Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Rita C. Peters

	This month, Pharmaceutical Technology’s sister publication, Pharmaceutical Technology Europe, marks its 25th anniversary of publishing technical papers, articles, news, and product information about drug- development processes in Europe.

	Anniversaries are the time to mark progress and project future potential. In a special issue, the editors of Pharmaceutical Technology Europe and experts from sectors of the bio/pharmaceutical industry share perspectives on technologies and trends that were key influencers in the development of drug therapies over the past 25 years. While I share some of the highlights here, complete content can be found 

	In “No Signs of a Slowdown in Mergers,” Faiz Kermani reflects on shifts in drug company ownership in the past three decades. In 1985, the top 10 pharmaceutical companies accounted for approximately 20% of worldwide sales. In 2012, the top 10 companies captured 42% of global sales, he writes. Reasons for mergers included improving R&D productivity and increasing revenues to compensate for lost sales of drugs losing patent protection. Another incentive for acquisitions is to expand to emerging markets, which are growing at a faster annual rate than Europe, the United States, and Japan.

	The use of contract service providers also expanded over the past 25 years, says Eric Langer, president and managing partner of BioPlan Associates. Borders and location have become less important, relative to a supplier’s technical, client service, and quality competence. In 1989, there were only a few biopharmaceutical CMOs and few biopharma companies that outsourced tasks. Instead, some companies purchased up- and downstream subsidiaries to ensure they were vertically integrated. This strategy did not work for many companies and outsourcing, especially in bioprocessing, became more common in the early 2000s.

	Sean Milmo tracks the evolution of regulatory oversight and enforcement in Europe, from legislative activity in the 1950s to introduce stricter regulations following the discovery that thalidomide caused birth defects, to the establishment of the European Medicines Agency. The European Regulatory Watch column can be found on pages 16-17 of this issue.

	Experts also provided predictions of technology approaches in key areas.

	Quality by design, continuous manufacturing, tooling, film coating, and polymers for solubility were identified as key contributions to the advancement of solid-dosage development.

	Softgel technology, which originated in the 1930s, has moved from consumer products to acceptance as an alternative drug-delivery vehicle for lead candidates that are difficult to formulate.

	Biosimilar drugs have gained approval in Europe, including monoclonal antibody products. While development costs, naming issues, and payer resistance  present some challenges, the future looks promising.

	Single-use technologies have moved from small-volume storage to standard practice in key areas of biopharmaceutical production. Experts say, however, that further advances are needed to resolve some operational limitations.

	Safety and security threats have resulted in drug packaging changes, industry experts report. For example, advances in needle shielding have helped reduce needle sticks by medical personnel, Currently, serialization is a challenge for the pharmaceutical industry, as manufacturers implement regulatory requirements for different regions.

	Supply chain issues are a global concern. Representatives of the European Fine Chemicals Group of the European Chemical Industry Council, IPEC Europe and EXCiPACT discuss programs to ensure the safety of APIs and excipients and how global harmonization can help improve supply-chain security and reduce the flow of falsified and sub-standard medicine into Europe. 

Articles

Pharmaceutical Technology Europe Marks 25 years of drug-development advances.

A Silver Milestone for Drug Development

Social media has changed the way people and organizations communicate. Platforms like Twitter and Facebook have demonstrated that they can be effective tools for widespread communication of emergency instructions during natural disasters and in organizing political change in countries with censored media. Social media outlets, however, have limitations when asked to deliver complex, technical information. In addition, the open platform nature of the Internet presents challenges for companies trying to maintain correct information about their products online.

Noting that patients and healthcare providers regularly get information about medical products through social media outlets, FDA in June proposed two draft guidances that share the agency’s current thinking about how drug and medical device manufacturers can accurately communicate about their products online.

Guidance for Industry, Internet/Social Media Platforms with Character Space Limitations--Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices

 (1) provides recommendations for conveying information about a drug on social media platforms such as Twitter or paid search results links. While the 140-character limit of Twitter may be enough for the latest life updates from figures in popular culture, it will be difficult for drug companies to use the platform under FDA’s proposed guidelines. 

