Industry
Pharmaceuticals
Challenge
Elpida is a small gene therapy team creating customized treatments for rare disease in children, including the son of founder Terry Pirovolakis. With extremely limited resources, they needed a GxP platform that could do it all without breaking the bank.
Results
Kivo's affordable platform offered Elpida the compliance they need without the overhead for their entire development team, including Clinical, Regulatory, and Quality.
Key Product
QMS, eTMF, RIM, DMS
"As a small company trying to save lives, we needed to get organized and maintain that organization, because we don't have time to mess around.
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About Elpida
On April 2, 2019, Terry and Georgia Pirovolakis received the heartbreaking news that their youngest son, Michael, had been diagnosed with a rare hereditary disease called SPG50. They were told to go home, love him, and give him the best life possible, as there was nothing available to prevent the paralysis he would eventually face. This marked the beginning of the Pirovolakis family's quest to find a better future for Michael, a journey that led to the creation of Elpida Therapeutics. As of 2025, Elpida aims to secure approval for five gene therapy programs, dosing 8-12 children each within the next 2-3 years.
The Challenge
All sponsors aim to improve the lives of patients. For some, that means attempting to save the lives of those with terminal illnesses. But rarely does that mean trying to save your own family. This is the reality for Terry Pirovolakis, founder of Elpida Therapeutics.
In 2019, Terry's son Michael was diagnosed with the rare neurodegenerative disorder Spastic Paraplegia Type 50 (SPG50) affecting only 80 children worldwide. Characteristic clinical manifestations of SPG50 include developmental delays, small head size, seizures, and stiffening of a child’s muscles that can expand toward the upper body and lead to paralysis in all limbs. And there were no treatments available.
Mr. Pirovolakis was not willing to accept that fate, nor the massive hurdle of funding to be overcome for the development of therapeutics targeting rare diseases. Instead, he and his family took it upon themselves to create CureSPG50 – an organization founded in hopes of raising money to develop an SPG50 gene therapy. Through Herculean efforts including crowdfunding, even car washes, Mr. Pirovolakis was able to found Elpida Therapeutics: a socially responsible corporation aiming to develop gene therapies as fast as possible, for as many children as possible.
Less than 3 years from the date of diagnosis, the clinical trial developed and delivered for Michael took place.
Elpida's modern approach required unique support. With extremely limited funding and resources, Elpida initially managed its program with a collection of DIY tools like SharePoint. However, the team was concerned about compliance standards and struggled to keep everything organized. It needed a one-stop solution that wouldn't slow down its essential, life-saving work.
"We're doing things completely differently. As a small company, we want to get organized and maintain that organization, because we don't have time to mess around. We need to be able to find documents and move forward. We need to be organized from the beginning and follow that process so that we're able to do the things that we need to do. "
The Solution & Results
Given the rapid development process, the importance of the mission, and unique funding landscape, Kivo worked with Elpida to create a custom package that included the full scope of Kivo's capabilities, including QMS, RIM, eCTD, eTMF, and DMS for Elpida's internal team and their vendors & consultants.
Following contract signature, Kivo got Elpida up and running in 3 weeks. Since go-live, Elpida has moved all 5 of their current candidates and trials into Kivo. Supporting Elpida's mission remains one of Kivo's highest priorities. Kivo CEO Toban Zolman spoke to the team after launch, saying:
"We are often so removed from the drug approvals our software enables. But this is a reminder that we can have a direct effect on improving and ultimately saving lives by building and delivering a great product. With Elpida, that impact will literally be measured one child at a time, and I’m deeply proud that we will be part of that story."
Kivo looks forward to supporting Elpida for years - and lives - to come.
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