Pearl IRB proudly announces the completion of a clean FDA audit

Pearl IRB clean FDA auditPearl IRB proudly announces the completion of a clean FDA audit. There were no significant findings during the May 2017 audit and FDA issued no 483s. Our AAHRPP accredited IRB operates in compliance with all federal and state regulations governing clinical research. These include FDA regulations 21 CFR Parts 50 and 56, DHHS regulations 45 CFR Part 46 (the Common Rule), the International Conference on Harmonization (ICH), and the Food and Drug Amendments Act of 2007 (FDAAA). Additionally, our independent review board adheres to the portions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA Privacy Rule) that apply to research as described in 45 CFR Parts 160 and 164.

Pearl IRB has also been audited by sponsors and contract research organizations (CROs) with no significant findings and we routinely engage in our own internal audits to ensure compliance with all relevant regulations.

Updated clinical trial common protocol templates aim to speed up research, align objectives & endpoints

common protocol templates clinical trial research stockThe NIH-FDA Joint Leadership Council and TransCelerate BioPharma released updated common protocol templates (CPT) last week to accelerate clinical development. An Outsourcing-Pharma.com article and interview with TransCelerate CEO, Dalvir Gill, details some of the key additions to the new templates and how they will help advance research.

First and foremost, both the FDA/NIH and TransCelerate BioPharma templates aim to increase efficiencies in clinical trial protocol development. The FDA/NIH template is intended for NIH-funded studies. Global, multi-center trials requirements are covered by the Transcelerate CPT. During the interview, Gill described the key principles needed in a Common Protocol Document. “Structure must be streamlined and consistent, it must enable common wording relevant for all phases, and… it must enable endpoints that map to objectives and support the use of [Clinical Data Interchange Standards Consortium] CDISC therapeutic area standards,” Gill explained. These requirements acted as the foundation on which Gill and his team built the new common protocol template.

Aligning objectives to endpoints

The CPT includes new elements that align objectives to endpoints. Most importantly, the newly established level 1 and 2 heading structure allows sites and regulator reviewers to easily find information. These structural changes appear in both the Transcelerate and NIH-FDA protocol templates. Additionally, “establishing common endpoints aligned to CDISC Therapeutic Area standards and common language when used consistently will speed the time to first draft and reduce human errors,” Gill stated.

The existence of a Common Protocol Template will ease protocol interpretation and review by sites, IRBs, and regulators. Protocols have increased in complexity as the number of new studies registered in Clinicaltrials.gov steadily increases year-by-year. Sponsors currently provide protocols in their own structure and sites spend more time deconstructing and interpreting protocols. That time could be spent more effectively, Gill lamented, which justified the need for a structural alignment between protocols. “[The] collaboration with NIH-FDA to align structures of CPT and their newly released protocol template will take harmonization and information sharing even further… a harmonized template will also enable review and even comparisons of studies by regulators.”

Next steps for the CPT initiative could include changes in automation, content reuse, and traceability. Gill hopes that these next steps could further reduce the time to study startup. Pearl IRB provides expedited and full board ICF/protocol reviews. Our efficient, experienced team delivers superior IRB services that effectively balance the needs of human subjects, sponsors, and institutions. Contact us today to discuss your clinical research needs.

Experienced clinical research associate joins Pearl IRB

Clinical Research Associate - New Hire - Masheka Fuqua - Pearl PathwaysPearl IRB is pleased to announce the hiring of Masheka Fuqua as a Clinical Research Associate (CRA) serving biopharmaceutical, medical device, and diagnostics companies. Fuqua brings over a decade of clinical research experience to Pearl Pathways, including the coordination, management, and submissions of clinical trial activity across many therapeutic areas of research.

Fuqua’s decade of industry experience involves roles within clinical and healthcare market research at other organizations including direct work with sponsors, sites, and clinical research organizations (CROs). Diana Caldwell, President and CEO, shares, “Masheka delivers strong, balanced, and uncompromising research administration skills with integrity and credibility… Our clients will benefit from her broad industry experience that encompasses all aspects of clinical research, from site to sponsor to CRO. We are thrilled to have Masheka join the team.”

To read more, view the full press release.

China FDA mimics US clinical trial application process to accelerate drug approvals

China FDA CFDA clinical trial accelerate drug approvalsChina’s Food and Drug Administration (CFDA) set a goal to push drugs to clinics faster. How will they accomplish this goal? Recent policy proposals suggest CFDA are looking at the US Food and Drug Administration (FDA) for answers. Imitation is the greatest form of flattery, right?

