Keeping biotech bolt-ons separate from its main organization is essential in retaining agility, speed, and innovation for cell and gene therapies, says Bayer’s Jens Vogel.

Despite relatively few reaching commercialization, cell and gene therapies (CGTs) have become a solid part of the wider pharmaceutical landscape with numerous big firms dabbling in the sector.

German biopharma giant Bayer became a serious fixture in the advanced therapy space in 2019 when it bought out cell therapy developer BlueRock Therapeutics. The following year, the firm paid $2 billion for Research Triangle Park, North Carolina-based Asklepios BioPharmaceutical (AskBio) – a firm developing AAV (adeno-associated virus)-based gene therapies.

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Since then, Bayer has launched the Cell and Gene Therapy Platform within its Pharmaceuticals division in an aim to bring its various acquisitions together. However, while the capabilities and assets are together, the teams within the unit remain separate from Bayer’s monolithic business, according to Jens Vogel, SVP and global head of Biotech, Bayer.

“When you look at our organization as a whole, our goal is to bring new products to patients and make this revolutionary potential style gene therapies a reality, for that we need world class product innovation engines, and that’s where we have an open innovation approach, where you see us partnering and also acquiring companies,” he told an audience at BPI West in San Diego, California last month.

Acquisitions like BlueRock and AskBio are deliberately kept “at arm’s length,” he explained. “We don’t want to – on purpose – integrate them into the global Bayer organization because we don’t want them to lose the agility, the speed, and the innovation: the thinking outside of the box approach.”

However, partnering or becoming part of a Big Pharma does bring advantages to the ‘innovative’ biotech, especially when it comes to later-stage and commercial production, he stressed.

“For that you need a really cutting-edge CMC development and manufacturing organization and culture. You need, in the space, quality by design-based CMC strategies. I think the whole industry is still learning how to even define the quality target product profile – what are the CQAs for cell therapies? We know some, but we don’t know enough of that and how to control it. And we need some real innovation in manufacturing technologies. And finally, we need actual flexible manufacturing capacities and ideally a global supply network.

“That’s where we [Bayer] have our strengths that we leverage for our partners. You basically get the best of both worlds: small, agile, nimble biotech with a large industrialization and commercialization organization.”

Sarah Mills, a principal at Dark Horse Consulting, agreed the blend of Big Pharma and CGT biotech is “a gentle balance” on a panel discussion following Vogel’s presentation. “If you innovate and you tinker too much you’re never going to get products to patients and that’s really what we want to do. And we don’t know how far we are going to get into development before we get into that Phase I/II . I think it’s really important to have that balance and to have the innovators add a company to bring in those new ideas.”