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 us first started in 2014, the strength and depth of our relationship was highlighted in Spring 2019. In May that year, more than 400 of our 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 our service delivery, “among all of the collaborators, they are probably the best time keeping CRO we have worked with.”

Challenge: Chinese pharma requires expedited SEND datasets for an FDA submission

It wasn’t long after Dr. Xu’s opening speech that a situation put our timeliness to the test. Over the summer months, Peg Bio submitted multiple studies carried out by us for review under the U.S Food and Drug Administration’s (FDA) Investigational New Drug (IND) program. The agency responded quickly to Peg Bio with a request that the submission be updated to include Standard for Exchange of Nonclinical Data (SEND) datasets as soon as possible.

This is not an uncommon situation for sponsors who are dealing with multiple regulatory authorities – especially given that SEND requirements are relatively new, and expertise and understanding are still developing across the industry.

As Dr. Xu explained, “Our pipeline drugs target both China and western market, therefore in order to achieve approval from respective authorities, studies need to be performed to the highest quality that can be desired. To this end, both FDA and NMPA [China’s National Medical Products Administration] were largely satisfied with the reports they generated.”

PegBio had successfully filed the study reports with their IND request, so how would they update their submission to include all of those SEND datasets now required by the FDA?

Solution: Leverage a global SEND team to generate 8 datasets in 5 business days

On August 9, after an initial dialog between Penny Wang, Sr. Business Development Director and Peg Bio, Penny contacted the SEND team to apprise them of the urgent need for multiple, expedited SEND datasets.

The SEND team understood the significant negative impact Peg Bio would experience if their IND submission was rejected by FDA and immediately went to work. Communication across a multi-site and multi-disciplinary team ensured retrieval of archived data, provision of contributor data in SEND format, and ultimately, generation of fully-integrated, submission-ready SEND datasets.

Penny coordinated the effort to gain the required commitment from multiple stakeholders and kept Peg Bio informed along the way. In the end, 8 SEND datasets had been delivered to the client within 5 business days. According to SEND Supervisor, Jason Pitzer, “This was truly a remarkable team effort…by a truly remarkable team!”

Every member of the team, and numerous others re-prioritized their responsibilities for the week and worked overtime as needed to demonstrate “our focus on providing our guests with a concierge experience—anticipating needs and exceeding expectations!” as stated by AsiaPac VP of Sales, Andrew Fleming.

After receiving all of the SEND datasets, Peg Bio Senior Director, Dr. Gao Sun noted, “Please allow me to use this opportunity to express my sincere gratitude to you [. . .] for the great service, team spirit and the client-centered attitude that have been shown this week to help us meet our FDA IND submission deadline. We understand that preparing 8 SEND datasets within one week is challenging or even impossible for many other CROs. I am really grateful that they are our service provider and we are extremely glad that we chose them for the service.”

Speed is incredibly vital in our industry. In the words of CEO Paul Kirchgraber, “Patients can’t wait. Neither can we.” Thanks to our SEND expertise, we can proudly say that they don’t have to.

Expediting SEND datasets for an international regulatory submission

Challenge: Chinese pharma requires expedited SEND datasets for an FDA submission

Solution: Leverage a global SEND team to generate 8 datasets in 5 business days

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Challenge: Chinese pharma requires expedited SEND datasets for an FDA submission

Solution: Leverage a global SEND team to generate 8 datasets in 5 business days

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