Kaleidescape teases movie download store; brings Rotten Tomatoes, Leonard Maltin to its servers

Last year at CEDIA we were introduced to Kaleidescape's iPad control app, and this year its back and enhanced with the addition of movie ratings from Rotten Tomatoes, and content rating info from Common Sense Media. Rotten Tomatoes can help viewers tell if a particular flick in their collection is any good, while Common Sense Media is built around detailed breakdowns of what potentially objectionable content is in each title so parents can decide what their children are ready to see. Both should reach end users with the free app by the end of this year. Another tweak it's adding to its movie servers is the Leonard Maltin Recommends Collection. It's a pack of movies updated quarterly (the 17-disc Blu-ray collection is available for the low, low price of $445) that the respected film critic feels are unappreciated greats, to which he adds his own thoughts, anecdotes and behind the scenes info.

A more ambitious development however, is the Kaleidescape Download Store the company was giving an "early sneak preview" of behind closed doors. While its claim to fame has always been disc servers that store user's movies, making them accessible with as little physical media interaction as possible (and antagonizing the MPAA) its next step is a full digital media distribution service, potentially tied into UltraViolet. There's not a lot in the way of specifics, but it will be interesting to see how Kaleidescape and Hollywood get along when it comes to selling downloadable content compared to the old wars of the past, whenever the new service actually arrives for its high-end customers.

Continue reading Kaleidescape teases movie download store; brings Rotten Tomatoes, Leonard Maltin to its servers

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Health Reform on Capitol Hill

The hotly debated discussion over health care reform has just heated up even more. As Kimberly Dozier reports from Washington, the senate casted its first vote on Health Care Reform.
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Health Care for Part-Timers

Most Americans have health insurance coverage from their employers, but only 60-percent of employers even provide health benefits. The numbers are worse for part timers. Michelle Miller reports.
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Is "Tremendous Momentum" Building On Health Care?

Sens. Ben Nelson (D-Neb.), Joe Lieberman (I-Conn.) and Jay Rockefeller (D-W.V.) spoke with Bob Schieffer about the momentum building for health reform in the Senate, even though apprehension exists over abortion language.
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Sunglasses Important for Eye Health

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Stephen works with a painter at one of the company's resorts, and realizes that the both the tools and method of performing his painting duties are inefficient and could even be hazardous.
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Health Care Fight Not Over

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A new ??leaf?: Sheamus discusses his devastating submission hold

Thanks to some persuasive health and safety arguments made by Harvard-educated legal expert David Otunga on the Sept. 7 edition of SmackDown, blue brand General Manager Booker T announced that World Heavyweight Champion Sheamus? Brogue Kick is officially prohibited from use. Although banning this incapacitating boot to the face seemingly puts The Great White at a disadvantage as his Night of Champions clash with Alberto Del Rio approaches, Sheamus has recently made an addition to his arsenal that more than levels the playing field.

On Monday Night Raw, the World Heavyweight Champion put away Jack Swagger in surprising fashion by utilizing a rarely seen Cloverleaf submission maneuver, a leglock innovated by WWE Hall of Famer Dory Funk Jr. (WATCH) Then, after Booker T handed down his shocking Brogue Kick-barring decree on SmackDown, The Celtic Warrior utilized the move once again, this time making Otunga ? the very Superstar that lobbied to have Sheamus? signature boot banned ? tap out. (WATCH | PHOTOS)

It?s no secret that Sheamus owes a great deal of his success over the past year to the Brogue Kick; besides earning him an 18-second World Heavyweight Title victory over Daniel Bryan at WrestleMania XXVIII, the move has helped him retain that title for the last five months. Yet even though Sheamus? signature pump kick has been his chosen method for finishing off his opponents, one would be unwise to underestimate the self-described ?hooligan?s? technical versatility.

?No matter what, you have to keep evolving. I?ve always believed that,? the World Heavyweight Champion told WWE.com. ?I?ve always tried to keep adding to my move set, and the one thing I?ve never fully utilized is a submission hold.?

Sheamus explained that WCW and WWE alumnus Dean Malenko, a competitor synonymous with the move commonly referred to as the ?Texas Cloverleaf,? inspired him to master the hold.
(MORE ON DEAN MALENKO)

?Dean was one of the greatest submission experts ever, and as history has seen, he?s made hundreds and hundreds of Superstars tap out [to the Cloverleaf],? Sheamus said. ?It?s one of the most agonizing and painful submission holds, and it?s also one of the most effective. Plus, being Irish, the Cloverleaf fits me well.?

