The Biopharma Educational Initiative An Industry & University Collaboration Rutgers Masters of Science in Clinical Trial Sciences Overview of BioPharma Educational Initiative Created April 2015 Lisa Palladino Kim Capstone Course Manager/Adjunct Faculty MS in Clinical Trial Sciences, BioPharma Educational Initiative School of Health Related Professions Rutgers, The State University of New Jersey, 65 Bergen St. Rm 171, Newark, NJ

The Biopharma Educational Initiative An Industry & University Collaboration Agenda Biopharma Educational Initiative Online Graduate Level Certification Program Master of Science in Clinical Trial Sciences Mentorship Opportunity Capstone Course BPHE7610 Open Discussion 2

The Biopharma Educational Initiative An Industry & University Collaboration Biopharma Educational Initiative Industry-University collaboration 100% Web-based (online) education Educate individuals to become Clinical Research Professionals who possess a thorough understanding of drug and device development and are either working in or desire to join the biopharmaceutical workforce Post-Baccalaureate Certifications (15 credits) Master’s Degree Program (36 credits)

The Biopharma Educational Initiative An Industry & University Collaboration Online Graduate Level Certification Programs Online, multi-school Academic Certifications (each 15 credits) Regulatory Affairs Clinical Recruitment Science Clinical Trial Informatics Drug Safety & Pharmacovigilance Credits taken can be accepted as Transfer Credit into the Masters Degree provided the student has earned a “B” or better.

The Biopharma Educational Initiative An Industry & University Collaboration Master’s Degree in Clinical Trial Sciences Awarded by Rutgers's School of Health Related Sciences Program goals vary depending on track chosen All students will be able to: Describe: Drug development process Identify and edit elements of a protocol Explain research designs Learn to apply Ethical principles to the development and conduct of clinical trials Interpret regulatory documents. 4 specialization tracks (27 credits): Clinical Trial Management and Recruitment Clinical Trials Informatics Regulatory Affairs Drug Safety and Pharmacovigilance 4 specialization tracks (27 credits): Clinical Trial Management and Recruitment Clinical Trials Informatics Regulatory Affairs Drug Safety and Pharmacovigilance Core content (9 credits): Clinical Trial Overview: Methods and Practice Regulatory and Ethical Requirements Capstone Course or Evidenced Based Literature Review Core content (9 credits): Clinical Trial Overview: Methods and Practice Regulatory and Ethical Requirements Capstone Course or Evidenced Based Literature Review Total of 36 credits Full or Part-time Total of 36 credits Full or Part-time 5

The Biopharma Educational Initiative An Industry & University Collaboration Courses in each Specialization track Clinical Trial Management and Recruitment Biomedical Informatics for Clinical Trials Multiple Analyses in Clinical Trials Overview of Disease Process and Treatment Applied Clinical Trials & Good Clinical Practices Principles of Subject Recruitment and Retention Clinical Operations Project Management Clinical trials informatics Health Care Information Systems Biomedical Informatics for Clinical Trials SAS Applications in Biomedical and Clinical Research Electronic Medical Records Healthcare Information Processing Using XML Applied Clinical Trials Regulatory Affairs Multiple Analyses in Clinical Trials Concepts of GxPs and Quality Assurance Writing for Submissions and Publication International Regulatory Affairs Advertising and Labeling of Pharmaceuticals Regulatory Requirements for Medical Devices Drug Safety and Pharmacovigilance Pharmacology and Analyzing Drug Safety Principles of Pharmacovigilance Adverse Events Reporting and Post marketing Risk Management Tools Pharmacoepidemiology Data Mining and Quantitative Benefit-Risk 6

The Biopharma Educational Initiative An Industry & University Collaboration Currently Accepting Applications for Fall 2015 MS Deadline: August 12, CERT/Non-Matriculated Deadline: August 19 Tuition For Academic Year is $ per credit NJ resident $ per credit non-resident All fees are included in the tuition except for an initial administrative fee and a graduation fee Application fee for: Masters Degree is $65 Certificate Program or as Non- Matriculated student is $100 Students enrolled in the Masters Degree may be eligible for Financial Aid All fees, tuition and charges are subject to change at any time at the discretion of the University. Tuition and Fees

The Biopharma Educational Initiative An Industry & University Collaboration But Wait, there is more to this Initiative... A Mentorship Opportunity for you! Rutgers partners with industry to mentor our Capstone Course students. A field/project experience course.

