Category: C-DOCTOR News

On January 1, 2024, Dr. Geoffrey Gurtner received the Flinn Foundation Bioscience Entrepreneurship Program award. This Arizona biotech funding agency focuses on helping new Arizona technologies accelerate commercialization of new clinical treatments for patients. The award ($100K) will be used to for drug product manufacturing of Kinase Inhibitors ahead of their planned clinical trial for Dr. Gurtner’s ITP “Prevention of Scar Formation in the Skin Using Topical Focal Adhesion Kinase Inhibitors (Click here to read more about his project.)

The 2024 C-DOCTOR Spring Retreat was hosted at the Residence Inn by Marriott at Berkeley, CA on June 3–4, 2024. The Center for Dental, Oral, & Craniofacial Tissue & Organ Regeneration (C-DOCTOR) is comprised of nine Interdisciplinary Translational Projects (ITP) teams, one having a recent successful IND filing and making efforts to begin a first-in human trial. This year’s C-DOCTOR retreat was supported in part by the California Institute for Regenerative Medicine (CIRM) through conference grant: EDUC1-16388. The retreat was an excellent opportunity for attendees to connect with other project teams, the C-DOCTOR leadership, and external advisors and consultants to network and collaborate. The event highlighted the progress of the projects in C-DOCTOR’s ITP portfolio. C-DOCTOR celebrated the progress of its ITPs with five ITP teams with eight FDA interactions (e.g., IND submission, Pre-Submissions and clarification teleconferences, and Requests for Designation). In addition to updates from the ITP teams, the retreat featured a variety of sessions and panels to demonstrate C-DOCTOR’s progress to date and opportunities to grow in the future. A summary of the sessions is below. CIRM Presentation Lisa Kadyk, PhD (Associate Director of Therapeutics Development) gave a presentation about CIRM’s mission, goals, and funding source; the different grant mechanisms available through CIRM; and non-grant resources available through or associated with CIRM. Sensors and Wearable Diagnostics Session: Clinical Applications and Use Cases in the DOC Space and their Role in Tissue Regeneration Geoffrey Gurtner, MD and Uttam Sinha, MD, gave presentations on the development of sensors or wearable diagnostics products and their clinical applications. Dr. Gurtner presented on the development of his smart bandage (Click here to read more). Dr. Sinha presented on his SaliSense technology aimed at early detection of head and neck cancer. These presentations served as the baseline for discussion to explore the role of these products in the future direction of the C-DOCTOR program. Best Practices for FDA Interactions Focusing on IND/IDE-Enabling Data: Experts from CDRH and CBER Srinivas Nandkumar, PhD, Adam Chin, PhD, Sherrill Lathrop Blitzer, PhD (FDA CDRH), and Mondona McCann, PhD (FDA CBER) presented on best practices for FDA interactions with a focus on IND/IDE-enabling data such as determining appropriate animal models, preparing data for the FDA, as well as common challenges/pitfalls during FDA interactions and how to avoid them. This session was timely as more ITPs in the C-DOCTOR portfolio plan for FDA interactions in the upcoming year in the form of full IND/IDE submissions, Pre-Submissions, and Requests for Designations. Bridging Academic Regulatory Science Centers and C-DOCTOR for Enhanced Regulatory Science Practice and Training Kathy Giacomini, PhD, BSPharm and Eunjoo Pacifici, PharmD, PhD presented on the  UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) and the training programs available at the USC School of Pharmacy’s Department of Regulatory and Quality Sciences. They provided discussion on how C-DOCTOR can create further collaborations with organizations like the FDA and improve internal C-DOCTOR practices. C-DOCTOR and Looking Ahead: Integrative Health Helene Langevin, MD presented on the mission and current initiatives at NIH RE-JOIN and provided an overview of musculoskeletal integrative health. Her presentation served as a springboard for how to understand and leverage mutual synergies between C-DOCTOR, NIDCR, and other NIH institutes.   C-DOCTOR receives funding from the National Institute of Dental and Craniofacial Research (NIDCR; award: U24DE029463) with the mission to shepherd new therapies through pre-clinical studies and into human clinical trials, commercialization, and broad clinical adoption. As C-DOCTOR enters year 5 of its funding cycle, it looks forward to achieving continued success with more IND/IDE filings and more FDA interactions. In addition, C-DOCTOR poises itself to be at the forefront of product development and innovation in tissue engineering/regenerative medicine in the dental, oral, and craniofacial field and beyond.

