“We came to the CDDG consulting group with questions around a mechanistic understanding of toxicity findings, and were very pleased with the thoughtful and thorough assessment provided in the form of an organized report that included a set of hypotheses and suggested experiments to address these. Together, Dirk, Wayne, Eric and Kirk offer an impressive breadth and depth of knowledge, particularly in the field of immunobiology and applications to drug development issues.”

-Rebecca Ericsson, PhD DABT

Principal Scientist - Toxicologist, Denali Therapeutics

“As a new company, we engaged CDDG for support with several programs involving both early stage research projects as well as projects nearing clinical development.  Working primarily with Dirk, Eric and Kirk, CDDG has provided (and continues to provide) extremely valuable support to Sonoma’s programs.  This includes project management as well as biological, toxicological, PK/PD and mechanistic support for various programs.  Importantly, the project management component exceeded the ‘routine’ management function - for example, they were a fantastic partner in developing the overall program and helped shape and deliver the program on time and with the data we needed.  The extensive and broad network has also allowed us to extend our relationship to PK, PD and toxicology support and keep our programs on-track.  We’ve gotten fantastic support and the existing relationships within CDDG have facilitated the interactions at each stage, providing a ‘full-service’ experience for Sonoma.  Overall, the structure, but more importantly, the experience of the CDDG consortia, has been a valuable asset to SonomaBio.”

-Fred Ramsdell, PhD

Chief Scientific Officer, Sonoma Biotherapeutics

“CDDG has a wealth of knowledge and experience. You can feel that once you talk with Dirk Smith, Wayne Tsuji, and Eric Butz. They have been very resourceful in evaluating our existing program and helpful in determining our path forward. I would absolutely recommend CDDG, but I would prefer our competitors did not know ! ”

-Robert Yu

CEO, Yuyu Pharma

“Wayne’s contributions are remarkable across multiple fronts.  First his knowledge of clinical development and the types of clinical endpoints one should be considering in the design of studies were injected into our discussions right out the gates.  Wayne also linked the different options to a translational piece making the discussions and his input very valuable when building a business case for our approach.”

-Laurent Audoly, PhD.

Founder & BOD member Ermium Therapeutics

“CDDG has helped us further evaluate the characteristics of our new product and broaden the rationale and possibilities for therapeutic applications. In support of a biotech company created by a VC based on academia seeds, the CDDG team is very effective at managing CROs for us to generate new data and help build our development strategy. We really appreciate Dirk and Bill’s professional support with their leadership and commitment, which have been important to drive the project forward cohesively as one team.”

-Taka Koda

Partner, Remiges Ventures and President Aqross Therapeutics, Inc.

“The consulting advisors at Cascadia Drug Development Group (CDDG) have been instrumental in helping us get our first IND pulled together and filed.  We are a small startup with a promising biologic drug candidate that we have taken on our own through what we understood to be the critical preclinical molecular characterizations, animal safety studies, stability and PK studies.  We believed we needed consulting help pulling all of it together for our first IND filing.  The CDDG group took our early drafts of IND document sections, did gap analyses, wrote or co-wrote needed gap sections, and project-managed the entire pre-IND process, including writing, integrating, editing, advising on clinical study design, advising on regulatory approaches, and hiring regulatory filing partners. Importantly, they also drafted a much-improved phase 1 and phase 2 study design that will accelerate our program’s clinical proof of concept.  We have been hugely helped through this process through their expertise and process management and plan to partner with them in future programs.

-Don Foster, PhD

CSO, Orphanon, Inc. (US Affiliate of Prosit Sole Biotechnology)

"CDDG has helped us to refine and execute a biomarker plan in support of an upcoming phase 2 clinical study. To do this, their subject matter experts drew from their knowledge of the pathway biology, as well as their extensive experience researching and developing therapeutics in the indication space. The team was able to pull in specific CDDG experts to help with work streams such as genetics, bioinformatics and inmmuno-phenotyping, so as to leverage cutting edge biomarker methodologies. All work and interactions have been coordinated by the CDDG Lead and communication has been open and easy. Engaging with CDDG has been a valuable component of our efforts to rapidly expand our organization, and cost-effectively expand our pipeline." 

