Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Rita C. Peters

	The buzzing of mosquitos, a hallmark sound of summer, is now for some an ominous alarm. While a warning call that the Zika virus was coming to the United States was issued in the dead of winter, inaction by elected officials to reduce the impact of the virus has made the threatening buzz even louder.

	As the thermometer rose, public health officials--particularly in the South--nervously monitored anticipated outbreaks of the virus. In mid-July, the Florida Department of Health announced an investigation into the first possible non-travel related case of the Zika virus in Miami-Dade County. Prior to this suspected case, more than 1300 cases of Zika were reported in the continental United States; however, all were related to travel to affected areas outside the US.

	According to the Centers for Disease Control (CDC), Zika is transmitted to people through the bite of an infected Aedes mosquito, which can also spread dengue and chikungunya viruses. The virus can also be spread through sexual contact, blood transfusions, and laboratory exposure.

	The CDC reports that the Aedes mosquito is present in 40 states and the District of Columbia. The method of transmission is simple: a mosquito bites an infected person, then carries the virus to the next person it bites. For most infected people, the symptoms of fever, rash, joint and muscle pain, headache, and conjunctivitis are usually mild.

	For pregnant women and their unborn children, the threat is greater. Zika is known to cause microcephaly and other fetal brain defects; an infected pregnant woman can pass the virus on to her fetus during pregnancy. As of mid-July, more than 1600 serious birth defects were reported, mostly in Brazil.

	The Zika virus is not new; it was first identified in 1947 in Uganda and spread around the world over the next six decades. In March 2015, Brazil reported its first outbreak and in October of that year reported an increase in the number of microcephaly cases among newborns. The number of cases grew, and on

	Feb. 1, 2016 the World Health Organization (WHO) declared a public health emergency because of clusters of microcephaly and other neurological disorders in some areas affected by Zika (1).
	On Feb. 22, 2016, President Obama requested $1.9 billion in emergency funding for vaccine and diagnostic research, mosquito surveillance and control, public education programs, and improved health services for low-income pregnant women.

	The response from Congress was unfortunately typical. Republicans argued that they did not want to provide a “blank check” for the administration to use for other purposes. The funding could be provided in next year’s budget, they said, and argued for cuts in other areas to offset any emergency appropriations. Legislation offered by the Republicans, which would have provided less funding, contained provisions that were not acceptable to the Democrats. In the end, Congress went on summer break without funding Zika-related projects.

	The Obama Administration reallocated nearly $600 million in funds from other projects to pay for Zika-related projects; state and local public health departments are also juggling budgets to increase mosquito control, education programs, and other prevention efforts.
	New funding for vaccine research will have to wait. In the meantime, Congress will have to sleep tight, and hope the mosquitos don’t bite.

	1. M.K. Kindhauser, “Zika: The Origin and Spread of a Mosquito-Borne Virus,” World Health Organization (Feb. 9, 2016), www.who.int/bulletin/online_first/16-171082/en/ accessed July 20, 2016.


	When referring to this article, please cite as R. Peters, “All Buzz, No Bite," 

Articles

Congressional partisanship creates noise, but no funding for Zika virus research.

All Buzz, No Bite

 receive press releases promoting potential: announcements of new products, services, methods, and processes destined to solve a problem, cure a disease, save money, and--in some cases of extreme hyperbole--change the world.

	As natural cynics, the editors question the validity of these projections of great success.  We also appreciate the true successes, as recognized by independent evaluations by industry experts. The CPhI Pharma Awards are one such program to recognize excellence in bio/pharma development and manufacturing.

	The awards program, now in its 13th year, recognizes companies and individuals helping to accelerate the development of bio/pharmaceuticals through the introduction of innovations, new approaches, technologies, and strategies that support drug development, manufacturing, and distribution. The awards program is organized by CPhI Worldwide, a global tradeshow for the pharma industry, scheduled for Oct. 4-6, 2016 in Barcelona, Spain.  CPhI and 

	The 2016 awards are organized into 12 categories:

. Technologies, products, processes, and services for the development and manufacture of active pharmaceutical ingredients (APIs).

