Roche GroupPharmaceutical IndustryFellowship Program

In partnership with

Roche GroupPharmaceutical IndustryFellowship Program

In partnership with

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Table of ContentsWelcome ......................................................................................................................3

About Roche Group ................................................................................................4

Fellowship Program .................................................................................................6

Preceptors ...................................................................................................................7

Clinical Operations ..................................................................................................9

Clinical Science - Late Stage Development .................................................10

Clinical Science - Translational Medicine .....................................................11

Drug Safety and Risk Management ................................................................12

Global Business Development and Licensing .............................................13

Medical Affairs/ Medical Communications ..................................................14

Regulatory Affairs ...................................................................................................15

US Medical Affairs/ Medical Science Liaison .............................................16

Rotation Opportunities .........................................................................................17

Rutgers Program History .....................................................................................18

Application Process and Eligibility Requirements......................................20

Alumni Testimonials ..............................................................................................21

Roche Group Fellowship 2015-2017 ...............................................................22

Welcome

Eriene Wasef, Pharm.D.Senior Associate Director, Translational Medicine - NORDProgram Director, Roche Innovation Center New York - Rutgers Fellowship Program

Beatrice Lavery, M.S.Vice President, Product Development Regulatory Program Director,Genentech - Rutgers Fellowship Program

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Dear Prospective Fellow:

On behalf of the Roche Group and the Ernest Mario School of Pharmacy at Rutgers University, we thank you for your interest in a Fellowship at Roche.

A global pioneer in healthcare since 1896, Roche is a world leader in biotechnology and in vitro diagnostics, creating and delivering innovative medicines and diagnostic tests for patients worldwide. We are passionate and rigorous about our science. We invest over 9 billion Swiss francs in Research and Development (R&D) every year, amongst the highest R&D spends in the world across all industries. Over half of the compounds in our product pipeline are biopharmaceuticals enabling us to deliver better-targeted therapies for patients. This year more than 74 new molecules are in clinical development and since 2013, 17 have been granted FDA breakthrough therapy designations.

For more than 30 years, Roche has also played a major role in fostering the professional growth of pharmacists in pharmaceutical research, development, and commercialization, especially for Doctor of Pharmacy graduates. We offer motivated PharmD Fellows, who share our purpose to improve the lives of patients, exciting opportunities to develop their skills and pursue their interests at two key locations:

• Genentech, a member of the Roche Group and US headquarters for Roche pharmaceutical operations, in South San Francisco, California, where the biotechnology industry began and continues to thrive.

• The Roche Innovation Center New York in New York City, with access to the practice of medicine and innovative research in world-class hospitals and academic institutions.

This program offers you an opportunity to make important contributions that can help shape the future of healthcare for patients as well as thrive professionally. We aim to cultivate one of the best educational environments for PharmD graduates through our commitment to quality and excellence. Fellows have the opportunity to develop or enhance their knowledge and skills while experiencing a corporate culture that encourages diversity of thought, style, skill, and perspective as well as a dynamic environment of international colleagues. While the Fellowship is structured, it is still flexible enough to allow participants to engage in a wide array of unique opportunities and obtain a solid experience in the healthcare industry.

We look forward to meeting you and discussing how this program can serve as your pathway to an exciting career in helping to improve patients’ lives.

Sincerely,

Dear Prospective Fellow:

On behalf of the Roche Group and the Ernest Mario School of Pharmacy at Rutgers University, we thank you for your interest in a Fellowship at Roche.

A global pioneer in healthcare since 1896, Roche is a world leader in biotechnology and in vitro diagnostics, creating and delivering innovative medicines and diagnostic tests for patients worldwide. We are passionate and rigorous about our science. We invest over 9 billion Swiss Francs in Research and Development (R&D) every year, amongst the highest R&D spends in the world across all industries. Over half of the compounds in our product pipeline are biopharmaceuticals enabling us to deliver better-targeted therapies for patients. This year more than 74 new molecules are in clinical development and since 2013, 17 have been granted FDA breakthrough therapy designations.

For more than 30 years, Roche has also played a major role in fostering the professional growth of pharmacists in pharmaceutical research, development, and commercialization, especially for Doctor of Pharmacy graduates. We offer motivated PharmD Fellows, who share our purpose to improve the lives of patients, exciting opportunities to develop their skills and pursue their interests at two key locations:

• Genentech, a member of the Roche Group and US headquarters for Roche pharmaceutical operations, in South San Francisco, California, where the biotechnology industry began and continues to thrive.

• The Roche Innovation Center New York in New York City, with access to the practice of medicine and innovative research in world-class hospitals and academic institutions.

This program offers you an opportunity to make important contributions that can help shape the future of healthcare for patients as well as thrive professionally. We aim to cultivate one of the best educational environments for PharmD graduates through our commitment to quality and excellence. Fellows have the opportunity to develop or enhance their knowledge and skills while experiencing a corporate culture that encourages diversity of thought, style, skill, and perspective as well as a dynamic environment of international colleagues. While the Fellowship is structured, it is still flexible enough to allow participants to engage in a wide array of unique opportunities and obtain a solid experience in the healthcare industry.

We look forward to meeting you and discussing how this program can serve as your pathway to an exciting career in helping to improve patients’ lives.

