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Friday, June 11, 2010
This may seem a little off-topic for those who don't know me but for those of you who do, you'll know this is a little mix of many of my primary loves - cell therapy/regenerative medicine, communications/public relations, social media, and all things internet/technology.
This is a reprint (with permission) of an article I was invited to write for the 2009 World Stem Cell Report.______________________________________________________________________
Some Do’s and Don’ts and 2.0s for orgs/co’s in cell therapy & ReGEN
You may be one of them. The scientist who can’t get the job or promotion you want. The company not securing customers fast enough. The investigator not finding collaborators. The company not finding quality employees. The company failing to secure much needed investment. The big company not effectively penetrating new, niche markets like cell therapy-regenerative medicine. The executive or investigator not getting the speaking invites to create the buzz needed to help move things forward.
Whatever the challenge, consider a healthy dose of marcom. 
Ok, I’m biased and it certainly isn’t a single panacea for all these problems, but seriously. A good profile (personal or corporate) – built from a solid reputation and strong relationship network – can help address almost any challenge you or your company is facing.
I know. You don’t believe me. Humor me and answer this one question. If you could double the number of people that know about your company or technology, the number of people that learn, hear, or read something about your research, product or service in the average 30–day period, and/or the number of people that interact with one of your employees or colleagues every week, would that – on the whole – likely help or hinder you in addressing at least some of the primary challenges you are currently facing?
See where I’m going with this? Even if your challenges are deeply scientific or technical, is it possible to imagine that if only you knew the right person …?
Your existence depends on human interaction. Your success depends on how well you interact and the impressions you make. The impressions are not solely or even primarily driven by the brilliance of your technology or the compelling weight of your data. This is likely more true than you may think. For those of you who have read Malcolm Gladwell’s book, Blink, you will appreciate just how much people’s perceptions are influenced not by logic, data, or comprehensive consideration but by the judgments of the subconscious in a matter of seconds.
The PR (public relations) I discuss in the following pages is not spin and it’s not advertising. It’s about establishing and maintaining relationships that result in profile among your various kinds of constituents be they your collaborators, peers, investors, employers, employees, customers, or potential strategic partners.
Successful people and companies use effective PR to create relationships, turn them into interactive networks, and then leverage them to help solve the challenges they face.
This has always been true. What are so radically changing today are the tools which people and companies can now employ to conduct effective PR, create relationships, and build networks all at a fraction of the cost, with greater returns, and performed by individuals or small companies not previously capable of affecting global impact. These tools are, of course, online.
A successful strategy for PR is now increasingly determined by how well online tools are employed to engage in conversation, create relationships, and build profile.
As it turns out, there are, in my opinion, too few people in this industry who, as yet, understand the power of PR and fewer still who understand the potential of web2.0 to change their fate.
What I will share with you in the next couple pages is:
1. why if you’re breathing, you’re in PR - if you can’t avoid it (and I don’t recommend you try), you should learn to embrace it;
2. the cost of dodging the embrace; and
3. how you can embrace it.
POINT #1: YOU’RE IN PR. REALLY.
There are a zillion reasons why you underestimate the importance of PR in your career or to your company. There are a zillion other reasons why you think online social media is irrelevant to what you do. Let’s look at five.
1. My company is a research-based, early-stage company conserving burn-rate, with few employees, and nothing to sell. Ergo we don’t have a need for PR stuff like marketing, communications, or profile building.
There is nothing new but certainly nothing outdated in the adage: Everyone is selling something.
Don’t pretend you have no one to impress, you have nothing to sell, or that content is the only thing that impresses in the science business. If you thing you have nothing to market, you just haven’t figured out what it is yet.
Are you looking to recruit quality people? Do you anticipate needing to find and impress new investors sometime this year or next? Would you be interested in engaging in discussions from parties potentially interested in licensing or acquiring some of your IP? Are you looking to impress potential academic or corporate collaborators? Do or will you need to recruit patients for a clinical trial? Do you need to start educating doctors about the potential of your therapeutic or engage them in giving advice about your trial or product? Would you benefit from increased government funding for cell therapy and regenerative medicine? Do you believe there are policy changes that could be made that would benefit this industry?
