Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Rita C. Peters

	The rapid spread of the novel coronavirus is a reminder of the interconnected nature of global populations and economies. A few other realities also should be obvious. First, no single individual, company, or country can solve the pandemic crisis alone. Second, while getting a vaccine to patients quickly is crucial, decisions about quality and efficacy should be based on science, not political or public pressure.

	The competition for vital medical resources in the early days of the pandemic illustrated how uncontrolled or misguided competition and anxiety can quickly overwhelm response to an emergency. Fortunately, collaborative efforts are shaping the development of treatments and vaccines. For example, the World Health Organization (WHO) is coordinating global efforts for vaccine development and clinical trials for treatment options.

	The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership is a public-private effort to develop a framework to prioritize vaccine and drug candidates, streamline clinical trials, coordinate regulatory processes, and leverage assets to respond to the COVID-19 and future pandemics. More than a dozen biopharmaceutical companies have joined the National Institutes of Health (NIH), Foundation for the NIH, Health and Human Services Office of the Assistant Secretary for Preparedness and Response, FDA, Centers for Disease Control and Prevention, and the European Medicines Agency in an effort to advance the most promising vaccine and therapeutic candidates (1).

	While groups are collaborating on development and clinical trial phases; the need for a coordinated manufacturing strategy cannot be overlooked.

	For an industry used to development timelines counted in years, the COVID-19 vaccine and therapy development process is moving very fast. Sponsors of the leading vaccine candidates now in early clinical trials are expressing confidence that the product can reach patients by the end of 2020, months or years earlier than predicted by experts just one week ago.

	To achieve that goal, manufacturing capacity for unproven vaccines must be created now, a risky prospect for the companies developing the capacity and for patients. Drug companies and contract manufacturers are accepting the challenge; governments and taxpayers may bear the financial risk.

	In April 2020, AstraZeneca and the University of Oxford announced a development and manufacturing partnership. Johnson & Johnson announced manufacturing agreements with Catalent and Emergent BioSolutions for its vaccine candidate, as did Lonza with Moderna for its mRNA vaccine. Both Johnson & Johnson and Moderna have received funding from the Biomedical Advanced Research and Development Authority.

	In late April, a Trump Administration plan-dubbed “Operation Warp Speed”-committed to make 300 million doses of coronavirus vaccine available by the end of 2020 (2). Details for this program-including which vaccines were going to be manufactured-were not available at press time.

	After weeks of stay-at-home orders, social distancing, closed restaurants, high unemployment numbers, and bad economic news, optimism about the early arrival of a vaccine, as well as treatments such as Gilead Sciences’ remdesivir, offers some good news and excitement.

	With anxiety for a resolution to the pandemic driving vaccine development activity, it is crucial that science-based information-from the global bio/pharma experts-should drive development, approval, and manufacturing decisions.<

	1. NIH, “NIH to Launch Public-Private Partnership to Speed COVID-19 Vaccine and Treatment Options,” Press Release, April 17, 2020.
	2. J. Jacobs and D. Armstrong, “Trump’s ‘Operation Warp Speed’ Aims to Rush Coronavirus Vaccine,” 

	When referring to this article, please cite it as R. Peters, “How Fast Is Too Fast?" 

Articles

Will moving at “warp speed” to develop a vaccine impact efficacy or safety?

How Fast Is Too Fast?

	The coronavirus pandemic is sweeping around the globe at a rapid pace, forcing governments, regulatory authorities, healthcare systems, and the bio/pharma industry to take novel measures to address the crisis.

	Some public health officials and doctors sounded early alarms about the spread of a novel coronavirus-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-in January 2020; however, many people and governments did not heed the alarms or were slow to respond to the spread of coronavirus disease (COVID-19).

	During the past few weeks, public sentiment has ranged from denial (crowded beaches during Spring Break) to panic (hoarding toilet paper). A new term-social distancing-became part of our vocabulary. Everyone was reminded about proper handwashing techniques. And kitchen tables and spare bedrooms became home offices and classrooms as governors ordered major segments of the population to stay home.

	As politicians weigh protecting public health versus the impact on the economy, medical professionals beg for adequate supplies of face masks and ventilators. Meanwhile, many drug companies and research organizations have announced R&D efforts to test approved therapies as treatments to minimize the effects of COVID-19. The research focus of drugs in development has been redirected to target coronavirus symptoms. And, groups around the world have accelerated efforts to develop much-needed vaccines.

