Our Affiliates
CDDG Affiliates are an essential part of the integrated team concept that we offer our clients. Every CDDG Affiliate is a subject matter expert in their field with extensive hands-on industry experience and all share the CDDG values. Moreover, Affiliates are covered by our Master Agreement and protected by our professional liability coverage. This means that by working with CDDG you have seamless access to a wide range of vetted experts that deliver the highest quality service. If you don’t see the expertise you’re looking for, just reach out. We have an extensive network of external consultants and strategic partners to draw on.
Research
Bill Dougall, Ph.D. has over 25 years’ experience in biotechnology drug development and academia. Previously as Scientific Director at Amgen he was Global Research Leader for denosumab (anti-RANKL antibody) in oncology, which was approved worldwide in 2010 and is registered as Xgeva® for the treatment of skeletal complications of bone metastasis and treatment of patients with giant cell tumor of bone.
Bill has experience with immunotherapy clinical trial design and broad range of drug modalities such as antagonistic and agonistic antibodies/ligands, antibody-drug conjugates (ADC), and bispecific antibodies and he led successful development of drugs representing each of these modalities at least through IND-enabling studies. Bill held a leadership role in the Therapeutic Innovation Unit at Amgen which was responsible for review and prioritization of cancer immunotherapy projects and he managed the scientific teams within the Oncology Research group responsible for development and Phase 1 testing of therapeutics including AMG 951 Apo2L/TRAIL (dulanermin), AMG 820 (anti-cFMS mAb; novel antagonist of CSF-1) and AMG 224 (an antibody-drug conjugate targeting BCMA for treatment of multiple myeloma).
Bill has been active in industry-academic collaborations throughout his career and is currently an investigator/contributor on 3 oncology clinical studies of denosumab either as monotherapy or concomitant treatment with immunotherapies. Bill is an author on 7 issued patents and over 80 scientific papers, including publications in Nature, Nature Medicine, Immunity, OncoImmunology, Nature Reviews Clinical Oncology, Cancer Immunology Research and Science Translational Medicine and has made frequent contributions to industry advisory boards or presented at international conferences.
Translational Sciences
Formulation science
Bruce Kerwin, Ph.D. has 30 years of leadership experience in industry developing drug products for biologics. He is a recognized expert in protein formulation and drug product design. During his career he has developed formulations and designed development strategies for multiple products from pre-clinical to commercial including Kineret, Aranesp and Imlygic. Bruce was formerly a Scientific Director at Amgen, VP of Drug Product Design at Just-Evotec Biologics and SVP of Process and Product Development at Umoja.
He has led numerous drug product development teams and scientific research teams developing novel solutions to formulation problems such as high viscosity, high concentration, co-formulation of proteins, protein aggregation and formulation of viruses for subcutaneous, intravenous, intrathecal intravitreal and device delivery technologies. Work on large and small volume parenteral formulations included recombinant hemoglobin, cytokines, monoclonal antibodies, antibody drug conjugates, PEGylated proteins, glycosylated and non-glycosylated proteins, oncolytic viruses and lentivirus. As an integral member of multiple product teams he has also written drug product sections for multiple regulatory documents, participated in writing FDA pre-meeting documents and in-person FDA meetings.
Bruce received his Ph.D. at the University of California at Davis followed by a Postdoctoral Fellowship at Washington State University. He has over 60 scientific publications, 14 patents and multiple invited lectures at international scientific conferences. He is currently a Scientific Advisor for Coriolis Pharma and a member of the editorial advisory board for the Journal of Pharmaceutical Science.
PKDM
Kelly Byrnes-Blake has been a pharmacokineticist supporting drug research and development for over 20 years. Kelly earned a PhD in pharmacology, with specific training in pharmacokinetics, from the University of Arkansas for Medical Sciences in 2001 where she studied antibody-based therapies for drugs of abuse. She also holds a dual bachelor’s degree in Biology and Mathematics from Western Washington University.
