Spotlight on Bio Advances

Spotlight on Bio Advances

How to cure soldiers' invisible wounds

by E. Teresa Touey on 06/20/17

Reprinted from The Tennessean 6.16.17

By Teresa Touey

 Military veterans turned endurance athletes can bring awareness to the invisible wounds of war.

“Not an easy course for a blind man,” said U.S. Army Maj. Ivan Castro after completing the London Marathon with British Army Lt. Karl Hinett.

Six days prior, respectively carrying the Union Jack and the Stars and Stripes, they crossed the Boylston Street finish line of the Boston Marathon.  A shoe string in each hand guided them through 26.2 miles of Boston and London as they supported Heads Together, an organization launched a year ago by the British royal family’s Prince Harry, Prince William and Duchess Catherine.

With Castro and British veterans, Prince Harry led a panel at the spring Veterans’ Mental Health Conference at King’s College London.

“The assumption is that 90 percent of veterans have mental illness from service,” he said.  “This simply is not true.  Phrases like ticking time bomb fuels this misconception as incredibly unhelpful.  PTSD (post-traumatic stress disorder) is short hand for mental illness in the armed forces. It is too simple.

“What I mean by that is it is not always the right diagnosis for everyone. It is OK to have depression. It is OK to have anxiety.  It is OK to have adjustment disorder.

“My main fear is that people will not yet get the appropriate help due to the stigma surrounding the more common condition.  We all have mental health in the same way that we have physical health.  Heads Together is encouraging people to be more open without fear of judgment, prejudice or stigma.”

We send 1 percent of Americans into war to defend it.  How do the 99 percent bring healing to the injured soldier, especially for invisible wounds?

As Veterans affairs Secretary David Shulkin remarked during BRAIN TRUST 2017 at Harvard’s Medical School, “While VA is uniquely positioned to contribute to the care of veterans with traumatic brain injury, we’re able to accomplish so much more when we work strategically with our private and public-sector partners. We look forward to working with our partners to improve care for veterans — as well as all Americans — affected by brain-related injuries.”

Innovators in traumatic brain injury, head trauma and PTSD served up idea pitches to connect existing innovations with VA practitioners, veterans and caregivers to identify promising pathways for healing.

Nine panelists, including Patrick J. Murphy, former undersecretary of the Army and the first Iraq veteran to be elected to Congress, weighed the 15 pitches.

Innovators are risk takers.  Recent studies show a correlation between the science of the brain of Alzheimer’s patients and PTSD patients.  Past investments of public funds into the National Institutes of Health has reaped some of this progress, helping innovators to leverage public funds into private capital markets for new drugs and devices, which could provide relief to the ravages of a range of brain disease.  We must support the medical research innovation efforts at the NIH, VA, and Department of Defense, which could face funding cuts in this Congress.

“Watching these innovators get after proactive solutions to take care of our returning veterans is inspiring,” Murphy said.

For Ivan Castro, his 2017 Boston Marathon run was a “lucky charm seven.”

In the fall, both Castro and Karl Hinett will run in Toronto at Invictus Games 2017.  By next year, a second Boston marathon for Hinett will arrive while 15 innovators will be getting to solutions, too.

E. Teresa Touey is editor and publisher of Spotlight on BIO Advances. 

Invest in our veterans fighting post-traumatic stress

by E. Teresa Touey on 12/07/16

Reprinted from The Tennessean 11.22.16

By Teresa Touey

 Invictus Games helps raise awareness of veterans' needs as do research efforts and NFL support.

Prince Harry of Wales launched the Invictus Games in London in 2014, to “demonstrate the power of sport to inspire recovery, support rehabilitation and demonstrate life beyond disability.”

Prince Harry talks about the invisible wounds of war and encouraging veterans to talk and seek workable interventions for injuries to the brain, namely post-traumatic stress disorder and traumatic brain injury. He expressed these sentiments at the Symposium for Invisible Wounds in Orlando in 2016 where Disney’s ESPN Wide World of Sports hosted the 15 competing nations.

Speaking after President George W. and Laura Bush, and Prince Harry, retired U.S. Army Four-Star General Peter Chiarelli said “There is currently no biologically-based diagnostic tool for post-traumatic stress.”

