Year 1

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.

Year 2

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.

Goals

1. To provide specialized training and experience in pertinent aspects of clinical research, particularly the design and conduct of translational and clinical studies of emerging oncology drugs as outlined under the Program Description above.
2. To provide clinical experience in the management of patients participating in new oncology/hematology drug development trials.
3. To provide specialized training in the design and interpretation of ancillary laboratory studies that support new oncology drug development and encompass related areas such as oncopharmacology, pharmacogenomics, regulatory issues surrounding clinical trials and the new drug registration process, in vitro and in vivo drug evaluation, biostatistics, grant/manuscript writing, and translational laboratory projects related to new drug development.
4. To promote an understanding of pharmaceutical industry drug development issues through interactions with company sponsors of IDD clinical research.

Objectives

1. To develop skills in:
• Conducting appropriate work-up of patient candidates for investigational drug studies.
• Formulating treatment plans for patients to be enrolled in a study of a new anticancer agent.
• Following the clinical course of patients treated on new agent protocols and administering patient care in compliance with the guidelines of the investigational protocol.
• Recognition, evaluation and management of investigational drug toxicity.
• Provide appropriate inpatient care as needed.
2. To learn the principles of new drug pharmacology, pharmacogenomics, and develop competence in pharmacokinetic blood collection, blood preparation and analysis.
3. To learn the principles of clinical investigation, informed consent, biostatistics, and good clinical practice consistent with FDA, NCI, and pharmaceutical company rules for the conduct of clinical trials.
4. To learn the principles of modern clinical trial design and to learn how to develop and write protocols to evaluate new oncology/hematology agents.
5. To be able to assess clinical and imaging responses to treatment according to international criteria.
6. Professional communications:
• To learn the principles of interaction with the sponsors of clinical trials through conference calls, site qualifications visits, audits and symposia.
• Develop the competencies in presenting research data at working groups and conferences. These can be poster or oral presentations.
• Work with patients to review specific requirements of clinical trials.
• Develop skills to interact with Research Nurses, Study Coordinators, Regulatory Affairs and Research Administration personnel.
• Create and sustain a therapeutic and ethically sound relationship with patients and families with regards to the specifics of early clinical trials.
7. Through psychosocial oncology/hematology education the Fellow will develop skills to help with symptom detection and management as well as interventions

Application

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:

1. Has graduated from a medical school accepted by the Texas Medical Board or that meets the requirements as determined by a committee of experts selected by the Texas Higher Education Coordinating Board.
2. If a foreign medical graduate, meets eligibility requirements for obtaining an appropriate visa and obtains an ECFMG certificate. The Advanced Oncology/Hematology Drug Development Fellowship Program has been approved by the American Board of Internal Medicine as a Non-Standard Program. Candidates meeting all other requirements and accepted by the program are eligible for ECFMG sponsorship of United States J-1 training visas.
3. Meets all eligibility criteria for a Texas license, or a Physician in Training Permit issued by the Texas Medical Board.
4. Has 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. Candidates are not required to be board certified.
5. Completes an application that includes applicant demographic information and education history including past and present program directors’ names and addresses. Also provides the following:
• Biographic information: full name, date of birth, current address (local and/or foreign), date of birth, and nationality/citizenship.
• Job experience.
• Transcripts (certified by school registrar or official).
• Postgraduate training certificates.
• ECFMG certificate (if foreign medical graduate).
• List all current and past visas issued by the United States to a foreign national applicant and/or immediate family.
• If applicable, biographic information for a foreign national applicant’s spouse and children.
• Copy of all passports, visas and I-94 for foreign national applicant and immediate family members joining the applicant.
• Current CV and/or resume.
• Any medical licenses current or prior.
• Current photograph.
• Essay or narrative describing applicant’s prior related experience, future goals and objectives, and reason that this program is of interest.

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/).

Acceptance

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.

Residency Training Requirements

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.

Systems-Based Practice

1. Demonstrate the ability to call upon system resources to provide care that is of optimal value for patients on clinical trials.
2. Use information systems, organizational techniques and other resources to develop skills in time management and efficient practice of medicine in early clinical trials.
3. Exhibit the ability to use real time data systems to relay clinical trial information directly to sponsor in a timely manner.
4. Understand the resources available to clinical trial patients including: patient and family wellness center (social services, counseling, nutrition and rehabilitation).
5. Understand the principles of cost effective health care delivery including the proper practice of billing and coding.

Practice-Based Learning & Improvement

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

Contact Information:

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
210-450-1226
weitman@uthscsa.edu
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.

Formal Educational Experiences

1. Grand Rounds, Departmental Meetings and Local Conferences.
• Weekly Grand Rounds at the UTHSCSA Department of Medicine.
• Meetings and conferences hosted by the IDD and UTHSCSA Department of Medicine, Division of Hematology and Medical Oncology.
• Presentations sponsored and/or presented by pharmaceutical company research executives as part of business development site visits.
• Seminars on drug discovery and development topics given by clinical members, translational scientists in the IDD Department of Pharmacology, and by visiting CTRC and UTHSCSA lecturers.
2. Seminars, Meetings and Conferences.
• Fellows will be encouraged to attend Phase I conferences in Bethesda, Maryland or FDA ODAC meetings each year.
• Fellows will attend one or more of the annual meetings of the American Society for Clinical Oncology (ASCO), the NCI/EORTC/AACR Drug Development Meeting, and the American Society of Hematology (ASH).

Research Requirements

1. Clinical Research




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.



2. Laboratory Research




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.

Clinical Research

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.

Clinical Experience

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.

Laboratory Research

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.

Pharmacology

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.

Pharmacy

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.

Billing

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