Excellence in Pharma: Formulation and Excipients

. Technologies, products, processes, and services related to the formulation of drug products, including excipients.

. Technologies, products, processes, and services related to primary and secondary packaging.

Excellence in Pharma: Drug Delivery Devices

. Technologies, products, processes, and services related delivery of drug products to patients.

Excellence in Pharma: Contract Services & Outsourcing

. Contracted services and processes for the bio/pharmaceutical industry including research, development, formulation, manufacturing, analysis, and consulting.

Excellence in Pharma: Regulatory Procedures and Compliance

. Technologies, products, processes, and services designed to ensure that bio/pharma companies comply with standards,  rules, and guidances established by regulatory and compendial authorities.

Excellence in Pharma: Supply Chain, Logistics, & Distribution

. Technologies, products, processes, and services for ensuring the safe handling and tracking of drug substances, raw materials, and drug products.

Excellence in Pharma: Analysis, Testing, and Quality Control

. Technologies, products, processes, and services for the analysis and testing of drug substances, raw materials, and drug products in a laboratory or production line setting.

. Technologies, products, processes, and services for the manufacture of biologic drugs.

Excellence in Pharma: Manufacturing Technology and Equipment

. Technologies, products, processes, and services for the manufacture of solid, semi-solid, parenteral, inhalation, or other dosage drugs.

Excellence in Pharma: Corporate Social Responsibility

. Innovation in improving transparency and public outreach.

. The chief executive officer of an innovator or generic-drug company is eligible for nomination. Attributes to be considered include financial performance, product performance, leadership skills, management capability, regulatory compliance, vision, marketing, acquisitions, and corporate strategy.

	Applications for the 2016 CPhI Pharma Awards must be submitted by Aug. 14, 2016 via the awards website at awards.cphi.com. Finalists will be announced in September 2016. The awards will be presented on Oct. 4, 2016 during the Pharma Awards Gala at CPhI Worldwide.

Pharmaceutical Technology
	Vol. 40, No. 7
	Page: 12

When referring to this article, please cite as R. Peters, “Recognizing Pharma Industry Excellence," 

CPhI Pharma Awards seek nominations for excellence in development and manufacturing.

Recognizing Pharma Industry Excellence

	Continuous manufacturing of pharmaceuticals is one of five manufacturing technology areas of emerging priority, according to an April 2016 report on advanced manufacturing issued by the National Science and Technology Council (NSTC), a government organization that sets national goals for federal science and technology investments (1).

	FDA has been actively encouraging bio/pharmaceutical companies to adopt continuous manufacturing processes as part of efforts to update manufacturing facilities, improve quality and efficiencies, and ultimately, reduce drug shortages. The National Science Foundation (NSF), National Institutes of Health, National Institute of Standards and Technology, Department of Defense, and the Biomedical Advanced Research and Development Authority (BARDA) are also promoting the use of continuous manufacturing.

	In addition, as FDA has accelerated approvals of breakthrough drugs, it has identified the need for earlier scale-up chemistry, manufacturing, and controls (CMC) work. To meet the development needs, FDA outlined a plan to develop an understanding these new technologies, in advance of the review process, in its draft guidance, 

Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base 

There has been some progress in continuous manufacturing. In April 2016, FDA approved a continuous manufacturing line, which replaced an existing batch process, for the manufacture of PREZISTA (darunavir) 600 mg tablets by Janssen Supply Chain in Gurabo, Puerto Rico. The development of the continuous process that integrates all manufacturing steps (weighing, milling, blending, compression, and coating) into one single line is a result of a five-year partnership with Rutgers University and the University of Puerto Rico.

	The Janssen Supply Chain conversion is a positive step forward in the move to continuous manufacturing. On the biologics drug manufacturing side, with more complex manufacturing processes, progress has been slower and incremental. At INTERPHEX 2016 in April, equipment manufacturers displayed systems that fit process development and scale-up continuum that could help drug companies move forward in these efforts. Several equipment manufacturers displayed systems that could work in a progressive chain, eliminating some batch process steps.