After obtaining her PhD, Kelly worked as an Investigator at GlaxoSmithKline in a drug discovery/lead optimization PK group where she directed preclinical PK studies and represented the group on multidisciplinary project development teams. She then worked for 10 years at ZymoGenetics, a Seattle biotech company, first as a Scientist, and later as the head of PK. In these roles she supported several protein-based therapeutic projects from early research through IND-enabling studies and into Phase 1 and 2 clinical trials. Kelly supported the development of growth factors, cytokines, as well as monoclonal antibodies and Fc-fusion proteins.
In 2011, Kelly founded Northwest PK Solutions, LLC where she works as a PK consultant in the pharmaceutical and biotech industry. Her services include designing, monitoring, and reporting of PK, PK/PD, TK, and biodistribution studies. In addition, she provides scientific expertise on issues regarding interspecies scaling and dose/regimen selection for preclinical toxicology and first-in-human studies. She helps investigate the relationship between PK and efficacy/safety biomarkers. Kelly also aids with scientific writing, contributing PK sections for patents, Investigator's Brochures, INDs, and other regulatory submissions. She is a co-author on several peer-reviewed scientific publications and abstracts. Kelly enjoys participating in the collaborative team effort needed to move drug candidates from early research towards clinical success.
Toxicology
Kirk Van Ness, PhD, DABT, has more than 20 years of drug development experience with both small molecules and biotherapeutics. He brings a strong preclinical development regulatory background in toxicology coupled with expertise in mechanistic toxicology focused on renal-, hepatic- and immunotoxicology. He is capable of designing, implementing and finalizing a broad range of nonclinical safety assessment studies for biopharmaceuticals (recombinant cytokines, mAbs, Fc-fusion proteins), small molecules, anti-sense RNA therapeutics and nanoparticle drug delivery systems.
Kirk has comprehensive knowledge of the nonclinical development regulatory requirements necessary to advance successful drug candidates through the pipeline. He has worked with small and large drug development companies to guide nonclinical study designs in support of all phases of clinical development and has assisted with FDA interactions and adherence to FDA-ICH guidelines. As an integral member of drug development teams at Amgen (and previously at Immunex), ZymoGenetics and Sarepta (formerly AVI BioPharma) he has experience working with pharmacokinetic, regulatory, clinical, research and manufacturing colleagues to ensure on time quality deliverables. Kirk is a board-certified toxicologist (Diplomate of the American Board of Toxicology) since 2009.
Dr. Marque Todd is a board-certified regulatory toxicology expert with more than 20 years of experience working in the biopharmaceutical industry. Dr. Todd has extensive experience with a variety of biologic modalities including monoclonal antibodies, bi-specific antibodies, Fc and other fusion proteins, antibody-drug conjugates, cytokines/interleukins, protein replacement therapies, nanoparticles, cell therapies, and oncolytic viruses for a variety of indications. She also has extensive nonclinical regulatory and toxicology experience in developing diverse biotherapeutic modalities and small molecules for oncology. Dr. Todd has been involved in the preparation and submission of nonclinical sections of early and late-stage regulatory documents including preINDs, INDs and BLAs/NDAs and has participated in numerous successful health authority meetings.
Dr. Todd was a Research Fellow at Pfizer and served as a Principal Scientist at Amgen and Chiron. In addition to her industry roles, Dr. Todd served as an Adjunct Professor with the University of California San Diego Extension, where she co-taught a course on nonclinical toxicology and drug development with sessions focused on the nonclinical development of biotherapeutics and oncology products.
Bioanalytics
Susan Pederson is a bioanalytical scientist with over 25 years of industry experience supporting nonclinical and clinical drug development programs for large molecule (LM) biologics. Her experience includes support of development programs for monoclonal and bispecific antibodies, antibody-drug conjugates, fusion proteins and immunoregulatory molecules. Susan earned her Bachelor of Science degree in Microbiology from the University of Washington, and began her early career developing diagnostic products that were used to screen for viruses in blood products which were critical to ensuring patient safety. In the 1990s she transitioned to biotechnology and has had a successful career across well-established pharmaceutical and biotechnology companies including ICOS Corporation, ZymoGenetics, Amgen and Alder Biopharmaceuticals.
