Angie Drakulich was editorial director of Pharmaceutical Technology.

Angie Drakulich

Every year, industry leaders gather at the JPMorgan Global Healthcare conference to discuss key opportunities for investment during the months ahead. About 9000 people attended this year's event in January, in San Francisco.  Several key themes emerged from the presentations given by the pharmaceutical industry C-suite executives about their upcoming initiatives and focus, with the most prevalent being sustainability and innovation.  

As part of these plans, several large companies highlighted the need to reboost R&D pipelines that have diminished during the past several years. Targets include not only new products (whether innovator or generic), many in the oncology area, but also personalized medicine and biosimilars. Threaded throughout most of the presentations was the importance of emerging markets as a critical factor to success in pipeline growth and sustainability.   

While the talks did not unveil any big surprises for investors looking at pharmaceutical development and manufacturing, the conference made it clear that the same hot growth areas (e.g., biosimilars, sustainable R&D, emerging markets) that have been on chief executives' minds for the past few years are not going away. In fact, these areas are becoming more cemented into the industry's future. Below are a few highlights from the show regarding how industry is thinking—and rethinking—about these targets. 

Approaching the R&D pipeline with an eye on sustainability was a large component of the talk given by Pfizer CEO and Chairman Ian Read, who noted that the company has several products at various stages of development. And although Pfizer reduced its R&D spending in 2011 by $1 billion, Read says he has "no illusions that we need to have an engine that can produce sustainable pipeline growth." As a result, the company "stopped spending where we didn't believe we had a competitive advantage, or we believe that we would be producing me-too products." This strategy involves looking at proof-of-concepts more from a business perspective and deciding whether or not to pursue certain projects in the value chain. It sounds as though the company is being more stringent in such decisions in order to save time and money in the long run. 

Merck & Co is also expanding its thinking around scientific innovation, according to CEO and President Kenneth Frazier's talk. "Many first-in-class medicines provide high return on investment, but they also come with some of the highest risks of failure. So to succeed, we have to have a balance between first-in-class investments and risks and drugs that can be considered best-in-class. Also, we must get the full value of discoveries through effective life cycle management for products...." He mentioned, like many other speakers, biosimilars as an area of innovation and how Merck plans to compete in this space.  

Bristol-Myers Squibb (BMS) CEO Lamberto Andreotti focused on what he called the "next generation biopharma." He presented this term as a combination of the best of biotech and the best of pharma, incorporating innovation, selective integration, and continuous improvement. BMS also noted R&D sustainability with a nod towards creative partnerships as well as integration of research, development, and regulatory issues. 

Amgen President, COO, and CEO-Elect Robert Bradway (he takes over as CEO in May) spoke about pipeline plans for 2012, with a strong focus on biosimilars. "We think in order to be successful in biosimilars, a company will have to have strong biologics manufacturing, regulatory, and commercial capabilities," he said. "...We think we have that and we expect that these biosimilar molecules will enable us to grow not just in the US but in international markets as well."  

Generic-drug leader Teva Pharmaceutical Industries focused on the fast-changing world of the generics sector, describing it as a new era for the pharmaceutical industry. CFO Eyal Desheh and CEO and President of Teva-Americas William Marth pointed to the growing markets in South America, such as Chile and Peru, as well as the predictable ones in America and Western Europe. They noted as many as 40 potential product launches for Teva in 2012. 

Many more companies of diverse sizes and investment opportunities presented at the JPMorgan healthcare conference, setting off a whirlwind of investment discussions. It will be interesting to watch where funds end up in the months ahead based on the renewed push to plump up pipelines while also keeping costs and resources at a sustainable level.  

Articles

Pharma announces plans for the year ahead at annual JPMorgan Global Healthcare conference.

Sustainable Investment

The pending ICH Q11 guideline incorporates risk management and a science-based approach for the development and manufacture of drug substances. 

ICH Q11, the pending guideline from the International Conference on Harmonization titled 

Development and Manufacture of Drug Substances

, may be one of the most anticipated guidelines in the global pharmaceutical industry in recent years (1). Since 2004, the industry has been working to reshape its approach to drug manufacturing based on FDA's 

Pharmaceutical CGMPs for the 21st Century

 initiative, which were cemented between 2005 and 2008 by the so-called ICH Quality trio guidelines (2). These globally harmonized guidelines, which include ICH Q8 

, detailed quality-by-design (QbD) concepts for pharmaceutical manufacturing and redefined the industry lexicon with terms such as quality target product profile, critical quality attributes and critical process parameters (CQAs and CPPs), knowledge management, product life-cycle management, and control strategy (3–5). The Q11 guideline, which was published as a draft in May 2011 and is expected to be adopted by the ICH steering committee this year, both complements and enhances these concepts by offering industry guidance and clarity "regarding the description and justification of development and manufacturing processes for drug substances and the type and extent of information to be submitted in regulatory dossiers" (6). 