A better profile and a wider network of contacts can’t help but help you address these needs. If you have anyone to impress (and everyone does), then you need to be talking with them. Will a bigger and better profile hurt your efforts to find good employees, seduce investors, recruit patients, identify collaborators, secure partners, etc? It’s hard to imagine how.
At the very minimum, as a member of the life sciences industry you have an obligation to get out of your lab and communicate to the world around you about the science you are so passionate about. As President Obama encouraged in his address to the April 27, 2009 National Academy of Sciences , we all have a duty to do a better job of engaging the people around us in a discussion about the importance of science and the science we’re doing.
2. My company is a big, public, multi-national company with departments that handle marketing, communications, PR, and advertising. Ergo I don’t need to pay attention to these things because they do that.
Firstly, unless you have tenure, chances are between now and retirement you may want/need/be recruited for another job. A strong, personal “brand” (profile) is certainly a huge asset in terms of ensuring you are successful in finding that job and negotiating the right remuneration.
Secondly, if you are ever let out of the lab/office or given internet access, you have the capacity to (and likely already) influence your company’s profile and brand. You are either complementing or distracting from your company’s primary messages and brand.
Thirdly, if you care about your company’s success, don’t assume your company’s department or external marcom firm is doing what needs to be done. Investor relations, marketing and communications firms or departments may be good at investor relations, marketing, and communications but that doesn’t necessarily mean they are good at the kind of profile building that is going to attract and support meaningful business development opportunities or potential investigators, customers, licensees, collaborators, employees, or clinical trial patients.
Finally, too many big companies haven’t yet figured out how or how to successfully use Social Media. If you’re using Social Media (e.g., Facebook, Twitter, FriendFeed, Digg, etc), you might be able to play a leadership role in being the face of your company on these platforms – just don’t do it without permission!
3. My company is a science-based company with a technical sale to scientists who are not receptive to glitzy marketing, advertising, PR, and-the-like. Ergo there is little ROI on spending money on these kinds of things. We don’t “do” marketing.
You may be in a company that believes putting out press releases is an unnecessary distraction from the business of science; or the company that believes that communications is something done only big companies, public companies, stock hustlers, or companies with something to sell.
Wrong. First you’re working on the assumption that all marketing looks like a drug ad.
Second your target audience is human. Humans are susceptible to having their perceptions influenced via all the usual means. Even if you don’t want to look at it so crassly, you would have to agree they are susceptible to forming more positive impressions of your company or product if information about it is available, packaged nicely, and easily accessible. You would also have to agree that any impression or sale is easier to make when there is a personal relationship/contact.
Your network is one of your most valuable assets to you and to your company. Building a global network and industry profile is marketing under what ever name you want to call it.
4. All this web 2.0 and social media stuff is for tech geeks and kids. They are not my target market and don’t have a critical mass of the kinds of people I need to building profile among.
Let’s assume for a moment, this is true. If you’re looking to be an attractive employer to potential, young employees you may want to reconsider.
Secondly, young people grow up and become industry leaders and executives. Is it too early to start shaping their perceptions?
Thirdly, there is the occasional executive that is actually occasionally influenced by input from their younger employees. I know – it’s crazy!
Furthermore, it’s not true. For example, I have a very high percentage of c-level executives on my LinkedIn Cell Therapy Industry Group, Jim Till who proved the existence of the stem cell in his ground-breaking nature paper in 1963, is an active poster on Twitter, and the average age of social media users is much older than you believe - check your data.
5. Twitter-schmitter. Today’s social media sites are tomorrow’s relics. They’re all hype when they launch and then they fall out of favor and are no longer useful. I’m a serious business professional with no time or need for these gimmicks that have no real business applications or executives like me on them.
If you think LinkedIn, Twitter, or Facebook (my three favorite and most used social media sites) are not going to be around and successful for long enough to have a real impact on your business, you’re definitely one to bet against the odds.
