happy halloween

Happy Halloween!

Love,

Jonah

(Click here to see how much I've grown since last year.)

bella

I wanted to repost here something that Tim wrote on Bella's blog regarding any uneasiness there might be in the "not knowing what to say" when you see them tomorrow, or even deciding not to come because of that:

One of the conversations on the blog I want to address is the worry that some people won't know what to say, either on here or in person. Don't worry about that. There are no words to say, just feelings to convey. If you don't know what to say, SAY THAT! In that moment of authenticity, humility, and vulnerability, we will be connected, and THAT is the point of words, really: to connect each other to each other.

Here's the thing: it is not the words that matter. It's the sentiment behind them that counts.

I'll say it again; It's not the words that matter, it's the sentiment behind them that counts.

Here is an example: If I say "THANKS" in a condescending way to someone for giving me poor service, is it the same as when I say "THANKS" to someone who just let me stay/eat in their home? Of course not. But, hey, I used the same word, didn't I?

I know this is a quick and dirty example, but the point remains. If you walk up to me, look me in the eye, and say, "I am so sorry for your loss, I just don't know what to say," and you mean it, you just gave me all you needed to give.

Here is another important piece of the puzzle (and by the way, this stuff goes for any person - not just us - that is grieving): don't project what you think we are feeling onto us. We are not the same, and each person grieves in their own way. If you would be devastated, that may be true for you, but it may not be the experience someone else is having.

Here are 4 reasons why I am not devasted by the death of our daughter Bella:

1) My faith. I believe that she is in heaven with Ang's and my dad happy and free, waiting for us to join them with great anticipation. In my heart I can see her smiling that giant grin in heaven, LIGHTING it up even brighter with her addition to the chorus of joy that exists there. True? Who knows, but it sure makes ME feel better believing this truth, so I do.

2) Bella is never going to cry in pain from EB again. That makes me feel very calm.

3) We've known that Bella could die at any time since the night she was born. There was no expectation for a happy and long life for Bella. That is why we went to Minnesota in the first place. With EB things start bad, and just get worse. Not every case of EB is that way, but Bella had one of the two rarest and most fatal versions of the disease, and not a day went by where it it didn't significantly impact her and our lives.

4) We began to grieve for her loss in the end of July/early August. Let's face it, we lost that little spark plug the day she was intubated. I never heard her speak again, I never saw her big smile, and what I did see of her eyes was a washed out, medicated shell of what I once gazed at. She lost all her hair, grew to an unrecognizable size, changed color, and even grew in different color eyebrows. All the while that I knew the spirit Bella was still there, that fun, angelic, smiling, laughing cherub was gone. July, August, September, 11 days into October. 99 days. My friends, the grief had already begun for Angelique and me long before Bella's heart stopped.

So, I share all of this to give you an insight into two things:

1) It's not what you do (say), it's who you are being (how you say it)

2) It is not as raw for us as you may think, so you can bring it up, you can break down and cry in front of us, it's okay. We've done it, too.

Finally, I think there is a pressure to feel like we have to be strong and support someone who is grieving. Like they need our help and assistance somehow. When we ourselves are grieving the same loss, and we find ourselves weak, how could we possibly support the person who lost their child?

These gatherings we are holding are not for you to come comfort us.

They are for us all to come together to comfort each other.

One level playing field.

Yes, we may be at the center of the field, but we are all on it (and in it) together. After all, is there a quantitative measurement for love? If you loved Bella, you loved Bella. Who cares from how far or for how long or in what capacity that love was borne? My point is once you have loved someone, when you lose them it will hurt. That is the price of love, and I for one am HAPPY to pay the fee every time, for the beauty of love always triumphs over the pain of loss.

So you don't need to be anxious if you are. I think Tim has confirmed that we're all in this grieving thing together. And please don't let it stop you from coming. We just want to get together, celebrate Bella, eat some good food, play on the playground, and hang out. No pressure.

Hope to see you there. You can just email me at momtobabyjonut (at) gmail (dot) com if you haven't already but would like to come. The more the merrier.

No More NICE by 2013?

Any drug developer who showed up at the Royal Society of Medicine in London this morning could have been forgiven for thinking Christmas has come early. By 2013, NICE probably won't be doing cost-effectiveness analyses of individual drugs anymore, according to Lord Howe, Parliamentary Under Secretary of State in the Department of Health.

