Viewpoints

Biosimilars, pricing strategies, and technology investments will influence growth in spending on drugs.

Drug pricing and reimbursement concerns will continue to hinder industry growth in 2019, according to data and analytics company GlobalData.

Pricing pressures, investment volatility, and government disfunction greet Biopharma in 2019.

Innovation may capture headlines, but quality programs are the foundation to biopharma success.

Survey results and record attendance may show positive signs for established and emerging biopharma regions.

Building up relevant expertise in-house will make writing spec sheets for software easier, according to Siegfried Schmitt, principal consultant at PAREXEL.

Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.

While food, shelter, and clothing are the primal essentials for life, hope-as embodied by modern medicine-has now become part of that human expectation.

In the second half of CPhI’s annual report, experts review industry trends and warn that trade and patent changes could increase healthcare cost by $100 billion over the next five years.

Sharing of bioprocessing know-how can help resolve pressing industry problems.

Experts from the Partnership for Research on Ebola VACcination report on progress and uncertainties regarding a safe and effective Ebola vaccine.

Frustrated by slow market adoption, Gottlieb maps out new plan for biosimilar competition.

The type of product, the packaging materials being used, and the process and materials used to manufacture the product will determine when E&L data should be submitted to regulators, says Susan J. Schniepp, executive vice-president, Post-approval Pharmaceuticals and distinguished fellow at Regulatory Compliance Associates.

Managing data at the different stages of the lifecycle, linking disparate systems together, and making the right data available to those who need it is problematic and time consuming.

After 30 years of biologic-drug advances, the industry and patients still have a lot to learn.

Biosimilars and biobetters face developmental challenges to achieving commercialization.

Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

By minding gaps in industry knowledge, bio/pharma companies can avoid development pitfalls.

Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.

While technology promises advances for healthcare, a skilled workforce is needed to deliver on the potential.

More diversified therapies and tighter payer budgets will challenge bio/pharma companies to think outside the industry.

Frustrated with high costs and drug shortages, hospitals adopt a DIY approach.

BioPharm International will mark 30 years of biopharma industry progress and challenges in 2018.

SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Developing and retaining qualified employees will test biopharma companies and CMOs alike.

CPhI Pharma Awards honor companies and individuals driving the pharma industry forward.

How soon could the pharmaceutical industry see a widespread adoption of emerging technologies that are poised to shape its future?

Reeling from financial and tropical storms, Puerto Rico needs stable industry to aid its recovery.

Focusing on whether the product meets its defined quality attributes should help one make reasonable, documentable, and defendable risk-based decisions, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

The differences between the quality control and quality assurance units can be found in their names, according to Siegfried Schmitt, principal consultant at PAREXEL.