pharmaceutical industry fellowship program · roche/genentech’s product development global (pdg)...

Pharmaceutical Industry

Fellowship Program

In partnership with

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Table of Contents

Welcome 3

Leadership Team 4

Overview 5

About Roche and Genentech

Fellowship Program

Fellowship Positions Offered 7

Preceptors 8

Fellowship Position Descriptions 10

Alumni 17

Rutgers Program 20

Program History

Application Process and Requirements

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

Genentech, a member of the Roche Group. 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. 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.

We offer motivated Pharm.D. graduates, who share our purpose to improve the lives of patients, exciting opportunities to develop their skills and

pursue their interests at Genentech’s US Headquarters for Roche Pharmaceutical Operations in South San Francisco, California, where the

biotechnology industry began and continues to thrive.

We aim to cultivate one of the best educational environments for Pharm.D.

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.

Beatrice Lavery, M.S.Vice President

Product Development Regulatory

Genentech RPIF Program Director

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Tian Sun, Pharm.D.*

Associate Program Director


Leadership Team

Michael Stamatis, Pharm.D.*



Patrick Schleck, Pharm.D., MBA*

Pharma Partnering

Global Head, Immunology and

Infectious Disease

Jerald Grace, Pharm.D.*

Program Director


Beatrice Lavery, M.S.

Vice President


Genentech RPIF Program Director

* RPIF/Genentech Alumni

Tania Szado, Ph.D.

Director, Oncology Science

Strategy and Business Lead

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Our History Who We Are

Our Purpose

Roche was founded in 1896 in Basel, Switzerland by Fritz Hoffmann-La Roche at atime when the industrial revolution was changing the face of Europe. He was amongthe first to recognize that the industrial manufacture of medicines would be a majoradvance in the fight against disease. Since then, Roche has grown into one of theworld's leading healthcare companies, with truly differentiated medicines inoncology, immunology, infectious diseases, ophthalmology and diseases of thecentral nervous system. Roche is also the world leader in in vitro diagnostics, tissue-based cancer diagnostics, and a frontrunner in diabetes management. The RocheGroup, headquartered in Basel, Switzerland, is active in over 100 countries and in2018 employed about 94,000 people worldwide.

Genentech was founded in 1976 as a biotechnology company dedicated to pursuinggroundbreaking science to discover and develop medicines for people with seriousand life-threatening diseases. Genentech’s transformational discoveries include thefirst targeted antibody for cancer and the first medicine for primary progressivemultiple sclerosis. Genentech became a member of the Roche Group in March of2009, at which time Roche and Genentech combined their pharmaceuticaloperations in the United States. Genentech's South San Francisco campus nowserves as the headquarters for Roche pharmaceutical operations in the UnitedStates. Genentech Research and Early Development operates as an independentcenter within Roche.

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. 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.

We believe it is urgent to deliver medical solutions right now – even as we developinnovations for the future. We are passionate about transforming patients’ lives.We are courageous in both decision and action. And we believe that goodbusiness 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.

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Genentech at a Glance

• Founded in 1976, Genentech currently employs approximately 14,000 people in the US and has been consistently ranked as employer of choice by its employees and by external institutions

• Genentech is a member of the Roche Group and is the U.S. Headquarters for Roche Pharmaceutical Operations

• In 2019, FORTUNE magazine ranked Genentech as one of the best 100 companies to work for

• In 2019, Forbes magazine placed Genentech on Best Employers for Diversity

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

• Genentech has been named by Fortune as a “Top Employer” for the past 21 years

The Work We Do Goes Beyond Science

• 127 million patients worldwide have benefited from our

medicines

• Over 40 FDA approved medicines for serious and life

threatening diseases

• 26 FDA Breakthrough Therapy Designations

• Over 70 investigational medicines in development

• Conducted over 1,150 clinical trials worldwide

• 6 areas of focus including Oncology, Immunology,

Infectious Diseases, Ophthalmology, and Neuroscience

Genentech by the Numbers

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• Invested over $57 million in charitable contributions to

advance science, support patients, and local

communities

• 60,000 patients receive free Genentech drug each year

• Global Clinical Operations (2)

• Clinical Science - Late Stage Development (1)

• Product Development Clinical Safety (1)

• US Medical Affairs / Medical Communications (1)

• Product Development Regulatory (2)

• US Medical Affairs / Medical Science Liaison (2)

• Pharma Partnering (1)

Genentech Headquarters – South San Francisco, CA

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Fellowship Positions Offered

Preceptors

US Medical Affairs / Medical Science Liaison

Jessica Priest, Pharm.D.

Senior Medical Science Liaison

Neuroscience

Clinical Science – Late Stage DevelopmentUS Medical Affairs / Medical

Communications - Oncology

Catherine Sterk, Pharm.D.