Speaking at the joint ABPI/BIA conference entitled "Our Vision for a New Decade" (where a few other worthy initiatives were announced), Howe declared that those highly visible, and controversial, opinions delivered by NICE on whether a particular new medicine should be reimbursed by the UK National Health Service "will probably be somewhat redundant" in a few years' time.

Don't get too excited: it's not that cost-effectiveness assessments are going away. It's just that, according to Howe's plan, by then the UK will have a spanking new value-based pricing system which will see a drug's value assessed and quantified during pricing discussions. That system will replace the current PPRS (Pharmaceutical Price Regulation Scheme, which caps companies' profits rather than drug prices directly) which expires at the end of 2013.

According to Howe, the new set-up will see "the price of a drug reflecting everybody's agreed perspective on the value it provides". We were unable to establish exactly who 'everybody' is, and how they might 'agree' on such a matter. But despite scant details, it appears that companies may in future discuss value with pricing authorities directly rather than have NICE--usually post hoc--impose its judgment on a drug's cost-effectiveness.

So it's not quite Christmas. But it seems the industry associations have done a good job lobbying for greater influence in pricing and value decisions, and for NICE's teeth to be blunted somewhat. (Perhaps the writing was on the wall in 2009 after Sir Ian Kennedy published his report on NICE's methodologies.) Plus a system wherein value is discussed at the same time as pricing is, arguably, simpler, and "anything that's simpler is better," says Roch Doliveux, CEO of UCB and a significant investor in the UK (largely courtesy of the 2004 Celltech acquisition).

No-one will admit outright that NICE is about to take a back-seat in cost-effectiveness decisions. Universities and Science Minister David Willetts was quick to refute that there will be a "lesser" role for NICE, saying instead it would be a "changing role". A more "advisory" role. NICE will move away from single technology assessments (drug assessments) towards setting quality standards more broadly for public health and for care within the NHS, including in social care.

Here's the Department of Health's summary of where NICE will fit in:

"We respect the expert independence of NICE, and believe that it must be allowed to continue to issue guidance free from political interference. However, we believe that there are fundamental failings within the wider system for drug pricing and access. We are determined to address this and are clear that NICE plays a vital advisory role."

Vital its advisory role in establishing a new drug pricing system may be, but a NICE focused on setting quality standards for public health will certainly be less controversial than in its existing form. And less powerful. Today, a NICE decision can--and quite often does--shatter a drug's commercial prospects in the UK. That power looks uncertain post-2013.

eb awareness week

In honor of EB Awareness Week (Oct 25 - 31st), I wrote the following letter and included the below photos. I'm printing off 100 copies and stuffing the mailbox flags of the 100 houses closest to ours.

Hi Friends and Neighbors.

My name is Jonah.

 I’m 20 months old and live in the white house at the corner of ....

Mommy wanted me to let you know that it’s EB Awareness Week (October 25^th-31^st). She said I should probably explain what EB is. EB stands for Epidermolysis Bullosa. It’s the skin disorder that I have. EB is a really rare genetic disorder with no cure. We all have proteins that hold our skin together, but I’m missing one (Collagen 17), and that means my skin is really fragile, like a butterfly’s wings. My skin blisters or shears off with any sort of friction or rubbing. I have to stay bandaged from my neck down to protect me. Tags on clothes, seams, regular diapers, a rub of my face with my hand, anything like that can cause my skin to blister or tear. EB also affects my fingernails, hair, and teeth, and in some forms, there can be internal problems, such as blistering and scarring in the esophagus, trachea, or intestines. My biggest risk is getting an infection in one of my wounds, but Mommy and Daddy work hard to keep me safe. I get a bath and my bandages changed every 24 hours.

I was born on February 27, 2009, and Mommy and Daddy had no idea there was going to be a problem. But when I was born, I was in bad shape. I was missing the skin from my elbows down and my knees down, and had other blisters and wounds all over.

My type of EB (Junctional Epidermolysis Bullosa) is recessive, so Mommy and Daddy each have a faulty gene they didn’t know about that they passed on to me. I spent 32 days in the NICU and only about 20% of babies with my type make it to their first birthday. But I’m almost two years old and doing great!

If you’d like to learn more about Epidermolysis Bullosa, please visit http://debra.org (The Dystrophic Epidermolysis Bullosa Research Association) or you can follow my story on my Mommy’s blog, http://patriceandmattwilliams.blogspot.com.