IAN SANDERSON/PHOTOGRAPHER’S CHOICE RF/GETTY IMAGES 

Q11 is one of the longest ICH quality guidelines at 26 pages and specifically addresses the drug-substance manufacturing process for chemical entities and biotechnological/biological entities.  

Although the ICH Quality trio guidelines apply to drug substance as well as drug product, industry and regulators felt there was a need to clarify QbD or "enhanced" concepts for drug-substance manufacture. "There are fundamental scientific differences in the process for drug-substance manufacture and the process for drug-product manufacture, including impurity control and removal and chemical transformations," according to the Pharmaceutical Research and Manufacturers Association (PhRMA) representatives on the ICH Q11 expert working group. These representatives include: Betsy Fritschel, Johnson & Johnson and the PhRMA Topic Lead for ICH Q11; Timothy Watson, PhD, Pfizer; and Steven R. Mendivil, Amgen.  

The quality of a drug product is linked to the quality of its drug substance. ICH Q11 therefore seeks to take into consideration and provide examples as appropriate for describing the principles and concepts which are included in ICH Q8, Q9, and Q10. ICH issued a concept paper for Q11 in April 2008 to identify these elements and to detail the goals of the proposed guideline. While defining differences between a "traditional" and an "enhanced" approach to drug-substance manufacture, Q11 states clearly that "Traditional and enhanced approaches are not mutually exclusive. A company can use either a traditional approach or an enhanced approach to drug substance development or a combination of both" (1). In the traditional approach, "set points and operating ranges for process parameters are defined and the drug substance control strategy is typically based on demonstration of process reproducibility and testing to meet established acceptance criteria" (1). 

Q11 defines an enhanced approach for drug-substance manufacture as using risk management and extensive scientific knowledge to select process parameters and unit operations that impact CQAs "for evaluation in further studies to establish design space and control strategies applicable over the lifecycle of the drug substance" (1). The guideline provides illustrative examples and approaches for demonstrating product and process understanding that is gained during the process development of drug substances. It also outlines the information recommended for describing the manufacturing process and control strategy as well as considerations for selecting starting materials for synthetic and semisynthetic entities and source materials for biotechnological/biological entities and the related justification. In addition, Q11 addresses the elements and development of a control strategy; process validation and evaluation; and the regulatory evaluation process of drug-substance manufacturing, including the harmonization of common technical document (CTD) submissions (see sidebar on CTD submissions).  

How to fill out the common technical document when using an enhanced approach

According to FDA members of the ICH Q11 working group, "identifying what is common and what is different between the development and manufacturing of chemical entities and biotechnological/biological drug substances was one of the key goals" in developing Q11 as well. These ICH Q11 working group members include: John Smith, PhD, CDER (ONDQA) and FDA Topic Lead; Patrick Swann, PhD, CDER (OBP), and FDA Deputy Topic Lead; Steve Wolfgang, PhD, CDER (OC), and Working Group Expert; Chris Joneckis, PhD, CBER, and Working Group Expert. 

The Q11 expert working group, which is made up of individuals from each of the six ICH parties (that is, the regulatory authorities and trade associations of the US, European Union, and Japan, plus numerous interested parties and observers), received more than 1300 comments during Step 3 (which is the regulatory consultation and discussion phase) of the ICH process and spent last fall working through them. Some of the comments were duplicates or very similar, according to the PhRMA Q11 expert working group members, and the highest percentage of the comments received requested clarification and revision of the guideline's process development section. 

Q11 states that manufacturing process development should include, at a minimum, the following elements: identification of potential CQAs associated with the drug substance so that those characteristics having an impact on product quality can be studied and controlled; defining an appropriate manufacturing process; and defining a control strategy to ensure process performance and drug substance quality (1).  

An enhanced approach to manufacturing process development would additionally include:  

A systematic approach to evaluating, understanding, and refining of the manufacturing process. This process includes identifying through prior knowledge, experimentation and risk assessment, the material attributes and process parameters that can have an effect on drug-substance CQAs. It further includes determining the functional relationships that link material attributes and process parameters to drug substance CQAs. 

