Indy Life Science event this Thursday

indiana life science eventThursday, February 23, Hoosiers Work for Health will host an event, Indiana Life Sciences Industry Update: Key federal issues including PDUFA. The federal briefing will feature Alicia Subasinghe of Pharmaceutical Research and Manufacturers of America, Washington D.C. Participants can look forward to learning about federal policy affecting the life sciences and biopharmaceutical industry in Indiana including the Prescription Drug User Fee Act.

The presentation will be held at Bose Public Affairs Group (111 Monument Circle Suite 2700 Indianapolis, IN 46204), and run from 8:30am – 10:00am EST. Please visit the Hoosiers Work for Health event page to learn more.

Save the date: RAPS Indiana Chapter hosts a senior FDA representative to speak about drug safety lifecycle management

raps indianaOn March 9th, the RAPS Indiana Chapter, chaired by Pearl Pathways COO Gretchen Bowker, will host an interactive presentation from a senior FDA representative. The FDA representative, Jill R. Bourdage, RPh, PMP, will speak about processes and procedures of the Office of Surveillance and Epidemiology (OSE) within the Center of Drug Evaluation and Research (CDER). The presentation will provide an overview of the OSE and its role in the continuum of drug safety lifecycle management. Anticipated updates from PDUVA VI will be covered and the audience will learn how the role of the OSE Safety Regulatory Project Manager and regulatory expert as point of contact for industry can help achieve optimal communication.

Presentation title: Optimizing Communications with the Office of Surveillance & Epidemiology

Date: March 9, 2017

Time: 5:30 – 8:00pm EST

Location: Purdue University: Seng Liang Wang Hall

West Lafayette, IN

Registration and more information about the content can be found here.

Now hiring: Clinical Research Associate

Pearl Pathways is pursuing a Clinical Research Associate to join our team! The CRA will be responsible for the coordination and conduct of clinical research activities either for the sponsor or at a research site. This role will include the day-to-day responsibility for clinical research ensuring studies are conducted in accordance with the protocol, relevant SOPs, and good clinical practices. Pearl Pathways is headquartered in Indianapolis, Indiana with a second office in Houston, Texas. Telecommuting may be an option as well. Please see the full job description and contact information here.

Common Rule changes will impact informed consent, IRBs, and more

HHS changes Common RuleOn January 18th, the US Department of Health and Human Services (HHS) and 15 other federal departments and agencies issued a final rule to revise the federal Policy for the Protection of Human Subjects. The Policy for the Protection of Human subjects, aka the Common Rule, outlines all federal regulations concerning clinical research involving human subjects. The final rule contains significant departures from the Notice of Proposed Rulemaking, issued in September of 2015, as a result of public feedback and concerns to the original notice of changes. The final revisions to the Common Rule can be found here, but continue reading for a condensed summary of the critical changes.

Regarding informed consent:

  • A requirement for simplifying research consent forms. Study consent forms must concisely state a study’s scope, risks, and benefits so that individuals can make informed decisions regarding participation.
  • Consent forms for certain federally funded clinical trials must be posted on a public website.

Regarding IRBs:

  • The Final Rule includes new requirements to use a single IRB for multi-institutional research studies. However, there is flexibility in allowing large groups of studies to be removed from this requirement. Researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement (e.g. for studies on stored identifiable data or biospecimens). Researchers will not be required to obtain consent for studies on de-identified, stored data, or biospecimens. The provision that would have required researchers to obtain consent before using a study participant’s de-identified blood and tissue samples for secondary research was removed from the NPRM.

Regarding risk-based monitoring:

  • There are new exempt categories of research based on the level of risk they pose to participants. For example, there is a new exemption for secondary research involving identifiable private information if the research is regulated by, and participants protected under, HIPAA.
  • Removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects (e.g. low risk studies).

These changes are set to take place in January of 2018 with the exception of the single IRB review requirement (slated for January of 2020). The political landscape remains uncertain with the possibility that Congress may overturn these and other regulations recently initiated by the previous administration. We at Pearl IRB recommend that you familiarize yourself with the full list of regulations and begin preparations for the new Common Rule. Our team of experts can help facilitate this process and meet the needs of your current and upcoming clinical trials.