Sincerely,

Beatrice Lavery, M.S.Vice President, Product Development RegulatoryProgram Director, Genetech - Rutgers Fellowhsip Program

Eriene Wasef, Pharm.D.Senior Associate Director, Translational Medicine - NORDProgram Director, Roche Innovation Center New York - Rutgers Fellowship Program

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Our history

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Doing now what patients need next

Who we areInnovation: it's in our DNA. We have always worked across disciplines and geographies to drive scientific discovery and redefine what is possible to improve patients’ lives.We are working on understanding how diseases differ down to the molecular level. So we can develop new tests and medicines that prevent, diagnose and treat diseases that matter and bring them to the patients who need them. With our combined strengths in diagnostics and pharmaceuticals, our personalized healthcare strategy aims to fit the right treatment to the right patient.

As the world’s largest biotech company, we develop breakthrough medicines, improving the standard-of-care across oncology, immunology, infectious diseases, ophthalmology and neuroscience. We are also the world leader in in vitro diagnostics. This track record allows us to build lasting and meaningful partnerships across the world with research academia and public healthcare institutions.

The founding families continue to hold the majority stake in the company. This stability allows for a tradition of sustainable thinking, so we can learn from setbacks and focus on lasting value for patients and society. We remain dedicated to the highest standards of quality, safety and integrity. Our legacy is based on respect for the individual, the communities and the world we live in.

An extraordinary workplaceWe are a force of over 90,000 people working together across more than 100 countries. Roche is consistently ranked as employer of choice by its employees and by external institutions.

Our purposeWe believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world.

That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world.

Our company was founded in 1896 in Basel, Switzerland by Fritz Hoffmann-La Roche at a time when the industrial revolution was changing the face of Europe. He was among the first to recognize that the industrial manufacture of medicines would be a major advance in the fight against disease and quickly established offices in Milan, New York, St. Petersburg, and London, among other locations. Since then, Roche has grown into one of the world's leading healthcare companies.

Since the 1900s, Roche has remained at the forefront of biomedical knowledge. The company’s achievements are significant and range from the first commercial synthesis of vitamins in the 1930s, to the introduction of antimicrobials in the 1940s; the discovery of psychotherapeutics in the 1950s and 1960s to the birth of biotechnology in the 1980s (recombinant interferon). The achievements also include breakthroughs in the diagnosis and treatment of AIDS to the prevention of organ rejection in the 1990s as well as the development of new treatments for influenza, osteoporosis, hepatitis, arthritis and various forms of cancer since the turn of the century. In 2016, 17 billion diagnostic tests for patients worldwide were conducted using Roche instruments and 26.5 million patients were treated with top 25 Roche medicines worldwide in the areas of for example: cancer, infectious diseases, inflammation, multiple sclerosis.

In 2009, the Roche Group completed the privatization of Genentech - founded in 1976 as the first and original biotech company. Within a few short years, Genentech successfully demonstrated the viability of using recombinant DNA technology and was later the first to develop a biotech product (recombinant human insulin).

At the end of 2016, Roche and its 15 R&D centers worldwide actively engaged in more than 200+ R&D partnerships with academia, startups and others to shape the future of healthcare in recognition of the company’s purpose: doing now what patients need next. This resulted in:

• 8 Next generation diagnostics instruments launched in 2015

17 FDA breakthrough therapy designations since 2013

In addition, Roche colleagues worked to put in place local solutions and plans for patients in 60+ countries to ensure their access to needed healthcare, especially tests and medicines.

Doing now what patients need next

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Our company was founded in 1896 in Basel, Switzerland by Fritz Hoffmann-La Roche at a time when the industrial revolution was changing the face of Europe. He was among the first to recognize that the industrial manufacture of medicines would be a major advance in the fight against disease and quickly established offices in Milan, New York, St. Petersburg, and London, among other locations. Since then, Roche has grown into one of the world’s leading healthcare companies.

Since the 1900s, Roche has remained at the forefront of biomedical knowledge. The company’s achievements are significant and range from the first commercial synthesis of vitamins in the 1930s, to the introduction of antimicrobials in the 1940s; the discovery of psychotherapeutics in the 1950s and 1960s to the birth of biotechnology in the 1980s (recombinant interferon). The achievements also include breakthroughs in the diagnosis and treatment of AIDS and prevention of organ rejection in the 1990s as well as the development of new treatments for influenza, osteoporosis, hepatitis, arthritis and various forms of cancer since the turn of the century.

In 2016, 17 billion diagnostic tests for patients worldwide were conducted using Roche instruments and 26.5 million patients were treated with top 25 Roche medicines worldwide in areas including: cancer, infectious diseases, inflammation, multiple sclerosis.

In 2009, the Roche Group completed the privatization of Genentech - founded in 1976 as the first and original biotech company. Within a few short years, Genentech successfully demonstrated the viability of using recombinant DNA technology and was later the first to develop a biotech product (recombinant human insulin).

At the end of 2016, Roche and its 15 R&D centers worldwide actively engaged in more than 200+ R&D partnerships with academia, startups and others to shape the future of healthcare in recognition of the company’s purpose: doing now what patients need next. This resulted in:

• 8 next generation diagnostics instruments launched in 2015

• 17 FDA breakthrough therapy designations since 2013

In addition, Roche colleagues worked to put in place local solutions and plans for patients in 60+ countries to ensure their access to needed healthcare, especially tests and medicines.

Our History Who we are

Innovation: it’s in our DNA. We have always worked across disciplines and geographies to drive scientific discovery and redefine what is possible to improve patients’ lives.We are working on understanding how diseases differ down to the molecular level. So we can develop new tests and medicines that prevent, diagnose and treat diseases that matter and bring them to the patients who need them. With our combined strengths in diagnostics and pharmaceuticals, our personalized healthcare strategy aims to fit the right treatment to the right patient.

As the world’s largest biotech company, we develop breakthrough medicines, improving the standard-of-care across oncology, immunology, infectious diseases, ophthalmology and neuroscience. We are also the world leader in in vitro diagnostics. This track record allows us to build lasting and meaningful partnerships across the world with research academia and public healthcare institutions.

