Celerion

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  • Celerion Achieves Milestone With CLIA Certification for Its Bioanalytical Laboratory, Expanding Capabilities in Clinical Trials and Diagnostic Testing

    LINCOLN, Neb.; Feb. 6, 2024 (Business Wire) – Celerion, a leading clinical research organization, proudly announces its recent achievement of obtaining the Clinical Laboratory Improvement Amendments (CLIA) certification for its state-of-the-art bioanalytical laboratory located in Lincoln, Nebraska. This significant milestone marks a pivotal step in Celerion’s commitment to advancing healthcare by integrating high complexity testing and diagnostic services into its comprehensive suite of bioanalytical solutions.

    Celerion’s clinical laboratories, including their Lincoln site, have been CLIA-certified and CAPaccredited for over 25 years, which helped facilitate the CLIA certification of the laboratory. The CLIA certification is a testament to Celerion’s adherence to the highest standards of laboratory quality and competence. It enables Celerion to conduct non-waived testing on human specimens, a critical component in the health assessment, diagnosis, prevention, and treatment of diseases. This certification is particularly crucial as it allows Celerion to perform these vital tests prior to the full accreditation inspection by a CMS-approved agency, ensuring continuous advancement in patient care and clinical research.

    With this certification, Celerion’s bioanalytical laboratory is now able to conduct lab-developed tests in specialized areas such as diagnostic immunology. These tests, recognized for their “high complexity” and stringent CLIA oversight, include but are not limited to ADA (anti-drug antibodies), NAb (neutralizing antibodies), and a wide array of biomarker assays. These assays are instrumental in determining patient inclusion and exclusion criteria for clinical trial enrollment, thereby enhancing the precision and efficacy of clinical studies. Moreover, the CLIA certification allows Celerion to engage in studies that require the reporting of patient-specific results. This capability is crucial for tailoring patient care and treatment, such as adjusting individual dosing based on specific data, distinct from the standard dosing for the general study population. This approach not only underscores the personalized aspect of patient care, but also significantly contributes to the optimization of therapeutic strategies and outcomes.

    Celerion’s Executive Vice President, Global Bioanalytical Sciences, Dr. Chad Briscoe, stated, “Achieving CLIA certification for bioanalytical assays is not just a milestone for Celerion, but a leap forward for the entire field of bioanalysis and clinical research. It underscores our unwavering commitment to quality, precision, and innovation. With this certification, we are poised to deliver enhanced value to our clients and contribute more profoundly to the advancement of healthcare and patient treatment options.”

    About Celerion

    Celerion, a global leader in early clinical research services, offers a unique combination of medical expertise, clinical operations experience, and scientific excellence that gives its clients the confidence to make fast, accurate decisions about their drug development path.

    For over fifty years, Celerion has leveraged the latest operational concepts and technologies to execute safety/tolerability, pharmacokinetic, and pharmacodynamic studies in highly controlled clinical environments. These include first-in-human dose escalation, drug-drug interaction, cardiac safety, bioequivalence and bioavailability, metabolism, and excretion studies, as well as pharmacokinetic evaluations in patients with impaired renal or hepatic function. In addition, Celerion offers data management, biostatistics, clinical monitoring, and bioanalytical services. Our founding mission is to help our clients get their drugs to market quickly, so that they touch the lives of our family, friends and people in need around the world. For more information, please visit www.celerion.com.

    Media Contact: 
    Michelle Maklas-Baker 
    Associate Director, Global Marketing 
    +1 732-306-7804 
    michelle.maklasbaker@celerion.com

  • Celerion Receives a 2023 CRO Leadership Award in All Categories for the Eighth Year Running

    LINCOLN, Neb.; May 10, 2023 (Business Wire) – Celerion, a leading clinical research organization, has been recognized for the eighth consecutive year as the winner of a CRO Leadership Award by global biopharmaceutical executives in Clinical Leader and Life Science Leader’s annual CRO Leadership Awards for 2023.