By ?fitting? him, The Great White is also referring to how relentlessly brutal the Cloverleaf is. Once properly applied, the move compresses an opponent?s legs while putting a strain on the spine and abdomen.

?I?m a brawler, and most of my moves impact the backs of my opponents,? Sheamus said, referring to a gamut of maneuvers that includes the notorious Irish Curse backbreaker and his punishing White Noise. ?The Cloverleaf definitely capitalizes on a weaker back, especially when you lock it in and sit back on it.?

Four-leafed clovers ? a rarity, as they commonly have only three ? are a symbol of good luck according to Celtic lore, but this Cloverleaf could spell misfortune for Del Rio at Night of Champions on Sept. 16. For the first time in both Superstars? tumultuous history, Sheamus has perfected a submission hold that can match up to The Mexican Aristocrat?s excruciating Cross Armbreaker.

?Del Rio?s Cross Armbreaker submission is highly effective ? it just recently made Randy Orton tap out,? Sheamus said, referencing The Viper?s No. 1 Contender?s Match with The Mexican Aristocrat on the Aug. 24 edition of SmackDown. (WATCH | PHOTOS) ?Alberto and I know each other very well, fella, but this will hopefully give me the edge going into Night of Champions, so I can finally put him away once and for all.?

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Source: http://www.wwe.com/shows/smackdown/2012-09-07/sheamus-discusses-cloverleaf-submission

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Source: http://www.jeroen-uyttendaele.org/?p=17895

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Being Obese yet Healthy? | FITNESS TOGETHER - 1 Client, 1 ...

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Source: http://ftcustomfitness.blogspot.com/2012/09/being-obese-yet-healthy.html

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Ex-NFL star Strahan becomes Kelly Ripa's co-host

Former football player Michael Strahan, right, poses Kelly Ripa on the set of the newly named "Live! with Kelly and Michael" on Tuesday, Sept. 4, 2012 in New York. Strahan joined the popular morning show as a permanent co-host on Tuesday, fulfilling a joking prophecy he made to Regis Philbin more than four years ago. The gap-toothed former New York Giant jogged onto the morning show set and picked up co-host Kelly Ripa in a bear hug, lifting her off her feet. He replaces Philbin, who left last November. Strahan was the survivor in a series of on-air tryouts of potential co-hosts since Philbin left, and his hiring has been an open secret for the past two weeks. (Photo by Charles Sykes/Invision/AP Images)

Former football player Michael Strahan, right, poses Kelly Ripa on the set of the newly named "Live! with Kelly and Michael" on Tuesday, Sept. 4, 2012 in New York. Strahan joined the popular morning show as a permanent co-host on Tuesday, fulfilling a joking prophecy he made to Regis Philbin more than four years ago. The gap-toothed former New York Giant jogged onto the morning show set and picked up co-host Kelly Ripa in a bear hug, lifting her off her feet. He replaces Philbin, who left last November. Strahan was the survivor in a series of on-air tryouts of potential co-hosts since Philbin left, and his hiring has been an open secret for the past two weeks. (Photo by Charles Sykes/Invision/AP Images)

Former football player Michael Strahan, right, sits with Kelly Ripa on the set of the newly named "Live! with Kelly and Michael" on Tuesday, Sept. 4, 2012 in New York. Strahan joined the popular morning show as a permanent co-host on Tuesday, fulfilling a joking prophecy he made to Regis Philbin more than four years ago. The gap-toothed former New York Giant jogged onto the morning show set and picked up co-host Kelly Ripa in a bear hug, lifting her off her feet. He replaces Philbin, who left last November. Strahan was the survivor in a series of on-air tryouts of potential co-hosts since Philbin left, and his hiring has been an open secret for the past two weeks. (Photo by Charles Sykes/Invision/AP Images)

Former football player Michael Strahan, left, jokes with Kelly Ripa on the set of the newly named "Live! with Kelly and Michael" on Tuesday, Sept. 4, 2012 in New York. Strahan joined the popular morning show as a permanent co-host on Tuesday, fulfilling a joking prophecy he made to Regis Philbin more than four years ago. The gap-toothed former New York Giant jogged onto the morning show set and picked up co-host Kelly Ripa in a bear hug, lifting her off her feet. He replaces Philbin, who left last November. Strahan was the survivor in a series of on-air tryouts of potential co-hosts since Philbin left, and his hiring has been an open secret for the past two weeks. (Photo by Charles Sykes/Invision/AP Images)

