News & Upcoming Events from ITMATEd

Symposiums, seminars, and workshops focusing on emerging topics in translational research

2016 Events

Pharmaceutical Industry Roundtable with Janssen — October 13, 2016

ITMAT is pleased to announce that Janssen Research and Development, the Pharmaceutical Company of Johnson and Johnson, will be visiting the Penn campus on October 13th to co-host a round table with interested fellows and junior faculty to discuss career paths in the pharmaceutical industry. Please join us to:

  • Network with former Penn trainees and faculty and have a discussion of what industry careers are really like.
  • Hear different perspectives from Research and Development and Medical Affairs
  • Learn about a newly created rotational program for physicians at Janssen (see attached brochure)

Register here


12:15-12:45 — Registration and Lunch
12:45-1:30 PM — Roundtable
1:30-2:30 — Networking
Smilow Auditorium — 3400 Civic Center Blvd, Philadelphia, PA 19104

Contact Rachel Bastian for more information.

2017 Events

Mentor Workshop Series - Next Cohort begins in 2017
Focused on enhancing the research mentoring skills of faculty mentors.
This program is a UPenn/CHOP Collaboration.

Junior Investigators Symposium March 21, 2017
A one-day symposium for junior investigators to provide information critical to the establishment of a successful academic research career.

CTSA Undergraduate Student Symposium - Coming in April 2017
Open to the entire Penn community.

Clinical & Translational Research 101 - Coming in August 2017
A half-day introductory workshop for residents and fellows on conducting Clinical and Translational Research.
Information and registration for the August 2016 event available here.

Newsletters

Fall 2015 Newsletter

Spring 2015 Newsletter

New & Returning Courses Fall 2016

*Non-degree students welcome; contact us at ITMATEd@mail.med.upenn.edu

REG 622 – New Trends in Medicine and Vaccine Discovery (New course!)
Claudine Bruck, PhD
T 3:00-6:00PM / 9025 Maloney, HUP
Modern drug discovery has evolved to include human genetic diagnosis and various biological approaches which has enabled progress in a variety of fields, including rare diseases, immuno-oncology, precision medicine, and biomarkers. The goal of this course is for students to understand newer treatment modalities and approaches beyond 'one size fits all' small molecule drugs, as well as the technologies that empower them. Students will learn regulatory processes that govern medicine discovery and development and also consider business and societal aspects of medical progress. Students will be able to apply concepts directly to work in the healthcare industry. Students will be taught by experts in the field internal and external to Penn. Prerequisites: MTR, MSRS, BGS students, or by permission from the department.

REG 611 - Clinical Study Management
Emma Meagher, MD
M/W 5-6:30pm / MAL 8030
This course will focus on the practical aspects of executing clinical trials in an academic environment in a GCP complaint fashion. Upon course completion students will be able to effectively implement and manage both investigator-initiated and industry-sponsored clinical research studies. Students will be guided through the operational aspects and regulatory processes for the three stages of study management: pre study, study start-up and implementation, ongoing compliance and study close out . Students will learn strategies for navigating the complex regulatory/operational clinical research environment and for successful protocol development and approval, subject recruitment, data management and IRB/FDA interactions. Protection of human research subjects and adherence to good clinical practices guiding research in humans is a critical concept that will be integrated throughout each of the lectures.

REG 613 – Drug Development Decision Criteria
Jeff Barrett, PhD
M/W 4:00-5:30PM / 9025 Maloney, HUP
This course reviews the critical junctures over which innovative and generic drugs are evaluated and the decision criteria used to judge performance and plan next steps. The nature of the collective data under review, the decision paths and the decision makers themselves often change depending on the stage of development. This course covers decision criteria from drug discovery through post marketing and even entertains decision points for generic drugs (pharmaceutical- and bio- equivalence). Metrics for evaluation, company and regulatory expectations and the tools used to facilitate decision (e.g., modeling and simulation techniques to generate what-if scenarios) making are all discussed in detail. A key feature of the course is 7 labs which involve instructor-led decision analysis role playing. The class will be divided into small teams that review data generated at different stages to examine the thought processes and decision criteria evaluable at different stages of drug development. Labs are constructed from actual case study examples and team performance will be evaluated at the conclusion of the lab session.