-Gregory Opiteck, PhD

Executive Director, Early Clinical Development & Precision Medicine. Gossamer Bio

“The Cascadia group has had a tremendous impact on both the business and scientific strategy for our new company in the field of inflammasome research.  At the highest level, they understand what information and decisions are needed to make investments into drug discovery programs.  They have broad expertise that spans immunology, small and large molecule drug discovery and development as well as the understanding of preclinical and clinical successes and failures over the last 2 decades.  Their collective expertise has helped guide not only our programs, but our company.  At the end of the day, where they really shine is on execution and the science: they are experienced, pay great attention to detail and are hypothesis- and data-driven.  They are always asking the right questions and seeking answers using robust data sets.  Finally, they are a pleasure to work with: very bright, very collegial, always prepared and looking for optimal ways to advance in the best interest for patients and the company.”

-Kevin Sprott, PhD

SVP, Drug Discovery, SMOC Therapeutics

“CDDG principals provided Celimmune with excellent consulting in a range of areas: biomarker design, implementation and analysis; medical monitoring and safety assessment; immunologic data interpretation and reporting. I can highly recommend CDDG for their Immunology drug development expertise”. 

-Francisco Leon, MD PhD

former CEO/CMO, Celimmune LLC CSO & Co-Founder, Provention Bio

“Dirk (the lead CDDG consultant) has played an important role in supporting Digestome as the company has advanced from lead selection to clinical study. By serving as Research Lead, Dirk has been instrumental in advancing the core biology and pharmacology of the lead program. This has included leading efforts towards target identification, mechanism of action, in vivo pharmacology and other important aspects. In addition to leading tactical work streams, Dirk works seamlessly with other team members, provides valuable strategic input and supports board of directors and investor interactions.”

-Ken Horne

President, Digestome Therapeutics, Inc.

“Context Therapeutics engaged CDDG as scientific lead on the conversion of a monoclonal antibody to a bispecific antibody. CDDG was instrumental in guiding the evaluation and manufacturing of a range of bispecific and t cell engager formats that ultimately led to the discovery of our clinical candidate. CDDG continues to be a pleasure to work with and will be a long-term partner of Context.”

-Martin Lehr

CEO, Context Therapeutics

“I have enjoyed working with the CDDG for many years. CDDG has made valuable contributions across our allogenic CAR T programs, providing Allogene with invaluable immunology and  histology expertise and support during periods of high scientific demand.  The flexibility of our relationship with CDDG has enabled Allogene to plug CDDG’s subject matter experts into Allogene’s strategic and tactical teams, allowing Allogene to more efficiently direct expenditures to help cancer patients in need.“

-Gregory J. Opiteck, Ph.D.

Vice President, Head of Translational Sciences, Allogene Therapeutics, Inc.

“We contacted CDDG to assist in the unraveling of complex cytokine networks to better position our assets. CDDG experts integrated biology, technology, and computation to better understand target networks and assisted in the development of appropriate testing paradigms for confirmation of mechanism of action. Dirk’s insights, leadership, and communication skills were highly regarded by our team members and over time we learned that CDDG has much more to offer companies in early clinical development, including subject matter experts in manufacturing and clinical development. They’ve been instrumental in building our development strategies, particularly regarding indication selection and manufacturing. Given the breadth of knowledge and expertise, we maintain a close relationship with CDDG and I can highly recommend them to early development companies looking to strengthen their teams and for assistance in preclinical research/development and early clinical development.