Chiarelli has seen the devastation caused by brain injury among soldiers in Iraq while serving as vice chief of staff of the U.S. Army from 2008 until early 2012. He now leads One Mind, crisscrossing the U.S., challenging scientists to accelerate large-scale research through open science data-sharing and collaboration.

Making this invisible disease visible means eliminating the stigma around brain illness while addressing two daunting complexities beyond stigma:  the biology of the brain and resources.

Starvation of investment in the science and technology of the brain occurs.Per a Biotechnology Industry Organizationreport in 2015, venture funding of companies with drug therapy programs in psychiatric diseases was just under $900 million over the last 10 years representing 2 percent of total venture capital raised with a decline in the last five years of 49 percent.  Similarly, neurological diseases received just over $4.6 billion over the last 10 years, representing 12 percent of total venture raised, with a decline in the last five years of 40 percent.

A collaborative benefit might come from the approval of fluid and imaging biomarkers now in the Food and Drug Administration approval process. It would stratify patients with mild and moderate TBI and reduce risk in investments which could impact these patients worldwide.

Also, in March 2016, Rep. Tim Murphy, R-Penn., and Diana DeGette, D-Colo., leading the US House Committee of Energy and Commerce’s Oversight Subcommittee gathered many of the nation’s experts on concussions such as retired Col. Dallas Hack, former head of U.S. Army Brain Research.

Jeff Miller, the NFL’s lobbyist, publicly stated a relationship between football play and concussion.

Lastly, NFL Commissioner Roger Goodell announced in a letter dated Sept. 14: “As mentioned earlier, our new scientific advisory board will be tasked with identifying new targets for the next wave of research. More than $40 million in funding has been allotted in the Play Smart. Play Safe. Initiative for medical research over the next five years, primarily dedicated to neuroscience.

This is in addition to the $30 million that the NFL has already committed to the National Institutes of Health.”

In 2014, 7,400 veterans took their own lives or about 20 per day.  As Point72 Asset Management founder Steve Cohen remarked to the brain experts gathered at the Cohen Veterans Care Summit in September, 2016 at the Ronald Reagan Building in Washington DC, “That’s more deaths in one year than all Americans killed in Afghanistan and Iraq.”

Cohen, a hedge fund investor, is committing $325 million during a five-year period in free mental healthcare clinics for veterans led by Anthony Hassan as well as scientific research dedicated to PTSD and TBI diagnosis and treatment led by Magali Haas, M.D., Ph.D.

“The treatments we have today fall short. There are no cures,” Cohen said. “Together, we’re going to change that,” by placing our research “breakthroughs to use in our clinics so our veterans can benefit right away.”

Donating one dollar weekly at NFL game gates attended by generous NFL fans to charities supporting brain health like Invictus Foundation, One Mind, Cohen Veterans Bioscience, Cohen Veterans Network, or Give an Hour would have great impact.

Also, the NFL Players Association could encourage its members to do estate planning aimed at donating brains to science at death for progress on concussion.  We are Invictus. Onto the games in Toronto 2017.

E. Teresa Touey is editor and publisher of Spotlight on BIO Advances based in Glenolden, Penn.



Fighting PTS: Who's Ready to Help Veterans?

by E. Teresa Touey on 07/22/16

REPRINTED From the Delaware County Daily Times 4.2.16

 Got game? Athletes – war veterans - brought their fiercest game faces to Orlando. Watching at Walt Disney’s ESPN Center, I closed my eyes and gasped. Athletes with missing limbs crashing their wheelchairs into each other scoring rugby goals while seamlessly standing with prosthetics intact proudly receiving medals. No body has limits with a determined mind and open heart. 

 Captain Wales’ team raised a budget of $25 million promising, “We would be moved, inspired, and entertained. It was 10 sports, 14 nations, 410 medals awarded, 485 veteran competitors, 836 volunteers, 13 service dogs, and 1,008 friends and family, thousands of hours of grueling competition, and more smiles, tears, hugs and cheers that you could ever count.”

Mother’s Day afternoon kicked off with the Symposium for Invisible Wounds. Prince Henry of Wales’ most impactful service may be the fight to make the invisible disease visible. Speaking after former President George W. Bush and former First Lady Laura Bush, and Prince Harry, U.S. Army Four-Star General Peter Chiarelli, a retiree with four decades of service, emphasized to the international leaders, “There is currently no biologically based diagnostic tool for post-traumatic stress,” he explained.