	Following initial criticism for delays in approving diagnostic testing to detect who had the virus, FDA stepped up its activity, issuing more than a dozen guidance documents in March 2020. Actions included issuing emergency authorizations for diagnostic test and ventilators, easing regulations for remote monitoring of patients and clinical trials, allowing the compounding of hydroxychloroquine sulfate under certain conditions, releasing guidance for the preparation of hand sanitizers, and facilitating access to COVID-19 convalescent plasma for use in patients with life-threatening infections (1).

	The immediate goal is to “flatten the curve” of new cases of COVID-19 to reduce strain on the healthcare system. Staying home, avoiding crowds, and washing your hands are simple measures we all owe the medical professionals, first responders, grocery store clerks, delivery services, transportation workers, and others on the front lines of maintaining our basic needs to get through this crisis.

	Obviously, these non-pharmaceutical measures are only part of a temporary solution; therapies are desperately needed to treat COVID-19 patients, and vaccines ultimately required for long-term control of the virus. Bio/pharma researchers, development and manufacturing professionals, and companies supporting drug development and manufacturing are essential to these efforts.

	At the same time, patients still need effective, affordable therapies to treat chronic diseases, cancers, and other conditions. A reliable drug supply is vital to maintain health and alleviate public concerns.

	During the past few weeks, we have learned about many drugs and vaccines as potential cures. The world could use a “magic pill” right now. But drug developers know the challenges of working the science and producing the data to ensure that the therapy is safe and efficacious.

	One challenge for those in the bio/pharma industry is to avoid using excessive hype about a potential therapy, which can create false hope. Now is the time to lead with the message that science-not hopes or gut feelings-should drive all healthcare decisions.

 team thanks those working to develop new treatments and vaccines and those maintaining the drug supply; we are here to support those efforts. In addition to our normal coverage of all phases of drug development and manufacturing, we offer added coverage of COVID-19 drug development programs, links to research, industry suppliers, and regulatory updates. Visit 

 for the latest news, updates, and access to an archive of previous issues.

	Stay safe, stay healthy, and we wish you success in your drug development efforts.

	When referring to this article, please cite it as R. Peters, “Pharma’s Leadership Role in a Pandemic," 

As the coronavirus pandemic unfolds, Pharma must practice science over hype.

Pharma’s Leadership Role in a Pandemic

In February 2020, a report from FDA’s Office of Pharmaceutical Quality (OPQ) noted that, “Quite simply, the quality of our drug supply is better than ever before.” With some FDA inspections on hold, will the US drug supply maintain its quality standards? Plus, which new drug applications must now be filed as biologic license application?

	When referring to this article, please cite it as R. Peters, “A “New Normal” for Quality?" 

Pharmaceutical Technology Regulatory Sourcebook and Reference

With some FDA inspections on hold, will the US drug supply maintain its quality standards?

A ‘New Normal’ for Quality?

	The rapid spread of the novel coronavirus, COVID-19, in China and beyond prompted the World Health Organization to declare a Public Health Emergency of International Concern on Jan. 30, 2020, and pushed regulatory organizations to evaluate needed response, researchers to accelerate studies of potential treatments and vaccines, and pharma companies to examine supply chain and business disruptions.

	For an industry accustomed to long development and approval times, stringent regulatory oversight, and a not-so-transparent supply chain, the coming months may test bio/pharma’s ability to react, adapt, and change.

	In a February 2020 report (1), FDA’s Office of Pharmaceutical Quality noted that nearly half of the physicians responding to a 2019 survey said drugs manufactured abroad were of lower quality than those manufactured in the United States. In light of the volume of APIs manufactured offshore, consumer confidence in drug quality may further erode with FDA’s suspension of facility inspections in China, in accordance with a State Department warning against travel in the region.

	The agency said its regular risk-based surveillance testing of imported products will continue, however. In lieu of inspections, the agency will use alternate measures, include import screening, import alerts, a firm’s previous compliance history, and information from foreign governments as part of mutual recognition agreements. The agency said it also will request records from firms “in advance or in lieu of” drug surveillance inspections in China to assess possible quality threats (2).

	A number of pharma companies and organizations are accelerating the investigation of treatments and vaccines. For example, in late February, the National Institute of Allergy and Infectious Diseases initiated the first US clinical trial to evaluate the safety and efficacy of remdesivir (Gilead Sciences) on a volunteer patient diagnosed with COVID-19 who was quarantined on a cruise ship in Japan and repatriated to the United States.

