Biopharma Educational Initiative- Student Handbook 2019-2021

MS in Clinical Trial Sciences
Regulatory Affairs Certificate
Recruitment Sciences Certificate
Drug Safety & Pharmacovigilance Certificate

Welcome to the Biopharma Educational Initiative.  The faculty extends a warm welcome and looks forward to mentoring and guiding you into the exciting world of Clinical Trials.

Your experiences at SHP may be somewhat different than your previous academic exposure.  First our classes are all online.  Web-based education requires more active participation by the student than in a traditional in-person lecture class.  The course content is available to you 24 hours a day, 7 days a week, which allows you to review the material at your own pace while juggling family and work responsibilities.  Many of the courses have audio lectures and these files may be downloaded to your computer to go with you during your travels.  Course content is presented in a manner commensurate with graduate level education and requires significant contributions and participation from the student.  The faculty will reinforce the content through guided discussion activities, feedback, and other assignments.  Successful students are self-directed learners who strive to understand the material on a conceptual basis rather than just through memorization.

Many of our faculty members are leaders in the pharmaceutical industry.  They enjoy teaching and look forward to sharing their experiences with you.  You will be treated as a professional and colleague, and we are assured that you will return that respect to your professors.

Please review this student handbook carefully and keep it accessible as you continue through the program.

The Biopharma Educational Initiative is a unique WEB-BASED program that brings together New Jersey’s biotechnology and pharmaceutical industries with the University in an academic partnership to develop career enhancing educational opportunities for existing or future biopharmaceutical employees.  Bringing to market new drugs and devices has become a complex process requiring the skills of specialized and talented clinical research professionals. Through both post-baccalaureate certificates, and a Master’s Degree Program we educate individuals to become “Clinical Research Professionals” who possess a thorough understanding of clinical trials, research design, ethics, national and international regulatory processes, and clinical trial monitoring.  Clinical Scientists utilize these knowledge areas to monitor the conduct and progress of trials either in the US or globally.

The Biopharma Educational Initiative sits in the heart of “Pharma Alley” in New Jersey.  Because of this proximity to both large and small pharmaceutical and biotech companies we have been able to add individuals who are among the brightest and most talented Pharma employee professionals to our already impressive coterie of University faculty.  In addition, we are one of the largest health care research institutions in the US with our own contract research organization and well-regarded research facilities.  Networking with industry leaders and gifted principal investigators are valuable assets offered to our students. Enrollment is available within our Master’s specialization tracks or our three Certificate Programs, and also to applicants seeking only visiting student enrollment in individual courses. These web-based courses were designed to fit into the busy schedules of working professionals.

The Biopharma Program provides education to those individuals who seek to gain expertise or advanced job skills in such fields as a Regulatory Affairs, Clinical Research Monitoring, Drug Safety & Pharmacovigilance or Medical Affairs, within the pharmaceutical industry.  We offer a Masters Degree in Clinical Trial Sciences as well as three graduate level certificates; Regulatory Affairs, Recruitment Sciences, and Drug Safety and Pharmacovigilance.  The Masters degree is 36 credits, with a 9-credit core and 27 credits of specialty courses and electives.  Students can choose one of four tracks for specialization (see below). Each certificate is 5 courses/15 credits in length.

Clinical Trials Management & Recruitment Sciences

This specialization track presents the knowledge and skills necessary for effective clinical trial management from the sponsors’ perspective as well as that of the individual study sites. Protocol development, IRB submissions, managing study budgets, facilitating proper data collection, and preparing for a study audit, conducted in an ethical manner are all essential skill sets required of persons working in clinical research.  In addition, students in this track will be on the forefront of developing strategies for a new and growing pharma job role, the Patient Recruitment Specialist.

Regulatory Affairs

The laws and guidelines that regulate the research, marketing approval, manufacturing and advertising of drugs, biologics, and medical devices are often complex and change frequently. Several new recommendations submitted to Congress may significantly broaden the Food and Drug Administration’s ability to monitor the safety of drugs and devices and to improve the agency’s ability to respond to emergent drug and device safety issues.  The material offered in this track prepares the student to conduct essential filings with regulatory agencies and to have a thorough understanding of law, policy, and business governing bringing product to market.

Drug Safety & Pharmacovigilance

There is a risk: benefit ratio for every drug, biologic and medical device.  Some of the risks are known early in the development phase and can be predicted by pre-clinical studies.  However, many safety issues first come to light only after large-scale clinical trials are conducted in the post-marketing phase of development.  Some issues are related to a drug’s mechanism of action but others may be related to manufacturing issues or problems with product labeling and information leaflets. As drug recalls grow there has been a greater emphasis put on identifying signals both in the clinical phase of study and after the product has been released on the market.