    Celerion was distinguished among 46 of their peers in the annual Contract Research Quality Benchmarking online survey conducted by Industry Standard Research. Celerion received a CRO Leadership Award in all five categories, including capabilities, compatibility, expertise, quality, and reliability.

    “We are honored to receive this prestigious recognition and would like to extend our sincere appreciation to our clients for their trust and support,” says Celerion CEO Susan Thornton, Ph.D. “This recognition is a reflection of our continued focus on innovation, quality, and customer satisfaction. We believe that our unwavering commitment to these principles is the foundation of our success and sets us apart from our competitors,” she added.

    About Celerion

    Celerion, a global leader in early clinical research services, offers a unique combination of medical expertise, clinical operations experience, and scientific excellence that gives its clients the confidence to make fast, accurate decisions about their drug development path.

    For over fifty years, Celerion has leveraged the latest operational concepts and technologies to execute safety/tolerability, pharmacokinetic, and pharmacodynamic studies in highly controlled clinical environments. These include first-in-human dose escalation, drug-drug interaction, cardiac safety, bioequivalence and bioavailability, metabolism, and excretion studies, as well as pharmacokinetic evaluations in patients with impaired renal or hepatic function. In addition, Celerion offers data management, biostatistics, clinical monitoring, and bioanalytical services. Our founding mission is to help our clients get their drugs to market quickly, so that they touch the lives of our family, friends and people in need around the world. For more information, please visit www.celerion.com.

    Media Contact: 
    Michelle Maklas-Baker 
    Associate Director, Global Marketing 
    +1 732-306-7804 
    michelle.maklasbaker@celerion.com

  • Celerion Expands Its Service Offering to Include GLP/GCP Compliant Molecular and Cell Biology Testing

    LINCOLN, Neb.; Nov. 10, 2022 (Business Wire) – Celerion, a clinical research organization (CRO) to the biopharmaceutical industry, announces the expansion of molecular and cellular capabilities to Good Laboratory Practice/Good Clinical Practice (GLP/GCP) standards to support the development of new modality therapies, such as cell and gene therapies. The expanded service offering is available in both of the company’s Lincoln and Zürich bioanalytical laboratories and includes ELISpot analysis, flow cytometry, and qPCR.                     

    Celerion’s expanded service offering provides platforms for immune monitoring and biomarker screening with high-throughput flow cytometry and ELISpot testing. Celerion has a pre-qualified interferon gamma ELISpot assay, allowing for a significantly faster validation process with study-specific antigens, thereby accelerating the development process for cell and gene therapies and vaccines alike. 

    Celerion also supports vaccine development programs by offering fully automated ELISA assays in a Biosafety Level 2 environment. 

    Flow cytometry is used to support the drug development of cell, gene, and immunotherapies with endpoints including immune-phenotyping of immune cells and receptor occupancy assessment. Celerion also provides high-throughput molecular biology testing for vector shedding analysis for gene therapies in compliance with current regulations as well as biodistribution to support GLP studies and transgene expression analysis using RT-PCR.

    “Our state-of-the-art cellular and molecular division has been built with the increased demand for new modalities in mind,” said Ray Farmen Ph.D., Vice President of Global Bioanalytical Sciences. “Celerion’s co-located clinical research facilities and bioanalytical laboratories enable timely method validation of many assays. We have qualified assays, validated analytical platforms, and trained staff available to quickly start your project and deliver to demanding timelines.”

    Farmen adds that Celerion has decades of regulatory experience, scientific excellence, and laboratory investments that enable accelerated development of these complex therapies. 

    About Celerion
    Celerion, a global leader in early clinical research services, offers a unique combination of medical expertise, clinical operations experience, and scientific excellence that gives its clients the confidence to make fast, accurate decisions about their drug development path.

