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FDA just announced that it will restart in-person, face-to-face meetings with industry sponsors of drugs and biologics, beginning Feb. 13, 2023, after a shift to all-virtual meetings during the COVID-19 health emergency for nearly three years. However, the 

that it has revised its definition of such formal meetings to include both in-person and virtual components utilizing IT platforms that allow for both audio and visual communication. The agency explains that a face-to-face (FTF) meeting between FDA and industry will be a hybrid session, with both in-person and virtual components using cameras.

This redefinition of “in-person” meetings was agreed on in the recently updated user fee agreements for drugs (PDUFA VII) and biosimilars (BsUFA III). FDA also plans to apply this process to formal meetings involving over-the-counter medicines, even though that new user fee agreement does not specify this policy. For now, the agency will limit face-to-face hybrid sessions to requests for Type A meetings, Biosimilar Product Development Type 1 sessions, and Type X meetings, with other meeting types continuing to be fully virtual, without an in-person component.

FDA says it is in the process of updating guidance documents for formal meetings to include this revised definition and is highlighting the new meeting policy on its website to “help reduce uncertainties” for all parties. This dual approach for in-person meetings reflects a hybrid workplace format at the Centers for Drug Evaluation and Research (CDER) and Biologics Evaluation and Research (CBER), where many staffers still work only a portion of the time at FDA’s White Oak facility. The agency is upgrading its conference rooms there in phases to better handle hybrid meetings, a process that limits the number of in-person sessions that can be accommodated at this time.

To better manage the in-person component of these hybrid sessions, FDA plans to limit the number of people in the room to “core participants” (i.e., those with “primary speaking roles”) and encourages industry to do the same. Other staffers from both parties will join the session virtually. As FDA gains more upgraded conference rooms, it will consider phasing in additional types of meetings for in-person scheduling, such as Type A and Type B (milestone meetings), BPD Type 1 and Type 2, and Type X and Type Y. Eventually, all FTF formal meetings may be eligible for the in-person format.

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FDA will restart in-person, face-to-face meetings with industry sponsors beginning Feb. 13, 2023, after a shift to all-virtual meetings during the pandemic.

FDA Resumes In-Person Meetings with Industry … Sort Of

Ahead of Pharmapack Europe 2023, taking place on Feb. 1–2, 2023, the event’s panel of experts predict increased consolidations in 2023, driven by supply chain concerns and big pharma preferences. A report to be published at the show, foresees continued challenges ahead for smaller and medium-sized packaging companies that are likely to face significant competitive pressures. The report highlights that many companies are looking to sell products globally, with multiple regulatory burdens and divergent standards. Companies turning over €20 million or less are more likely to be potential acquisition targets.

“Pharma customers like to have suppliers they can reply upon for more than single components (e.g.. cap, bottles, etc.) and increasingly want providers that can provide complete solutions,” said Gregor Nischer, MP corporate finance GmbH managing partner, in a press release. “At the same time, regulations are becoming more complex, and small companies don't have the necessary resources, meaning the development of products is becoming prohibitively expensive.”

The event, which is at the center of pharma’s packaging and drug delivery devices industry, will take place at the Paris Expo, Porte de Versailles (Hall 7.2) and will see 5500 attendees and more than 300 companies.

Pharmapack Europe experts say smaller and medium European packaging companies to grow or be acquired.

Pharmapack Experts Predict Increased Packaging Consolidations in 2023

Thermo Fisher Scientific and AstraZeneca announced a collaboration to develop a solid tissue and blood-based companion diagnostic (CDx) test for osimertinib (brand name Tagrisso) on Jan. 24, 2023. The CDx is intended to help identify patients with non-small cell lung cancer (NSCLC) who may be eligible for treatment with osimertinib by identifying tumors that exhibit epidermal growth factor receptor (EGFR) alterations, including exon 21 L858R mutations, exon 19 deletions, or T790M mutations.

According to a company press release, the test will use the Oncomine Dx Express Test on the Genexus Dx System, a fully integrated next-generation sequencing platform. The platform features an automated specimen-to-report workflow and can deliver results after 24 hours.

“As part of our ongoing partnership with AstraZeneca, today’s announcement will help bring targeted oncology treatments to more patients in need of new care options,” said Garret Hampton, president of clinical next-generation sequencing and oncology, Thermo Fisher Scientific, in the press release. “By leveraging the Genexus Dx System’s unprecedented turnaround time, we can help ensure molecular testing results are more readily available to inform vital treatment decisions.”

AstraZeneca and Thermo Fisher will collaborate to develop a solid tissue and blood-based companion diagnostic test for osimertinib.