Using the enhanced approach in combination with quality risk management to establish an appropriate control strategy (e.g., proposed design space(s) and/or real-time release testing) (1). 

Q11 asserts that the increased knowledge and understanding obtained from taking an enhanced approach could facilitate continual improvement and innovation throughout the product lifecycle.  

 CQA is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. Drug-substance CQAs typically include those properties or characteristics that affect identity, purity, biological activity, and stability, states Q11 (1). 

Impurities are an important class of potential drug-substance CQAs because of their potential impact on drug product safety. For chemical entities, impurities can include organic impurities (including potential genotoxic impurities), inorganic impurities (e.g., metallic residues and residual solvents). For biotechnological/biological products, impurities may be process-related or product-related. Process-related impurities include: cell substrate-derived impurities, cell culture-derived impurities, and downstream-derived impurities (1). 

The identification of CQAs for biotechnological/biological products can be particularly challenging because they typically possess a large number of quality attributes, making it difficult to fully evaluate the impact on for safety and efficacy of each one, states Q11. The guideline therefore recommends that in such cases risk assessments be performed to rank quality attributes using prior knowledge and updating that knowledge with development data (e.g., knowledge regarding mechanism of action and biological characterization).  

CQAs for biologics products, therefore, should also include consideration of contaminants, "including all adventitiously introduced materials not intended to be part of the manufacturing process (e.g., adventitious viral, bacterial, or mycoplasma contamination)," recommends Q11 (1).  

Selecting and justifying starting and source materials.

 The draft Q11 guideline defines starting materials (synthetic, semi-synthetic) and source materials (biotechnological/biological), and provides six science-based principles to consider when selecting the starting or source material. For synthetic drug substances, these principles include recognition that changes in material attributes or operating conditions that occur early in the manufacturing process have lower potential to impact the drug-substance quality; regulatory authorities should be provided with an adequate description to understand how impurities are formed, how the process affects formation, fate, and purge of impurities, and the suitability of the control strategy; a starting material should be a substance of defined chemical properties and structure and a starting material is incorporated as a "significant structural fragment" (1, 7).  

When justifying the selection of synthetic or semi-synthetic drug substances, CTD applicants need to justify how each proposed starting material is appropriate in light of the above principles, suggests Q11. Justifications may include the ability of analytical procedures to detect impurities in the starting material; the fate and purge of those impurities and their derivatives in subsequent processing steps; or how the proposed specification for each starting material will contribute to the control strategy (1). Q11 recommends using a flow diagram to outline the synthetic route(s) for the manufacture of the drug substance and to clearly indicate the proposed starting materials.  

ICH Q11 further notes that an applicant generally need not justify the use of a commercially available chemical as a staring material and goes on to define a commercially available chemical as one that is sold as a commodity in a pre-existing, nonpharmaceutical market in addition to its proposed use as a starting material. Chemicals produced by custom syntheses are not considered to be commercially available and therefore should be justified when used as starting materials (1). Selection and qualification of biological source materials (e.g., cell banks) are not described in the new guideline, but rather, the industry is referred  to ICH Q5 for such steps (8).  

It's important to note that the CTD submission strategy does not change as a result of the starting material proposal, say the PhRMA Q11 expert working group members. "Overall impurity knowledge and control (fate and purge), including starting materials, intermediates, raw materials, etc., are still important whether using a traditional or enhanced development approach."  

 Control strategy and process validation are also large components of the Q11 guideline. A control strategy is a planned set of controls, derived from current product and process understanding, that assures process performance and product quality (5). Every drug-substance manufacturing process, whether developed through a traditional or an enhanced approach (or some combination thereof) has an associated control strategy (1).  

The process validation section of Q11 includes General Principles as well as highlighting specific principles for biotechnological/biological products, including the consideration of scale up, impurity removal, and the use of platform technology. The guideline's recommendations in this area, note the industry Q11 expert working group members, reflect current practice and expectations for biologic products.  

 The ICH Q10 guideline on the pharmaceutical quality system includes quality system elements and management responsibilities intended to encourage the use of science-based and risk-based approaches at each life-cycle stage (5). Q11 reinforces Q10's life-cycle management approach while also providing more detail for drug-substance process control. "Manufacturing process performance, including the effectiveness of the control strategy and suitability of any design spaces, should be periodically evaluated," states the draft guideline (1).  

