Derek D. Poore is an accomplished scientist with extensive experience in molecular and cellular biology, drug discovery, and assay development. He has over 10 years of experience developing cellular and biochemical assays at GlaxoSmithKline. He is skilled in various screening platforms and assay technologies and is an effective communicator and collaborative team player.
Delivering More Efficient Therapeutic Protein Expression Systems Through Cell...Merck Life Sciences
Historically cell line performance has been enhanced through media, feed and process optimization, primarily through trying to meet the basic nutritional requirements of the cells so that they can sustain high growth and productivity throughout the production runs.
However, the omics (genomics, transciptomics and metabolomics) era, sequencing of the CHO genome and enhancements in genome editing technologies over the past several years have enabled scientists to take a more direct route in cell line optimization through the modification of specific genes that have direct implications on cell culture performance, protein quality attributes and upstream and downstream manufacturing processes. These targets include but are not limited to genes that may be involved in cell cycle regulation, cellular metabolism, cellular transcription and translation, the secretory pathway and protein glycosylation or other post-translational modifications.
In this webinar we will discuss specific genetic modifications that have been made to CHO cell lines and how these modifications can lead to more efficient expression systems.
Prota cs and targeted protein degradationDoriaFang
PROTACs (proteolysis targeting chimera) induced targeted protein degradation has emerged as a novel therapeutic strategy in drug development and attracted the favor of academic institutions, large pharmaceutical enterprises, and biotechnology companies. PROTACs opened a new chapter for novel drug development.
Watch the presentation of this webinar here: https://bit.ly/3ELoVzo
Understanding how your mAb behaves under various conditions is a crucial part of product characterization and quality assurance programs. Join this panel-style webinar to gain insights into key aspects of stability testing, from regulatory expectations to timeline and design considerations.
To ensure product safety and enhance understanding of product attributes, careful study of the effects of environmental conditions on your mAb is required throughout all phases of development.
Long and short-term stability studies are a critical part of a product development program and required by ICH guidelines. However, stability programs require extensive preparation and without this proper planning you may face additional hurdles.
Join our experts, Drs. Greg Pirozzi and Pamela Hamill, in a panel style discussion to learn how to proactively plan and execute a testing program to assess changes in stability that may impact product purity, potency and safety.
In this webinar, you will learn:
• Key considerations on when and how to effectively plan your stability testing program
• How to ensure the right selection of assays for your testing package
• How forced degradation/accelerated studies may fit into your overall plan, and evaluating repeat stability requirements after CMC changes
Presented by:
Greg Pirozzi, Ph.D.
Senior Project Manager, Custom Projects
Pamela Hamill, Ph.D.
Technical Consultant, Field Technology Management
Process Impurities: Don’t Let PEI or HCP Derail Your BioTherapyMerck Life Sciences
View our webinar here: https://bit.ly/2lKNdWX
Many different impurities are present in or generated during biotherapy manufacturing. This webinar will address how process contaminates can arise from raw input materials, occur as residual processing agents, or form as reaction by-products. We will review strategies within product characterization to de-risk the manufacturing process, including the use of routine and high complexity assays; and the recommended testing to meet regulatory requirements for clinical submission. Learn methods to avoid costly pitfalls and implement procedures to expedite product quality decisions at critical junctures in your development plan. We will discuss two types of therapies:
Cell & Gene Therapies
Polyethylenimine (PEI) is a transfection agent used in nearly all cell and gene therapy products. We will review the regulations and the liquid chromatography with charged aerosol detection (LC-CAD) methodology to demonstrate PEI removal during the production process.
Monoclonal Antibodies (mAb) and Cell & Gene Therapies
During mAb manufacturing and inherent to Cell & Gene Therapies, a significant proportion of process impurities arise from the host cell used to express the drug. Host cell protein (HCP) impurities, present at PPM-levels, are a major immunogenicity risk because they can elicit an unpredictable immune response in patients. We will review why their complex and diverse nature makes them challenging to monitor, and theho best practices, specifically HCP identification by mass spectrometry, for detection.
Learning points:
1. Accurate detection and characterization of residual PEI in cell and gene therapy products
2. Effective detection and characterization of residual host cell proteins (HCP) in mAbs
3. Available technology and assays for quantifying process impurities
4. Current regulatory requirements for detecting, quantifying, and removing process impurities during biotherapy manufacturing
Watch the interactive recording here: https://bit.ly/30FTDG0
The quest for a viable upstream process relies on generation of a cell line expressing the protein of interest. Unfortunately, the search for the best-producing clone is often compared with looking for a needle in a haystack. Making this more challenging is the pressure to get it right the first time, quickly and while mitigating risk and costs.
Although a lot of efforts are made on the clonal selection, there is often few to none optimization done on the expression cassette, including promoter and enhancer selection, or signal peptide. The statistical approach on how many clones should be screened to get to a good producer is often overlooked as well.
We combined a new generation of promoters and enhancers to improve strategies on pool and mini pool screening with both CHO-K1 and our own CHOZN® GS which helped deliver high-producing clones in an accelerated timeline. In addition, we are able to begin process development in parallel with cell line development, further reducing timelines.