Mommy just wanted you to know me and about my disorder. She and Daddy hope you’ll speak and wave to me when you see me. I’m not contagious, and I’m just about the sweetest thing in the world, according to Mommy anyway. So if you see a little boy with boo boo’s on his face come to your door on Halloween, it’s not part of my costume. It’s just me: beautiful, perfect, just-right Jonah (that was Mommy’s input again).

Thanks for taking the time to read this note. We love our neighborhood and hope to get to meet you soon!

Love,

Jonah

I'm excited about it! Also, if you follow @EBResource on Twitter today and retweet their EB tidbits for the next 24 hours (or really, until 9 am tomorrow... I'm behind), we'll earn $1 for DebRA, for every tweet, up to $2,500. Make sure you include #ebfund in your tweets today because that earns money too! Thanks, Friends.

And please make sure to email me if you plan to attend Friday night's EB Gathering with us and Bella's family. See below post. 

HbA1c Smackdown: FDA’s Woodcock, UK’s Breckenridge Go Toe-To-Toe Over Diabetes Drug Approval Standards

Just when you think everything that can be said about Avandia has been said, along comes an impromptu, verbal sparring match between high-level officials of the U.S. and UK drug regulatory agencies over the role and value of hemoglobin A1c reduction in diabetes drug approval.

In one corner: Sir Alasdair Breckenridge, chairman of the UK’s Medicines and Healthcare products Regulatory Agency, better known as the MHRA.

And in the other corner: FDA Center for Drug Evaluation and Research Director Janet Woodcock.

The setting: the Third Annual Risk Management and Drug Safety Summit in Washington, D.C. on Oct. 18.

Woodcock, who was the first presenter at the meeting, spoke about CDER’s efforts to improve risk management and drug safety since passage of the FDA Amendments Act. She was followed at the podium by Breckenridge, who presented the European perspective on risk management and a pharmacovigilance “tool kit” for assessing and mitigating drug risks.

Near the end of his presentation, Breckenridge turned to the recent regulatory decisions on Avandia, GlaxoSmithKline’s beleaguered thiazolidinedione. Even though FDA and the European Medicines Agency took different regulatory paths – with FDA restricting distribution under a Risk Evaluation and Mitigation Strategy, and EMA suspending rosiglitazone’s license – Breckenridge stressed the extensive collaboration between the two agencies that culminated in simultaneous announcements on Sept. 23.

“If you think about the difference between what Europe has done and what the U.S. has done, in fact I would suggest there was very little difference indeed, and it was an example of regulatory authorities working together in a global manner,” he said. ("The Pink Sheet" offers an analysis of why they diverged in their final judgment.)

Following these glowing remarks about alignment among regulators on both sides of the Atlantic, Breckenridge took the Avandia post-mortem a step further, and perhaps one too far for Woodcock.

“The question I’ve asked myself is if Avandia came through for licensing today, with the information we had, what should be done, what would we have done? How has regulation advanced? Well firstly, it wouldn’t have been approved for efficacy on a surrogate marker [HbA1c]. That would not be accepted,” he said. Some in industry concur that there is now a higher hurdle, at least commercially, for diabetes products.

Fortunately for the audience, Woodcock hung around after her presentation to hear Breckenridge’s speech, and during a question and answer session, while still sitting in the audience, Woodcock pounced on the British knight’s skepticism toward HbA1c. Here is an abbreviated transcript of the exchange, along with some first-hand, editorial observations noted in brackets:

Woodcock: “If you’re not going to use hemoglobin A1c or serum glucose … what are you going to use for efficacy in diabetes? No drug in type 2 diabetes has ever been shown to improve cardiovascular outcomes.”

Breckenridge: “I believe this illustrates the problem with antidiabetic drugs. I believe it’s going to be increasingly difficult to develop any drug for diabetes which has got a suggestion that Avandia did have, and I think drugs like Avandia are going to die at a much earlier stage and be killed at a much earlier stage than developed.”

Woodcock: “I would say the question with rosiglitazone is a safety issue, it’s not an efficacy issue … I think hemoglobin A1c is more than a surrogate … I date as an internist from the era when people walked around with untreated type 2 diabetes. They hit my emergency room they were in hyperosmolar coma. That’s a life-threatening disease. Or they had severe invasive soft tissue infection with gram negative organisms, or they were dehydrated and had blurry vision and CNS issues.”

