Category: Pharmaceuticals

Medical Device Accelerator ZeroTo510 Kicks Off Fourth Year

In announcements made in early 2015 by the popular tech news website TechCrunch and at the SXSW Interactive Festival, a medical device accelerator known as ZeroTo510 was listed among the leading programs in the US for growing early stage startups.

Based in Memphis, Tennessee, ZeroTo510 Medical Device Accelerator provides seed capital and an intensive 12-week program to help young companies develop their most innovative medical devices. The number of aspiring applicants to the program has increased dramatically since the accelerator began just four years ago. Despite growing competition from other up-and-coming accelerators, ZeroTo510 received numerous submissions from startups in every geographical region in the US, and in countries on six continents.

ZeroTo510 has a strong track record of successful medical device startups in a fairly short period of time. Since its inception, it has assisted in starting 16 new companies, which have collectively created 30 jobs and drawn well over $7 million in investments. Of those alumni companies, three are actively generating revenue in their respective markets. One has recently received product clearance from the U.S. Food and Drug Administration, and another one is currently treating patients in a study.

Four teams are participating in ZeroTo510 this year. These companies have received $50,000 in seed funding in order to develop their flagship products:

– GlucosAlarm: a device for measuring diabetics’ sugar levels.

– Inspire Living: an easy-to-use electronic monitor for a child’s health status.

– SiteSaver: a simple IV site preservation and protection technology.

– SweetBio: a tissue regeneration membrane for use in oral surgery.

ZeroTo510, which has been particularly successful as a medical industry accelerator, has attracted a lot of attention—not only in the U.S., but around the world.  The Seed Accelerator Rankings Project named it one of the Top 15 most effective accelerators across all industries in the U.S. In addition, an accelerator recently established in Australia is closely modeled on ZeroTo510.

As more tech accelerators like ZeroTo510 are inspired to support international health care entrepreneurs, we can hopefully expect to see an increasing number of truly innovative medical devices on the market in the coming years.

3-D Printing Offers New Options for Drug Delivery

3D Printer

Of all the ways to deliver medication, the most widely recognized is probably the humble pill. Aside from their color, size, and flatness, there is not a lot to differentiate one pill from another.

However, recent research suggests that the shape of the pill actually can affect how it is absorbed into the body. This is significant because the dosage and time-release requirements for a drug often depend on each patient’s particular case. The relationship between drug release kinetics and a tablet’s shape offers doctors a way to fine-tune how that drug is administered to a particular patient.

The problem arises with the manufacturing of these novel forms of the pill. Bulk production is generally not a viable approach, given the great number of patients with different needs. Moreover, some shapes are simply impossible to manufacture with standard techniques.

Scientists at the UCL School of Pharmacy at University College London have identified a possible solution: 3-D printing. Using a process called “hot melt extrusion,” researchers have been able to produce pharmaceuticals in a wide variety of unusual shapes.

Three-dimensional printing is not new to the field of medicine. This sort of technology has already found other uses throughout the health care industry, including such applications as prosthetic limbs and artificial joints. Indeed, in many surgical subspecialties, 3-D printing is proving disruptive. Could it prove to be disruptive for the pharmaceuticals industry, as well?

traditional medication shapeFrom the perspective of drug makers and pharmacists, applying 3-D printing technology to medication distribution has the potential to keep costs down for the consumer and make many drugs more widely available, especially in remote areas. The limiting factor, of course, is the cost of the 3-D printer itself and raw materials. Moreover, there are competing avenues of research that also promise to provide highly customized medications, including genomic screening.

Whether the industry ultimately adopts the 3-D printing approach to medication depends on how it impacts businesses’ bottom line. While the procedure works fine in a lab operating on a small scale, turning it into a marketable product still requires some advancements in printer speeds and efficiencies– and that will require time and money.

Perhaps more importantly, how the tech is received by health insurance companies and benefits managers will ultimately determine how marketable it is. If they can justify including it in their benefits packages, 3-D printing of medications may have a bright future.

Data Stresses Need for Transparency in Clinical Trial Reporting

Transparency in the reporting of results from clinical trials has always been a challenging issue for the pharmaceutical industry. While publicly available information on successes and failures is critical for the effective operation and ongoing growth of the industry as a whole, many companies still appear reluctant to adopt a “prompt and full disclosure” approach. This dilemma was recently highlighted in a new report from the New England Journal of Medicine, which makes it clear that there is still a great deal of progress to be made when it comes to timely and comprehensive reporting on clinical trials.