In this webinar, you will learn:
* How the strategy approach can help reducing the overall timeline of cell line generation
* How we have expanded our platform by designing a completely new vector/cell/process template
* How we have worked on promoters, enhancers, pool/mini-pool approach as well as on timelines from DNA to clone
Delivering More Efficient Therapeutic Protein Expression Systems Through Cell...Merck Life Sciences
Historically cell line performance has been enhanced through media, feed and process optimization, primarily through trying to meet the basic nutritional requirements of the cells so that they can sustain high growth and productivity throughout the production runs.
However, the omics (genomics, transciptomics and metabolomics) era, sequencing of the CHO genome and enhancements in genome editing technologies over the past several years have enabled scientists to take a more direct route in cell line optimization through the modification of specific genes that have direct implications on cell culture performance, protein quality attributes and upstream and downstream manufacturing processes. These targets include but are not limited to genes that may be involved in cell cycle regulation, cellular metabolism, cellular transcription and translation, the secretory pathway and protein glycosylation or other post-translational modifications.
In this webinar we will discuss specific genetic modifications that have been made to CHO cell lines and how these modifications can lead to more efficient expression systems.
Prota cs and targeted protein degradationDoriaFang
PROTACs (proteolysis targeting chimera) induced targeted protein degradation has emerged as a novel therapeutic strategy in drug development and attracted the favor of academic institutions, large pharmaceutical enterprises, and biotechnology companies. PROTACs opened a new chapter for novel drug development.
Watch the presentation of this webinar here: https://bit.ly/3ELoVzo
Understanding how your mAb behaves under various conditions is a crucial part of product characterization and quality assurance programs. Join this panel-style webinar to gain insights into key aspects of stability testing, from regulatory expectations to timeline and design considerations.
To ensure product safety and enhance understanding of product attributes, careful study of the effects of environmental conditions on your mAb is required throughout all phases of development.
Long and short-term stability studies are a critical part of a product development program and required by ICH guidelines. However, stability programs require extensive preparation and without this proper planning you may face additional hurdles.
Join our experts, Drs. Greg Pirozzi and Pamela Hamill, in a panel style discussion to learn how to proactively plan and execute a testing program to assess changes in stability that may impact product purity, potency and safety.
In this webinar, you will learn:
• Key considerations on when and how to effectively plan your stability testing program
• How to ensure the right selection of assays for your testing package
• How forced degradation/accelerated studies may fit into your overall plan, and evaluating repeat stability requirements after CMC changes
Presented by:
Greg Pirozzi, Ph.D.
Senior Project Manager, Custom Projects
Pamela Hamill, Ph.D.
Technical Consultant, Field Technology Management
Process Impurities: Don’t Let PEI or HCP Derail Your BioTherapyMerck Life Sciences
View our webinar here: https://bit.ly/2lKNdWX
Many different impurities are present in or generated during biotherapy manufacturing. This webinar will address how process contaminates can arise from raw input materials, occur as residual processing agents, or form as reaction by-products. We will review strategies within product characterization to de-risk the manufacturing process, including the use of routine and high complexity assays; and the recommended testing to meet regulatory requirements for clinical submission. Learn methods to avoid costly pitfalls and implement procedures to expedite product quality decisions at critical junctures in your development plan. We will discuss two types of therapies:
Cell & Gene Therapies
Polyethylenimine (PEI) is a transfection agent used in nearly all cell and gene therapy products. We will review the regulations and the liquid chromatography with charged aerosol detection (LC-CAD) methodology to demonstrate PEI removal during the production process.
Monoclonal Antibodies (mAb) and Cell & Gene Therapies
During mAb manufacturing and inherent to Cell & Gene Therapies, a significant proportion of process impurities arise from the host cell used to express the drug. Host cell protein (HCP) impurities, present at PPM-levels, are a major immunogenicity risk because they can elicit an unpredictable immune response in patients. We will review why their complex and diverse nature makes them challenging to monitor, and theho best practices, specifically HCP identification by mass spectrometry, for detection.
Learning points:
1. Accurate detection and characterization of residual PEI in cell and gene therapy products
2. Effective detection and characterization of residual host cell proteins (HCP) in mAbs
3. Available technology and assays for quantifying process impurities
4. Current regulatory requirements for detecting, quantifying, and removing process impurities during biotherapy manufacturing
Watch the interactive recording here: https://bit.ly/30FTDG0
The quest for a viable upstream process relies on generation of a cell line expressing the protein of interest. Unfortunately, the search for the best-producing clone is often compared with looking for a needle in a haystack. Making this more challenging is the pressure to get it right the first time, quickly and while mitigating risk and costs.
Although a lot of efforts are made on the clonal selection, there is often few to none optimization done on the expression cassette, including promoter and enhancer selection, or signal peptide. The statistical approach on how many clones should be screened to get to a good producer is often overlooked as well.
We combined a new generation of promoters and enhancers to improve strategies on pool and mini pool screening with both CHO-K1 and our own CHOZN® GS which helped deliver high-producing clones in an accelerated timeline. In addition, we are able to begin process development in parallel with cell line development, further reducing timelines.
In this webinar, you will learn:
* How the strategy approach can help reducing the overall timeline of cell line generation
* How we have expanded our platform by designing a completely new vector/cell/process template
* How we have worked on promoters, enhancers, pool/mini-pool approach as well as on timelines from DNA to clone
Solubility Enhancement, Stability and Scalability of Mesoporous Silica Formul...MilliporeSigma
In these slides, you will be introduced to the science and scale-up behind mesoporous silica technology, an emerging formulation option for poorly soluble drug delivery.
