Biotechs Should Go With An Uber Not A Limo
By Louis Garguilo, Chief Editor, Outsourced Pharma
Bob Discordia had been in stealth mode for a while, but I was certain when he finally emerged, his newco would include a precise model of outsourcing.
The reveal came earlier this year.
Long after 26 years at Bristol Myers Squibb culminated as Executive Director, Global Business Operations for Global Product Development and Supply, and his subsequent joining/founding other biotechs, Bob Discordia is now Co-Founder, President & CEO of EQUULUS Therapeutics.
The company utilizes a transdiagnostic approach to the development of therapeutics to identify and target fundamental factors that transcend standard diagnostic categories and are tied to clear disease-driving physiology.
So how will Discordia, one of the deepest thinkers on outsourcing I know, utilize external partners this time?
Good Start, Bad Start
Outsourcing philosophy should inform the functioning components of your business model and goals.
EQUULUS, Discordia says, is and will remain a largely “virtual biotech,” and has started with these components:
- attracted investors, and is pursuing serious grant money
- a fantastic board, and equally fantastic academic advisors
- a tremendous chief scientific officer (CSO) who will soon come on board
- exciting small-molecule assets to develop
“I’m putting all my years of pharmaceutical development to good use as one part of ‘the secret sauce’ in creating an efficiently designed pharmaceutical-development outfit,” he says.
That translates to fast-progressing and cash-efficiently moving discovery assets into clinical compounds via an all-outsourcing model.
“I have failed to be so efficient at times in the past,” he confesses.
Most professionals have, too.
Missteps can be shared between a “faulty internal approach,” and external partners.
However, today’s industry-accepted development model may be the real culprit.
Typically, explains Discordia, when biotechs plan to nominate a small-molecule lead program to advance into preclinical testing and a phase-one clinical trial, “at the time you nominate that compound you already assume you require over a year – and sometimes two – to get through IND-enabling testing.”
“By that time, millions of dollars have been paid out to CROs and CDMOs just to be able to file the IND. It doesn’t have to be that way,” says Discordia. “It doesn’t have to be standard practice.”
A Better Recipe
At EQUULUS, Discordia has put procedures in place that in most instances can “get this done in less than a year, and for significantly less cost.”
That brings us to the first component of his secret sauce, and the ‘we-do-everything CDMO’ is not an ingredient for streamlined outsourcing.
Discordia understands the allure, but is weary of ceding all pre-IND enabling activities to a single CDMO, including in vitro and in vivo testing, toxicology, off-target liability items, etc.
“It can become a ‘must do everything mentality,’” with an elongated service package and a big price tag.
However, Discordia says, “over the years, I've noticed there's a fair amount of stuff that you can do during or even after your phase one that's built into your CDMO’s preclinical package, unnecessarily extending timelines, and burning your cash.”
A common example of this includes unnecessarily developing a formulated dosage form for a phase one study when often times this is not required.
Doing so places formulation development, GMP manufacturing and stability studies into the cost and timeline of your outsourcing when opting for a simple on-site preparation of drug-in-capsule could obviate nearly all of this.
Discordia strongly advises for more discretion.
If your initial business plan is to get to phase one as quickly as possible and having conserved cash, opting for all these services initially can amount to an element of “uninformed outsourcing.”
The sponsor needs to take responsibility for clearly communicating the goal of the relationship to the CDMO. That goal might be to move through phase one economically, “teed up for a potential pharma partnership or out-licensing at phase two.”
And it is the CDMO who demonstrates it understands the sponsor’s plan, and offers a package that truly meets those ends, that the sponsor should select.
Psychedelics Outsourcing
Discordia explains that while Equulus is inspired by the science and potential of psychedelics, “we are first and foremost, a neuroscience company, whose mission is to develop transformational therapeutics for brain disorders which continue to be the leading causes of suffering and mortality in the world.”
However, Discordia is, in fact, immensely inspired by what psychedelics research has brought to neuroscience and he’s convinced it holds great promise for patients. But, specifically for psychedelics, Discordia says “we are focused on the translation of the promise of psychedelics into practical therapeutics that will be readily enjoined by the pharmaceutical industry as conventional therapeutics that can and will be accessed by patients world-wide.”
“On the other hand,” he adds comparatively, “compounds such as psilocybin, LSD and ibogaine will struggle to gain broad health authority approvals (the recent setback with the rejection of MDMA by the FDA being a prime example) or to fit into existing reimbursement and/or payer systems.”
None of this changes the Discordia outsourcing paradigm for biotechs.
With rare exceptions, start-ups are relatively cash strapped, can’t afford nor do they need to hire a lot of professionals or consider leasing or even building facilities.
You need excellent external partners, but Equulus has an internal mantra as a guidepost:
At this point in time, why hire the limousine when you can call an Uber?.
“We’re going to call the CDMO that will be our Uber,” Discordia explains. “I only need to go from here to there. When the ‘Uber’ drops me off, I know where I am and have paid for that ride.”
To be clear, Discordia is not minimizing th importance of CDMO relationships; he just wants to ensure they are strategic and on point.
“We do want to get to know the Uber driver, and continue to call that same driver as needed, but first we determine exactly where we need to go, and what the cost should be for that exact service.”
Biotechs by nature, he adds, encounter “a lot of potential for failure,” and need to be nimble and ready to pivot.
“If you've created elongated multi-service contracts with CDMOs that leave you in one lane longer than you want, you're now wasting time and money.”
Worse, you may never reach your destination.