The Advanced Oncology/Hematology Drug Development Fellowship Program is designed for Medical Oncologists who desire additional fellowship training and clinical experience in clinical research with particular emphasis on early drug development methodology. Although the fellowship training and experience largely revolves around the clinical aspect of new oncology drug development at the Institute for Drug Development (IDD), training also encompasses related areas such as oncopharmacology, regulatory affairs, in vitro and in vivo drug testing, and laboratory projects related to new drug development. The program offers the unique opportunity to be involved with oncology drug development issues from the perspective of an NCI designated cancer center, cooperative group setting, interactions with the pharmaceutical industry, and a regulatory perspective.
The IDD Fellowship Program is a two year training program. Fellows are expected to participate in all clinical research meetings, including all new study start-up meetings, sponsored by the National Cancer Institute (NCI), Southwest Oncology Group (SWOG), investigator initiated, and the pharmaceutical industry. Fellows will become intimately acquainted with all clinical research projects at IDD including Phase I and Phase II trials, and specialized laboratory, ancillary, and clinical pharmacology studies. Each Fellow is expected to design, write and execute at least two clinical research studies during each fellowship year.
Fellows will learn the clinical management of patients with advanced malignancies receiving treatment on Phase I clinical trials. This will also include documentation necessary for clinical research subjects, the ethical aspects and regulatory process of informed consent as well as the capture of data including understanding the common toxicity criteria used in toxicity assessment. Each Fellow will gain insights into clinical trial protocol writing and regulatory approval. This will entail several months of writing research protocols and gaining approvals from the Institutional Review Board(s) and a sponsor (National Institutes of Health or corporate). Attendance at several regularly scheduled conferences and research meetings is mandatory for Fellows. These include general Phase I rounds, protocol review and priority meetings, a drug development lecture series, didactic courses held throughout the year on subjects such as pharmacokinetics and drug level analysis, a drug development journal club, and conferences sponsored by UTHSCSA and CTRC. In addition, it is expected that Fellows will have the opportunity to spend time in a variety of laboratories at either UTHSCSA, UTSA, or UT-Austin to gain exposure to different aspects drug discovery or development. Fellows will be expected to present their work at several of these conferences. Fellows will participate in 2.5 days/week of research clinics. At least one of these clinic days will be spent evaluating new patient referrals for clinical trials under the supervision of licensed clinical research staff physicians.
Fellows will continue to be involved with the clinical research and projects from year 1. In addition each Fellow will run and initiate an entire study until completion of their program, under the supervision of staff. This will incorporate patient selection, data management, necessary decisions related to protocol adherence as well as necessary changes and amendments to improve feasibility as well as patient safety. Furthermore each Fellow will serve as a co-principal investigator on several other studies and a sub-investigator on his or her colleagues’ protocols. In addition, Fellows will be encouraged to design and initiate an Investigator Sponsored study. Each Fellow will also learn the basics of data analysis and pharmacokinetics and incorporate this knowledge into the execution of each study. Continued attendance at several regularly scheduled conferences and research meetings is mandatory for Fellows as outlined above for Year 1. In addition, for those Fellows who express interest, more dedicated time to work in a drug discovery/development laboratory will be made available. Each Fellow will assume responsibility for walk-in patients on a rotating basis, and will be responsible for this activity for 2-3 months each year. Again, direct supervision by licensed medical staff will be provided. Fellows will be given “protected time” for at least 2.5 days each week to pursue their individual research projects. Each Fellow will analyze the data gained from the protocols that they have successfully executed as well as the studies that they have participated in. Furthermore detailed pharmacokinetic and pharmacodynamic analysis of the results will enable the Fellow to fully satisfy the scientific nature of the study and assist in a further understanding of the experimental agent examined. Each Fellow will produce a manuscript that ultimately will be submitted for peer-reviewed publication, and is expected to publish at least 1-2 manuscripts that detail projects worked on since inception. At this stage of the program, the Fellow should be able to construct the next steps for both the clinical development of the agent studied as well as learning the essentials of grant writing for further career development.
Candidate application for the Advanced Oncology/Hematology Drug Development Fellowship Program is initiated by referral, query from the candidate, advertisement in leading oncology journals (e.g., J Clin Oncol) or by recruitment by CTRC/IDD faculty during travels and networking. The applicant must meet the following criteria to be considered for acceptance into the program:
All application documentation including without limitation photographs, certified copies, and certified translations into English from foreign languages, must meet the requirements of the Texas Medical Board (http://www.tmb.state.tx.us/).
