Among the regulatory pathways for small molecule drugs in the United States, the 505(b)(2) option occupies a middle ground. Intended for modifications of an existing treatment, it requires much more evidence than a generic but allows the sponsor to use data from a previous application. Companies can thus avoid unnecessarily repeating studies and shorten their development time.
At a recent Covance clinical seminar in Shanghai, attendees learned about the intricacies of 505(b)(2), the corresponding hybrid medicinal product pathway in the European Union and the differences from applications for biosimilars or generics. Developers in the Asia Pacific region are eager to better understand this topic because the Chinese pharmaceutical industry is developing rapidly with support from the government. “They view 505(b)(2) as a potentially faster way to market,” said Eric Lang, MD, Vice President and Global Head of Clinical Drug Development Leaders, Early Phase Development Solutions. To succeed, however, sponsors will need to consult with experts who can help them develop a regulatory strategy and consider market access issues as well. Continue reading →
As any drug developer knows, clinical trials generate a lot of raw and electronic data from multiple sources. Yet tracking progress and reviewing results from each separate database can be cumbersome in traditional environments. This “rear-view” mirror approach to monitoring doesn’t support preventative planning to mitigate future risks and can account for 20-30% of a trial’s costs.
Recognizing the opportunity increase efficiency and deliver information faster, Covance created Xcellerate® Monitoring, a platform that integrates clinical trial data to help sponsors proactively decrease the inherent risks associated with clinical trials.
At a recent clinical seminar in China, Dimitris Agrafiotis, PhD, Vice President, Chief Data Officer discussed how Xcellerate Monitoring tracks quality, patient safety and protocol compliance in clinical trials. Continue reading →
Drug development in China is progressing quickly, due in part to shifting regulations, increased innovation and growing opportunities for global partnerships. However, making the most of market opportunities requires not only a focus on the intended end results but also careful, early phase planning. At a recent clinical seminar in China, a panel of Covancemarket access experts shared their thoughts on how to increase a product’s commercial potential.
Incorporating a business case
“In China, we discussed the theme of ‘beginning with the end in mind,’” said Eric Lang, MD, Vice President and Global Head of Clinical Development Leaders, Early Phase Development Solutions. “We find that a lot of biopharmaceuticals are focused more on the science of their treatment and don’t realize that they also need a strong business case to develop a product,” he said. Continue reading →
Chinese biopharmaceuticals are expanding development beyond generics to focus on producing more personalized medicine, novel therapies, biomarkers and companion diagnostics. Steven Anderson, PhD, chief scientific officer at Covance, recently discussed his thoughts on biomarkers and precision medicine in China’s drug development and translational medicine landscape.
An emerging focus on biomarkers
“Efficacy of a drug therapy can vary widely and adverse effects can be common, but these parameters are not easily predicted,” explained Anderson. “That’s why biomarker-based, targeted treatments can guide therapy decision-making and better identify those individuals most likely to benefit.”
Our industry is witnessing increasing growth in the rare disease market, thanks to financial and regulatory incentives to develop orphan drugs. This has been good news for both sponsors and patients, but the fact remains that rare disease trials are inherently challenging to run. In addition, completing a complex study and reaching regulatory approval does not necessarily translate to market success.
John D. McDermott, Jr., Vice President of Covance Market Access Services, recently shared his insights on the market access challenges in rare disease drug development and discussed key considerations for sponsors and stakeholders.
Provide early education about the disease
Even though rare diseases as a whole are getting more attention, sponsors cannot assume that their potential payers know much about the particular condition they are targeting and its importance to patients. Continue reading →
Rare diseases affect more than 350 million people worldwide but patients often face limited options for approved therapies. As a result, many patients have joined advocacy groups first and foremost to connect with others struggling with their rare disease, but also to promote research, unite multiple stakeholders and stimulate new possibilities in the therapeutic pipeline. Research and orphan drug development efforts are starting to follow suit by increasingly incorporating patients’ needs and examining potential outcomes.
Addressing clinical challenges in rare disease and orphan drug development
With government-driven financial incentives, advances in genomic technology to identify promising targets for drug development, increasingly organized patient communities, and above average regulatory approval rates, drug developers are motivated to address rare diseases. While these trends are promising for patients with urgent unmet medical needs, orphan drug development still faces many challenges. The very nature of rare disease places pressure on identifying and accessing a sufficient number of patients for clinical trials.
The Chinese pharmaceutical market continues to grow steadily, but drug developers in China face similar challenges as their global counterparts: Development times are increasing and success rates are declining. Xiaoning Guo, PhD, PMP, clinical development program director of Covance Asia Pacific, recently discussed potential strategies to improve investment returns and accelerate global development.
An evolving landscape
“Regulations in China have changed a lot with new policies and guidelines as the China Food and Drug Administration (CFDA) is strongly promoting innovation,” said Guo. “Domestic pharma companies in China can benefit from revised IND review timelines and approval processes to get their clinical trials in Phases I through III approved simultaneously.”
Each year, new medicines are launched globally but few are available to Chinese patients, in comparison to those in the US or EU. Drug developers are working to reduce this gap and expand the reach of new molecular entities (NMEs) so that they can improve healthcare to patients in need. Confronting this issue requires navigating the evolving regulatory environment in China and capitalizing on parallel development opportunities in the global market.
Bill Hanlon, PhD, vice president, head of Global Regulatory Affairs, shares some of the latest thoughts and strategies from his recent presentation at the Covance Clinical Seminar in China.
Last month while at Disruptive Innovations US, Soloman Babani, Global VP, Alliance Management at Covance caught up with Valerie Bowling from The Conference Forum to discuss the role of the CRO in creating disruptive innovations in pharma and clinical development. Check out the interview below to gain expert insight into the topics discussed at this unique event, which brought together senior leaders from top CROs to discuss this issue openly and honestly. Learn about what the future looks like, specifically related to profits and R&D spending, as well as what can be done to help reduce prices.
When it comes to clinical trials, sample collection kits need to arrive on time, or precious samples will not be able to be tested within stability, meaning their data is irretrievably lost. Adverse weather events and other disruptions to the sample chain of transport represent a serious threat to specimen stability and data integrity.
To combat this threat, Covance has invested in a team of global logistics personnel who continually monitor shipments and potential transportation problems around the world, implementing contingency plans when necessary to maintain an extraordinary record of 99.9% on-time deliveries. Even when faced with the largest storm so far this year, Winter Storm Jonas, Covance delivered.