	The investigational broad-spectrum antiviral treatment was previously tested in humans with Ebola virus disease and has shown promise in animal models for treating other coronaviruses (3).

	FDA stated that the agency is providing regulatory advice, guidance, and technical assistance to sponsors developing medical countermeasures to emerging threats. These efforts include the review of development proposals including the design and set-up of clinical trials. The agency also noted that under Emergency Use Authorization authority, the agency may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency when clinical circumstances warrant (2).

	As US manufacturers rely on manufacturers in China for a significant portion of APIs and other raw materials, the potential for supply disruptions and drug shortages is likely. FDA noted that the agency is “proactively reaching out to manufacturers as part of our vigilant and forward-leaning approach to identifying potential disruptions or shortages” and is adding resources to monitor potential vulnerabilities. In the event of a potential shortage or disruption, FDA says it will work with manufacturers to expedite review of alternate supplies to prevent shortages (2).

	FDA also is taking action to protect the nation’s supply of blood, human cell, tissue, and cellular/tissue-based products. And, the agency is also monitoring for fraudulent products claiming to prevent, treat, or cure COVID-19 and its effects.

	Whether a disruption in the pharma ingredients supply chain is incentive for US-based manufacturers to seek alternate suppliers in the West will be just one factor to watch.

Office of Pharmaceutical Quality, 2019 Annual Report, One Quality Voice

,” www.fda.gov, February 2020.
	2.  FDA, 

, www.fda.gov, accessed Feb. 26, 2020.
	3. NIH, “

NIH Clinical Trial of Remdesivir to Treat COVID-19 Begins


	Vol. 44, No. 3â¨
	March 2020
	Page: 6

	When referring to this article, please cite it as R. Peters, “Coronavirus Response: Reaction or New Reality," 

Emergency action to protect patients and the drug supply may have long-term implications.

Coronavirus Response: Reaction or New Reality?

In an automobile race, a vehicle must be well designed, highly tuned, and have the proper fuel to outperform the other competitors. If corners are cut on any of these elements, the car may stall or be forced out of the race.

	In the traditional drug development race to get a molecule to clinic, drug companies sometimes look for shortcuts. Questions about manufacturability and drug performance may not be answered until formulation steps are initiated after the filing of the investigational new drug application. As a result, the commercialization finish line may be farther away, or never reached.

	The traditional approach works if APIs that are easy-to-formulate, are water-soluble, and have a conventional route of administration (e.g., oral dosage forms) are used, says Robert W. Lee, president, Lubrizol Life Science Health’s CDMO division, “but this level of ease is no longer the reality in drug development.” The complex and poorly soluble molecules that are typical of many novel drug candidates in research phases are prompting drug developers to consider more factors about a drug earlier in in the development cycle.

	The drug formulation process requires time, money, specialized expertise, and resources that may not be available to small drug companies in early research phases. Development-phase companies anxious to get to clinic may seek to gain an advantage by postponing early stage formulation development. Instead, they place priority on activities traditionally considered to have the largest impact, such as optimizing potency and determining efficacy determination, says Darren Matthews, research leader, pharmaceutical sciences at Charles River.

	“The biggest disadvantage to delaying formulation activities is that the inherent risk is significantly increased, resulting in a potentially poor candidate being nominated,” Matthews explains. “Consequently, any challenges relating to bioavailability post-candidate nomination must be solved using formulation strategies alone, whereas prior to candidate nomination a different molecule could have been selected or the medicinal chemistry optimized further.”

	“For Developability Classification System (DCS) I compounds (1), this is a low-risk approach, because the formulation is not likely to have much impact on drug performance,” says Meredith Perry, director of pharmaceutics, Catalent Pharma Solutions, San Diego. “But for all other DCS class compounds, understanding the bioavailability in various preclinical species is critical.”

	Newer drugs present new formulation challenges

	Unfortunately, most new molecular entities have low aqueous solubility; if preformulation or formulation studies are not conducted to solve this issue, it may not be possible to deliver the drug to its target. “Without investigating advanced drug delivery technologies at this early stage, you’re not creating the best chance of success and may end up eliminating a good molecule. Formulation groundwork should be done up front to at the very least identify a viable candidate,” says Lee.