If you think serious business is not being done and useful business connections being made on these sites (see the last paragraph in the point above), you’re dead wrong. I’ve found customers, employees, and collaborators for my customers using social media in addition to getting them speaking engagements and highlighted in publications.
The point? Everyone has some kind of PR (marketing, communications, profile building, networking, advertising, community participation, publishing, speaking, etc) to do. Your potential audience, network, and impact are all much bigger than likely believe to be true.
My guess? You have more than likely significantly underestimated the value of engaging in PR. And, you have likely significantly overestimated the time and financial cost of engaging in PR.
That brings me to Point #2.
POINT #2: THERE IS A REAL COST TO YOU AND YOUR COMPANY IN PRETENDING YOU DON’T DO OR NEED TO DO PR.
All I should really have to do here is refer you back to point #1. The benefits of engaging in PR are the costs for not. Nevertheless, I will briefly expound.
Your next job, employee, collaboration, investor, customer, patient, etc will be influenced by the profile of you and/or your company. While your CV – comprised of its peer-reviewed publications, presentations, and collegial references – is still an important driver in people’s perceptions in our industry what often makes someone or some company stand out among the others (perhaps even imperceptibly) is the overall profile one has created. One’s profile is increasingly judged online.
That brings me to revise Point #2 to the following:
There is a real cost to you and your company in pretending you can/should ignore the PR power of web2.0’s social media.
I’m going to steal now from my October 2008 blog posting on the subject. 
Only a few minutes ago (relatively speaking in the passage of time) most companies didn't think they needed to have a website or a domain name strategy. This seems as foolish now as ignoring social medial will seem in a few minutes from now.
In 1995 - a mere 14 years ago - I was a young associate in a downtown law firm making a pitch to a skeptical management committee at a weekend retreat that the firm needed a website and an email "system". It was not an easy sell. They "knew" lawyers would never send their own emails and certainly not use it to communicate with clients. Similarly they were convinced a website would likely not bring in any new clients and existing clients would not likely find a website useful.
How quickly they were proven wrong.
We are at a similar technological threshold. Most companies are ignoring the importance of "social media" to their corporate strategy. Most consider using social media an unnecessary "luxury" in exactly the same way websites, domain names, and email were considered by people in their positions only a few years ago. They do not understand how social media is already changing the way they do business, the importance of staking position/profile early, nor the pain they will feel in the very near future for having failed to be proactive in building and leveraging online communities.
This is very understandable. In times of fiscal constraint one tends to focus on that which hurt you yesterday or causes you the most pain today. Nonetheless, the companies that will succeed tomorrow are looking at tomorrow now and preparing for it. Tomorrow's mainstream business activities involve social media as much as today's involves website and email.
For those thinking that this will be true only for businesses that deal direct with the retail consumer, they’re dead wrong. If you have a constituency that you need to keep informed about and actively engaged in your company, then this applies to you. Whether its business (B2B) customers, investors, media, patients, recruits, employees, or collaborators, they are online and engaging in social media. If you're not there, they're listening to and engaging with someone else.
LinkedIn now has 42 million members with 1,945,047 members who identify themselves in biotech, pharma, or healthcare. Some 300,000+ of them are in biotechnology. There are 293 biotechnology groups in LinkedIn and 375 biotechnology groups on Facebook. The LinkedIn cell therapy industry group has 400+ members engaging in active discussions and exchanges of information in the public forum and using the platform to make and strengthen connections offline.
Bottom line? There are so many different kinds of social media out there that can be used to reach so many different kinds of audiences at a fraction of the cost of traditional media that it's just good business to figure out how to use it to your advantage. In fact, you may be feeling the pain of ignoring it already and just don't know it...
Which brings me to point #3.
POINT #3: WEB 2.0 HAS PUT THE ABILITY TO DO EFFECTIVE, LOW-COST PR IN YOUR HANDS. THERE ARE NO MORE GATEKEEPERS.
