Curriculum

Track 1: Discovery

Discovery/preclinical seminars will cover competencies of preclinical therapeutic development, including 1) identification of therapeutic targets, 2) chemical probe discovery and screening, 3) drug candidate development, 4) animal models, 5) issues of drug delivery and pharmacogenomics in pediatric patients, and 6) overviews of classes of drugs, including biologics and small molecules. This curriculum will review how to move from systems biology and genomics discovery into the design of molecules and proof of concept studies, as well as the required preclinical data that will maximize the chance for further drug development. Track 2 and 3 fellows will gain an appreciation for the experimental strategies and model systems underlying therapeutic discovery.

Track 2: Clinical Trials

Clinical Trials seminars will focus on competencies of first in human and phase 1-3 clinical trials, including 1) clinical trial design in children, 2) statistical and methodologic challenges (including small sample size and variability), 3) clinical operations and ethics (i.e. justification for placebo and single dose studies), and 4) regulatory/FDA specific requirements, IND approval, GMP practices, safety surveillance and pharmaceutical partnering.  Fellows will learn pediatric trial operations from the protocol design through study closeout, including interpretation of data and “extrapolation” from adult trials to pediatric trials.

Track 3: Real World Experience

Whereas competencies in Track 2 deal with the testing of novel therapies in highly selected patients in intermediate sized populations based on short term outcomes, Track 3 seminars emphasize evaluation of the effectiveness of therapies when used in “real world” practice, generalizing to populations, including minorities and those typically excluded from clinical trials (such as those with a wider range of severities, comorbidities, co-medications and alternative indications). Track 3 competencies will thus include 1) comparative effectiveness (for example, how does a new treatment compare with other existing classes of treatment, rather than placebo), 2) the discovery of unexpected side effects only detected when large numbers of children are treated, 3) consideration of the broad range of outcomes that are important to patients, clinicians and payers (patient related outcomes, quality of life, cost utilization, market determinants), and 4) strategies to explore implementation and quality improvement (QI). Track 1- and 2-focused fellows will appreciate the complexities and challenges facing therapies moving from a controlled environment to a complex “real world”.

UPTiC Colloquium

A monthly seminar series sponsored by UPTiC, held at alternating locations (Duke/UNC) and made available via WebEx for the non-host institution.  Sessions will alternate among didactic sessions on topics ranging from Track 1-Track 3 and led by UPTiC Faculty or other experts in the field at Duke or UNC; faculty facilitated journal clubs; and works-in-progress sessions led by Katz-Denny Fellows. 

UPTiC Symposium

An annual UPTiC Symposium will alternate between Duke and UNC campuses.  This symposium will also coincide with the annual External Advisory Board Meeting, at which current Katz-Denny Fellows will briefly present their work and meet individually with an External Advisor.

Presentation Skills Training

Katz-Denny Fellows will present their research in at least one national annual meeting relevant to their specialty, based on input from their SOC, in addition to the T32 Trainees in Pediatric Clinical Pharmacology Meeting.

Department of Pediatrics Research Forums (Duke and UNC)

Ethics Training

Submission of Research Manuscripts to Peer-reviewed Journals

Mentor and Research Project Selection

Establishment of a Scholarship Oversight Committee (SOC)

Creation of an Individual Development Plan (IDP)

Didactics

Katz-Denny Fellows are required to attend the following at least once during their training:

• Writing from the Reader's Perspective (Dr. George Gopen)
• Writing Winning (NIH) Grant Proposals (Grant Writers' Seminars & Workshops)
• Duke and UNC Grant Writing "K Clubs" (For fellows in their third year of fellowship, when appropriate)

UPTiC Grant Writing Program

Katz-Denny Fellows will benefit from a structures and graduated series of grant writing assignments throughout their appointment period, intended to culminate in a mock study section and internal review and at least one grant application. Fellows will draft an R21-style grant (Research Strategy of 6 pages) that also includes a Career Development Section (modeled after a K application). The timing of the program can be modified based on individual grant submission plans.

Grant Submission

All Katz Denny Fellows are required to submit at least one grant application during their UPTiC appointment.  The particular grant mechanism targeted will be determined by the fellow and mentor(s), with assistance from the SOC and EC as appropriate for their stage of career and project development. 

The ability to obtain an advanced degree can be instrumental for career progression and success of physician-investigators. Every Katz-Denny Fellow will consult with the EC, SOC and primary research mentor during the latter half of their clinical year to formulate a plan for degree obtainment during fellowship based on their previous experience that is consistent with their proposed training track and project—this will be part of their IDP. Of note, Katz-Denny fellows entering into Tracks 2 and 3 without graduate training beyond an MD will be highly encouraged to participate in a master's degree-granting program during their T32 appointment. 

Potential degree-granting programs include: 

• North Carolina TraCS: Institute 2-year degree granting Master of Science in Clinical Research that includes coursework in study design, biostatistics and epidemiology
• Duke: Clinical Research Training Program (CRTP, Master of Health Sciences in Clinical Research); Master in Public Health; Master of Management in Clinical Informatics (MMCi); Master of Biostatistics
• UNC: Master's programs offered in the UNC Schools of Pharmacy, Public Health (Master's of Public Health), Medicine (Biological and Biomedical Sciences Program; Curriculum in Toxicology), Dentistry, Nursing, Arts and Sciences, or other schools.