    For over fifty years, Celerion has leveraged the latest operational concepts and technologies to execute safety/tolerability, pharmacokinetic, and pharmacodynamic studies in highly controlled clinical environments. These include first-in-human dose escalation, drug-drug interaction, cardiac safety, bioequivalence and bioavailability, metabolism and excretion studies, as well as pharmacokinetic evaluations in patients with impaired renal or hepatic function. In addition, Celerion offers data management, biostatistics, clinical monitoring, and bioanalytical services. Our founding mission is to help our clients get their drugs to market quickly, so that they touch the lives of our family, friends and people in need around the world. For more information, please visit www.celerion.com.

    Media Contact:

    Michelle Maklas-Baker
    Associate Director, Global Marketing
    1.732.306.7804
    michelle.maklasbaker@celerion.com

  • Adaptive Trial Designs

    Flexibility of Adaptive Early Phase Study Designs

    Sabina Paglialunga, PhD   Director, Scientific Affairs

    Adaptive clinical trials are characterized by innovative and flexible designs that incorporate safety and other information acquired during a study to instruct the next steps in a trial. Typically, these pre-planned adjustments include sample size refinement, subsequent dose level selection, or allocation ratio. In the case of patient studies, adaptive elements may consist of inclusion/exclusion criteria adjustment or stopping rules based on success or lack of efficacy [1].  Adaptive study designs are well established for cancer trials [2], and while they are applied to a lesser degree in other indications, a limited search in ClinTrials.gov revealed nearly 95 non-oncology industry sponsored adaptive trials over the past decade. 

    Regulatory Perspective on Adaptive Designs

    As interest in flexible design elements grows across all indications, both the FDA and EMA have issued updated guidance on adaptive trial designs for drugs and biologics in recent years [3, 4]. For early phase exploratory studies, the FDA touts the advantages of an adaptive design that advises dosing, pharmacokinetic (PK) and pharmacodynamic (PD) responses, which may improve the design and possibly the chances of success of later-phase trials [3]. 

    Adaptive Early Clinical Trial Designs

    For single ascending dose (SAD) and multiple ascending dose (MAD) studies, adaptive design elements can be incorporated into the study protocol to add flexibility. This can be a valuable approach when there are still many unknowns in the initial clinical drug development phases. Case examples of recent adaptive protocols are highlighted in Table 1. These elements, such as alterations to drug dose, number of cohorts, or schedules of PK sampling and PD assessments, must be pre-specified in the protocol. For each adaptable component, limits should be set to address any safety concerns and to operate within acceptable risk parameters [5]. For example, if a blood sample schedule can be adjusted to optimize evaluable PK or PD data, the maximum number of blood draws should be noted in the protocol and not exceeded. 

    Table 1. Case Studies of Early Clinical Trial Adaptive Study Designs

    Case StudyStudy DesignAdaptive ElementsImplementation
    Adaptive Dose and PK2-part SAD and MAD study in healthy volunteersDrug dose, infusion volume and/or rate, PK schedule (time points and number of samples)Adaptive elements were modified based on AEs, clinical finding, safety and tolerability resultsProtocol allowed for reduced PK sample number if data permitted 
    Adaptive Cohort NumberSAD study in healthy volunteersCohort number and dose levels defined for groups 1-5 Option to add up to 2 additional cohorts Upon review of cohort 1-5 safety and PK data, the decision will be taken to continue with increased dose levels, or an intermediate dose, or to cancel cohorts 6-7  
    Adaptive PD ResponseMAD study in participants with obesityNumber of PD assessments Multiple PD assessments evaluated in cohort 1 with option to omit or adjust PD schedule in subsequent cohorts Protocol also indicated the maximum number of PD assessments that can be taken
    Adaptive Sample SizeFixed-dose combination vs free dose cross-over bioequivalence (BE) study in healthy volunteersSample size re-estimation Clinical study activity paused during COVID-19 pandemic before all participants completed cross-over scheme  Adaptive and interim analysis was performed to re-evaluate  study sample size and power, using a validated method for crossover BE design [6]. Trial results demonstrated BE based on completed participant data [7]