This undated photo shows former football player Michael Strahan, right, and host Kelly Ripa during Strahan's guest-host appearance on "Live! with Kelly," earlier this year in New York. Strahan is getting a permanent job in morning television as Kelly Ripa's co-host. Strahan replaces Regis Philbin on the syndicated "Live! With Kelly" show, adding his name to the title. The gap-toothed former New York Giant is currently a host of "Fox NFL Sunday." He was one of several men to get tryouts with Ripa as the show rotated several potential replacements since Philbin left last November. (AP Photo/Disney-ABC Domestic TV, Donna Svennevik)

FILE - This May 22, 2011 file photo shows former NFL football player Michael Strahan at The 26th Annual Sports Spectacular The Hyatt Regency Hotel Century City in Los Angeles, Calif. Strahan is in talks to be named co-host of "Live!" beside Kelly Ripa. Strahan, a former NFL star and currently co-host of "Fox NFL Sunday," was in negotiations to be named as replacement for Regis Philbin, according to a source familiar with the talks. Broadcasting & Cable, citing multiple sources with knowledge of the situation, said ABC was expected to announce him as co-host in early September. (AP Photo/Katy Winn, file)

NEW YORK (AP) ? The only worry on Michael Strahan's mind when he made his entrance Tuesday as the new co-host of "Live!": "Don't trip," he summed up after the show.

He didn't.

When Kelly Ripa introduced him, the gap-toothed former football player jogged onto the morning show set and gathered her up in a bear hug, lifting her off her feet.

"When I was hugging Kelly, that's when I was calming down," Strahan explained.

The rest of the hour was clearly a snap for him and for Ripa, who was getting a permanent partner nine months after Regis Philbin retired from the show and after having welcomed Strahan and 58 other guests in the chair beside her.

Taking his seat on Tuesday, the former New York Giant joked that it felt "comfy, like it was molded for my body."

Strahan was relaxed, amiable and playful, and drew "ahhhs" from women in the studio audience when he presented Ripa with a dozen red roses.

"It's so nice to have a co-host literally sweep you off your feet," Ripa told viewers, "and I know that he can bench press me if he wanted to."

Maybe his arrival was fulfilling a prophecy. Ripa played a clip of Strahan's first appearance on the show in 2008, shortly after the Giants had won the Super Bowl. Philbin asked Strahan what he would want to do after retiring from football, and Strahan said that Philbin's job looked pretty good.

"I was joking," Strahan said on Tuesday, "and I'm glad the joke came true."

Strahan's hiring has been an open secret for the past two weeks. His selection was made official a couple of minutes into what, since November, had gone by the stripped-down title "Live! With Kelly" and now rechristened "Live! With Kelly and Michael."

Or rather, "live! with kelly and michael." Eyeing the brand-new all-lowercase logo during a commercial break, the co-hosts pondered whether the first letters of their names would look better capitalized.

During their breezy first "host chat," Strahan amusedly shared from a list of obnoxious pet names for women ("babe" and "sweet cheeks" among them). The pair discussed parenting policies, in particular how much money the Tooth Fairy should award for a lost tooth.

"Homeland" star Claire Danes was the first guest, followed by singer Phillip Phillips.

Then Olympic gold-medal gymnasts Aly Raisman and Jordyn Wieber each teamed with one of the co-hosts in a challenge on balance beams. Strahan was totally game for the stunt, which called for carrying eggs balanced on a spoon. (The two teams tied with 13 eggs apiece.)

After the broadcast, Strahan downplayed any suggestion the show would be changing much.

"I think you have two people who can laugh at themselves, who can laugh at each other, who have a good time, who get along ? and make sure that anyone who watches the show enjoys it," Strahan said. "I think it's the same formula."

The formula was cooked up by Philbin, the original host, nearly 30 years ago. Ripa joined him in 2001.

Executive producer Michael Gelman, who oversaw that transition from Kathie Lee Gifford to Ripa, was asked how Strahan emerged as the favorite in the current competition.

"Chemistry isn't something you can really put your finger on," he said. "But there was something special individually with Michael, and the chemistry was there."

