Posts Tagged by life science

NuGEN Launches BaseSpace Cloud App to Help Streamline NGS Analysis

 Sequence data generated with NuGEN’s target enrichment technology can be processed in BaseSpace using new app to mark duplicates and perform quality trimming
San Carlos, CA -OCT. 6– NuGEN Technologies is pleased to announce that scientists and clinicians using its Ovation Target Enrichment System to prepare biologic samples for genomic analysis can now process resulting sequence data in BaseSpace–a cloud computing platform, hosted by Illumina, Inc.
“NuGEN’s new Ovation Target Enrichment System Data Processing Application will allow the large community of Illumina sequence platform users to further streamline the rapid and convenient workflow of our Ovation Target Enrichment System products,” said Alan Dance, VP of Marketing at NuGEN.

The Ovation Target Enrichment product line employs Single Primer Enrichment Technology (SPET), a novel approach for enrichment of genomic DNA targets or cDNA for RNA target regions. SPET products allow researchers and clinicians to quickly and accurately enrich biologic samples for sensitive detection of a wide range of genomic markers including mutations, SNPs, indels, gene fusions, alternately spliced transcripts and copy number variants.

The new NuGEN-application, published on BaseSpace on September 30, provides an intuitive user interface for uploading sequence data. The application performs quality trimming and probe trimming on the parsed data – removing data derived from bases with low sequencing quality scores and aligning high quality data to the UCSC human reference genome.
Subsequently, PCR duplicate reads created during the library amplification process are identified using a random N6 sequence, unique to the Ovation Target Enrichment System workflow positioned adjacent to the barcode index.

Output files from the Ovation Target Enrichment System Data Processing Application for BaseSpace include processed BAM files with PCR duplicates removed or marked, processed FASTQ files with duplicates removed, and UCSC bigWig tracks with duplicates removed for visualization using the UCSC human genome browser.

For full details, visit http://www.nugen.com/content/ovation-target-enrichment-system-data-processing-application.
NuGEN Technologies Inc. is a rapidly-growing, privately-held company providing innovative products and systems for the preparation of biologic samples for targeted genomic analysis. Founded in 2000 and based in San Carlos, CA, NuGEN has long been at the cutting edge of genomic technology, with accurate, cost-effective reagent kits for even the most challenging sample types. NuGEN products are used in more than 1000 leading life science institutes and in diagnostic and pharmaceutical companies in 40 countries.
Media Contact:
Anita Harris, Harris Communications Group

The Harris Communications Group is an award-winning PR and marketing firm specializing in outreach for health care, life sciences and technology, worldwide.

 

Life Science PR: 3 Companies Validate NGS Sample Prep Workflow

MULTI-SITE STUDY VALIDATES END-TO-END RNA-SEQ SAMPLE PREP WORKFLOW FOR HUMAN WHOLE BLOOD CLINICAL SAMPLES
System integrates PreAnalytiX GmbH and NuGEN Technologies innovations to ensure reliable, reproducible, cost-effective RNA-Sequencing analysis. Corporate study alliance model critical to standardization, bringing genomics to the clinic.

San Carlos, CA and Piscataway, NJ, July 15, 2015— A multi-site study has clinically validated an end-to-end workflow for the collection, storage, transport and preparation of human whole blood samples for RNA-Sequencing (RNA-Seq). The study, initiated in January 2015, integrated products from PreAnalytiX GmbH and NuGEN Technologies, which worked collaboratively with RUCDR Infinite Biologics at Rutgers University to measure the system’s efficacy for transcriptome profiling with clinical samples.

