Gene Therapy Clinical Trials Hit The Big Time

Anyone reading  medical research headlines in recent years has become aware of how charged the topic of gene therapy is. Recent clinical results treating certain types of blindness and adrenoleukodystrophy may leave people re-examining some of their thoughts and positions.

Leber’s congenital amaurosis is an inherited eye disease that appears shortly after birth. It’s caused by a recessive gene called RPE65 that controls production of an enzyme that recycles retinol. The result is sluggish pupil response with blindness or severe vision loss which until recently, doctors have been unable to treat. Doctors at both Children’s Hospital of Philadelphia and London’s Moorfield Eye Hospital have had substantial success treating this disease with gene therapy. The physicians surgically deliver modified adeno-associated virus (AAV) prepared by a Seattle company called Targeted Genetics behind the retina. AAV can affect both dividing and non-dividing cells with in the body and begins recoding the DNA for proper formation of the enzyme. One of the keys seems to be treating it at a young age, but the results of these trials particularly in the Philadelphia study are astonishing, and appear to be free of side effects according to Moorfield’s article in April 2008 New England Journal of Medicine article. Pretty astonishing.

The astonishing advancements don’t just stop there. Adrenoleukodystrophy, the subject of the 1992 film Lorenzo’s Oil, is another inherited disease. Instead of blindness adrenoleukodystrophy leads to progressive brain damage and death. Sufferers of adrenoleukodystrophy fail to transport a necessary enzyme for breaking down very-long chain fatty acids to where it’s needed. The eventual build up leads to damage of the adrenal glands and an inability of the body to myelinate nerves, leaving them unable to conduct impulses. The November 2009 publication of Science magazine has published the results of a French study in which two children with adrenoleukodystrophy have been successfully treated using gene therapy.

While both of these studies are in clinical trials and not yet available to the public they do offer hope of exciting advances in the near future. Additional studies not yet in clinical trials such as the University of Washington’s success in producing color vision in squirrel monkeys or the successful growth of bigger, stronger muscles in monkeys at Nationwide Children’s Hospital in  Columbus will undoubtedly lead research relating to color blindness of muscular dystrophy. Either way, the results of gene therapy are beginning to bear some of the fruits long talked about in the years of debates.

Moorfield Eye Hospital Information

Children’s Hospital of Philadelphia

Adrenoleukodystrophy Article

University of Washing Color Blindness Treatment

Deepen your client relationships with sendoutcards.com

I’m old, not really, but I feel that way some days. I’m old enough to remember when the first web browser came out my junior year of college. It took until graduation for the dial-up connect to download that first web page I attempted to open the year before. I also remember that first round of Fortune 500 sales training when they introduced ACT and computer based contact management systems. I know many a sales rep who turned to heavy drinking after unsuccessfully attempting to get ACT to do what they wanted. Fortunately times have changed and so have automated options for keeping in touch with your clients

If you’re not familiar with contact management systems and the effect they can have on your numbers you’re selling yourself short. They are a major tool in deepening client relationships, generating referral business, and staying at the forefront of your clients’ minds. While they should never replace networking or actual sales calls, they are an effective and powerful tool in your arsenal. I use a couple of different things in conjunction with each other but one of my favorites in Send Out Cards.

Send Out Cards is an online service that allows you to  design and send regular or custom cards. Specific campaigns can be set up for groups, individuals, or your entire client list. Let’s look at an example or two. I like to send my clients something personal once a quarter; holiday cards, birthdays, event invitations, etc. I can sit down for 45 minutes once a year and ensure that every single one of my clients receives these specific regular hand written cards exactly when I want without any additional effort or time whatsoever.  Send Out Cards fills out the cards, puts them in the envelopes, puts the stamps on them and drops them in the mail for about a dollar forty a piece. If a doctor shares with you that they’ve had a family member pass you can log in instantly and in under a minute send a signed card expressing your condolences before you ever have a chance to leave the office and forget. Handwritten cards are always opened, read every time, and consistently pass the gatekeeper at the front desk. Send Out Cards does chocolates and gifts too. I used it to send my mom brownies after she had a rough day last week. I’ve walked in six months later and still seen my card sitting on a back desk, something I can never claim about most other literature I’ve dropped off. It’s takes the work out of something we all know we should do but rarely have the time to follow through with. Drop by their web site and check it out soon.

www.sendoutcards.com

NicVax – How Effective Is The Nicotine Vaccine

There’s something new in the air for people trying to quit cigarettes and it’s not the smell of smoke. In case you haven’t read about it yet, Nabi Biopharmaceuticals is currently running their nicotine vaccine NicVax through the paces of the FDA’s phase three clinical trials. NicVax is surrounded by an understandable excitement and fervor, but what are the facts?