The founding families continue to hold the majority stake in the company. This stability allows for a tradition of sustainable thinking, so we can learn from setbacks and focus on lasting value for patients and society. We remain dedicated to the highest standards of quality, safety and integrity. Our legacy is based on respect for the individual, the communities and the world we live in.

An extraordinary workplace

We are a force of over 90,000 people working together across more than 100 countries. Roche is consistently ranked as employer by choice of its employees and by external institutions.

Our purpose

We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world.

That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world.

Basel, Switzerland

Welwyn, United Kingdom

New York City, New York

Shanghai, China

Tokyo, Japan

Roche at a Glance

Headquartered in Basel, Switzerland; more than 94,000 employees worldwide

Top investor in healthcare R&D with over 9 billion Swiss Francs annually; 2/3 of R&D is focused on combining targeted therapies with companion diagnostic tests

26.5 million patients were treated with one of Roche`s 25 leading products in 2016

Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy

74 new molecular entities (NMEs) in clinical development; 17 FDA Breakthrough designations since 2013

Genentech at a Glance

Headquartered in South SanFrancisco, CA; employs approximately 14,000 people

Genentech is a member of the Roche Group and is the U.S. Headquarters for Roche pharmaceutical operations

In 2016, FORTUNE magazine named Genentech among the “100 Best Companies to Work For” for the nineteenth consecutive year...

Named by Science as a "Top Employer" for 13 years (2002-2016)

In 2017, FORTUNE magazine ranked Genentech No.12 on its inaugural list of "Top 50 Workplaces for Giving Back"

In 2016, Genentech was named one of the “Top Twenty Employers” in biotechnology and pharmaceuticals by Science careers

In 2012, Genentech was named to Fast Company’s 2012 “The World’s 50 Most Innovative Companies” list for mak-ing targeted, genetics-based cancer therapies. According to the magazine, the list is comprised of companies “whose innovations are having an impact across their industries and our culture.” Genentech was also ranked number two in the “Biotech Industry” category

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Top employer award 2017: Roche Pharma, Diagnostics, and Diabetes Care- UK and Spain; Roche Pharma and Diabetes Care- France; Roche Pharma- Poland and Italy; Roche Pharma and Diagnostics- China; Nederland

Ranked No. 6 this year.

In 2017, DiversityInc named Genentech among the “Top 50 Companies for Diversity,” and “Top 12 Companies for Employee Resource Groups"

• Headquartered in Basel, Switzerland; more than 94,000 employees worldwide

• Top investor in healthcare R&D with over 9 billion Swiss Francs annually; 2/3 of R&D is focused on combining targeted therapies with companion diagnostic tests

• 26.5 million patients were treated with one of Roche`s 25 leading products in 2016

• Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy

• 74 new molecular entities (NMEs) in clinical development; 17 FDA breakthrough designations since 2013

• Top employer award 2017: Roche Pharma, Diagnostics, and Diabetes Care- UK and Spain; Roche Pharma and Diabetes Care- France; Roche Pharma- Poland and Italy; Roche Pharma and Diagnostics- China; Nederland

• Named by Science as a “Top Employer” for 13 years (2002-2016)

• Headquartered in South San Francisco, CA; employs approximately 14,000 people

• Genentech is a member of the Roche Group and is the U.S. Headquarters for Roche pharmaceutical operations

• In 2016, FORTUNE magazine named Genentech among the “100 Best Companies to Work For” for the nineteenth consecutive year; Ranked No.6 this year

• In 2017, FORTUNE magazine ranked Genentech No.12 on its inaugural list of “Top 50 Workplaces for Giving Back”

• In 2017, DiversityInc named Genentech among the “Top 50 Companies for Diversity,” and “Top 12 Companies for Employee Resource Groups

• In 2016, Genentech was named one of the “Top Twenty Employers” in biotechnology and pharmaceuticals by Science careers

• In 2012, Genentech was named to Fast Company’s 2012 “The World’s 50 Most Innovative Companies” list for making targeted, genetics-based cancer therapies. According to the magazine, the list is comprised of companies “whose innovations are having an impact across their industries and our culture.” Genentech was also ranked number two in the “Biotech Industry” category

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Fellowship Positions & Locations

Roche Innovation Center New York - New York, NY

Second Year Rotations:

During the second year of certain fellowships, the Fellow may elect to rotate through various departments within Genentech or Roche that are of interest to the Fellow and have an available preceptor or manager.

Clinical Science - Translational Medicine (2)

Global Busines Development - I nflamation, Immunology, and Infection Disease ( I2I ) (1)

Genentech - South San Francisco, CA

Clinical Operations (2)

Clinical Science - Late Stage Development (2)

Drug Safety and Drug Management (1)

Medical Communications (1)

Regulatory Affairs (2)

US Medical Affairs/Medical Science Liaison (2)

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Purpose of the Fellowship

Roche has the distinction of being one of the first Rutgers Fellowship sponsors and has been a participating company for over 30 years. The purpose of this unique program is to provide PharmDs with the opportunity to gain specialized and in-depth training and experience in a particular discipline within the pharmaceutical industry. The Fellowship Program within Roche Innovation Center New York and Genentech is designed to allow Fellows to develop the specific skills required to function independently and competently in their area of practice.

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Inflamation(1)

The duration of all fellowship positions at the New York and San Francisco locations is 2-years.