	Single-use systems are key components of the adoption of continuous manufacturing. Complexity and scale, however, are two stumbling blocks to the implementation of single-use systems on the commercial manufacturing scale, according to participants in a panel discussion hosted by Pharmaceutical Technology and BioPharm International. The time needed to develop a process is often underestimated because the process is more involved than people expect. In addition, single use is not practical to use for very large volumes, such as 10,000 L; practical use of the system, versus volume, must be considered.

	A continuous supply of consumables is vital to both batch and continuous manufacturing processes. At INTERPHEX, suppliers reported increased demand for custom formulations and packaging, and quality control reports. Several suppliers reported facility expansions to increase capacity and offer redundant operations to ensure a continuity of supply of vital materials in the event of manufacturing problems at another facility. Another trend is a shift toward in-line dilution and systems that provide access to large volumes of buffers without having to expand buffer storage areas.

	With a goal to provide a continuous supply of quality drugs to patients, the bio/pharma industry is seeing some incremental progress. It is up to bio/pharma companies to see that this trend continues.

1. Executive Office of the President, National Science and Technology Council “Advanced Manufacturing: A Snapshot of Priority Technology Areas Across the Federal Government,” by the Subcommittee for Advanced Manufacturing of the National Science and Technology Council (April, 

2. FDA, Draft Guidance-Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base


	When referring to this article, please cite as R. Peters, “Industry Moves Closer to Continuous Manufacturing," 

With technology advances, continuous manufacturing shows steady progress to more widespread adoption.

Industry Moves Closer to Continuous Manufacturing

	The fragmented nature of the global API supply market provides drug license holders with more options for sourcing supplies. A less expensive choice does not necessarily equate to the best choice when it creates more qualification and monitoring responsibilities for the drug owner.

	At the annual gathering of the Drug, Chemical and Associated Technologies (DCAT) organization in New York City in mid-March 2016, representatives of pharma companies and industry suppliers examined shifts in sourcing of APIs and the business drivers behind the changes. They also heard cautionary advice about regulatory challenges for drug companies involved in global sourcing.

	Enrico Polastro of Arthur D. Little Benelux shared observations and statistics about the shifts in the APIs market noting the movement from in-house API production to a more strategic approach of outsourcing drug substance manufacturing (1). Between 1995 and 2014, the share of the merchant API market has shifted from 45% to 54%.

	European API manufacturers produce $12 billion in product through approximately 200 suppliers, with a focus on custom synthesis and complex APIs. Custom synthesis is also the primary focus of the approximately 50 producers in Japan where production is estimated to be $3 billion and demand is $2.5 billion. Latin America produces only $500 million in APIs, primarily for its domestic market; demand is estimated at $7 billion. North America, with an API demand of $13 billion, produces only $2.5 billion through 40 suppliers, with a focus on large-volume analgesic API and niche-type APIs.

	China and India are predominant producers and exporters of APIs, with a combined production of $27 billion, but a demand of only $10 billion. These countries-which primarily produce catalog products-also have the largest number of suppliers; China and India have approximately 1500 and 2300 API suppliers, respectively. 

	In the past 20 years, API sourcing from China and India has been attractive due to capacity build up in those regions and regulatory hurdles imposed on producers in the West.

	The rapid growth, however, can create higher non-conformance to Western regulatory standards, illustrated by the higher proportion of warning letters issued by FDA and statements of non-compliance issued by the European Union. Presenters noted that some compliance-related issues at API suppliers in India and China are due to a lack of knowledge by the supplier about good manufacturing practices, which places a greater burden on the drug owner to ensure the safety of all products in the supply chain.

	Supplier audits are becoming more important, said Robin Kumoluyi, vice-president and global head group quality audit, Novartis (2), and third-party audits that are conducted to industry standards can provide the needed audit functions for drug companies.

	The large number of producers, questions about the reliability of China and India as a supply source, and the strength of the US dollar may bring some API production back to the West, Polastro said. Suppliers, however,  need to invest in equipment, and customer relations to keep the pendulum swinging back to Europe and North America, he said.

