Speed, Safety and Scalability: An Integrative Approach To Drug Development

Linda Cherry, Vice President

The COVID-19 pandemic has impacted every aspect of business differently, but perhaps one thing that every industry can agree on is that there is no playbook for moving forward. The expectations surrounding the industry’s rapid response to the pandemic required a change in approach across the entire bio pharmaceutical industry: every party involved in creating and developing COVID-19 assets had to find ways to accelerate therapy without sacrificing quality, safety and public trust.

The industry’s swift and radical path to COVID-19 asset approval has heightened the desire to examine how drug development lifecycles could be accelerated across other therapeutic areas. The traditional model for drug development— starting with a predetermined handoff from clinical to commercial—is no longer sustainable. An integrative approach to drug development—clinical and commercial teams working seamlessly through the process—may be the best strategic move forward for companies not only bringing COVID-19 drug therapies to market, but for all.

WHY AN INTEGRATIVE APPROACH TO ASSET DEVELOPMENT?

The historical approach to asset strategy was based purely on regulatory approval considerations rather than a blend of regulatory, clinical, market access and commercialization insights at every stage of the development process. This contributed to the high number of clinical and commercial failures that we see in the industry today. Parallel processing regulatory, clinical, Real World Evidence (RWE) and commercialization activities conducted in an integrated manner strengthens the regulatory package, and can significantly reduce development timelines. The integrative model mitigates the risks inherent in drug development more effectively.

The pressure to speed new therapies to market while the landscape continues to evolve requires the drug development platform to be built quickly and with an integrated view toward product development. Commercial planning, traditionally initiated just prior to launch by commercial functions, is now required much earlier in the development process for effective up-front clinical trial design and successful pursuit of approval. In expedited/accelerated approval cases or emergency use authorization (EUA), the early commercial view is even more of a requisite for approval. During the clinical phase, an integrated model can accelerate benchside development.

“During the clinical phase, an integrated model can accelerate benchside development”

A dedicated team focused on the asset’s entire development life cycle can facilitate more focused trial design and submission requirements (e.g., combined Phase I/ II trials, use of accelerated regulatory pathways, pricing and distribution models,and patient education plans). A holistic methodology can also integrate RWE, commercial strategy and market access insights into the clinical plan, which is critical for the asset’s scientific and clinical narrative. In addition, this full-spectrum clinical to commercial perspective can help illuminate higher-yield commercial paths to take during the asset development process.

With more and more investors coming on board as key stakeholders, the asset’s net present value (NPV) is greatly affected by speed to market, cost efficiency and risk. For an integrative approach to work effectively, teams need to have a constant lens toward NPV, especially in implementing innovative statistical models and commercial designs, to maximize pull through and return on investment (ROI).

KEY ACTIONS FOR LAUNCHING AN INTEGRATIVE DRUG PATHWAY

Demand for quick approval is as critical as safety and efficacy outcomes. A successful integrative approach will be able to:

• Leverage an integrated approach with a single dedicated point of contact to ensure full, streamlined and timely access to cross-disciplinary experts across the partner organization

• Deliver global operational scale to de-risk use of funding across the clinical to commercial spectrum •Provide comprehensive and continuous surveillance of real-time therapeutic insights and data allowing for rapid pivots in asset strategy, if needed

• Supplement in-house expertise with therapeutic[1]specific clinical, regulatory, access, policy and commercial capabilities

• Focus on transitioning assets from one value inflection point to the next as quickly and efficiently as possible, de-risking asset value and thus delivering on shareholder expectations

• Deliver optionality and scalability for internal expansion that allows for a more balanced approach to investment into the organizational footprint

INTEGRATIVE DRUG DEVELOPMENT: TRANSCENDING THE TACTICAL AND TRANSACTIONAL

Hastened timelines and the unpredictable market have made traditional analogs for success scarce, and the competitive landscape crowded. These factors impose significant risk for therapy organizations and create uncertainty in providing viable therapies to patients. For these reasons, drug development demands a more fully integrated and holistic solution, transcending the tactical and transactional, to provide emerging drug developers a powerful combination of asset strategy and execution.