Clinical trials and pharmaceuticals adapt to growing digital health market

digital health wearableDescribing the rise of medical “wearables” in the U.S. and global marketplace as meteoric seems fitting given the rapid growth of the industry over the past decade. Wearable technology has been around for decades (check out an amusing history of some medical and not-so-medical wearables here), but mainstream adoption of the technology occurred more recently. Fitbit entered the scene in 2009 followed by several offshoots. Pebble kicked off the smartwatch craze just five years ago, in 2012. Now, one in six consumers in the United States currently use wearable tech such as the aforementioned fitness bands and smartwatches1. This trend will not slow any time soon, as the industry could see more than 3x growth in the next few years, expanding from $5.1 billion in 2015 to $18.9 billion in 20202. How will the expansion of medical wearables impact the life sciences industry?

An article on Insights, a division of Samsung focused on researching how their devices are used by everyday people in everyday life, reports on the adoption of digital health tech in clinical trials and pharmaceuticals. The article cites a survey by digital health technology vendor, Validic, on how digital health devices and data impact clinical trials:

  • “Sixty percent of respondents said they have used digital health technology to conduct clinical trials.
  • Ninety-seven percent of respondents said they will increase their use of digital technologies in clinical trials in the next five years.
  • Mobile apps and in-home clinical-grade devices are currently the most commonly used devices in clinical drug trials, but wearable activity trackers and sensors will be the focus of future use.
  • Seventy percent of respondents said patient-generated health data (PGHD) could have the greatest impact on improving treatments for chronically ill populations.”3

Current consumer-grade wearables are accessible and powerful, but a number of companies see the need to advance the use of clinical-grade devices as well. For example, the Insights article notes a collaboration between Validic and Sutter Health with the Office of National Coordinator for Health Information Technology. Their pilot project aims to determine how to best deliver patient generated health data (PGHD) to healthcare clinicians and researchers. The project “monitors and collects data from Sutter Health patients with Type2 diabetes through the SutterMpower app, which connects to devices measuring patient blood glucose, blood pressure, weight, and activity level.”3.

Medical wearables make remote monitoring of patients a powerful option for clinicians. The Insights article describes another pilot study that explores if patient hospitalization can be avoided through the combination of clinician visits to patient homes and advanced continuous electronic digital patient monitoring. In addition to improving an individual’s health, digital health tech could also reduce healthcare costs. Insights references a study published in The American Journal of Managed Care that analyzed anonymized medical and pharmacy claims data from over 1.2m patients with diabetes, high blood pressure, or high cholesterol. It was found that “payers could save approximately $38 million to $63 million per 100,000 members by deploying resources for improving medication adherence in specific patient populations.”3.

Digital health technology’s transformation of the health care and life science industries has just begun. Medical wearables bring opportunities for individual consumers to track and assess personal vital health information. Health care and life science professionals face the challenge of managing and analyzing this data while continuing to find innovative and safe ways to improve patient health while maintaining the confidentiality of private health data. Our team of experts at Pearl IRB can promptly review your study to prepare for human subject trials or support your company’s efforts to develop new digital health devices by navigate the changing regulatory landscape impacting these products.

 

1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4737495/#pmed.1001953.ref002

2 https://ww2.frost.com/news/press-releases/clinical-grade-wearables-accelerate-growth-opportunities-internet-medical-things-iomt-solutions/

3 https://insights.samsung.com/2016/12/05/digital-health-tech-takes-off-in-clinical-trials-and-pharmaceuticals/

Join us for a Kelley School Life Sciences event on February 17

Indiana University’s Kelley School Center for the Business of Life Sciences is hosting a conference titled  2016 Election Effects on Life Sciences and Healthcare.

Overview:

Now that the winner of the presidential election and composition of the House and Senate has been determined, what will happen next with healthcare reform, regulatory oversight, new product approvals and the pricing of medical products?

Stakeholders and observers will be sharing their thoughts on the next phase of remaking the nation’s healthcare sector.

Date & location:

This event is part of the Indiana Life Sciences Collaboration Conference Series. The conference will take place on February 17, 2017 at the One America Tower in downtown Indianapolis.

Pearl IRB is a proud sponsor of the Kelley School Life Sciences series. Please click here to register for the event.

Save the date: IMDMC Medical Device event at the Indiana Statehouse February 15, 2017

On February 15, 2017, the Indiana Medical Device Manufacturers Council (IMDMC) will host the annual Medical Device Exhibit and Breakfast at the Indiana Statehouse. This event provides the opportunity to interact with state and federal officials about the industry. To register for the event, click here.