    Advantages of Adaptive Early Clinical Trials

    With pre-defined adaptive protocol elements, no amendments are required, which can save time and result in scheduling efficiencies. In the case of future pandemic outbreaks or other extraordinary situations, adaptive designs can serve as a mitigation step and potentially ‘save’ a study from timely delays or the need to repeat the trial. This approach was applied in a BE study, where sample size was re-assessed midway through trial conduct using validated statistical methods to complete the trial without further interruption from a COVID-19 outbreak [7]. Ultimately, the advantage of adaptive, early clinical trial designs can lead to both time and costs savings. Celerion’s Protocol Design and Development Scientists are trial experts and can design early clinical trials with flexible and adaptive elements to get the most out of a study, for less.

    References

    1. Pallmann P et al. BMC Med. 2018;16(1):29.   

    2. Bothwell LE et al. BMJ Open. 2018;8(2):e018320.

    3. Food and Drug Administration. Adaptive Designs for Clinical Trials of Drugs and Biologics  Guidance for Industry. 2019. https://www.fda.gov/media/78495/download.   

    4. European Medicines Agency. Adaptive Pathways. https://www.ema.europa.eu/en/human-regulatory/research-development/adaptive-pathways    

    5. Lorch U et al. BMC Med Res Methodol. 2014;14:84.   

    6. Potvin D et al. Pharm Stat. 2008;7(4):245-62.   

    7. Csonka D et al. Pharmacol Res Perspect. 2021;9(5):e00846.

  • CRO Leadership Award Goes to Celerion for a 7th Consecutive Year

    Annual survey of biopharmaceutical clients recognizes Celerion for delivering customer service excellence.

    Lincoln, Neb. (June 15, 2022) — For the seventh consecutive year Celerion has been named recipient of the Life Science Leader and Clinical Leader’s CRO Leadership Awards in all five award categories. Well respected within the pharmaceutical industry, the awards recognize the winning Clinical Research Organization (CRO) in five categories: capabilities, compatibility, expertise, quality, and reliability in meeting the needs of big and small pharmaceutical clients alike.


    “We are of course honored again for such comprehensive recognition,” said Celerion CEO Susan Thornton Ph.D. “This award validates the many things we do to enable clients to bring drugs quickly to market, bettering the lives of people in need around the world. It’s gratifying that our commitment to excellence is noted by this pillar of our industry,” she added.

    Celerion was additionally designated a Champion performer for scoring one standard deviation or more above the weighted average in each award category including capabilities, compatibility and quality.


    “Industry Standard Research continues to consider it an honor to provide the primary market research data for Life Science Leader and Clinical Leader’s CRO Leadership Awards. ISR’s stringent screening process ensures that only highly qualified industry decision-makers participate in our CRO benchmarking market research. This is paramount as we ask the research participants to provide experiential, not perceptual, feedback on their involvement with contract suppliers over the past 18 months,” said Kevin Olson, CEO of Industry Standard Research.

    “The data enable users of ISR’s market research to make confident business decisions based on
    the experiences of their industry peers,” he added.

    About Celerion

    Celerion, a global leader in early clinical research services, offers a unique combination of medical expertise, clinical operations experience, and scientific excellence that gives its clients the confidence to make fast, accurate decisions about their drug development path.


    For over fifty years, Celerion has leveraged the latest operational concepts and technologies to execute safety/tolerability, pharmacokinetic, and pharmacodynamic studies in highly controlled clinical environments. These include first-in-human dose escalation, drug-drug interaction, cardiac safety, bioequivalence and bioavailability, etabolism and excretion studies, as well as pharmacokinetic evaluations in patients with impaired renal or hepatic function. In addition, Celerion offers data management, biostatistics, clinical monitoring, and bioanalytical services. Our founding mission is to help our clients get their drugs to market quickly, so that they touch the lives of our family, friends and people in need around the world. For more information, please visit www.celerion.com.