“We have determined that the PreAnalytiX/NuGEN integrated workflow ensures reproducible, accurate and sensitive results in RNA-Seq of whole blood. Importantly, this integrated workflow enables gene expression from total RNA, allowing researchers to study both protein coding and regulatory transcripts from human whole blood,” said Dr. Andrew Brooks, Chief Operating Officer of RUCDR Infinite Biologics, who led the study. Brooks is also an associate professor of Genetics at Rutgers University and directs the Bionomics Research and Technology Center at the Environmental and Occupational Health Science Institute there.  Brooks will outline the study results on Tuesday, July 14 at the  International Leaders in Biobanking Conference, in Toronto.

“This study is critical for clinical researchers because it demonstrates that by using the combined PreAnalytiX and NuGEN workflow, scientists in laboratories around the world can confidently share not only their data but also their samples,” Brooks said.  “And, by joining forces to validate the combination of their proprietary technologies, PreAnalytiX and NuGEN have taken the lead with RUCDR to deliver the standardization needed for broader adoption of genomics in the clinic.”

Brooks explained that total RNA derived from patient blood samples is used for a myriad of clinical genomics applications—such as discovery and analysis of disease-related biomarkers, identification of new therapeutic targets and monitoring disease progression and treatment. But there are factors that present challenges to data integrity when using whole blood. Collection, storage, purification, handling and transport methods may vary. Nucleic acids can degrade during handling and processing, resulting in unreliable results and bias in transcript abundance. Whole blood also contains high levels of uninformative ribosomal RNA and reticulocyte globin RNA, which can reduce sequencing efficiencies and increase costs.  Moreover, variation between sites and operators makes it difficult to standardize results among researchers and laboratories. “If researchers across multiple sites obtain different results, we need to be sure the variations are attributable to changes in the biology and not the technology,” he said.

At the Biobanking Congress, Brooks reported tight correlation in results across three sites in New Jersey with multiple operators, using several nanograms of total RNA from each of 10 subjects. That is, using PreAnalytiX technology for extraction, storage and transportation of samples and NuGEN technology for library formation and depletion of ribosomal RNA and globin prior to whole transcriptome analysis, the study team found high reproducibility of results across sites, operators and equipment. “The combined workflow led to reproducible whole blood collection and storage; reproducible and robust RNA extraction; reproducible and consistent library creation; and tight performance correlations across and within sites,” he said.

“This integrated sample prep workflow will be important for scientists seeking new genetic biomarkers for disease. It will be valuable to pharmaceutical clinical trials for determining if a therapeutic leads to genetic changes in a particular cancer. And it is  important to the future of clinical research because it allows the development of guidelines and standards for scientists who want to share samples, not just data, globally, across sites and experiments,” Brooks said.  “Without such standardization, many results might never advance to the clinic.”

The study used the PreanalytiX  PAXgene Blood RNA System for whole blood collection, storage and RNA extraction and NuGEN’s Insert Dependent Adaptor Cleavage (InDA-C) technology from the NuGEN Ovation Human Blood RNA-Seq System  to prepare strand-specific RNA-Seq libraries and for ribosomal/globin depletion. RUCDR Infinite Biologics oversaw sample collection, processing and data analysis.

About NuGEN

NuGEN Technologies is the leader in providing solutions which make biological samples accessible for genomic analysis, enabling scientists to capture the truest biology achievable, independent of the quantity or quality of the samples. The company has commercialized numerous proprietary DNA and RNA sample preparation products for use in research and diagnostic applications. Founded in 2000, NuGEN Technologies, Inc. is privately held and headquartered in San Carlos, CA. For more information please visit www.nugen.com

About RUCDR Infinite Biologics

RUCDR offers a complete and integrated selection of biological sample processing, analysis and biorepository services to government agencies, academic institutions, foundations and biotechnology and pharmaceutical companies within the global scientific community. RUCDR provides DNA, RNA and cell lines with clinical data to hundreds of research laboratories for studies on mental health and developmental disorders, drug and alcohol abuse, diabetes and digestive, liver and kidney diseases. RUCDR completed an $11.8 million expansion and renovation of its facilities in May 2013. Read more at www.rucdr.org

NuGEN and Ovation are registered trademarks of NuGEN Technologies, Inc.. PreAnalytiX and PAXgene are registered trademarks of PreAnalytiX GmbH.