Included in the slides:
- A broad overview of mesoporous silica technology
- An introduction to the unique stability advantages of mesoporous silica
- Case studies of in vitro and in vivo performance of mesoporous silica formulations
- How to scale-up from lab to production scale
Watch the webinar here: https://bit.ly/2IoV8k7
Microbial community analysis in anaerobic palm oil mill effluent (pome) waste...eSAT Journals
Microorganisms play a key role in wastewater bio-treatment processes and understanding the microbial community structure is of great importance to improve treatment performance. Denaturing gradient gel electrophoresis (DGGE) was used to monitor succession of the microbial community and thus predominant bands were sequenced to reveal the microbial community composition inside palm oil mill effluent (POME) wastewater.DNA bands from DGGE gels were excised with a sterile blade and placed in 1.5 ml eppendorf tube containing 50 μl deionized water (ddH2O). Tubes were incubated overnight at 4C to elute the DNA. Eluted DNA was purified using QIAquick gel extraction kits (QIAGEN, Inc., Valencia, CA) and was frozen and thawed three times.Microbial DNA successfully excised and purified from DGGE was amplified using polymerase chain reaction (PCR).Five micro liters of the supernatant were used as a template to re-amplify the DNA using 16s rDNA primers,341f (with no GC-clamp) (5'- cct-acg-gga-ggc-agc-ag-3') and reverse(r) primers 907r (5'-ccc-cgt-caa-ttc-att-tga-gtt-t-3'). Amplification was repeated referring to the steps in ‘PCR amplification of 16s rDNA’. PCR products from agarose gels were cut and purified using QIAquick Gel Extraction Kit (QIAGEN, Inc., Valencia, CA), which were similar to the purification steps after recovery of DNA from DGGE, and sequenced in both directions with the same primers (with no GC-clamp) as used in PCR. Moreover, start-up is an important step in establishing proper community structure in all kinds of biological treatment processes. In anaerobic POME wastewater, 6 sequences of Firmicutes, 5 sequence of Proteobacterium and 2 sequences of Bacteroidetes were found through denaturing gradient gel electrophoresis (DGGE) results. Sequence closely related to Rummeliibacillus suwonensis strain G20 was detected grows at band BE10, BE11, BE12, BE15, BE16, BE17 and BE18. Meanwhile BE25 and BE26 were found at band after treatment process done.Rummeliibacillus suwonensis is an aerobic, Gram-positive, rod shaped, round-spore-forming bacteria which were isolated from aerobic condition. Keywords: Palm oil mill effluent (POME), anaerobic POME, Denaturing gradient gel electrophoresis (DGGE), and microbial community.
Advancing Microbiome Research: From challenging samples to insight with Confi...QIAGEN
Microbiome research encompasses sample types as diverse as the human gut, Antarctic soil, ocean water and acidic hot spring biofilms. These samples are challenging because they are difficult to lyse, with some microbes containing a tough extracellular matrix. Incomplete lysis of a microbial community results in an inaccurate representation of the microbial content of the sample. Additionally, PCR inhibitors present in these samples, especially humic acids, polysaccharides, polyphenolics, lipids and heavy metals result in inaccurate quantification of nucleic acids that may inhibit downstream applications such as qPCR and NGS.
Presented here is a case study for the synthesis of two customized payload-linker complexes via the “DrugLnk” organic synthesis service. SN38 is the payload of choice and two cleavable linkers are used to formulate the SN38-linker complexes. For the protection of custom IP, the reaction conditions, catalysts, as well as solvents are omitted from the synthesis routes. https://www.creative-biolabs.com/adc/druglnk-custom-synthesis.htm
The warhead of an antibody-drug conjugate (ADC) is comprised of a cytotoxic payload drug and a molecular linker that covalently bridges the antibody and the payload. SN38 is the ADC payload of choice and two cleavable linkers are used to formulate the SN38-linker complexes. For the protection of custom IP, the reaction conditions, catalysts, as well as solvents are omitted from the synthesis routes. https://www.creative-biolabs.com/adc/drug-module.htm
ADC Case Study-Custom Synthesis of ADC Linker-payload SETbiolabs-marketing
Presented here is a case study for the synthesis of two customized payload-linker complexes via the "DrugLnk" organic synthesis service. SN38 is the payload of choice and two cleavable ADC linkers are used to formulate the SN38-linker complexes. For the protection of custom IP, the reaction conditions, catalysts, as well as solvents are omitted from the synthesis routes.
See the Whole Picture: Using SV-AUC for Empty/Full AAV Capsid AnalysisMilliporeSigma
Watch this webinar here: https://bit.ly/31ZZM3n
Join this webinar for key insights on using the SV-AUC assay for empty/full analysis of your AAV viral vector. We’ll cover the technical requirements for this assay, data interpretation, and finally how this assay fits into the larger picture of AAV characterization.
Recombinant adeno-associated viruses (AAV) are widely used as gene transfer vectors. However, AAV production generates mixed populations of viral capsids containing either complete viral vector genome (full capsids); partially filled, and those lacking the viral genome (empty capsids). Sedimentation Velocity Analytical Ultracentrifugation (SV-AUC) offers a robust, accurate, and consistent method for characterizing empty/full AAV capsid composition. In this webinar we will review the key technical requirements for performing an AUC assay as well as analysis and data interpretation of the results generated.