In the guidance, FDA notes: “… regardless of the platform, truthful, accurate, non-misleading, and balanced product promotion best serves the public health. For some products, particularly those with complex indications or extensive serious risks, character space limitations imposed by platform providers may not enable meaningful presentations of both benefit and risk … If an accurate and balanced presentation of both risks and benefits of a specific product is not possible within the constraints of the platform, then the firm should reconsider using that platform for the intended promotional message.”
In the draft guidance, FDA indicates that a drug’s risk information, including the most serious risk associated with the drug, must be presented with benefit information in the same limited-character message, such as a tweet.  A mechanism, such as a hyperlink, must direct people to more information about risks. That is a lot of information to get into 140 characters.

Guidance for Industry, Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices

 (2), FDA explains that drug companies generally are not responsible for comments from third parties who are independent of the drug company that are posted on the company’s website forum, an independent website, or in social media. The document notes approaches to correcting misinformation and posting corrective information. 

If a firm voluntarily and truthfully undertakes the correction of misinformation that is within the scope of the guidance, “FDA does not intend to object if these voluntary corrections do not satisfy otherwise applicable regulatory requirements, if any,” the draft guidance reads. 

In a blog post (3), Thomas Abrams, director of FDA’s Office of Prescription Drug Promotion for the Center for Drug Evaluation and Research, noted that the agency sees social media as an important resource and is committed to developing additional guidance for drug manufacturers, with the best interests of the patient in mind.

However, the task of maintaining proper information about regulated products in an unregulated environment may be too great a challenge for FDA or drug companies to manage.

, Draft Guidance (Rockville, MD, June 2014).
  2.	FDA, 

, Draft Guidance (Rockville, MD, June 2014).
3.	FDA, 

FDA Issues Draft Guidances for Industry on Social Media and Internet Communications About Medical Products: Designed with Patients in Mind


Rita Peters is the editorial director of 

FDA draft guidances seek to maintain accurate drug information for patients in new media.

Benefits and Risks of Drug Information on Social Media

The US biopharmaceutical industry’s status as the global leader in innovative biopharmaceutical R&D is not guaranteed. Both R&D and manufacturing could shrink or shift to other countries if the business operating environment for the biopharmaceutical industry in the nation does not improve. 

This prediction is the focus of a new report, 

, published by Battelle and the Pharmaceutical Research and Manufacturers Association or PhRMA. The conclusions were based on industry statistics and input from senior-level executives at companies that represent 75% of US biopharmaceutical sales.

Leading threats to US dominance are the increasing capability of emerging economies to meet rising manufacturing demand for new medicines to treat their own growing middle class populations and a global race to attract research and development investment. Therefore, the nation "must assess its policies relative to other countries to ensure that the nation’s ability to compete is not impeded," the report says.

The report identified 10 attributes necessary to "advancing a more favorable business operating environment" in the United States. These factors include a competitive corporate tax rate; private funding of R&D in early stage and emerging companies; robust government investment in basic R&D; a strong R&D and science, technology, engineering, and mathematics workforce; favorable trade policy environment for US biopharmaceutical products; a robust manufacturing workforce; and competitive state-level incentives for innovation. 

However, the executives identified three other factors as crucial to bolstering US competitiveness.

Coverage and payment policies that value innovative medicines. 


According to the study findings, executives feel that US payers increasingly are not adequately valuing new treatments and are too focused on reducing prescription drug costs. This short-term approach creates uncertainty about reimbursement and can make drug development companies more risk-adverse to developing more expensive therapies.

Strong, science-based regulatory  system.


FDA has long been viewed as the gold standard for a science-based regulatory system. However, the report says, the number and complexity of regulatory requirements has increased, and executives are concerned that the US regulatory process may soon be less favorable than that of other countries. 

Robust intellectual property (IP) rights and enforcement in the US and abroad. 


