It’s no secret that the nearly 1,300 miles of the West Coast of the United States is an incubator for some of the world’s most advanced and sophisticated medical research and technologies.  With dozens of biotech companies packed into the San Francisco Bay Area of California, stem cell scientist, Rekha Nair had her pick of the litter when it came to selecting which company would take her career to the next level.  But as bountiful as the San Francisco Bay Area is for the booming biotech space, it has also become as big a graveyard for many bio-business ventures.  As Rekha’s previous company faced acquisition, she decided to bypass the lateral move of going to another biotech company and decided to make the big leap into Big Pharma.

Now a Senior Process Development Scientist at Novo Nordisk’s stem cell manufacturing site in Fremont, California, US Rekha works on developing a robust process for taking the small-scale lab procedure of coaxing an undifferentiated pluripotent cell into a differentiated cell and scaling it up to a magnitude that can be repeated at the manufacturing level. While this line of work might be full of obstacles, it was just the kind of challenge that Rekha was looking for.

“Where I work in the process development sector, the type of technology we get to work with is really what attracted me,” explained Rekha.  “The idea of scaling up where we go from working in really small dishes to big bioreactors…that was something we were trying to get to at my previous company for a while – but it requires funding, it requires investment.”

Unfortunately, for many scientists in the biotech space, discoveries of new molecular entities never leave the lab due to lack of funding.  “In developing the process that leads to clinical studies, there’s a disconnect and part of the reason for that is because of investors.  I was painfully aware of this at the small biotech level.  Investors want to see the clinical outcomes because that’s what makes the headlines – that’s what makes them interested in giving up their money.  But there’s a huge leap between scaling it to where it needs to go for downstream studies and getting the funding for that.”  

Rekha notes that at Novo Nordisk, this wasn’t the case.  “Novo Nordisk is at a really big advantage.  Funding has already been dedicated and is already available for technology, so the challenge of having to convince investors isn’t there.”  With the golden ticket of funding in her back pocket, Rekha can continue to focus on developing a manufacturing process that can keep up with clinical studies and ultimately keep pushing therapies forward.  

While still a pharmaceutical company, Novo Nordisk has been adopting a biotech best practice of working as a TRU or translational research unit.  The TRU is a concept that enables companies to work at the speed of a small biotech but on a larger pharmaceutical company scale.  “The idea is that if changes need to happen, that we should be able to implement them quickly and move forward quickly instead of getting caught up in all the machinery,” explained Rekha, whose team sits within the Stem Cell TRU.  While integrating this innovative best practice is still a work in progress, Rekha has high hopes for it making a large impact in the future of getting processes to clinical trials.

As Novo Nordisk begins to expand its reach into the stem cell field, Rekha believes that the growth won’t stop there.  “There's a multitude of technologies that are not only hot right now, but have a lot of promise and there's reason to believe that these technologies can help improve patient lives,” stated Rekha as she described the immense potential of several cutting-edge technologies that are sweeping the pharmaceutical space.  “One thing that I've been really impressed with at Novo Nordisk is that the leadership is really open to hearing what the new and most promising technologies are.  They're not focused solely on what has historically worked well for the company and what continues to work well but they're open to understanding what’s out there.”

When asked what the next few years will hold for Rekha and her work, she explained that her sights are set on beginning a human dose and bringing the first Novo Nordisk stem cell product to clinical trial.  “It’s an extremely exciting milestone to reach,” exclaimed Rekha.  With this achievement, one of the key outcomes of Rekha’s work coming to culmination will be the framework that her team will have put into place.  This framework will provide the foundation needed to quickly and efficiently bring future projects to clinical trials for multiple therapies.  “We're paving the way for multiple other projects to come in and get to more and more first human dose targets,” said Rekha excitedly.