The paper, published in March of 2015, analyzed the timeliness in reporting of over 13,000 American clinical trials conducted between January 1, 2008 and August 31, 2012. For the reporting of each trial, researchers examined two time points: the 12-month deadline mandated by the Food and Drug Administration Amendments Act and five years after each trial’s completion date.

The findings were not encouraging for anyone hoping to see a strong commitment to transparency and timely reporting. For trials funded by industry, just 17% were reported by the 12-month mark, and 41.5% were reported by the five-year mark. Trials funded by the National Institutes of Health fared even worse, with only 8.1% reported after 12 months and 38.9% after five years.

Critics of these large time gaps between trial completion and trial reporting, and of failure to publish results altogether, can hardly help drawing the conclusion that the dearth of comprehensive and promptly available data is the result of the pharmaceutical industry’s desire to carefully select only positive results for publication, hide negative data, and conceal side effects of new drugs. Many hope that the Pharmaceutical Research and Manufacturers of America’s new set of principles for the conduct of clinical trials and the communication of their results will help to make a difference for this critical industry issue. The standards go into effect June 1, 2015.

Precompetitive Collaborations Are the New Pharma Industry Reality

Faced with a growing set of industry-wide challenges—low clinical testing success rates, rapidly increasing research and development costs, and reduced product life cycles—pharmaceutical companies around the globe are increasingly turning away from a competitive working model and embracing a new collaborative one.

These new types of research-and-development relationships between companies and other institutions that would normally work in isolation from and compete with each other are known in the industry as “precompetitive research collaborations.” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, has defined precompetitive research as a type of research dedicated to improving tools and techniques instead of developing specific products. In other words, the focus of this model is on working together to improve the environment in which new drug discoveries can be made—by increasing efficiency, sustainability, and the potential for innovation thanks to pooled resources—rather than on the discoveries themselves. It certainly seems to be the most effective way forward for many pharmaceutical companies, whose former working model of in-house research is becoming increasingly less viable.

Increasingly, the pharmaceutical industry is not the only one creating these partnerships. Academic research centers and government organizations are also forming new and productive relationships with pharmaceutical companies and with each other. One recent such collaboration is the new Center for Therapeutic Target Validation, formed through a partnership between GlaxoSmithKline, the Wellcome Trust Sanger Institute, and the European Bioinformatics Institute. The three organizations will pool their resources towards the discovery of new potential drug targets, which would then be accessible to all three partners. Similar precompetitive partnership examples include the Target Discovery Institute at Oxford University, the Innovative Medicines Initiative based in Europe, and the Critical Path Institute in the US. All of these partnerships are dedicated to original translational research toward the eventual goal of commercializing new medicines.

What Are Biosimilars, and What Do They Mean for US Big Pharma?

What Are Biosimilars, and What Do They Mean for US Big Pharma?

Thanks to a recent approval from the US Food and Drug Administration (FDA), a revolutionary new type of drug will soon be making its way to the United States.

The particular approved drug in question is Zarxio, manufactured by Sandoz and used to reduce infections resulting from chemotherapy. What is unique about Zarxio is that it belongs to a new and innovative category of drug known as “biosimilars.”

Many of the drugs that treat chronic or life-threatening diseases fall into the category of biologics or biological medicines: disease-treating drugs that are synthesized from living cells. Approved by the FDA under a process distinct from small-molecule drugs like aspirin, these large, complex drugs are manufactured under highly specialized conditions. They also assist in a wide range of therapeutic areas, such as oncology, diabetes, rheumatology, and inherited conditions.

Biosimilars, as the name implies, are highly similar versions of biologics; essentially, they are less costly imitations of existing approved and authorized drugs. They are similar to generic drugs (which are mainly small-molecule drugs) except for one detail: while generic drugs have an identical chemical structure to their non-generic counterparts, biosimilars are structurally different to biologics, though they achieve the same outcomes. In other words, biosimilars are not exact copies of the biologics they replicate.

It is for this reason that, although they could account this year for $4.8 billion in European sales, biosimilars have been slow to gain a foothold in the US. Drug approvals for biosimilars cannot be easily granted based on matching chemical structure as they are for generics; rather, each new biosimilar must run clinical trials to prove that it achieves the same results as the biologic it is imitating. This has made the process of bringing biosimilars to market in the US both costly and time consuming.

However, the approval of Zarxio may now pave the way for a flood of biosimilars to enter the US market, an outcome that could have an enormous impact on both manufacturers and consumers. In addition to improving access to and cost for these drugs for individual patients, more available biosimilars also means more savings for the US government. A 2014 Rand analysis estimates that biosimilars could make it possible for the US to reduce its spending on biologics by roughly $44 billion over the next decade.