"ICH Q11 promotes awareness of the sources of and potential for variation in the CQAs of the drug substance," explain the FDA members of the Q11 working group. "This knowledge supports well-informed selection of suppliers capable of consistently controlling the drug substance manufacturing process." Risk management and quality systems, which are defined in ICH Q9 and Q10, apply throughout the lifecycle of the drug substance when it comes to identifying, qualifying, and overseeing suppliers, and in the management of contractual agreements, adds FDA.  

Furthermore, say the agency's representatives, it is important that senior management play a critical role in establishing a qualification program that assesses the supplier's ability to provide the drug substance using a defined supply chain. "These critical relationships should be managed through use of strong communication processes, written quality agreements, ongoing review of the performance of the supplier, and the identification and implementation of any needed improvements." 

 The Q11 document includes several illustrative examples for application of Q11 principles to the drug-substance manufacturing process, including how to: link material attributes and process parameters to drug-substance CQAs, select appropriate starting materials, use quality risk management to support life-cycle management of process parameters, and present a design space for a biotechnological product unit operation.  

The PhRMA Q11 expert working group members point out that the examples contained in Q11 are not to be used as templates or best approaches. "The intent of the examples is important for the illustration of a high-level concept not clarified in the text .... (and) are an oversimplification of science to streamline the document." 

ICH Q11 should go a long way in helping industry to implement QbD concepts across the entire drug-manufacturing process, including the application of an enhanced approach beginning with starting materials of synthetic and semisynthetic products and source materials for biological entities. Still, challenges remain. Among them, say the Q11 expert working group PhRMA representatives, will be "the ability to make continual improvement in a manufacturing process that is described in detail in filings in many different countries. The problems begin when one country approves the change while other countries are still considering whether or not to approve the change. Unfortunately Q11 is not able to resolve or even address that problem because regional postapproval changes were specifically out-of-scope." 

 In the meantime, says FDA, "ICH Q11 should help continue the dialogue regarding quality and risk-based approaches and expand the scope of participants in that dialogue to include those focused on drug-substance development and manufacture." 

Online Exclusive Sidebar: The relationship between manufacturing and regulatory flexibility

Quality-by-design or “enhanced” approaches to drug manufacturing offer several benefits to industry, including better process understanding and better understanding of the interrelationship of material attributes and process parameters. This knowledge can lead to fewer nonconformances and less rejection and rework, according to several International Conference on Harmonization (ICH) Q11 expert working group members.

Such an approach can also bring flexibility, whether it be regulatory flexibility or manufacturing flexibility. PharmTech asked the FDA members of the ICH Q11 working group about this issue and what industry should focus on and expect when applying a QbD approach. 

“For the purposes of this discussion, ‘regulatory flexibility’ can be defined as a manufacturer having greater freedom to make postapproval changes to a drug-substance manufacturing process and controls, without waiting for prior approval from regulators, than the manufacturer may have had for similar changes approved in the past. ‘Manufacturing flexibility’ can be defined as a manufacturer being more capable of accurately predicting the consequences of changes to a drug substance manufacturing process and controls, based on the increased knowledge and understanding of the drug substance and its manufacturing process obtained from taking an enhanced approach to manufacturing process development. 

FDA went on to say that, “manufacturing flexibility is valuable to manufacturers because it provides them with operational flexibility including the assurance that changes can be made without adversely affecting the quality of the material being produced. Regulatory flexibility is valuable to manufacturers because it allows changes to be made more quickly, which in most circumstances will help save money. 

“In an ideal world, manufacturing flexibility and regulatory flexibility would go hand in hand. No manufacturer should be granted regulatory flexibility that exceeds the extent of the manufacturer’s manufacturing flexibility. Likewise, a manufacturer’s ability to make changes will be constrained unnecessarily if the extent of the manufacturer’s regulatory flexibility is smaller than the manufacturer’s manufacturing flexibility. Both types of disparities can exist. Manufacturers should not request a degree of regulatory flexibility that exceeds their manufacturing flexibility, and they should provide sufficient information in their submissions to justify the degree of regulatory flexibility being requested. Manufacturers should also consider pursuing the issue of regulatory flexibility internationally: As long as manufacturers receive different degrees of regulatory flexibility in different regions of the world, the full benefits of achieving manufacturing flexibility will be beyond their reach.”