For the last five years Chiarelli has led the non-profit One Mind, crisscrossing the nation challenging our scientists to accelerate large-scale research through open science data-sharing and collaboration. He saw the devastation caused by brain injury among soldiers in Iraq while serving as vice-chief of staff of the U.S. Army from 2008 until early 2012. 


Making this invisible disease visible means engaging the public in eliminating the stigma around brain illness. At the White House, the Obamas, surrounded by face-making service members, kidded Prince Harry about the projected games results. From Buckingham Palace, Her Majesty delivered a deadpan “please” when her grandson showed her the trash talk video tweet on his iPhone.

A light contrast to the two dauntingly serious complexities beyond the stigma: the biology of the brain and money. “There are 42 different scientific definitions of concussion,” Chiarelli lamented two weeks later at the annual One Mind Summit held near the Pentagon. 

Conquering the puzzle of brain science and medicine requires money. Many reservists return to jobs with commercial health insurance allowing for private medical attention. Thus, the Mental Health Parity Addiction and Equity Act of 2008 affects them. It requires our health insurers to treat equally physical and mental health benefits.

This law’s passage was led by two House members. Patrick Murphy did floor arguments as a congressman from Pennsylvania. He now serves as the Undersecretary of the Army and attended Invictus. Rep. Patrick Kennedy, D-Rhode Island, was the House lead author and worked with late Sen. Edward M. Kennedy, D-Mass., and Sen. Christopher Dodd, D-Conn., attaching it to TARP, the Troubled Asset Relief Program, signed by President Bush on October 2, 2008. In 2011, One Mind for Research Campaign was launched by Patrick Kennedy with the Staglin Family hiring General Chiarelli as CEO.

  Implementation has been slow on insurance company transparency. As Rep. Joseph Kennedy III, D-Mass., said on June 15 about HR2646, Helping Families in Mental Healthcare Crisis, passing out of the Committee on Energy and Commerce by a 53-0 bipartisan vote, “Despite good provisions, however, this bill is not good enough. No matter what improvements we make to our mental health system, no matter how many resources we commit, if we do not ensure that those suffering from mental illness are treated fairly by their insurance companies then we leave treatment and care out of reach for far too many patients in need. I appreciate Chairman Upton’s, R-Michigan, promise to hold a hearing dedicated specifically to parity this fall and look forward to working across the aisle to address this significant gap in our efforts to date. This bill is a small, bipartisan step forward, which is nothing to take for granted in Congress today.”

  Simultaneously, another mass shooting tragedy was unraveling. In a letter to Orlando’s Mayor Dyer, Prince Harry expressed “my sincerest condolences to the people of Orlando after the horrific attack on the Pulse nightclub on Sunday.”

Rep. Tim Murphy, R-Pa., was sparked to action by the devastating loss of children at Newtown, Conn. Rep. Eddie Bernice Johnson, D-Texas and he have spent three years leading passage of HR2646. They bring unique backgrounds: the only clinical psychologist and psychiatric nurse. Two co-sponsors from across the aisle were Rep. Pat Meehan, R-7, of Upper Darby, and Rep. Brendan Boyle, D-13. 

  In addition, there is the starvation of investment dollars to brain research. Per a Biotechnology Industry Organization report in 2015, venture funding of companies with drug therapy programs in psychiatric diseases was just under $900 million over the last 10 years representing 2 percent of total venture capital raised with a decline in the last five years of 49 percent . Similarly, neurological diseases were just over $4.6 billion over the last 10 years representing 12 percent of total venture raised with a decline in the last five years of 40 percent. 

Despite our competitive advantage in science and medicine and NIH funding increases in 2015’s federal budget, there is no time to spare. The adult son of Diana, Princess of Wales, “her spare,” is asking for ambassadors for the spirit of Invictus Joe and Jill Biden, Invictus Games Medal presenters, dedicated the new Joint Force Headquarters Delaware National Guard Reserve Center to their son, Major Joseph R. “Beau” Biden III on Memorial Day. The exact cumulative daily loss count matters to our vice president reminding us that we are Invictus.

I am. We are.

