Dave Luke, PharmD, FACA, FCCP, Joins Target Health as Sr. Director of Clinical and Scientific Affairs

 

As part of the continuing growth of Target Health Inc. we welcome Dave Luke, PharmD, FACA, FCCP, as Sr. Director of Clinical and Scientific Affairs. Dave will work closely with all departments at Target Health to provide both clinical, scientific and leadership support for all of our programs.

 

Prior to joining Target Health, Dave spent 20 years at Pfizer where he was Senior Medical Director, MSL in the areas of Infectious Diseases, Oncology, Immunology, Cardiology, Neurology, Pain; National Medical Council Coordinator, MSL; Faculty Member, Pfizer Research University; and Senior Associate Director, Clinical Research – Phase 3 Development. Prior to joining Pfizer, Dave was Director of the HIV Clinical Research, Clinical Pharmacology Unit at Hoffmann-La Roche Inc., and held academic positions at Rutgers, State University of New Jersey, University of Houston, and University of Texas M.D. Anderson Cancer Center, Houston, TX. Dave has a Doctor of Pharmacy degree from the University of the Sciences in Philadelphia (formerly known as the Philadelphia College of Pharmacy and Sciences).  Between 1997 and 2004 Dave was also a Member of the NASA/Johnson Space Center Steering Committee.

 

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 or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website, and if you like the weekly newsletter, ON TARGET, you’ll love the Blog.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

Happy Holidays to Our Friends and Colleagues From All Over the World

 

The Target Health Inc. community wishes all of our colleagues, friends and their families, Seasons Greetings and Happy New Year.  This year, we passed 6,000 readers of ON TARGET which allows us to say hello each week with articles of interest to all. Our special feature, Target Healthy Eating, created and maintained by our CEO Joyce Hays, with new recipes every week, will keep you and your families healthy as well.

 

As we again will be taking a respite between Christmas and New Year, see you all next year.

 

©Joyce Hays, Target Health Inc.

 

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 or Ms. Joyce Hays. 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

 

Electronic Informed Consent (Target e*ICF™)

 

Target Health Inc. is pleased to announce that 65% of patients in a dermatology study, for a large big pharma company, seamlessly used Target e*ICF™. This multicenter center study, performed in the US and Japan, also used our full suite of software supporting the paperless clinical trial, including Target e*CTR® (eClinical Trial Record), our patented eSource solution fully integrated with Target e*CRF®.  For the entire duration of the study, patients, site staff and monitors go to one website and use any device with Internet access. In addition, we  provided full CRO services for this study. We are also pleased to announce that study enrollment was completed 2 days ahead of schedule. All of Target Health Inc.’s processes are tied into the workflow of a direct data entry and paperless study, which makes all the difference in duration and accuracy of the study. We have also confirmed that the study sites can see twice as many patients in a day with the same staff, so this is a win-win for all.

 

Target e*ICF™ is web-based, bring your own device (BYOD), and allows for questions and answers, language control and of course version control.  It is no longer possible to sign the wrong version of the informed consent form. Data cannot be entered into our EDC system without the signatures of the study participants and authorized site personnel. Target e*ICF™ can also be used as stand-alone software in a similar manner that our SAE management module can be used.

 

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 or Ms. Joyce Hays. 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

 

WHAT’S NEW – Sunrise in New York’s Central Park – Fall 2016

 

Yes, there is nature in New York City. Central Park is both the heart and lungs of our great city. Our international clients and even those from the US, love to come to NY. Last week we hosted clients from Israel, Korea and of course the US. This week a favorite client from Sweden is arriving. Our doors are always open, even for a coffee.

 

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Sunrise in New York’s Central Park – Fall 2016 © Jules Mitchel, Target Health Inc.

 

 

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 or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website, and if you like the weekly newsletter, ON TARGET, you’ll love the Blog.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

James Farley Photographs Supermoon Over Winston-Salem, NC.