During her career she has supported programs from early phase proof of concept studies, as well as IND enabling studies through post approval Phase IV clinical trials. Her experience covers pharmacokinetic methods, anti-drug antibody methods and neutralizing antibody assays, both cell based and ligand binding assay formats. She has a solid understanding of the FDA/EMA regulatory requirements for bioanalytical support of new drug entities, comparability studies and biosimilar programs. Across multiple programs she has addressed the complexities associated with the immunogenicity assessment required for large molecule drug development programs. Her experience is practical as well as strategic to ensure success in collecting the bioanalytical data needed to interpret drug treatment. She has actively participated in the preparation and filing of two Biological License Applications (BLA). Susan has also participated in the development and completion of an Integrated Summary of Immunogenicity (ISI) as a full data summary for inclusion within the BLA dossier. In 2015, Susan founded Bioanalytical Perspectives, LLC where she provides review, guidance and strategies to clients on the bioanalytical support they will need to support their programs from early discovery through registration.
Protein Science
November, 2024. It is with surprise and sadness that we regretfully report the sudden passing of Tom Boone. Tom exemplified the best qualities of our Affiliates and we were privileged to work with him on many projects. he will be deeply missed.
Tom Boone has more than 36 years of accomplishments in the discovery and development of protein therapeutics. Tom worked at Amgen for 28 years and served in positions of increasing responsibility in growing Amgen Protein Sciences to an organization of over 300 researchers across five different sites while maintaining a long tradition of industry excellence. His career at Amgen began in 1981 as a bench scientist with the isolation and cDNA cloning of novel cytokines and growth factors including G-CSF. He was also responsible for purifying many of Amgen’s recombinant proteins. Tom’s responsibilities grew from Scientist to Director and he developed proprietary processes used to produce recombinant G-CSF and other therapeutic candidates for clinical applications. His continuing success led to leadership of all research protein technologies, and the evolution of Protein Sciences as an independent organization.
Tom was the first Vice President of Amgen Protein Science and his teams were responsible for the majority of the current Amgen product portfolio and late stage clinical programs. Tom was the lead scientist in the development of Nplate®, a treatment of thrombocytopenia. His critical role in the discovery and process development of G-CSF (Neupogen) is widely recognized. Tom has recently helped start several companies and has helped them license in clinical stage molecules. He is also currently a consultant or scientific advisor for more than 20 companies.
Michael Wittekind, Ph.D. is founder and CEO of Olympic Protein Technologies, a protein-science focused contract research organization specializing in the engineering and expression of proteins, including antigens and antibodies. Mike formerly served as the Chief Scientific Officer and SVP of Research at ContraFect Corporation where he led the research team to build their discovery and development pipeline, including CF-301 and CF-404 for the treatment of infectious diseases.
Prior to ContraFect, Mike was the Executive Director of Research for Amgen Inc., where he directed the Protein Science Departments at the Amgen-Seattle and Amgen-Massachusetts sites leading discovery efforts for multiple protein therapeutics including antibodies, antibody-drug conjugates, bi-specifics, and protein fusions. Under his direction, over ten programs were transitioned from discovery to the preclinical and clinical stages, including brodalumab (Siliq™), brazikumab, AMG-820, tezupelumab, as well as epitope mapping studies for evolocumab (Repatha™). Prior to that he held positions at Phylos Inc. and at Bristol-Myers Squibb Pharmaceutical Research Institute, directing groups at multiple sites leading protein expression and structural biology research for protein and small molecule therapeutic efforts including atazanavir (Reyataz™/Evotaz™).
Mike received his Ph.D. in Biochemistry from the University of Wisconsin-Madison followed by postdoctoral studies at the University of Washington and is the author of over 40 peer-reviewed publications and 13 patents. Mike’s technical expertise includes molecular biology, protein expression/production/characterization, protein structure determination, and antibody and protein engineering & design incorporating protein structural insights.
Computational biology
Jonathan Derry, PhD, has over 25 years of research experience in academic, pharmaceutical and non-profit environments. He was trained in molecular genetics at the University of Cambridge, Medical Research Council UK and Stanford University and spent 14 years in the biotech/pharma industry in drug and biomarker discovery. He has carried out extensive independent research and directed large scientific teams at Amgen, Merck & Co. and Sage Bionetworks. He has been a key driver of molecular science projects and the application of system biology approaches to understanding complex diseases and has a history of collaborative relationships and building successful cross-functional teams.
