Business

Opportunities in Latin America Beyond the Olympics

Olympics fans aren’t the only ones turning their eyes toward Brazil. According to JLL’s fourth annual Life Sciences Outlook, the 2016 Summer Games host nation is also one of the world’s top 10 “Global Clusters to Watch,” thanks to its proven capacity for medical device manufacturing and a growing healthcare market. Increasingly, Latin America overall has been on the radar for life sciences companies seeking greater operational efficiency and opportunity, expanded market access, promising demographics, lower-cost land and labor, and…

Responding to an FDA Form 483: A Five-Step Approach

When the US Food and Drug Administration (FDA) inspects your company’s biomanufacturing facility, investigators use the FDA Form 483 to record observations and findings (1). Such inspections typically review all good manufacturing practices and good laboratory practices (GxP) quality systems documents. If those investigators find compliance issues, they deliver a summary of their observations and findings using a Form 483, a copy of which will be provided to your company at the end of the inspection visit. How to Respond…

Developing Markets Bring Opportunity But Not Without Real Estate Risk

Life-sciences markets develop in their own way, but one aspect they all have in common is the unpredictability of their growth. Not only are local economies unpredictable, but so are companies and their needs. Driven by competing pressures to seek new markets and new innovations while operating more efficiently, biopharmaceutical companies are increasingly setting their sights on new horizons abroad. Those investments are not without risks, however. Real estate is at the core of overseas expansion, and that’s where it…

Hiring and Staffing in Biopharmaceutical Manufacturing: Five-Year Trends Indicate Difficulty in Filling Positions

The biopharmaceutical manufacturing industry continues to expand rapidly, with growth in revenue for both suppliers and drug innovators averaging about 15% per year. Understandably, much of the industry’s recent focus has been on the pace of technological improvements that have boosted productivity and performance. But another issue is becoming just as critical: The flow of skilled staff able to keep up with the industry’s growth isn’t keeping pace. Results from our 2015 annual industry study suggest that the hiring market…

Disposable Components in Biomanufacturing: A Regulatory Perspective

On a holistic level, the decision regarding whether to use single-use or stainless steel equipment in a biomanufacturing plant is a significant one. It greatly influences the design, construction, layout, and operation of a plant — and consequently, the timing and cost of the overall project. And regulatory review can add an element of risk to using anything new. Disposables have been viewed as a revolutionary concept, and they are. But from a routine regulatory operational perspective, I believe it…

Bioindustry Researchers Take Strides in Preventing Diseases: Developments in Genetic Diagnosis and Therapy

Johnson & Johnson’s pharmaceutical research arm recently launched a drug-development project that will intercept diseases before patients even realize they’re sick. In the company’s words: “The future of healthcare will increasingly depend on identifying and correctly interpreting the earliest signals of disease susceptibility, preventing or intercepting disease before it even begins.” (1). The first targets include Alzheimer’s, some forms of cancer, heart disease, rheumatoid arthritis, multiple sclerosis, and type 1 diabetes. The company’s Disease Interception Accelerator group will search for…

Accounting for Portfolio Risk: Creating an Analytical Framework for Optimizing the Portfolio Mix

In the biopharmaceutical industry, portfolio risk is categorized as clinical/technical or commercial (Figure 1). Both types pose challenges to quantify. Portfolio managers tasked with optimizing the mix of products in a company’s pipeline often struggle to create apples-to-apples frameworks that can consistently compare risk across asset categories. The framework described herein can help you account for both technical and commercial risk using simple analytical tools. The foundational analytical element of portfolio management is traditionally the asset forecast: a composite best…

From Silos to Synergy: Optimize Your Managed-Markets Division with Cross-Team Collaboration

Like many other industries, life sciences faces rapid, technology-driven changes and a shifting business environment. Many patients are covered by Medicare, Medicaid, or national healthcare organizations outside the United States. That necessitates pricing and reimbursement negotiations that are complicated by rules and regulations. Patients whose health plans belong under a managed-care organization (MCO) or pharmacy-benefit manager (PBM) have access to prescriptions primarily through staff-model pharmacies, mail-order pharmacies, and network pharmacies. Drug manufacturers offer incentives to such organizations in the form…

Decision-Support Tools for Monoclonal Antibody and Cell Therapy Bioprocessing: Current Landscape and Development Opportunities

Industrial-scale manufacturers in a number of fields — from automobiles to biotherapeutics — have long relied on powerful computational and mathematical tools to aid in the scale-up, optimization, quality control, and monitoring of product development (1–5). Typical process pathways are highly multifactorial, with numerous branch points, feedback steps, instrumental attributes, and target parameters. Moreover, margins for error are minimal for most industrial processes, requiring high standards of precision from industrial and operational pathways (6). For those reasons, the complexity of…

Spotlight

Niche Disease: Epidermolysis Bullosa by Cheryl Scott Epidermolysis bullosa (EB) is a group of rare diseases that cause skin to blister easily. In severe cases, blisters may even be internal (e.g., in mucosal tissues or organs). More than 300 mutations have been identified in this condition. Most of the many types of EB are inherited, and the condition usually manifests in infants and young children; some patients don’t develop symptoms until adolescence or early adulthood. Exceptionally mild cases may remain…