In this webinar, you will learn:
• Regulatory expectations for empty/full analysis
• Key technical requirements for running an AUC assay and how to interpret the data from the results generated
• How the AUC assay fits into the larger picture of AAV characterization
Webinar: Benefits of Monodisperse Activated PEGs in ADC DevelopmentMilliporeSigma
Watch the webinar here: http://bit.ly/PEGsWebinar
As the field of antibody-drug conjugation chemistry has advanced, the use of linkers to impart "drugability" has also been growing. Recent literature shows a variety of linear and branched monodisperse PEGs being called on to modify the PK/PD profile of some of the most active but lipophilic payloads. In this webinar, we will survey the types of PEGs that are used in ADCs and give examples of successful implementation to change the biophysical properties of the construct. In addition, we will focus on PEGs and why activated PEGs are widely used to improve the pharmacokinetics of drugs (such as pegylated proteins, peptides etc.). Raw materials used in this field may have a variety of polydispersity. However, when it comes to the use of activated PEGs as linkers for ADCs, the requirements are significantly higher. Therefore, the choice and control of the PEG linker is crucial for the successful development and accelerated time to market for your ADC.
This webinar addresses critical success factors such as:
• Survey of current PEG enhanced ADCs
• Why PEGs are used designing ADCs
• Critical parameters for aPEGs used as linkers
• Requirements in terms of analytical capabilities
Straight to the Point: Reaching Clinical Stage Development with a CHOZN® Cell...MilliporeSigma
Participate in the interactive webinar: http://bit.ly/CHOZNWebinar
In this case study, we will present how we support our clients thanks to advantages provided by the CHOZN® Cell Line, and a specific strategy for clone selection where semi-automation and pool selection are leveraged, to get upstream right first time.
Explore our webinar library: www.emdmillipore.com/webinars
Integration of Cell Line and Process Development to Expedite Delivery of Bisp...KBI Biopharma
Authored and Presented by: Dane A. Grismer, Yogender K. Gowtham, Srivatsan Gopalakrishnan, David. W. Chang,
Niket Bubna, Ph.D., and Sigma S. Mostafa, Ph.D.
Solubility Enhancement, Stability and Scalability of Mesoporous Silica Formul...MilliporeSigma
In these slides, you will be introduced to the science and scale-up behind mesoporous silica technology, an emerging formulation option for poorly soluble drug delivery.
Included in the slides:
- A broad overview of mesoporous silica technology
- An introduction to the unique stability advantages of mesoporous silica
- Case studies of in vitro and in vivo performance of mesoporous silica formulations
- How to scale-up from lab to production scale
Watch the webinar here: https://bit.ly/2IoV8k7
Microbial community analysis in anaerobic palm oil mill effluent (pome) waste...eSAT Journals
Microorganisms play a key role in wastewater bio-treatment processes and understanding the microbial community structure is of great importance to improve treatment performance. Denaturing gradient gel electrophoresis (DGGE) was used to monitor succession of the microbial community and thus predominant bands were sequenced to reveal the microbial community composition inside palm oil mill effluent (POME) wastewater.DNA bands from DGGE gels were excised with a sterile blade and placed in 1.5 ml eppendorf tube containing 50 μl deionized water (ddH2O). Tubes were incubated overnight at 4C to elute the DNA. Eluted DNA was purified using QIAquick gel extraction kits (QIAGEN, Inc., Valencia, CA) and was frozen and thawed three times.Microbial DNA successfully excised and purified from DGGE was amplified using polymerase chain reaction (PCR).Five micro liters of the supernatant were used as a template to re-amplify the DNA using 16s rDNA primers,341f (with no GC-clamp) (5'- cct-acg-gga-ggc-agc-ag-3') and reverse(r) primers 907r (5'-ccc-cgt-caa-ttc-att-tga-gtt-t-3'). Amplification was repeated referring to the steps in ‘PCR amplification of 16s rDNA’. PCR products from agarose gels were cut and purified using QIAquick Gel Extraction Kit (QIAGEN, Inc., Valencia, CA), which were similar to the purification steps after recovery of DNA from DGGE, and sequenced in both directions with the same primers (with no GC-clamp) as used in PCR. Moreover, start-up is an important step in establishing proper community structure in all kinds of biological treatment processes. In anaerobic POME wastewater, 6 sequences of Firmicutes, 5 sequence of Proteobacterium and 2 sequences of Bacteroidetes were found through denaturing gradient gel electrophoresis (DGGE) results. Sequence closely related to Rummeliibacillus suwonensis strain G20 was detected grows at band BE10, BE11, BE12, BE15, BE16, BE17 and BE18. Meanwhile BE25 and BE26 were found at band after treatment process done.Rummeliibacillus suwonensis is an aerobic, Gram-positive, rod shaped, round-spore-forming bacteria which were isolated from aerobic condition. Keywords: Palm oil mill effluent (POME), anaerobic POME, Denaturing gradient gel electrophoresis (DGGE), and microbial community.
Advancing Microbiome Research: From challenging samples to insight with Confi...QIAGEN
Microbiome research encompasses sample types as diverse as the human gut, Antarctic soil, ocean water and acidic hot spring biofilms. These samples are challenging because they are difficult to lyse, with some microbes containing a tough extracellular matrix. Incomplete lysis of a microbial community results in an inaccurate representation of the microbial content of the sample. Additionally, PCR inhibitors present in these samples, especially humic acids, polysaccharides, polyphenolics, lipids and heavy metals result in inaccurate quantification of nucleic acids that may inhibit downstream applications such as qPCR and NGS.