	“Not addressing solubility challenges through formulation prior to conducting clinical studies can render the clinical data meaningless and potentially ‘kill’ good molecules that would become good drugs if formulated correctly,” states Lisa Caralli, director of science and technology, pharmaceutics, Catalent Pharma Solutions, San Diego. Physicochemical characterization, preformulation, and drug metabolism and pharmacokinetics (DMPK) analyses are needed to identify hurdles to bioavailability that an enabled formulation can overcome, she says.

	An understanding of how a drug may behave in vivo is predicated on initial 

 studies, as well as an understanding of basic drug substance physicochemical characteristics, says Stuart Madden, vice-president, drug development and consulting, ICON. “Lacking knowledge of key aspects of a drug product’s characteristics may hinder an understanding of 

 data related to the product’s performance,” he explains. “So, although initiation of a clinical program may be quicker and cheaper, in the longer term it may be more difficult to make rationale choices for formulation and process development for any follow-on clinical program.”

	Using a drug substance for dosing patients in small, early-phase clinical trials saves the cost of developing, manufacturing, and testing a product for a compound that may be discontinued, says Eugene McNally, vice president, consulting, PPD. “The disadvantage is, not all drugs are candidates for such ‘powder in bottle’ dosing.”

	Getting quickly to clinical studies using API in capsule or powder in a bottle is an advantage, agrees Sanjay Konagurthu, senior director, Thermo Fisher Scientific–Pharma Services Group. “Based on outcomes, a formulated drug product might have to be developed in a short time,” he explains. For fast track and breakthrough therapies, developing a formulated, commercial dosage form is advantageous, he says.

	Managing expectations and the amount of available API also must be considered. “Companies desiring to sell early stage assets should consider that buyers expect to see formulation and manufacturing process development results that demonstrate the product can be commercialized,” says McNally. And, Perry notes, “Determining whether formulation enhancement is feasible can decrease the doses needed for efficacy, which decreases the risk of side effects and reduces the quantity of API needed throughout the program.”

	Formulation and manufacturing process development is driven by the route of delivery and the anticipated human dose, says McNally. For small-molecule drugs-typically oral doses-knowledge about a compound’s solubility and permeability is crucial.

	For oral solid-dosage drugs, the DCS can be an effective predictive tool to determine risks associated with a compound’s bioavailability by classifying a drug into one of five different categories. “Classifying a potential drug using the DCS provides the formulator with an appropriate strategy for maximizing bioavailability, especially for sparingly soluble drugs,” Matthews says. “The DCS provides a simple approach, by using solubility and permeability data, to understand and predict a complicated subject (e.g., bioavailability of a potential drug).”

	Charles River uses DCS for hit-to-lead and lead optimization stages, and Matthews sees the hit-to-lead stage as an early opportunity to understand potential development risks associated with a chemical series. “Determination of the DCS risk number at this stage empowers the medicinal chemists to choose an appropriate series to take forward to determine a suitable development pathway during lead optimization,” he says.

	Understanding the molecular properties of the drug is crucial. “Bioavailability can be impacted by the fraction absorbed, which is dependent on the drug’s solubility and permeability,” says Caralli. “But it can also be impacted by gut wall and hepatic metabolism. If the source is the former, it can be addressed through formulation. If the issue is metabolism, the basic molecular structure of the candidate may need to be reconsidered.”

	Detailed preformulation studies can help drug developers understand a molecule’s physicochemical characteristics, solid-state characteristics, and dissolution rate, says Lee. “This will indicate whether the use of enabling technologies like nanomilling will be needed to help formulate the molecule.” Other factors to consider include the molecule’s stability in water, acid/base, oxidation, heat, and light; excipient compatibility; potential for polymorphic transformation; particle size distribution powder flow; and hygroscopicity.

	Typically, biologic drugs require extensive preformulation studies because they are more complex with aggregation and degradation of special concern as they are much more sensitive to stresses from manufacturing and environmental conditions, says Madden.

	“For large molecules, it’s not just the sequence of the monomers (i.e., amino acids or nucleotides) that is a concern but also the three-dimensional structure,” says Lee. “During formulation development, it’s important to track this 3D structure as this may be key to its biological activity, and this may very well be impacted by the formulation.”

	An indication of solution stability, and whether a lyophilized, or dried, formulation will be needed to maintain stability, is typically the starting point for development of large molecules, adds McNally.