• Roche Innovation Center New York - New York, NY

• Genentech - South San Francisco, CA

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• Clinical Science - Translational Medicine (2)

• Global Business Development and Licensing- Inflammation, Immunology, and Infectious Disease (1)

• Clinical Operations (2)

• Clinical Science - Late Stage Development (2)

• Drug Safety and Risk Management (1)

• Medical Affairs/ Medical Communications (1)

• Regulatory Affairs (2)

• US Medical Affairs/ Medical Science Liaison (2)

During the second year of certain fellowships, the Fellow may elect to rotate through various departments within Genentech or Roche that are of interest to the Fellow and have an available preceptor or manager.

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Salah El-Saheb, Pharm.D. Operations Program Director Clinical Operations, Oncology Product Development

Clinical Operations

Tania Szado, Ph.D. Director, Oncology Business Manager Clinical Science Oncology - Late Stage Development

Clinical Science - Late Stage Development

Melissa Aldinger, Pharm.D.Clinical ScientistClinical Science Oncology - Late Stage Development

Nicole Richie, Ph.D. Clinical Science Business Strategy Leader I2O/PDN Clinical Science - Late Stage Development

Eriene Wasef, Pharm.D. Senior Associate Director Translational Medicine - NORD

Clinical Science - Translational Medicine

Aileen Le, Pharm.D., BCPS Senior Medical Communications LeaderUS Medical Affairs

Medical Affairs/ Medical Communications

Susan Eng, Pharm.D. Safety Science LeaderAssociate DirectorSafety Science Oncology

Drug Safety and Risk Management

Patrick Schleck, Pharm.D., MBAa.i. Global Head Partnering, Inflammation, Immunology, and Infectious Disease

Global Business Development and Licensing

Preceptors

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Roshni Shah, Pharm.D. Regulatory Associate Program DirectorProduct Development Regulatory (PDR)

Regulatory Affairs Brisdell Hunte, B.S.Regulatory Group DirectorProduct Development Regulatory (PDR)

Jeffrey Miller, B.A. Regulatory Associate Group DirectorProduct Development Regulatory (PDR)

Jessica Priest, Pharm.D. Senior Medical Science LiaisonNeuroscience

US Medical Affairs/ Medical Science Liaison

Sandra Nino-Siddens, Pharm.D. Regulatory Group DirectorProduct Development Regulatory (PDR)

Catherine Sterk, Pharm. D.Associate Director, Medical Science LiaisonsThoracic/Head and NeckBioOncology

Medical Affairs/ Medical Communications

Linda Wang, Pharm.D.Medical Communications LeaderUS Medical Affairs

Anna Cheng, Pharm.D. Medical Communications LeaderUS Medical Affairs

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Global Clinical Operations is a key component of Roche/ Genentech Product Development (PD) in bringing more medicines to patients around the world. This is achieved through planning and efficiently delivering high quality clinical programs to evaluate the safety and efficacy of our development molecules. These programs meet scientific, medical, regulatory and patient demands for medicines globally. As PD’s primary link with clinical sites, we bring our clinical trials to patients.

Clinical Operations activities for the diverse Roche/Genentech late stage portfolio are overseen by three groups, one of which is dedicated entirely to the oncology therapeutic area. Clinical Operations Oncology comprises approximately 300 employees in five sites in North America, Europe and Asia. This group of professionals plan, manage and execute all global late stage clinical trials for approximately 20 molecules for Roche/Genentech: the number one oncology company in the world.

The role involves providing the operational expertise and leadership to one or more clinical operations teams to ensure the effective and efficient delivery of all operational

• Leading the development of study deliverables such as feasibility questionnaires; study level patient recruitment plan and retention strategies

• Organizing investigator meetings, monitor trainings and Contract Research Organization kick off meetings

• Developing and managing operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, study timelines, resources, quality and clinical supplies management

• Ensuring operational tracking tools are identified which meet the needs of the operations team and reporting to the Global Studies Leader

• Developing and managing clinical study budgets and contributing to the staffing/resourcing plans

• Establishing study milestones and ensuring accurate tracking and reporting of study metrics

• Providing direction and leadership to the clinical operations team, whilst liaising with other functions as necessary to the role

• Providing operational input into the development of study deliverables to ensure operational feasibility and delivery

aspects of one or more studies through all phases of Clinical Study Management (Plan, Initiate, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.

Fellow responsibilities and accountabilities include:

Clinical Operations - Oncology (Two Years)

Alexandra MarkusPharm.D.Fellow 2016-2018University at BuffaloSchool of Pharmacy and Pharmaceutical Sciences

James Wall Pharm.D.Fellow 2016-2018University of the PacificThomas J. LongSchool of Pharmacy

Sowmya BandaPharm.D.Fellow 2017-2019Rutgers Ernest Mario School of Pharmacy

Anh-ton DangPharm.D.Fellow 2017-2019Drake UniversityCollege of Pharmacy and Health Sciences

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Patient safety and the development of effective medications for patient care is our primary concern at Genentech. The mission of Product Development Clinical Science (PDC) is to develop and execute innovative and robust product development programs to deliver well-characterized and differentiated medicines to patients with medical need. The primary platform to develop these medications are through clinical trial design and execution. PDC includes 3 therapeutic areas: Oncology (PDO), Neuroscience (PDN), and Inflammation, Infectious Diseases, and Ophthamology (I2O).

The Fellows accepted into our program will have a contributing role in clinical trial design and execution by assisting in writing protocols, informed consent forms, medical data review, scientific publications and presentations, as well as providing ongoing scientific guidance throughout the conduct of the study. In addition to clinical studies, the Fellows may also be involved in the analysis of molecule wide safety signals, analysis of study related data, and contribute to authorship of regulatory related documents.