Presented here is a case study for the synthesis of two customized payload-linker complexes via the “DrugLnk” organic synthesis service. SN38 is the payload of choice and two cleavable linkers are used to formulate the SN38-linker complexes. For the protection of custom IP, the reaction conditions, catalysts, as well as solvents are omitted from the synthesis routes. https://www.creative-biolabs.com/adc/druglnk-custom-synthesis.htm
The warhead of an antibody-drug conjugate (ADC) is comprised of a cytotoxic payload drug and a molecular linker that covalently bridges the antibody and the payload. SN38 is the ADC payload of choice and two cleavable linkers are used to formulate the SN38-linker complexes. For the protection of custom IP, the reaction conditions, catalysts, as well as solvents are omitted from the synthesis routes. https://www.creative-biolabs.com/adc/drug-module.htm
ADC Case Study-Custom Synthesis of ADC Linker-payload SETbiolabs-marketing
Presented here is a case study for the synthesis of two customized payload-linker complexes via the "DrugLnk" organic synthesis service. SN38 is the payload of choice and two cleavable ADC linkers are used to formulate the SN38-linker complexes. For the protection of custom IP, the reaction conditions, catalysts, as well as solvents are omitted from the synthesis routes.
See the Whole Picture: Using SV-AUC for Empty/Full AAV Capsid AnalysisMilliporeSigma
Watch this webinar here: https://bit.ly/31ZZM3n
Join this webinar for key insights on using the SV-AUC assay for empty/full analysis of your AAV viral vector. We’ll cover the technical requirements for this assay, data interpretation, and finally how this assay fits into the larger picture of AAV characterization.
Recombinant adeno-associated viruses (AAV) are widely used as gene transfer vectors. However, AAV production generates mixed populations of viral capsids containing either complete viral vector genome (full capsids); partially filled, and those lacking the viral genome (empty capsids). Sedimentation Velocity Analytical Ultracentrifugation (SV-AUC) offers a robust, accurate, and consistent method for characterizing empty/full AAV capsid composition. In this webinar we will review the key technical requirements for performing an AUC assay as well as analysis and data interpretation of the results generated.
In this webinar, you will learn:
• Regulatory expectations for empty/full analysis
• Key technical requirements for running an AUC assay and how to interpret the data from the results generated
• How the AUC assay fits into the larger picture of AAV characterization
Webinar: Benefits of Monodisperse Activated PEGs in ADC DevelopmentMilliporeSigma
Watch the webinar here: http://bit.ly/PEGsWebinar
As the field of antibody-drug conjugation chemistry has advanced, the use of linkers to impart "drugability" has also been growing. Recent literature shows a variety of linear and branched monodisperse PEGs being called on to modify the PK/PD profile of some of the most active but lipophilic payloads. In this webinar, we will survey the types of PEGs that are used in ADCs and give examples of successful implementation to change the biophysical properties of the construct. In addition, we will focus on PEGs and why activated PEGs are widely used to improve the pharmacokinetics of drugs (such as pegylated proteins, peptides etc.). Raw materials used in this field may have a variety of polydispersity. However, when it comes to the use of activated PEGs as linkers for ADCs, the requirements are significantly higher. Therefore, the choice and control of the PEG linker is crucial for the successful development and accelerated time to market for your ADC.
This webinar addresses critical success factors such as:
• Survey of current PEG enhanced ADCs
• Why PEGs are used designing ADCs
• Critical parameters for aPEGs used as linkers
• Requirements in terms of analytical capabilities
Straight to the Point: Reaching Clinical Stage Development with a CHOZN® Cell...MilliporeSigma
Participate in the interactive webinar: http://bit.ly/CHOZNWebinar
In this case study, we will present how we support our clients thanks to advantages provided by the CHOZN® Cell Line, and a specific strategy for clone selection where semi-automation and pool selection are leveraged, to get upstream right first time.
Explore our webinar library: www.emdmillipore.com/webinars
Integration of Cell Line and Process Development to Expedite Delivery of Bisp...KBI Biopharma
Authored and Presented by: Dane A. Grismer, Yogender K. Gowtham, Srivatsan Gopalakrishnan, David. W. Chang,
Niket Bubna, Ph.D., and Sigma S. Mostafa, Ph.D.
Current CV .
My objective is to obtain a rewarding and challenging research scientist position where my background and experience will contribute to the success of a growing company or research center.
Currently, I am a Senior Associate Scientist at Amgen Inc. and certified Molecular Biologist with the American Society of Clinical Pathology MB (ASCP). I have more than 10 years of experience in the biotechnology/ pharmaceutical industry. I am highly proficient in various lab techniques, technologies, and automation. I demonstrated consistent success in the execution of assay development and method validation activities supporting clinical stage programs within GCP and GLP regulated environments. I possess extensive experience in optimization and validation of drug potency assays (ELISA and cell based assays), protein purification and characterization, and DNA/RNA extraction and quantitation. I am a subject matter expertise in the areas of human and rodent cell lines propagation and tissue dis-aggregation. I have proven operational capabilities in the establishment of standard operating procedures to ensure our laboratory meets regulatory and business requirements.