	Advances in screening and characterization have enabled more rapid and accurate analysis of molecules, providing support for formulation steps. “Materials science-based characterization of the drug substance using modern compaction simulators, Raman spectroscopy, electron microscopy, chromatography, crystallography, thermal characterization, and dissolution and absorption technologies can help in the characterization,” explains Konagurthu.

	“Physical characterization of each API lot requires very small amounts of API (milligram quantities),” says Perry. “It is worthwhile to use the sensitive, API-sparing tools that are now available, such as differential scanning calorimetry, thermogravimetric analysis, powder X-ray diffraction, and scanning electron microscopy.” In addition, she notes, the use of software modeling, in addition to actual characterization, can help expedite the process. “Predictions for solubility, permeability, and DMPK performance are all helpful tools,” she says.

	Tools developed in the past 20 years are allowing formulation scientists to do more, says Matthews. For example, biorelevant dissolution media allow the formulation scientist to predict the solubility and dissolution behavior of sparingly soluble drugs in vivo. When coupled with small-scale dissolution equipment with in-situ measurement by fiber optics, automated pH adjustment, or automated media addition, these systems can mimic the 

 environment. And, in-silico prediction tools that consider formulation, polymorphic, and particle sizes effects on 

 performance can be powerful tools for the formulator. “Such a method can be used to triage potential approaches to enhancing bioavailability without the need for expensive animal studies,” he says.

	Madden also notes the importance of software to aid development, ranging from programs to calculate basic physicochemical parameters for drug substances to bioavailability development toolkits and excipient interactions software. “There are also strategies developed by contract research organizations that allow the rapid 

 screening of numerous formulation prototypes to aid rapid formulation selection prior to the start of any formal clinical program,” he states.

	Physiologically based pharmacokinetic modeling is essential to ensure that the correct delivery route and dosage form is pursued for a molecule, says Caralli. “These in-silico models can incorporate both 

 data from biphasic dissolution studies, to predict the performance of a formulated API in human clinical studies.”

	Konagurthu notes that predictive models are of great benefit in early development, citing Thermo Fisher’s Quadrant 2 platform as an example. “Implementation of in-silico predictive models are being used to guide formulation,” he says, citing materials science and characterization (e.g., compaction simulation), accelerated stability assessment, discrete element modeling, computational fluid dynamics, and pharmacokinetics and pharmacodynamics models. “An ensemble approach can help developing quantitative models that relates product structure to performance,” he says.

	Predictive pharmacokinetic and pharmacodynamic modeling certainly helps to inform the ‘best’ dose and dose frequency, formulation, and route of administration to take forward into clinical trials, says Scott Dove, vice president, early development, PPD.

	While models can help direct studies, they do not necessarily replace laboratory analysis. “Computational models can give you an idea of the molecular characteristics in silico and predict solubility and a host of other properties. Some are particularly effective and can guide your lab work, but they are not a substitute for actual lab work-this must still be carried out,” Lee says. “If you are looking at several different molecules to synthesize in early development, then using predictive models to do a computer screen of potential structures can help direct your work and narrow your choices.”

	Using predictive models as a substitute for experimental data in the early stages of drug development can save time and money, allowing the development program to move to wet chemistry more quickly, says Madden. “For example, screening a series of analogues to determine bioavailability, solubility, or even potential genotoxicity signals by quantitative structure-activity relationship can be of tremendous value in early development and accelerate lead optimization efforts enabling faster development.”

	Balancing priorities to maximize resources

	A decision to divert limited resources from early formulation studies may come back to haunt many drug developers, especially when the solubility or other issues associated with a compound are revealed in clinical trial stages. However, notes Perry, “Formulation screening at small scale is significantly less expensive than a failed clinical trial.”

	The consequence of not gaining insight early in development can result in batch failures that lead to delays or cancellations of trials due to a lack of understanding of the

	“It is critical for companies to understand that investing in formulation and process development during the early phases can yield dividends in the long run,” says Konagurthu. “The company should obtain a mechanistic understanding of the formulation and process.”

	“Companies must have a viable formulation for 

 studies and beyond, so it’s important to invest effort and resources in the most effective formulation,” says Lee. “At the same time, it’s a balancing act, and it’s not cost effective to waste resources on the wrong technologies.”

