Expediting SEND Datasets for an International Regulatory Submission

A case study with Peg Biomedical Co., Ltd

Peg Biomedical Co., Ltd. (Peg Bio), is a Suzhou, China-based biopharmaceutical company specialized in developing innovative medicines for metabolic diseases including type 2 diabetes, obesity, and non-alcoholic hepatitis.

While business between Peg Bio and Covance first started in 2014, the strength and depth of our relationship was highlighted in Spring 2019.  In May that year, more than 400 Covance employees relocated to a new facility – the Aland Center in Zhangjiang Hi-Tech Park of Shanghai’s Pudong District-  and Dr. Michael Xu, CEO of Peg Bio, was invited to deliver a speech for the new site opening ceremony. In his address, Dr. Xu expressed his gratitude for Covance’s service delivery, “among all of the collaborators, Covance is probably the best time‑keeping CRO we have worked with.”

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Covance Opens New State-of-the-Art Genomics Laboratory in Indianapolis

Covance celebrated the grand opening of its new flagship Genomics Lab in Indianapolis, Indiana on February 14th. Co-located with its established, industry-leading Central Laboratory and Bioanalysis Lab, the site provides greater testing efficiencies and comprehensive scientific solutions to help biopharmaceutical companies develop therapies faster and with a greater probability of success.

The new Genomics Lab adds 16K ft2 of new, dedicated laboratory space to deliver applied genomics solutions from single target to whole genome analysis. The laboratory also consolidates exploratory studies and biomarker development, patient management (CAP/CLIA) laboratory testing and Companion Diagnostic (CDx) development.

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Understanding Biocidal Products Regulation (BPR) in the EU

BPR is the legislation governing the use of biocidal products in the European Union. Read on to find out how to navigate the authorization process and understand the information required.


Biocidal products are used to control unwanted organisms (e.g., pests, such as rats, or micro-organisms, like bacteria) that are harmful to the health of humans or animals, the environment, or that cause damage to . As such, biocides play an important role in everyday life and reflect a huge range of product types, from disinfectants to insecticides.

The European Chemicals Agency (ECHA) regulates the specific biocide products that are available in the EU/EEA and Switzerland, as well as the active substances that they contain, under the Biocidal Products Regulation (BPR). The aim of the BPR is to ensure that all marketed biocidal products perform their intended role (i.e., have efficacy) and pose a low hazard to humans, animals and the environment when used as specified.

Quick Overview of BPR

The EU Biocides Regulation 528/2012 has been in effect since September 2013. It has a two-step process requiring at first an active substance application, and secondly the authorization of any biocidal products containing that active substance. The regulation also allows for the authorization of biocidal products as a biocidal product family. A product family allows the authorisation of multiple biocidal products within one submission. All products within the family must contain the same active substance(s) but can appear at different concentrations. If your product is identical to an existing formulation, but marketed under a different trade name, it is possible to apply for a same biocidal product authorization, which can reduce administrative burden.

You can choose to authorize products at a national level (which is beneficial in cases where the product is marketed in a few EU/EEA countries) or at Union level (which covers the entire EU/EEA and Switzerland). Up to the end of 2017, total of 115 Union authorizations for biocidal products had been submitted – of these 83% were submitted for biocidal product families. This may illustrate the attraction of the lower administrative burden and cost associated with a product family authorization.

Union and National authorization require submission via R4BP to a competent authority in a member state. There are some practical and logistical variations in how different member states approach BPR, so it’s worth considering the options available to you before you settle on a specific one.

Biocide Categories and Product Types

Annex V of the BPR contains 22 different product-types (PT) which fall into four main groups;

  • Disinfectants (PTs 1–5): for disinfectants in human and veterinary hygiene, surface disinfectants, drinking water disinfectants and for disinfectants that may enter into contact with food
  • Preservatives (PTs 6–13): biocides used to maintain product shelf-life (other than food or feed), protect construction materials or textiles, preserve wood and prevent slime growth
  • Pest control (PTs 14–20): for rodents, birds, fish, molluscs and insects
  • Other: for biocidal products which don’t fit within the other groups and include antifouling products (PT 21) and embalming fluids (PT 22)

Union Authorization (UA) is not an option for active substances within PTs 14, 15, 17, 20 and 21. Union authorization becomes an option for PTs 7-13, 16 and 22 from January 1, 2020 with all remaining PTs currently able to apply for UA.