• Design and execute clinical development plan (CDP) for the confirmatory phase for the first indication and lifecycle of a product

• Establish complete clinical safety profile of our products

• Manage medical content of registration dossier and lead medical support of registration/approval process

• Collaborate (when appropriate) with diagnostics

PDC has the following key clinical development deliverables:

Clinical ScienceLate Stage Development (Two Years)

Brandon CroftPharm.D.Fellow 2016-2018University of OklahomaCollege of Pharmacy

Sarah TroutmanPharm.D.Fellow 2017-2019UNCEshelman School of Pharmacy

PDC specializes in late stage clinical development conducting primarily Phase II/III clinical trials with a goal of further characterizing the efficacy profile of a molecule in a specific disease area. During the fellowship term, the Fellow will receive professional experiences in the following capacities:

• Develop a deep understanding of the molecules in the PDC pipeline

• Ascertain the risk/benefit profile of tested molecules and understand the criteria for moving further in development

• Author key scientific documentation for clinical studies

• Enhance scientific communication skills through presentations, medical congresses and professional meetings

• Assist in ongoing clinical development plans by working closely with Medical Directors on strategic initiatives

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At Roche, all our efforts and activities begin and end with the patient. Therefore, the priority of this department is to ensure that benefit always outweighs risk before proceeding to the next phase of drug development.

During a clinical study, the Fellow may be involved in writing protocols, training study staff and providing scientific/medical support during the entire duration of the study. The Fellow may also be involved in safety signal detection, review and analysis of safety and efficacy data, interim analyses, database start-up or closure activities, and writing/updating regulatory report documents.

The Neuroscience, Ophthalmology, and Rare Diseases Translational Medicine Group provides the scientific and medical contribution to clinical trials. The focus of this global department is Phase I and Phase IItrials with the ultimate goal of bringing new, medically impactful therapies to patients in need.

• Ascertaining the safety and tolerability profile of new drugs in Entry into Human trials in healthy volunteers and patients

• Deepening the understanding of disease biology and the molecular basis of disease heterogeneity by conducting exploratory and proof-of-mechanism studies in healthy volunteers and patients

• Delivering on individual patient needs through the implementation of biomarkers and Personalized Healthcare strategies

• Fully leveraging technologies and capabilities to progress new compounds to the next stage of clinical development through proof-of-concept efficacy trials, which help determine the probability of success for a new therapy

We pursue this difficult, yet rewarding and exciting mission by:

Clinical Science Translational MedicineNeuroscience, Ophthalmology, and Rare Disease (Two Years)

Jessica GarzonPharm.D.Fellow 2016-2018Rutgers Ernest Mario School of Pharmacy

Brittney StarlingPharm.D.Fellow 2017-2019UNCEshelman School of Pharmacy

The Roche Clinical Science Translational Medicine fellowship will be recruiting for up to two new fellows: one fellowship focused in neuroscience and the other in ophthalmology.

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Roche/Genentech has the responsibility to ensure its products are used in a safe and effective manner. To achieve this goal, Roche’s Drug Safety and Risk Management department works closely with study investigators and the medical community in collecting, investigating, monitoring and reporting adverse events. In conjunction with the preceptor and mentor, the Fellow is responsible for evaluating the profiles of Roche/Genentech products throughout their lifecycle to identify potential safety concerns.

The Fellow will be involved in three primary areas of safety surveillance: signal detection, risk assessment and risk management.

The Fellow will develop skills to function in these areas by becoming familiar with pharmacovigilance practices and will have active participation in the following:

• Single case assessment for possible drug causality

• Evaluation and analysis of serious adverse events (SAEs)

• Signal detection and management

• Evaluation and work-up of identified safety issues

• Aggregate safety reports (e.g., Development Safety Update Report, Periodic Safety Update Report)

• Risk Management Plan creation and maintenance

• Maintain integrity and consistency of safety related information in the US and global product labels

• Presentations at department meetings

• In addition to the primary areas of safety evaluation, the Fellow will actively participate in cross-functional activities (e.g., Study Management Teams, global filings) to learn and understand the role of safety in the drug development and lifecycle process

Drug Safety and Risk Management (Two Years)

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Partnering strengthens Roche’s internal research, development, and commercial portfolio by building alliances with world-class leaders in the pharmaceutical and biotechnology industries. By mobilizing other functions at Roche and Genentech, Partnering maximizes the potential of these assets through creative deal terms and fostering a collaborative relationship with the partner.

The Fellow will play an integral role in the I2I team’s “WANT” and “FIND” initiatives in identifying, monitoring and triaging new partnering opportunities. In doing so, the Fellow will gain a general understanding of business development and licensing, build skillsets in competitive intelligence and critical review of preclinical and clinical data, expand internal and external networking skills, understand market drivers in biotech and pharma, and leave with a better understanding of Roche corporate strategy and decision making.

Therapeutic area remit will depend on project load, but is expected to be mostly immunology, inflammation and infectious disease focused.

Scouting / Finding • Monitor and identify new partnering opportunities using both internal and external sources including competitive intelligence databases, press releases, scientific journals, medical and partnering conferences, etc

• Prepare in-depth Competitive Landscape analyses using multiple data sources

• Evaluate and monitor emerging trends in new mechanisms of action

• Prepare in-depth reviews of disease biology, pharmacology, standard of care, and unmet need in new “white space” / opportunistic areas of interest

• Support Roche Partnering I2I team preparation and analysis of scientific, partnering, and investor conferences. Screen and triage companies, data, and presentations to identify areas of focus. Internal and external networking:

• Establish and maintain close collaboration with Partnering colleagues

• Establish and maintain relationships with senior stakeholders involved in asset review and triage

• Attend therapeutic, partnering and investor conferences and network with pharma and biotechnology companies, investors, venture funds, etc.