The Harris Communications Group is an award-winning Life Science PR and thought leadership firm based in Cambridge, MA. 

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Reimbursement, Regulatory Expert Edward Berger Joins HarrisCom Advisory Board

I’m more than happy to announce that Ed Berger, CEO at Larchmont Strategic Advisors,  has joined the Harris Communications Group Advisory Board.

Ed has worked for nearly 30 years in healthcare , medical technology and  life science fields.  His expertise encompasses biomedical regulatory and reimbursement policy as well as corporate communications.

He  brings a wealth of experience  and insight to our group and to our clients.

As a member of the senior management teams of Fresenius Medical Care, Thermo Cardiosystems and ABIOMED, Dr. Berger exercised responsibility for strategically sensitive communications with government agencies, news media and investors and served as principal corporate spokesperson through numerous crises and other high visibility events.

Through his consultancy, Larchmont Strategic Advisors, he helps life sciences companies create and implement integrated strategies to address the obstacles and opportunities they face in their efforts to secure public and private insurer coverage and optimal reimbursement for new or evolving technologies.

Focusing on issues that arise at the intersection of public policy, corporate strategy development, and internal and external advocacy, Dr. Berger helps clients to deal effectively with the strategic challenges posed by the rapidly evolving healthcare regulatory and policy environment.  His clients have included companies in fields such as mechanical circulatory support, cardiology, orthopedics, neural monitoring and neuromodulation, gastrointestinal surgery, pulmonary medicine, nuclear medicine, diagnostic imaging, clinical laboratory testing, and personalized medicine.

Dr. Berger is a member of Mass Medical Angels, a mentor in Boston University’s IGNITE program, and Past President of the Medical Development Group, a 400 member professional association of individuals professionally committed to the medical device and related life sciences business sectors.

He has a Bachelor’s Degree in Government from Harvard College, and earned his Ph.D. in Political Science at Boston University, where he was later Assistant Professor of Political Science and Chair of the Urban Affairs and Planning program.

–Anita M. Harris

Anita Harris is the founder and managing director of the Harris Communications Group — an award-winning public relations firm specializing in integrated strategic communication, content marketing and thought leadership   for clients in healthcare, life sciences, technology and energy, worldwide.  Based in Kendall Square, Cambridge, HarrisCom  on the pulse of some of the most innovative ideas, technologies and products,  anywhere. 

 

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Scientia Advisors Names Randy Goodman Manager of Pricing and Market Access Group

Pleased to post the press release we wrote for Scientia Advisors–
–Anita Harris

Health economics, policy & reimbursement expert to help healthcare, diagnostics, biotech, medical device, health IT and pharma companies bring products to market

Randy Goodman, PhD, a nationally recognized expert in pricing, reimbursement and managed care, has joined global strategy firm Scientia Advisors as manager of the firm’s Pricing and Market Access Group, Scientia Advisors announced, today.
Scientia Advisors is a global management consulting firm specializing in strategy, operations and pricing/reimbursement for major and emerging companies in healthcare, life sciences, pharma, biotechnology, and health IT. The firm’s Pricing and Market Access Group helps companies determine how best to introduce and develop pricing structures, and obtain reimbursement from third-party payers–within a context of highly competitive industries and rapidly changing health and regulatory systems, worldwide.
“Dr. Goodman comes to Scientia with a wealth of experience in the managed care, medical device, and biotech industries,” said Harry Glorikian, Scientia Advisors’ founder and managing partner. “He has directed pricing, reimbursement and managed markets strategies for a variety of US and global healthcare and device companies and has served as a consultant to the White House on health reform. We are delighted to welcome him to our firm.”
Immediately before joining Scientia, Dr. Goodman was Consultant/Director of health economics, reimbursement, managed markets and government relations for Welldoc, Inc., a leading provider of mobile health diabetes solutions in the US.
Previously, he served in a similar capacity for medical device/equipment companies ImpediMed, Inc., in San Diego; Access Mediquip, LLC, in Houston; and Hoveround,Corporation, in Sarasota. At–where, at various times, he has overseen he oversaw and managed strategic development, financial analysis, clinical reimbursement policy, regulation and financial analysis, business development, sales and marketing, among other duties.
Dr. Goodman served as a Health Care Reform Policy Consultant to the White House Office of Health Reform in 2009 and 2010 and counseled and collaborated with the White House and Congress on health reform proposals in 1992 and 1993.
He holds a PhD in Health Policy and Master of Health Administration from Harvard University and a BA from the University of Texas. He is a fellow in the American College of Healthcare Executives, a Director of the National Association of Specialty Health Organization, among other affiliations.

