Five minutes with: a sexual health specialist

Jane Hatfield was inspired to work in healthcare when she saw one in five children dying before they were two in Africa.

Describe your role in one sentence: Supporting healthcare professionals to deliver the highest standards of sexual and reproductive healthcare to anyone who needs it.

Why did you want to work in healthcare? I worked in Africa in my early 20s where one in five children were dying before they were two. I worked with women who wanted to educate each other to tackle the health issues they faced. This remains my motivation.

How do you want to see the sector change in the next five years? I would like to see sexual and reproductive healthcare services at the forefront of the move to a more people-focused, community-based and open access model of healthcare.

My proudest achievement at work was ... getting a commitment from David Cameron to collecting data on the number of people diagnosed with metastatic breast cancer (so that services to this group could be properly designed).

The most difficult thing I've dealt with at work is ... the inertia that is built into a system as complex as the NHS, including outdated attitudes to contraception.

The biggest challenge facing the NHS is ... how to encourage people to take more responsibility for their own health when facing many other challenges in their lives.

The people I work with are ... extremely knowledgeable about our members and their work in delivering sexual and reproductive healthcare in many different settings.

I do what I do because I ... like to organise things well that make a difference.

Sometimes people think that I am ... very serious because of my expression but I'm actually quite funny.

Right now I want to ... make everything work perfectly and deliver a great service to our members.

At work I am always learning that ... everything you do in a charity must lead back to improvements for your users.

The one thing always on my mind at work is ... what can I tell my son that I learned today?

If I could go back 10 years and meet my former self I'd tell them ... that everything you are learning now will be useful later (and to smile!).

If I could meet my future self I'd ... expect them to be making a difference.

What is the best part of your job? The passion of our officers and members in delivering family planning services to their patients.

What is the worst part of your job? Setting limits to what we can sensibly achieve.

What makes you smile? Remembering that I can look very serious.

What keeps you awake at night? My own children waking up and the impact of the lack of access to contraception for women in all parts of the world – on their own health and their families' [health].

If you would like to feature in our "Five minutes with ..." series, or know someone who would, then you can let us know by emailing healthcare@theguardian.com

This article is published by Guardian Professional. Join the Healthcare Professionals Network to receive regular emails and exclusive offers.

View the original article here

Halozyme: Drug Delivery Specialist With Multiple Near-Term Catalysts

Halozyme Therapeutics (HALO) (Q2 2013 conference call transcript, a source for many of the projected catalyst time frames outlined below) develops enzyme-based (hyaluronidase) products for a wide variety of conditions, which include diabetes, cancer, autoimmune disorders and cosmetic medicine (cellulite).

CLINICAL AND REGULATORY CATALYSTS:

Below is a summary of the Company's clinical development pipeline which includes collaborations with Roche (RHHBY.OB), Pfizer (PFE) and Baxter (BAX) in addition to an FDA approved product, HYLENEX (human recombinant formulation of hyaluronidase), which improves the absorption and dispersion of drugs injected under the skin (subcutaneously) (e.g. insulin) on a temporary basis (approximately 24 hours) with plans to increase sales through a recently initiated post-marketing study in Type 1 diabetes using insulin pumps.

1.) Herceptin-SC (trastuzumab) and MabThera-SC (rituximab) (novel subcutenous injected rHuPH20 formulations) are currently pending European Medicines Agency (EMA) decisions in the form of line extension applications for new formulations of approved anti-cancer drugs. In late June, partner Roche received a positive CHMP opinion for EU approval of Herceptin-SC with final EU approval expected approximately two months later by late August-early September.

Partner Roche filed a MabThera-SC line extension application in December 2012 with the next CHMP meeting scheduled for September 16-19 and a meeting update to follow on Friday 9/20/13. The May Pharmacovigilance Risk Assessment Committee (PRAC) meeting minutes posted in June (page 40-41) indicated that both line extension applications are acceptable with Herceptin-SC subsequently receiving a positive CHMP opinion in late June.

In addition, Roche has two ongoing Phase III clinical trials to evaluate patient preference and support pending European marketing efforts upon final approval for both Herceptin-SC (ClinicalTrials.gov ID NCT01810393) and MabThera-SC (ClinicalTrials.gov ID NCT01724021) compared to the standard, longer IV infusion delivery route for these products.

2.) HyQvia (novel subcutaneous injection formulation of immune globulin) received a Complete Response Letter (CRL) in August 2012 for a Biologics License Application (BLA) seeking approval as a novel formulation of immune globulin for subcutaneous injection due to elevated anti-rHuPH20 antibody titers and partner Baxter expects to submit additional data to the FDA by year-end 2013 to support potential FDA approval by mid-2014 to H2 2014 (Baxter Q2 2013 conference call transcript). In May, HyQvia received EU approval with the initial product launch ongoing.

3.) HTI-501 (recombinant human cathepsin L) (lysosomal proteinase) is currently being evaluated in a Phase II clinical trial and in late June HALO presented interim Phase II results from 12 of planned 34 evaluable patients in a fully enrolled Phase I/II clinical trial for the treatment of cellulite with the last patients dosed in July and final follow-up results through six-months post-treatment expected in early 2014.