C-DOCTOR ITP PI, Geoffrey Gurtner (Chair, University of Arizona, Department of Surgery) was recently featured on NPR’s Morning Edition and The Wall Street Journal discussing the development of his “smart bandage”. He is developing this product in collaboration with Stanford University and with funding from the Department of Defense. This “smart bandage” senses impending infections and delivers electrical pulses to treat them. The aim of this technology is to aid field medics in treating wounded soldiers on the battlefield. Beyond military applications, smart bandages could eventually diagnose and treat postoperative infections, with the first generation expected on the market in two to three years. With ongoing advancements, smart bandages promise to revolutionize wound care, offering advanced, real-time treatments that improve patient outcomes and save lives. Though this product differs from the one being developed as part of his Scar Formation Prevention ITP, C-DOCTOR celebrates Dr. Gurtner’s translational research efforts to develop innovative products to address wound healing. Click here to read more on this technology. 

In April 2024, C-DOCTOR receives the CIRM Conference Grant in support of the annual C-DOCTOR retreat. The conference will be held in Berkeley, CA, in June 3-4, 2024. The objective of the CIRM Conference Grant is to support valuable mission-specific scientific conferences where people assemble to exchange scientific information and explore specific scientific subject relevant to CIRM’s mission. Under this program, the C-DOCTOR retreat aligns with CIRM’s short and long-term goals and addresses critical topics related to stem cell-based therapy and discovery/stem cell biology. 

Please join us as the International Association for Dental, Oral, and Craniofacial Research (IADR) will host its 102nd General Session & Exhibition with the 53rd Annual Meeting of the American Association for Dental, Oral, and Craniofacial Research (AADOCR) and the 48th Annual Meeting of the Canadian Association for Dental Research (CADR). This event will be hosted in New Orleans, Louisiana, USA, March 13-16, 2024. This event will feature success stories in the product development journey from projects/small businesses that used various NIDCR funding mechanisms along with many prestigious guest speakers. Click the following links to learn more: https://www.nidcr.nih.gov/news-events/events/2024/nidcr-75-accelerating-product-innovation-development-research-commercialization https://www.aadocr.org/2024iags  

Please join us at the 2024 C-DOCTOR Spring Retreat on June 3-4, 2024 at the Marriott Residence Inn in Berkeley, CA.

C-DOCTOR celebrates Dr. Derrick Wan’s successful IND filing for their interdisciplinary translational project “Transdermal Deferoxamine to Enhance Fat Graft Retention for Reconstruction of Irradiated Soft Tissue Defects” (Deferoxamine Patch for Radiation-Injured Skin)!” Their team filed the IND application on November 30, 2023, and received their “study may proceed” letter on January 3, 2024, allowing them to begin their clinical trial. The Deferoxamine Patch for Radiation-Injured Skin ITP is the very first C-DOCTOR ITP to successfully file an IND application since C-DOCTOR has been established. This is a landmark achievement for Dr. Wan, C-DOCTOR, and DOCTRC (Dental, Oral and Craniofacial Tissue Regeneration Consortium). C-DOCTOR has worked diligently and efficiently with the Wan ITP team to ensure that they have all the necessary resources to file a successful IND and graduate from the C-DOCTOR program. The Deferoxamine Patch for Radiation-Injured Skin ITP team has developed a transdermal patch delivery system for an FDA-approved medication, deferoxamine, to treat chronic, fibrotic radiation-injured soft tissue. Preclinical studies showed that injection of this medication into irradiated tissue results in improved blood flow and tissue quality. Given the frequency and severity of debilitating radiotherapy side effects and limited available treatment options, their novel approach meets a large clinical need with potential for rapid clinical adoption. The next step for Dr. Wan is to secure funding for a first-in-human clinical trial as C-DOCTOR does not support clinical trials. We congratulate Dr. Wan and his team for this exciting feat and what it means for C-DOCTOR. We hope this inspires all the ITP teams working towards their approval for clinical trials.