Scientia Advisors, headquartered in Cambridge, Massachusetts, is a global management consulting firm specializing in growth, operations and pricing/reimbursement strategies for companies operating across the healthcare industry value chain. Strategies developed by Scientia Advisors are fueling growth of the leading firms in biotechnology, medical devices, diagnostics, pharmaceuticals, and health and nutrition.

Anita Harris is managing director of the Harris Communications Group, an award-winning PR, digital and content marketing firm based in Cambridge, MA.

TauRx launches phase 3 trial for early-dementia drug

Very pleased to be working on outreach to let people know about the launch of phase 3 clinical trials for a promising new drug from UK/Singapore company TauRx that is aimed at halting the progression of frontotemporal dementia (FTD).

FTD is an early dementia that affects an estimated 50-60,000 Americans, most between 40 and 60, but some even younger. FTD, often called Pick’s disease, encompasses a group of disorders that affect behavior, emotions, communication and cognition.

As described in a May 5, 2012, page 1 story in the New York Times</a>, “FTD is different from Alzheimer’s, the most common form of dementia…But it is perhaps even more devastating, because it strikes younger people, progresses faster and, unlike Alzheimer’s, does not attack memory at first but begins with silence, apathy or bizarre personality changes.”

What is more, the Times reports, the scientific findings in frontotemporal dementia may also reshape thinking about the fundamental flaws involved in Alzheimer’s disease.

Tau Rx’s latest press release follows. It lays out the science, describes the company, and includes information about how to get more information about the trials.

–Anita M. Harris, President
Harris Communications Group

Phase 3 clinical trial begins in early form of dementia 10 September 2012

Investigational drug study follows earlier study with promising results in mild to moderate Alzheimer’s patients

Manchester, UK – TauRx Therapeutics today announced the initiation of a global Phase 3 clinical trial in a type of Frontotemporal Dementia (FTD) also known as Pick’s Disease. The announcement, which immediately follows The 8th International Conference on Frontotemporal Dementias, held 5-7 September in Manchester, England, underscores the need for new treatments for this form of dementia that is similar to Alzheimer’s Disease, except that it tends to damage different areas of the brain and affects people as early as 40 years old.

The study focuses on a type of FTD known as behavioural-variant, or bvFTD, which can cause early changes in personality and loss of empathy. A large percentage of these patients have a specific pathology that involves abnormal collections of tau protein in the brain.

The study drug, LMTX®, targets a process in the brain whereby a normal form of tau protein begins to self-aggregate due to binding neuronal waste-products. Once the process has started, the aggregates are able to propagate themselves indefinitely, using up normal tau protein and converting it into the toxic aggregates. After destroying the nerve cells where they are initially formed, the aggregates go on to infect nearby healthy neurons, progressively spreading and accelerating the destruction throughout the brain. LMTX® stops this aggregation process in its tracks and releases the trapped tau protein in a form which can be easily cleared by nerve cells.