The internet has blown the sense of community up and redefined it. Gone are the days when it was feared the web would destroy “community”. Instead web 2.0 is all about creating more and larger communities than we ever thought possible eliminating all kinds of barriers and cutting across all kinds of definitions.
It used to be (before web 2.0) that corporate profile, marketing, communications, PR, advertising was all quite carefully controlled by managing the one-way push of information to the open receptacles we called “readers” or “audience”. If you wanted a global profile, you needed a global PR firm.
Just like the internet has taken the magic out of the business of travel agents, web 2.0 has forever changed the grip that marketing, communications and PR firms had on the business of managing global corporate profiles. Similarly, a global profile is no longer only the purview of companies sufficiently large to retain the services of such firms or have big, internal PR departments.
Just as the information on how to build long-range missiles is no longer the exclusive domain of rocket scientists, with the empowering tools of web 2.0, successful marcom can now be effectively done by subject-matter experts who are not big-budget marcom professionals.
It’s why newspaper are dying and bloggers are thriving. It’s why small companies are building niche profiles that beat out their Fortune 500 competitors. It’s why startups can have a global profile in weeks on next-to-no budget.
All of that is a rather lengthy introduction to primary point of this article:
In this new world of interconnectedness and easy-to-access information, it is easier than ever for everyone and anyone to influence the profile of a company and what it is offering to the world. That’s the good news. The bad news is that you are expected to. All of which leads to one not-so-original observation of the impact of web 2.0 on companies.
If you’re breathing with an internet connection, you can and should have significant and immediate impact on the awareness and perceptions of your company among people around the globe.
If you’re not creating global awareness and positive perceptions, it may be assumed you’re terminally short of breath.
Like it or not. You can’t help it and you certainly can’t avoid it. And the people forming these perceptions are not just the potential customers of companies with something to sell – they’re current or potential investors, partners, collaborators, patients, purchasers, journalists, regulators, policy-makers, employees, employers, etc.
LIGHTS, CAMERA, ACTION
So what can you do to begin leveraging the power of the PR tools at your fingertips and turn a bungalow profile into a chateau; a respectable list of contacts into a vibrant, enviable network of relationships?
10 Ways to a Better Profile for RegenMed and Cell Therapy Organizations
I’ll start with some rules that apply regardless of the PR platform you’re employing (e.g., traditional ones like conference presentations or journal publications or web2.0 ones like blogging or social networking).
1. You need to have a communications strategy and then mandate and empower your people to communicate your message/story to your audiences.
This doesn’t have to be complicated. It’s about defining your primary/secondary audiences, messages, keywords, and tactics to accomplish your primary/secondary goals.
2. Talk about what you’ve done not about what you’re going to do.
It is very rare that news about what you are going to do is really newsworthy. Don’t be tempted to put out a press release that’s not news just because you haven’t put one out in awhile. For example, a press release that your executive is going to speak at a conference is not news unless they are presenting new data or they are the keynote at the biggest conference of the year. That doesn’t mean you can’t post it on your website or let your network know in other ways but the press release should be used judiciously.
3. Make sure you tell the market story not just the science story. Similarly, be clear about what problem your technology solves not just how brilliant it is.
4. Be upfront about the limitations of your product/service. Don’t try to pretend you have the perfect product/service. Don’t try to be everything to everyone – defining who you are (your company and its product/service profile) is just as much what about what it is than what it is not.
5. Avoid the temptation to promise when you will do something by (e.g., begin or end your trial, submit your IND, launch your product, etc) unless it’s the subject of a contractual obligation. There are too many unknowns that may prevent you from meeting the expectation you created. The ensuing disappointment will hurt your profile and perceptions of your company and its product/service and management.
6. Don’t over communicate your regulatory interactions with the FDA – this is one area where the less said is often better.
7. Wait on that hiring announcements just a little while. It’s critically damaging to put out a press release that now has a very, long online life outside of your control announcing the hire of a key executive only to have him/her not last beyond the first few weeks.