This specialization track educates the students on how to recognize, quantify, analyze, and communicate the benefits and risks associated with drug and related products.  The Certificate in Drug Safety and Pharmacovigilance will have a similar goal but will be primarily intended for the student currently working within the profession or for the student who wishes to pursue work on the regulatory aspects of pharmacovigilance and not signal detection.

Medical Affairs

This specialization track teaches the knowledge and skills necessary to enter various facets of medical affairs which is a high growth area in the biopharmaceutical industry.  Positions in this area are necessary to manage the growing vital sector in today’s industry in providing key opinion leaders, regulatory agencies and healthcare professionals with scientific and medical information relating to the value and correct usage of the products. Medical affairs personnel strive for the highest scientific integrity so as to produce successful clinical trials and supply the greatest support for the market. Medical affairs groups perform many activities often overlapping with sales, Medical marketing, clinical growth, and customer service. In parallel, they serve as the bridge between the company’s internal stakeholders, especially clinical development and the company’s external stakeholders. Medical Affairs’ focus on generating meaningful evidence, strategic engagement of key opinion leaders and the dissemination of relevant scientific information makes it paramount for them to ensure their knowledge and skills are well supported by a formidable education system.

This specialization track educates the  student on the role of medical affairs in commercialization, in particular, to develop research hypotheses and designs for medical affairs studies, disseminate study results in an effective and efficient way to various stakeholders, design communication strategies, develop brand strategies, understand stakeholder needs (e.g., regulatory affairs, market access) and develop strategies for win-win partnerships, address challenges that medical affairs faces in commercialization, and interpret regulatory and clinical guidelines.

The Biopharma Educational Initiative was designed as an Industry and University collaboration to develop academic programs and courses to meet the needs of the biopharmaceutical industry and their employees.  During the Academic Year 2004-05, University-wide meetings were held to discuss greater collaboration with the pharmaceutical industry. The primary focus was to develop a curriculum and appropriate academic programs centering on clinical trials. In the summer of 2005, the University identified resources to establish an administrative office to deal with infrastructure considerations. The office was charged with developing appropriate committees to deal with various academic, faculty and student issues as well as the development of requisite administrative policies and processes.  Since the University is made up of numerous and diverse schools, both in terms of instructional content and governing policies, attempts to develop a blend of policies, grading scales, and admission and registration policies was a challenge. The School of Health Professions took the lead in this effort by creating a Director of Admissions & Registration for Corporate Education and a Director of Curriculum Development.  Fees, admissions policies, grading scales were coalesced, and one portal of entry into the University was created to obviate students having to apply to each of the schools individually. In addition, interested faculty from the various schools developed new or modified existing courses for on-line presentation.

In 2004 we were approached by Merck & Co. to develop our first academic certificate in Clinical Recruitment Sciences. This was established secondary to the need to provide graduate level education for a new job title in the biopharmaceutical industry entitled “Patient Recruitment Specialist”. Subsequently, other companies have asked for graduate courses in clinical data management and regulatory affairs and hence served as the impetus for development of two other certificates, Clinical Trials Informatics (which has since been eliminated) and Regulatory Affairs.  These 15 credit (5 courses) certificates were then phased in starting in the Fall of 2006.

Due to the complexities involved in running a clinical trial both in the US and abroad, it quickly became apparent that a 5 course curriculum did not offer the depth and breadth of information needed by the Clinical Research Professional.  Hence in the Spring of 2008 we began putting together a Masters degree in Clinical Trial Sciences with finalization and approval from New Jersey’s Commission on Higher Education obtained in March of 2009.

As mentioned earlier, the Biopharma Educational Initiative is a collaborative effort.  The certificates are University certificates and thus awarded by the school directly involved in the students’ course of study; however, a degree program (meaning a MS or PhD) must be awarded through a school.  Since Biopharma is technically not a school, it cannot award a degree; hence the Masters is awarded through the School of Health Professions.  This technicality, however, has led to possible confusion in the application process.

Students applying to the Masters Degree in Clinical Trial Sciences must use the SHP application and their paperwork and supporting documents are processed through the SHP Enrollment Services Office.  Once accepted, students will register for courses through the Banner Information System via my.rutgers.edu.

Students applying to the Certificate programs, as well as students registering for individual courses on a non-matriculated basis must use the CACE Application for Certificate of Studies and their paperwork and supporting documents are processed through the SHP Enrollment Services Office. Once accepted, students will register for courses using the Non-Matriculated Course Enrollment Form.