E. Teresa Touey, of Glenolden, is editor and publisher of Spotlight on BIO Advances

Urgent need for Alzheimer's research funding

by E. Teresa Touey on 01/25/16

This article appears in THE TENNESEAN (1.21.16)
By E. Teresa Touey, Contributor

The Dementia Discovery Fund is a recently created $100 million global fund to assist small biotechs and entrepreneurial ventures in finding a treatment or cure for Alzheimer’s. The fund is sponsored by the British government, the charity Alzheimer’s Research UK, Johnson and Johnson, Eli Lilly & Co., Pfizer, Biogen Idec and GSK.

“This fund is great news; however, funding for Alzheimer’s is still much lower compared to cancer funding,” said Christopher U. Missling, Ph.D., president and CEO of Anavex Life Sciences Corp., a publicly traded biopharmaceutical company headquartered in New York City.

Anavex’s lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, a combination of ANAVEX 2-73 and donepezil (marketed under the trade name Aricept), are in a Phase 2a clinical trial for Alzheimer’s. The ongoing, multicenter Phase 2a clinical trial in Melbourne, Australia, started in January 2015, with The Alfred Hospital as the lead site.

To support its operations and advance its clinical trial work, Anavex has secured key funding commitments and had approximately $15.3 million in cash and cash equivalents as of Sept. 30. The company also has filed a $100 million shelf financing and entered into a purchase agreement with Lincoln Park Capital to sell an aggregate of $50 million worth of shares. Anavex previously reported that it is fully funded through completion of the current Phase 2a clinical trial.

The multicenter Phase 2a clinical trial of ANAVEX 2-73 consists of two parts and a total of 32 mild to moderate Alzheimer’s patients. Part A is a simple randomized, open-label, two-period adaptive trial, crossing over between oral (30mg/50mg) and IV (3mg/5mg) administration, lasting up to five weeks for each patient. Part B is an open-label extension for an additional 52 weeks. Initially planned for 26 weeks, Part B, which is now underway, was extended to 52 weeks as a result of requests from patients and caregivers.

Encouraged by its findings, the company looks to advance ANAVEX 2-73 into a larger Phase 2/3 study for Alzheimer’s. It also hopes to initiate a double-blinded, randomized, placebo-controlled Phase 2 trial for ANAVEX 2-73 in an additional indication associated with cognitive impairment.

In July, Reps. Fred Upton, a Michigan Republican, and Diana DeGette, a Colorado Democrat, led passage of the 21st Century Cures Act by a 344-77 vote. Norm Ornstein wrote in The Atlantic, “The act does many things, including making research collaborations easier; promoting therapies like biomarkers to enhance personalized drug treatments, targeted at individuals and not just broadly at diseases; reforming and streamlining clinical trials and making it less challenging and expensive for companies to bring drugs to market; creating incentives for developing drugs for uncommon but deadly diseases; creating an Innovation Fund to encourage young scientists to do path-breaking research; and putting more money into both the National Institutes of Health and the Food and Drug Administration to make these innovations work.”

The bill may impact the mathematics of Alzheimer’s funding. As previously reported by the Alzheimer’s Association, for every $27,000 Medicare and Medicaid spends on caring for individuals with Alzheimer’s, the NIH spends only $100 on Alzheimer’s research. Further, Medicare’s annual expenditures are projected to triple from $300 billion currently to $1.5 trillion by 2050 if no cure for Alzheimer’s is found. Missling said the caretaking costs could put Medicare in a precarious place financially, even possibly bankrupting it.

In early December, an increase of nearly 60 percent for Alzheimer’s research was passed by the U.S. Congress in the federal spending bill, expanding funding from $586 million in 2015 to $936 million in 2016.

The next steps with the potential for impact for Alzheimer’s will happen at the U.S. Senate Committee on Health, Education, Labor and Pensions. Respectfully, I urge Chairman Lamar Alexander to pass this bill in the committee, which he co-leads with ranking member Patty Murray. It will take 22 senators to deliberate to find common ground by giving and taking and incorporating key ideas. Patients and their families know the urgency. Those afflicted regularly confuse past and present memories. Unleashing this act’s potential could capture lost time.

E. Teresa Touey is the editor and publisher of Spotlight on Bio Advances, a blog that showcases the stakeholders in the life sciences sector of the mid-Atlantic states.

