Surveying Pharma Workers on Employment Trends

Drug Solutions

Appreciating the full impact certain select technologies will make on the industry by 2026.

Six Approaches Significantly Impacting in the Future

Pharma workers appear ready for flux, change, evolution, and expanding molecular diversity.

Crossing the Same River Multiple Times

Experts weigh in on trends in the biotechnology market, psychedelics, and India.

Predicting Pharma’s Future

Inhaled vaccines must resist degradation and penetrate the mucosal lining in the airways and lungs.

Inhalation Vaccine Development

Analytical techniques for cleaning validation must evolve with the therapeutic landscape.

Cleaning Up in Bio/Pharma

Pharma Trends Dissected by 3 PR Agency Luminaries

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.

Articles

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.

USPTO Issues Notice of Allowance for Zika Vaccine Patent 

Jill Murphy, editor, and Grant Playter, associate editor, discuss the results from Pharmaceutical Technology’s latest employment survey. This survey, which polled approximately 300 members of the pharmaceutical industry, is designed to gather insights on topics like the broader state of pharmaceutical employment, trends going on in the industry, and predictions for its future. In this episode, Jill and Grant take a deep dive into these statistics and discuss what underlying factors might be at the root of it all.

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

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Jill Murphy, editor, and Grant Playter, associate editor, discuss the results from Pharmaceutical Technology’s latest employment survey.

Drug Solutions Podcast: Surveying Pharma Workers on Employment Trends

Takeda and Hutchmed, a commercial-stage biopharmaceutical company, announced an exclusive licensing agreement on Jan. 23, 2023. Per the terms of the agreement, Takeda will pay Hutchmed $400 million for the rights to further develop and commercialize fruquintinib outside of mainland China, Hong Kong, and Macau. An additional $730 million, as well as royalties on net sales, is contingent on the drug meeting various regulatory, development, and sales milestones.

Fruquintinib is an orally administered, tyrosine kinase inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, 2, and 3; according to a company press release, the inhibition of VEGFR has been linked to blocking tumor angiogenesis. The treatment was designed to improve kinase selectivity, with the goal of minimizing off-target toxicities, improving tolerability, and providing more consistent target coverage. The drug was approved for use in colorectal cancer (CRC) in China in 2018.

“Fruquintinib has the potential to change the treatment landscape for patients with refractory metastatic CRC who are in need of additional treatment options. We look forward to utilizing our development and commercial capabilities to expand the potential of this innovative medicine to patients beyond China,” said Teresa Bitetti, president, Global Oncology Business Unit, Takeda, in the press release. “Working with Hutchmed will enable us to expand our oncology portfolio, bringing us one step closer to achieving our aspiration to cure cancer.”

“We are pleased to be partnering with a company that shares our mission to improve treatment outcomes for cancer patients and has the scale and expertise in global drug development and commercialization to advance fruquintinib globally outside of China,” said Weiguo Su, executive director, CEO, and chief scientific officer, Hutchmed, in the release. “We believe that fruquintinib has a very strong future and look forward to working with Takeda to unlock its potential.”

Fruquintinib received fast track approval for treatment of metastatic CRC from FDA in 2020. Hutchmed submitted a new drug application in December 2022, which is expected to be completed in the first half of 2023. Takeda plans to submit additional applications to the European Medicines Agency and the Japan Pharmaceuticals and Medical Devices Agency.

Takeda will pay approximately $400 million upfront for the exclusive worldwide rights to Hutchmed’s fruquintinib, a tyrosine kinase inhibitor, outside of China.

Takeda Strikes $1.13 Billion Deal for Hutchmed Colorectal Cancer Treatment

Eli Lilly and Company (Lilly) announced that FDA had rejected its accelerated approval application for donanemab as a treatment for early symptomatic Alzheimer's disease on Jan. 19, 2022. In its response letter, FDA cited concerns surrounding an insufficient quantity of clinical trial data.