Triage • Support initial screening and review of data packages provided by Biotech and Pharma partners to determine potential Roche interest based on: mechanism of action (MoA), link to human disease biology, unmet need, strategic fit, and commercial opportunity.

• Prepare robust disease background and MoA analyses for specific assets

• Prepare reviews of unmet need, prescriber base, and market drivers in new areas

• Participate in Roche review team meetings including Q&A with potential partners

• Field and support internal Q&A with Roche cross-functional experts on specific assets

• Present findings and recommendations to RP I2I stakeholders

Participation/Support on Due Diligence Projects: • For identified opportunities that advance to formal Due Diligence, work in close collaboration with Deal Team Leader and other team members

• Assist in Diligence data review, Diligence team debriefs, and preparation of proposals to senior management

Global Business Development and Licensing-Inflammation, Immunology, and Infectious Diseases (I2I) (Two Years)

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As an integral component of the Medical Affairs organization at Genentech, Medical Communications is responsible for communicating customer-focused, relevant, timely, accurate, and balanced information on Genentech’s products to healthcare professionals (HCP) and patients, positively influencing their safe and effective use. We utilize our clinical expertise to respond to unsolicited medical information questions, review and approve medical content in promotional materials, support and collaborate with internal partners, and share customer insights with the medical teams to drive medical strategy.

The Fellow will have the opportunity to develop core competencies in medical information and build relationships with other functional groups at Genentech such as Medical Teams, Managed Care Medical Communications, Global Medical Information, Clinical Development, Regulatory Affairs, Legal, Drug Safety, Field Medical Teams, and Marketing. In addition, the fellowship program is designed to provide the fellow the necessary skills to contribute as an active team member on various multidisciplinary teams. The fellow will also have the opportunity to gain experience in other departments through a second year rotation. Past rotations include Global Medical Information, Medical Education and Grants, Pathways and Guidelines, and Medical Science Liaison.

The Fellow will develop skills to function in these areas by:

• Gaining proficiency with verbal and written communications skills through direct interaction with external HCPs in clinical practice and internal multidisciplinary teams

• Enhancing medical writing expertise through researching, creating, updating, and reviewing fair and scientifically- balanced response documents to meet the medical information needs of worldwide and local customers

• Leveraging clinical expertise to proficiently search internal and external databases, critically evaluate scientific data, and develop evidence-based medical content for responses

• Understanding the legal and compliance guidances that frame the activities in Medical Communications

• Providing medical and scientific support to the Medical and Commercial initiatives, such as identifying emerging insights from customer inquiries

• Working closely with Medical Directors/Medical Science Directors in executing tactics that support the overall medical strategy

• Participating in the medical/scientific review of promotional and non-promotional materials to ensure materials meet legal, medical, regulatory and commercial objectives

• Developing medical educational materials to train cross-functional team members

• Providing medical information support at national medical conferences

Medical Affairs/ Medical Communications (Two Years)

Vivian NguyenPharm.D.Fellow 2016-2018University of Pittsburgh School of Pharmacy

Linh TranPharm.D.Fellow 2017-2019University of New England College of Pharmacy

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Drug development within the pharmaceutical industry is complex and requires compliance with global (U.S. and non-U.S. government; Health Authorities) regulations. Pharmaceutical companies are required to adhere to regulations relevant for preclinical and clinical drug development, product manufacturing, labeling, advertising and marketing.

Regulatory Affairs departments provide the interpretation of global regulations (including the Food and Drug Administration-FDA) within their companies to facilitate drug development that meets the needs of Health Authorities, patients, purchasers and prescribers. The Regulatory Affairs department designs and implements the regulatory strategy to optimally develop, license and market Roche products globally.

Each Regulatory Fellow will receive individual guidance from Regulatory Professionals and obtain an understanding of the role of a Regulatory Affairs department in the drug development process. Each Regulatory Fellow will learn how to apply global regulatory guidelines in the drug development process and will interact with global project teams and interact with Health Authorities, as appropriate.

• Investigational New Drug Applications

• New Drug Applications

• Biologics License Applications

• Development products

• Marketed products activities

• Companion diagnostics

• Chemistry, Manufacturing, and Controls

• Clinical Documentation

• Labeling

• Regulatory records and information

• Regulatory Intelligence

• Health Authorities Interactions

The Regulatory Fellow will acquire a better understanding of the drug development process and the Regulatory Affairs role within a pharmaceutical company through direct experience and/or exposure to:

Regulatory Affairs (Two Years)

Anna GruzmanPharm.D., B.S.Fellow 2016-2018University of California, San Francisco School of Pharmacy

Tian SunPharm.D.Fellow 2016-2018Rutgers Ernest Mario School of Pharmacy

Himika PatelPharm.D., M.S.Fellow 2017-2019University of Southern CaliforniaSchool of Pharmacy

Anthony GuanPharm.D.Fellow 2017-2019Rutgers Ernest Mario School of Pharmacy

Nikole ShpilfogelPharm.D.Fellow 2017-2019 (RICNY)MCPHS University- Boston

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The Medical Team within US Medical Affairs is responsible for developing and executing the medical strategy for both marketed products and pipeline molecules for the US affiliate. In addition to ensuring seamless strategic alignment across various Medical Affairs functional areas, the Medical Team supports Medical Science Liaison (MSL) activities and serves as the liaison between field-based Medical personnel and its Medical counterparts at Genentech’s headquarters in South San Francisco.