New Course Summer 2016:

*Non-degree students welcome; contact us at ITMATEd@mail.med.upenn.edu

REG 610 – Fundamentals of FDA Regulation
Monica Ferrante, DPA
M 4:00-7:00PM / 8029 Maloney, HUP
This introductory course provides an overview of Regulatory Affairs in relationto three key areas of development: Drugs, Biologics, and Medical Devices. The course will look at the rules governing prescription and over-the-counter drugs as well as the changes introduced by the influence of genetic engineering and biological product development. Throughout the course, practical issues facing regulatory specialists as they work with the FDA and other international regulatory bodies to secure and keep product approval will be addressed. Prerequisites: MRA, MTR, MSRS, BGS students, or by permission from the department.

New Courses Spring 2016:

*Non-degree students welcome; contact us at ITMATEd@mail.med.upenn.edu

MTR/REG 621 – Cell and Gene Therapy
Michael Milone, MD, PhD
W 8:30-11:30AM / 9025 Maloney, HUP
This course will provide students with a general overview of translational research in the area of gene and cell therapy.  This would include technical considerations, translating preclinical investigation into therapeutics, the execution of gene and cell therapies clinical trials, and key regulatory issues. Entrepreneurial considerations will be discussed as well. By the end of this course, students will understand the basic technologies employed for gene and cell therapy along with approaches and pitfalls to translating these therapies into clinical applications including regulatory and commercial aspects of this emerging area. Prerequisites: MTR, MSRS, BGS students, or by permission from the department.

New Courses Fall 2015:

*Non-degree students welcome; contact us at ITMATEd@mail.med.upenn.edu

REG 611 - Clinical Study Management
Emma Meagher, MD
M/W 5-6:30pm / MAL 8030
This course will focus on the practical aspects of executing clinical trials in an academic environment in a GCP complaint fashion. Upon course completion students will be able to effectively implement and manage both investigator-initiated and industry-sponsored clinical research studies. Students will be guided through the operational aspects and regulatory processes for the three stages of study management: pre study, study start-up and implementation, ongoing compliance and study close out . Students will learn strategies for navigating the complex regulatory/operational clinical research environment and for successful protocol development and approval, subject recruitment, data management and IRB/FDA interactions. Protection of human research subjects and adherence to good clinical practices guiding research in humans is a critical concept that will be integrated throughout each of the lectures.

MTR 642 - Building a Life Sciences Startup 
Tomas Isakowitz, PhD and Nalaka Gooneratne, MD 
Tu/Th 5:30-7pm / BRB 251
This class simulates the experience of building a life sciences startup. It is a hands-on, “lab-style”, class where students learn practical applications of technology commercialization knowledge. The kernel of this framework consists of two elements: the Customer Development methodology and the Business Model Canvas. The former lays out a process whereby students formulate hypotheses about their startup ideas and test them by going outside of the classroom and interviewing potential customers, partners, and other key stakeholders. To formulate the key elements of a startup vision, we utilize the Business Model Canvas, which provides a succinct way to clearly identifying the key aspects of a business model. The class adopts a flipped-classroom approach, whereby lectures are delivered via online video and class-time is devoted to working on students’ projects. In addition to the video lectures, students spend a significant amount of time out of the classroom performing primary market research in the form of interviews. Classroom time is devoted to (1) grounding lecture concepts in real life by analyzing how they relate to student projects, (2) starting on week 6, weekly project-progress presentations by students,  and (3) allowing teams to work on their own projects. This class it works well in combination with MTR 620 for students who are interested in the topic of commercializing academic technology.