Experienced clinical research associate joins Pearl Pathways

Clinical Research Associate - New Hire - Masheka Fuqua - Pearl PathwaysPearl Pathways 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.

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

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 Pathways 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 entrepreneurship startups 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.

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. Our AAHRPP accredited independent review board can promptly review your next study to prepare for human subject trials. Contact Pearl IRB for more information.

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 life sciences collaboration conference seriesIndiana 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 Pathways is a proud sponsor of the Kelley School Life Sciences series. Learn more about the conference or register today to join Pearl Pathways at the event on May 12.

New medical device & IVD regulations adopted by European Parliament

European Parliament Commission stockIt’s official: regulation of medical devices and in vitro diagnostics (IVD) will undergo significant changes over the next five years. Last week, the EU Parliament approved the proposed changes, disregarding a proposal from the UK Independence Party to reject the new regulations. The new regulations “include stricter premarket review of high-risk devices, strengthened criteria for notified bodies, improved traceability, as well as a risk-based classification system for IVDs… [and are the] result of a multi-year negotiation process between the European Commission, Parliament, and Council to address gaps in oversight that led to several device-related scandals.”1

The new regulations will be published in the Official Journal of the European Union in May. Once published, the new Medical Device Regulations (MDR) will be implemented in three years and the new In Vitro Diagnostics Regulations (IVDR) in five years.

The new medical device and IVD regulations should strengthen transparency of information for consumers, ensuring that vital information is easy to find. For example, patients will receive an implant card containing all essential information; furthermore, a unique device identifier will be mandatory for every product, allowing each product can be found in the new European database of medical devices.2 Elżbieta Bieńkowska, Commissioner for Internal Market, Industry, Entrepreneurship and SMEs at the European Commission, said “I’m extremely happy that our push for stricter controls of medical devices on the EU market will now become a reality. Whether for medical devices, cars, or other products, we must ensure stronger supervision in the interest of our citizens. We should not wait for another scandal instead we should start a discussion how to strengthen European oversight over Member States’ surveillance activities.”2

The regulatory landscape for medical device and in vitro diagnostics will continue to change as products advance and become more connected. Our experts at Pearl Pathways commit themselves each day to driving our clients’ products to market faster. If you have a device or diagnostic in development, contact us today to learn how we accelerate our clients’ product development pathway here in the U.S. market and abroad.

 

1http://www.raps.org/Regulatory-Focus/News/2017/04/05/27279/EU-Parliament-Adopts-New-Medical-Device-IVD-Regulations/?utm_source=Email&utm_medium=Informz&utm_campaign=Informz-Emails

2http://ec.europa.eu/growth/tools-databases/newsroom/cf/itemdetail.cfm?item_id=9119&lang=en

Official press release

Drug master files (DMFs) electronic submission deadline extended

FDA DMFs eCTDOn April 7, the Food and Drug Administration (FDA) announced an extension of the compliance date for submitting drug master files (DMFs) in electronic common technical document (eCTD) format. FDA pushed the deadline back one year to May 5, 2018. The compliance date for submitting new drug applications (NDAs), biologics licensing applications (BLAs), and abbreviated new drug applications (ANDAs) electronically remains unchanged (May 5, 2017).

Shifting to the eCTD format represents FDA’s initiative to make the drug application review process more efficient. eCTD standardizes how the life science industry submits applications, amendments, supplements, and reports. FDA states that implementing electronic DMFs will improve the efficiency of the DMF review process. Electronic drug master files allow FDA to review applications more easily and better meet the associated PDUFA and GDUFA performance goals.

Our team of advisors at Pearl Pathways expertly prepare electronic drug master files for FDA submission. We understand the eCTD format and process. We have already helped several life science companies electronically submit DMFs, NDAs, BLAs, and ANDAs. Contact us today to discuss your submission needs.

 

 
Here are some helpful resources to prepare for the upcoming deadlines:

Guidance Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document (eCTD) Specifications

New Requirements for Electronic Submissions of DMFs

DMF Tip Sheet

eCTD Submission Requirements: What You Need to Know

FDA Electronic Submissions Gateway

New diagnostics bill could dramatically alter regulations

diagnostic diagnostics lab developed testsDiagnostic and lab-developed test (LDT) regulations could soon receive a significant overhaul. RAPS reported this week that a bipartisan duo, Rep. Larry Buchson, M.D. (R-IN) and Diana DeGetter (D-CO), released a discussion draft for a bill proposing a new path for the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS).