Development and Manufacture of Drug Substances (chemical entities and biotechnological/biological entities),

 Step 2 Draft Consensus Document (2011). 

Pharmaceutical CGMPs for the 21st Century 

(2005). Note: The revised Q8(R2) version was finalized in 2009.  

Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 

FDA and industry expert working group representatives discuss the pending ICH Q11 guideline.

An Enhanced Approach to Drug-Substance Development and Manufacture

Quality-by-design or “enhanced” approaches to drug manufacturing offer several benefits to industry, including better process understanding and better understanding of the interrelationship of material attributes and process parameters. This knowledge can lead to fewer nonconformances and less rejection and rework, according to several International Conference on Harmonization (ICH) Q11 expert working group members. (

 is the pending guideline on drug substance and manufacture.) Such an approach can also bring flexibility, whether it be regulatory flexibility or manufacturing flexibility. PharmTech asked the FDA members of the ICH Q11 working group about this issue and what industry should focus on and expect when applying a QbD approach.

		“For the purposes of this discussion, ‘regulatory flexibility’ can be defined as a manufacturer having greater freedom to make postapproval changes to a drug-substance manufacturing process and controls, without waiting for prior approval from regulators, than the manufacturer may have had for similar changes approved in the past. ‘Manufacturing flexibility’ can be defined as a manufacturer being more capable of accurately predicting the consequences of changes to a drug substance manufacturing process and controls, based on the increased knowledge and understanding of the drug substance and its manufacturing process obtained from taking an enhanced approach to manufacturing process development.

		FDA went on to say that, “manufacturing flexibility is valuable to manufacturers because it provides them with operational flexibility including the assurance that changes can be made without adversely affecting the quality of the material being produced. Regulatory flexibility is valuable to manufacturers because it allows changes to be made more quickly, which in most circumstances will help save money.

		“In an ideal world, manufacturing flexibility and regulatory flexibility would go hand in hand. No manufacturer should be granted regulatory flexibility that exceeds the extent of the manufacturer’s manufacturing flexibility. Likewise, a manufacturer’s ability to make changes will be constrained unnecessarily if the extent of the manufacturer’s regulatory flexibility is smaller than the manufacturer’s manufacturing flexibility. Both types of disparities can exist. Manufacturers should not request a degree of regulatory flexibility that exceeds their manufacturing flexibility, and they should provide sufficient information in their submissions to justify the degree of regulatory flexibility being requested. Manufacturers should also consider pursuing the issue of regulatory flexibility internationally: As long as manufacturers receive different degrees of regulatory flexibility in different regions of the world, the full benefits of achieving manufacturing flexibility will be beyond their reach.”

		This blog post is part of the February 2012 

Quality-by-design or “enhanced” approaches to drug manufacturing offer several benefits to industry, including better process understanding and better understanding of the interrelationship of material attributes and process parameters.

FDA on the Relationship between Manufacturing and Regulatory Flexibility

written by Janet Woodcock, MD, Director for FDA’s Center for Drug Evaluation and Research
	


	Targeting a drug for small subgroups of patients is a new way to find effective therapies. This is often called personalized medicine, and it’s one of today’s most promising areas of new drug development. Last year, FDA approved two important targeted medicines: Xalkori (crizotinib), a lung cancer drug that targets tumors with the abnormal ALK gene, and Zelboraf (vemurafenib), a drug to treat malignant melanomas that have a certain gene mutation. Both drugs were approved with companion diagnostic tests to identify if patients have a susceptible tumor.

	Today, the FDA approved Kalydeco (ivacaftor) to treat a specific subgroup of patients with cystic fibrosis (CF). Cystic fibrosis is an inherited genetic disease that affects a person’s lungs and other organs and may lead to an early death. What makes the availability of Kalydeco even more unique is that the drug’s developer, Vertex Pharmaceuticals, teamed up with the Cystic Fibrosis Foundation to develop and study the drug.

	This success story began in 1989 when a team of researchers, including Francis Collins, now the director of the National Institutes of Health, discovered the gene that is involved in cystic fibrosis. This gene, known as CFTR, plays an important role in producing a protein that regulates the flow of salt and water out of the cells that line the cavities of the body. There are a number of different mutations that can cause the CFTR gene to produce a defective protein. This results in lung congestion and digestive problems.