    Media Contact:

    Michelle Maklas-Baker
    Associate Director, Global Marketing
    1.732.306.7804
    michelle.maklasbaker@celerion.com

  • Celerion Announces Investment in ADME Suite of Services


    The leader in early clinical development expands ADME suite to meet ongoing demand.


    LINCOLN, Neb., April 6, 2022 /PRNewswire/ — Celerion, a clinical research organization (CRO) to the biopharmaceutical industry, has announced that it has made a significant investment in its ADME (Absorption, Distribution, Metabolism and Excretion) suite of services to meet continuously increasing demand to conduct these studies. This investment includes expanding laboratory space, adding new capabilities as well as a dedicated customer service team.


    Celerion has invested in new state-of-the-art equipment and laboratory space to perform onsite scintillation counting allowing for radioactivity recovery results to be delivered in real-time. This service ensures high total recovery of radioactive dose while providing for efficient clinical study conduct. What’s more, this investment has also enabled Celerion to double capacity of lab throughput.


    In addition to running human ADME studies, Celerion offers innovative metabolite identification and profiling. Celerion is one of the few laboratories using the newest and most advanced High Resolution Mass Spectrometry (HR-MS) Metabolite Profiling and Identification instrumentation and technologies to identify major metabolites, important metabolites (MIST), and unique metabolites.


    “With over 100 radiolabeled studies and 800 participants dosed, our experience in ADME studies ensures clients’ studies run efficiently and effectively from initial planning through to the final report,” said Phil Bach, Celerion’s Vice President of Global Clinical Research. “Additionally, our clinical and bioanalytical services are located within the same facility, enabling faster access to quality data and savings in time and cost.”


    Celerion has dedicated pharmacy staff consisting of Pharm D’s and registered technicians with over 40 years of Phase 1 experience. We have an authorized nuclear pharmacist to run all ADME studies and assign a lead pharmacist to each new study. The pharmacist will be involved with the study from start-up to close out and available for any consultation needed. All pharmacy staff are cross-trained on all protocols and all pharmacy functions. “From compounding formulation through data received our dedicated operational team along with a
    nuclear pharmacist and lab director work to provide a one stop shop for all of your ADME needs”, Phil Bach added.


    About Celerion

    Celerion, a global leader in early clinical research services, offers a unique combination of medical expertise, clinical operations experience, and scientific excellence that gives its clients the confidence to make fast, accurate decisions about their drug development path. For over fifty years, Celerion has leveraged the latest operational concepts and technologies to execute safety/tolerability, pharmacokinetic, and pharmacodynamic studies in highly controlled clinical environments. These include first-in-human dose escalation, drug-drug interaction, cardiac safety, bioequivalence and bioavailability, metabolism and excretion studies, as well as pharmacokinetic evaluations in patients with impaired renal or hepatic function. In addition, Celerion offers data management, biostatistics, clinical monitoring, and bioanalytical services. Our founding mission is to help our clients get their drugs to market quickly, so that they touch the lives of our family, friends and people in need around the world. For more information,
    please visit www.celerion.com.


    Media Contact:


    Michelle Maklas-Baker
    Associate Director, Global Marketing
    1.732.306.7804
    michelle.maklasbaker@celerion.com

  • Celerion Expands Early Phase Clinical Pharmacology Units

    The leader in early clinical development adds to its facilities and services to meet continually growing demand for Phase I Studies.

    LINCOLN, Neb., March 8, 2022 /PRNewswire/ — Celerion, a clinical research organization (CRO) to the biopharmaceutical industry, has announced completion of additions to its research capacity and services. This includes the opening of a new Screening and Return Center, upgraded pharmacy compounding suites, expanded Absorption, Distribution, Metabolism and Excretion (ADME) laboratory capacity and fifty additional beds.

    “The industry’s critical need for early phase clinical research continues to validate our aggressive expansion strategy,” says Phil Bach, Celerion’s Vice President of Global Clinical Research. “These latest facility upgrades provide a timely boost to our overall clinical capacity, capabilities, and start up timelines even beyond the unique needs generated by a global pandemic.”

