Monitoring Development Milestones of Competitors in Pharma: A Brief Study

The pharmaceutical organizations are facing a double whammy since the need for rapid innovation has been fuelled by evolving treatment landscapes and patient needs, and patent expiry for approved drugs. The need to keep the pipeline rich and strong has driven fierce competition in the industry. This in turn requires keeping a close watch on the competition with a robust pharma competitive intelligence strategy which is comprehensive, credible, and tailored to meet the specific needs of the organization conducting it.
An efficient CI strategy helps you understand your competition better and may guide your next move.

Clinical trials are vital in a drug developmental cycle. Companies deploy a variety of CI strategies that help monitor competitors’ trials and related milestones to understand what is happening in markets globally and gauge the conversations that their competitors are having with regulators and payers. Recurring delays to trial initiation or completion could indicate multiple things at play in a competitors’ organization such as dearth of resources/funds or shifting strategic focus.

There are many clinical milestones, which can be monitored to answer key strategic questions. Few important milestones are given in the chart below along with the questions they can answer.

Besides, there are few other milestones such as dosing of first patient and recruitment completion that indicate overall progress of the competitor’s development program. Trials are often terminated/ suspended due to inability to recruit eligible patients in a timely manner. Monitoring updates in trial locations is also useful as it helps in identifying the key geographies that our competitor may be eyeing.
With strong CI tactics, research and strategy teams can track industry failures and prevent pharma companies from making the same errors in drug development and save precious resources. It helps companies to stay updated about latest breakthroughs in therapies and trials and gives them a good direction to re-establish and scale up drug development plans.
Clinical trial databases help CI professionals gather data wherein they can analyze both the competitor’s high-level objectives, such as the clinical trial endpoints, inclusion - exclusion criteria, cohorts, dosing, enrolment as well as the company’s strategies to analyze how to best benchmark development strategies. Drug companies also keep an eye out for new technologies, treatment processes employed in clinical trials by the competitors, as they could potentially shift the market. This also helps the drug companies plan their production timeline, and marketing strategies accordingly.

Over the past few years, life sciences companies have been facing mounting regulatory pressures from regulatory institutions across the globe. Traditional pharma commercialization strategies included launching drugs in one country/region and a very slow geography expansion. Most of the specialty drugs were available only in developed economies, and sometimes, within selective countries. A lot of drug manufacturers often partner with local companies in new geographies to take advantage of latter’s local expertise. Competitive monitoring in commercialization processes enables drug makers to mine these market movements for better perspective and understanding of how new drugs can effectively be made available in specific locations. This becomes even more important for companies with single lead candidates or those who have a conservative pipeline so that expenses can be managed for future developmental projects through royalty earnings and less responsibility and reduced stake in marketing success. Understanding such collaborations also provide manufacturers a way to capitalize on their R&D expenditure and develop robust pipelines.

Tracking applications can also identify and predict future responses of regulatory authorities and helps companies understand competitor goals and initiatives. Monitoring clinical and regulatory milestones of drug companies also aid in estimating the drug approval dates in a particular market and understanding the best and worst-case scenarios of launching a drug into a market. Another key regulatory milestone could be tracking label updates for first to market/ first-in-class agents. Such updates help inform other players working on the same class/ MoA about the fate of their assets. When Pfizer’s JAK inhibitor Xeljanz was tagged with a black box warning, it was obvious that the follow-on assets might have to go through the same scrutiny by the regulatory bodies.

Following are a few critical regulatory milestones that help a client hone its own development strategy.