CUSTOMIZED ITP SUPPORT

Consultative 

Clinical Indications/ Trial Preparation

Comprised of practicing clinicians and clinical research experts, and advises ITP Project Teams on product impact on clinical needs. In addition to its Consultative role, this team will continually scout clinical needs that may be addressed by future ITPs.  In its Core role, this team will capitalize on its members’ expertise in good clinical practice guidelines to assist in the preparation of clinical trials, including development of SOPs, clinical trial calibration and training protocols in collaboration with the Regulatory and QA/QC Core.

Team members:

• Darnell Kaigler, DDS, PhD (University of Michigan)
• Allen Ali Nasseh, DDS, MMSC (RealWorldEndo)
• Sean Edwards, MD, DDS (University of Michigan)
• Craig Misch, DDS, MDS (Misch Implant)
• Janet Kinney, RDH, MS (University of Michigan)
• Hom-Lay Wang, DDS, MSD, PhD (University of Michigan)
• Michael McGuire, DDS (McGuire Institute)
• Jed Jacobson, DDS, MPH (formerly Delta Dental)
• Sabiha Bunek, DDS (Dental Advisor)
• Steve Buchman, MD (University of Michigan)
• Stephen Feinberg, PhD, DDS (University of Michigan)

Regulatory and QA/QC

Comprised of the University of Michigan’s MICHR, the University of Pittsburgh’s Office for Investigator-Sponsored IND and IDE Support, and Medical Device Regulatory Solutions LLC, this team brings regulatory expertise and experience from both academia and industry. This core will not only provide comprehensive regulatory support, guidance, and education, but will also assist teams in preparation and filing of regulatory submissions, including Request for Designations, and IND/IDE.  In close collaboration with the Commercial Translation/ Future Clinical Adoption team, this team will provide strategic recommendations to navigate the regulatory pathways to position technologies for facile clinical adoption.

Team members:

• Jeanne Wright, RN, BSN, RAC (University of Michigan)
• Kay Fuller, RAC (MDRS, LLC)
• Shawn Bengston, RQAP-GLP (University of Pittsburgh)
• Denise Deverts, PhD (University of Pittsburgh)

Preclinical Validation

Advises ITP Project Teams on scientific/ technical issues including experimental design, endpoints, and quantitative functional outcomes, including mechanical, biochemical, and imaging analyses for benchmarking against a “gold standard”. As some members straddle across this team and the Scientific Core, there will be a coordination of advising and work performed.

Team members:

• Jan Stegemann, PhD (University of Michigan)
• Steve Schwendeman, PhD (University of Michigan)
• Renny Franceschi, PhD (University of Michigan)
• Jacques Nor, DDS, PhD (University of Michigan)
• John Powers, PhD (Dental Advisor)
• Giuseppe Intini, DDS, PhD (University of Pittsburgh)

Statistics

Advises ITP Project Teams on data management and biostatistics, and in experimental design and statistics that affect the analyses and reporting of results.

Team members:

• Tom Braun, PhD (University of Michigan)
• Cathie Spino, ScD (University of Michigan)

Manufacturing

Comprised of expertise in bringing clinical grade materials, devices, and therapeutic cells to human clinical trials.  With members that also perform work through Scientific Cores, this team will provide guidance, as well as fabricate and test clinical products, and assist in the development of manufacturing processes that concur with scalability and robustness.  The ultimate goal of this team is to support IND/IDE-enabling data under appropriate GxP conditions.

Team members:

• Alexander Stafford, MS (Wyss Institute)
• Christopher Johnson, BS (Wyss Institute)
• Albert Donnenberg, PhD (University of Pittsburgh)

Training

Training for ITP Project Teams as well as RC membership will be executed on a few levels. Modeled after MICHR’s Research Development Consultations, the Training Core will be comprised of experts from across the Cores, to provide customized training for each ITP Project team as well as for the general RC membership to elevate awareness for certain subject topics (e.g., QA/QC, regulatory, clinical trials).  This team will also facilitate cross-training with C-DOCTOR, and promote translational research/ commercialization courses through home institutions and other local opportunities.

Team member:

• Dan Clauw, MD (University of Michigan)

Commercial Translation/Future Clinical Adoption

Comprised of experts with substantial experience in industry, marketing, and commercial translation, this Core will collaborate with other Cores, as well as with resources available at home institutions (Technology Transfer, Business Development) to develop a comprehensive roadmap for each ITP that incorporates elements required to improve the likelihood of successful commercialization and clinical adoption.

Team member:

• Jeanne Ambruster (The Avenues)
• Francine Berkey, PhD (The Avenues)
• Andrew Brown, PhD (University of Pittsburgh)
• Paul Kostenuik, PhD (Phylon Pharma Services)
• Sam Lynch, DMSc, DMD (Lynch Biologics, LLC)
• Donald Taylor, PhD, MBA (University of Pittsburgh)

Cores

Each of the 3 institutions have unique expertise, with existing, functional Scientific Cores which are made available to support the ITPs.  Depending on the specific needs of an ITP, the Scientific Cores, as well as other Cores, may interface with external Contract Research Services.