In a pilot series of cases, LMTX® was found to arrest the progression of the disease. LMTX® has been found to act in a similar way on the aggregation of TDP-43 protein. Tau or TDP-43 aggregates each account for about 50% of patients with this early form of dementia.

Speaking to patients and caregivers at the FTD conference in Manchester, Professor Bradley Boeve of the Mayo Clinic in the U.S., one of the investigators of the study, said: “Clinicians devoted to FTD clinical trial development have been refining the measures to use in an experimental trial in FTD spectrum disorders for years, and frankly have been waiting for a promising agent. The basic science data for this agent, particularly in the tauopathies, looks sound and the excitement among investigators and among families is high.”

The Phase 3 double-blind placebo-controlled study is designed to evaluate the safety and efficacy of LMTX®, the second-generation Tau Aggregation Inhibitor (TAI) developed by TauRx. The study aims to confirm the results first seen in the pilot cases in a larger controlled clinical trial in bvFTD patients over a 52-week timeframe. Participating study sites are located in Canada, U.S., U.K., Germany, The Netherlands, Australia and Singapore. Because the condition is relatively rare, TauRx was granted Orphan Designation for LMTX® in 2010, which provides a basis for more rapid approval for marketing if the trial is successful.

“This is an important step forward in our quest to find an effective treatment, with a goal to actually arrest the progression of the disease,” said Professor Claude Wischik, founder and CEO of TauRx Therapeutics and Professor of Old Age Psychiatry at the University of Aberdeen. “We are building on over thirty years of research, and the encouraging results from our previous Phase 2 clinical trial in Alzheimer’s Disease, which is also correlated with abnormal tau aggregates in the brain.”

TauRx previously tested rember©, the first-generation TAI on which LMTX® is based, in a Phase 2 clinical trial involving 321 patients with mild and moderate Alzheimer’s Disease in the UK and Singapore. This study found a 90% reduction in the rate of disease progression over two years in Alzheimer’s Disease. Professor Wischik and his team have spent nearly 24 years investigating the structure and role of Tau tangles in the development of Alzheimer’s disease, FTD and other neurodegenerative diseases. They were the original discoverers of the Tau protein pathology of Alzheimer’s.

“It’s very exciting news that a treatment is being tested for FTD in a clinical trial,” said Penelope Roques of the Frontotemporal Dementia Support Group in the UK. “This is encouraging progress in a disease where there is currently no treatment available.” The group has about 1,000 members across the UK, ranging from FTD patients, caregivers and family members.

If successful, this will be the first investigational drug that is able to arrest the progression of this disease. TauRx Therapeutics, a Singapore-based company spun out of the University of Aberdeen, developed the novel treatment based on an entirely new approach which targets aggregates of abnormal fibres of tau protein that form inside nerve cells in the brain. The TauRx team have since discovered that LMTX® could also have beneficial effects on other proteins which aggregate abnormally, including TDP-43 in FTD and synuclein in Parkinson’s disease. In FTD, the frontal and temporal lobes are affected first, which impacts behaviour and emotion. As the disease progresses, other parts of the brain are affected, eventually producing a global dementia.

Patients and caregivers are invited to sign up for future updates as more news is available at www.PicksDementiaStudy.info.

About Pick’s Disease:

According to the Association for Frontotemporal Degeneration (AFTD), bvFTD – or Pick’s disease as it was originally known – can cause early and progressive changes in personality, emotional ‘blunting’ and loss of empathy. A person with the disorder may have difficulty controlling their behaviour, which can result in socially inappropriate responses or actions. Language may also be impaired after behavioural changes take place, as well as neurological symptoms such as movement and coordination difficulties. Over time, these symptoms worsen. The bvFTD form of the disease is particularly aggressive and progresses faster than Alzheimer’s disease.