The new CFDA policy proposals are twofold.  First, they suggest loosening restrictions on trial sites. By backing away from the current certification system, which requires any facility trying to conduct new clinical trials to go through a “laborious certification process,”1 CFDA should be able to foster new trial sites. Second, the agency is proposing a “no response means approval mechanism akin to the U.S. FDA’s trial approach [which would] cut the waiting time for researchers starting new studies.”1

CFDA’s proposed changes (Chinese) posted last week are very similar to the U.S. FDA’s Investigative New Drug (IND) process. The agencies current rules require a drug company to wait for CFDA’s official approval before proceeding with a clinical trial. Under the proposed rule, the agency would be allowed only 60 working days to reject or question an application before the application would automatically be considered a go. The 60-day deadline would still exceed U.S. FDA’s 30-day response window, but greatly reduce the 195-day average that CFDA currently maintains.1

It remains to be seen whether CFDA is capable of such a significant reduction of approval time. Still, reducing the red tape around trial sites and speeding up IND evaluations could do wonders for innovation within China’s life science sector. Demand for trial sites has “been scarce for years…the number of clinical trial sites has been a bottleneck in China for both innovative and generic drugs.”1 These policy proposals coupled with CFDA’s plans to admit foreign clinical trial data to support registration of biopharmaceuticals and medical devices could quickly transform the life science landscape in China.

Pearl IRB will continue to monitor the rules impacting clinical trials and human subject research abroad and domestically. If you need strategic study design support or have are seeking approval for your next study, contact our experts at Pearl IRB.

 

1http://www.fiercebiotech.com/cro/china-s-fda-to-shift-to-u-s-style-clinical-trial-application-process?utm_medium=nl&utm_source=internal&mrkid=863333&mkt_tok=eyJpIjoiTlRNNVpXUTFNR1JrTkdRMCIsInQiOiJXQlRyMTFnNW5zTGNrXC84ekc1WVJ6WG42UlhVc1BEWHRJcTdveW9tTTRvZVJIQ3lVZHFrZXkrdzNQMitpMnZ5ZnU4cmE2TVN0THlrXC9YTDFoNG1CdXYyNm96dTFORlpUeEh3blhIOUdldnJJVE9UUmFlcnhJKzVGOGw0SDRGUEwxIn0%3D

Regulatory 101 workshop for medical device industry will feature Gretchen Bowker, co-founder & COO of Pearl IRB

IMDMC regulatory 101 workshop REG 101 indy life science eventThe Indiana Medical Device Manufacturers Council (IMDMC) is hosting a workshop on May 17, 2017 designed to provide someone new to the medical device industry a background in FDA regulation and to hone the skills of more experienced practitioners. This program has been developed to provide practical examples and regulatory information through interactive teaching methods, from experts in each field. Attendees will take a hypothetical device from pathways to market, through clinical trials, promotion and advertising. Participants will then work through recalls, QSR & MDR reporting and inspections, while addressing other areas of regulation along the way.

Pearl IRB COO and co-founder, Gretchen Bowker RAC, FRAPS, will present during REG 101, which is Day 1 of the two-day workshop. REG 102 will occur the following week on May 24.

What: A workshop exploring FDA regulations of medical devices and pathways to market.

When: Wednesday, May 17, 2017, 8:00 AM to 5:00 PM EDT (REG 101) and

Wednesday, May 24, 2017 8:00 AM to 5:00 PM EDT (REG 102)

Where: The Montage – 8580 Allison Pointe Boulevard, Indianapolis, IN 46250

Are you new to the medical device industry? Do you want to learn more about the FDA and the Pathways to Market? Register here today for one of the classes or register for both at a reduced price!

Day 1 Agenda 5/17/17 (8:00 AM – 5:00 PM)

  • Breakfast is 7:30 – 8:00
  • FDA Overview & intro to Hypothetical
  • Clinical Trials/IDE’s
  • Pathways to Market 510K Requirements
  • Pathways to Market PMA Requirements
  • Other Submissions & Special Issues
  • Pre-Market QSR
  • Labeling, Advertising & Promotion
  • Panel Discussion “Linking the Pieces” and Q&A

Day 2 Agenda 5/24/17 (8:00 AM – 5:00 PM)

  • Breakfast is 7:30 – 8:00
  • Review of Hypothetical
  • Post-Market QSR
  • Complaint Handling/Medical Device Reporting
  • Sales & Marketing: Regulatory Aspects
  • Recalls and Field Corrections
  • Inspections
  • Other Liability Mechanisms
  • Enforcement
  • Panel Discussion “Linking the Pieces” and Q&A

Registration closes this week. Register today to learn from medical device industry experts and network with your peers!