AstraZeneca and ThermoFisher to Collaborate on Companion Diagnostic Test

Be The Match BioTherapies, a provider of solutions for developing and commercializing cell and gene therapies, in conjunction with the Center for International Blood and Marrow Transplant Research (CIBMTR), is offering expanded clinical research organization (CRO) services. These services are designed to help companies reduce the time required to launch and execute clinical trials.

According to a Jan. 17, 2023 company press release, the new CRO Services provide turn-key solutions, including protocol development and approval oversight, project management, site selection, site start-up, data management, research sample/laboratory coordination, study monitoring, statistical analysis, patient-reported outcomes, and financial administration. Companies also have the option to only choose select services, including data analysis, surveys, site selection and management, and sample management.

The CRO services feature built-out clinical infrastructure, including a single institutional review board, a dedicated data safety monitoring board, master contracts, and 

 compliant software. Customers will also gain a direct link to the CIBMTR outcomes database, consisting of data from more than 575,000 patients.

“Be The Match BioTherapies and its partners have successfully supported bone marrow transplant and cellular therapy clinical trials for nearly 20 years,” said Erin Leckrone, senior director, Clinical Trials, CIBMTR, in the release. “Today, with our formal launch of CIBMTR CRO Services, the expertise and resources honed over decades of work by the leading experts are accessible to small-to-mid-sized biotechnology companies. These services, whether used in whole or as ad hoc support, will accelerate time-to-trial and bridge the transition from research to patients.”

Be the Match BioTherapies’ and CIBMTR’s expanded service offering is intended to aid in the design, implementation, and oversight of cellular therapy clinical trials.

Be The Match BioTherapies Launches CRO Services for Cell and Gene Therapy

Scientific Laboratory Supplies (SLS), a supplier of laboratory equipment, materials, and supplies based in the United Kingdom, recently announced the acquisition of C&M Scientific, a scientific calibration, maintenance, and validation company also based in the UK.

According to a press release from Jan. 12, 2023, the acquisition aligns with SLS’ strategy of acquiring companies across the UK and Ireland. Operating throughout northern England and Scotland, C&M is fully accredited to ISO 9001, ISO 14001, ISO 45001, and ISO/IEC 17025 certification, and also adheres to Medicines and Healthcare products Regulatory Agency, FDA, and Good Manufacturing Practice standards.

“Our multidisciplinary service and product range combine to provide a complete solution for laboratories across Scotland and the North of England. Joining the SLS Group will help us further extend our reach and expand our product offering,” said Ian Alexander, managing director, C&M Scientific, in the release.

“We are thrilled to welcome C&M Scientific to the ever-growing SLS family,” said Ian Roulstone, managing director, SLS, in the release. “This deal represents another great addition to the SLS Group as C&M Scientific have cultivated a reputation for unrivaled technical expertise.

We are excited to further expand the SLS Group service provision and this acquisition continues our recent focus on developing a world-class service offering.”

Scientific Laboratory Supplies’ acquisition of C&M will bolster the company’s scientific calibration, maintenance, and validation offerings.

Scientific Laboratory Supplies Acquires C&M Scientific

A more harmonized formula and schedule for administering COVID-19 vaccines gained strong support from FDA’s expert advisory panel last week, with agreement on the need to reduce confusion over which shot to take and when in order to increase vaccination rates among both adults and children in the United States. The 21 members of FDA’s Vaccine and Related Biological Products Advisory Committee (VRBAC) voted unanimously for a more simplified approach, setting the stage for the agency to authorize a common bivalent shot for all patients that targets both the original COVID-19 strain and the Omicron subvariants. The new program would end use of Pfizer and Moderna monovalent vaccines that only target the original COVID strain.

FDA received less support for setting a schedule for annual vaccination against COVID, as the advisors expressed uncertainty about the effectiveness of the current shots and questioned what time during the year would be best for a national COVID vaccination campaign. Several panel members urged additional research on the effectiveness of the new formulations on frequently changing variants and the possible need for different vaccination schedules for both young children and older adults with health impairments. The experts called on FDA to provide additional data on vaccine effectiveness and timing to better determine whether all patients would need an annual shot.

The strategy to set a common formula for anti-COVID vaccines across the country aims to increase vaccination rates overall. New data from the Centers for Disease Control and Prevention (CDC) indicates that less than half of all older Americans (over age 65) have received the updated booster, and that vaccination rates are a meager 10% for children under age 4. The hope is that a shift away from differing vaccine compositions and varying immunization schedules, along with clearer alignment between US and European vaccination recommendations, will encourage more people to get such protection.