Testing Under BPR

For authorization of a biocidal product, you need to provide all the information requirements set out by ECHA. There are two main data sets which are included within the IUCLID dossier – the core dataset (CDS), which all products require, and the additional dataset (ADS), which depends on the PT, its use, type of formulation and application method. Table 1 summarizes the analytical requirements, for both CDS and ADS, for biocidal products and active substances.

Table 1: CDS and ADS analytical methods for active substances and biocidal products

In addition to the IUCLID dataset, a risk assessment and a summary of product characteristics (SPC) are also required. The most time-consuming data to collect relates to long-term stability. These tests take two years to conduct, so forward planning for BPR submission is essential.

Conclusions

There are multiple things to consider when navigating your biocidal product through BPR – focus on gathering the right information and selecting the most appropriate authorization approach for your product, and consider the value of the biocidal product family approach.

Visit our website for more information about Covance’s regulatory services for crop protection.


About the Author

David’s main focus and area of expertise is biocides regulations, including regulatory advice and strategy. The latter often involves preparing documents such as data gap analysis, or setting up and identifying the format of product families.

Taking International Women’s Day to New Heights

While International Women’s Day (IWD) is officially recognized on March 8, the collective action and shared ownership necessary to drive gender parity is a constant undertaking. Last year, our drug development team located in India took the “Balance for Better” theme to heart. This year, they’re planning for an even more impactful 2020 that’s part of a commitment to make a positive difference for women across all of our global sites.

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Addressing the Challenges of Data Management for Pharmaceutical and Biotechnology Companies: Introducing Laboratory FSPx

The process of ensuring clinical trial records are accurate and fully reconciled between laboratory and clinical data sources can be a point of frustration for today’s pharmaceutical and biotechnology companies. Whether the data is coming from a contract research organization (CRO), a central laboratory or third-party laboratories, the need for timely availability of clean data based on unique sponsor format/industry requirements has become extremely complex.

“As the complexity of today’s studies grow, sponsors are often working with a greater number of laboratories in their studies,” explained Richard Cesarski, SVP, Patient Solutions, Safety and Data Sciences. “While these labs are specialists in sample management and generating results, their standard report formats may not be aligned to individual sponsor requirements.”

Recognizing this gap between sponsors, their clinical partners and the labs, Covance has launched Laboratory Data Management FSPx (Lab FSPx), a new solution within its Functional Service Provider (FSPx) offering.

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The Rewarding Career Path From a Study Technician to a Clinical Veterinarian

As a biology major, Tai had always planned on being a medical doctor, but when she reached her senior year in college she decided to explore other professions.

“My family had always told me, ‘you will be a doctor,’ and I didn’t think twice about it. But when I was finishing my undergraduate degree, I realized I wanted to figure out another way to make a difference with my career.”

After graduating, Tai explored positions in a variety of areas, including a volunteer position with the local humane society. At the shelter, she met another volunteer who was in a program to become a veterinary technician, and who encouraged her to learn more about the line of work.

“I enjoy working with animals, and a career in the veterinary field seemed like something that I could be excited about getting up for every morning,” Tai shared.

Starting a career with Covance, the drug development company of LabCorp

As she was completing her veterinary technology program, Tai needed to decide where, such as an animal hospital, research laboratory, animal shelter or private veterinary center, she wanted to work in the industry. Her program invited different guest speakers across the veterinary technology community to share their roles with the students.

“Hearing the guest speaker from a local research laboratory made me interested in learning more about the research side of the vet tech role. It seemed like a natural fit to work with animals and apply my scientific background from my undergraduate studies,” said Tai.

“When I became a licensed vet tech, a position for a study technician at Covance was available. I applied and was hired. Even though I had a 90-minute commute each way, I literally loved every single moment of the job.”

