Vaccine development news, FDA actions, manufacturing approaches, and more. 

COVID-19 Update

People often embrace information sources that align with their personal beliefs and reject opposing viewpoints that they do not want to hear. If they don’t like the message, they find another messenger that tells them what they want to hear. When the source of the information is not subject to fact-checking or ethical standards, inaccurate information, disinformation, and outright conspiracy theories replace science-based expert insight and facts.

Disinformation from many different—and sometimes unknown sources—is contributing to a growing credibility problem for institutions normally entrusted with public health decisions. At the same time, actions by some of those institutions, including the Centers for Disease Control (CDC), FDA, and biopharma companies, may be lowering public trust in vital health matters.

This article will appear in the October 2020 issue of 

Missteps, such as the September 2020 release, then retraction by the US CDC of a guidance on airborne transmission of the virus (1), undermine confidence in the very institutions that should be the “gold standard” for health information.

The credibility of pharmaceutical development, public health authorities, and FDA are in question, as illustrated in a survey by the Kaiser Family Foundation (KFF) (2). A majority of people (62%) surveyed from Aug. 28–Sept. 3, 2020 said they are concerned that pressure from the Trump Administration will cause FDA to rush approval of a vaccine without ensuring it is safe and effective. About 40% said FDA and CDC are paying too much attention to politics when reviewing and approving treatments or issuing guidelines and recommendations.

Despite the volume of information that has been published by credible sources, the KFF survey found that nearly half of the respondents held at least one misconception about six coronavirus-related facts about the existence of a cure or vaccine, the effectiveness of hydroxychloroquine, whether children can transmit the virus, and the wearing of face masks.

When KFF conducted the survey in April 2020, 83% of respondents said they had a “fair amount” or “great deal” of trust in the CDC; in the latest study, that number dropped to 67%, with declines among voters across the political spectrum. Trust in Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and the leading government figure on pandemic response, declined; 78% of respondents in the April poll said they had a “fair amount” or “great deal” of trust in Fauci compared with only 68% in the September poll.

In an open letter issue in early September 2020, leaders of the Biotechnology Innovation Organization urged biopharmaceutical companies to ensure the “integrity, transparency, and objective assessment” of clinical data when seeking drug and vaccine approvals. Top executives of nine companies developing COVID-19 vaccines promised to adhere to the scientific process and regulatory guidelines and prioritize patient safety (3). And, career FDA leaders maintained that the agency is committed to science, while acknowledging it operates in a political environment (4).

The COVID-19 pandemic has been a new, unnerving experience for society. Scientific and medical communities scrambled to research, react, and develop appropriate medical responses. The lack of a coordinated, authoritative message about best practices to control the virus spread has fueled more than infections; it has sown distrust that will undermine further response and recovery.

1. M. Mishra, “US CDC Takes Down Coronavirus Airborne Transmission Guidance,” 

2. H. Hamel, et. al., “KFF Health Tracking Poll–September 2020: Top Issues in 2020 Election, The Role of Misinformation, and Views on A Potential Coronavirus Vaccine,” 

FDA’s “Gold Standard” Critical for Biopharma R&D

Career FDA Leaders Say Science Is Agency’s Guide

Rita Peters is the editorial director of 

When referring to this article, please cite it as R. Peters, “The (Dis)Information Pandemic, 

Articles

Misleading messages contribute to eroding trust in public health agencies

The (Dis)Information Pandemic

The recent addition in September 2020 of a state-of-the-art suite of cellular analysis platforms at its Discovery Biology facility in Cambridge, MA, gives India-based Sai Life Sciences, a discovery, contract development, and manufacturing solutions company, expanded screening capabilities. The Cambridge facility now includes the Opera Phenix high content screening platform, FACSCelesta flow cytometer, and FACSMelody flow sorter, technologies that enable the company to better serve start-up and biotech companies in the region, especially in projects exploring novel biology in oncology, neuroscience, and rare diseases.