The draft, named the Diagnostic Accuracy and Innovation Act (DAIA), would “create a classification system for in vitro clinical tests (IVCTs), require premarket FDA approval for high-risk tests, and create a new center under FDA to regulate these tests.”1 Additionally, the discussion draft would “create a new user fee program…[though] user fees will not be the primary funding source for the new regulatory structure (i.e., user fees will be capped at 30%).” Under this bill, the CMS’ Clinical Laboratory Improvement Amendments (CLIA) program to oversee laboratory operations would be modernized. Furthermore, FDA’s responsibilities would expand to regulate “the design, development, and validation of an IVCT as well as the production of an IVCT for distribution to another facility or third-party”

Assuming the draft discussion advances and FDA issues a full guidance, a transition phase will allow the industry and regulators time to “implement the following framework:

  • IVCTs introduced by laboratories prior to three months before enactment of the bill will be grandfathered and no submission obligations will apply to such IVCTs prior to the effective date of the regulations (i.e. five years after enactment)
  • New regulations would be required to be promulgated within three years of enactment, and compliance would be required no later than two years after that (with some opportunity to take advantage of the new system one year post promulgation).” 1

Regarding other post-market requirements, test developer’s responsibilities will “largely resemble current FDA requirements for in vitro diagnostics, except adverse event reporting will be updates to: (1) limit individual submissions to those events that involve death or imminent threat to public health, and (2) use quarterly summary and trend reporting for all other adverse events, including malfunctions. There will be no overlap of CLIA and FDA requirements.”2 We will continue to monitor the advancement of this draft discussion and the possible impact on diagnostic and lab-developed test regulations. Check back to the Pearl Pathways blog or follow us on Twitter for more immediate updates.

 

1http://raps.org/Regulatory-Focus/News/2017/03/27/27196/Diagnostics-Bipartisan-Duo-Offers-Bill-to-Alter-Regulations/?utm_source=Email&utm_medium=Informz&utm_campaign=Informz-Emails

2https://bucshon.house.gov/sites/bucshon.house.gov/files/documents/DAIA%20Summary.pdf

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

Tobacco products escape FDA final rule on intended use, for now

FDA final rule tobaccoLast Friday, the US Food and Drug Administration (FDA) announced it will not implement its final rule specifying when tobacco products are regulated as medical products until March of 2018, RAPS reports. The delay comes in the wake of a petition presented by biopharmaceutical industry groups. These groups voiced concerns regarding the rule’s impact on the current definition of intended uses for drugs and medical devices. The petition’s backers included the Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Biotechnology Organization (BIO). The filed petition calls for FDA to “stay the final rule and revert back to language found in the proposed rule1.

Why the delay?

  • FDA intends to collect more feedback on its final rule from the public. Stakeholders now have 60 days to respond to the final rule before FDA works to finalize the rule once again.

Why the petition?

  • The proposed rule (September 2015) defined when tobacco products are regulated as drugs, devices, or combination products.
  • It also proposed to amend FDA’s definition of intended use found in 21 CFR Sections 202.128 and 801.4 by deleting a clause that had “long troubled the industry… under the clause, FDA is not only able to regulate products based on their intended uses, but on their actual uses based on whether a manufacturer ‘knows, or has knowledge of facts that would give him notice, that a drug or device introduced into interstate commerce…is to be used for conditions, purposes, or uses other than the ones for which he offers it’”1
  • Industry professionals expressed concern over the knowledge clause, fearing the provision could allow FDA to require new marketing applications based on a company’s knowledge of a product’s off-label use.
  • Language in the final rule amended the knowledge clause to read: “And if the totality of the evidence establishes that a manufacturer objectively intends that a drug introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than ones for which it is approved (if any), he is required, in accordance with section 502(f) of the Federal Food, Drug, and Cosmetic Act, or, as applicable, duly promulgated regulations exempting the drug from the requirements of section 502(f)(1), to provide for such drug adequate labeling that accords with such other intended uses.”2

Pearl Pathways will monitor this situation as it develops. Check out our blog in the coming weeks for updates on amendments to the final rule once the 60-day feedback period concludes. Our team has helped several companies navigate the difficult regulatory pathway tobacco products face under the Family Smoking Prevention and Tobacco Control Act. Contact us today to discuss what regulatory pathway your tobacco product falls under. We can help with your premarket tobacco application (PMTA), modified risk tobacco product (MRTP), and more.

 

 

1http://www.raps.org/Regulatory-Focus/News/2017/03/17/27145/FDA-Delays-Final-Rule-on-Intended-Uses/

2https://www.federalregister.gov/documents/2017/01/09/2016-31950/clarification-of-when-products-made-or-derived-from-tobacco-are-regulated-as-drugs-devices-or