Program Administrative Staff and Faculty

Director
Barbara Gladson, PT, PhD
gladsobh@shp.rutgers.edu
Ph: 973-972-2375
Office: Newark, SSB, Suite116Program Director
Doreen W. Lechner, PhD
lechnedw@shp.rutgers.edu
Ph: 973-972-5984
Office: Newark, SSB Suite. 359Program Assistant
Iris Pena
Iris.pena@rutgers.edu
Ph: 973-972- 8444
Fax: 973-972-7228
Office: Newark, SSB Suite 359
Faculty
Lisa Palladino Kim, MS
palladlm@shp.rutgers.eduNadina Jose, MD
Ncj26@shp.rutgers.eduPat Beers- Block M.Distance Ed
beersbpm@rutgers.eduBarbara Tafutio, MLIS, PhD
bat82@shp.rutgers.edu

The goals and objectives of the program vary depending on track chosen but all students will be able to describe the drug development process, identify/edit elements of a protocol, and explain a variety of research designs. They will learn to apply ethical principles to the development and conduct of clinical trials, interpret and summarize major regulatory documents in the U.S. and compare and contrast these with international regulations. Students will understand how to provide safe, competent clinical care to the participants in clinical trials.

Core Competencies

  • Formulate a basic study design incorporating knowledge on sample size, placebo response, significance, blinding, minimizing bias, randomization, as well as concepts surrounding multiple analyses and multiple treatment arms and endpoints;
  • Select and utilize appropriate software for data entry, tracking recruitment, and managing the budget and expenditures for study managers;
  • Improve research designs and epidemiological studies, and identify how changes in health policy and economics influence study design;
  • Critique the drug literature with regard to study design, methods, statistics, quality of literature review, conclusions, and writing style and organization;
  • Apply ethical principles to the development and conduct of clinical trials, including informed consent and subject recruitment and retention, and identify cases of error, misconduct and fraud;
  • Interpret and summarize major regulatory documents in the U.S. and compare and contrast these with international regulations;
  • Assess adverse effects by utilizing several methods including severity scales, toxicity criteria, and similar response variables, and document the event for the sponsor, appropriate regulatory agencies, and in the literature;
  • Explain the drug/device/biologic evaluation process including all phases of product development in clinical research and GCP guidelines impact on quality
  • Disseminate study results in the form of reports to regulatory agencies, to the sponsor and contributions to publications in medical journals;
  • Construct plans for training investigators and/or study staff to promote standardization of study procedures;
  • Discuss principles of pharmaceutical project management and identify components of the project strategy (target product profile, business strategy, clinical strategy, regulatory strategy, financial analysis);
  • Identify important clinical questions to develop a research hypothesis;
  • Learn how to provide safe, competent clinical care to the participants in clinical trials.

 Regulatory Affairs Competencies

  • Develop and submit applications for permission to study and market products to a variety of international and national regulatory agencies;
  • Interpret regulations involved in the investigation, production, labeling and distribution of drugs, food, additives, medical devices, biological products, pesticides and other similar products, and provide guidance on these rules to the project team;
  • Assist in protocol development to satisfy new requirements for post-marketing commitment studies;
  • Understand the various regulatory documents involved in pharmacovigilance
  • Develop Regulatory Strategies that enable the launch of drugs in foreign markets
  • Identifying concepts involved with GXP as it relates to Good Manufacturing Practices (GMP), Good Clinical Practices (GCPs) and Good Laboratory Practices (GLPs); Outline the steps in a preventive action investigation by documenting the background of the issue and to identify a corrective action to the deviation and a suggested timeline of completion

Clinical Trials Management & Recruitment Competencies

  • Demonstrate knowledge of pathophysiology and pharmacology;
  • Interpret the appropriate portion of the CFR and use this document to guide the execution of Clinical Research professional;
  • Conduct study specific activities for a study and conduct protocol feasibility such as preparing case report forms/electronic data capture, storage of study materials and documents, informed consent documents, as well as budget, close-out procedures and perform post study analysis;
  • Design and monitor recruitment campaigns with an understanding of influences such as disease, pharmacogenomics, culture and religion;
  • Research and test methodologies used for patient recruitment to develop evidence based approaches to this study area;
  • Formulate a business plan for a clinical trial including managing external funding, budgeting processes, cost-benefit and cost-effectiveness data;
  • Demonstrate a working knowledge of databases used to capture outcomes, biomarkers, and endpoints from the site investigators.
  • Design a quality assurance plan to coincide with study initiation procedures

