Brazilian National Sanitary Surveillance Agency (ANVISA) Certifies Next Breath, LLC as a Center for In Vitro Pharmaceutical Equivalence

(PRWEB) March 18, 2014

Next Breath, LLC, a specialty Contract Research Organization (CRO) with analytical expertise for pharmaceutical, biotechnology, and consumer health product development focused on pulmonary, nasal, topical and ophthalmic delivery systems, is pleased to announce that the Brazilian National Sanitary Surveillance Agency (ANVISA) has certified the company as a Center for Pharmaceutical Equivalence (EQFAR). As a result, Next Breath is now integrated into the Brazilian Network of Analytical Laboratories on Health (REBLAS). ANVISA performed a week-long comprehensive audit of Next Breath's quality systems in November 2013.

The audit focused on ensuring that all quality systems, analytical capabilities, regulatory expertise and statistical capabilities meet ANVISA's rigorous standard for becoming an approved Center for Pharmaceutical Equivalence. The successful audit approves Next Breath for performing in vitro pharmaceutical equivalence and submission of Nasal, Dry Powder Inhalers (DPIs), and Pressurized Metered Dose Inhalers (pMDIs) drug products to the Brazilian authorities.

Only ANVISA certified laboratories are authorized to perform in vitro pharmaceutical equivalence testing. The Center for Pharmaceutical Equivalence certification makes Next Breath the only laboratory outside Brazil certified to perform in vitro pharmaceutical equivalence testing for use in the Brazilian market.

Julie Suman, R.Ph., Ph.D. President said, "Next Breath has been committed to working with ANVISA and our Brazilian partners for many years. Recognition as an EQFAR laboratory allows us to bring our scientific expertise and know-how to advance generic drug approvals. We are very pleased with this certification."

Badre Hammond, MBA, Associate Director of Business Development stated, "ANVISA's authorization is an important milestone for Next Breath. We will continue our ongoing efforts to reach new and geographically diverse partners in this space. The ability to support our partners will be greatly enhanced with Next Breath's direct engagement of ANVISA."

ANVISA

ANVISA is a regulatory body of the Brazilian government. It has a role similar to that of the FDA in the United States, and is responsible for the regulation and approval of pharmaceutical drugs. For more information, please visit: portal.anvisa.gov.br/wps/portal/anvisa/anvisa/home.

Next Breath

Next Breath, a member of AptarGroup, is a cGMP CRO for pharmaceutical, biotech and medical device companies that bring pulmonary, nasal, and ophthalmic drug products to market. Next Breath provides comprehensive solutions to the development processes from proof of concept to commercialization. Next Breath has led successful submissions for pulmonary and nasal drug products and devices in the US and international markets.

For more information, please visit http://www.nextbreath.net or http://www.aptar.com.

Next Breath Contact:
Badre Hammond, MBA +(1)352-642-2141 / badre(dot)hammond(at)nextbreath(dot)net

Increased ELISA Signal Using Plasmonix QuantaWell Plates

My ATM banks $1 million for iWebgate Technology acquisition

Wednesday, March 19, 2014 by Proactive Investors

My ATM Holdings (ASX: MYA) has completed a placement of 25 million new shares to sophisticated investors, raising $1 million at $0.04 per share.

In December last year, MYA entered into a Heads of Agreement to acquire iWebgate Technology, which controls patented software for data transfer security.

This could be integrated into ATM networking and information sharing, and may be particularly useful with cloud computing applications.

Since the acquisition was announced, MYA shares have risen tenfold to a high of $0.06, from $0.006, and last traded at $0.056.

As part of the transaction, MYA was required to advance $1 million to iWebgate, which it finalised in January.

Accordingly, the $1 million raised from this placement will be used to replenish MYA’s cash balance as it works towards completion of the acquisition.

Upbeat Update on Marion's Waste-to-Energy Plan

MARION, Iowa - Keynote speaker Craig Stuart-Paul, chief executive officer of waste-to-energy company Fiberight, told a luncheon crowd of 315 on Wednesday that his company will be able to keep 80 percent of what they toss in the garbage out of the landfill.

The message has been a welcome one for city and community leaders in Marion, which has the local Solid Waste Agency’s Site 2 landfill on its northern border.

Stuart-Paul told the Marion Economic Development Co.’s annual meeting that Fiberight will begin this summer to build a new garbage sorting, shredding and recycling facility in Marion’s industrial center at 4390 Third Ave. The facility should be up and running in the last quarter of 2014, he said.

Lon Pluckhahn, Marion’s city manager, said city regulatory steps have slowed down the "materials reclamation facility" by a few months.

He also said Fiberight’s Marion’s plan now comes in two phases, with the first phase creating 26 jobs and a possible second phase another 17.

Stuart-Paul’s $15-million investment in Marion is part of a larger project that includes the conversion and expansion of a former corn-based ethanol plant in Blairstown in Benton County into a plant that turns the organic material in trash separated in Marion into ethanol. The Maryland-based Fiberight calls its product Trashahol.