Breckenridge: [apparently attempting to explain that not all type 2 diabetics are in such dire straits] “I can remember as well, and I’m not sort of swapping stories with you, but patients with type 2 diabetes are the rather large ladies who you see walking around in the United Kingdom and I’m afraid Washington as well.” [disapproving murmurs from the audience]

Woodcock: “But if you go untreated long enough with type 2 diabetes that’s what you get into. It’s a progressive disease. So the idea that you don’t need treatments for type 2 diabetes I think is an incorrect …. ”

Breckenridge: “I’m not suggesting that ….”

Woodcock: “You will get renal failure, you’ll get amputation … It’s a symptomatic disease. People have studied this and they’ve looked at central nervous system effects of hyperglycemia … There are people walking around with blood sugar 300, 400 and so on. That is not good for you, acutely. And sub-acutely, glycemic control has been shown to be correlated with progression of retinopathy, renal failure and so forth, and neuropathy to some extent. [By now standing, holding the microphone and looking as comfortable as a talk show host on a TV production set] So I would take issue with the fact that hemoglobin A1c is a bad surrogate. I think it’s a very good surrogate for efficacy. I don’t think it tells you anything about safety of a drug just like most surrogates for efficacy.”

Breckendridge: “I’m afraid I disagree with you there, Janet. I think by the definition of a surrogate, hemoglobin A1c fulfills all the criteria … and the point I was trying to make was that if you take, in the development of a drug in the latter phase of the drug, and you had a drug which was effective by affecting the surrogate, but it had some other not just potential but huge changes, big changes which were known at the time in a possible adverse event which diabetics are already prone to, the manufacturers, I would suggest, would have a very, very careful look at that before continuing with its development.”

Woodcock: “I don’t think we’re in disagreement, I’m simply saying I thought the earlier definitions [of a surrogate] were mainly done by statisticians, like Prentiss and others … that it should contain all outcomes. That’s completely naive from a biological perspective, because you may perfectly control the disease and kill people from something else. It’s unrelated to the pathway of the disease. So I think expectation that a surrogate for efficacy would take care of your safety evaluation is unrealistic, and I think we’re saying the same thing, which is for chronic diseases there’s going to have to be a much more thorough safety evaluation, it’s longer term, includes more patients, looks for more outcomes than we have traditionally had.”

Breckenridge: “And I think diabetes is an especially difficult case for the reason I described. If you’ve got a disease whose natural history is to develop vascular disease anyway, then a drug which is going to influence that in any kind of adverse way is not good news.”

Woodcock: “The sulfonylureas have long had a warning in the United States for cardiovascular disease because the only time that was studied long-term there was a signal.”

Breckenridge: “And so do the thiazide diuretics, too.”

Woodcock: [laughing] “So there’s a lot of things we don’t know.”

During a break in the meeting later in the day, Breckenridge was overheard describing Woodcock as “feisty.”

Feisty? Perhaps. But definitely defensive of the view strongly held within CDER’s Office of New Drugs that HbA1C reduction, not cardiovascular benefit, is an appropriate efficacy endpoint for new antidiabetics. Woodcok's eagerness to enter the ring on the issue is especially interesting given that outcomes data is now essentially required to demonstrate the safety of the products.

– Sue SutterPhoto "Natalya" by flickr user Snerkie used under Creative Commons License.

meet the Ringgolds (and Jonah!)

Hi Friends,


Something has come up and I need your help. 


Tim Ringgold (Bella's dad) emailed me yesterday and said that he, Ang, and Ali are coming here, to Winston-Salem, later this week. And Tim would like to have a get together between our two families and anyone else who reads either or both of our blogs and would like to come. It will be a great time of meeting one another, hanging out, and celebrating Bella and the love and support we've found in each other.


But we don't have much time! (Tim, you and your visionary spirit are KILLING me and my Type A/Planner personality... but I'll forgive you, this time.)


So, this coming Friday, October 29, please join us for a potluck dinner at Bolton Park Shelter at 5:00 (I'll probably be there a little early, and there's a playground right there, so feel free to come earlier). 


So...


What: a Potluck dinner celebrating Community and remembering Bella
When: Friday, October 29
Time: 5:00pm-7:30pm (or dark, whichever comes first)
Where: Bolton Park, large shelter


Here's what I need from you -
I have NO IDEA how many to expect. It could be 20. It could be 200. That's why I decided to do Potluck style, so no matter how many people come, there will be enough food. I'll plan on getting napkins, cups, plates, and forks/spoons. I need y'all to bring drinks, main dishes, sides, and desserts. 