Over the past year, Sai has delivered a range of projects, including genetic and pharmacological target validation studies and reagent validation. It has also developed a variety of assays, such as cellular target engagement assays and 

 lab in Cambridge creates opportunities for local biotechs to have frequent face-to-face collaboration with Sai scientists and to accelerate the pace of externalized research by reducing cycle-times. The lab’s focus on exploratory research allows for complex biology projects that necessitate more fluid experimental design with real-time decision making.

“We are committed to helping our clients successfully advance their internal discovery portfolios and are investing considerable resources to provide world-class service in the Boston area. These new capability additions are just the latest in our strategic growth plan with significant additional capabilities coming soon,” said Krishna Kanumuri, CEO and managing director of Sai Life Sciences, in a Sept. 10, 2020 press release.

Following a recent expansion at its Cambridge, MA, facility, the company now houses a new suite of cellular analysis platforms that enhance its exploratory capabilities into oncology, neuroscience, and rare diseases.

Sai Life Sciences’ Screening Capabilities Enhanced with Expanded Cellular Analysis Platforms

A new benchtop capillary electrophoresis (CE) instrument, the Spectrum Compact CE System, an integrated DNA analysis instrument by Promega, a provider of innovative solutions and technical support to the life sciences industry, enhances analysis by enabling the ability to perform Sanger sequencing and fragment analysis at the bench. The system, which was developed in collaboration with Hitachi High-Tech, can be used by life scientists in laboratories of all sizes.

On-site installation and operational training.

The instrument also supports applications such as microsatellite instability analysis, mixed sample analysis, forensic short tandem repeat analysis, and cell line authentication. The instrument can process up to 32 samples in a single run and can be controlled by either an integrated touchscreen or by additional software that allows access from any registered computer on the same network.

“The Spectrum Compact CE is personal, and that’s one of the huge advantages that scientists will see with this instrument,” said Promega Head of Research Doug Storts, in an Aug. 31, 2020 press release. “An individual can walk into the laboratory and, with minimal training, be able to change all the consumables, select which chemistries they want to use for both DNA sequencing as well as for fragment analysis, and perform the experiment. Literally everybody has access. It democratizes the use of the instrument in the laboratory.”

Promega also offers support to laboratories integrating a Spectrum Compact CE System into their workflow, including on-site instrument and software installation and operational training. Technical services scientists can assist with data analysis and summary reports, and field support and validation services scientists will be made available to assist with maintenance and validation requirements.

Promega launched the new system in August 2020.

The new personal capillary electrophoresis system, Spectrum Compact CE, performs Sanger sequencing and fragment analysis.

Promega’s New Capillary Electrophoresis Instrument Enhances Benchtop Analysis

A new data analysis suite by Aigenpulse, a life science and data technology innovator company, offers an automated, end-to-end, machine learning solution aimed specifically at streamlining and automating cytometry analysis at scale and replacing manual gating processes. The new technology, CytoML Experiment Suite, allows users to benefit from a single point-of-truth about all cytometry data across any organization.

CytoML enables the automation of every stage of the flow cytometry data lifecycle—from data acquisition to insight generation— and it can help increase throughput of data processing and analytics by as much as 600%. At the same time, the data analysis suite increases the accuracy, reproducibility, and quality of flow cytometry data.

CytoML also makes it possible to leverage machine learning to scale-up and automate gating, using both unsupervised and guided population identification. This allows it to clearly visualize populations and have full control over gating parameters in the Decision Space, according to Aigenpulse in a Sept. 9, 2020 press release. Further, the suite retains all algorithm parameters, which offers fully transparent and reproducible cytometry gating.

The data analysis suite was developed from the ground-up to be a validated computerized system to comply with good automatic manufacturing practices issue 5. For instance, every analysis, dataset, parameter, and report generated in CytoML is retrievable and reproducible with timestamps, user information, parameters used, and data input and output.