Field Lead West

Lung/GU/Dermatology, BioOncology

Kevin Henderson, Pharm.D., MBA

US Medical Science Liaison

Team Lead

Hematology, BioOncology

Daniela Ferrara, M.D., M.S., Ph.D.

Senior Medical Director

Clinical Science – Ophthalmology

Siv Lam, Pharm.D.

Senior Clinical Scientist

Clinical Science – Oncology

Marco Prunotto, Ph.D.

Senior Clinical Development Scientist

Immunology Infectious Diseases &

Ophthalmology (I2O)

Linda Wang, Pharm.D.

Senior Medical Science Director

US Medical Affairs – BioOncology

Archie Yellow-Duke, Pharm.D.

Medical Science Director

US Medical Affairs – BioOncology

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Preceptors

Regulatory Affairs

Robyn Harrington, M.S.

Associate Regulatory Group Director

Product Development Regulatory –

Oncology

Sandra Nino-Siddens, Pharm.D.

Regulatory Group Director


Oncology

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Pharma Partnering

Patrick Schleck, Pharm.D., MBA

Pharma Partnering

Global Head, Immunology and

Infectious Disease

Beth Odeh-Frikert, Pharm.D.

Pharma Partnering

Head, SSF Global Alliance and

Asset Management

Global Clinical Operations

Monica Eason

Operations Program Leader, Product

Development Global Clinical

Operations – I2ON

Jenee Pan, Pharm.D.

Operations Program Leader, Product

Development Global Clinical

Operations - Oncology

Product Development Safety Science – Oncology

Susan Eng, Pharm.D.

Associate Group Director

Portfolio Clinical Safety

Danny S. Gonzalez, Pharm.D.

Pharmacovigilance Process Leader

Safety Science – Oncology

Cynthia Nguyen, Pharm.D.

Program Director

Product Development Regulatory -

Oncology

Michael Stamatis, Pharm.D.



Oncology

Activities

Fellow responsibilities and accountabilities may include:

• Providing operational expertise and leadership to one or more cross-functional

global Study Management Teams (SMTs) to ensure operational feasibility and

quality execution.

• Developing and maintaining effective working relationships with SMT members,

with particular focus on affiliate teams, external Contract Research Organization

(CRO) teams, and co-development partner study teams.

• Providing direction and leadership to the global country clinical operations team,

while liaising with other functions as necessary to the role.

• Developing and managing operational plans including site monitoring strategies,

risk mitigation strategies, trial budgets, site selection, study timelines, resources,

quality and clinical supplies management.

• Leading identification and selection of vendors; performing ongoing vendor

management (e.g., CROs, Central Labs, IxRS, etc.), including negotiation of scope

of work, budgets, performance management, and issue resolution.

• Developing and supporting site and CRO/vendor audit and quality plans.

• Leading the development of study deliverables such as feasibility questionnaires,

study-level patient recruitment/retention plans, and patient-centric strategies.

• Establishing study milestones and ensuring accurate tracking and reporting of

study metrics.

Overview

Roche/Genentech’s Product Development Global (PDG) Clinical

Operations organization is dedicated to the planning and management

of clinical trials across the globe. Our vision is to be a key driver of

Roche's success in bringing more medicines to patients around the

world. This is achieved through planning and efficiently delivering high

quality registrational clinical programs (Phase Ib-III) to evaluate the

safety and efficacy of our development molecules. Like all of our

colleagues across Roche, at PDG we are inspired first and foremost by

the millions of people around the world who are waiting for new

treatments that will help them conquer disease and preserve wellness.

Genentech offers two fellowship positions in Global Clinical Operations

within two exciting therapeutic areas: Oncology (Onc) and Immunology,

Infectious Diseases, Ophthalmology and Neuroscience (I2ON). As part of

a global, cross-functional team, fellows will develop and execute study

management strategies to deliver on all operational aspects of a clinical

trial. Fellows will have the opportunity to work closely with other

functions responsible for trial strategy and delivery (i.e. clinical science,

regulatory, safety, biostatistics, and country affiliates). Fellows will also

play a key role in driving clinical trials to run faster and smarter - from

streamlining processes that improve the patient experience to using

innovative strategies to elevate the quality and value of trial data.

Global Clinical Operations

Eva Cybulski, Pharm.D.

Fellow 2019-2021

Midwestern University

Chicago College of Pharmacy

Joseph Hubbard, Pharm.D.

Fellow 2019-2021

University of Michigan

College of Pharmacy

Melissa Kimura, Pharm.D.

Fellow 2018-2020

California Northstate University

College of Pharmacy

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OverviewThe development of effective and safe medications for patients is our

primary focus 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 unmet medical need. PDC

includes 3 therapeutic areas: Oncology (PDO), Neuroscience (PDN),

and Inflammation, Infectious Diseases, and Ophthalmology (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 a study. 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 documents.