About TauRx:

TauRx Therapeutics was established in Singapore in 2002 with the aim of developing new treatments and diagnostics for a range of neurodegenerative diseases based on its technology platform. The TauRx team includes highly skilled and internationally recognised pharmaceutical experts in drug discovery and development. The company’s Tau Aggregation Inhibitors (TAIs) include rember® and LMTX™, the second-generation drug that is being studied in Phase 3 clinical trials in Alzheimer’s and FTD. TauRx is headquartered in Singapore with primary research facilities in Aberdeen, Scotland.

Collaboration a key trend at 2012 BIO International Convention, Boston

Had a great time at the BIO International Convention in Boston, last week. Met teams from Norway, Australia, France, India, Israel…not to mention New York, North Carolina, Maryland, Oklahoma, etc.

Attendance, at 15,000, was down from its  25,000 high here five years ago but I found participants friendly and accessible.  HarrisCom advisor Christa Bleyleban said she counted more than 70 parties or networking gatherings (not a few of which I attended).

While the overall theme was” innovation,” it was a trend toward collaboration that I noticed most.

 

At a meeting sponsored by Polaris Ventures, industry execs and VCs discussed the shift of VC funds from biotech to the tech sector–which is occurring in part because tech investments can lead to quicker returns. One observer commented that pharma companies themselves are the new VCs–investing in early stage research rather than doing the research themselves.

In that regard, I  partnered with the Communications Strategy Group on a press conference and outreach in which the Swiss company AC Immune  announced a $400M licensing agreement with Genentech for development of an antibody to combat Alzheimer’s disease.

Also of interest was a keynote talk, sponsored by Scientific American, in which CNN’s Fareed Zakariah asked whether the US will continue to maintain its lead in technologic innovation.

For  more details,  please visit  my postings at New Cambridge Observer.

–Anita M. Harris

Anita Harris is President of the Harris Communications Group, an award-winning  PR, marketing and communications firm headquartered in Cambridge, MA.

UK Life Science Consulting Firm Alacrita to launch US HQ in Cambridge, MA

Met the other day with Rob Johnson, who will soon be launching UK-based Alacrita, a global life science consulting firm, to Cambridge, MA.

Johnson  co-founded the company two years ago with  Anthony Walker, who had previously served as Executive Director of Global External R&D Europe at Eli Lilly. Johnson had led business development at Onyvax, a biotech company that developed biopharmaceuticals to combat cancer.

Drawing on the capabilities of more than 50 consultants worldwide, Alacrita provides strategic, operational, technical advice or hands-on project management to organizations of all sizes in the pharma, biotechnology and life science industries, Johnson said.

The company name is based the Latin, “alacritas,” or “lively.”It is meant to convey “a cheerful readiness.”

Clients may be academic institutes, tech transfer experts, life science investors, startups or established companies in need of expertise in business development and marketing, intellectual property, product development, and regulatory affairs, according to Johnson.

Whitepapers available for free on Alacrita’s Web site  include:

  • Biotech in Israel: A Land of Promise » May 2012 – by Anthony Walker, PhD
  • FDA Approvals Provide Reason For Cheer » March 2012 – by Robert Johnson
  • Deal Watch Annual Review 2011 » January 2012
  • Viewpoint: Pharma Industry Myths » January 2012 – by Anthony Walker, PhD
  • Europe’s stellar decade of prostate cancer innovation » September 2011 – by Rob Johnson
  • Are we all biotech now? » June 2011 – by Anthony Walker and Rob Johnson
  • China: Opportunities for biotech firms » March 2011 – by Rob Johnson and Li Zeng
  • Re-Profiling: a Hidden Threat to Originators? » February 2011 – by Dr Jo Davies
  • Deal Watch Annual Review 2010 » January 2011 – by Roger Davies and Jill Ogden
  • Mitigating Out-sourcing Risk » December 2010 – by Robert Johnson and Anthony Walker
  • Deal Watch: a Review of Notable Deals » October 2010 – by Sharon Finch

Alacrita’s US offices will be located in the Cambridge Innovation Center in Kendall Square, Johnson said.