8. Understand that communications, marketing and profile building are very different from advertising. Act accordingly.
9. Value the untapped potential of your existing customers and prospects to spread your gospel.
One of the real discoveries from social media is the alarming willingness of people to zealously proselytize on behalf of companies and products win which they believe. Find ways to actively engage them in doing so. 
10. Engage online.
The 8-step Plan to Enhance your Online Profile and Network
If you’ve decided your profile matters, then your online profile really matters. The fastest way to an impressive online profile is Search Engine Optimization. There are a lot of tricks up the SEO tricksters sleeve and I’m not about to give them all away but suffice it to say that SEO is a multi-pronged attack and there are many arrows in the quiver each with a different use to the same end: higher rankings on the major search engines = increased traffic to the website = greater profile = whatever your end goal is (sales, investors, collaborations, changing the world, etc).
2. Listen & Monitor.
Whether you employ Google Alerts, Twitter search tools, or simple subscriptions to topical news services or blogs, there is a lot of content and discussions being added to the internet every day. You will likely be amazed how much (or how shockingly little) your company and product/service is being discussed and who is behind the discussions. Listening to and reading what’s going on the internet will get you intel about your competitors, new ideas for potential products or studies, new leads for potential collaborators or customers, etc.
Find your favorite content providers, writers, resources, publications, etc and follow or subscribe to the content their pushing out and discussions they are leading.
There’s no harm in joining. People join for all different reasons. There’s no problem in being an observer. In fact it’s likely best you just observe for a while after you join to assess the flavor of the group and discussion so when you do participate you don’t offend.
Once you’re comfortable, start to participate. Engage in discussion, exchange information, and above all make sure you are providing value to the other participants not just talking about yourself. This will be punished.
6. Connect (yourself and others)
There’s a reason why these are called online networks or communities. Use them to connect with people not just for the sake of building a bigger ‘friends’ list but because you have something in common and want to begin building a relationship.
Be original. Create something of value you can share. That might just be facilitating a channel in which 3rd party information is exchanged. It might be you writing original content. It might be facilitating introductions.
8. Enjoy and don’t offend.
Most importantly find the online networks that you enjoy, that give something of value to you, then contribute value in return and ensure you don’t offend the rules. Nothing slaps harder than an online, viral slap from a community you’ve offended online. 
Don’t pretend you have no one to impress. Everyone needs to engage in PR.
Even in the business of science, man cannot live on data alone. You need more than just solid content to affect the kind of impressions that will be critical to your success. Don’t let your data or career speak for itself – it can’t talk.
Web 2.0 has made it exponentially easier – if not expected - to engage in PR and profile building.
What’s missing from this article is the web 2.0 tools I’d recommend you use to put the 8-step plan in place. For that, watch here for further blog postings on the subject. See what I did there?
 In this article, I use “PR” not to mean “public relations” as you may have come to understand it used but rather simply to mean any kind of relating to the public via marketing, communications, writing, profile building, networking, advertising, community participation, publishing, speaking, proselytizing, lobbying, etc. It’s a not-so-dirty little secret that we all do it in one form or another or several all at once.
 See http://www.youtube.com/watch?v=k5-MgZD5IMc at around the 30 minute mark.
 Oh, I haven’t mentioned my blog? It’s at http://www.celltherapyblog.com/. Of course if you are a subscriber, this will be a refresher. For those who haven’t read this on my blog, you would have benefited from reading these same thoughts back in October 2008 if you had been a blog subscriber, or if you followed me on Twitter (I’m @celltherapy) or if you were connected with me on LinkedIn (http://www.linkedin.com/in/celltherapy). I’m just saying…
 Just ask Johnson & Johnson about the power of mommy bloggers. Look it up.
