Neurology and Psychiatry Studies at Target Health

 

Fortunately, based on Sigmund Freud’s monumental and transformational insights into the human mind, followed by basic research in the workings of the brain, there is now major recognition of the Latin phrase “mens sana in corpore sano.” This phrase, only mentioned once by the poet Juvenal: “Orandum est ut sit mens sana in corpore sano,” is translated as “a man should pray for a healthy mind in a healthy body.”

 

Current and past programs at Target Health include: 1) Alzheimer’s disease; 2) ADHD, 3) Autism; 4) Bipolar disorder; 5) Epilepsy; 6) Multiple sclerosis; 7) Rete syndrome; 8) Schizophrenia; and 9) Tourette’s syndrome;.  To be noted, these studies are very difficult from the perspectives of study design, patient recruitment and retention, diagnosis, comorbidities, variable endpoints, etc.  In these studies, sometimes the “totality of the evidence“ may be more valuable than a single endpoint.

 

For more information about Target Health, contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

Greetings to all of our readers.

My father once referred to life as: this veil of tears. Indeed it has been for us. We are still devastated by the death of our son, Alex Hays, last month. Our deep grieving has sapped the energy needed to put out the weekly newsletter this weekend.

Alexander Monroe Hays passed away on Wednesday, August 8, 2018 in Manhattan while visiting us at his home in Manhattan. He had been joyfully creating new architectural forms on a new graphics laptop, before he headed back to Los Angeles. And then the terrible news from the hospital, cardiac arrest. We tried everything to save him, but could not.

 

 

Alex was born at New York Hospital in Manhattan, to the sound of Mozart. That may sound dramatic. Alex really was born to Mozart, because I had brought tapes of my favorite music to the room we shared at New York Hospital. Right after he was born, the first sounds he heard were Mozart’s Clarinet Concerto, which he focused on in an instant, listening in rapture. I was amazed to see a new born focus so intently, for so long, without moving or fussing. It was phenomenal. If he was cranky, the classical music I played, refocused his attention. He always listened attentively.

 

Alex graduated from Columbia Grammar and Prep School in Manhattan.

 

He worked for the family business in Manhattan, Target Health Inc. In the company’s weekly newsletter, ON TARGET, Alex was responsible for the section called, History of Medicine.

 

He entered New York University with a major in history and ended up at SCI-Arc school of architecture in Los Angeles, CA. He worked at Griffin Enright Architects, a firm in Los Angeles, and was very fond of the owners of that firm. Alex had planned to get his license and return to New York, with a friend and open a small firm. The head of his school has sent condolences, talking about Alex’ talent and how so many at SCI-Arc loved him and will miss him.

 

Alex was a non-stop reader of history, politics and great literature and loved art, theater and music. He was an early musician and played piano, guitar, double bass and the saxophone. At three years old, he played his guitar on the apron of the stage with Willie Nelson’s band in Atlantic City, NJ. Willie signed his guitar, out of great respect for this curly haired child’s ability to play for 1.5 hours, non-stop.

 

Alex loved classical, especially Mozart and Chopin, and raw jazz. At fifteen, he formed a jazz band and played in the Village on weekends. He was a great photographer. His favorite opera was, “Cosi“ which he saw recently at the MetOpera.

 

Alex knew every museum in NYC like second homes. He traveled as far as Africa and as close to home as the Adirondacks which he loved.

 

Alex Hays was erudite and kind. Everyone who knew him, loved him.

 

This past Spring, with his girlfriend Samantha, we all went to the MetOpera’s, Cosi Fan Tutti, Alex’s favorite opera.

 

The musical life circle was completed when at the funeral service, Adam Harris of Regulatory Affairs at Target Health, sang the gorgeous aria from Cosi, along with the string quartet, musicians from the MetOpera, who also played other music classic favorites of Alex. He was born and passed away to music and especially, Mozart.

 

And, so life moves in mysterious ways.

 

The life of Alex Hays is a beautiful star, rising, shining, now exploding, like a super nova. He will be missed by a great many people; but lives on in our hearts forever.

 

Survivors: his mother, Joyce Hays; stepfather, Dr. Jules Mitchel; father, Dr. James D. Hays: sister, Vanessa C. Hays; stepbrothers, Daniel, Richard and Ben; stepsister Rachel; and many other relatives and friends.

 

Goodbye beautiful boy of my heart.

 

Later.