Ripa, declaring that she had had "a little bit of a say" in Strahan's selection, said, "I wear my heart on my sleeve, so it's pretty obvious that I love him. So I was definitely on board."

"It seems like we've been doing it all along," she added.

In return, Strahan said Ripa has "done a great job for 11 or 12 years, and hopefully we'll do it for the next 11 or 12 years."

In the meantime, he will continue as a host of "Fox NFL Sunday," which originates from Los Angeles, where he lives. He will commute to New York to do "Live!"

How will he handle that routine?

"Get on a plane," he cracked. "Coming here during the week and doing this show, it's fun. I don't look at it as if it's a chore."

Before bringing Strahan out, Ripa joked about the lengthy search, advising people to stop sending her resumes.

"I have enjoyed every single solitary person ? except for one," she said. "The staff is laughing because they know that's true."

Asked afterward who that one spoilsport had been, she stated with a laugh, "I would never reveal the co-host I did not enjoy being with."

"But I will!" Strahan jumped in.

"He figured it out," said Ripa, offering yet more evidence of their rapport. "He watches the show and he knows my body language."

___

AP Television Writer David Bauder contributed to this report.

Associated Press

Source: http://hosted2.ap.org/APDEFAULT/3d281c11a96b4ad082fe88aa0db04305/Article_2012-09-04-TV-Ripa's%20Co-Host/id-d9f6a754291144c4bc6827a936dfec83

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Parental income increasing; should I inform student finance? - The ...

Discussion and questions about student financial support arrangements - from government loans and grants to university bursaries. Please use the main Money & Finance forum for more general financial topics.

1. Junior Member Thread Starter Join Date: Feb 2012 Posts: 34

   Parental income increasing; should I inform student finance? So, I've already organised all my student finance and got the confirmation through and everything, but just last week my mum got a new job with more money. Do I need to inform student finance, or do they base it on last year's tax income? I've had conflicting advice from people, some saying they base it only on last year's income, and other people saying I need to inform them of the increase. What have you heard about it?

2. Exalted Member Join Date: Feb 2012 Posts: 339

   Re: Parental income increasing; should I inform student finance? So, I've already organised all my student finance and got the confirmation through and everything, but just last week my mum got a new job with more money. Do I need to inform student finance, or do they base it on last year's tax income? I've had conflicting advice from people, some saying they base it only on last year's income, and other people saying I need to inform them of the increase. What have you heard about it? http://www.direct.gov.uk/en/Educatio...rted/DG_171586 Although do they base it on last years tax I think you still have to change it. Just ring them up just to be safe.

3. Exalted Member Join Date: Feb 2012 Posts: 339

   Re: Parental income increasing; should I inform student finance? I have a similar question to anyone else answering this: i'm living with my mum now and my student finance is based on our income this year. but once i've moved from this home to start university i'm not allowed to return. I'm being kicked out. So will next years finance be based on me living with her or me living alone? as i will no longer have a 'home' to go to and no household income? It will be based on you living alone, since your being kicked out they'll be no-one 'funding/helping' you as well as someone with an income. I'd still recommend ringing student finance just to be safe. Where will you be staying then if you don't mine me asking?

Source: http://www.thestudentroom.co.uk/showthread.php?t=2110662

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Carpool from your phone: Ride-sharing apps take off

More and more Americans are opting to leave the driving to others ? and taking advantage of the growing number of ride-sharing apps available today. Here are four of the most popular.

By Suzanne Kane,?Guest blogger / September 2, 2012

Traffic stacks up in front of the carpool van dubbed "Don't Worry Be Happy" on the highway south of Atlanta in this 2006 file photo. With the number of ride-sharing apps now on the market, it might be the perfect time to convince some of the 76 percent of commuters who drive alone to start buddying up.

Ric Feld/AP/File

Enlarge

From urban dwellers to long-distance commuters, more and more Americans are opting to leave the driving to others ? and taking advantage of the growing number of ride-sharing apps available today.

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The potential audience is huge. Census survey data shows the percentage of people car-pooling has remained around 10 percent for several years. Some 5 percent of commuters use public transportation and a whopping 76 percent drive alone. But convincing people to give up a car and share a ride with a stranger? With the number of ride-sharing apps popping up recently, it could just be that the time is right.