Jonathan has published over 40 primary research papers including articles in Cell, Nature Genetics, and PLoS. At Sage Bionetworks he was responsible for raising multi-million dollars in funding through government grants and pharmaceutical partnerships. Jonathan prides himself on teamwork and delivery of a high-quality product.
Regulatory Experts
Mary Ellen Cosenza, PhD, DABT, ATS, RAC is a regulatory consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. Most recently, she served as the Executive Director, U.S. Regulatory Affairs, at Amgen, Inc. During her 20-year tenure at Amgen, she led the International Emerging Markets Regulatory Department and served as an Executive Director of Global Regulatory Affairs and Safety. In addition to her leadership roles in Regulatory Affairs, she also served as the Senior Director of Toxicology at Amgen. Prior to joining Amgen, she served as a Principal Scientist for the Medical Research Division of American Cyanimid Company (now Pfizer).
While at Amgen, Mary Ellen was responsible for both early- and late-stage development programs resulting in numerous successful IND, CTA, NDA, MAA, and BLA submissions in a broad variety of therapeutic areas and modalities. In addition, she played a key leadership role in preparing teams for global health authority meetings with FDA, EMA, and regional country health authorities, including several FDA Advisory Committee Meetings. Mary Ellen is also experienced in the implementation of corporate integrity agreements and review of promotional materials.
She is recognized as an expert in preclinical biologic drug development as demonstrated by her participation as a member of an Expert Working Group, operating under the auspices of the International Conference on Harmonisation (ICH), where she influenced international policy guiding the development of both biologics and traditional small molecules in the U.S., Europe, and Japan.
Mary Ellen is a Diplomat of the American Board of Toxicology, a Fellow of the Academy of Toxicological Sciences, member of the Society of Toxicology (SOT), Drug Information Association (DIA) and Regulatory Affairs Professional Society (RAPS), and holds Regulatory Affairs Certification for both the U.S. and EU. Mary Ellen has been a member of ACT since 1988, serving as an active speaker and session chair. Most notably, she developed the first Study Director Training Course in 2001 and has served as a member of the ACT Education Committee, as Councilor, and as Treasurer. Mary Ellen is a Past-President of ACT. She is also an instructor at the University of Southern California where she teaches a graduate level course on Food and Drug Toxicology.
Mary Ellen received her PhD from St. John’s University, New York, and her MS in Regulatory Science from the University of Southern California, Los Angeles.
Janet Nokleby is a board-certified toxicologist and regulatory affairs expert with over 30 years of drug development experience in multiple therapeutic areas and modalities. Janet’s career encompasses over 18 years of experience at Amgen, where she served in a variety of roles including Global Regulatory Lead, US Regulatory Lead, and Toxicologist. In addition to representing Regulatory Affairs on Amgen product teams she was a Director for the US Regulatory Affairs team with direct supervision of the US Regulatory Affairs staff. She also served as a toxicologist on multiple drug development project teams in several modalities, including small molecules, biologics, peptides, and peptibodies, and in multiple therapeutic areas.
After leaving Amgen, Janet has been a regulatory consultant providing regulatory support for small companies developing innovative investigational therapies. Janet received her BA in Biology from Augustana University and served as a US Peace Corps Volunteer in the Philippines.
Technical and Regulatory Writing
Jun Yan, Pharm.D is a regulatory medical writer with 15 years of experience in the pharmaceutical industry. She is the principal of Jun Yan Medical Writing, LLC in the Washington, DC metropolitan area.
Jun received clinical training and earned her pharmacy degree at University of Southern California, Los Angeles. She worked as a medical writer at Centocor (now Janssen Biotech) and MedImmune (now AstraZeneca) and as a Labeling Reviewer at the Food and Drug Administration. As a freelance medical writer for over 10 years, she has written and compiled many regulatory documents and manuscripts for pharmaceutical and biotechnology companies of all sizes, including Covance, Parexel, and Amgen. She has contributed to new drug applications and biologics license applications that led to product approvals. She has worked in most therapeutic areas, but her expertise is in immunology and neurology/psychiatry.