Friday, May 21, 2010
Biotech tax credit appears perfectly designed for cell therapy companies to recoup research dollars spent in 2009-10
Lyman points out a few important details about the application schedule including:
1. The Formal IRS applications (Form 8942) will not be available until June 21st or thereabouts.By way of a little more background, the following is excerpted from a March Forbes.com article by Dean Zerbe:
2. The application period opens on June 21 and ends on July 21. The postmark on the application is deemed to be the date of delivery. Preliminary review of the applications is to be completed by Sept. 30; this is to ensure that applicants are eligible taxpayers and that their applications are complete. Applicants will receive determinations as to whether or not they qualify for credits and/or grants, and how much they will receive, by Oct. 29.
What does the credit cover?The Cell Therapy Group will be collecting more information about the tax credit and service providers who might be recommended to assist in the application if needed. Contact CTG for more details or watch here for more information.
The credit/grant covers research in tax years beginning in 2009 and 2010. The taxpayer is provided a 50% credit/grant for qualified investments in "qualifying therapeutic discovery projects." What expenses count as qualified investments? The aggregate amount of costs paid or incurred in the taxable year for expenses necessary for and directly related to the conduct of a qualifying discovery project. What doesn't count? The pay of employees covered by 162(m)(3) of the tax code--think CEOs--doesn't count. Other excluded items: interest expenses; facility maintenance expenses (e.g. mortgage or rent payments, insurance, utility and maintenance and costs of employment of maintenance personnel); and certain indirect costs (basically general and administrative costs) as defined in the Treasury Regulations at 1.263A-1(e)(4).
What is a qualifying therapeutic discovery project?
According to the legislation, it's a project designed to do one of three things:
--Treat or prevent diseases or conditions by conducting pre-clinical activities, clinical trials and clinical studies, or carrying out research protocols for the purpose of securing federal government approval by the FDA.
--Diagnose diseases or conditions or to determine molecular factors related to diseases or conditions by developing molecular diagnostics to guide therapeutic decisions.
--Develop a product, process or technology to further the delivery or administration of therapeutics.
Finally, to qualify, a venture may not have more than 250 employees in all businesses of the taxpayer--meaning a small biotech project at a big company wouldn't qualify.
Which biotech companies might benefit?
Those that are investing significant resources in pre-clinical or clinical studies, which may take years to come to fruition to ultimately satisfy FDA requirements, could now recoup a significant portion of their expenses. Additionally, biotech start-ups focusing on the development of diagnostic assays or applications to advance therapeutics and treatments can also benefit. Finally, companies currently engaged in basic or applied research which may ultimately contribute to curing caner within the next 30 years may also be excellent candidates. Along these lines, companies studying signal transduction pathways, gene therapy and stem cell research seem like prime candidates.
Wednesday, May 5, 2010
No suggestion here that GOOG is being altruistic, just that this is the way the new entrepreneur and investor class thinks. Opportunity and money are to be found in technologies that improve the way we live, work, play, eat, and think... and perhaps even improve the world.
To Google Ventures this has already meant wind farms, carbon emission reduction systems, green vehicles, and medical cures. To former Microsoft chief scientist Nathan Myhrvold and his high-level think tank, Intellectual Ventures, this means creating TerraPower - a company intending to revolutionize the nuclear power by developing reactors run on waste uranium - and also actively looking at regenerative medicine technologies.
Having formed the fund a little over a year ago, Google is only now starting to make a splash with the fund. Officially the fund has no specific industry focus saying on the Google Ventures website FAQ:
We are interested in a wide range of industries, including (but not limited to) consumer Internet, software, hardware, clean-tech, biotech, health care and others. First and foremost, we're looking for entrepreneurs who are tackling problems in creative and innovative ways, with the potential for significant financial return.Unofficially and yet not so quietly, Google has named a few broad areas of interest. An article in Monday's New York Times quoted Google Ventures' managing partner, Bill Maris as saying that while they were not going to name particular investment themes, a few broad ares of interest include:
regenerative medicine, bioinformatics, cloud storage, companies that use large data sets, online monetization and mobile.There it is. Regenerative medicine right there front and center.
