date will remain the same. Look forward to seeing you all there!

ORIGINAL MESSAGE FOLLOWS
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As per the original description of this event, PLEASE NOTE NEW DATE AND TIME!

Though it didin't make the kind of splash it was expected to when it first arrived, Virtual Reality is becoming increasingly popular as a scientific tool in the medical and pharmaceutical community. In my presentation on Monday night, October 22nd, we'll explore a little bit more about how prolific this tool is becoming and new ways in which people are using it to accomplish things they can't accomplish in the real world.

The presentation will be an extension of the article I wrote on August 24th, and will further explore some of the virtual reality applications I mentioned such as Mindstorm and the Virtual Hallucinations Lab in second life. If you'd like to read up on the article, you can find it here.

I'll also lead a discussion on other possible applications for virtual reality outside of just "having fun," and whether this kind of tool would have a positive or negative sociological imact on the people who use it regularly.

For those of you looking forward to the demonstration of the Personal Range Finder this month, unfortunately I was unable to coordinate with the presenter in time to make it, so we'll be working on this presentation for November 12th!

Looking forward to seeing you there!