4.) ClinicalTrials.gov ID NCT01839487 is the identifier for a Phase II clinical trial with results expected during Q3 2015 in a study evaluating PEGPH20 (PEGylated form of rHuPH20) in combination with nab-paclitaxel and gemcitabine for the first-line treatment of metastatic pancreatic cancer.

HALO will present more complete Phase IB data at the EU Cancer Congress on 9/30/13 following initial results presented at ASCO 2013 (42% overall response rate) and the Company is also developing a companion diagnostic with a planned start of a Phase II pancreatic cancer trial by Southwest Oncology Group by the end of Q3 2013.

5.) ClinicalTrials.gov ID NCT01848990 is the identifier for a fully enrolled Phase IV post-marketing clinical trial evaluating HYLENEX (rHuPH20 hyaluronidase human injection) in combination with rapid-acting analog insulin in Type I diabetics using insulin pumps with results expected in early 2014. HYLENEX is FDA approved to facilitate subcutaneous fluid administration for a variety of indications (e.g. hydration and to increase dispersion of other drugs as illustrated in the pipeline above).

6.) In December 2012, HALO announced an agreement with Pfizer to develop and commercialize biologic agents using Halozyme's Enhanze (hyaluronidase-based) drug delivery technology in up to six targets. Pfizer paid HALO an initial cash payment of $8 million for the initial two targets along with the right to add four more targets (additional fees apply) and the deal also includes potential regulatory and sales-based milestone payments of up to $507 million plus royalties.

FINANCIAL STATS (Q2 2013 results press release):

- On August 12 & 14, director Kathryn Falberg purchased a total of 100,000 shares of HALO on the open market at an average price of $6.82 increasing her stake to 280,000 shares (SEC filing link) while CEO Gregory Frost exercised options into 20,000 shares of common stock which increased his large ownership stake to approximately 3.6 million shares (SEC filing link).

- On 8/14/13, Swiss BB Biotech reported a 5.1% ownership stake (5.75 million shares) in HALO (SEC filing link).

- HALO currently has a high percentage of insider and institutional investors which account for nearly 70% ownership of outstanding common stock and includes major holders such as Randal Kirk / Third Security (combined ownership stake of 23.3 million shares which equates to a 20.6% ownership stake) and Baker Brothers (6.5 million shares).

- Randal Kirk is a billionaire biotech entrepreneur who recently netted over $1 billion on the highly successful IPO for Intrexon (XON) (Forbes overview article) and he also serves on the Board of Directors for HALO.

- As of 6/30/13, HALO reported $76 million (M) in cash and equivalents with $11.4M in cash used to fund operations during Q2 2013.

- During 2Q13, HALO reported revenue of $14.5M vs. $7.8M in the year-ago period.

- As of 8/5/13, HALO reported approximately 113M shares of common stock outstanding with $29.7M in total debt as of 6/30/13 ($26.1M classified as long-term debt which reflects a term loan from Oxford Finance and Silicon Valley Bank with a maturity date of 12/1/16).

- HALO has provided guidance for potential to be cash flow positive in 2014 (PR link) based upon key partner product launches that include HyQvia, Herceptin-SC and MabThera-SC in Europe with adequate cash to fund operations into late 2014 based upon the current cash and burn rate with an expected decrease over time as additional revenue offsets R&D expenses for the Company's three wholly owned programs (HTI-501 for cellulite, Hylenex for use w/ insulin pumps and PEGPH20 for pancreatic cancer).

TRADE SUMMARY & OUTLOOK:

With final European approval for Herceptin-SC due any day now and a very likely (90%) positive CHMP opinion for MabThera-SC in the near-term; I expect shares of HALO to fill the gap-down in the chart if positive news comes in as expected in the coming weeks with the potential to reach low double digits during H2 2013 ($10-12 target) as additional catalysts approach and the Company continues narrowing the cash burn with a goal of becoming cash flow positive by next year.

I believe the decision by ViroPharma (VPHM) to discontinue development of Cinryze-SC will have no impact on other programs as discussed by HALO on the most recent quarterly conference call and the enzyme-related antibodies have never been linked to any side effects with no clinical impact observed to date for an issue that was known in summer 2012 and being addressed by Baxter as part of plans to resubmit a BLA for HyQvia which is already being marketed in Europe following approval earlier this year.

In addition, HALO spiked by approximately $2 earlier this year on both Phase 1b pancreatic cancer data for PEGPH20 and again in late June on the positive CHMP opinion for Herceptin-SC so there is potential for another $1-2 upside each for upcoming Phase 1b data being presented on 9/30 and an expected positive CHMP opinion for MabThera-SC.

Other recent bullish developments include a recent open market insider/director buy for nearly $700,000 and bullish trading in the September $7.50 and October/December $10 call options so in the short-term, I expect the positive uptrend in the six-month chart below to continue with an upper $7-lower $8 short-term swing / run-up target with key risks being potential for an overall market correction and unexpected bad news on any of the upcoming regulatory or clinical trial catalysts which would have the potential for downside risk that is similar to the upside targets outlined earlier.