 

There will be no ON TARGET next week as we are taking off for the Thanksgiving holiday. Our best to all of our readers.  We now have over 6,000 current subscribers to ON TARGET. From time to time we receive newsworthy events and/or photos from our loyal readers.

 

A Supermoon happens when a Full Moon or New Moon coincides with the Moon’s closest approach to Earth; also called perigee. A Super Full Moon looks around 12% to 14% bigger than its counterpart, the Micromoon. The Supermoon on November 14, 2016, was the closest a Full Moon has been to Earth since January 26, 1948. The next time a Full Moon is even closer to Earth will be on November 25, 2034.

 

Our friend and colleague James Farley, photographer extraordinaire, took Supermoon photos in Winston-Salem, NC, which were featured by Lanie Pope on WXII 12 Winston-Salem!

 

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Supemoon over the R J Reynolds building, Winston, NC. ©jfarley Photography.

 

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 or Ms. Joyce Hays. 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

 

UN Panel Discussion on Climate Change and Its Impact on Children’s Health

 

Target Health Inc. is honored that Jules Mitchel, PhD has been invited to speak at a UN Panel Discussion on “Climate Change and Its Impact on Children’s Health.“ His topic will be “The view from FDA and Biotech World.“ Other presenters will include World Health Organization (WHO) staff, pharmaceutical industry experts and representatives of civil society organizations specializing in climate policy issues. The discussion will consider the issue of climate change and its impact on children’s health and will be followed by an interactive Q&A session with the audience.  This is a free event.

 

Date: Thursday, November 17, 2016

Time: 2:00 pm – 5:00 pm

Location: UN Church Center

777 United Nations Plaza, 2nd Floor Conference Room

44th Street between First and Second Avenue, New York, NY, 10017.

Please RSVP before November 15

Aaron Etra, aaron@etra.com

Jules Mitchel, jmitchel@targethealth.com

http://www.unausa.org/membership/council-of-organizations

http://www.globalfoundationdd.org/

 

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 or Ms. Joyce Hays. 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

 

eSource Solutions and Risk-Based Monitoring (RBM)

 

Last week we attended CBI’s RBM 2016 Conference where we shared Target Health’s extensive clinical trials experience using our eSource solution which is fully integrated with Target e*CRF and fully integrated with our approach to RBM.

 

The presentation included the results of flawless regulatory inspections of Target Health and 8 clinical sites. The title of the presentation was “eSource and Risk-Based Monitoring – Learn to Monitor Clinical Trials with Real-Time Data.“ Other presenters from Pfizer, Abbvie and Janssen shared their experience and future plans. Our colleagues, Jim Streeter, Vice President, Life Sciences Product Strategy at Oracle and Sina Djali, Senior Director, Risk Management – Central Monitoring, Global Clinical Development Operations at Janssen R&D, co-chaired the meeting.

 

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 or Ms. Joyce Hays. 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

 

We Were All Chefs at the eClinical Forum Meeting

 

This past week, we had the opportunity to attend the Fall meeting of the eClinical Forum. At our meetings and during the year, we are able to share with our friends, colleagues and yes, our competitors, novel technology approaches to solve complex problems in the clinical trial space. This week we also had the opportunity to cook our dinner under supervision of a master chef. A great time was had by all.

 

And yes, OUR TEAM, CHICKEN TUSCANESE, won the chef’s 1st prize.  Congratulations to all, for meals well done.

 

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Our Exalted Team. Working Together ©Target Health Inc. 2016

 

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Chicken Tuscanese. ©Target Health Inc. 2016

 

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 or Ms. Joyce Hays. 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

 

Clinical Trials of the Future

 

Target Health Inc. is the industry leader and champion of the fully integrated paperless clinical trial. We also “put our money where our mouth is“ with an FDA approval last December that used our web-based eSource solution for data entry at the time of the patient encounter, and an NDA program with 7 studies where 90% of the clinical trial data needed for FDA review was entered in real time. Many ongoing programs including pivotal trials in ADHD and autism.  Next year you will see programs with full integration with the electronic health record and the “virtual clinical trial.