-Scott Lonning, DVM PhD

Head of Research and Development

Bluefin Biomedicine

"As an entrepreneur working with a VC firm to explore new biotech company creation, I found myself needing to get expert assistance in fleshing out promising areas of science. In particular, CDDG have helped me with building a solid assessment of the biological validation, clinical and therapeutic rationale. They were able to bring to bear some very sophisticated genetic analyses to further refine opportunities that were not apparent in the published literature. I am also impressed with their pragmatic approach and understanding that a clear translational "line of sight” is what I really need. Easy to work with, responsive and understanding of budget constraints. Strong recommendation and I will work with them again."

-Christopher Roberts, PhD

CEO & Founder, Princeps Therapeutics

Entrepreneur in Residence, SR one, LLC

“CDDG has been a highly credible, cooperative and useful consulting group for ImmuNext. As a small biotech we do not have access to a broad array of highly experienced pharmaceutical clinicians within our own company.  CDDG’s experts possess decades of combined  practical Pharma experience and extensive industrial/scientific/clinical professional connections. Integrating their input into our strategy enables us to compete globally in the competitive marketplace of drug development. In particular, CDDG was critical for helping us identify the appropriate clinical context to position our drug for commercialization.  This focus helped streamline our preclinical research to better suit the needs of our Pharma partners as we look to the future.”   

-Jay L Rothstein, PhD

Chief Scientific Officer, ImmuNext, Inc

“My company retained CDDG for expert guidance on a series of pivotal in vivo experiments that had repeatedly failed to provide useful data in our hands. CDDG's subject matter experts were extremely responsive to our needs and provided insights that ultimately enabled generation of high quality in vivo results key to a successful financing. I strongly recommend CDDG and will definitely work with them again.”

-David Meininger, PhD MBA.

President & CEO Link Immunotherapeutics, Inc.

“I have had the pleasure of working with Dirk Smith at CDDG on a number of different projects over the years, and have always been grateful for his intellectual leadership and support. Dirk has always delivered high quality results in helping to solve a diverse array of complex problems. At Pareto Bio, Dirk stepped in seamlessly as part of our team, and has been an integral part in helping form our future product and company R&D strategy. I appreciate Dirk for the range of support he has always provided, from taking a hands-on role when needed to being able to step-back and offer higher level guidance when appropriate. I also appreciate that Dirk has always put himself in the shoes of the management team when making recommendations and decisions. He has consistently helped to balance the needs of rigorous, best-in-class research with approaches that are pragmatic, and feasible, for early-stage biotech companies.”    

-Nurry Hong

Chief Executive Officer Pareto Bio

“CDDG has helped us with evaluating multiple projects in the fields of immunology and hematology. We have had a very good experience working with the team, who were knowledgeable, thorough and responsive. Their insights and analysis provided us with in- depth understanding around biology, clinical strategy and market positioning, and made a significant contribution to our decision process.”

-Ohad Hammer

Partner, Pontifax Venture Capital

“We engaged the CDDG team to help us design a scientific plan and pre-IND strategy for a novel therapeutic program we are developing in partnership with the Bill & Melinda Gates Foundation. Their expertise in drug development and network of subject matter experts helped us address important questions around immunology, manufacturing and regulatory interactions. The Cascadia team have been easy to work with and their support has been key to our mapping a clear path to the clinic and very positive early feedback from regulatory agencies.”

-Brian Finrow

CEO Lumen Bioscience, Inc.

“I worked with the members of CDDG in the context of a small start-up antibody engineering company. Cascadia helped us understand two of our targets.  They taught us about the basic biology, preclinical models as well possible endpoints for early stage clinical studies.  They knew and could summarize the relevant literature.  In addition, they helped us understand the unmet medical needs where these pathways might be important.  Finally (and most unusually), they made clear recommendations regarding prioritization of one target vs the other and gave their reasoning. All members of this group were easy to work with, professional, smart and very responsive to our needs. I would strongly recommend them as a group with which to work.”

-Susan Goelz, PhD

Translational Scientist