Morning View From the 24th Floor at 261 Madison

 

Target Health has been on the 23rd and 24 Floors at 261 Madison since 2001. There are a lot of breath-taking views at sunset which we have shared for many years, but this morning view of shadows, the spectacular sky and eclectic architecture, has left us breathless.

View From the 24th Floor.  ©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

Orphan Drug Development at Target Health Inc.

 

Target Health is very pleased that it has prepared, submitted and obtained over 20 orphan drug designations, with 3 of these products reaching the market. There were 2 additional orphan programs in which Target Health played a major role. One program was in cystic fibrosis, on behalf of our good friend and colleague, Dr. Tibor Sipos President and CEO of Digestive Care Inc, which was approved by FDA in 2012, without an ODD. The second program was for Regeneron, where Target e*CRF was used in the development program of Arcalyst, for the treatment of Cryopyrin-Associated Periodic Syndromes which was approved in 2008.

 

Ongoing clinical development programs treating orphan diseases include Dravet syndrome, Fabry disease, Growth Hormone, and Huntington’s disease.

 

The following is the list of orphan diseases for which Target Health obtained ODD on behalf of its clients:

 

Alagille syndrome; Aplastic anemia; 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 (EMA Approved 2012); Edema-related effects in hospitalized patients with 3rd degree burns; Fibrolamellar carcinoma (FLC); Fungal Infections; Gaucher Disease (NDA Approved 2012); Growth Hormone (Licensed to Big Pharma); Hereditary angioedema (NDA Approved 2011); Hodgkins 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 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

 

Ongoing and Completed eSource Programs at Target Health and ICH E6(R2)

 

Target e*CTR® (eClinical Trial Record) is Target Health’s patented eSource solution fully integrated with Target e*CRF®. A de novo 510(k) was cleared in December 2015 that used direct data entry at the time of the office visit, and an NDA was submitted to FDA with 7 studies which all used Target e*CTR. There were no FDA inspection findings in any of these programs. Ongoing studies include a large pivotal trial in Autism, a phase 2 study in dermatology and a device study. A new study in psychiatry will start in Q2 2017 as well as several other programs. Recently, a phase 2 study in neurology was completed with 900 subjects at 40 clinical sites.  Completed programs include ADHD, urology, and phase 1 studies.

 

As part of the ICH E6(R2), sections were modified to address electronic records and associated roles and responsibilities. Target Health Inc. congratulates our colleagues at ICH who clarified the acceptance of electronic records as original records in lieu of a requirement to have paper source records.

 

The following are some highlights of the revisions as they relate to electronic records. Also refer to a paper recently authored by Mitchel and Helfgott, published on 4 January 2017 in Applied Clinical Trials entitled, “Regulatory Considerations when Designing and Running 21st Century Paperless Clinical Trials

 

 

Glossary: Certified Copy

A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original. (section 1.6.3)

 

Section 5. Sponsor

Record Access: The sponsor should ensure that it is specified in the protocol or other written agreement that the investigator(s)/institution(s) provide direct access to source data/documents for trial-related monitoring, audits, IRB/IEC review, and regulatory inspection. (Section 5.15.1)

 

6.4 Trial Design

The scientific integrity of the trial and the credibility of the data from the trial depend substantially on the trial design. A description of the trial design, should include: The identification of any data to be recorded directly on the CRFs (i.e., no prior written or electronic record of data), and to be considered to be source data. (section 6.4.9)

 

8. Essential Documents for the Conduct of a Clinical Trial (Addendum)

 

The sponsor and investigator/institution should maintain a record of the location(s) of their respective essential documents including source documents. The storage system used during the trial and for archiving (irrespective of the type of media used) should provide for document identification, version history, search, and retrieval.

 

The sponsor should ensure that the investigator has control of and continuous access to the CRF data reported to the sponsor. The sponsor should not have exclusive control of those data.

 

When a copy is used to replace an original document (e.g., source documents, CRF), the copy should fulfill the requirements for certified copies.

 

The investigator/institution should have control of all essential documents and records generated by the investigator/institution before, during, and after the trial.

 

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

 

The Paperless Clinical Trial – New Publication in Applied Clinical Trials

 

On 4 January 2017, Applied Clinical Trials published an online paper, entitled, “Regulatory Considerations when Designing and Running 21st Century Paperless Clinical Trials.“ The paper is coauthored by Jonathan Helfgott, MS, former the Associate Director for Risk Science at FDA CDER OSI and the main author of FDA’s eSource Guidance, and Jules Mitchel, MBA, PhD, President, Target Health Inc. Jonathan is currently the Coordinator of the Regulatory Science Graduate Program at Johns Hopkins University.

 

The following are some excerpts from the paper which is meant to be both informative and evocative.

 

 

Introduction: The regulatory push to the paperless clinical trial has occurred despite a pharmaceutical industry that has been risk-averse in adopting modern-day technology tools that could support clinical trials. This risk aversion is in part due to fear by sites and sponsors of receiving a FDA Form 483. What if the FDA turns down an application if it discovers that, for example, a patient was born in 1982, when in the study database it is recorded as 1983, even when there is no impact on the study results? The clinical sites are also fearful of losing business as a result of any FDA Form 483 finding, however minor.

 

Risk Assessments: A quality by design (QbD) methodology, which includes a risk assessment and risk mitigation strategies, is a critical exercise when building software. Using a Boeing 787 analogy, a plane has several electrical systems that control the engine and the coffee machine. We should not assign the same risk to the coffee machine not delivering hot coffee as we do to the engine failing on takeoff.

 

Discussion and Conclusion: For more than a decade, technologies and processes allowing for the paperless clinical trial have been substantiated and encouraged from both the business and regulatory perspectives. The time is ripe to put away fears of regulatory sanctions when using modern technology, and make changes to modernize and optimize the drug and device development processes that will ultimately, positively, support the regulatory approval process.

 

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

 

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!

 

20161121-24

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

 

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