Pfizer, Moderna, and Novavax reported to VERBAC on efforts underway to produce reformulated bivalent vaccines and supported the plan to establish a common formulation for all manufacturers of the adopted shot to simplify vaccination recommendations and reduce patient uncertainty over effectiveness and safety of vaccines from different companies. The manufacturers emphasized the need for specifics from FDA on the process for updating vaccine strains, including the timing, process, and methodology for producing a data package for new licensure. While such filings are expected to include new preclinical and manufacturing data, sponsors opposed requirements for additional clinical trials, indicating that it will be more productive to assess post-authorization real-world data to confirm effectiveness.

FDA officials proposed to meet with the advisory panel in May or June to decide on which COVID strain to target in vaccines for later this year, anticipating a fast reformulation by manufacturers of messenger (mRNA) vaccines. But Novavax officials indicated that it might need to identify the strain earlier, probably in March, to produce a new vaccine by fall with its more traditional vaccine production process. All three shot manufacturers reported that they were already shifting to use prefilled syringes and single-dose vials, which are important for physicians, clinics and pharmacies planning to administer the new vaccines more widely in the wake of reduced federal government involvement in the program.

A related question is whether FDA will ask manufacturers to produce combination influenza/COVID vaccines to further simplify annual vaccination programs. The three firms reported that they are already studying such combination shots, but any shift towards such products will involve much further assessment of the need for and effectiveness of annual COVID vaccines or combination products.

While advisory committee experts and officials from FDA and other health agencies acknowledged the value of utilizing mRNA platforms to produce anti-COVID vaccines so quickly and effectively at the start of the pandemic, some panel members called for further research on how well the new formulations provide long-term protection and avoid safety issues, urging continued examination of whether more traditional vaccine production methods may have broader benefits moving forward. In its presentation, Novavax presented data indicating a “robust breadth of immunity” and strong manufacturing consistency for its more recently approved preventive.

In concluding the meeting, Peter Marks, director of the Center for Biologics Evaluation and Research, reiterated the need for a “data-driven approach” to achieve a vaccine regimen that is as simple as possible. But he also noted the importance of monitoring vaccine safety and assessing product effectiveness in shifting to a next generation of COVID vaccines able to provide “greater depth of protection.”

FDA plans to authorize a common bivalent shot that targets both the original COVID-19 strain and Omicron subvariants.

FDA Seeks to Simplify COVID-19 Vaccination Program

FDA released the Biosimilar User Fee Amendments (BsUFA) III Regulatory Science Pilot Program: Research Roadmap to provide additional information about the biosimilar regulatory science research pilot program. The agency also opened a public docket to collect feedback, according to a press release.

The BsUFA facilitates the development of safe and effective biosimilars and interchangeable biosimilars for patients by supporting FDA review of biosimilar submissions. FDA will pilot a regulatory science program to facilitate biosimilar and interchangeable biological product development, as outlined in the BsUFA reauthorization commitment letter for fiscal years 2023–2027.

The regulatory research pilot program is targeted at knowledge gaps and direct research to advance biosimilar development. The BsUFA III regulatory research pilot program has two goals, also known as demonstration projects, which are: advancing the development of interchangeable products, and improving the efficiency of biosimilar product development.

In the roadmap, research areas are highlighted where advancement is expected to impact science-based recommendations and regulatory decision making. More specifically, the research aims to:

increase the accuracy and capability of analytical (structural and functional), and chemistry, manufacturing, and controls characterization

develop alternatives to and/or reducing the size of studies involving human subjects

The research team, both external and internal to FDA, should use this roadmap to guide research proposals, collaborations, and other efforts as they seek BsUFA III research funding opportunities. Further, the roadmap includes information on research project deliverable dates and methods to consider for research conducted as part of the pilot program.

In all, the objective of the pilot program is to increase the efficiency and predictability of biosimilar development to help reduce the cost and time of development. This helps increase availability and access to much needed biological treatment options for patients.

The BsUFA facilitates the development of safe and effective biosimilars and interchangeable biosimilars for patients by supporting FDA review of biosimilar submissions.

FDA Releases Research Roadmap for Biosimilars Pilot Program

Agilent and Quest Diagnostics entered into an agreement to expand access to the Agilent Resolution ctDx FIRST liquid biopsy next-generation sequencing (NGS) test. The ctDx FIRST is a single-site premarket approved test that is approved by FDA (1) as a companion diagnostic (CDx) to identify advanced non-small lung cancer (NSCLC) patients who may benefit from treatment with adagrasib (brand name Krazati). Adagrasib is a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy.