Pharmacology and Clinical Support
Clinical Pharmcology
Maurice (Maury) Emery, PharmD, PhD, has over 20 years in drug discovery and development. Maury received his BS Pharm and PharmD degrees from the University of Minnesota. Following graduation, he joined the University of Utah faculty in Pharmacy Practice for 10 years where he attained the rank of Associate Professor with an emphasis in neonatal/perinatal medicine therapeutics. After a 3-year position in the post-marketing medical department at Bristol-Myers, he returned to the University of Washington to complete a PhD degree in Pharmaceutics/Drug Metabolism focusing on the regulation of cytochrome P450 in obesity, diabetes and non-alcoholic steatohepatitis. Following his completion of the PhD program, he joined Abbott Laboratories in Chicago supporting drug discovery for 4 years working on novel mechanisms of vitamin D2 analog metabolism and novel diabetes small molecule programs.
Maury then spent 12 years at Amgen working on several small molecules and monoclonal antibodies for programs in diabetes, inflammation and oncology. Maury was the lead non-clinical ADME and clinical pharmacologist the for an anti-PCSK9 monoclonal antibody (Repatha), approved in 2014. He then spent 3 years with the Seattle Genetics Clinical Pharmacology Group working on antibody-drug conjugates for the treatment of AML, breast, cervical and urothelial cancer. He also and served as the Amgen representative to SimCYP (PBPK modeling) Consortium. After a very short retirement, he joined Esperion Therapeutics as a clinical pharmacologist completing the NDA and MAA filings for a novel lipid lowering therapy (Nexlitol) and a fixed-dose combination with ezetimibe (Nexlizet), approved Feb 2020 by the FDA.
Maury has experience across all stages of drug development in the areas of oncology, inflammation, metabolic and cardiovascular therapeutics and regulatory filing experience with the FDA, EMA, PMDA, SwissMedic, Australia, Health Canada. He is a member of the American Society of Clinical Pharmacology and Therapeutics and was appointed to their Board of Directors. He has authored over 40 peer reviewed publications and 4 book chapters. He is married with 4 daughters and enjoys a small amount of farming in addition to driving (and occasionally working on) British roadsters.
Joanna Z. Peng, PhD, has nearly 15 years of experience in Clinical Pharmacology and Pharmacometrics and has worked with multiple modalities (e.g., small molecules, peptides, monoclonal antibodies, and antibody-drug conjugates). Her broad experience also extends to several therapeutic areas, including autoimmune diseases, cancers, diabetes, cardiovascular diseases and HIV. Joanna founded Q-Q PK Consulting, LLC in 2016.
Prior to consulting, Joanna had a successful career at several well-established pharmaceutical and biotech companies, including Abbott, Merck, Amgen and Seattle Genetics. As the Clinical Pharmacology Lead for 12 programs, she was instrumental in the design, analysis, and interpretation of several types of clinical pharmacology studies, including renal, hepatic, pediatric, QT, DDI, BE/BA, SAD, and MAD, but her experience also extends to Phase 2 through Phase 4. As the Clinical Pharmacology Lead for Humira she contributed to a successful sBLA approval and her innovative population PK/PD analysis resulted in a novel dosing regimen that was approved for labeling. She also conducted PK/biomarker analyses to support a more rapid and efficient development path for AMG 557 (anti ICOSL). Joanna is able to produce key drug development reports under tight timelines, including CSRs, PK reports, PK/PD modeling reports and regulatory documents, including INDs, sBLAs, Briefing Books, Scientific Advice Requests (SARs), and Investigator Brochures. She has also attended regulatory meetings with the FDA, EMEA and MPA.
Joanna earned her PhD in pharmaceutics, specializing in PK, from Dr. Ronald Sawchuk’s lab at the University of Minnesota. Dr. Sawchuk’s thesis advisor was Dr. Tom Tozer, one of the two founding fathers of the principle of PK.
Clinical operations
Beth J. Llewellyn is the President and founder of 2L Pharma, LLC, a clinical operations consulting firm. With over 15 years of experience in the industry, Beth’s dynamic career has provided her with valuable insight into trial site and sponsor clinical operations.
