Unlocking Opportunities: Insights from 3 Biotech Leaders on Achieving Success in R&D
For emerging biotechnology firms, encountering failure is often more prevalent than achieving success when launching new drugs. Navigating drug development presents a myriad of challenges, including unsatisfactory clinical trial outcomes and funding issues, which can derail a project swiftly.
During a panel discussion hosted by BioPharma Dive on November 13, three industry experts stressed the importance of mitigating risks, highlighting product distinctions, and effectively engaging with investors regarding timelines for potential returns on investment.
“It’s crucial to maintain focus on a viable product or drug in a timely manner,” remarked Chris Bardon, co-managing partner at investment firm MPM BioImpact. “We need ongoing validation throughout the development process.”
She emphasized the significance of maintaining fiscal discipline within biotech operations. “Observing a private company spending over 0 million annually creates significant challenges for both the company and its backers.”
The following are three key insights shared by Bardon and her fellow panelists:
Speeding Up Clinical Trials
The process of identifying and preparing drug candidates for human trials is fraught with risks and delays. Panelists indicated that finding ways to expedite this phase can be beneficial.
For instance, Arialys Therapeutics, established to develop treatments for neuropsychiatric conditions, acquired a drug initially discovered by Astellas Pharma, which already had progressed towards clinical trials.
“This acquisition signified that a substantial amount of preliminary work, perhaps to million, had been accomplished, giving us a level of validation that fosters faster and more confident advancement,” stated Arialys CEO Peter Flynn, noting the challenges of starting from scratch with only academic observations.
Nevertheless, Andrew Miller, chairman of Progentos Therapeutics and founder of Karuna Therapeutics, cautioned that such strategies may not universally apply across all drug development sectors.
“It would be challenging to present a compelling narrative around a novel immuno-oncology asset that has successfully completed Phase 1 trials yet remains obscure,” Miller commented. “However, emerging sectors may offer unexplored opportunities awaiting discovery.”
Distinguishing from Competitors
Panelists urged new biotechnology companies to clearly illustrate how they differentiate themselves from existing competitors.
“There may be hypothetical advantages now, but empirical evidence will eventually reveal your differentiation,” noted Miller, emphasizing the importance of pursuing meaningful value propositions.
With increasing understanding of genetic causes of diseases, particularly in neurology and psychiatry, companies are cropping up focused on specific genetic components, Bardon explained. “Current examples include advancements in Alzheimer’s and ALS research, where targeting genetic subcomponents can substantiate broader market applications.”
However, Flynn remarked that competitive advantages may arise outside purely genetic research. “Evaluate any leverage in your approach, mechanism, speed of clinical data delivery, or clinical execution,” he suggested.
Focusing on Drug Candidates, Not Platforms
Platforms for drug-making are often appealing, suggesting the ability to create numerous drug candidates from a single technology. However, this narrative may not always captivate investors, particularly in tougher market climates.
“Owning a specific asset gives you a clearer direction, versus relying on a vague platform that complicates matters,” Flynn stated.
Bardon pointed out, “The challenge lies in discerning the appropriate investment in the platform and determining when to pivot toward a concrete drug candidate.” She observed that many companies become mired in continuous iterations without progressing towards tangible drug development, adversely affecting themselves and their investors.
Furthermore, Flynn cautioned that as platform-oriented firms produce clinical-stage drugs, they could face significant operational strain. “While aspirations for an extensive pipeline are commendable, they can induce considerable downstream pressure within the organization,” he remarked.
Nonetheless, Bardon acknowledged that innovative developments in neurological diseases have indeed sprouted from drug development platforms. “Recent breakthroughs in neurology are linked to advancements in antisense technology,” she mentioned.
Editor’s note: The panel discussions referenced were hosted by BioPharma Dive on November 13, 2024. For a replay, you can register here.