    The new 40,000 square foot facility adjacent to the Phoenix, Arizona (AZ) clinic is designed to increase screening capacity and cater to the participant experience. It allows Celerion to better segregate ongoing in-house clinical trials and outpatient visits and screening to increase throughput and volume. 

    The addition of fifty new beds increases the total bed capacity to 350 at their Phoenix, AZ Clinical Pharmacology Unit, and brings Celerion’s total global bed count to over 650 beds.  These additional units are designed for complex Phase I protocols including first-in-human, intense cardiac monitoring, Thorough QT studies and unique biomarker collections and procedures. What’s more, this adds increased capacity to Celerion’s core clinical pharmacology studies such as drug-drug interaction, bioavailability and bioequivalence studies.

    “Multi-million dollar expansions of Celerion’s Lincoln, Nebraska (NE) and Phoenix, AZ pharmacies were also made to include a USP <797> compliant clean room and individual suites that are US <795> and <800> compliant for complex extemporaneous compounding of sterile and non-sterile investigational products. The expanded pharmacy capabilities offer clients a quick and cost-effective way to start clinical trials, without the need for extensive CMC investment in the early stage of development. Dose preparations are made in “real time,” enabling clients to make seamless adjustments to the dose or formulation and to respond quickly to changes in the first-in-human protocol design. All of this can deliver an accelerated timeline without the need for clients to have to work with multiple vendors.”

    Bach adds that doubling the ADME Lab capacity in Lincoln, NE gives clients additional flexibility in scheduling human mass balance studies. Celerion has invested in new state-of-the-art equipment and laboratory space to expand on-site scintillation counting, allowing for radioactivity recovery results to be delivered in real time. The on-site laboratory and Phase I clinical facilities offer seamless integration of services and data, he says.

    “Combined with our vast experience in delivering early-stage clinical pharmacology studies, these solutions allow clients to reach clinical proof-of-concept faster,” Bach adds.

    About Celerion

    Celerion, a global leader in early clinical research services, offers a unique combination of medical expertise, clinical operations experience, and scientific excellence that gives its clients the confidence to make fast, accurate decisions about their drug development path.

    For over fifty years, Celerion has leveraged the latest operational concepts and technologies to execute safety/tolerability, pharmacokinetic, and pharmacodynamic studies in highly controlled clinical environments. These include first-in-human dose escalation, drug-drug interaction, cardiac safety, bioequivalence and bioavailability, metabolism and excretion studies, as well as pharmacokinetic evaluations in patients with impaired renal or hepatic function. In addition, Celerion offers data management, biostatistics, clinical monitoring, and bioanalytical services. Our founding mission is to help our clients get their drugs to market quickly, so that they touch the lives of our family, friends and people in need around the world. For more information, please visit www.celerion.com.

    Media Contact:

    Michelle Maklas-Baker
    Associate Director, Global Marketing
    1.732.306.7804
    michelle.maklasbaker@celerion.com

  • Women in Leadership Spotlight: Zori Cheshmedzhieva

    Women in Leadership Spotlight: Zori Cheshmedzhieva

    Our Celerion team values the competencies and perspectives women in leadership bring to our company and our industry. Zori Cheshmedzhieva, Vice President Global Clinical Development,  shares insight on what makes a great leader.

    There is a balance good leaders strive for in today’s world. “Be strong, but not rude; be kind, but not weak; be bold, but not bully; be thoughtful, but not lazy; be humble, but not timid; be proud, but not arrogant; have humor, but without folly,” explains Zori. “This is the challenge of leadership.”

    She has learned waiting for the perfect conditions to begin something may mean you may never get anything completed. Zori advises women moving up into professional  leadership roles, “If you want something you never had, you have to do something you’ve never done!”