First it’s important to outline what NicVax is not. It’s not a cure for the rigors connected with the fight to quite smoking or a guarantee that one will be successful at stopping. NicVax is intended to be an aide to smoking cessation and the clinical trial numbers on Nabi’s site appear to indicate just that. Of the test subjects with a high antibody response 16% showed significant abstinence at twelve months versus 6% in those that received a placebo. While 16% may not be the results recovering smokers where hoping for, the odds of success are substantially greater than without. So how does it work?

NicVax works on a similar philosophy to most vaccines but there are some important differences. Upon injection into the bloodstream NicVax triggers the immune system to begin producing antibodies that specifically bind to nicotine molecules. The binding of the antibodies with nicotine creates a particle too large to cross the blood-brain barrier thereby inhibiting the trigged release of stimulants like dopamine. While many of the vaccines the public is accustomed to require only a single dose, NicVax requires four. Additionally the life expectancy of the vaccination is roughly a year.

Again, even though these results and statistics many not be the golden ticket people hoped for, they are a compelling improvement over current alternatives. Moreover, time may give Nabi the opportunity to fine tune dosages and further improve results. In any case, there are definitely more than a few people eager for FDA approval.

by Ward Sieben

NicVax Clinical results

http://www.nabi.com/pipeline/pipeline.php?id=3

Orthopedic Reps, help improve post-op knee replacement recovery and pain management.

So I spent a little time watching a unicompartment knee replacement with one of the new custom knee replacements units. First let me say that the fit and installation ease with these appears to be superior to off the shelf units. Each unit is custom built for the the patient using a 3d CT scan and comes with custom guides for installation, way cool. Toward the end of the surgery there was a practice that’s becoming more common and is being shown to help with post operative knee replacement recovery and pain management, injection of a cocktail of drugs into the joint capsule and surrounding tissue during the operation. For you orthopedic reps out there this represents an opportunity for you to bring your doctors another one of those informative tidbits that differentiate you from the competition.

Generally the cocktail will include a numbing agent, anti-biotic, morphine, and an antiinflammatory steroid. Studies have indicated marked post-op improvement in function, mobility, and patient satisfaction.  Examining the components in the cocktail, the improvements don’t come as a big surprise. I’ve included the link to the surgery as well as a short article on eOthopod about. I encourage you to do a little more research and bring something extra to your orthopedic surgeons today.

Video of a custom knee replacement

eOrthopod article

 

by Ward Sieben

Become the physician’s trusted expert: ORLive

After over a decade of sales I occasionally take a breather to reflect on the various sales tactics I’ve witnessed or tried.  It’s a long and embarrassing list traversing the emotional gamut from uncontrollable laughter to intense self-loathing. Personal favorite??? It has to be the photo of my stare down with the 300lb pound pig for the Fourth of July BBQ marketing piece.  It’s been five years and I still receive a couple of phone calls about it every Independence Day. While I still make it a point to afford my clients with the occasional laugh, most of my effort is focused on the more important goal of establishing myself as the trusted expert. It’s an undertaking but the results are well worth the effort. It entails continually educating myself in order to deliver helpful, pertinent information to clients. My latest tool is a site called ORLive.

ORLive is a website that broadcasts live videos form the surgical suite for free. The presentations are full surgeries at top hospitals, with educating commentary by the performing physicians. It affords medical device reps the opportunity to learn first hand about some of the latest surgeries and products. Take a few minutes exploring the site and see what you think.

www.orlive.com

Developmental lymphoma treatment pharmaceutical to watch

Let me start by saying that the clinical statistics and information on the product discussed in this post is available either on the Seattle Genetics site or  US government clinical trail website. Now that that’s out of the way let’s get on to the good stuff.

I’m a nerd. As much as I might strive to prove otherwise through various endeavors of machismo, or engaging in melodramatic altercations with that middle aged guy in the mirror, I’m still a nerd. Don’t get me wrong, you want to strap on a parachute and jump out of a plane or barrel down the mountain on a pair of skis and I’m your’re man. I just also happen t0 periodically read biochem books for fun and dream up half crocked laboratory experiments to pitch at the head of state university’s biosciences department. Yep, I’m a geek.  As a result, I have a tendency to strike up some unusual conversations and get excited about some pretty obscure things, hence the subject matter for this post.