CTRC/IDD faculty will interview eligible candidates. If a personal interview is not possible, the interview may be conducted by teleconference. Acceptance and continued enrollment is contingent upon the candidate obtaining and maintaining the necessary certifications and permits including, where applicable, a United States visa and work permit, ECFMG certification, and a license or a Physician in Training Permit issued by the Texas Medical Board.
The Fellowship applicant must have successfully completed postgraduate training in Internal Medicine and Medical Oncology/Hematology according to criteria set forth by the American Board of Medical Specialties for the American Board of Internal Medicine with added qualifications in Medical Oncology/Hematology, or international equivalents. The applicant is not required to be board certified.
To provide specialized training and experience in pertinent aspects of clinical research, particularly the design and conduct of clinical studies of emerging oncology/hematology drugs
If you are interested in applying for the program, please send your CV and a letter of intent to the following address:
Steve Weitman, MD, PhD
Director, Institute For Drug Development
AT&T Distinguished Chair of Drug Development
University of Texas Health Science Center at San Antonio
7979 Wurzbach Road, Zeller Building, 4th Floor
San Antonio, Texas 78229
Attention: Advanced Oncology/Hematology Drug Development Fellowship Program
The Fellow is expected to provide medical management for inpatients and attend daily inpatient rounds on patients being treated at CTRC/IDD on clinical trials. The inpatient “on call” rotation is for approximately 2-3 months per year as the Fellows rotate in sequence. In addition, each Fellow is expected to attend at least two outpatient Phase I clinics each week including Phase I clinics at the CTRC.
The Advanced Drug Development Fellowship consists of a two-year training period. The Fellowship is offered through the Oncology/Hematology Drug Development Program at CTRC/IDD. The Fellow is expected to participate in all clinical research meetings, including new study start-up meetings sponsored by the National Cancer Institute or pharmaceutical companies. The Advanced Drug Development Fellow is expected to develop the skills necessary to design, write and execute clinical research studies during the course of the Fellowship. The Fellow serves in the capacity of sub-investigator under the supervision of CTRC/IDD faculty and is expected to provide medical management for inpatients and attend daily inpatient rounds on patients participating in IDD drug studies.
The Fellow will have the opportunity to undertake laboratory research in a variety of laboratory disciplines including investigations related to cancer cell biology, pharmacology, drug formulation, molecular biology, and translational biology. Owing to the relatively limited time of the Fellowship and the large number of other demands, only limited, problem-oriented, translational projects related to new anticancer drug development may be undertaken.
The supervision of trainees in the Advanced Oncology/Hematology Drug Development Fellowship Program is designed to provide gradually increased responsibility and maturity in the performance of the skills attendant with competency of a subspecialist in these disciplines.
Each Fellow will be assigned a physician faculty mentor who will provide guidance. The Program Director and Associate Director, Drs. Weitman and Sarantopoulos, will monitor individual performance and handle any disciplinary issues. The Program Administrator will provide administrative support and facilitate the processing of documents and permits. Supervision for specific program components will be provided by appropriate faculty depending on the activity and requirements.
The Fellow serves in the capacity of sub-investigator under the supervision of CTRC/IDD faculty, and has graded authority to identify new patients for clinical trials, obtain informed consent, administer investigational agents, manage observed toxicity, and participate in special ancillary studies.
The Fellow serves in the capacity of attending physician under the supervision of CTRC/IDD faculty and will provide care for clinic patients, arrange hospital admissions, consult with the inpatient care team for hospitalized patients, participate in care management decisions and actively participate in patient care. The Fellow may perform a variety of procedures including thoracentesis, paracentesis, bone marrow aspiration/biopsy, and fine needle aspiration of lymph nodes.
The Fellow serves in the capacity of sub-investigator under the supervision of CTRC/IDD faculty in conducting laboratory research related to new anticancer drug discovery and development.
The Fellow will be scheduled for one-on-one tutorial exploratory sessions with CTRC/IDD faculty pertaining to the use and relevance of clinical pharmacology, pharmacogenomics, drug discovery and formulation, analytical assay development, basic pharmacological principles, and advanced pharmacokinetic modeling. The Fellow will also have the opportunity to utilize pharmacokinetic modeling software to analyze data relevant to individual clinical projects. Core educational materials will be provided.
The IDD Investigational Drug Pharmacy Director will provide core educational materials and supervise the Fellow during Investigational Drug Pharmacy tutorials where the Fellow will learn pharmaceutical quality assurance, documentation, and drug accounting practices.
It is required for a Fellow to have an attending physician in the exam room for both new and follow up visits. The Fellow must put an addendum in the patient chart stating that an attending was present during the exam. The Fellow then forwards the dictation to the attending for approval to ensure reimbursement