I am a self-motivated professional who works effectively as an individual contributor or within a team matrix. As a quick learner, I can efficiently deliver results, easily adapt to changing environment and provide fresh ideas. My strengths include statistical analysis/guidance, report writing, and communication.
Thank you in advance for your consideration. Please feel free to call me at (805-990-6258), or by e-mail at (mahawally46@gmail.com) if you have questions or would like a list of references.
Sincerely,
Maha Rizk
1. Derek D. Poore
107 Crestwood Court | Douglassville, PA 19518 | 717-449-9520 | pooreder@hotmail.com
Summary
Accomplished and highly talented scientist with extensive experience in molecular and cellular biology and early drug discovery.
Keen understanding of cellular models, various screening platforms and assay technologies. Dedicated team player committed
to managing projects impeccably while contributing to team programs and company goals. Effective communicator who easily
interfaces and collaborates with colleagues and external collaborators. A versatile and dependable professional who can adapt
to new technologies and disciplines.
Areas of Expertise
Cellular and biochemical medium and high throughput
compound screening
Cellular and biochemical mechanism of action assays
Phenotypic cellular assay compound screening
Cellular assay formats (MSD, LanthaScreen, TR-FRET,
HTRF, ELISA, reporter, proliferation and ALPHALISA)
Biochemical assay formats (TR-FRET, HTRF, FP, and
FLINT, DELFIA)
Cell culture (primary cells such as PBMCs, stable,
transfected and transduced cell lines)
Receptor radioligand binding assays
GPCR functional screening assays (EIA, SPA and
FlashPlate)
Parallel Artificial Membrane Permeability Assay (PAMPA)
compound screens
Western blot analysis
Protein expression and purification
HPLC compound separation
Molecular techniques (gel electrophoresis, PCR, DNA
isolation, cloning and sequencing)
Automated liquid handling systems (Echo, Bravo, Quadra
96 and Biomek 2000/FX)
Plate readers (MSD, Pherastar, Envision and ViewLux)
Upload data to internal databases and maintain relevant
internal databases (Abase and KATE)
Computer skills: MS Excel, MS Power Point, MS Word,
MS Access, Windows, Spotifre, Prism GraphPad,
SigmaPlot, OR&M, Helium and literature search
(PubMed)
Professional and Academic Honors
GSK Silver R&D Recognition Award for contributions to immuno-oncology program in development of human PBMC assays
that enabled candidate selection of the program, 2014.
GSK Bronze R&D Recognition Award for development cellular functional assays in human PBMC’s support to Sirt1
program, 2014.
GSK Silver R&D Recognition Award for championing key ideas, innovative and creative experimentation on developing key
cellular assays for biosynthetic chemistry project, 2012.
GSK Silver R&D Recognition Award for development of high throughput cellular mechanistic assay that demonstrated
compound cell permeability and potent inhibitors for immuno-inflammation program, 2011.
GSK Exceptional Science Award for outstanding and instrumental contributions to generation of Nrf-Keap1 and Cul3-Keap1
TR-FRET, two key assay which helped establish Nrf2 program, 2010.
GSK Bronze R&D Recognition Award for development and implication of key biochemical assays (FP & TR-FRET) for hit
triage and MOA studies of Nrf2-Keap1 interactions, 2010.
GSK Bronze R&D Recognition Award for contributing to DELFIA cellular assay development for cardiac heart failure
program, 2009.
GSK Bronze R&D Recognition Award for development of robust 1536 cellular based assay for NOD1 program, 2009.
GSK Bronze R&D Recognition Award for efforts in development of LDHA cellular assay, 2009.
GSK Bronze R&D Recognition Award for significant impact on kinase program by developing a sensitive and robust DNA-
PK LanthaScreen assay, 2008.
