PH: Frontida is a newcomer to the industry. Please tell us who they are.

Ron Connolly

Connolly: The company was founded in June 2016 by the founding leaders of Frontage Laboratories, a CRO which is active in pre-clinical and clinical research spaces in the US and China. Dr Song Li, who is the CEO of both, originally came from China for post-doctorate studies at McGill University in the 1980s and is now a highly successful US entrepreneur. I first met him when we were working at Wyeth in 1994. In 2014, Frontage received a new strategic investor in TigerMed, a South-East Asian clinical CRO who wanted to expand their capabilities and presence in the USA. This investment allowed our team to buy several commercial manufacturing facilities in Philadelphia and near Chicago in 2016 from Sun Pharma and originally URL Mutual Pharma, then launch Frontida.

PH: So, are you a part of Frontage?

Connolly: No, Frontida is a stand-alone business, although Frontage has a minority stake in it. Our model is to help companies to progress through later-stage development to commercialisation by offering enabling oral delivery technologies for dosing in Phase II and III trials and commercial production.

PH: What are you your key technologies?

Connolly: Besides our abilities to manufacture immediate and controlled-release oral dosage forms, the most important is AdaptDose, which is a way to streamline the scale-up and dosing of new molecules or fixed combinations of approved molecules. It does this by creating a miniature version of a dose for oral delivery, such as a mini-tablet or drug-layered bead, and combining it with a high-tech, three-hopper capsule filling system. This can create multiple versions of the drug with, for instance, different release rates or different dosing regimens, without the need to mix them together before filling into the capsule. Drug companies are doing more adaptive clinical trials with formulations; AdaptDose gives them a modular means of dosing, such that they can add the exact number of mini-tablets into a capsule or give them a pH-dependent coating. URL Mutual was one of the first companies to use this technology for an approved product, so in effect the FDA has validated it at commercial scale. We now want to offer it at development scale

PH: Is that your main focus here at DCAT Week?

Connolly: This week is one of our first forays with introducing it, following on from CPhI Worldwide. We have five people here and about 100 meetings arranged, as well as having impromptu discussions.

PH: And what is your business model?

Connolly: A lot of commercial-stage companies work on a fee-for-service model and I know there is a degree of frustration about the potential for escalating costs and ownership of responsibility in commercial supply. Many manufacturing ‘partners’ aren’t really partners at all. As a late entrant in this market, we wanted to offer a flexible model, that is transparent about costs and profitability on both sides. We believe this will particularly suit smaller biotechs, generics companies and those seeking to do a 505 (b) (2) application for a new indication for an existing drug. In one recent supply agreement with Oncoceutics, we formed a deal to reduce our fee structure and take a stake in them in an effort to truly partner with them. They have a very promising compound for brain tumours and other cancers, so we were ready to share the risk with them.  We are interested in forming such relationships with companies in the US and Asia.