Maximizing the Value of a Product: A Perspective from China

Drug Development Market Access Covance Shanghai at night, ChinaDrug 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 Covance market 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

The Shift Toward More-Personalized Medicine in China

image of a world map with pills placed on top. Topic: Personalized Medicine in China

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.”

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Advancing Rare Disease Drug Development: Four Key Considerations for Market Access

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 Covance Rare Disease Drug Development Market Access Blog. Photo of a man holding a pill. 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.

  1. 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

Accelerating Rare Disease and Orphan Drug Development: Opportunities for Biomarkers, Diagnostics & Patient Engagement

Rare diseases affect more than 350 million people worldwide but patients often face limited Covance Labs Rare and Orphan Drug Development. Photo of DNA Strandoptions 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.

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Capitalizing on Global Drug Development Opportunities from China

The Chinese pharmaceutical market continues to grow steadily, but drug developers in Covance China Drug DevelopmentChina 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.”

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Addressing the Drug Development Gap in China

Each year, new medicines are launched globally but few are available to Chinese patients, Covance Drug Development In China 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.

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Video: Disrupting the CRO

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.

Disrupting the CRO:

For more videos from Covance, visit our Knowledge Library or SlideShare pages.

Facing the Storm In Stride

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.

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Evaluating New Antiviral and Antibiotic Drug Candidates

The development of anti-infective treatments to combat illnesses caused by viral and microbial agents has witnessed many unique advances, most notably in the
Covance Infectious Disease eBookfights against bacterial infections, hepatitis and HIV. The momentum in this exciting area continues with new tools and methods to better support the development journey. From improved microbial identification to quantitative technological platforms, let’s explore emerging opportunities to develop assays, interpret results and improve clinical trials.

Learn how novel technologies and analytical techniques are accelerating discoveries and transforming results in infectious disease drug development. Download our new infectious disease eBook today.

More Attention to Patients Can Increase Inflammation Study Effectiveness

(This is part 3 of a 3-part series on Inflammatory Disorders Studies. View part 1 here.View the complete series in our Inflammation eBook.

Patient-reported outcomes, compliance and retention are key components of success.

Recent research contends some underlying immune system response mechanismsCovance Inflammation Studies -BLOG are common to inflammation-related diseases, such as asthma, COPD, psoriasis, rheumatoid arthritis, lupus and inflammatory bowel disease. These diseases are referred to as Immune-Mediated Inflammatory Disorders (IMIDs). There is a significant shift in the approach to managing traditional inflammatory diseases from organ-based symptom relief to tackling common underlying pathways of immune dysregulation which offers the hope of disease modification. Continue reading