New FDA draft guidance points to problems with multiple endpoints in clinical trials

FDA clinical trials draft guidanceThe US FDA released draft guidance this week on the “problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in drug and biologic clinical trials,” Zachary Brennan of RAPS reports. The FDA justifies the guidance due to the greater likelihood of making false conclusions about the effects of a given drug as the number of endpoints in a single clinical trial increases.

The FDA states that the guidance serves to “describe various strategies for grouping and ordering endpoints for analysis and applying some well-organized statistical methods for managing multiplicity within a study in order to control the chance of making erroneous conclusions about a drug’s effects.” (FDA Draft Guidance). Efficacy endpoints measure a drug’s effects. They may include assessments of clinical events (e.g. mortality, pulmonary exacerbation), patient symptoms (e.g. pain, depression), measures of function (e.g. ability to walk or exercise), or surrogates of these events or symptoms. The draft guidance lists the three families for classifying endpoints within a clinical trial: primary, secondary, and exploratory. To demonstrate the study objective of effectiveness, a statistical analysis must be performed to rule out chance as the explanation for a trial’s results. The guidance goes on to discuss the test of hypothesis and several other statistical methods used within clinical research to test against the probability of chance.

The FDA’s explanation of various statistical models and their usage cases dominates the rest of the draft guidance. However, this in-depth analysis drives home the message of this guidance. The FDA states that “the chance of making a false positive conclusion, concluding that a drug has a beneficial effect when it does not, is of primary concern” (FDA Draft Guidance). Our team of experts at Pearl IRB strive to stay up to date with FDA’s guidance to ensure that our clients remain informed about the necessary regulations. This allows clinical trials to run smoothly as our clients march towards product commercialization. If you have a study that needs reviewed or are in the beginning phases of research for a new treatment, please contact us today.

21st Century Cures Act: potential impact on the clinical research landscape

clinical trialsThe historic 21st Century Cures Act, written into law last December, is a 362-page bill comprised of several initiatives impacting the life sciences industry. The allocation of $4.8 billion for the “Cancer Moonshot” portion of the bill won over most headlines during news cycles leading up to the bill’s signing, but several other sections will impact the clinical research ecosystem over the next several years. An article published in this month’s volume of the Journal of Clinical Research Best Practices outlines the major sections of the Cures Act that affect clinical trials.

The aforementioned Cancer Moonshot leads the bill, creating a $4.8B “NIH Innovation Account” that will allocate funds to the Precision Medicine Initiative, BRAIN Initiative, Cancer, and Adult Stem Cells research. Another $500M will be set aside for an “FDA Innovation Account.” The Eureka Prize Competition section allocates prize money for significant advancements in biomedical sciences and/or improving health outcomes in serious yet disproportionate research areas. Three sections address confidentiality of personal health information for study participants: Privacy Protection for Human Research Subjects, Protection of Identifiable and Sensitive Information, and Data Sharing.

To support emerging scientists, the NIH will develop and prioritize policies that promote opportunities for new researchers. The NIH also addresses Educational loan repayment addresses by increasing repayments from $35k to $50k in exchange for research work in the areas of basic science, AIDS, and emerging needs. This section also instructs the NIH to prioritize research conducted by professionals from disadvantaged backgrounds.

Reducing administrative burden for researchers also makes up a large section of the bill. Within two years, HHS is to “harmonize and eliminate duplicative Conflict of Interest reporting… [and] examine the varying minimum thresholds, consider allowing for just in time reporting, and consider redefining which investigators and sub-investigators need to report.” Several sections address the patient experience during clinical trial studies. The FDA will create guidance explaining the use and requirement of patient experience data such as data collected by non-clinicians (e.g. patients, family, etc.), the impact of disease and therapy on patient lives, and patient treatment preferences.

The bill would not be complete without detailing the penalties for violation of grants, contracts, and other agreements created under the 21st Century Cures Act. The bill outlines fines from $10k-$50k for each false statement or omission in addition to $10k-$15k fines per day for delays in the transfer of funds to HHS.

Do you need assistance with your NIH funded research? Please contact us at Pearl IRB.

Happy Holidays from the Pearl team

Over the past two weeks, the Pearl team celebrated the holiday season with various “12 Days of Christmas” activities. Events ranged from reindeer racing to gingerbread house building with plenty of company pitch-ins along the way.

As 2016 winds down and you reflect upon the year’s challenges and successes, we wish you and yours a fabulous holiday season full of peace, hope, and relaxation.

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