The technology, moreover, makes it possible for users to parse, integrate, and standardize all popular flow cytometry data formats into the system using one seamless process as well as importing data with an easy-to-use web interface, or via command line or application programing interface. Quality assurance reporting is instantly generated during integration, which provides full visibility of data quality.

CytoML also provides fully federated and audited logging for processing and integration parameters, which enables re-use and enhances efficiency. Built in plotting tools allows for users to easily derive insights by exploring data in different planes, and, because of the reliable gating, events can be sorted and annotated into populations that are presented to the user in a hierarchy tree. The latter empowers the user to select sub-populations for analysis and save/reload collections that can be shared with colleagues. Users can thus calculate and visualize selected sub-populations-to-parent ratios, enabling them to quickly focus on identifying significant findings from their experiments.

“The clear advantages of the high throughput, multiparameter functionality of flow cytometry are hampered by the immense output of highly complex data. Significant expertise is required to interpret this data correctly, and there is a lack of standardization in assay and instrument set up. Aigenpulse’s CytoML Experiment Suite offers an automated end-to-end process for large numbers of raw files by leveraging machine learning to empower cytometry data processing and enables users to integrate population counts identified by manual gating to increase the value of data and allow for cross-project analysis,” said Steve Yemm, chief commercial officer, Aigenpulse, in the press release. “This provides significant savings in terms of both time and money and will tackle the all-too-common bottlenecks in the research process, making it possible to maximize the true value of flow cytometry data in pharma R&D.”

The company’s new CytoML Experiment Suite fully automates each stage of the flow cytometry data lifecycle, allowing for clearer data visualization and analysis.

Aigenpulse’s Data Analysis Suite Automates Flow Cytometry

Lonza announced on Sept. 21, 2020 that it has formed a Scientific Advisory Board consisting of leading industry and academia experts for its Bioscience Business Unit.

According to a company press release, the board will work with Lonza’s research scientists and product managers to offer guidance on the company’s research and scientific programs for 

 absorption, distribution, metabolism, and excretion (ADME) and toxicology testing.

“The ADME-Tox testing space continues to evolve at an impressive rate, and we see incredibly exciting advancements as drug developers strive for greater efficiency and early predictivity of success,” said Maureen Bunger, senior product manager, Lonza, in the press release. “By convening a select committee of esteemed experts to help guide our innovation programs, we’ll continue to stay ahead of this rapidly changing landscape and maximize our ability to support cost-efficient drug development.”

“Each member of the new Scientific Advisory Board has made significant and extensive contributions to their respective fields, [and] they bring a comprehensive understanding of the myriad challenges faced by early drug discovery researchers,” added Katrin Hoeck, director of Cell Biology, Lonza, in the press release. “The new panel provides a unique opportunity to tap into a reservoir of rich knowledge, and this will ultimately allow us to further strengthen our renowned portfolio of in vitro ADME-Tox testing tools.”

Antonio Da Silva, PhD, head of Innovation and New Technologies and head of Preclinical Development for Sandoz Biopharmaceuticals.

Merrie Mosedale, PhD, a research assistant professor in the Division of Pharmacotherapy and Experimental Therapeutics at the University of North Carolina and assistant director of the Institute for Drug Safety Sciences.

Raphael Nir, PhD, co-founder, president, and chief scientific officer of SBH Sciences and SBH Diagnostics.

Marian Raschke, PhD, head of Mechanistic Toxicology within Investigational Toxicology at Bayer.

The board will work with Lonza’s research scientists and product managers to offer guidance on the company’s research and scientific programs for in vitro ADME and toxicology testing. 

Lonza Forms New Scientific Advisory Board

Regulatory Compliance Associates (RCA), a life sciences consultancy, announced on Sept. 22 that Steven J. Lynn will serve as the company’s new executive vice-president of Pharmaceuticals.

Prior to joining RCA, Lynn held positions at FDA’s Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, and the Office of Regulatory Affairs, a company press release said. Additionally, Lynn worked with leading brand and generic pharmaceutical and biopharma manufacturers and in private consulting for post-market good practice (GxP) quality, compliance, and regulatory affairs.