 

–Anita M. Harris

Anita Harris is president of the Harris Communications Group, a strategic PR & marketing communications firm located in Cambridge, MA.

 

 

Clarifying CIC Venture Cafe’s New Policy

Just spoke with Venture Cafe manager Chris Myles, who said he’ll  be providing more information about Venture Cafe’s new incarnation shortly–including the list of affiliated organizations whose members may attend without applying.   Those do include the Cambridge Innovation Center and various entrepreneurial groups…

Chris said the The Cafe’s new incarnation is not meant to be elite or exclusionary–but rather to encourage participation from the innovation community. More to follow.

 

–Anita Harris

 

Anita Harris is the founder and president of the Harris Communications Group of Cambridge, MA. HarrisCom is a strategic communications firm specializing in public relations, thought leadership, marketing communications and social media for emerging companies and research institutes in health, science, technology and energy, worldwide.   She also blogs at New Cambridge Observer.  

Harris Communications Advisor Robert Langer Founds Blend Therapeutics

Life Science Startup to  Target Multiple Disease Mechanisms

I’m pleased to report that Harris Communications Group Advisory Board Member Robert Langer of MIT is involved in yet another life science startup.

It’s a biotech company called “Blend Therapeutics” that will develop a new class of medicines possessing  “unprecedented ability to precisely control each agent’s therapeutic action in concert… ”  The goal is to   “predictably, effectively, and safely target the multiple mechanisms underlying complex diseases, ” according to a press release.

Blend was founded by three leaders in the fields of chemistry and nanomedicine:  Langer, who is David H. Koch Institute Professor at the Massachusetts Institute of Technology;   Stephen J. Lippard, PhD, Arthur Amos Noyes Professor of Chemistry at MIT; and Omid Farokhzad, MD, Director of the Laboratory of Nanomedicine and Biomaterials and Associate Professor of Anesthesia, Brigham and Women’s Hospital and Harvard Medical School.

Blend has received financial backing from  Flagship Ventures, New Enterprise Associates and NanoDimension.

Langer said:  ” We see unparalleled opportunity to translate innovative science into important drugs for patients in need, and we’re excited by the strength of our founding investors and management who share our vision of building a successful biotechnology company that is foremost about improving the lives of patients.”

In addition to Langer, Lippard and Farokhhzad,  Blend’s  Scientific Advisory Board includes eight thought leaders in the fields of chemistry, cancer biology, immunology and medicine:

• Dennis Ausiello, MD, Chief of Medicine and Jackson Professor of Clinical Medicine, Massachusetts General Hospital and Harvard Medical School

• Philip Kantoff, MD, Chief Clinical Research Officer and Professor of Medicine, Dana Farber Cancer Institute and Harvard Medical School
• Alexander Klibanov, PhD, Novartis Professor of Chemistry and Bioengineering, Massachusetts Institute of Technology;
• Ulrich von Andrian, MD, PhD, Mallinckrodt Professor of Immunopathology, Harvard Medical School
• Bruce R. Zetter, PhD, Charles Nowiszerski Professor of Cancer Biology, Children’s Hospital Boston and Harvard Medical School.

MaestroTM is a trademark of Blend Therapeutics, Inc. More information is available at http://www.blendtx.com.

 

—Anita M. Harris

Anita Harris is the president of  Harris Communications Group, a  Cambridge, MA  public relations firm specializing in strategic marketing communications,  thought leadership and social media for companies involved in health, science, technology and energy, worldwide. She also blogs at newcambridgeobsersver.com. 

 

 

PhotOral launched to develop “blue light” consumer device to combat gum disease

[Disclosure:  please see below]

Two Forsyth Institute scientists and a Lexington, MA entrepreneur have launched PhotOral (TM)to develop and market the first consumer device using  blue light to combat gum sisease.

