A Wisconsin pharmacist and a Nevada pharmacologist were arraigned on an indictment today in Federal Court in Central Islip, New York, before United States Magistrate Judge Gary Brown. The defendants are charged with conspiring to supply at least four million misbranded and counterfeit pharmaceuticals to an illegal Internet pharmacy based in Costa Rica that catered to U.S. customers.

Vir Biotechnology, Inc. (VIR) and Alnylam Pharmaceuticals, Inc. (ALNY) announced Monday that they have selected a development candidate (DC) for VIR-2703 (ALN-COV), an investigational RNAi therapeutic targeting the SARS-CoV-2 (COVID-19) genome.

BASF recently announced the launch of Accelon™ absorption accelerating technology, developed as a breakthrough solution to the bioavailability challenge of today’s omega-3 supplements.

APEC member economies launched the APEC Women in STEM Principles and Actions, a set of suggested principles and actions for encouraging women’s participation in the fields of science, technology, engineering, and mathematics, commonly referred to as STEM.

A duo of innovative programmers from Malaysia are the winners of the 2019 APEC Digital Prosperity Award, announced on the sidelines of the APEC Informal Senior Officials’ Meeting in Langkawi.

“I would like to express our appreciation to APEC member economies that put their faith in Malaysia’s leadership and made it a point to participate.”

We may call them “site inspections”, but it’s not the site that’s being inspected when a regulator visits; it’s the Principal Investigator. Though a PI typically delegates study tasks to other staff members, he or she remains solely responsible for the conduct of the study. In fact, the ICH E6(R2) addendum adds two new sections to the international guidance that emphasize PI supervision.

That’s what makes the Delegation of Authority (DoA) log so important and why regulatory inspectors care about it so much. A DoA log serves as evidence that a PI has assigned study tasks only to those staff members with the education, training, and experience to carry them out. If delegates are unqualified to perform their tasks, subject safety could be at risk and it’s highly likely that the study data would be unusable.



Monitors – you can really make a big contribution here. At the outset of the study, you can verify that your PI has made appropriate delegations and the DoA log is complete. You can cross-match the log with training records, CVs, licenses, and source documents and correct any problems as early in the study as possible. Then, throughout the study, you can verify that the DoA log is being maintained.

Coverage
Without referencing any other site document, monitors can spot two types of DoA log omissions.

(1) Missing Assignments. Are there study tasks to which no one has been delegated? The tasks in a DoA log are often represented by a short code to conserve space. A legend at the end of the log translates the code into its corresponding task. Monitors can compare the legend to the DoA log entries to see if any tasks are omitted.


(2) Gap in Assignments. Due to staff turnover, reassignment, leaves of absence, etc., delegation for a task frequently does not last the duration of the entire study. A column in the DoA log indicates the delegation start and stop date.  Monitors can check to make sure that when the delegation for a task ends for one staff member, it is picked up by another.

Qualifications
Once you’re satisfied the DoA log completely covers all tasks for the duration of the study, you can check to make sure delegates have the necessary qualifications. You’ll want to compare the log with training records, CVs, and medical licenses from the regulatory binder.

• Has the staffer charged with recording vital signs during a subject visit been formally trained to take blood pressure? Is it documented?
• Did an incoming pharmacist receive protocol training prior to the start date of his study assignments?
• Does state law allow a registered nurse to dispense investigational product, or is a nurse practitioner or physician’s assistant required? Does the protocol require only an M.D. conduct certain procedures? Does the DoA log show the requirement is being followed?

Study Procedures
Even after the focus of the monitoring visit moves past the DoA log itself, you should revisit the log during source document review.

• Have any study tasks been conducted by staff members who have not received official delegation to do so?
• Perhaps the protocol requires a blinded IP dispenser. If so, has the delegated dispenser conducted any other study procedure?

PI Oversight
The PI is responsible for ensuring subject safety, compliance with the regs and the protocol, and control of the investigational product. That obligation cannot be delegated away. PI oversight is critical to a successful study, and the DoA log is where PI oversight starts.

Procedures that are performed by unqualified or ineligible personnel put both study participants and study data at risk. These are the very things regulatory inspectors work to guard against. Good monitors know it and make verifying the DoA log a priority.

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A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

True or False:

(1) eSource in clinical trials means eliminating the possibility for transcription errors.

(2) Data collected in Electronic Data Capture (EDC) systems is eSource.

Strictly speaking, both statements are false. If that surprises you, it’s probably because many casual uses of the term “eSource” actually differ from the formal definition laid out by FDA. If the participants in any discussion share the same interpretation of “eSource”, or if it’s clear from context how “eSource” is being used, then no harm, no foul. (Contemporary translation: “Meh.”) BUT…and you know where we’re going with this…when a term can be interpreted in multiple ways, there’s always a possibility for miscommunication and cross talk.



FDA Guidance on eSource in Clinical Investigations
FDA defines eSource as *any* data initially recorded in electronic format. That’s a broad definition, one that includes:
     a) equipment-generated data, such as digital imaging and labs
     b) electronic Patient Reported Outcome (ePRO) transmissions
     c) data streams from mobile health devices, such as Apple ResearchKit
     d) data entered directly into an EDC, known as Direct-Data-Entry (DDE) solutions
     e) data entered into an Electronic Health Record (EHR) or electronic Medical Record (EMR) system


Discussion of Direct-Data-Entry (DDE)
DDE systems allow research staff members to use portable devices to enter study data directly into an EDC system. DDEs have been garnering a lot of industry attention of late, and a number of companies offer solutions that offer a DDE data flow. As independent 3rd party auditors, we don’t want to play favorites by mentioning specific systems as examples, but if your company sells or uses a DDE system that you want to highlight, feel free to add a comment below to give it a shout out.