	“Scientists must often justify their chosen scientific path to management, who may have limited understanding of the underlying science. For low-solubility molecules, this inability to translate the ‘why’ can lead to decisions being made for purely financial reasons,” says Caralli. “Using a visual tool like the DCS, solubility, permeability, and dose can be plotted to demonstrate the need for an enabled formulation to ensure a successful clinical trial outcome.”


	Vol. 44, No. 3â¨
	March 2020
	Pages: 52–56

	When referring to this article, please cite it as R. Peters, “Fast vs. Formulated? " 

Can investing in early formulation studies drive a new therapy successfully across the commercialization finish line?

Fast vs. Formulated?

	An outbreak of viral pneumonia cases in Wuhan, China at the end of 2019 sparked concerns of another coronavirus (CoV) jumping species from animals to humans, causing a global pandemic. Fears of a repeat of the severe acute respiratory syndrome (SARS) outbreak in 2002 or the Middle East respiratory syndrome (MERS) in 2012 rattled financial markets, led to the lockdown for millions of people, and mobilized R&D efforts around the world.

	Chinese officials announced the identification of a novel CoV-2019-nCoV-on Dec. 31, 2019; one month later, the number of confirmed and suspected cases exceeded 10,000 and more than 100 deaths were reported. While nearly all of the cases were in China, other countries, including the United States had small numbers of suspected or confirmed cases. Authorities in China implemented public health measures, enforcing aggressive travel restrictions and screening programs. Other nations employed screening and travel restrictions.

	Meanwhile, the medical research and pharmaceutical communities scrambled to answer basic questions about how the virus is transmitted, stages of contagion, incubation period, and the types-or lack-of symptoms in infected patients. Lessons learned from the SARS and MERS outbreaks are guiding researchers in these efforts.

	Following previous outbreaks, the World Health Organization (WHO) placed the SARS-CoV and MERS-CoV on its Priority Pathogen list to encourage the development of countermeasures. Researchers are adapting platform diagnostic modalities used in the previous outbreaks for early recognition and isolation of 2019-nCoV infections and to assess the potential use of broad-spectrum antivirals and vaccines (1). A genomic sequence of 2019-nCoV has been released to public databases, enabling researchers around the world to find clues to detection of the virus and potential treatment options.

	The urgency for sharing data and biological material was emphasized in a January 2020 meeting between Tedros Adhanom Ghebreyesus, the director-general of the WHO, and President Xi Jinping of the People’s Republic of China (2). WHO also is launching a clinical data platform where anonymized clinical data can be shared to support the public health response to the outbreak.

	FDA Commissioner Stephen M. Hahn said in a statement that the agency is “employing the full range of our public health authorities to facilitate the development and availability of investigational medical products to help address this urgent public health situation.” These efforts include explanations of the development pathways, including Emergency Use Authorization, sharing reference materials for diagnostic development, and directing sponsors of therapeutics to the agency’s Pre-Investigational New Drug Application Consultation Program (3).

	A number of drug companies are investigating the potential for the use of existing therapies as treatment against the virus. Others-backed by the Coalition for Epidemic Preparedness Innovations-are using platform technologies to expedite the development of new treatments. Inovio Pharmaceuticals will use its DNA-based platform development and testing of a coronavirus vaccine matched to the outbreak strain. The University of Queensland in Australia will use its molecular clamp rapid-response technology to develop a new vaccine. And, Moderna will manufacture an mRNA vaccine against 2019-nCoV; the National Institute of Allergy and Infectious Diseases, which collaborated on the vaccine design with Moderna, will conduct investigational new drug and Phase I studies (4).

	 For an industry accustomed to a slow, methodical development pace, the urgency presented by this health emergency will put R&D skills and resources to the test.

	1. C. I. Paules, H. D. Marston, A.S. Fauci, 

 (Jan. 23, 2020).
	2. WHO, “WHO, China Leaders Discuss Next Steps in Battle Against Coronavirus Outbreak,” Press Release, Jan. 28, 2020.
	3. FDA, “

FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures

,” Press Release, Jan. 27, 2020.
	4. CEPI, “CEPI to Fund Three Programmes to Develop Vaccines Against the Novel Coronavirus, nCoV-2019,” Press Release, Jan. 23, 2020.


	Vol. 44, No. 2
	February 2020
	Page: 10

	When referring to this article, please cite it as R. Peters, “The Call for a Rapid Response," 

Bio/pharma researchers mobilize to diagnose and treat patients in pandemic threat.