According to a Jan. 23, 2023 company press release, under the agreement, Quest will offer ctDx FIRST to healthcare providers in the United States seeking a minimally invasive liquid biopsy test option as a CDx for adagrasib. The test can be ordered online through Quest’s online connectivity platform, and healthcare providers may additionally direct patients to provide specimens at one of Quest’s 2100 patient service centers in the US.

“We are looking forward to the Quest Diagnostics alliance facilitating broad access to ctDx FIRST, our liquid biopsy solution,” said Paul Beresford, vice-president and general manager, Companion Diagnostics Division, Agilent, in the release. “This expands the testing options available for NSCLC patients as patients don’t always have tissue available for molecular analysis.”

"The addition of the ctDx FIRST test to our oncology menu underscores our commitment to providing access to precision medicine innovations to improve care for patients with cancer," said Kristie Dolan, vice-president and general manager, Oncology Franchise, Quest Diagnostics, in the release. "It also reflects our ability to optimize our national physician and patient access network to extend access to important medical innovations with the potential to improve patient outcomes."

1. FDA, “FDA Grants Accelerated Approval to Adagrasib for KRAS G12C-Mutated NSCLC,” Press Release, Dec. 12, 2022.

Agilent will work with Quest Diagnostics to distribute the ctDx FIRST test.

Agilent and Quest Diagnostics to Collaborate on Lung Cancer Diagnostic

Illumina, a DNA sequencing and array-based technologies provider, and Nashville Biosciences, a subsidiary of Vanderbilt University Medical Center (VUMC), have teamed up with Amgen to provide whole-genome sequencing of approximately 35,000 DNA samples. The sequencing of this sample cohort, which primarily comprises DNA from African-Americans, is intended to mitigate their underrepresentation in research for clinical applications of genomics. The sequencing will be performed by deCODE genetics, a subsidiary of Amgen.

According to a press release from Jan. 9, 2023, the sequencing of these samples is the first step in Illumina and Nashville Biosciences Alliance for Genomic Discovery (AGD) program. The agreement intends to whole-genome sequence at least 250,000 de-identified human DNA samples from VUMC’s BioBU biobank over the course of two and a half years.

"The initial cohort will be among the largest sequencing efforts involving African Americans to date," said Leeland Ekstrom, CEO, Nashville Biosciences, in the release. "Once complete, this data set will provide a wealth of new information about the human genome and accelerate the study of disease in—and discovery of new therapeutics for—populations less well represented in prior large-scale sequencing efforts. The opportunity to sequence this diverse set of samples will help broaden our understanding for individuals who have been underrepresented in genetic research and continue to experience health disparities."

"deCODE's sophisticated human data capabilities are well positioned to sequence these samples and analyze the resulting data to provide a better scientific understanding of disease through the context of human diversity," said Kári Stefánsson, founder, deCODE genetics, in the release. "Insights from human data, including both genetics and clinical records, can help inform how medicines may affect different patient populations."

deCODE genetics, a subsidiary of Amgen, will whole-genome sequence 35,000 African-American samples provided by Illumina and Nashville Biosciences.

Amgen, Illumina, and Nashville Biosciences Announce Genome Sequencing Agreement

GeoVax announced on Jan. 25, 2023 that the United States Patent and Trademark Office issued a Notice of Allowance for Patent Application No. 17/000,768 titled, “Method for Generating a Zikv Immune Response Utilizing a Recombinant Modified Vaccinia Ankara Vector Encoding the NS1 Protein.”

According to GeoVax, Zika virus (ZIKV) is linked to an increase in microcephaly in infants and neurodegenerative disease, Guillain-Barre syndrome, in adults. The claims to be granted in the patent cover GeoVax’s modified vaccinia Ankara (MVA) vector comprising a nucleic acid sequence encoding a ZZIKV nonstructural (NS1) protein, of which GEO-ZM02 is designed. The company states its MVA platform holds the potential to address the critical unmet need in vaccination of women of childbearing age and newborns against ZIKV.

“Our novel Zika vaccine candidate, GEO-ZM02, is constructed using our modified vaccinia Ankara (MVA) vector platform. Preclinical studies demonstrated a single dose of GEO-ZM02 provided 100% protection against a lethal dose of Zika virus,” stated GeoVax CEO David Dodd, in a company press release. “Addressing many of the world’s most threatening infectious diseases is part of our vision and corporate priorities for MVA’s applications, which also includes an MVA-based next-generation COVID-19 vaccine currently in Phase II clinical trials.”

The United States Patent and Trademark Office issued a Notice of Allowance for Zika vaccine patent to GeoVax.

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