 

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Sunrise to Sunset the Big Apple: View From Target Health’s Offices at 261 Madison Avenue (24th Floor)

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Sunrise to Sunset:  View from Target Health ©Jules Mitchel

 

How beautiful it is watching the greatest city in the world wake up and go to sleep each day. Photographed using the iPhone 6. 

 

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 or Ms. Joyce Hays. 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

 

Orphan Drug Development at Target Health Inc.

 

Target Health’s esteemed regulatory team which provides regulatory strategic planning, FDA representation and regulatory operation services for 47 of our clients, is also very active in the Orphan Drug space.

 

Here is the list of Orphan Drug Designations obtained by Target Health on behalf of its clients. Also included is the the status of the drug products:

  1. Alagille Syndrome
  2. Behcet’s disease
  3. Burn progression in hospitalized patients
  4. Caries prevention, head and neck cancer
  5. Cushing’s syndrome secondary to ectopic ACTH secretion
  6. Debridement in hospitalized patients with 3rd degree burns (EMA Approved 2012)
  7. Edema-related effects in hospitalized patients with 3rd degree burns
  8. Fibrolamellar Carcinoma (FLC)
  9. Fungal Infections
  10. Gaucher Disease (sold to Pfizer; NDA Approved 2012)
  11. Growth Hormone (Licensed to Pfizer)
  12. Hereditary angioedema (sold to Shire; NDA Approved 2011)
  13. Hodgkin’s Lymphoma
  14. Intradialytic Hypotension (Symptomatic hypotension in the immediate post-dialysis)
  15. Invasive Aspergillus Infections
  16. Multiple Myeloma
  17. Osteonecrosis of the jaw
  18. Ovarian Cancer
  19. Rabies
  20. Scleroderma

Hope to see you at the NORD meeting in Washington DC this week.  Dr. Jules Mitchel will be on a panel entitled “Collaborations Across Borders-Addressing Rare Diseases as a Global Public Health Challenge,“ discussing global drug development challenges for orphan diseases.

 

Target Health Inc. Cultural Liaison Goes To Scandinavia House in New York City

 

A rapidly warming Arctic is threatening Arctic Communities through coastal erosion, thawing of the permafrost and changing ecosystems. As the Arctic faces a critical moment in history, US special representative for the Arctic Admiral Robert J. Papp shared his thoughts last month at Scandinavia house, which is located just a block away from Target Health. The topic was Cooperation In the Arctic – Reflections on the U.S. Chairmanship of the Artic at its halfway Point. (click on the link to hear the lecture)

 

Admiral Robert J. Papp is the state department’s special representative for the Arctic Region, and with a focus on climate change, economic, and environmental issues. The Unites Sates holds the chairmanship of the Arctic Council from 2015-2017. He gave a lovely speech outlining the progress and key accomplishments of the U.S. Chairmanship of the Arctic council. He spoke about many relevant issues such as the council’s work on energy and water security to try to improve economic and living conditions in the communities through the coastal region. He also address the impact of climate change in the Artic region where people, animals and plants have thrived for thousands of years. Climate change is threatening these communities and their way of life, as well as the ecosystems that the communities depend on.

 

Fortunately, the Arctic Council recognizes the impacts of climate change and tries to raise awareness of the Arctic by promoting the development of climate change tools such as high-resolution mapping and by targeting short-lived climate pollutants through reduction of black carbon and methane emissions. General Papp hopes to partner with the Nordic countries and their partners to increase scientists, communities, policy makers and the general public’s understanding of the impacts of climate change. He spoke about his travels with Secretary John Kerry through the Northern Hemisphere and describe his job as gratifying since he gets to travel to other countries and speak to other UN Councils while promoting sustainable development and environmental protection. He also hopes to get people into long term involvement in working together to promote Arctic ocean safety, security & stewardship.

 

Also included is a hot link to a talk by Noam Chomsky, on Climate Change.

 

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 or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website, and if you like the weekly newsletter, ON TARGET, you’ll love the Blog.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

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