Stuart-Paul has been embraced by Marion city officials and the City Council leaders, who signed a development agreement with Fiberight last summer and committed to sending the city’s municipal solid waste to his facility.

The facility, though, needs significantly more trash than the city itself can steer its way in a county where agreements among cities call for garbage to be taken to the Cedar Rapids/Linn County Solid Waste Agency’s Site 2 landfill. The landfill, which opened its own $12-million recycling and resource-recovery facility in January, is just a few miles north of where Fiberight intends to build its waste facility in Marion. The Solid Waste Agency depends on revenue from garbage to support its operation and its community recycling and education programs, and so it has been looking on at the Fiberight plan with great interest and some skepticism.

After Wednesday’s speech, Stuart-Paul met with Karmin McShane, the executive director of the Solid Waste Agency.

After the meeting, McShane said she still wondered how Fiberight would make its plans work economically for the company.

Stuart-Paul said Fiberight began conversion work at the Blairstown facility in the second half of 2013, and he said construction to expand the existing facility there will begin in April.

Linn County Supervisor Brent Oleson, a Marion resident and chairman of the Solid Waste Agency, on Wednesday said Stuart-Paul made "a good initial salvo of arguments" at the Marion lunch event for why the Fiberight facility in Marion is a good idea.

Oleson said he views the proposed Marion garbage facility in two ways, as a Marion resident and Linn supervisor on the one hand, and as a Solid Waste Agency board member on the other hand.

"(In the first two roles), I’m excited, I want to learn more," he said. "Any time a company of that kind wants to come here and make that kind of investment in our community, it’s something to be excited about."

As a member of the Solid Waste Agency Board, he said he wants to review the plan more to make sure it is best for the county and the region.

"I have no reason not to think that," he said.

Stuart-Paul, who has worked in the recycling industry for years, said Fiberight has operated a small demonstration facility in Virginia for two years to work out the kinks in the waste-to-energy process.

The company has secured a $25-million loan guarantee from the U.S. Department of Agriculture’s biorefinery program as well as a $2.9-million grant from the Iowa Power Fund.

Fiberight is also in negotiations with the city of Iowa City to set up a garbage sorting facility at the Iowa City Landfill, from where it will take organic material — food waste, pizza boxes and diapers, for instance — and truck it to the Blairstown ethanol plant.

Stuart-Paul said he is building in Marion because of the city’s "unwavering commitment to zero waste" and the support from city officials to bring the Fiberight project to reality.

"At the end of the day, what’s not to love?" he said.

One questioner asked about odor, and he said garbage stinks. But he said an odor-treatment system will eliminate any odors outside the Marion plant.

Each year, one of the highlights at NBIA’s International Conference on Business Incubation is the announcement of those incubation programs and companies that have been selected as NBIA Incubation Award winners. NBIA Incubation Awards are internationally recognized standards of excellence; just being nominated is an honor in itself.

To find out which outstanding incubation programs, networks, clients and graduates have been nominated for these prestigious awards, click here.

To learn who has won this year’s awards, plan to attend the NBIA Incubation Awards Luncheon on Tues., May 20, in New Orleans.

Of course, to attend the luncheon you need to attend the conference. And if you attend the conference, you can enjoy substantial savings by taking advantage of the early-bird rates that will save you $100 on your registration fee – if you register byApril 4.

But the awards are only part of the conference. There, you’ll have access to informative and cutting-edge training sessions, incubator tours, in-depth workshops, changes to network with your fellow incubation professionals and so much more – all in exciting, romantic New Orleans.

There’s every reason for you to register today!

Newest Cyber Incubator Company, IntrusionOnline, Interview on Cyber Attack

The Maryland Department of Business and Economic Development this week is sponsoring Dancing with Startups, a partnering event series that pairs multinational corporations with innovative start-up companies in the areas of technology, media services, big data, and cybersecurity, among other industries.

The event is being hosted by Exelon Corp. and The Economic Alliance of Greater Baltimore and will take place in the CyberHive at bwtech@UMBC Research and Technology Park on March 11^th. Invited companies will make their pitches, then discuss with Exelon’s management team.

For more information, please contact Allie Gold, bwtech@UMBC Cyber Incubator Manager at golda@umbc.edu.

Light Point Security's Gonzalez takes on CEO role

Cyber startup Light Point Security has a new CEO, someone who has already been the face of the company without the formal title.

Zuly Gonzalez, chief operating officer at Light Point, will take on the title as CEO in a move she says has been discussed between her and her business partner Beau Adkins for the past five months but just became official.

Adkins had been CEO and will now just hold the role as chief technology officer of the firm.

“We had discussed it, but we kind of just dropped it because we weren’t really pushing it,” Gonzalez said of the CEO shift. “After I got back from RSA (a cyber conference in San Francisco) we had another conversation and we figured let’s just do it.”

Light Point, which launched in 2010, is based at bwtech@UMBC Research and Development Park.

Gonzalez was already performing the roles of a top executive, Adkins said.

“She has been doing a lot of public speaking for our company, she talks to customers, she coordinates sales, pilots, and partnerships, and she keeps us in the news,” he said.

Light Point now has four employees.