According to a company press release, FDA specifically requested that Lilly provide data from at least 100 patients who received a minimum of 12 months of continued treatment on donanemab. Lilly cited the experimental design of the study, which allowed patients to complete their treatment once targeted deposits of amyloid plaque were reduced to predefined endpoints, as causing the insufficient quantity of data. Lilly is currently in the middle of a confirmatory Phase III clinical trial (TRAILBLAZER-ALZ 2), with topline data expected in the second quarter of 2023.

"We anticipate [TRAILBLAZER-ALZ 2] will confirm the benefit and safety profile we observed in the TRAILBLAZER-ALZ Phase II study and believe that patients and physicians will be well served by having the full Phase III data available alongside our Phase II data when they need to make treatment decisions," said Anne White, executive vice-president and president, Lilly Neuroscience, Eli Lilly and Company, in the press release. "We are committed to working with the FDA to ensure the fastest possible path to bring this potential medicine to patients in need."

In a response letter, FDA stated that it could not grant Eli Lilly and Company accelerated approval due to concerns surrounding insufficient quantity of clinical trial data.

FDA Rejects Accelerated Approval for Lilly’s Alzheimer’s Drug

The FDA is issuing a new guidance to support sponsors in the development of drugs for monkeypox (mpox). The guidance is intended to provide nonclinical, virology, and clinical considerations for mpox drug development programs, targeting on recommendations to support initiation of clinical trials.

In the past, FDA has approved drugs for the treatment of smallpox under regulations commonly referred to as the Animal Rule, but this pathway is not applicable to drugs for mpox because the research team can design and implement clinical trials for mpox that are both ethical and feasible.

The FDA’s guidance documents do not establish legally enforceable responsibilities but instead describe the Agency’s current thinking on a topic and should only be viewed as recommendations.

The guidance is intended to provide nonclinical, virology, and clinical considerations for mpox drug development programs, targeting on recommendations to support initiation of clinical trials.

FDA Issues Guidance on Development of Drugs for Monkeypox

AmMax Bio announced on Jan. 19, 2023 that the European Medicines Agency (EMA) has granted AMB-05X Priority Medicines (PRIME) designation for the treatment of tenosynovial giant cell tumor (TGCT).

“The positive proof-of-concept data from our prior 12-week Phase II study of AMB-05X in TGCT provided the basis for our PRIME application,” said Larry Hsu, PhD, chief executive officer of AmMax Bio, in a press release. “We appreciate EMA’s decision to award AMB-05X its PRIME designation, which validates the high potential therapeutic value of the program and the significant unmet medical need for patients impacted by TGCT.”

AmMax Bio presented positive Phase II data for the novel local administration of AMB-05X in patients with TGCT at the Connective Tissue Oncology Society meeting in November 2022. The efficacy data across multiple clinical endpoints and a favorable safety profile support the potential of AMB-05X as a best-in-class therapy for the treatment of TGCT regardless of surgical resectability.

The PRIME designation was launched by EMA to boost support for the development of medicines that target an unmet medical need. EMA will continue to offer early and proactive support to medicine developers to optimize the generation of robust data on a medicine’s benefits and risks through PRIME, according to the company press release.

The efficacy data across multiple clinical endpoints and a favorable safety profile support the potential of AMB-05X as a best-in-class therapy for the treatment of TGCT regardless of surgical resectability. 

AMB-05X Receives EMA PRIME Designation for Treatment of Tenosynovial Giant Cell Tumor

Asimov, a synthetic biology company advancing the design and manufacture of therapeutics, announced a strategic partnership with Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization (CDMO) on Jan. 18, 2023.

The partnership led to Asimov licensing its clonal GMP HEK293 suspension cell line to CBM for pre-clinical and clinical production of viral vectors for its clients. According to the press release, HEK293 cell lines are the industry standard for producing therapeutic viral vectors, which are used mainly in gene therapies.