Roughly a year ago in one of my habitual bouts of networking I made the acquaintance of the owner of a clinical trails oversight company. He’s a really awesome guy and unfortunately for him, our occasional morning coffees provide a great excuse for me to indulge my internal dweeb. I of course salivate over the chance to explore the mechanism of action on the latest pharmaceutical concoction, which lead to a conversation about Seattle Genetics and some of their upcoming cancer treatment drugs. Our discussion of Seattle Genetics began over year ago. At that point my friend had been monitoring their trails for some time and was stunned by the results. Right now they’re either preparing to or have begun stage three trials for at least one drug, which means things could hit the market in a couple of years. There have been almost no adverse reactions, especially in comparison to standard chemotherapy, and according to the conversations we’ve have had, the remission levels are astounding. Here’s the skinny on how it works.

Seattle Genetics has created what’s know as an antibody-drug conjugates or ADC. There are essentially two parts to it. The first, known as the antibody portion bonds with a structure that is unique to the surface of lymphoma cells. It could be described as a lock and key situation where this key only fits a lock exclusive to lymphoma cells. When the antibody portion comes in contact with that specific structure, called a glycoprotein, it bonds with it and causes the cell to absorb it. Outside of the cell the second part of the system known as the drug payload, is inactive. Once it’s absorb inside the cell, the cell attempts to digest in and in turn activates the drug payload. As soon as it’s activated the drug payload kills and destroys the lymphoma cell. In essence what Seattle Genetics appears to have designed is a drug which targets and kills ONLY lymphoma cells. It’s a brilliant piece of bioengineering and could prove to be monumental if it continues to deliver the results communicated thus far.

While this blog’s primary theme is general sales skills, its secondary motif is to relate to medical and pharma. As an effective sales person you always have to keep an ear close to the ground for changes coming within your industry and this one could have huge ramifications for the oncology market. Information like this is helpful in structuring and setting longer term goals and I hope it help some of you medical folks. On the flip side, if any other overly science minded individuals happen to come across this post, I hope you enjoy the elegance of this drug as much as I did. Thanks for reading.

 

Effective Sales Openings – The 30 Second Infomercial

Okay folks I have a confession, I’m a sales person. That’s right, a social extrovert who if not careful will attempt to cram more words in than Jim Carey after a three hour red bull and skittles bender. Trust me, I know exactly when it’s happened. Right about the time my stomach gets that tight empty sensation,  the blood vessel in my temple nearly ruptures, and a crack of sheer terror flashes through my frontal lobe as I grasp the fact that I should have shut my yapper two minutes before. Admit it, you know the sensation.

We’re all prone to our moments of verbal regurgitation? Specifically in those sixty seconds right after someone utters our second favorite question, “what do you do?”. Oh the glee… the excitement… the overwhelming urge to give them every single reason why they should love our product! Do it quick before they get away!  We give them the full Baghdad shock in awe campaign with the hope that one of those wonderful little nuggets will be just the hot potato they’re looking for. Unforeseen to us they’ve reached auditory overload and our magnificent sales pitch sounds to them like Charley Brown’s teacher in the Peanuts Christmas special. So what’s the answer, what do we do? The key is to have a distinct and specific twenty  to thirty second infomercial.

It may appear daunting, but you need to be able to deliver who you are, what you do, and a catching bullet point in thirty seconds or less. Once the  person has responded it’s okay to go into detail but your opening intro should always be short and sweet. Think “rifle” not “shotgun”. There are a few things that should be key in every infomercial.

1. A unique way in which you help your clients that sets you apart

2. Your name

3. Your company

4. A specific description of one thing that you do.

5. Who you sell to.

6. An open ended question.

Thirty seconds max. Let me give you an example.

Doctor: (rushing of course) I only have a minute, what exactly do you do?

Rep: I work with general practitioners to prevent heart attacks. Ward Sieben with Biomedix. We diagnose Peripheral Arterial Disease. Have you had any patients with circulatory issues in their legs or feet?”

You want to give the prospect a limited number of specific bullet points to focus on. In this case I’m trying to focus the physician on heart attack prevention, peripheral arterial disease, and who is the patient in their practice that they need it for. Think of the person as a database. If you type thirty different search words into a database you’re going too much information to wade through, but if you give specific, distinct parameters you’ll get exactly what you’re looking for. The same is true with people. In this case patients with circulatory issues in their legs or feet. I’ll bet the bank they’ve run across an overweight diabetic with foot pain issues in the last couple of weeks that they suspect might have a partial occlusion.  Last of all, practice, practice, practice. You may have two or three versions for different situations but they all  need to flow as freely those excuses to your mother as to why you can’t make every Sunday evening dinner this month.

In the meantime, happy hunting out in the field and remember…   it’s a good life!