The US Medical Affairs/ MSL Fellowship is a two-year program based out of South San Francisco that is designed to expose the Fellow to a broad range of both corporate and field-based US Medical Affairs activities within their respective medical unit. The focus of the second year is determined by the mutual interests of the fellow and the company.

Primary goals of the Fellowship are to provide the Fellow with a thorough knowledge of US Medical Affairs core function and to develop foundational scientific and professional skill sets required for a successful career within pharmaceutical industry.

• Support pre- and peri-launch preparations for new molecular entities

• Plan and oversee the development of Medical field materials for the MSL team

• Attend national/regional medical conferences and participate in Medical Affairs responsibilities

• Provide clinical and scientific insights to colleagues in Marketing, Managed Care, and other cross functional departments as needed

• Enhance presentation and communications skills through interactions with other healthcare providers (HCPs)

Amy LiPharm.D.Fellow 2017-2018UNC Eshelman School of Pharmacy

Lotanna MonekePharm.D.Fellow 2017-2018University of Charleston School of Pharmacy

Medical Science Liaison Component: Alongside with the Medical Affairs experience, the Fellow will also have an opportunity to develop an appreciation of the MSL role. In this capacity, the Fellow will have the opportunity to:

US Medical Affairs/ Medical Science Liaison (Two Years)

• Gain understanding of the MSL role through out the product life cycle

• Participate in MSL strategy and planning sessions with MSL Leadership

• Study the legal and compliance guidances that frame MSL activity and apply in planning of activities

• Gain experience in-field providing HCPs the information they need to take care of patients

• Provide medical support at medical congress meetings by planning and assisting in MSL coverage of key oral and poster presentations

• Assist in planning and analyzing MSL research support

• Gain therapeutic proficiency in products within the Medical Unit’s portfolio

• Work closely with Medical Directors/Medical Science Directors in executing tactics that support the overall medical strategy

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Rotation Opportunities

Certain fellowships offer internal and external rotation opportunities during the fellow’s second year. Here are some rotations that fellows have done in the past. Go explore!

Daniel Da Costa, Pharm.D.Translational MedicineOncology - pREDRoche Innovation CenterNew York, New York2015-2016

Daphne Torre, Pharm.D. US Oncology Marketing - Commercial Genentech, Inc.South San Francisco, CA 2015-2016

Andrew Chia, Pharm.D., M.S. Global Product Strategy Genentech Inc.South San Francisco, CA 2014-2015

Maksim Nestor, Pharm.D. Business Development Roche Innovation Center New York, NY2014-2015

Mary Liu, Pharm.D.Regulatory Policy, Strategy, and IntelligenceHoffman-La Roche, Inc. Washington, DC2011-2012

Jerald Grace, Pharm.D. Regulatory Affairs Roche Diagnostics Indianapolis, IN2011-2012

Bond Vo, Pharm.D.Client Account ServicesLyonHeart (LLNS)Advertising AgencyNew York, NY2009

Alex Morris, Pharm.D.Clinical Science - Pediatric Oncology Genentech, Inc. South San Francisco, CA 2017

Matthew Schmidt, Pharm.D.Competitive IntelligenceGenentech, Inc.South San Francisco, CA2017

Georgina Dall, Pharm.D.Clinical PharmacologyModeling and SimulationMetrum InstituteTariffville, CT2010-2011

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Program HistoryIn 1984, at Rutgers, The State University of New Jersey, the Ernest Mario School of Pharmacy and two pharmaceutical companies began a collaborative pilot program to evaluate the potential contributions of clinically-trained pharmacists within a pharmaceutical industry practice setting. Follow-ing the successful pilot, the Rutgers Pharmaceutical Industry Fellowship (RPIF) Program grew significantly and expanded to include 19 companies within the pharmaceu-tical and biopharmaceutical industries and over 160 fellows annually.

In 2002, Dr. Ernest Mario generously provided an endow-ment to establish the Institute for Pharmaceutical Industry Fellowships to enhance and promote the role of pharma-cists in industry through the RPIF Program. The Institute staff members:

The RPIF Program has thrived under the leadership of the founder, Dr. Joseph A. Barone, Dean and Distinguished Professor II of the Ernest Mario School of Pharmacy and Dr. Michael Toscani, Research Professor and the Fellow-ship Director for the Institute for Pharmaceutical Industry Fellowships.

More than 850 post-doctoral fellows have completed the RPIF Program, most of whom are pursuing influential and rewarding careers in the pharmaceutical and biopharma-ceutical industries throughout the US and abroad. The RPIF Program has preceptors/mentors from industry who share their knowledge and experiences with the fellows through an intense but closely-guided training program. Assignments and projects are challenging, meaningful, and designed to enhance understanding of the pharma-ceutical and biopharmaceutical industries and the fellow’s functional area.

Provide leadership and administrative support;

Promote quality, communication, and scholarly activity; and

Arrange specialized fellowship training opportunities within the pharmaceutical and biopharmaceutical industries.

All fellows gather at Rutgers once or twice monthly as a group to participate in the Professional Development Day (PDD) Series, an important component of their training that complements the hands-on experience provided at the partner companies. The PDDs are steered by a committee of fellows and are designed to enhance the fellows’ presentation skills, emotional intelligence, promote connectivity and a sense of community among fellows from different companies and disciplines, develop new skill sets under the guidance of external trainers, and provide general knowledge about various aspects of drug development and issues facing the pharmaceutical and biopharmaceutical industries.