Please email me if you plan on coming and let me know what you would like to bring. I just don't want us to get 40 Bundt Cakes and no real food, know what I mean?


You can email me at momtobabyjonut (at) gmail (dot) com and let me know. 


I hope we can see you there.

PS - If this doesn't work out and we don't get much response, we'll change it to BYOFF (Bring Your Own Fast Food) and everyone can just bring food and drinks for your own family. But I'd like to try the Potluck idea first, because dang it, we're The South, people, and that's just what we do. 


Looking forward to meeting as many of you as can come! Hooray!

DotW Strategies

As 2010’s days grow shorter, the pharmaceutical industry’s larger players face fundamental challenges, both in how they invest in internal research and how they ensure continued growth commercially for their medicines in the face of increasing scrutiny from regulators and payers. An analysis of Elsevier’s Strategic Transactions database in the October IN VIVO shows that, to date, most companies have adapted with a three-pronged strategy that places an emphasis on externalization, emerging markets, and unmet medical need.

This week’s edition of deals of the week doesn’t stray far from these established themes. (Poison ivy was apparently considered optional.)

Sanofi-Aventis’s alliance with Harvard University illustrates the ongoing allure of academic relationships, as drugmakers look to identify innovative new medicines ever earlier in the development cycle. Meantime, Glaxo’s tie-up with two Italian foundations in the development of a gene therapy to treat a disorder affecting only a few hundred people worldwide shows that no disease is too rare to attract Big Pharma’s interest--as long as the unmet medical need is high. Finally Pfizer’s deal with Indian biotech Biocon, illustrates drugmakers’ growing interest in both diabetes AND emerging markets.

GlaxoSmithKline/Fondazione Telethon & Fondazione San Raffaele: Big Pharma’s interest in rare diseases shows no signs of waning. This week’s rare disease pact – it seems like one a week is now pro forma for DOTW – aligns GlaxoSmithKline and two Italian foundations. On October 18, GSK announced plants to pay Fondazione Telethon and Fondazione San Raffaele €10 million upfront (about $14 million) for worldwide rights to a Phase I/II stem cell-based gene therapy for ADA-SCID, also known as "bubble boy disease." ADA-SCID, a single-gene defect which prevents the body from producing the enzyme adenosine deaminase, afflicts about 350 children worldwide, with about 14 EU patients and 12 U.S. patients born each year. (Thus, this isn’t simply GSK investing in a rare disease; ADA-SCID counts as one of those “ultra” orphan indications, a valid term even if it makes industry and advocacy groups squeamish.) Beyond the ADA-SCID program, the two foundations will partner with GSK on clinical programs in Wiskott-Aldrich Syndrome and metachromatic leukodystrophy, as well as four additional programs, all currently in preclinical development. In addition to the upfront payment, the foundations could earn specified development milestone payments for each program. In a same day business presentation, GSK’s Global Head of Rare Diseases Marc Dunoyer offered additional color about the rare disease unit’s strategic intent. The pharma intends to address 200 rare diseases with a focus in four primary areas: metabolism and inherited disorders, central nervous system and muscle disorders, immuno-inflammation, and rare malignancies and hematology. It continues to build its portfolio via dealmaking, including ongoing collaborations with Isis, Prosensa, and JCR Pharmaceuticals.—Joe Haas

Genentech/Biogen Idec: The longtime Rituxan partners have amended their co-development terms for next-generation anti-CD20 compounds. Biogen now gets slightly higher royalties on sales of the still-experimental compounds ocrelizumab and GA101, and their introduction will not trigger lower Rituxan royalties, as was previously outlined in their agreement. The firms squabbled for years over rights to what comes after Rituxan, and an arbiter ruled last year that Biogen had the right to participate in all anti-CD20 program development decisions. Historically Biogen has received 30% of the first $50 million in US and Canadian operating profits, then 40% of everything over $50 million, a threshold passed by Rituxan in the first quarter in each of the last three years, according to ISI Research analyst Mark Schoenebaum. Commercialization of ocrelizumab will no longer reduce Biogen's share of Rituxan profits, but certain regulatory and sales milestones of GA101 will. Also, Genentech will pay for all ocrelizumab development in multiple sclerosis, with Biogen receiving between 13.5% and 24% of US sales. With GA101, which in 2008 Genentech licensed from Glycart -- itself wholly owned by Roche -- Biogen will now pay 35% instead of 30% of US development costs and receive between 35% and 39% of profits based on certain sales milestones. GA101 is in advanced development for CLL and NHL. Ocrelizumab is in Phase II for multiple sclerosis but is no longer being tested in rheumatois arthritis. -- Alex Lash