The Biopharma Educational Initiative An Industry & University Collaboration Field/Project Mentorship Experience Overview Provides: An opportunity for students to integrate knowledge and skills acquired throughout the program in a practice setting intricately involved in drug development Individualized experiences based on identified goals and competencies, and the student’s specialization track Designed to be flexible: Project is on a topic of mutual interest On-site or remote Current employer or outside organization Typically up to approximately 270 hours over one (or two) semester(s) Additional facts: Non-paying position Student complete the HIPPA and CITI certifications If the company requires, Criminal Background Check, drug screening, additional immunizations, and/or signing confidentiality disclosure forms Students are required to have a B or better in ALL previous coursework if paired with an outside organization 9

The Biopharma Educational Initiative An Industry & University Collaboration Rutgers has placed students with clinical study sites, IRBs, CROs, service providers, advocacy foundations, and pharmaceutical companies. Our students have: Reconciled adverse events Created source document templates for a protocol Prepared an Investigator binder Created a Research Data Repository Identified patients at a sites database that are likely to experience disease progression and create a diagnostic tool Performed aspects of a study coordinator/assistant role Our students investigated: Understanding and implementing Clinical Trial Management Systems to their fullest potential Informed Consent in Pediatric Research Bridging the Gap of Challenges and Issues related to Adaptive Design for Clinical Trials Humanitarian Use Devices Improving Minority Participation for Recruitment in Clinical Trials Co-Development of Personalized Medicine and In Vitro Diagnostic Companion Devices 10

The Biopharma Educational Initiative An Industry & University Collaboration 11 I wish I could find somebody to investigate and compare new technologies for my department? FDA just released a new guidance, I wonder how that will impact our deliverables and cycle time? We would love to create a white paper on how patients can provide protocol feasibility insight. We just developed a new process, now we need to create an implementation plan and training program. Should our department start tracking AEs related to birth if the study subject was a male instead of a female? Students from a field mentorship program could be an asset to my organization.

The Biopharma Educational Initiative An Industry & University Collaboration 12 Roles: Rutgers Capstone Manager (Lisa Palladino Kim, Provides assistance in establishing a contractual relationship with the site and assisting with the development of project objectives per Preceptor (for students performing field mentorships): Provides assistance to define students objectives, scope or work, and site specific deliverables. Signs final contract. 1.Decide if your company is interested in this opportunity 2.Proactively work with Rutgers Capstone Manager to: –Ensure standard contract is legally and/or human resource approved (edits to the standard language will require Rutgers legal agreement (this requires time)) –Identify the types of opportunities available (logistics, topics, interests) so Rutgers can identify a student to match opportunity 3.When a match is identified (normally one semester prior to start of student experience), –Provide assistance to define measurable student objectives, scope of work, and site specific deliverables –Finalize contract with specific students objectives (legal contract must be signed with site prior to the first day of the students experience) 4.Provide field mentorship to student during semester What does this mean to you?

The Biopharma Educational Initiative An Industry & University Collaboration Roles during the semester During the semester, students would work closely with their assigned faculty project advisor and preceptor (you or your colleague) to produce a project plan and one or two main deliverable(s) (research/white paper, oral presentation or webinar, abstract & poster presentation submitted to a conference, or organizational specific documents created from scratch/without a template), through in-depth research.. Rutgers faculty project advisor: Provides high level guidance to student, addresses any conflicts or concerns that might arise, and periodically checks in with you regarding student’s progress. Rutgers faculty project advisor will be responsible for grading the students main course deliverables. (Note, deliverables can be de-identified or advisor can sign your companies confidentiality disclosure agreement, if required.) Preceptor: Provides assistance to refine students objectives, scope or work, and site specific deliverables. Provides the most guidance on the students activities, project plan, and other deliverables. The Rutgers faculty project advisor’s role is to make sure it is robust enough and scholarly for course credit. At the end of the semester, Rutgers will reach out to obtain your overall semester feedback, which translates into points and is counted towards the students grade. 13

The Biopharma Educational Initiative An Industry & University Collaboration Your Opportunities Mentor a MS Clinical Trial Science Capstone Course Student Continue Your Education MS in Clinical Trial Sciences Continue Your Education Certification Share Your knowledge about this program with your colleagues and friends

The Biopharma Educational Initiative An Industry & University Collaboration Looking forward to collaborating on these amazing opportunities! Any questions, please contact: Lisa Palladino Kim Capstone Course Manager/Adjunct Faculty Mobile Website: 15

The Biopharma Educational Initiative An Industry & University Collaboration Back up 16 ee of placement.