    As she looks for inspiration and guidance for herself, Zori is inspired by the words of Eleanor Roosevelt, “Great minds discuss ideas. Average minds discuss events. Small minds discuss people.”

    Through her professional journal, Zori has compiled words of wisdom for emerging women leaders. Among those words of wisdom, she emphasizes, “Scheduling specific times in your day or week to focus on enhancing your personal well-being – even if it means putting others on the back burner temporarily – ultimately benefits you and everyone around you.”

    She also shares knowing how to best cultivate your own personal energy allows you to ultimately give more of your best self. “Make choices that honor your own happiness and well-being, and if you can do that, you will be better equipped to make a difference in the lives of those around you.”

    Leaders address and solve challenges on a daily basis. Making individual commitments and sacrifices for the best interests of the team, or the end goals has always been a challenge. “We face people coming from different generations, cultures, and maturity. Bringing and managing to keep everyone together in a cohesive team takes a lot of energy, “ Zori acknowledges.

    Her way to overcome this challenge is to “Keep positive, keep the trust, keep away from emotions, and keep the passion – that passion coming from the daily magic we live in by delivering for clinical research worldwide!” If you are looking for an opportunity to grow professionally, make a difference in the medical and science communities, and work for a great company, apply to join the Celerion team today. https://celerion-one.jobs.net/en-US/search

  • Women in Leadership Spotlight: Michelle Combs

    Women in Leadership Spotlight: Michelle Combs

    Celerion fosters a workplace environment that welcomes diversity and strong leaders. Michelle Combs, Vice President, Data Management and Biometrics, explains great leaders are those who are driven to achieve success while exhibiting courage, integrity, hard work, a sense of gratitude, and the ability to communicate their vision in an inspiring way to their team.

    Michelle explains, “Someone once shared with me to be a successful leader, you need to ‘be someone that people want to work for’ and with that advice, I must remember, although I chose many of the people on my team, they choose to remain part of the team so my behavior must remain worthy of that choice.”

    Michelle shares that creating a strong network of people you admire and trust provides crucial support, especially for women in leadership roles. This allows you to continue to learn from others and constantly build skills to foster professional growth throughout your career. For inspiration and support, Michelle turns to her mother. “She is probably the strongest person I know.  She seems to have an endless capacity for giving of herself,  nurturing her family, and serving her community.  I am grateful for the example she has provided for me and for setting the standard to which I aspire.”

    Michelle advises the next generation of women leaders to take advantage of every opportunity to learn something new. This guides you in determining what you may or may not want to do in the future.

    With opportunities also come challenges. Often, women in leadership roles battle the feeling they are having to choose between having careers or being present for their families. Finding a flexible employer like Celerion can reduce the internal struggle. Celerion recognizes and values the importance of family.

    “I eventually realized that it is not an either/or choice. Sometimes I have to give a little more to one aspect of my life, but doing so actually helps me with the other aspects of my life, like prioritizing important events in my family’s life. Hopefully, I set a good example for my girls on how to have a great career and a great family,” explains Michelle.

    Celerion offers one of the most experienced clinical pharmacology research networks in the industry and welcomes women to pursue their dreams, be a part of change, and impact the medical community. If you are looking for an opportunity to grow professionally, make a difference in the medical and science communities, and work for a great company, apply to join the Celerion team today at https://celerion-one.jobs.net/en-US.

  • Tackling the Complexity of Complex Generic Drug Development

    Sabina Paglialunga, PhD Director, Scientific Affairs

    Generic drugs account for nearly 90% of all prescription medication filled in the US. Generic drugs are substitutes of a brand-name innovator medication, having the same (bioequivalent) active ingredients, dosage form, route of administration, safety profile and performance compared to a reference list drug (RLD). The FDA approves generic drugs through an abbreviated new drug application (ANDA) process, and has prioritized generic drug development to promote marketplace competition and make drugs more affordable. 