2. Virginia Military Institute Post-Graduate Education Scholarship, Virginia Military Institute, 2001
Young Scientist Travel Fellows, 27th Meeting of the Federation of European Biochemical Societies, 2001
Tharp Travel Award (given to outstanding graduate student presenting at a meeting), University of South Florida, 2001
American Society for Biochemistry and Molecular Biology Graduate/Postdoctoral Travel Award
ASBMB/ASPET Joint Meeting, 2000
Tharp Travel Award (given to outstanding graduate student presenting at a meeting),University of South Florida, 2000
Professional Experience
GlaxoSmithKline
Collegeville, PA
Senior Scientist
2010-Present
Provided assay and screening strategies for a phosphatase program, including developing multiple cellular based assays
and MOA studies
Instrumental in establishing high throughput cellular assays in measuring cytokines in primary cells such as PBMCs which
helped drive various programs and solve critical questions about compounds
Provided scientific input and strategic guidance to phosphatase and immuno-inflammation programs which guided
programs’ chemistry efforts
Lead and directed corroborations efforts with analytical chemistry group on cellular based Rapidfire assay for immuno-
oncology program
Trained colleagues on isolation of immune cells from whole blood and developing cell based flow cytometry assay for
immuno-oncology program
Supervised a co-op worker in cell culture techniques and cellular based assay development
Elected as a PTS reviewer for GSK Discovery Fast Track academia proposals
Development of disease-relevant cell based assay for immuno-oncology program that enabled candidate selection of the
program
Instrumental in the development of a vitamin D sensor cell based assay that guided the efforts of a biosynthetic chemistry
project
Championed Keap1 high throughput mutagenesis project for respiratory stress repair program which established new
molecular biology and purification techniques in for high throughput mutagenesis
Supported and developed array of Nrf2 biochemical assays (TR-FRET & FP) that were instrumental in the selection of
candidate molecules of Nrf2 program for stress and repair DPU in respiratory therapeutic area
Evaluation and development of a cell based GFP LanthaScreen assay using customized neoepitope antibody for DELFIA
assay which established compound permeability and cellular potency
Scientist
2007-2009
Instrumental in setting up human PBMC screening assays in the department for hit identification
Developed a sensitive DNA-dependent protein kinase (DNA-PK) Lanthascreen assay that provided timely and critical
compound data for kinase program
Successfully developed a high throughput cellular luciferase gene reporter assay for cardiovascular program
Instrumental in evaluating and implementing new assay technologies such as AlphaLISA and Lanthascreen in the
department
Developed immuno-inflammatory cellular assay for the detection of the inhibition of NOD1 protein by measuring IL8 levels
Developed oncology cellular assay for the detection of the inhibition of LDHA enzyme by measuring pyruvate levels through
enzymatic coupling assay that was critical for supporting hit triage following biochemical HTS
Palatin Technologies
Cranbury, NJ
Associate Scientist
2006-2007
Developed assays to characterize drug-receptor interactions and mechanism of action that key for compound progression
Developed MAP Kinase western blot analysis to screen obesity lead compounds for MAP Kinase activity
Developed radioligand binding assays for atrial natriuretic peptide receptors
3. Characterized species selectivity of lead compounds by developing cellular functional assays for cardiac heart failure program.
Quantified cGMP levels in animal plasma for cardiac heart failure program
Presented data at weekly group meetings and journal club meetings
Senior Research Associate
2004-2006
Melanocortin receptor drug screening and assay development for obesity, cachexia and sexual dysfunction programs through
radioligand binding assays
Melanocortin receptor drug screening and assay development for obesity, cachexia and sexual dysfunction programs through
receptor cellular functional assays (HTRF, ELISA and Flash Plates)
Developed, validated and performed radioligand binding assays to screen compounds against dopamine receptors
Developed PAMPA assay to determine permeability of obesity lead compounds through various phospholipid layers
Looked at displacement of 125I NDP-MSH against obesity compounds in rat brain through autoradiography
Maintain obesity melanocortin compound functional screening database that included data from both low and high receptor density
levels
Presentation of data at weekly group meetings
Research Associate
2002-2004
Developed, validated and performed radioligand binding assays to screen compounds against melanocortin, bombesin and
calcitonin gene-related peptide receptors
Quantified Bremelanotide (erectile dysfunction drug) levels in animal plasma through RIA and SPA for erectile dysfunction program
Presented data at weekly group meetings
University of South Florida Department of Chemistry
Tampa, FL
Research Assistant
1999 – 2002
Purified enzyme, acyl-CoA:glycine N-acyltransferase from bovine liver
Cloned, expressed and purified recombinant enzyme, acyl-CoA:glycine N-acyltransferase
Developed reversed phase HP liquid chromatography to monitor conversion of N-fatty acylglycines to primary fatty acid
amides by peptidylglycine-alpha-amidating monooxygenase
Teaching Assistant
1999 - 2002
Taught Basic Biochemistry lab, Organic Chemistry I, General Chemistry I and II labs to undergraduate college students
Duquesne University Department of Chemistry
Pittsburgh, PA*
Research Assistant
1998 - 1999
*Left graduate program at Duquesne University when mentor took a faculty position at USF
Developed reversed phase HP liquid chromatography separation protocols for the separation of N-fatty acylglycines and
primary fatty acid amides
Learned various molecular biology techniques when studying the mechanism of transposons
Teaching Assistant
1998 - 1999
Taught Organic Chemistry I and II labs to undergraduate college students.
Virginia Military Institute Department of Chemistry
Lexington, VA
4. Undergraduate Research Intern
Summer 1997
In vitro and in vivo chemo-attraction of cell populations in response to different chemo tactic agents imbedded in an alginate
matrix implanted into bone wound sites
University of North Texas Health Science Center
Fort Worth, TX
Undergraduate Research Intern
Summer 1997
Examined the role of fetuin in retinal development
Academic Qualifications
Master of Science
July 2002
University of South Florida, Tampa, FL
Concentration: Biochemistry
Bachelor of Science
May 1998
Virginia Military Institute, Lexington, VA
Concentration: Biology with chemistry minor
Oral Presentations
Derek D. Poore. Cellular HTRF Based High Throughput Screening: Parameters To Identify Quality Hits. Oral presentation at 6th
Cisbio HTRF Symposium, Brewster, MA, September 14-17, 2015.
Publications
1. Rickard DJ, Sehon CA, Kasparcova V, Kallal LA, Haile PA, Zeng X, Montoute MN, Poore DD, Li H, Wu Z, Eidam PM,
Emery JG, Marquis RW, Gough PJ, Bertin J. (2014) Identification of selective small molecule inhibitors of the
nucleotide-binding oligomerization domain 1 (NOD1) signaling pathway. PLoS One. May 7;9(5).