“RCA clients will benefit from Steve’s expertise with FDA’s insights regarding compliance and regulatory framework and will help them navigate regulatory challenges in the medical product and biologics sectors,” said Erika Porcelli, CEO of RCA, in the press release. “His extensive background spanning industry, consulting, and the FDA gives Mr. Lynn a unique perspective in providing RCA clients with wholistic and seasoned guidance as they bring new life-sustaining medicines to the market as well as maintaining compliance with FDA and other global health authorities’ quality oversight.”

​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 

Steven J. Lynn previously held positions at FDA’s Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, and the Office of Regulatory Affairs. 

RCA Announces New Executive Vice-President of Pharmaceuticals

Novavax and Par Sterile Products, a subsidiary of Endo International, announced on Sept. 25, 2020 that they have entered into a non-exclusive agreement under which Par Sterile will provide fill/finish manufacturing services for Novavax's COVID-19 vaccine candidate, NVX-CoV2373, at Par Sterile’s plant in Rochester, MI.

Through the agreement, Par Sterile will produce the vaccine for use in Novavax's Phase III clinical trial in the United States, while also providing fill/finish services for commercial distribution in the US, a Par Sterile press release said.

"This agreement puts an important piece in place as we finalize our supply chain for the US clinical trial and eventually, commercial distribution of NVX-CoV2373, our nanoparticle vaccine adjuvanted with Matrix-M," said Stanley C. Erck, president and CEO, Novavax, in the press release. "Endo's partnership and expertise are enabling rapid delivery of the vaccine for pivotal clinical testing, which we expect to get underway very soon."

"We are very pleased to help bring Novavax' COVID-19 vaccine to the public," said Blaise Coleman, president and CEO of Endo, in the press release. "Our Rochester, Michigan facility has a long history of manufacturing critical vaccines and sterile injectable products for the US market and we are proud to partner with Novavax on such a critical initiative. This partnership further underscores Endo's commitment to helping everyone we serve live their best life through the delivery of life-enhancing therapies."

Par Sterile will produce the vaccine for use in Novavax's Phase III clinical trial in the United States, while also providing fill/finish services for commercial distribution in the US.

Novavax and Par Sterile Products Enter into Fill/Finish Manufacturing and Services Agreement for COVID-19 Vaccine Candidate

Grand River Aseptic Manufacturing (GRAM), an injectable contract development and manufacturing organization (CDMO), announced in a September 25, 2020 press release that it has entered into an agreement with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to support the fill/finish manufacture of its SARS-CoV-2 vaccine candidate. Teams from GRAM and Janssen are working to transfer the manufacturing process to GRAM’s new facility in Grand Rapids, MI in preparation for the start of vaccine production.

“Should their vaccine candidate be approved, the opportunity to serve the population with a vaccine to combat the COVID-19 pandemic alongside Johnson & Johnson is an extraordinary privilege,” said Tom Ross, president and CEO of GRAM, in the press release.

GRAM is expanding domestic fill/finish capacity for COVID-19 vaccines and therapeutics for companies that have agreements with the federal government to meet its Operation Warp Speed goals, the company said in the press release. The GRAM expansion is funded, in part, by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, in collaboration with the Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND).

GRAM is expanding fill/finish capacity and is working with Janssen on tech transfer in preparation for production of Janssen’s SARS-CoV-2 vaccine candidate at GRAM’s Grand Rapids, MI facility. 

GRAM Partners with Johnson & Johnson for Fill/Finish of Vaccine Candidate

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

With little more than a month to go until the national election, President Trump 

 designed to reduce what consumers pay for prescription drugs, while also promising to protect coverage for pre-existing health conditions

. However, analysts noted that administration-backed legal challenges to the Obama Administration’s Affordable Care Act (ACA) stand to eliminate health benefits for millions, even as Americans face a critical need for health care under the threat of infection by COVID-19.