Pfizer/Biocon: Pfizer and India's biotechnology flag-bearer Biocon finally -- after months of speculation -- announced a comprehensive global commercialization pact to bring to market a range of insulins including analogs of medicines marketed by Sanofi-Aventis, Novo Nordisk and Eli Lilly. Pfizer is doling out $200 million in upfront payments to Biocon, with the Indian biotech eligible for further milestone payments of up to $150 million. Biocon will also be entitled to additional payments linked to Pfizer's sales of its four insulin biosimilar products across global markets. As part of the deal, Biocon will take up clinical development, manufacture and supply of the biosimilar insulin products and regulatory activities needed for approvals in various geographies. Pfizer has told analysts that the deal will be "incremental," not "instrumental" to its strategy in emerging markets, biosimilars, and established products. Pfizer will be responsible for commercializing the products, while Biocon will develop and manufacture them. "Pfizer's participation in this market does raise the bar for the major producers of insulin over the long term," Leerink analyst Seamus Fernandez wrote in a same-day note. But it won't have a near-term impact because Pfizer brings little to the table beyond marketing muscle and the biggest opportunity lies in developed markets, where some of the products are patent protected for several more years. Sanofi's Lantus, for example, doesn’t lose exclusivity until 2015. – Vikas Dandekar

Romark/Intercell: Romark Laboratories and Intercell said they will collaborate on their hepatitis C programs by conducting trials on a combination therapy that will include Romark’s anti-viral drug nitazoxanide and Intercell’s HCV vaccine, IC41. The combination will seek to improve on the standard of care by adding IC41’s immune-boosting properties to nitazoxanide’s ability to slow cell replication without inducing mutations. The drug pairing will be studied side-by-side with the currently used combination of Pegasys (peginterferon alfa-2a) and Copegus (ribavirin), as well as a three-way combo of nitazoxanide, IC41, and Pegasys in a European Phase II trial slated for the first half of 2011. Nitazoxanide, an anti-infective agent in the drug class known as thiazolides that appears to activate protein kinase R, is already marketed to treat diarrhea caused by viral infections. It has been studied in conjunction with peginterferon and ribavirin as well. Tampa, Fla.-based Romark and Vienna-based Intercell did not announce financial terms of the deal.—Paul Bonanos

Sanofi-Aventis/Harvard University: Technically the tie-up between Sanofi and Harvard is a deal of last week, but with so much industry activity--and playoff mania--IVB somehow overlooked a deal that ought to be seen as a sign of the times. On October 14, Sanofi and Harvard announced they were joining forces in a broad translational alliance that gives the French pharma an early look at cutting edge science that could be important future pipeline substrate. Deal terms were not disclosed, but the collaboration is designed as a grants program, with a joint steering committee from both entities awarding funding based on scientific merit and “the potential to generate translational insight and value to biomedical research.” The boon for Harvard: scientists get access to flexible and rapidly available funding without spending hours – it’s really more like weeks or months – writing up government grants. Sanofi, in turn, has the opportunity to develop diagnostic, therapeutic, and prognostic applications of any discoveries made under the collaboration. Partnerships with academia have shown a marked uptick in number in 2009 and 2010 compared to years prior. According to Elsevier’s Strategic Transactions, the number of industry-academia partnerships jumped from 6 in 2007 to well over a dozen thus far in 2010. Nor are these the typical outsourcing relationships of yore; most are structured as true partnerships that aim to share both risk and reward. Notable recent examples: AstraZeneca’s alliances with University College London and Cancer Research Technology to create stem cell therapies for ophthalmic diseases and novel cancer medicines, respectively.--EFL