The 2023 4th Annual Joint DOCTRC was hosted at the USC Health Sciences Conference Center. The Dental, Oral, and Craniofacial Tissue Regeneration Consortium (DOCTRC) is comprised of two NIH-funded resource centers, the Center for Dental, Oral & Craniofacial Tissue & Organ Regeneration (C-DOCTOR) and the Michigan-Pittsburgh-Wyss Regenerative Medicine (MPWRM) Resource Center. These resource centers receive funding from the National Institute of Dental and Craniofacial Research (NIDCR) with the mission to shepherd new therapies through pre-clinical studies and into human clinical trials, commercialization, and broad clinical adoption.  The event highlighted the progress of the projects in each Resource Center’s Interdisciplinary Translational Project portfolio and feature keynote speeches from Srinivas Nandkumar, PhD (US Food and Drug Administration’s Center for Radiological and Device Health, Director of Dental and ENT Devices) and Dr. Rena D’Souza, DDS, MS, PhD (NIDCR, Director). There was also a special presentation from the retreat’s co-funder, the California Institute for Regenerative Medicine (CIRM) by Lisa Kadyk, PhD.  The retreat was an excellent opportunity for attendees to connect with other project teams, the DOCTRC leadership, NIDCR program staff, DOCTRC operations staff, and external advisors and consultants to network and collaborate.

Congratulations to the “Transdermal Deferoxamine For Treatment Of Irradiated Soft Tissue” ITP team led by Derrick Wan on their IND submission.

On October 27, 2023 – C-DOCTOR Interdiscplinary Translational Project Team, Hydronovo, received a $2.3 million California Institute for Regenerative Medicine (CIRM) Translational Stage research grant to fund development of their small molecule therapy and related translational activities. This funding, leveraged in addition to the funding and support for proof-of-concept studies provided by C-DOCTOR and the National Institutes of Health/National Institute of Dental and Craniofacial Research, will enable their goal of completing pivotal preclinical studies ahead of IND filing with the FDA. The Hydronovo team (consisting of principal investigators, Sarah Knox, PhD, Chelsea Bahney, PhD, and Eben Alsberg, PhD) takes a monumental step towards clinical trials with their outstanding accomplishment in receiving this grant. The CIRM Translational Stage grant mechanism is a highly competitive opportunity for promising regenerative medicine projects that accelerate completion of translational stage activities necessary for advancement to clinical study. Hydronovo’s product will advance CIRM’s mission to accelerate world class science to deliver transformative regenerative medicine treatments. With funding from this CIRM grant, Hydronovo’s product is one step closer to reaching clinical adoption. Xerostomia, or dry mouth, affects over 8 million U.S citizens due to salivary dysfunction which severely decreases oral health and quality of life. The goal of Hydronovo’s proposed product is to overcome radiation-induced xerostomia/dry mouth through neurogenic stimulation of salivary gland stem cells. Hydronovo will use this grant to focus on safety and dosing studies in a large animal model; R&D grade Ceviginate production; quality controls/analytical protocol development and validation, packaging stability testing/aging, and first-in-human (FIH) clinical trial design development. With no regenerative treatments available, they plan to fulfill this unmet need by developing a long-term therapeutic treatment to restore salivary flow through activating salivary gland regeneration. Hydronovo expressed, “This will be the first regenerative treatment for this medical condition and gives cancer survivors and their families the chance to restore their quality of life.” Click here to read more: https://www.cirm.ca.gov/about-cirm/newsroom/press-releases/cirm-invests-more-than-42-million-in-translational-stage-research/ Click here to read more about the Hydronovo ITP: https://c-doctor.org/wp-content/uploads/2023/06/Hydronovo-Salivary-Gland-Regeneration-Knox.pdf