Discussion of EMR/EDC Integration
Not long after finalizing its e-Source guidance, FDA hosted a webinar that encouraged companies to explore direct EMR/EDC integration. While a few industry players have taken up the effort, movement has been slow. One difficulty: generally EMRs are built with healthcare in mind, not clinical research. Secondly, with so many EMR and EDC vendors, ensuring that EMR data from one system is mapped to appropriate EDC fields in another system relies heavily on data standards that are still being defined and need to be implemented on both sides. 

Source Data Verification (SDV)
If data is transmitted directly from the source system to an Electronic Data Collection (EDC) system, SDV is not required, since the source data isn’t being transcribed manually. (Note: other types of Source Data Review (SDR) activities are still necessary, even if SDV isn’t. SDR must be conducted to verify ALCOA-C data principles such as attribution, originality, accuracy, completeness, etc.) Direct transmission from source system to EDC system is the typical pathway for items (a) – (d) above, and so SDV is not required for these types of eSource.


Common Confusions
SDV. Unless there is EMR/EDC integration – Item (e) above – source data from an EMR system needs to be manually transcribed. This is what makes T/F question #1 false. Just because source data originates in an EMR, it does *not* suggest SDV checks are superfluous. You could argue, as many have, that SDV is not a high-value activity and uncovers only a small percent of data error. That argument may well influence how much SDV is conducted, but whenever data is transcribed from original source into an EDC system, SDV is a relevant discussion.

EDC Data. It’s not unusual for someone to refer to data stored in EDCs as eSource. Data stored in EDCs are electronic, and may be source, but only if the EDC is the first place the data is recorded. This is what makes T/F question #2 false.

In Summary
If you’re ever in a discussion about eSource and things start going sideways, it may be time to haul out the formal definition of eSource -- in all its tedious detail -- to make sure everyone is using the term the same way. 

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Image Credit: Paradox by Brett Jordan

There are major regulatory lapses in the manufacturing of similar biologics in India. The use of scientific audits could strengthen the regulatory system and improve the provision of high quality biosimilars in the country, according to a recent opinion piece [1] by Dr GR Soni, which was published in GaBI Journal.

Biological drugs remain unaffordable for many in the US due to strategies used by pharmaceutical companies and negative messaging about biosimilars, explains a recent commentary by Dr Joel Lexchin, School of Health Policy and Management at York University, Canada [1].

On 7 April 2020, China’s Center for Drug Evaluation (CDE) published draft guidance on clinical trials for the approval of bevacizumab copy biologicals. This guidance is the second specific guideline released by the CDE in April. The agency also released guidance on adalimumab on 1 April 2020 [1].

Neurological symptoms are common in patients with COVID-19, particularly if they have a severe infection, research published in JAMA Neurology suggests.

To read the whole article click on the headline

Just a few months after Alexion snapped up complement inhibitor biotech Achillion, Gemini Therapeutics has nabbed one of its key R&D execs as its new chief medical officer.

This semester I’ve embarked on an adventure to co-teach a class in the University of Wisconsin-Madison Masters in Biotechnology program. What sold me on the experience was the majority of my responsibility is interacting with second year students on their final major project (essentially their thesis). That said, I will give one lecture, which will be “health

Last week, the New York Times had a nice piece “A Faster Way to Try Many Drugs on Many Cancers” on basket clinical trials, which matches patients to a therapy based on the genetics of their tumor as opposed to the site of their primary tumor. This type of trial feeds into the current excitement about precision

Yokogawa Electric Corporation (TOKYO: 6841) announces that it has acquired a nanopipette*1 technology that was developed by BioStinger, Inc., a spin-off from the University of California, Santa Cruz.

Yokogawa Electric Corporation (TOKYO: 6841) announces that it has developed the SU10 Single Cellome Unit, a device that uses a nanopipette to inject substances such as genes and drugs and aspirate intracellular materials at target locations in individual cells.

Yokogawa Electric Corporation (TOKYO: 6841) announces that on March 20, 2020, it completed the acquisition of all shares in Denmark-based Grazper Technologies ApS (Grazper), as mutually agreed. Grazper has developed advanced artificial intelligence (AI) technologies for analyzing images, and Yokogawa aims to leverage these technologies within its various existing businesses and to develop new industrial AI solutions.

Yokogawa Electric Corporation (TOKYO: 6841) announces the release of artificial intelligence (AI)-enabled versions of the GX series panel-mount type paperless recorders, GP series portable paperless recorders, and GA10 data logging software, which are components of the highly operable and expandable SMARTDAC+data acquisition and control system. This new AI functionality includes the future pen, a function developed by Yokogawa that enables the drawing of predicted waveforms. Yokogawa is also releasing a new CPU module for the e-RT3 Plus edge computing platform that is environmentally robust and Python compatible. The GX/GP and e-RT3 release is set for April 8, and the GA10 software will be released on May 13. The SMARTDAC+ system is a product in the OpreX Data Acquisition family, and the e-RT3 Plus is part of the OpreX Control Devices family.

Yokogawa Electric Corporation (TOKYO: 6841) announces that on April 8, it completed the acquisition of all shares of Fluid Imaging Technologies, Inc., as mutually agreed.

Existing investors Matrix Partners India, Stellaris Venture Partners, and Alteria Capital also participated.

The post India: Logistics startup LoadShare secures $13.2m led by BEENEXT, others appeared first on DealStreetAsia.

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