 

For your listening pleasure, here is some of the beautiful music played at services for our son by the string quartet made up of musicians from the MetOpera orchestra:

 

https://www.youtube.com/watch?v=Y-hCC3DdRaQ&start_radio=1&list=RDY-hCC3DdRaQ

Antonio Vivaldi

 

https://www.youtube.com/watch?v=TXyqnzXwk9Y

W.A. Mozart, Pavarotti, Cosi Fan Tutti (sung by tenor Adam Harris at services)

 

https://www.youtube.com/watch?v=UK2GJ6cw8XM

W.A. Mozart (tenor) Don Giovanni (adapted for strings)

 

https://www.youtube.com/watch?v=BKy967puebk

W. A. Mozart (adapted for string quartet)

 

https://www.youtube.com/watch?v=Les39aIKbzE

Gustav Mahler

 

https://www.youtube.com/watch?v=Hvno17nl7vg

Jules Massenet

 

https://www.youtube.com/watch?v=k1-TrAvp_xs

W. A. Mozart

 

https://www.youtube.com/watch?v=bCnuEWLeEEE

J.S. Bach

 

https://www.youtube.com/watch?v=GwDpCiKBRHQ

Frederic Chopin (this was adapted for strings, for the service)

 

https://www.youtube.com/watch?v=-ywL_zokELE

J. S. Bach

 

https://www.youtube.com/watch?v=I68F7Ra-SO4

Ludwig Beethoven

 

https://www.youtube.com/watch?v=_58AnhnbIgI

Levon Minassian (Duduk)

 

https://www.youtube.com/watch?v=AiuC_CaObbI

Samuel Barber

 

https://www.youtube.com/watch?v=rBrQhInsibs

Saint-Saens

 

https://www.youtube.com/watch?v=g0yt_RThjzE

Antonin Dvorak

 

https://www.youtube.com/watch?v=J-qoaioG2UA

Richard Wagner

 

https://www.youtube.com/watch?v=ubZwC-FmlOE

Frederic Chopin

 

https://www.youtube.com/watch?v=JbbYKEodp0Y

Frederic Chopin

 

https://www.youtube.com/watch?v=JxPj3GAYYZ0

Tears in Heaven, Eric Clapton (sung beautifully by Michael Gruters, one of Alex’s cousins, at the funeral services)

 

Target Health’s Mary Shatzoff on FDA Panel

 

At the invitation of Office of Antimicrobial Products (CDER), Mary Shatzoff, Senior Director of Regulatory Affairs at Target Health, will be a speaker at the FDA workshop entitled: “Development of Non-Traditional Therapies for Bacterial Infections.” The purpose of this public workshop is to discuss the general development considerations of non-traditional therapies, including pre-clinical development, early clinical studies, and the design and evaluation of safety and efficacy in phase 3 clinical trials. This workshop will be held on August 21, 2018 from 8:30 to 4:30, and on August 22, 2018 from 8:30 to 12. This public workshop will also be available via a webcast.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

One of Target Health’s Sweet Spots is Rare and Orphan Diseases

 

This past week, Dr. Mitchel presented at the Rare Disease Symposium, supported by the Westchester Biotech Project and Hosted by Iona College. His presentation was entitled: Novel Approaches to Clinical Research. The Westchester Biotech Project, a not-for-profit created to foster scientific research and collaboration by researchers, engineers, and data scientists, is working to create the Rare Disease Research Hub. It plans to establish a bio-incubator that would house tenant startups, as well as a venture fund that would invest in up to 12 startups.

Not only has Target Health obtained multiple orphan drug designations for our clients, but also contributed to FDA and EMA marketing approvals. Here are some examples and more to come:

 

Alagille Syndrome; Behcet’s disease; Burn progression in hospitalized patients; Caries prevention, Head and neck cancer; Cushing’s syndrome secondary to ectopic ACTH secretion; Debridement in hospitalized patients with 3rd degree burns; Dravet syndrome; Edema-related effects in hospitalized patients with 3rd degree burns; Fibrolamellar Carcinoma (FLC); Fungal infections; Gaucher disease; Growth hormone;Hereditary angioedema; Hodgkin’s Lymphoma ; Intradialytic Hypotension (Symptomatic hypotension in the immediate post-dialytic period); Invasive Aspergillus Infections; Multiple myeloma; Osteonecrosis of the jaw; Ovarian cancer; Rabies; Scleroderma.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

Target Health Inc. Congratulates MDGH on Approval of Moxidectin for the Treatment of River Blindness (Onchocerciasis)

 

New York, NY – 5 July 2018: Target Health Inc. would like to congratulate Medicines Development for Global Health (MDGH) and the World Health Organisation Special Programme for Research and Training in Tropical Diseases (TDR) upon U.S. FDA approval of moxidectin 8 mg oral for the treatment of river blindness (onchocerciasis) in patients aged 12 years and older. River blindness is caused by a parasitic worm, Onchocerca volvulus. This tropical disease manifests as severe itching, disfiguring skin conditions and visual impairment, including permanent blindness caused by the worm’s larvae (microfilariae). The approval of moxidectin was based on data from two randomized, double blind, active controlled clinical studies. Each study met its respective primary endpoints, showing a statistically significant superiority of moxidectin over the current standard of care, ivermectin, in suppressing the presence of the microfilariae in skin.