Scientists Nikos Soukos, director of Forsyth’s  Applied Molecular Photomedicine Laboratory and J. Max Goodson, senior member of the staff,  found when testing the effectiveness of blue light in tooth whitening equipment,  their patients’ gum health improved.  They determined through research published in 2005 (see below)  that such light can selectively kill pathogenic oral bacteria–without harming so-called “good bacteria” that exist in normal mouths–and began work on a device.

This year, Forsyth received a patent for the proposed blue-light treatment method;  Soukos, Goodson and entrepreneur Stamatis Astra founded PhotOral; and, in September, PhotOral received an exclusive license from Forsyth to commercialize the technology.

The device  will  look  “either like a mouth guard or a lollipop,”   Soukos said.

It will work by shining certain light wavelengths onto the teeth, which act as mirrors to deliver the light to dental pockets between the teeth.  Inserted into the mouth twice a day for 30-60 seconds, it should selectively target pathogenic bacteria and, as a cumulative effect, suppress them to prevent periodontal disease. It will not replace brushing or flossing–but, rather, will allow consumers an additional method for improving their oral health.

Most current consumer treatments–such as flossing, tooth brushing and antiseptics–seek to eliminate all sorts of the 700 bacteria found in the mouth,  Soukos explained.  But some of those bacteria are beneficial.  “Our device aims to selectively target ‘bad bacteria’ in order to restore a healthy balance in the mouth.”

By doing so,  the team hopes to help prevent or treat gingivitis, which occurs in 90% of adults, and periodontitis, which affects some 34% of adults in the US over 30.  Severe periodontitis, which may be treated with medication, by scaling and planning or surgically,  affects 13% of all adults. It can lead to loss of bone and teeth and is suggested as a risk factor for coronary based heart disease, atherosclerosis, pre-term births and chronic kidney disease.

Stamatis, the PhotOral CEO,  said he  is currently raising funds  to support prototype production, clinical trials and marketing operations. “The potential market for the device is  greater than $7B”

 

Scientific background: 

Soukos and Goodson’s research, published in the April, 2005 Journal of Antimicrobial Agents and Chemotherapy, suggested that light in the blue region of the visible spectrum might be useful in preventing, controlling or treating periodontitis-an oral infection that can lead to loss of bone and teeth.

Among the most destructive oral bacteria are the so-called  “black-pigmented” bacteria  (BPB), which are implicated as pathogens associated with periodontitis. Such bacteria accumulate black pigment consisting mainly of organic compounds called porphyrins . Some porphyrins are photosensitive and, when activated  by light, induce a photodynamic reaction that kills the microorganism within seconds.

Before starting their research, Soukos and Goodson knew that other  researchers had used lasers to deliver red or green light, which partially inactivated certain oral bacterial. The team also knew, from published reports, that porphyrins absorb blue light more readily than light that is red or green.

The Forsyth scientists employed a halogen lamp source commonly used for tooth whitening to shine broadband light composed mainly of  blue and a small percentage of green light on pure cultures of BPB and on dental plaque samples obtained from individuals with chronic periodontitis. They found that the light rapidly killed BPB in pure cultures and that it selectively eliminated BPB in plaque samples containing 50o0-6000 different bacteria. They also found that certain species were more readily inactivated by the light than others and that varying the intensity and exposure time had different impacts on different bacterial species. The researchers concluded that intraoral light exposure can selectively reduce pathogens in dental plaque.

 

–Anita M. Harris

Anita Harris is president of the Harris Communications Group, a Cambridge, MA public relations firm specializing in strategic communications,  thought leadership and content strategy for companies and organizations in health, science and technology, worldwide.  The Forsyth Institute and Goodson are former clients; Soukos serves on her advisory board, and she is an unpaid advisor to PhotOral.  Harris won a 2006 International Communicator Award for her work in publicizing  the Forsyth “Blue Light ” paper.  She also blogs at New Cambridge Observer.