(click to enlarge)

Disclosure: I am long HALO. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)

How would you like your alerts on   delivered?

Added to your bookmarks on the Seeking Alpha homepage

new SA.Pages.Article.bookmark("_bottom");

View the original article here

Purchasing Individual Medical Health Insurance 3 Essential Tips From the Medical Health Insurance Specialist

When you are purchasing individual medical health insurance, you'll most likely get overcome through the prices and options of health plans online. Medical health insurance has become one of the most costly products within the budgets of numerous people, but it is also among the best choices you are making for those who have some know-how choosing the best health arrange for your family. Here' provides you with the three Essential Tips which i advise my clients to make use of when buying individual coverage of health.

Tip 1: Don't take medical health insurance advice from someone that's totally unqualified to provide you with these tips!!

I am unable to stress this enough. It shocks me the number of sensible people take assistance with what medical health insurance to select from those who are totally unqualified to provide you with this critical advice. For instance, after i see medical health insurance messes, (that we see just about any day) and that i request where they were given their own health plan information, I inevitably hear such things as: "My buddy-in- law explained to select this health plan, he utilized to work on a healthcare facility.Inch or "I just read articles that states this is actually the best plan available." And so forth. Everyone's got a viewpoint by what health plan you need to choose. Just since they're your relative, or involved with some section of healthcare totally unrelated to insurance, does not necessarily mean they are fully aware the solutions for your individual needs and questions! Readily insurance specialist Prior to the problems show up! You've no clue the number of clients I've labored with arrived at me once they decided on a health plan on the internet and then have a coverage problem and expect me to repair it, I wish to let them know: you ought to have arrived at me for help before! Most insurance specialists get compensated through insurance service providers, so their services can you. Rely On Them!!

Tip 2: Determine your actual needs.

The 3 items to bear in mind when identifying your requirements are: budget, designs of physician and hospital visits, and prescription medication usage. Request yourself these questions: How often would you go to your physician? Do you opt for examinations only or do you opt for sick visits? The number of occasions are you currently within the hospital previously 24 months? Would you take regular medications? What exactly are they? Generic or Brands? This really is another area where the majority of my clients neglect. It's not easy to have maximum coverage in most of those areas in almost any affordable way, maximum coverage for that physician and hospital plus medications leaves a dent or dimple within the budget. However, most medical health insurance plans offer several version of the identical plan. For instance, if you have "health plan A" that provides maximum coverage for that physician, maximum coverage for that hospital, and maximum coverage for the prescription medications. But "health plan A" costs just like your mortgage. The good thing is "Health Plan A" probably also offers easy to customize options, meaning if after examining your requirements, you uncover that you simply rarely go to a hospital, you can change "health plan A' s" hospital coverage to moderate or perhaps minimal that will bring lower the premium a good deal. If these choices are confusing for you, again, any adverse health insurance specialist will have the ability to assist you to. They're already conscious of "health plan A' s" easy to customize features and may suit your must the right form of "health plan A". Any adverse health insurance specialist also can access versions of health plans that are not available as choices to the typical consumer purchasing .

Tip 3: Resist the need to in excess of-insure!!

After you have examined your requirements, resist the need to in excess of-insure! Probably the most common medical health insurance messes I see has ended-insurance. People believe that should they have maximum coverage for doctors, hospitals, and medications, they've "good" insurance. The simple truth is, many people who definitely are approved for individual medical health insurance will not need all of this coverage. A couple of things I counsel my clients to understand: Healthcare Reform and prevent-Loss. First, Healthcare Reform enables for maintenance services to become covered at 100%. For instance, should you only get examinations, why sign up for the program with 100% doctor's visit coverage? Sign up for the program having a lower premium and pay a $10 copay for the sick visit. The main difference in premium with this particular small detail is $hundreds of dollars! In addition, a few of these "maximum coverage" medical health insurance plans exclude such things as pregnancy. The final factor for you to do is pay a lot of money for "good" medical health insurance simply to uncover it will not cover something you require it for! Second, most medical health insurance plans possess a stop-loss included in them which essentially states that whenever your out-of-pocket costs achieve a specific amount, the program covers you at 100% for those services. And you do not need the "maximum coverage" arrange for this benefit. Your wellbeing insurance specialist may even personalize this stop-loss amount!

Then, choose your plan after following My 3 Essential Tips:

1. Don't take medical health insurance advice from someone unqualified to provide these tips. Seek any adverse health insurance specialist, they've analyzed and therefore are licensed to provide these tips and they are liberated to you. Rely On Them!!

2. Consider your actual needs. Request yourself questions so guess what happens your particular health plan needs are, that method for you to make certain you choose an agenda that fits them. In the end, if you do not understand what you really need inside a plan, how would you determine if you've run into the best fit?

3. Resist the need to in excess of-insure! Healthcare Reform has transformed the number of plans work and you'll have the ability to receive ample or superlative coverage without over-covering. And more importantly, with no hefty rates!

That's it, online medical health insurance consumers! I really hope it was useful!

View the original article here