Drug Safety & Pharmacovigilance Competencies

  • Analyze differences in safety regulations/guidances between different global regions
  • Analyze adverse events based on seriousness and labeledness/ expectedness
  • Prepare drug safety narrative
  • Describe the key drug safety reporting requirements that must be filed with a regulatory agency
  • Outline traditional and statistical data mining methods
  • Perform risk identification (signal detection) and characterize identified risks, potential risks based on signal analysis to develop a risk management plan
  • Identify the different Risk Management Tools such as RMPS and REMS
  • Review published literature of clinical and preclinical reports to provide a framework to judge adverse events
  • Describe databases containing adverse drug events, such as MedDRA and Eudravigilance and explain how they are used.
  • Identify major drug induced adverse events or safety signals and the rationale for their development

Medical Affairs

  • Demonstrate scientific and technological thought leadership to enable to think across therapeutic areas, assess critical value, analyze risk versus benefit and exploit technological advances
  • Demonstrate a deep understanding of compliance in order to appreciate the options and constraints of an increasingly compliance driven environment
  • Develop emotional intelligence and communication skills to understand and engage customers and colleagues
  • Formulate and Implement strategies to partner with commercial and development colleagues and engage in lifecycle planning; understand the changing customer landscape
  • Demonstrate business leadership to partner with commercial and development colleagues and engage in lifecycle planning; understand the changing customer landscape
  • Apply and demonstrate learning agility to take current knowledge and adapt it for future use both within and outside the core medical capability

The following is a sample curriculum based on taking two courses/semester:

Semester/

Year

Regulatory Affairs Clinical Trial Management & Recruitment Drug Safety Medical Affairs
Fall/

 Year 1

Regulatory Requirements in Clinical Investigations

Adverse Event Reporting & Postmarketing Activities

Regulatory Requirements in Clinical Investigations

Overview of Disease Processes and Treatment

Regulatory Requirements in Clinical Investigations

Overview of Disease Process & Treatment**

 Clinical Trials Overview:  Methods and Practice

Overview of Disease Processes and Treatment

Spring/

 Year 1

Clinical Trials Overview: Methods and Practice

Data Analysis and Interpretation or Multiple Analyses in Clinical Trials

Clinical Trials Overview: Methods and Practice

Multiple Analyses in Clinical Trials  or

Data Analysis and Interpretation

Clinical Trials Overview: Methods and Practice

Adverse Events

Regulatory and Ethical Requirements in Clinical Investigation

Applied Clinical Trials and GCP

Summer/

Year 1

(Mandatory for Medical Affairs)

Advertising & Labelling in Pharmaceutical Medicine

Strategy, Insight Generation  and Patient Journey

Fall/

Year 2

International Regulatory Affairs

Concepts of GxPs & Quality Assurance

Clinical Operations

Biomedical Informatics in Clinical Trial Management

Risk Management Tools

Pharmacoepidemiology

International Regulatory Affairs

Scientific Writing for Translation for Medicine

Spring/

 Year 2

Elective

Elective

Applied Clinical Trials & GCP

Elective

Principles Of Pharmacovigilance

Data Analysis and Interpretation or Multiple Analyses in Clinical Trials

Elective

Special Topics in Clinical Trial Sciences

Summer / Year 2 (Mandatory for Medical Affairs) Capstone

The Practice of Medical Affairs

Fall/

 Year 3

Regulatory Requirements for Medical Devices/Diagnostics

Elective

Elective

Elective

Signal Detection & Quantifying Risk

Elective

Spring /Year 3 Regulatory Writing for Submissions & Publication

Capstone Course (or Evidence Based Literature Review or Scientific Writing for Translation for Medicine)

Principles of Subject Recruitment and Retention

Capstone Course (or Evidence Based Literature Review or Scientific Writing for Translation for Medicine)

Clinical Pharmacology

Capstone Course (or Evidence Based Literature Review or Scientific Writing for Translation for Medicine)

**Physicians/PharmDs/Nurses may replace this course with an elective or a course from one of the other tracks.

The Biopharma Educational Initiative offers three, 15 credit online certificates: Certificate in Recruitment Sciences, Certificate in Regulatory Affairs, and Certificate in Drug Safety & Pharmacovigilance.  The Requirements for Graduation (RG) for each certificate are listed below.

Certificate in Clinical Trials Recruitment Sciences

Course Code Title Credits
Core-Required  
BPHE 5510P Overview of Disease Processes and Treatment 3
BPHE 5521P Regulatory and Ethical Requirements in Clinical Investigation 3
BPHE 6985P Principles of Subject Recruitment and Retention 3