While some are limited to certain cities or geographic areas, other startups have intentions of going national, while yet still more are already doing business nationwide. The basic principle is the same: passengers looking for a ride use the app to post their request and the app searches for drivers in the vicinity willing to provide rides. Security concerns about riding with a stranger are handled by thorough prescreening. Cost of the ride varies, with some fares a voluntary donation at a recommended amount. User ratings help keep things on an even keel. A low rating of a passenger may mean drivers will refuse that person?s ride request in the future.

Here's a round-up of a few of the larger ride-sharing operations currently available.

SideCar

San Francisco-based SideCar launched its on-demand ride-sharing app at the end of June, available for iPhone and Android devices across the U.S. SideCar vets drivers with a background check, proof of valid insurance, proof of driver?s license and proof of registration. Rides are also tracked using GPS. As for passengers, they need to register with a valid credit card.

Zimride

Passengers in need of a local or long-distance ride can hook up with Zimride, now serving San Francisco, Los Angeles, Sacramento, Tahoe and Las Vegas. The app uses Facebook to enable real connections: setting up a profile, booking a ride or posting a ride. What?s it cost? Recent postings on the site included $40 per passenger from Los Angeles to San Francisco, $35 per person from Santa Barbara to Berkeley, and $40 per person from Oakland to Los Angeles.

Lyft

From Zimride, Lyft is an on-demand ride-sharing app competitive with SideCar. Lyft screens drivers, runs criminal background checks, and conducts a phone interview followed by an in-person interview with prospective drivers. Lyft rider fares are voluntary, based on a community average. Like SideCar, Lyft has a rating system for drivers and passengers. Drivers and passengers authenticate using Facebook. Currently, Lyft is only available in San Francisco using iPhone.

Avego

Using the Avego iPhone app, drivers can offer their unused seats to other people in real-time. The app combines GPS-enabled real-time ride-matching with fully automated payment transaction management, safety features, real-time passenger information, and commute reporting. At the end of the journey, Avego automatically charges the rider a fair and predetermined price for the trip, based on a per-mile default rate. Users (driver and passenger) rate each other using 1 to 5 stars. If either rates the other with 1 star, they will never again be matched together. See our previous coverage of the Avego ride-sharing app or check out the video below for more details.

The Christian Science Monitor has assembled a diverse group of the best auto bloggers out there. Our guest bloggers are not employed or directed by the Monitor and the views expressed are the bloggers' own, as is responsibility for the content of their blogs. To contact us about a blogger,?click here.?To add or view a comment on a guest blog, please go to the blogger's own site by clicking on the link in the blog description box above.

Source: http://rss.csmonitor.com/~r/feeds/csm/~3/ks00LAW8xG8/Carpool-from-your-phone-Ride-sharing-apps-take-off

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Public Speaking for Beginners - Persuasive Oral Presentation Tips ...

In Part I of this series, I have discussed three tips to help you to make your oral presentation more persuasive. It is my hope that you will apply these tips in your next presentation. Do you think I have more tips to share? Of course! Welcome to Part II of this series and let?s continue our discussion.

1. Use of Flip Charts and Not PowerPoint

Can I share with you a real story? Recently, I was talking to one of my clients regarding a training engagement and we were debating the use of flip charts vis-?-vis PowerPoint slides.

As a Certified Trainer in Accelerated Learning Method, I am fully aware that PowerPoint is not an effective training tool because participants will focus on the slides more than the trainer. If you agree with me, can you sense or feel the detrimental effect it might create on your presentation? Regardless of how good you think your presentation might be, your participants do not really care as their focus is on the slides. How many of you know what I am talking about?

Here is my feedback. Use flip charts if you want your oral presenstation to be more?persuasive. There are certain techniques I use when writing words or drawing pictures on the flip charts. Guess what? My participants will be anxious about what I am doing on my flip charts and indirectly, they will also pay attention to what I am going to say too. Is that good news to you as a trainer?

2. Mind your Body Language

How many of you have seen trainers who remained standing in the same position throughout the entire session? If so, how many of you would find it challenging to stay focused because these trainers did not exhibit any body language? Personally, I can relay to this because I was exactly like this during my early career as a trainer. Somehow, I feel that it has something to do with a trainer?s self-esteem and confidence although I cannot prove to you that?s the case.

As my mentor suggests, some people decide to become trainers because the Universe takes the view that these people have their own message to share with other people. One of the key lessons I learnt as a trainer is to identify the ?Bigger Me? inside my body. My mentor told me that the bigger I feel I am, the more powerful my message will be. How many of you can relay to this?