    As more “complex” drugs are marketed, the need to develop complex generic drugs has arisen. Over the past year, the FDA issued several key generic product guidance documents (see links below) as well as hosted workshops and webinars specifically addressing complex generic drug development. 

    Complex Generic Drugs

    Complex generic products can contain a mixture of active ingredients, peptides or polymeric compounds. They can also comprise liposome, suspension or emulsion formulations; dermatological or inhalation drugs which may be part of a drug-device combination; or possess complex dosage forms such as long-acting injectable or implantable drugs. 

    Recently approved complex generic drugs include: Glucagon injection to treat hypoglycemia (December 28, 2020); Ferumoxytol injection RLD: Feraheme for iron deficiency anemia (January 15, 2021); and Linaclotide capsules RLD: Linzess to treat IBS and chronic idiopathic constipation (February 9, 2021). 

    Recommendations for some complex generic products can be found in Product-Specific Guidance (PSG). PSGs represent the FDA’s current thinking on bioequivalence (BE) approaches for generic drug development. A PSG will cover the recommended number of studies, study design, study population, fasting conditions, analyte(s) to measure and biological matrix as well as special considerations.  Presented in early May during a PSG-focused webinar (May 5, 2021), the FDA reported that nearly 40% of recent PSGs published pertain to complex products.  Moreover, a list of planned new PSGs for complex generic products is also available.

    FDA Feedback on Complex Generic Drug Development

    The “nuts and bolts” of an ANDA submission were reviewed in April during the FDA Generic Forum (April 28-29, 2021).  Special attention was paid to the types of communication pathways available to generic drug sponsors, such as Pre-ANDA Meeting and Controlled Correspondences. Overall, a Pre-ANDA Meeting are highly encouraged for complex products, especially when no PSG exists. This is an opportunity to obtain FDA feedback on new approaches to BE studies prior to submitting an application to the agency.  Meanwhile, Controlled Correspondence are for questions related to existing PSGs or alternative proposals to PSG recommendations. 

    Bioequivalence Studies

    BE studies may have pharmacokinetic (PK) or comparative clinical endpoints. Generally, a two-period, two-sequence, two-treatment, single-dose crossover study is sufficient for typical small molecule BE studies with PK endpoints. However, parallel or fully/semi-replicate study designs may apply for compounds with a long half-life or high variability. The PSG for a clinical endpoint BE study may recommend a placebo-arm as well as specific enrollment criteria for the patient population, prohibited medications and clinical endpoints. Additional studies for complex products may also be required; for instance, adhesion, skin irritation and sensitization studies are recommended for generic adhesive patch products.

    Bioequivalence and Biosimilar Experts 

    Over the past decade, Celerion has successfully conducted over 170 BE studies with approximately one-quarter classified as complex products, including inhaled, adhesive and sublingual products. Our expert team can support complex drug development through optimized protocol design, efficient clinical conduct at our 3 clinical pharmacology units as well as regulatory support. In addition, we offer an extensive list of validated bioanalytical assays that are readily available to evaluate test and reference PK endpoints.  Furthermore, Celerion also supports biosimilar drug development and provides turnkey and bioanalytical solutions for these drug programs. Biosimilar products are generic versions of approved biological therapies such as peptides, enzymes and antibodies. 

    Lowering the Cost of Prescription Medication

    There are less costs involved in an ANDA by avoiding duplication of non-clinical and clinical studies, and these savings can be passed along to patients. The price reductions are considerable with generic prices being approximately 80-85% lower than those of the brand-name medications, which translates into billions of dollars in savings per year to the US healthcare system.  As newer drugs on the market rely on more sophisticated devices for administration, advanced formulations as well as molecular-based therapies, the field of complex generic products and biosimilars is anticipated to grow.  Working with a CRO with a strong track record in complex generic products and biosimilar drug development with world-class bioanalytical facilities is just another efficient cost-saving step in this process.   

    Links to Recent FDA Guidance Documents for Generic Drug Development 

    Upcoming PSGs for Complex Generic Drug Product Development