Most surprising is the President’s plan to distribute a $200 drug benefit card to seniors. The cards would help pay prescription drug copays for 33 million Medicare beneficiaries, at an estimated cost of $6.6 billion. Because the initiative is unauthorized and unfunded, the administration proposes to implement the benefit through a demonstration program and to cover the cost with anticipated savings from its earlier plan to link Medicare drug reimbursement to a “most favored nation” calculation based on lower drug prices in Europe. Without that program, though, which has not been enacted, there are no Medicare funds to support the discount cards. Earlier, the press reported that President Trump had proposed that pharma companies underwrite $100 discount cards for seniors in exchange for the administration dropping the plan to link US drug prices to those overseas, but that manufacturers had rejected that plan. This new drug card proposal is even less attractive to industry and likely to be challenged in court if it does move forward.

Separately, the administration promoted consumer access to less costly medicines from abroad in finalizing its Safe Importation Action Plan that permits states to import certain drugs from Canada. A 

 issued Sept. 24, 2020 authorizes states, Indian tribes, and possibly pharmacies and wholesalers to create their own import plans, which must meet FDA standards and gain agency authorization.

 Importation programs can cover drugs approved by Health Canada, but not many of the most expensive biotech therapies—making it difficult for the plans to meet the requirement of providing “significant cost reductions” to American consumers. The process is complicated, potential savings are unclear, and its impact is expected to be minimal.

FDA advanced the administration’s drug import program by publishing a 

outlining the standards and procedures for drug manufacturers to be able to import their own products approved for overseas sale

. The advisory specifies the process for pharma companies to obtain a National Drug Code for certain FDA-approved prescription drugs that are manufactured and intended for sale in a foreign country to permit the firm to offer these products at lower prices in the United States. When originally proposed last July, analysts predicted that few pharma companies were likely to implement this program and that it was not expected to have any impact on the US pharmaceutical market. But consumers facing high out-of-pocket costs for medicines often see drug import programs as an appealing way to gain access to less expensive drugs.

Indications that the White House aims to distribute “some” of the $200 drug discount cards before the November 3rd election, despite unclear funding or authority, drew sharp rebukes from Democrats that the President was promoting non-existent savings on pharmaceutical outlays merely to attract voters. Even advocates of US drug pricing reform recognize that the current Trump proposals are unlikely to save money for consumers or the government and believe that it’s more important for the administration to focus its health-related efforts on combatting the COVID-19 pandemic.

President Trump announced a revised initiative designed to reduce what consumers pay for prescription drugs, while also promising to protect coverage for pre-existing health conditions.

Trump Health Policies Again Thrust Drug Pricing and Access into the Spotlight

Telstar has announced, in a Sept. 17, 2020 press release, that it has reinforced its consultancy service to aid pharmaceutical companies in the compliance of the latest version of the European Union Good Manufacturing Practice (GMP) Annex 1 guidance.

The strengthened service specializes in assessment, diagnostic, and implementation of comprehensive solutions for sterile process and critical installations. Focused on helping pharmaceutical laboratories with sterile production to drive strategies and technologies integration, the specialized service is aimed at assuring the sterility of finished products in line with the new Annex 1 requirements.

At the time of writing, the new Annex 1 guidance is under formal review, with expected enactment of regulatory requirements to happen over the next few months. The changed guidance is aimed at preserving safety throughout the whole manufacturing process and requires companies to formally document a contamination control strategy, which considers all technical and organizational measures in place to ensure sterile products meet quality critical attributes.

The complete service offered by Telstar comprise the design, assessment, implementation, tracking, and support of all phases of sterile medicine manufacture and changes adopted in installations or equipment, in addition to the development of the quality management system. The service will be led by Rafael Beaus, global consultancy manager at Azbil Telstar.

Telstar has reinforced its consultancy service to aid pharmaceutical companies in the compliance of the latest version of the EU GMP Annex 1 guidance.