2. Rickard DJ, Sehon CA, Kasparcova V, Kallal LA, Zeng X, Montoute MN, Chordia T, Poore DD, Li H, Wu Z, Eidam PM,
Haile PA, Yu J, Emery JG, Marquis RW, Gough PJ, Bertin J. (2013) Identification of benzimidazole diamides as
selective inhibitors of the nucleotide-binding oligomerization domain 2 (NOD2) signaling pathway. PLoS One. Aug
1;8(8).
3. Carpenter T, Poore DD, Gee AJ, Deshpande P, Merkler DJ and Johnson ME. (2004) Use of reversed phase HP liquid
chromatography to assay conversion of N-acylglycines to primary fatty acid amides by peptidylglycine-alpha-amidating
monooxygenase. J Chromatogr B Analyt Technol Biomed Life Sci. 809(1): 15-21.
4. Miller LA, Baumgart LE, Chew GH, deLong MA, Galloway LC, Jung KW, Merkler KA, Nagle AS, Poore DD, Yoon CH,
Merkler DJ. (2003) Glutathione, S-substituted glutathiones, and leukotriene C4 as substrates for peptidylglycine alpha-
amidating monooxygenase. Arch Biochem Biophys. 412(1): 3-12.
5. Poore, D.D., Merkler, K.A. and Merkler, D.J. (2001) Cloning, expression and purification of bovine liver acyl-coa:
glycine N-acyltransferase in E. coli strain BL21(DE)pLysS. European Journal of Biochemistry. 268 (1),166.
6. Poore, D.D., Aycock, H., Gee, A.J., Johnson, M.E. and Merkler, D.J. (2000) Reverse-phase HPLC separations on N-
acylglycines & acylamides. FASEB Journal. 14 (8), 618.
Poster Presentations
1. Hongwei Qi, Derek D. Poore , Wangfang Hou, Thomas D. Sweitzer, Sharon Sweitzer, Robert S. Ames and Hu Li.
Expression, Purification and Validation of Keap1 protein using Keap1/Nrf2 TR-FRET Assay. Poster pesented to Society of
Biomolecular Sciences 14th Annual Conference & Exhibition, Orlando, FL, March 27-31, 2011.
5. 2. Derek D. Poore, Hongwei W. Qi, Matthew V. Will, Wangfang Hou, Thau Ho, Robert S. Ames and Hu Li. Development of
Keap1/Nrf2 and Keap1/Cul3 TR-FRET assays. Poster pesented to Society of Biomolecular Sciences 14th Annual
Conference & Exhibition, St. Louis, MO, April 7-11, 2008.
3. J. Michael Padron, R.J. Setters, G.W. Herbert, A.A. Hause, Y. Shi, P. Purma, Z. Wu, B. Hu, R. Rajpurohit, Shobha E.
Senadhi, D. Poore, U. Mirshahi, A.M. Shadiack, S.D. Sharma, and K.D. Burris, Novel small Melanocortin-4-Receptor
Agonist decreases feeding and body weight without aversive effects, illness or erectile activity. Poster presented to North
American Society for the Study of Obesity (NAASO) Meeting, Las Vegas, NV, November 14-18,2004.
4. Robert Setters, J. Michael Padron, Yi-Qun Shi, Papireddy Purma Zhijun Wu, Annette M. Shadiack, Ramesh Rajpurohit,
Shobha Senadhi, Derek Poore, Uyenlinh Mirshahi, Shubh D. Sharma and Kevin D. Burris. Regulation of food intake by
MCR4 agonists. Poster presented to Neuroendocrinology of Energy Balance and Obesity Seminar, Washington, D.C, 2004.
5. Poore, D.D., Merkler, K.A. and Merkler, D.J. (2001) Cloning, expression and purification of bovine liver acyl-coa: glycine N-
acyltransferase in E. coli strain BL21(DE)pLysS. Poster presented to 27th Meeting of the Federation of European
Biochemical Societies, Lisbon, Portugal, June 30-July 5, 2001.
6. Poore, D.D., Aycock, H., Gee, A.J., Johnson, M.E. and Merkler, D.J. Reverse-Phase HPLC Separations on N-Acylglycines
& Acylamides. Poster presented to American Society for Biochemistry and Molecular Biology/ASPET 2000 Meeting, Boston,
MA, June 4-8, 2000.
7. Poore, D.D., Aycock, H., Gee, A.J., Johnson, M.E. and Merkler, D.J. RP-HPLC Separations of Peptidylglycine Alpha-
Amidating Monooxygenase Substrates. Poster presented to Florida Annual Meeting and Exposition, Florida Section
American Chemical Society, Orlando, FL, May 12-13, 2000.
8. Poore, D.D., Gee, A.J., Johnson, M.E., and Merkler, D.J. HPLC Separations of Fatty Acids, N-Acylglycines and Acylamides.
Poster presented to 31ST Central Regional Meeting of the American Chemical Society, Columbus, OH, June 21-23, 1999.
Scientific Meetings Attended
American Association for Cancer Research 102nd Annual Meeting, Orlando, FL, April 2-6, 2011.
Life Science Regional Technology Symposium, Iselin, NJ, September 15-16, 2009.
Society for Biomolecular Sciences Cell-Based Assays: Innovations in Reagents,Technologies, and Screening Symposium,
King of Prussia, PA, October 22-24, 2008.
Geisinger G Protein Coupled Receptor Signaling: Bench to Bedside Meeting, Danville, PA, September 21, 2007.