CBM will now be available for clients to get immediate access to a high-performance clonal good manufacturing practice qualified cell line as a measure of its comprehensive capabilities for vector manufacturing designed to deliver high yields and higher throughput without comprising quality.

“Our partnership with CBM is a major step forward in our goal to advance therapeutics manufacturing,” said Alec Nielsen, CEO of Asimov, in a press release. “This validates our efforts in the viral vector space, and supports other research directions in host cell optimization, genetic system engineering, and bioreactor process modeling and development. By licensing our HEK293 viral vector production platform, CBM will be able to provide their clients with immediate access to reduce the cost of manufacturing these complex therapeutics.”

The agreement finds CDM offering its clients access to the platform as a part of its end-to-end comprehensive capabilities for vector manufacturing designed to accelerate development and manufacturing timelines of vector-based advanced therapies.

“We believe this is the initial step of many with Asimov, an industry leader in mammalian synthetic biology and cell line development,” said Avi Nandi, chief technical officer at CBM, in a press release. “We continue to make significant investments into our technology platforms to ensure our clients have access to an end-to-end solution that allows them to develop and manufacture at lower costs. Our goal is for rare disease therapies to be accessible to as many patients around the world as possible and our relationship with Asimov removes a key barrier to therapy developers.”

The partnership led to Asimov licensing its clonal GMP HEK293 suspension cell line to CBM for pre-clinical and clinical production of viral vectors for its clients. 

Asimov and Center for Breakthrough Medicines Collaborate for Viral Vector Production

Editor of Pharmaceutical Technology Europe

Towards the latter half of 2022 (on 27 Sep. 2022), CRB launched its 

 industry report, providing a snapshot of how the industry is doing and how it might progress (1). To create the report, CRB surveyed a wide selection of the top companies in the life sciences industry and then combined those views to create and overarching perspective into the status of the industry and future prospects.

The 2022 report marks the first one to include an expanded audience, as many European countries were also included in the survey, which has raised some interesting insights. To learn more about the report and the outcomes revealed, 

spoke with Peter Walters, Fellow—Advanced Therapies, CRB.

 Based on the results of CRB’s latest report, what are the biggest challenges facing European pharma companies over the next five years?

Some of the biggest challenges reported by our European respondents were: attracting and retaining key talent—talent shortages are at a high right now, and companies are struggling to get the staff they need to progress forward; financing—strapped by investment issues worldwide, companies are being forced to scrutinize and optimize their spending a lot more than in the previous couple years; innovative technologies—European clients are facing a need for better, more effective technological solutions to their manufacturing challenges.

 Where might the biggest opportunities lie for European pharma companies over the course of the next five years?

 Attracting and retaining key staff is becoming critical within the life science industry. The continued evolution of therapy approaches, and the resultant needs for development and new technologies, means having the right staff to lead and drive your organisation. Building the right personnel foundation can make all the difference in your ability to move forward or get caught in a talent trap.

How do the challenges and opportunities for European pharma line up with the rest of the world?

We received survey responses that showed much better global alignment than we anticipated. The report saw regulatory perception, including around global harmonization efforts, closely aligned. The report also saw close alignment around companies’ intentions for Pharma 4.0 and digitalization initiatives.

 How has the COVID-19 pandemic shaped the European pharma landscape and what continuation of these changes should we expect to see over the next five years?

Financial constraints have become far more prevalent post-COVID. Companies are indicating they are still expecting company growth and expansion, but at a much more conservative, methodical pace than pre-COVID.

When will the next report be scheduled and how can European companies be involved?

 report every year, so keep an eye out for the 2023 edition, most likely on shelves around Q4. For companies interested in specifically taking part in our industry survey, please reach out and we will do our best to incorporate them in our survey effort when that goes out.

Felicity Thomas is the European/senior editor for Pharmaceutical Technology Group.



CRB’s latest industry report includes an expanded audience to include many European countries, which has provided some interesting insights.

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