The Biopharma Educational Initiative An Industry & University Collaboration CERTIFICATE IN CLINICAL TRIALS RECRUITMENT SCIENCES As the number of clinical trials increases globally, so has the competition for study subjects. This certificate was designed specifically to assist the biopharmaceutical employee to develop and validate strategies for clinical trial subject recruitment and retention. This 15 credit (5 courses) online program provides students with a solid understanding of the new discipline – Patient Recruitment Science – and prepares them to apply these strategies to reduce drug cycle time. Required BPHE 5510POverview of Disease Processes and Treatment3 cr BPHE 5521PRegulatory and Ethical Requirements in Clinical Investigation3 cr BPHE 6985PPrinciples of Subject Recruitment and Retention3 cr Approved ElectivesElectives-choose Two (with Advisement) BINF 5075EBiomedical Bioinformatics for Clinical Trial Management3 cr BPHE 6352PApplied Clinical Trials & GCP3 cr BPHE 6510PClinical Operations3 cr Courses from the other Biopharma Certificates may be taken as electives with approval

The Biopharma Educational Initiative An Industry & University Collaboration CERTIFICATE IN CLINICAL TRIALS REGULATORY AFFAIRS The laws and regulations related to the development and marketing of drugs, biologics and medical devices are often complex and continually changing. Regulatory Affairs professionals are needed to interpret these laws both in the US and internationally, file the appropriate documents, and provide strategic and operational guidance in meeting the requirements of global regulatory agencies. This 15-credit online certificate provides students with a comprehensive review of food, drug, and device law and concepts of quality control and quality assurance to ensure compliance with government regulations. Required BPHE 5310PClinical Trials Overview: Methods and Process3 cr BPHE 5521PRegulatory and Ethical Requirements in Clinical Investigation3 cr BPHE 5725PAdverse Event Reporting & Postmarketing Activities3 cr Approved ElectivesElectives-choose Two (with Advisement) BPHE 5110PFood and Drug Law3 cr BPHE 6200PConcepts of GxPs and Quality Assurance3 cr BPHE 6500PRegulatory Requirements for Medical Devices3 cr BPHE 6530PInternational Regulatory Affairs3 cr BPHE 6600PAdvertising & Labeling in Marketing Pharmaceuticals3 cr BPHE 6800PRegulatory Writing for Submission & Publication3 cr Courses from the other Biopharma Certificates may be taken as electives with approval

The Biopharma Educational Initiative An Industry & University Collaboration CERTIFICATE IN CLINICAL TRIALS INFORMATICS Rapidly expanding research data sets used in clinical trials provide the Biopharma industry with prized information to guide drug development, marketing, and surveillance. Understanding how to collect and utilize that information through medical bioinformatics is a key skill for the clinical research professional. This 15-credit online certificate provides students with both the theoretical and practical experience to design data bases for the collection of clinical trial outcome measures and adverse events. In addition, as a clinical data manager, students will be prepared to make meaningful contributions to trial design based on principles of data collection. Required BINF 5005EHealthcare Information Systems 3 cr BINF 5075EBiomedical Informatics for Clinical Trials Management3 cr BPHE 5800Using Computerized Systems in clinical Research & Risk Management3 cr Approved ElectivesElectives-choose Two (with Advisement) BINF 5210ESAS Application in Biomedical & Clinical Research3 cr BINF 5311EIntroduction to Electronic Health Records3 cr BINF 5312EHealth Information Processing in XML3 cr BPHE 5310PClinical Trials Overview: Methods and Process3 cr BPHE 5521PRegulatory and Ethical Requirements in Clinical Investigation3 cr BPHE 6352PApplied Clinical Trials & GCP3 cr Courses from the other Biopharma Certificates may be taken as electives with approval

The Biopharma Educational Initiative An Industry & University Collaboration CERTIFICATE IN DRUG SAFETY & PHARMACOVIGILANCE There is a risk: benefit ratio for every drug, biologic, and medical device. Some of the risks are known early on during the drug development process, but some risks do not become apparent until after the drug has been marketed. In either case the drug company must report these risks to the regulatory agencies. The emphasis of this certificate is placed on the processing and reporting of serious adverse events, understanding global regulations, filing the necessary regulatory documents, answering regulatory approval queries, and promoting the use of risk mitigation strategies. Students will be able to assess adverse events according to severity, file all necessary documents to inform the regulatory agencies of adverse events, develop and prepare a Risk Management Minimization System and the European equivalent, and identify post-marketing adverse event data from multiple sources. Required BPHE 5521PRegulatory & Ethical Requirements in Clinical Investigation3 cr BPHE 5725PAdverse Event Reporting & Postmarketing Activities3 cr BPHE 5780PPrinciples of Pharmacovigliance, Regulations, & Drug Safety Reporting3 cr Approved ElectivesElectives-choose Two (with Advisement) BPHE 5510POverview of Disease Processes and Treatment3 cr BPHE 6000PRisk Management Tools3 cr BPHE 7510PClinical Pharmacology or NUTR 7510 Nutrition & Pharmacology3 cr BPHE 7600PAnalyzing Clinical Data To Determine Adverse Events3 cr