Workforce Issues – Life Sciences Human Capital

Indiana University’s Kelley School Center for the Business of Life Sciences will host a conference titled “Workforce Issues – Life Sciences Human Capital.” The full-day conference will take place on Friday, May 12, 2017 at the Cook Group Headquarters in Bloomington, Indiana.

Overview

Since Indiana is one of the nation’s largest exporters of healthcare products, how can manufacturers across the state attract, maintain and grow their workforce talent to meet the needs of the industry? How can partners in Indiana’s educational systems prepare the workforce of the future? Join stakeholders from both workforce training and acquisition as they discuss current best practices and what lies ahead.

This past May, BioCrossroads and Batelle’s TEConomy Partners affiliate issued the report, Indiana’s Health and Life Sciences Talent and Workforce: Developing Strategies to Compete in a Global Economy. The report detailed that Indiana’s high-skilled work force is above the national average. Additionally, employment is above-national demand for positions in the industry compared to other sectors in the state. Included in the report were four broad strategic priorities to address Indiana’s health and life sciences talent dynamics. This conference will update existing efforts in support of the strategic priorities as well highlight new initiatives to bolster the state’s life sciences human capital.

This event is part of the Indiana Life Sciences Collaboration Conference Series. Pearl IRB is a proud sponsor of the Kelley School Life Sciences series. Learn more about the conference or register today to join Pearl IRB at the event on May 12.

Single IRB requirement intended to streamline multi-site clinical research

NIH national institutes of health logo single IRBBeginning September, 2017, the National Institutes of Health (NIH) will require that a single IRB (sIRB) of record be used in the ethical review for all NIH-funded non-exempt, multi-site human subjects research protocols in the United States (NOT-OD-16-094). The sIRB policy applies to all multi-site human subjects research regardless of the NIH funding mechanism (e.g., SBIR/STTR awards, grants, cooperative agreements, contracts or other mechanisms such as Cooperative Research and Development Agreements (CRADAs), and Interagency Agreements (IAA)).

The goal of this policy is to enhance and streamline the IRB review process, in the context of multi-site research, so that research can proceed as effectively and expeditiously as possible. In addition to streamlining some aspects of IRB reviews, the new sIRB policy presents an opportunity to harmonize the standards used in clinical research in the United States and streamline future administrative responsibilities.

The sIRB policy takes effect on September 25, 2017. This date is four months later than the effective date that appears in the sIRB policy document. NIH extended the effective date to allow additional time for successful implementation.

Finally, beginning in January 2020, the revised Common Rule will expand the studies to which this requirement will apply. The revised rule will require single IRB review for all multi-site studies conducted in the United States, rather than having each site’s IRB bear regulatory responsibilities. This had been a controversial provision of the NPRM, but became less so following the issuance of the NIH policy for research it funds.

Resources and guidance are available on the NIH Office of Science Policy website (http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/models-irb-review). But for now, the question remains on whether the requirement for sIRB review will be equally protective of subject interests and actually demonstrate to be more effectual.

Pearl IRB will keep you updated on future developments impacting clinical research through our blog. For immediate updates, follow us on Twitter or send your inquiries to our experts directly.

RMAT Designation from the 21st Century Cures Act now live

21st Century Cures Act regenerative medicineThe 21st Century Cures Act, signed into law on December 13, 2016, includes several provisions related to regenerative medicine. Regenerative medicine covers a wide range of innovative products including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and certain combination products using such therapies. Examples of regenerative medicine include chimeric antigen receptor T-cell (CAR-T cell) treatments (FDA recently granted IND approval to the first gene-edited CAR-T cell therapy in the US), human tissues grown on scaffolds for subsequent use, and more.

The Regenerative Medicine Advanced Therapy (RMAT) Designation is a product of the Cures Act. The RMAT designation builds on FDA’s existing expedited programs available to regenerative medicine products and was established to foster the development and approval of these products. In an FDA blog, Peter Marks, M.D., Ph.D. (director of the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration), explains that “sponsors of certain products may obtain RMAT designation for their drug product if the drug is intended to tread serious or life-threatening diseases or conditions and if there is preliminary clinical evidence indicating that the drug has the potential to address unmet medical needs for that disease or condition.”1 The RMAT designation applies to:

  • Certain cell therapies
  • Therapeutic tissue engineering products
  • Human cell and tissue products
  • Certain combination products

Marks goes on to explain the process and benefits of the RMAT designation, which is summarized below:

  • Sponsors may make such a request with or after submission of an investigational new drug application and the agency then will take action on the requests within 60 calendar days of receipt
  • Sponsors of RMAT-designated products are eligible for increased and earlier interactions with the FDA
  • Sponsors may be eligible for priority review and accelerated approval
  • Once approved, the FDA can permit fulfillment of post-approval requirements under accelerated approval through the submission of clinical evidence, clinical studies, patient registries, or other sources of real world evidence, when appropriate

The FDA has already begun receiving RMAT designation requests and they will likely receive more as regenerative medicine research and treatments continues to advance. Our experts work diligently with our clients to accelerate the product development process. We have helped countless sponsors receive priority review and expedited approval for their product, such as with the Breakthrough Therapy Designation. Contact us today to discuss how we can help with your next investigational new drug application.

 

1 https://blogs.fda.gov/fdavoice/index.php/2017/03/this-is-not-a-test-rmat-designation-goes-live/?source=govdelivery&utm_medium=email&utm_source=govdelivery

RAPS seeking nominations for 2018-2020 Board of Directors

raps indianaRegulatory Affairs Professionals Society (RAPS) is seeking qualified individuals to serve on the RAPS board of directors for the 2018-2020 term. RAPS, the largest global organization of and for those involved with the regulation of healthcare and related products (e.g. medical devices, pharmaceuticals, biologics, and nutritional products). Board members serve as the strategic governing and policy body of RAPS and identify opportunities that advance the profession and improve/expand association programs that support the profession globally.

2018-2020 Board Position Openings:

  • President-Elect (one open position)
  • Directors (four open positions)

Learn more about the nomination process and open positions here

Gretchen Bowker, COO and co-founder of Pearl IRB, currently serves as the chair of the RAPS Indiana Chapter. Bowker states that the “RAPS Indiana Chapter conducts a number of professional development and networking activities throughout the year to help members connect, build relationships, and increase knowledge, competence, and performance… RAPS is a volunteer-driven organization and I’ve found that the more I put into it, the more I get back.”

Interested in joining RAPS? Find your local chapter here and learn how to get involved today!

Diana Caldwell speaking at 3rd annual KLLC Women’s Empowerment Retreat on March 3rd

kelley-school-of-business diana caldwellOn March 3rd, the Indiana University Kelley Living Learning Center (KLLC) will be hosting their third annual Women’s Empowerment Retreat. This impactful event gives 50 first-year KLLC women an opportunity to network with successful business women and learn how to be a successful female leader. The goal is to build confidence and abilities, and discuss planning, navigating, and recalculating the future. We are proud that our own Pearl IRB President and CEO, Diana Caldwell will speak and share her own lessons learned in business.  Diana will speak to the successes and challenges she experienced starting her own company with the freshman business students attending. This event is by invite only.

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/

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