The executives expressed concern about patent challenges occurring earlier and more frequently, and with efforts by policymakers to reduce the favorability of IP rights in the US.

If the current "negative trends increasing business uncertainty" continue, the report says, the US industry can expect 19% growth in domestic biopharmaceutical R&D activities and a 21% increase in domestic biopharmaceutical manufacturing activities over the next decade. However, efficiencies in productivity could result in a decrease of 4.5% in industry employment, translating to more than 140,000 total jobs lost across the US economy over the next decade.

However, if "reasonable" improvements are made to the US business operating environment, a 36% increase in US biopharmaceutical R&D activities, a 31% increase in US biopharmaceutical manufacturing output, and a 5.4% increase in employment, or a gain of 180,000 total jobs across the economy, could occur over the next decade. However, the executives projected that this scenario has a less than 20% chance of taking place within the current business environment.

The report spells out some sobering projections and daunting challenges for the US biopharmaceutical industry. However, if the industry wants to be the leader in innovation, it needs to find business, as well as technological solutions.  

Changes are needed to maintain US biopharma innovation leadership.

Biopharma Takes a Nervous Glance Over Its Shoulder

US Biopharma Worries About Losing Lead in Innovation

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	which AstraZeneca has resisted. Unnamed investment bank and industry representatives were cited as the sources of the report.

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Britain’s Sunday Times has reported that Pfizer approached AstraZeneca with a $101 billion purchase offer.

Report: Pfizer Makes $101 Billion Offer to AstraZeneca

With the growth of digital publishing options, the traditional magazine article has taken on a new form. For editors, this is good news, providing opportunity to expand coverage in terms of length, scope, and format. 

 introduced its first eBook; this month, we are adding a second, focusing on solid dosage manufacturing and excipients. Two additional eBooks are planned for later this year. In addition, the editors initiated video and audio content on 

While the traditional “article” has evolved to diverse “media,” the core value of the content remains the same. The editors seek quality, objective contributions from drug development experts. The following is a summary of our editorial guidelines.
  


) publishes peer-reviewed technical articles and expert analyses for scientists, engineers, and managers engaged in process development, manufacturing, formulation and drug delivery, API synthesis, analytical technology, packaging, IT, outsourcing, and regulatory compliance. 

Readers are PhD-level scientists, senior-level scientists, or senior production professionals involved in formulation development, process development, and manufacturing of active pharmaceutical ingredients and finished drug-products; drug-delivery technologies; analytical methods development and testing; quality assurance/quality control and validation; and advances in pharmaceutical equipment, machinery, instrumentation, facility design, and plant operations. 


  Manuscripts accepted for peer review are published simultaneously in both Pharmaceutical Technology and Pharmaceutical Technology Europe. Papers are also posted on www.PharmTech.com. Articles submitted for peer review may fall into four main categories: standard data-driven, novel research paper; topical literature or patent review; technical case studies/technical application notes; and science-based opinion papers. 

Technical articles and analyses, published in monthly issues and supplements, must be objective and technically relevant. An article can be a technical case study, demonstrating a problem resolution with related technical data and analysis; an explanation of a new or enhanced technology and related applications; an explanation of new compendial or regulatory standards; a topical literature review; a review of industry developments in a given area; or a review of regulatory developments and compendial requirements and related analysis. 
  
  


  Peer-reviewed submissions are reviewed on a rolling basis. Depending on the manuscript, peer-reviewed articles usually take about one to two months for review, revision, and acceptance by the editors. Once accepted, an article is published within four to eight months. 

Technical, non peer-reviewed articles fit topics on the annual editorial calendar and are typically assigned three to five months before the issue is published. If you would like to contribute an article, send an outline or abstract proposal to 

. If your topic is accepted, an editor will assign you an official deadline, approximately six weeks before the publication date. 


  If you are interested in writing for traditional print or digital alternatives, visit 

 to discuss these new media opportunities.

More media options open publishing opportunities for drug development experts.