As soon as we are confident in delivering the message, amazing thing will happen. What is it exactly? Our body and mind will become congruent, making our oral presentation more persuasive and powerful. Guess what? Your participants will feel this. Conversely, if a trainer is not confident in delivering his message, would you agree that his body and mind would not be congruent? Do you think that his participants will be able to tell that he is nervous? If so, do you also agree that his oral presentation may not be persuasive and powerful at all?

3. The use of VAK Learning Style

What is VAK? It stands for ?Visual, Auditory and Kinesthetic?. Each of us has our own learning style. What this means is that as trainers we have to be flexible and increase our vocabulary of actionable words to cater to different learning styles of our participants.

For example, how many of you notice in this article, sometimes I use ?feel? as the verb and other times I use ?think? as the verb. ?Feel? is more for kinesthetic learners while ?think? is more for visual learners. Another example is the use of ?see? and ?tell?. The word ?see? is more for visual learners while the word ?tell? is more for auditory learners.

I hope you understand that whether our speech is considered persuasive is a matter of our audience?s perception. Appropriate use of actionable verbs that cater to different learning styles of your participants will increase your chance to engage the entire group, making your oral presentation more persuasive and powerful.

4. Practice, Practice and More Practice

You should have heard this before. The word is ?practice?. Public speaking is a learnable skill. After you have prepared a speech, say it out loud and have it record so that you can identify any room for improvement before the actual delivery. If possible, get your friends and colleagues involved in this process too as it would be beneficial for you to hear any constructive feedback and suggestion from them.

I hope you will find my sharing useful. If you have any comments or experience to share, please drop a note in my website as I would love to hear them.

Source: http://empoweredrangers.com/2012/09/04/public-speaking-101-public-speaking-for-beginners-persuasive-oral-presentation-tips-part-ii/

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Speed Reading | How To Memorize - Self Help Hypnosis

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Source: http://selfhelphypnosis.co.uk/reading-and-comprehension-speed-reading-how-to-memorize

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North Lake Tahoe Real Estate Sales August 2012 Comparison ...

• North Lake Tahoe Real Estate Sales?August 2012 Comparison

In?August the number of Sold Residential properties?had a significant increase?compared to 2011 and 2010 consolidating July numbers and showing a healthier Real Estate market in the Incline Village and Lake Tahoe area. Helped by a lower Sales Price there were 15 Homes sold in?August 2012, compared to only?9 in?August 2011 and 7 in August 2010.

• Residential Home Sales Report

- Please note that the report above was created using data extracted from the MLXChange System and reflects Residential Property sales.

Also the Condominium Sales had a?big jump to 18 Sold Condominiums in?August 2012 compared to?9 Sold Condominiums?August 2011 and August 2010.

- Please note that the report above was created using data extracted from the MLXChange System and reflects Condominium sales.

To access all the Incline Village and Lakeshore Realty listings please click here. You can also contact us by email or call us at 775-831-7000. If you are in Incline Village, please visit us at 954 Lakeshore Blvd. Incline Village, NV 89451.

Source: http://www.lakeshorerealty.com/Blog/North-Lake-Tahoe-Real-Estate-Sales-August-2012-Comparison

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Challenges and advances in biotech drug regulation | pharmaphorum

Posted 4th September 2012 in Articles, Interviews | Register to comment

Hannah Blake interviews Mark Richardson

Richardson Associates Regulatory Affairs Ltd

Mark Richardson shares his views on the regulatory landscape, with regards to the biotech industry, and how important it is for pharma to have a good relationship with their regulatory team starting with product development through to distribution and marketing.

Ahead of Management Forum?s Biotechnology for the non biotechnologist event, we speak with independent regulatory affairs consultant, Mark Richardson, about the regulatory aspect of the biotech industry.

Mark explains some of the regulation trends in the EU, compared with those in the USA and also shares his thoughts on what advances in biotech regulations we can expect to see in the next decade.

Interview summary

HB: Hello Mark thanks for taking part in this interview. Could you start by explaining your current role, please?