The fellows learn from each other through individual and group presentations and debates on topics and issues related to the pharmaceutical and biopharmaceutical industries. This dynamic forum provides an opportunity for open discussion and debate among fellows, Rutgers faculty, and company preceptors. In addition, outside experts provide training and professional development in a variety of areas (e.g., tools for corporate success; profes-sional writing, presentations, meeting facilitation, negotiat-ing, influencing, networking, and conflict resolution skills; giving and receiving feedback; and business and dining etiquette). Other PDD guest speakers include senior industry executives, patient advocacy groups, and successful RPIF Program alumni who share their insights and experiences. Importantly, PDDs provide an excellent opportunity for fellows to interact with each other and develop lasting personal friendships and a strong profes-sional network of fellows, faculty, alumni, and other industry executives.

Professional Development Series

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The Rutgers Pharmaceutical Industry Fellowship Program FOSTERs the growth and development of future pharmaceutical and biopharmaceutical industry professionals through the following key program features:

Family of Leading Companies – Partners include several of the top 19 global pharmaceutical and biopharmaceutical companies.

Outstanding Alumni Track Record – Over 850 alumni hold prominent positions at many different companies.

Strong Network – Over 160 fellows each year develop valuable, lasting connections with each other, alumni, preceptors and faculty.

The Pathway to Industry – Since 1984, the Rutgers program has been nationally recognized, trusted, and proven as the pathway to industry for pharmacists.

Enhanced Career Path – Increasingly challenging assignments build depth of experience and enhance the potential for an accelerated career path.

Rigorous Academic Component – Rutgers affiliation provides academic and professional development opportunities.

The Ernest Mario School of Pharmacy, Rutgers University

Rutgers, The State University of New Jersey, with approximately 65,000 students in its three campuses, is one of the major state university systems in the United States. The New Jersey College of Pharmacy was founded in 1892 and was incorporated into the University in 1927. The Ernest Mario School of Pharmacy is the only state school of pharmacyin New Jersey, with approximately 1,400 students in its Doctor of Pharmacy program.

The Rutgers Ernest Mario School of Pharmacy is located on the University’s main science and technology campus in Piscataway, New Jersey. Because of its close proximity to the nation’s leading pharmaceutical and biopharmaceutical companies, the Ernest Mario School of Pharmacy and the RPIF Program are uniquely capable of providing fellows with exposure to the pharmaceutical and biopharmaceutical industries.

Key Program Features

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1,300

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Fellows for the Rutgers Pharmaceutical Industry Fellowship Program are selected on a nationally- competitive basis. Candidates must have completed a Doctor of Pharmacy degree from an ACPE accredited institution before July 1 of the fellowship term.

Participation in the ASHP Midyear Clinical Meeting/PPS is strongly encouraged. Interested individuals are invited to electronically submit a curriculum vitae, three letters of recommendation and a letter of intent and complete a program interest form online by visiting our website at: pharmafellows.rutgers.edu

Please address all correspondence to:

Joseph A. Barone, Pharm.D., F.C.C.P. Dean and Professor IIErnest Mario School of PharmacyRutgers, The State University of New Jersey160 Frelinghuysen RoadPiscataway, NJ 08854-8020

All application materials must only be submitted electronically via our website, pharmafellows.rutgers.edu (Applicant Portal) as early as November 18th. Applicants are strongly encouraged to submit a CV, Letter of Intent and (1) Letter of Recommendation by December 1st.

Application Process and Eligibility Requirements

Joseph A. BaronePharm.D., F.C.C.PDean and Professor IIErnest Mario School of Pharmacy

Michael ToscaniPharm.D.Research ProfessorFellowship DirectorInstitute for Pharmaceutical Industry Fellowship

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Alumni Testimonials

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Patrick Phuong, Pharm.D.Clinical Science AssociateProduct Development OncologyGenentech, A Member of the Roche Group2015- 2017 Clinical Science- Translational Medicine Fellow

Alex Morris, Pharm.D.Program ManagerProduct Development Regulatory - Program ManagementGenentech, A Member of the Roche Group2015- 2017 Regulatory Affairs Fellow

Matthew Schmidt, Pharm.D.Program ManagerProduct Development Regulatory - Program ManagementGenentech, A Member of the Roche Group2015- 2017 Regulatory Affairs Fellow

Angeline Lo, Pharm.D., MAGlobal Studies ManagerProduct Development Global OperationsGenentech, A Member of the Roche Group2015 - 2017 Clinical Operations Fellow

Jennifer Chang, Pharm.D., MBAGlobal Studies ManagerProduct Development Global OperationsGenentech, A Member of the Roche Group2015 - 2017 Clinical Operations Fellow

Sierra Hill, Pharm.D.Program Manager Scientific Collaborations and Congresses, US Medical Affairs Genentech, A Member of the Roche Group2016-2017 Medical Affairs/ MSL Fellow

Hannah (Xinhui) Huang, Pharm.D.Safety ScientistSafety Science OncologyGenentech, A Member of the Roche Group2015-2017 Drug Safety and Risk Management Fellow

Daphne Torre, Pharm.D.Product ManagerOncology MarketingGenentech, A Member of the Roche Group2014-2016 Regulatory Fellow

Anna Cheng, Pharm.D. Associate Global Medical Information Leader

Genentech, A Member of the Roche Group

Daniel Da Costa, Pharm.DClinical Scientist IEarly Clinical DevelopmentStemcentrx, Inc. 2014-2016 Clinical Science - Translational Medicine Fellow

Shannon Dervin, Pharm.D. Associate Medical Science Director

Genentech, A Member of the Roche Group

Michael Stamatis, Pharm.D. Program ManagerProduct Development Regulatory - Program ManagementGenentech, A Member of the Roche Group2014-2016 Regulatory Fellow

Roche Group Fellowship 2014- 2016Where are they now?

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Roche Group Fellowship 2015 - 2017

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