Recognizing the value of animal welfare

Although Tai had been inspired by the research technician who visited her vet tech program, she still wasn’t entirely sure what she would be doing as a study technician.

“I think the reason a lot of people don’t go into laboratory animal medicine is because they are not sure what it is about. I think people will find it’s much different than they expected,” said Tai. “When I started, I only had a vague idea about animal research and what it meant, but Covance provided me with a lot of on-the-job training.”

Tai also learned how study techs can help ensure that animal welfare remains a top priority.

“One day while we were running a study, a fellow study tech noticed an issue with a mouse. We called the veterinarian and he was there in less than five minutes to evaluate the mouse and make sure it got the care it needed. I saw first-hand how the animals were treated humanely and with respect, and valued the importance of my role as the voice for these animals.”

Growing her career and recognizing her impact on healthcare

Inspired by her work as a study tech, Tai decided to continue her education in the field. She left Covance and enrolled in a veterinary medicine program, earning her degree as a Doctor of Veterinary Medicine (DVM). During her studies, she and her husband adopted two red-footed tortoises after being a volunteer coordinator for the tortoises on campus. “We fell in love with the tortoises,” she laughed. “They have unique personalities, believe it or not.”

After completing both an internship and a residency program in laboratory animal medicine, she rejoined Covance, this time as a Clinical Veterinarian.

“I came back seven years later, and saw that some of the same people are still at Covance, including the veterinarian that had made such a positive impression on me,” she said. “I was so excited to be working with some of the same staff.”

Beyond working with familiar faces, Tai is motivated by her role in improving laboratory animal medicine.

“Good research comes from happy, healthy animals. I take pride in advocating for our animals and making a positive impact in their lives,” explained Tai. “Whether I am helping refine procedures to improve animal welfare, ensuring animals have the right enrichment in their environments, or simply changing cages, I enjoy the process of caring for our animals. Ultimately, I see how the care we provide for our animals results in valuable data that helps ground-breaking drugs come to life for both humans and animals alike.”

Learn more about our study tech opportunities here.

Minimizing Placebo Effect in Inflammatory Bowel Disease Clinical Studies

With 93 Crohn’s Disease (CD) and 168 Ulcerative Colitis (UC) Phase I-III industry-sponsored studies planned and open to enrollment, there is a significant focus on research into new therapies for inflammatory bowel disease (IBD)1.

Remission is the main aim of IBD therapy, but IBD studies often face challenges with minimizing the placebo effect2,3,4. Placebo effect can be categorized into placebo response/benefit (patients demonstrating an improvement) or placebo remission (patients achieving remission). Factors believed to impact the level of placebo effect can be contradictory depending upon whether a study’s focus is upon placebo response/benefit or placebo remission5.

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How to Renew Plant Protection Products – US Regulations

Important patent expiries are expected this year, and merger and acquisition activity among agrochemical companies is changing the competitive landscape. Against this backdrop, the history, knowledge and insight about established active substances could get ‘lost’, and such changes may pose risks for reauthorization of plant protection products (PPP). Find out here.

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Brexit: Leveraging the Mutual Recognition Agreement to Mitigate Potential Risk With Commercial Drug Product Release Testing

Updated February 3, 2020 – Brexit1 has been completed and the UK will now enter into a transition agreement with the EU until December 31, 2020. Until then, the current GMP regulations will continue to apply. . However, drug manufacturers and contract test laboratories should be proactive in understanding the potential regulatory considerations relating to commercial drug product release testing.

This article provides a brief overview of the EU-US Mutual Recognition Agreement (MRA) and discusses considerations for implementing viable alternatives for testing to support EU, UK and US drug product releases after Brexit.

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ECHA Decision Letters – What to Expect

The last REACH deadline was in May 2018 and brought to a close the period of active information gathering on the safety of chemical products marketed in the EU/EEA. It has resulted in a massive database of safety information on a wide range of substances and heralds an exciting new phase of evolution in scientific and regulatory thinking. So, with the data in, the decision letters start to roll out.

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