MR: Thank you for inviting me to contribute. I am an independent regulatory affairs consultant specialising in the development of small molecule, biotech and advanced therapy products. I provide advice and support to a range of organisations from academic spin-off virtual start-ups to blue chip global (bio) pharma companies, from clinical contract research organisations (CROs) to law firms and the European Commission. The majority of my clients are based in the EU and the US. The nature of the work varies considerably; compiling technical documents for clinical trial applications, programme compliance / gap analysis, advising on regulatory strategy, meetings with national and regional regulatory authorities, paediatric investigation plans, regulatory due diligence on licensing opportunities, orphan drug designations, expert witness in litigation, CRO business development and training in regulatory affairs. I work from my home just outside Oxford in the UK.

?

?What works well is enabling the regulatory team to be proactive in informing development decisions??

?

HB: How important is it for pharma to have a good relationship with its regulatory team?

MR: Of course it is very important, as are all of the relationships in a project team. Regardless of how the relationship is structured in terms of responsibilities, management and reporting lines, it is critical that there is open, continuous and clear communication between the regulatory function and the other elements of the development team. What works well is enabling the regulatory team to be proactive in informing development decisions by ensuring it has all of the facts at its disposal. It is not the role of the regulatory function to determine the development pathway, but it is important that the pathway should be fully illuminated to see the way ahead and to identify future potential hazards.

What works less well is when the project team uses the regulatory function as a post hoc compliance checking mechanism for isolated decisions taken out of the wider context of the programme. In these circumstances, the input might well be appropriate within the confines of the specific issue at hand, however it might not take into account related but (to the regulatory team) unknown activities or information which might have a consequential impact.

HB: How has the biotech regulation landscape in Europe changed in the past decade?

MR: In the past decade there has been nothing less than an avalanche of new regulation of medicinal products in the EU. We have seen a radical overhaul of the system of clinical trial regulation and the introduction of paediatric drug regulations, both of which have had a major impact on the development of all medicinal product types; Europe has led the world in the creation of a new and effective regulatory pathway and a library of guidance enabling the development and approval of biosimilar products; and it has established a body of regulation for the sector of highly innovative biological drugs known collectively as advanced therapies which were not previously well served.

?

?The success is manifested in the opening of the EU market for biosimilars in 2006??

?

Some of these new regulations have been more successful than others. At the top of the successful list must be the endeavour in biosimilars where Europe has effectively created the framework for regulators worldwide. There are now unambiguous expectations of the standard of similarity required between a biosimilar and the marketed reference product of which it is a copy version, and clear guidance on how to achieve this standard. The success is manifested in the opening of the EU market for biosimilars in 2006 and is being consolidated by the widening of the body of technical guidance to include more product types and the revision and updating of the existing guidance on the basis of the experience gained to date. The next significant landmark in this story will be the approval of the first biosimilar monoclonal antibody product, a copy of infliximab, which is currently under evaluation at the EMA.

The development of the biosimilar regulations and guidance has been rigorously science-led; a feature which the new advance therapies regulations also shares. This class of medicines includes cell and gene therapies and tissue engineered products, all highly innovative and technically very complex. In their case, the new tranche of regulation was required because the existing regulatory framework, which serves conventional small molecule and biotechnology derived protein products well, does not take into account the different level of complexity and diverse origin of the biological materials of which they are composed. In addition to the regulatory control of these different product specific attributes, there was also the need to ?close the gap? between the regulation of medicinal products and the regulation of medical devices; historically entirely separate regulatory domains in EU law. This becomes necessary because of the hybrid nature of matter and use of some tissue engineered products, for example matrix-supported tissue implants, which straddle the regulatory divide.

The greater harmonisation of clinical trial regulation across the EU in 2004 has been helpful, but needs to be further streamlined and the remaining differences between individual Member States must be mitigated or eliminated; a new framework has been published. The paediatric regulations have a clear and laudable purpose to ensure the appropriate development of paediatric drugs but their expectations are burdensome, inflexible, sometimes inconsistently applied and are very time and resource intensive.

HB: How does this compare with the regulatory trends in the US market?

MR: The US regulatory landscape over the last decade has been more tranquil in comparison to the EU. Unlike the EU, there has been no driver for fundamental change to clinical trial regulation. However, there has been the institution of broadly equivalent regulation ensuring the development of paediatric drugs under the Pediatric Research Equity Act, although this has a much lighter and more flexible framework which is far easier to navigate and comply with.

?

?The development of the biosimilar regulations and guidance has been rigorously science-led??

?