In typical Google tradition, Maris, who looks all of 30 years old on the website, has a successfull and multidisciplinary track record. He was involved in founding Web hosting pioneer Burlee.com (now part of Web.com), where he built much of the key computing, network and technological infrastructure.Prior to that, Bill was a biotechnology and healthcare portfolio manager for Stockholm, Sweden-based Investor AB. Bill’s background also includes research at the Duke University Medical Center, Department of Neurobiology.
Google Ventures is said to be aiming at investing about $100 million a year. Any portion of that for regenerative medicine is more than welcome.
While traditional VC money remains reticent to back RM in any signifant way, Google's move confirms a trend we've been seeing and talking about at the Cell Therapy Group for the past 12 months or so. The multinational lifescience, biopharmaceutical, and healthcare companies along with strategic investors all now have regenerative medicine on their radar. They are all quietly and not-so quietly developing internal and external regenerative medicine strategies.
Please join us in welcoming regenerative medicine to the radar screen. It's bound to be an exciting ride ahead.
Thursday, April 29, 2010
FDA NEWS RELEASE
For Immediate Release: April 29, 2010
FDA Approves a Cellular Immunotherapy for Men with Advanced Prostate Cancer
The U.S. Food and Drug Administration today approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease.
Provenge is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment.
Prostate cancer is the second most common type of cancer among men in the United States, behind skin cancer, and usually occurs in older men. In 2009, an estimated 192,000 new cases of prostate cancer were diagnosed and about 27,000 men died from the disease, according to the National Cancer Institute.
“The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.
Provenge is an autologous cellular immunotherapy, designed to stimulate a patient’s own immune system to respond against the cancer. Each dose of Provenge is manufactured by obtaining a patient’s immune cells from the blood, using a machine in a process known as leukapheresis. To enhance their response against the cancer, the immune cells are then exposed to a protein that is found in most prostate cancers, linked to an immune stimulating substance. After this process, the patient’s own cells are returned to the patient to treat the prostate cancer. Provenge is administered intravenously in a three-dose schedule given at about two-week intervals.
The effectiveness of Provenge was studied in 512 patients with metastatic hormone treatment refractory prostate cancer in a randomized, double-blind, placebo-controlled, multicenter trial, which showed an increase in overall survival of 4.1 months. The median survival for patients receiving Provenge treatments was 25.8 months, as compared to 21.7 months for those who did not receive the treatment.
Almost all of the patients who received Provenge had some type of adverse reaction. Common adverse reactions reported included chills, fatigue, fever, back pain, nausea, joint ache and headache. The majority of adverse reactions were mild or moderate in severity. Serious adverse reactions, reported in approximately one quarter of the patients receiving Provenge, included some acute infusion reactions and stroke. Cerebrovascular events, including hemorrhagic and ischemic strokes, were observed in 3.5 percent of patients in the Provenge group compared with 2.6 percent of patients in the control group.
Provenge is manufactured by Seattle-based Dendreon Corp.
Tuesday, April 27, 2010
- believe in the power of interactive, online network-based activism,
- support the potential of stem cells to change people's lives, and
- wanna have a little fun raising awareness for our otherwise-sometimes-stodgy-science!
Tuesday, March 23, 2010
My previous reference to the letter as a "warning letter" was a colloquial rather than legal use of the term. In any event, to avoid possible confusion, I hereby formally point out that the letter was not a "Warning Letter".
Despite the FDA's observations of what it then said appeared to them as Regenexx "violations" of FDA regulation in that Untitled Letter, since the date of the letter the FDA has not followed up with any Warning Letter, Cease and Desist Letter, or sought any other relief in court either in an action of its own or in the action brought against the FDA by Regenerative Sciences, Inc.
This fact has emboldened many to believe that the FDA will not take any action to remove Regenexx from the market despite its observations in 2008 that Regenexx appeared to violate the existing FDA regulatory framework.
Some take this one step further and believe that by its lack of action the FDA has demonstrated it now believes the product does not, in fact, violate the regulations. Others are convinced the FDA's lack of action is merely a lack of action and not a change of conviction. In the face of a lawsuit by RSI, after all, the FDA has to pick its battles carefully.
Only time will tell...