Entrepreneurship panel event aims to teach startups how to connect with big biz

entrepreneur startup event stockAre you a startup owner looking to learn from established business owners and executives in Indianapolis? Do you find it difficult to connect with big businesses in meaningful ways that benefits your company’s goals? Or, are you an entrepreneur still in the idea development phase and wish to hear from other leaders who were once in your shoes? President and CEO of Pearl Pathways, Diana Caldwell, will speak on a panel with other local business owners/C-level executives spanning most major industry sectors. The May 9th event is geared towards helping Indy area startups connect with “big biz”.

Overview

The overarching goal of the event is to connect startups with big businesses. This is not strictly a networking event; the panel discussion will focus on how startups can develop relationships with big biz to solve problems. The program is designed to help startups understand a few critical questions:

  • How do big businesses utilize small business & startups to solve problems?
  • How can a startup engage with big biz & discover what existing problems they have?
  • How do you maintain the relationship?

Plenty of opportunities exist for startups to connect with big biz to solve problems. Most often, startup owners do not realize this or have difficulty finding meaningful ways to connect and develop productive relationships with big biz. The panel discussion will address these issues and more to help startups implement new strategies to grow their business.

When and Where

The panel discussion will take place at 3:00pm EST on Tuesday, May 9th, 2017 at The Speak Easy in Broad Ripple. Learn more about the entrepreneurial ecosystem at The Speak Easy here.

The guided panel discussion will last 45 minutes, with 30-45 minutes following for questions. After that, feel free to hang out and network over some free beer from the Speak Easy tap!

Accelerating clinical trials during an epidemic

Map of Ebola outbreak stock image clinical trials epidemic

Map of Ebola outbreak – October, 2014

How should clinical trials be executed during a crisis such as an epidemic? Which aspects, if any, of the clinical trial process will change? Who needs to be involved and when do people need to act to ensure efficient management of the research? The National Academies of Sciences, Engineering, and Medicine (NASEM) turned to the 2014 Ebola epidemic as a case study to answer these questions and others.

The Office of the Assistant Secretary for Preparedness and Response, the National Institute of Allergy and Infectious Disease, and the US Food and Drug Administration (FDA) tasked NASEM to analyze clinical trials conducted in West Africa during the Ebola epidemic. Upon completing their analysis, NASEM recommended ways to improve and accelerate clinical trial research during future infectious disease outbreaks. The committee determined that randomized clinical trials (RCTs) are “both ethical and preferable in the context of an epidemic as RCTs provide the fastest way to identify beneficial treatments and vaccines while minimizing risk.”1 Michelle Mancher, program officer for the NASEM report, explained that “during the Ebola outbreak, while the trial teams moved at lightning speeds, the trials started after the peak of the epidemic and were still too late… to be successful in the future, work will have to be done during and between outbreaks” during in an Outsorcing-Pharma.com interview. The NASEM report covers three recommended focus areas: communication and community engagement, capacity strengthening, and internal coordination and collaboration.

The global community and CROs

Effectively responding to the next epidemic and preventing future epidemics will require a global effort. Healthcare providers, life science professionals, the at-risk population, and others all have roles to play. Contract research organizations (CROs) must participate as well. “During a future epidemic,” Mancher explains, “when time is of the essence, CROs can play critical logistical support roles for clinical trial teams…For example, to immediately address the technical or infrastructure demands, including establishing contracts to secure clinical monitoring, safety monitoring, data management, and cold chain assistance.”1

Assuming clinical trials can be planned and coordinated efficiently and without delay after and during an outbreak is “unrealistic” according to Mancher. Work needs to be done in the interim, before and between epidemics, to ensure the best response can be administered quickly to reduce a disease’s impact on a given population.

Our AAHRPP accredited independent review board can promptly review your next study to prepare for human subject trials. Contact Pearl IRB for more information. Looking for support services for your clinical research such as safety monitoring, data management, quality services, etc.? Contact us at Pearl Pathways to learn more about our niche CRO offerings.

 

1http://www.outsourcing-pharma.com/Clinical-Development/How-to-accelerate-clinical-trials-during-an-epidemic?utm_source=newsletter_weekly&utm_medium=email&utm_campaign=From%2014-Apr-2017%20to%2021-Apr-2017&c=nscr0mx%2F7rdqa%2FmxPJfLFU3H%2Bwo40Q4w&p2

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

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