Meet Our Affiliates

CDDG affiliates are an essential part of the integrated team concept that we offer. Every affiliate is a subject matter expert in their field with extensive hands-on industry experience developing therapeutics 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. 


Fred Ramsdell, Ph.D., is a veteran biotechnology leader in immunology with nearly three decades of experience. He currently leads the development of collaborative research programs at the Parker Institute for Cancer Immunotherapy as Vice President of Research. 

After a fellowship at the National Institutes of Health, Dr. Ramsdell joined Immunex, studying T-cell activation and tolerance. A major part of his work included the identification and characterization of various tumor necrosis factors and their receptors, proteins that play an important role in inflammation and immunity. He later joined Darwin Molecular, which was acquired by Celltech, to establish the immunology program. His work there included important discoveries about regulatory T-cells that counteract harmful immune reactions in arthritis and other autoimmune diseases. He demonstrated that mutation in the gene now known as FOXP3, which is vital to regulatory T-cells, causes a severe congenital disease called IPEX. The Royal Swedish Academy of Sciences, which also awards the Nobel Prizes, honored Dr. Ramsdell and two other scientists in 2017 with the Crafoord Prize for their pioneering work related to regulatory T-cells and the role of the FOXP3 gene.

In 2004, Dr. Ramsdell joined ZymoGenetics, where he led teams studying novel proteins with potential regulatory activity in lymphoid cells. In 2008, Novo Nordisk brought Dr. Ramsdell on to help establish the company’s new Inflammation Research Center in Seattle and lead the immunobiology group.  Dr. Ramsdell also recently served as vice president at aTyr Pharma in San Diego and serves on several scientific advisory boards. He earned his doctoral degree in microbiology and immunology from the University of California, Los Angeles and holds a bachelor’s degree in biochemistry and cell biology from the University of California, San Diego. 

 

Kelly Byrnes-Blake has been a pharmacokineticist supporting drug research and development for over 16 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.

 

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.

 

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.

 

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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.

 

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.  

 

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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.

 

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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. 

 

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.

 

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.

 

Cindy Willis is an industry-trained research scientist with over 20 years of experience in immunology-based research, drug-development project leadership and scientific communication. Since 2014, Willis Consulting Group, LLC has provided scientific and medical writing, scientific writing instruction, and drug-development consultation for biotechnology companies, contract research organizations, research-based clinicians, and academics whose research focuses on immune-mediated disease mechanisms and oncology.

Cindy’s broad experience in large-molecule drug development, project management, and non-clinical pharmacology uniquely enables her to assist scientists with research analysis and presentation. Cindy’s research support services include: target assessment and validation (expertise with development of in vitro assays and preclinical models), due diligence, and interpretation of datasets for autoimmune, inflammatory, dermatology and immuno-oncology indications.  

Cindy helps clients communicate clearly and effectively about scientific research by facilitating production of high-quality scientific and regulatory documents within a framework of a collaborative environment. With her full-spectrum approach, Cindy can analyze and interpret raw data, and draft or edit/revise scientific and medical documents such as conference abstracts and posters, presentation slides, journal manuscripts, and regulatory documents such as IND-enabling reports. To ensure the client’s message resonates with their audience, Cindy does more than copyedit and proofread. Her comprehensive approach to organizing, restructuring, and improving readability ensures crucial results advance the science. Cindy also conducts a multi-day, on-site course to train scientists to communicate effectively and efficiently about their research. This highly-rated and proven scientific writing course has been co-taught with an academic scientific writing instructor since 2007. 

 

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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.   

 

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.  

 

Jeannette Bigler, earned a PhD in molecular biology and has over 25 years of research experience in academic and biotechnology settings. She was instrumental in the application of molecular biology tools for biomarker research in cancer prevention and epidemiological studies at Fred Hutchinson Cancer Research Center, where she founded the Molecular Epidemiology Laboratory in the Public Health Sciences Division.

For 9 years at Amgen she directed biomarker discovery and biomarker implementation in clinical trials. She worked on small and large molecule programs in the fields of oncology and inflammatory diseases. She has more than 15 years of experience working in cross-functional/interdisciplinary teams and academia/industry collaborations.

In 2016, she founded BJ Group, LLC, providing consulting services on biomarkers discovery, development, and implementation in clinical trials. Jeannette has published extensively on her work in basic research and biomarker discovery in academic and biotechnology settings.