As a former Clinical Research Coordinator, Beth managed trials in a wide array of therapeutic areas including HIV and Cardiovascular disease. She furthered her knowledge of the industry by assuming leadership roles in Data Management, Clinical Monitoring and Project Management. Beth was responsible for the successful execution and management of the Phase 2 program for larazotide acetate, a novel treatment for celiac disease.
This program finished with statistically significant results, allowing the product to advance to Phase 3 trials. Beth’s work in celiac disease has gained her international recognition as an expert in the indication.
Most recently Beth functioned as the Director of Global Clinical Operations for a clinical development-stage immunotherapy company focused on treating and preventing immune-mediated diseases. In this position Beth was responsible for overseeing all aspects of clinical operations both in the United States and abroad.
Beth received a B.A. in Psychology from Ohio University. Her graduate training in Experimental Psychology included studies in Research Design and Statistical Analysis. She is certified as a Clinical Research Associate by the Association of Clinical Research Professionals.
Kirsten Anderson brings more than thirty years’ clinical development experience and is an accomplished strategist with a record of delivering innovative solutions within emerging biotech companies. Recently as Chief Operating Officer of a clinical stage biotech she led clinical, regulatory and business development efforts including portfolio and IP planning. Kirsten oversaw manufacturing, supply chain operations, and drug safety initiatives, leveraging her expertise to translate vision into actionable strategies and concrete deliverables. Her strategic insights have been instrumental in identifying growth opportunities and evaluating risks to support the expansion of growing companies.
Previously, as Senior Vice President of Clinical Development at Presage Biosciences, a pioneering oncology research company, Kirsten spearheaded the regulatory strategy that secured FDA approval for a Master Protocol, optimizing company resources, and enabling a groundbreaking Phase 0 platform.
Throughout her career, Kirsten has held key leadership roles in clinical development operations at several small biotech companies developing therapeutics for oncology, rheumatology, respiratory and other rare disease indications. She has successfully led global clinical research initiatives and navigated complex regulatory landscapes to advance therapeutic innovations.
Kirsten holds a Master’s in Biotech Enterprise from Johns Hopkins University and a bachelor’s degree in Zoology from the University of Vermont.
Clinical development
Philip E Silkoff, MD is a pulmonologist and senior clinical trial physician executive with more than twenty years of experience in the pharmaceutical and medical device industry across all phases of drug and medical device programs. Dr. Silkoff’s industry career was preceded by a long and successful academic career including appointment as Associate Professor at National Jewish Health, the University of Colorado, published intellectual property in the field of exhaled nitric oxide and pulmonary hypertension, and multiple peer-reviewed articles and book chapters in the field of pulmonary medicine. Areas of focus include early and late-stage clinical development, regulatory strategy and tactics including FDA interactions, discovery and preclinical development, and assistance in the business strategy with assessment of market opportunities.
Niti Goel, MD is a board-certified rheumatologist with over 25 years of academic, preclinical to late-stage drug development, and medical affairs experience. Niti is highly knowledgeable in autoimmune, autoinflammatory, and musculoskeletal diseases, both common and rare. Niti has extensive expertise in bespoke and novel clinical trial design, recruitment, and delivery, and has had successful global regulatory interactions and approvals for biologics, cellular therapies, and small molecules. She has held senior leadership roles at TrialSpark (SVP), Abcuro (CMO), Kezar Life Sciences (CMO), and IQVIA (VP), and as well as various roles at Array BioPharma, Inc., UCB Pharma, and P&G (Procter & Gamble) Pharmaceuticals. Niti is an adjunct Assistant Professor of Medicine at Duke University School of Medicine in the Division of Rheumatology and continues to treat people with rheumatologic conditions while precepting residents and fellows. Niti received a B.S. degree from Pennsylvania State University and her M.D. degree from Jefferson Medical College of Thomas Jefferson University. She completed her internal medicine and rheumatology training at Duke University Medical Center.