Brain Concussion Recovery

by E. Teresa Touey on 01/20/16

This article appears in the January 2016 issue of Cohen Veterans Biosience:

Candy, apple, coin!  I repeated these three simple words slowly, clearly and confidently during a brain test at the Office of my wonderful doctor.  Jeff, a highly skilled healthcare professional, had given the words to me during the exam as he moved on with other brain tests.  He then quizzed my memory.

E. Teresa ToueyRemembering three simple words was my Thanksgiving gift on Monday, November 23, 2015.   My heart beat joyfully many times during that appointment.  As my physician proceeded with his iterative, thorough, neurological tests on me, I could see positive change.  My word recall was matched by better balance, as well as on that day, responding negatively to all symptoms on his brain checklist of 20 questions given to concussion patients during every appointment.  I had no headaches, no broken sleep, no anxiety or sadness, no disorientation, and no fatigue.  When he asked me to follow his index finger in front of my eyes, I could do so without the feeling of a heavy weight on my eyelids – a noticeable improvement.

As a result, he was able to release me from his care after seeing me every two to three weeks since an automobile accident on July 31st.  He reassured me that his staff and he were available by phone if I had any questions in the future.  I expressed my gratitude to him and his terrific staff in that moment of good news.

As a writer, researcher, and consultant doing work on national policy with the US Congress on brain disease, I rely on my ability to use my words carefully.  Over the last three years, I have organized an annual conference on Capitol Hill to gather experts, members and staff of the US House and Senate, and other advocates on challenges to a law that requires our insurers to treat physical and mental benefits equally or in parity.

My doctor told me during my first visit on August 5th that if I listened to his advice, I could expect full recovery.  If I did not, I would delay it.  Throughout these weeks, I kept that serious advice front and center of my busy life. As a result, I sense now at more than 85 percent recovery that full recovery will come in 2016.

While struggling to work full-time, I was able to learn the tools of managing not only the headaches, balance issues, memory challenges, sleeplessness, and anxiety, but also the main element of the beginning, the fear.  I learned to rest and to pace my exposure to my work on the computer, cell phone texts and television.  I did limited workouts through daily walks in my neighbor’s backyard pool and around my borough.  I convinced myself to sleep longer in the morning and go to bed earlier at night.  I took fish oil and melatonin every day and night.  I ate salmon regularly.  I learned to let go of stress and focus on what mattered most each day.

At the very start, my physicians seriousness of purpose and tone put the fear of God into me about following his words and advice so that eventually he and his staff saw me as the poster child of a well behaved concussion patient.  Yet, this prize is not the most cherished; rather it has become my newly acquired knowledge about unseen wounds.

My doctor works with the athletes of the Philadelphia Union, our region’s professional soccer team, and many county public and private school athletes.  Concussions are trending upwards among school athletes throughout the nation.  These cases serve also as a point of common ground with concussion cases sustained in car accidents as well as from injuries occurring from war.

Some telling statistics about our returning veterans as reported by the American Psychiatric Association include:  300,000 veterans of the wars in Iraq and Afghanistan have been diagnosed with PTSD; more deaths by suicide than by war combat in 2012; 8 to 20 percent of military personnel deployed in Iraq or Afghanistan experienced a traumatic brain injury; 20 percent of national suicides are completed by veterans; military suicide are at their highest rate in ten years; and traumatic brain injuries can increase suicidal thoughts and behavior.

In December 2015, Cohen Veterans Bioscience’s CEO Magali Haas sponsored my third annual roundtable on the Mental Health Parity Addiction and Equity Act of 2008.  She co-led a panel with retired US Army Colonel Dallas Hack on the need for a national model to treat the veterans with PTSD and TBI.   Cohen Veterans Bioscience is harnessing the power of high-performance computing and data analytics to discover and develop predictive disease models from integrated biomarker, biosensor, and phenotypic data. The hope is that, in the next three years, there will be a first generation of diagnostics for PTS and TBI.  “Once we have a better understanding of the science of PTS and TBI, we can advance a new pipeline of therapeutics and improve the delivery of medical care,” says Dr. Haas.

As I said to my physician throughout last year, my personal life has brought me a real lesson of empathy and insight into the challenges of these veterans as well as other patients suffering with concussion, which I can now bring to my professional work.  This motivation is more than enough to follow the good doctor’s advice while hoping and working for FULL RECOVERY in 2016.

Jane Hollingsworth, CEO of NuPathe, with the migraine patch.
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