GE/Clarient: With cancer diagnosis and characterization in the vanguard of molecular diagnostics development and investment, it’s no surprise that GE Healthcare chose the area for its first major external investment in molecular test content. On Friday it announced an approximately $580 million tender offer for Clarient, which provides laboratory tests using important clinically validated cancer molecular markers including BRAF, EGFr, and KRAS. The deal, at $5 per share, is roughly a 25 % premium over its closing price yesterday of $3.77. Clarient hit profitability earlier this year, taking in $28.7 million for its testing services in the second quarter ending June 30. It utilizes most of the standard cancer testing technologies including immunohistochemistry, flow cytometry, FISH, and imaging. GE, working through its subsidiary in the UK (the former Amersham, which it acquired in 2003), expects to combine Clarient’s chemistry and molecular platforms with its own diagnostic imaging expertise, which would give it a full suite of triage and cancer diagnostic capabilities. In a sense, the link to imaging brings Clarient full circle. It originated as ChromaVision, a developer of digital microscopes, then morphed from an equipment maker into a service provider. Safeguard Scientifics, a 26% owner of Clarient going back to its ChromaVision days, said it will net approximately $145 million in the deal.-- Mark Ratner

St. Jude Medical/AGA Medical: St. Jude Medical’s announcement on Monday that it would pay $1.3 billion ($20.80 per share, a 43% premium) for AGA Medical, which had sales in 2009 of just $199 million, likely caused jaws around the industry to drop. Pick your chins off the floor, people. The transaction makes sound strategic sense, driving growth in key areas where St. Jude has significant resources but slower growing products. Case in point: St. Jude’s atrial fibrillation business grew by only single digits in the past year in the US, and the cardiac rhythm management sector is forecast to grow on a global basis by only 3% in the coming year. In contrast, AGA, operating in structural heart disease--a product segment that includes heart valves and various closure devices--enjoys double digit growth thanks to its leading share of the $250 million market for PFO closure. AGA also offers a number of new product areas to drive growth for St. Jude, including a next-generation vascular plug technology to replace embolic coils and a proprietary mesh-braided nitinol platform that will enhance the big device maker's product pipeline. In the company’s recent third quarter conference call, St. Jude Chairman and CEO Daniel Starks described the acquisition as a bolt-on to its cardiovascular franchise; the company is keeping on AGA president and CEO John Barr as head of the 550-person division. St. Jude’s recent deal flow indicates the company is trying to enter new markets via the business development suite. In September, the cardiovascular giant invested $60 million in remote monitoring company CardioMEMS, developing an implantable sensor for AAA and congestive heart failure monitoring. Early this year St. Jude also acquired intravascular imaging company Light Lab Imaging Inc. for $90 million.--Mary Stuart

Image courtesy of flickrer Neil Boyd used with permission via a creative commons license.

taking it all back

I have A LOT on my heart these days and a lot I want to write out, here on the blog, but it seems I don't have adequate uninterrupted time to get my thoughts together and find a good starting place, so I guess there's nothing left to do but just jump in. It's against my nerdy straight A character to not have a good intro paragraph or an outline, but I just can't get a hold on any of it enough to start... so I guess I just ask God to give me the words and move forward.

I feel guilty when you guys call me an inspiration. It makes me feel like I've unintentionally duped you or have been dishonest. It makes me feel like I shouldn't write anymore because I don't want to put on a false face or make you think I'm someone I'm not. I am a decent mother. I am an inadequate wife. I'm not writing this so you'll leave comments to reassure or affirm me. Seriously, that is the last thing I want. I just want to be real. I want to represent Jesus with my life, and when I don't, I need to confess.

There are days Matt comes through the door and I'm snarling at him... or days he comes home and I'm barely speaking. And I don't know why. He hasn't done anything. I'm just bitchy and ill. It drives me crazy not being able to pinpoint it and it drives him crazy not knowing what to expect when he walks through the door. He is so amazing, y'all. I could not ask for a better husband and father to my kids. He had never even changed a diaper before Jonah was born, but it has not slowed him down. He has jumped in, from the beginning, with both feet, helping in Jonah's care, being an equal partner. He doesn't have expectations of me. If he comes home and the house is a wreck, I'm in a bad mood, and there's no dinner, he takes Jonah from me, straightens up, and happily settles for a bologna sandwich. 

So why oh why am I so difficult?

I'm saying all of this so you'll know that I struggle. S-T-R-U-G-G-L-E with how to be a good mother AND wife. The truth is, Jonah will one day go home to be with Jesus or will live a long life, grow up, and move out, and as much as I love him and want to care for him, I made vows and promises to Matt long before Jonah came along. When Jonah's no longer here, I want to have more than a shell of a marriage. I want a rock solid foundation of love, trust, and genuinely wanting to put the needs of each other before our own. I want to treat and love him like Christ loves me. I want to let him lead and be ecstatic about following and submitting.