	Kalydeco targets a gene mutation that only occurs in about 4 percent of CF patients. Before using this medicine, doctors will test CF patients to determine whether they have this mutation (many CF patients have already been tested to understand what caused their CF). If the patient is a match, the drug may provide substantial benefits including improved lung function and weight gain.

	Patients have played an important role in how new drugs are developed and studied since the HIV/AIDS activists in the 1980s and 1990s. But what the Cystic Fibrosis Foundation pioneered is a new form of patient power that some have called venture philanthropy. The Foundation helped with a portion of the drug’s development costs, provided researchers with useful insights about the CF patient population and helped in the recruitment of study participants – contributions that were critical to quickly bringing the innovative new therapy to patients.

	The unique and mutually beneficial partnership that led to the approval of this new therapy for some CF patients serves as a great model for future drug development and patient group collaboration moving forward.

	Here’s to innovation and continued cooperation and progress for patients!

This blog was originally published on the FDA blog, 

Targeting a drug for small subgroups of patients is a new way to find effective therapies. This is often called personalized medicine, and it’s one of today’s most promising areas of new drug development.

How Science and Strategic Collaboration Led to a New, “Personalized” Cystic Fibrosis Treatment for Some Patients

Last night, President Obama issued a call to action for manufacturers that involves reducing outsourcing. His 2012 State of the Union 

 provided a blueprint for rebuilding America’s economy-and a large component is of that plan is to bring manufacturing back to the US. “Tonight, my message to business leaders is simple: Ask yourselves what you can do to bring jobs back to your country, and your country will do everything we can to help you succeed,” he said.

		The President noted that the economy had been weakened in part by outsourcing, and he used the terms manufacture, manufacturing, and manufacturers no less than 18 times in his speech.

		But just how will this alleged opportunity to “bring manufacturing back” affect the pharma industry? Outsourcing is a huge part of the industry.

		The global contract manufacturing market for pharma has been estimated at around $40 billion. Contract manufacturing of bulk and dosage form drugs alone may reach $86 billion worldwide by 2016, according to 

. Emerging nations such as India and China are largely reaping the benefits of this spend.

		PharmTech’s most recent annual outsourcing 

, done in conjunction with PharmSource, showed that bio/pharmaceutical companies who are actively outsourcing to these two nations rose to 32% between 2010 and 2011. Those percentages are expected to keep rising.

 thoughts on this issue. Is it feasible and/or desirable for pharma manufacturers based in the US to bring manufacturing back? Why or why not?

Addendum: Several industry reps  have commented on this topic via Pharm Tech’s LinkedIn Group. Check it out at LinkedIn.com and search for the Pharm Tech group.

Last night, President Obama issued a call to action for manufacturers that involves reducing outsourcing. His 2012 State of the Union address provided a blueprint for rebuilding America’s economy-and a large component is of that plan is to bring manufacturing back to the US.

Bring Manufacturing Back, Orders Obama

Ever wish you were a fly on the wall in another laboratory? Well, a new journal website offers the industry opportunities to do just that-to see through video how other scientists carry out particular experiments and processes.

		As a doctoral student at Harvard Medical School, Moshe Pritsker asked to recreate a method of culturing embryonic stem cells that had been reported by researchers in the United Kingdom. He tried following the steps in a related article but could not get the experiment to work, so he ended up flying to the UK to spend time with the scientists who authored the article to watch how they conducted the experiment. With a first-hand look, Pritsker was able to replicate the method-but not everyone has the resources to fly around the world to get an in-person perspective on a particular lab’s methods.
		Based on that experience, Pritsker, along with Nikita Bernstein and Klaus Korak, founded the Journal of Visualized Experiments (

). The site provides step-by-step video demonstrations of experimental techniques and procedures. The site was established in 2006 and today, contains many detailed descriptions of advanced research methods through videos. Each video is published together with a peer-reviewed article to explain the video’s scientific quality, applicability, and technical details.

		To date, Harvard, MIT, Yale, Oxford, Cambridge, Max Planck, and others have participated in the online journal. About 50 video articles are published per month.

		Although journal articles and training workshops provide scientists with insight into how others do something, not every step comes across. “Even if they had the time, experimenters would probably not bother to document many of these nuances or tricks because they are a personal habit or established practice at the lab they are working at,” says JoVE about why the site is useful.  And yet, “these details can often mean the difference between success and failure,” JoVE adds.

		The industry has been talking about the idea of sharing information for some time. JoVE offers a new way to help share best practices and to help train train those new to the laboratory or new to certain manufacturing methods.