	For drug license holders, quality, compliance, and monitoring need to be factored with product price when selecting and evaluating API suppliers for the long term.

1. E. Polastro, “Pharmaceutical Fine Chemicals Outsourcing Back to the West?,” DCAT Week 2016 Presentation (New York, March 15, 2016).
	2. R. Kumoluyi, “API Compliance Trends, “DCAT Week 2016 Presentation (New York, March 15, 2016).

:
	When referring to this article, please cite it as R. Peters, “More Outsourcing? More Monitoring," 

Pharma companies must weigh cost efficiencies of global API sourcing with increased complexities of monitoring for compliance and quality.

Going Global Increases API Monitoring Burden

A global API marketplace increases the burden of supply chain monitoring for drug companies.

More Outsourcing? More Monitoring.

	At INTERPHEX 2016 at the Javits Center in New York, Pharmaceutical Technology will host a Keynote Series on leading bio/pharma industry issues. Sessions will be presented on the Innovation Stage in the exhibit hall. Admission is free to any attendee with an exhibit hall pass. The following is a preview of the topics.

Overcoming Bottlenecks in Biopharmaceutical Development


	(Tuesday, April 26, 10:15-11:45 am)
	Industry experts discuss how technology advances are addressing challenges in biopharmaceutical development.

Innovations in Solid Dosage Development and Manufacturing

Drop-On-Demand Manufacturing System for the Flexible Production of Solid Oral Dosage Forms.


	Dropwise additive manufacturing of pharmaceutical products uses drop-on-demand printing for automated and controlled deposition of solution-, melt-, or suspension-based formulations onto edible substrates.

Polymer Thin Films for Drug Delivery: Process and PAT Development.


	Polymer thin film is a platform technology for continuous manufacturing, in which in-line monitoring of product quality can be accomplished using various sensing and process analytical technologies, making the technology amenable for real-time release.
	

Minitablets: Manufacturing, Characterization Methods, and Future Opportunities.


	Manufacturing techniques used to produce minitablet-based dosage forms are essentially the same as manufacturing of larger tablet images; however, some special considerations to manufacturing techniques and analytical tests may be required.


	(Wednesday, April 27, 10:30-11:30 am)
	How will consolidation in the bio/pharmaceutical and contract services market, a changing financial market, and an active political and regulatory year shape the fortunes of the contract services market? In his annual presentation, Jim Miller, founder and president of PharmSource Information Services, will offer his perspectives on the contract services landscape for the next few years.

Strategies and Innovations to Reduce Drug Shortages and Improve Availability of Medicines

An Interdisciplinary Approach to Address Drug Shortages.

 The effects of drug shortages on patients, caregivers, hospitals, and medical professionals are often not observed or understood by the bio/pharmaceutical manufacturing segment. This presentation will explore alternative, innovative, and cost-effective ways to provide needed therapies to patients.

BARDA Innovation Initiatives in Medical Countermeasure Manufacturing.

 This presentation will describe the Biomedical Advanced Research and Development Authority’s (BARDA) program initiatives in manufacturing technologies for medical countermeasure advanced development, including opportunities with the Centers for Innovation in Advanced Development & Manufacturing and in continuous manufacturing.
	

Continuous Manufacturing for Rapid Process Development.

 The pharmaceutical industry has begun to adopt continuous manufacturing technology for the manufacture of traditional solid-dosage forms. Benefits include lower cost and expedited development due to the ability to develop at scale. This presentation will outline some of the new approaches and potential benefits.

Panel Discussion: Addressing Sterile Manufacturing Challenges


	(Wednesday, April 27, 3:30-4:30 pm)
	Sterile injectables have been in extremely short supply, and industry efforts have been focusing on root causes involving infrastructure, quality, and efficiency. Experts involved in this work discuss recent initiatives, and offer insights into what must be done to prevent injectables shortages in the future.

	For more information about the Keynote Series, visit: 

When referring to this article, please cite it as R. Peters, " Keynote Series Addresses Crucial Industry Issues," 

Thought leaders tackle drug shortages and manufacturing innovations.