But man, Satan claws his way in and makes me an arrogant, selfish, pompous ass, and it sure is hard to overcome all of that.

Depressed yet?

Never fear. Aslan is on the move. God is working. I am getting my butt kicked, and I LOVE it. I am so desperately thirsty and dried up, I'm devouring our Bible study book (Satisfy my Thirsty Soul by Linda Dillow) and the Bible with excitement. I am not a non-fiction girl. I've never been able to read these type books (except Blue Like Jazz... which happens to be laugh-out-loud funny and amazing) with any real enthusiasm. But I can't get enough. And it makes me hunger for The Word like I never have before. 

I am PUMPED!

And I'll tell you this (this post is all over the place... but that's not what I wanted to tell you), I am so sick of the stereotype of marriage being this "trap" where the husband is a lazy, aloof, selfish idiot and the wife is a bitchy, nagging, emotional basket case. (Okay, maybe I've been that wife a little bit, but that's not the point.)

Marriage is a gift. Children are a gift. LIFE is a gift.

And I'm taking my gifts back, thankyouverymuch. I refuse to live a mediocre life. When did life become about longing to make it to Friday, complaining to anyone who will listen on your Facebook and Twitter pages, and only seeing the negative??? (Hello Kettle, I'm Pot.) Ugh. I hate it. I want the fullness and promise of what God offers... and it's not just the promise of Heaven and Eternal Life. I mean, sure, I'm excited about that, but WHAT ABOUT RIGHT NOW?

We have been given so much more than a life of mediocrity. Everything we have or don't have. Everything we've been given or have been denied. We can use that to praise God and enrich the life we have right now. Gabe died. That sucked. Jonah has EB. That sucks. Like 90% of parents who've lost a child and/or have a child with special needs get divorced. That scares the living you-know-what out of me.

But y'all. I have Jesus. The things that have happened in our lives have brought me to this place - this dried up, oh-so-thirsty, what am I going to do place. 

Praise God!

For this reason I kneel before the Father, from whom his whole family in heaven and on earth derives its name. I pray that out of his glorious riches he may strengthen you with power through his Spirit in your inner being, so that Christ may dwell in your hearts through faith. And I pray that you, being rooted and established in love, may have power, together with all the saints, to grasp how wide and long and high and deep is the love of Christ, and to know this love that surpasses knowledge—that you may be filled to the measure of all the fullness of God. Now to him who is able to do immeasurably more than all we ask or imagine, according to his power that is at work within us, to him be glory in the church and in Christ Jesus throughout all generations, for ever and ever! Amen.

I'm empowered. He dwells in me. His love is beyond my wildest dreams. He can do more than I ask or imagine. I can have fullness, contentment, and complete joy in this life, right now, in this very moment. (mouth agape)

I'm working for that, folks. Scratch that. I'm accepting that gift, folks. I'm asking my Abba to bind up Satan, take away his foothold, and I'm accepting my Father's unimaginable love and unending grace. 

I am his beautiful and perfect daughter, and I deserve more than mediocrity.

I'm taking my life back. Care to join me?

(to be continued...)

meeting ella!

Last Friday, we had very special visitors. Ella and her beautiful mom, Katie, came for a visit. Ella has Recessive Dystrophic EB, and Katie was one of the first EB folks to contact us after Jonah was born. Katie has been a constant source of support and love (and a POSITIVE outlook) for us, and it was SO AWESOME to finally get to meet them. They were down here from DC visiting some family in Durham. 

We got to enjoy a great walk with the kids. It was a beautiful day. 

 Sweet Ella. Three years old with the vocabulary of a nine year old. :)

The four of us. (Jonah playing with Katie's earring... no concept of personal space.)

It's nice to spend time with someone who really gets what your life is like... not just the physical requirements of EB, but the emotional ups and downs of being an EB mommy. We didn't really have to do introductions or small talk. (I did cry a little bit, but that's kind of my thing. When I apologized for crying, Katie said, "Don't worry. Crying is my spiritual gift." Ha ha. I'm stealing that one!) We just got each other. And Ella is just as amazing as Jonah and Weston (an EB not-so-baby we met last year). The strength and determination of these EB kids young people (sorry, Weston) continue to blow me away.

We love you, Katie and Ella. Hope you come back down our way soon!