But the standout difference between the two jurisdictions over the decade is on biosimilars. The historical and legal origins of the regulation of small molecule drugs and generics (by CDER) and biologics (by CBER) effectively prevented the framing of a biosimilar pathway until there was a very significant change in the law in March 2010. FDA guidance followed in February 2012. The pathway and requirements for biosimilars in the US are broadly similar to those in the EU, but there are two categories of biosimilars. One which is equivalent to the EU standard of similarity and in a second, higher standard a biosimilar is ?interchangeable? with the reference product. Interchangeability enables drug selection (but not initial prescription) to be taken out of the hands of physicians, as is the case for generic medicines.

HB: What are the differences between regulating small molecule generics and biosimilars?

MR: The principle difference is that a small molecule generic can be manufactured and demonstrated to be essentially identical to its reference product and only very limited clinical bioequivalence studies can support approval. Neither of these is true for biosimilars because they are complex, heterogeneous products of inherently variable biological systems in which they are manufactured. Small differences between a biosimilar and the reference product (including the types of impurities) can have significant biological, immunological and / or clinical consequences. The demonstration of biosimilarity must therefore be a rigorous comparative assessment which demonstrates that, if there are any differences, the biosimilar must be indistinguishable in its clinical effects from the reference product. This is the focus of biosimilar regulation.

HB: One of the biggest challenges for start-up biotech companies is in understanding regulatory requirements and processes ? how best can this challenge be overcome?

MR: Start-up managements must recognise that regulation starts with the idea of the product and compliance must be built in at the very outset of the programme. They must obtain enabling advice by accessing the appropriate experienced resource. This is an integral part of the planning and the cost of the initiation of a development programme to avoid an early wrong turn.

?

?It remains to be seen whether or not EU biosimilar regulation will follow the ?two standard? model of the US??

?

HB: How can biosimilar products stand out in the competitive space, in order to achieve commercial success?

MR: This is much more a question of commercial and marketing strategy than of regulatory control. EU level regulation and legislation does not determine how or where biosimilars are priced, sold or prescribed. In essence, they are developed to be lower cost alternatives to their corresponding reference products which no longer have patent protection; in these respects biosimilars are no different from small molecule generic drugs. Their only differentiating characteristic when they first hit the market is price. It might be that subtle differences in safety and efficacy emerge as clinical experience accrues which could affect prescribing decisions, but any such claims would need to be very diligently substantiated.

HB: What advances in biotech regulations do you expect we will see over the next 10 years?

MR: I am encouraged to believe that advances and refinement of regulation in the biologicals and biotech sector in the EU will continue to be science-led. The evidence from the biosimilar and advance therapies regulations has demonstrated this principle well in the last decade. It remains to be seen whether or not EU biosimilar regulation will follow the ?two standard? model of the US, which is clearly driven by pharmaco economics. We can expect more tractable clinical trial regulation. The more foreseeable significant shift in the regulatory landscape has already begun where the science is leading, that is in personalised (or biomarker directed) medicines. One thing is absolutely for sure, there is unlikely to be less regulation.

HB: Thank you for your time, Mark.

?

?

About the interviewee:

Mark Richardson, PhD FTOPRA, is a Drug Development Regulatory Affairs Consultant and is also Director of Richardson Associates Regulatory Affairs Ltd.

After postdoctoral research in molecular biology at the Universities of Dundee and California at Berkeley, Mark joined British Biotech in 1988 to work on recombinant vaccines before becoming Head of Assay Development, then Biopharmaceutical Development Manager and subsequently moving into Regulatory Affairs with responsibility for rDNA products in preclinical and clinical development. In 1997 he moved to Groupe Fournier as Head of the Gene Therapy Development Unit to lead a European oncology clinical development programme. Joining the CRO sector in 1999, first with Orion Clinical Services and later with i3 Research, Mark headed and expanded the Regulatory Affairs departments providing advisory and regulatory support for global development and clinical investigation of recombinant proteins, gene and cell therapy products, as well as for small molecule drugs. In September 2008 Mark established the consultancy Richardson Associates Regulatory Affairs Ltd.

E: mark.richardson@richardsonassociatesra.com

T: +44 (0)1844 279821

M: +44 (0)7827 299566

This interview was coordinated by Management Forum.

How do you think biotech regulations will evolve in the next decade?

Source: http://www.pharmaphorum.com/2012/09/04/challenges-advances-biotech-drug-regulation/

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