 

“MDGH sincerely thanks Target Health, our US Agent and electronic submission contractor for post-NDA submission activities” said Danielle Smith, PhD, Associate Director of MDGH. Dr. Smith added that, “Target’s professionalism and expertise ensured that MDGH’ s submissions were appropriately presented for approval to the FDA, and Target Health’s flexibility was also very much appreciated as there were multiple NDA amendments, many with tight turnaround times.  Jules Mitchel,, MBA PhD, President of Target Health added that “Target Health very much looks forward to continuing our successful relationship as MDGH now heads into the post-approval phase.” MDGH US Agent and post-submission electronic submission activities at Target Health were managed by Mary Shatzoff, Sr. Director of Regulatory Affairs at Target Health.

 

The FDA awarded MDGH a priority review voucher (PRV) and full results from the Phase III study were published in the Lancet in January 2018 (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)30101-6/fulltext).

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

Judy Schloss Markowitz is Now a Retiree

 

From the desk of Dave Luke, PharmD, Sr. Director, Clinical and Scientific Affairs at Target Health Inc.

 

Target Health Inc. is announcing the retirement of a longtime colleague, Judith (Judy) Schloss Markowitz. Judy is a first generation American whose mother, Ruth, is a Holocaust survivor, and her father immigrated from Germany to the US when he was 2 years of age. A true New Yorker from Queens, with an accent and attitude to prove it, Judy graduated with a Master’s degree in Education from Queens College, CUNY.

 

Judy joined PhRMA as a clinical monitor at Ives Laboratories – which was then a division of American Home Products (AHP). She then watched the industry merge over her 32 year career from AHP to Ayerst Laboratories, to Wyeth-Ayerst, to Wyeth and finally to Pfizer. Judy joined Target Health as Senior Clinical Project Manager in 2010.

 

I had the privilege of meeting Judy 18 months ago when I joined Target Health. Judy helped me onboard and we worked very closely on many time-critical projects. I depended on Judy as a very experienced project manager and I will miss her more than I think she will miss her role. Over the last 5 weeks, I keep catching myself saying “What would Judy do?“ I don’t know the answer but Judy is just a phone call away. Judy will be missed but not easily forgotten.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

To unsubscribe from the On Target mailing list, click on the following link: unsubscribeontarget@targethealth.com

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

Target Health – Champions of the Paperless Clinical Trial™

 

A good time was had by all at DIA this year. We were able to demo both the current version of Target e*CRF® a one log-in, web based, paperless clinical trial solution built by Target Health Inc., aka, the “Champions of the Paperless Clinical Trial.™

 

Starting with Target e*ICF™ and all the way to patient lock, no need to travel outside the website. Not only does the site use one website for signing of Target e*ICF™, data entry and randomization, but study monitors can create and sign monitoring reports, perform central monitoring, track IMP from depot to the study site, and access standard and RBM reports etc. Medical monitors can perform SAE management including initial and follow-up 3500A and CIOMS reports, And yes, a lot more.

 

In addition to the United States, we now have EMA and Australia marketing approvals for products which used our paperless clinical trial solution, which also includes direct data entry (BYOD) at the time of patient encounter.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

To unsubscribe from the On Target mailing list, click on the following link: unsubscribeontarget@targethealth.com.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

The Talented Mr. Farley

James Farley, photographer extraordinaire, friend and colleague, sent us some recent photos. Hard to choose, but we all agreed that one below was exceptional.

 

Here are the specs:

The camera perspective (on a tall tripod) was above the head. That’s how high-up the flowers were. They were at the height of my eyes, as I stood.

RShot on Canon 5D Mark IV with Canon 17mm Tilt-shift lens using Lee Filters 0.6 standard filter.

 

Rhododendrons at Sunset on Roan Mountain, North Carolina, June 14, 2018. Jane Bald and Round Bald in view. © Copyright Advanced Fine Art 2018 / All Rights Reserved

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

2018 DIA Meeting in Boston

 

Let us know if you are attending, and if yes, visit us at Booth 2337.

This year we will feature:

 

1. CRO services: Reg Affairs, Clinical Research, Biostats, Data Management and Medical Writing

2. Our paperless clinical trial operation

3. Target e*CRF® fully integrated with Target e*CTR®, our patented web-based direct data entry solution

4. Target eICF™ fully integrated with Target e*CRF®

5. A glimpse into our next software version which will be EDC for All

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

2018 DIA Meeting in Boston: We’ll be at the DIA from June 25th to June 27th

 

Let us know if you are attending, and if yes, visit us at Booth 2337. This year we will feature:

 

1. CRO services: Reg Affairs, Clinical Research, Biostats, Data Management and Medical Writing

2. Our paperless clinical trial operation

3. Target e*CRF® fully integrated with Target e*CTR®, our patented web-based direct data entry solution

4. Target eICF® fully integrated with Target e*CRF®

5. A glimpse into our next software version which will be EDC for All

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

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