Scott Baumgartner, M.D. is an accomplished medical professional, leveraging more than 30 years of experience as a clinical rheumatologist and senior executive with companies including Ardea Biosciences (a member of the AstraZeneca Group), Amgen, Inc., and Physicians Clinic of Spokane (now Providence Internal Medicine). He has led teams in global clinical development and medical affairs. Scott has interacted globally with pharmaceutical industry experts, regulatory bodies, academic and clinical experts, and payer organizations regarding drug development.
Scott joined Ardea Biosciences (a member of the AstraZeneca group) in 2011, as Executive Medical Director responsible for the development, initiation, and management of a Phase III clinical program for lesinurad in gout. He subsequently was Vice President Clinical Research & Development, where he led a 45-employee team, managing Clinical Operations, Biostatistics, and Data Management functions for that program. He most recently served as Vice President of Medical Affairs, supporting the regulatory approval, launch readiness, and payer interactions for lesinurad. As a member of the Ardea Executive Management Team, Scott was involved in long-term planning and business development to broaden the company focus. Scott left Ardea in 2016 and founded drB Consulting, LLC.
Earlier, Scott served as Medical Director, Global Clinical Development, Inflammation at Amgen, Inc. He served as Global Development Lead (GDL) for Enbrel rheumatology, where his responsibilities included developing, articulating, and executing the global development strategy for Enbrel’s rheumatologic indications. Subsequently as GDL for the Phase II development program for brodalumab, an IL-17 inhibitor with clinical trials in 4 indications, his accountabilities included protocol development and execution, strategy, and medical leadership for regulatory interactions. He had joint accountability with regulatory colleagues for the development and submission of a Pediatric Investigational Plan for four indications.
Prior to Amgen, Inc., Scott served as President of the Board and Medical Director, Clinical Research at Physicians Clinic of Spokane (now Providence Internal Medicine, owned by Providence Healthcare), where he spent two decades in private practice. In addition to providing input to business operations, he initiated and completed mergers with three practices and established a successful clinical research unit.
Scott holds board certifications in Internal Medicine and Rheumatology. He is author or co-author of numerous peer reviewed publications and abstracts. He holds an M.D. from the University of Washington School of Medicine and a B.S. in Biology from Seattle University. Scott currently resides with his wife in Spokane, Washington.
laboratory GCLP quality assurance
John Hural, PhD, brings extensive background in both preclinical and clinical vaccine research in the infectious disease and cancer immunotherapy arenas. He has served as the Associate Director for Laboratory Operations for the HIV Vaccine Trials Network (HVTN) headquartered at the Fred Hutchinson Cancer Research Center for over 14 years. Dr Hural has been responsible for coordinating all clinical trial-related laboratory activities, including oversight of immunologic and virologic endpoint monitoring. He has played key roles in protocol development, specimen management, laboratory quality assurance and fiscal management of several vaccine trials. He has extensive experience in qualification and validation of laboratory assays providing primary endpoints for clinical trials evaluating the immunogenicity and efficacy of vaccines.
Dr. Hural guided the HVTN Laboratory Program through full implementation of a comprehensive laboratory GCLP quality assurance program across four endpoint laboratories and over 30 clinical site-associated specimen processing laboratories. In addition to his role in the operational and quality aspects of HVTN trials, Dr. Hural contributes substantial scientific input toward clinical trial design and evaluation, particularly for the immunologic and virologic objectives and endpoints, including selection and prioritization of assays and analyses.
Retired Affiliates
Kathryn E. Stein, PhD is an immunologist with over 40 years of experience in biotechnology as a senior manager at the FDA and as an executive in industry. Katy has retired from consulting in 2021.
Scott Taylor is an established biotech professional with 25+ years of research and development experience with contributions that include 30+ publications, patents, and licensable software. Scott left CDDG in 2021 to pursue a new biopharma opportunity.
Jeannette Bigler, PhD has deep expertise in biomarker validation and use in clinical trial settings. She now works as a scientific writer.
Fred Ramsdell, PhD is an esteemed immunologist who co-discovered FoxP3 and helped usher in the concept of harnessing Treg biology for therapeutic impact. Most recently he served as CSO of the CAR-Treg company Sonoma Biotherapeutics.