Iris To, Pharm.D.

Fellow 2018-2020

University of Washington

School of Pharmacy

Ernest Mofor, Pharm.D.

Fellow 2018-2020

Roseman University of

Health Sciences - Utah

Anastasia Loukitcheva, Pharm.D.

Fellow 2018-2020

Midwestern University, Chicago

College of Pharmacy

Clinical Science - Late Stage Development

Matthew Birrenkott, Pharm.D.

Fellow 2018-2020

University of Utah

College of Pharmacy

ActivitiesPDC specializes in late stage clinical development, conducting primarily Phase

II/III clinical trials with a goal of further characterizing the clinical efficacy and

safety profile of a molecule before the registration/approval process. During

the fellowship term, the Fellow will receive professional experiences in the

following capacities:

• Develop a deep understanding of the molecules in the late-stage 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

Clinical Scientists and Medical Directors on strategic initiatives

Kevin Lanzo, Pharm.D.

Fellow 2019-2021

University of North Carolina

Eshelman School of Pharmacy

Danh Huynh, Pharm.D.

Fellow 2019-2021

University of California, San Francisco

School of Pharmacy

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Activities

• Evaluation and analysis of adverse events in clinical trials

and post marketing signal detection and signal management

• Aggregate safety reports

• Risk management plan development and maintenance

• Maintenance and update of safety related information in US

and global product labels, investigator brochures, and informed

consent forms

• Special projects and presentations

• Cross-functional interactions with other departments within Product

Development

Overview

The Safety Science organization within the Product Development

Safety (PDS) department is responsible for the characterization of

the safety profile of Roche's products at all stages of development.

Safety scientists work collaboratively across the Roche

organization to bring strategic, proactive, and scientific value to

our pharmacovigilance and risk management strategies. This work

ensures that Roche products are effective therapies with a

positive benefit-risk ratio for our patients.

The Fellow will develop skills in pharmacovigilance practices

through active involvement in clinical trial and post marketing

safety surveillance, assessment of safety signals, and risk

management activities. This is achieved through learning and

understanding of global requirements for the reporting and

surveillance of adverse events, understanding methods for signal

detection, safety signal tracking, the use of safety data analytics

tools, preparing written safety assessment reports, and through

interaction with cross functional development groups.

Product Development Clinical Safety

Samuel McCallum, Pharm.D., MHIT

Fellow 2018-2020

South Carolina College of Pharmacy

Elaine Chun, Pharm.D.

Fellow 2019-2021

Temple University School of Pharmacy

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OverviewProduct development within the pharmaceutical industry requires compliance

with global (U.S. and non-U.S. governments and/or Health Authorities)

regulations. Pharmaceutical companies are required to adhere to regulations

relevant to the development of drugs/medicines including: preclinical

research; clinical development; manufacturing; labeling; advertising and

marketing; risk management; and communication with physicians and

patients. Regulatory Professionals 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. These Professionals are

responsible for the design and implementation of regulatory strategies to

optimally develop, license, and market products globally.

At Genentech, each Product Development Regulatory (PDR) Fellow will

receive individual guidance from Regulatory Professionals and obtain an

understanding of the regulatory roles and responsibilities in the drug

development process.

Each PDR Fellow will learn how to apply regulatory guidelines in the drug

development process and will collaborate with global project teams and

interact with Health Authorities, as appropriate.


ActivitiesThe PDR Fellow will acquire an understanding of the early and late stage

drug development process across distinct therapeutic areas: Oncology,

Immunology, Infectious Disease, Ophthalmology, and Neuroscience,

through direct experience and/or exposure to:

• Regulatory Strategy

• New Drug Applications

• Health Authority Interactions

• Post-Marketing Activities

• Regulatory Intelligence

• Companion Diagnostics

• Regulatory Records and

Information

• Investigational New Drug

Applications

• Biologics License Applications

• Labeling

• Clinical Regulatory Documentation

• Clinical Trial Conduct

• Chemistry, Manufacturing,

and Controls

Carlos Jara, Pharm.D.Fellow 2018-2020

University of Illinois at Chicago

College of Pharmacy

Christine Cid, Pharm.D.Fellow 2018-2020

Massachusetts College of Pharmacy

and Health Sciences

Diana Ndunda, Pharm.D.Fellow 2019-2021

Creighton University, School of

Pharmacy and Health Professions

Karishma Patel, Pharm.D.Fellow 2019-2021

Rutgers University

Ernest Mario School of Pharmacy

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During the second year of the Fellowship, PDR Fellows have the

opportunity to participate in a broad range of internal rotations while at

Genentech. Additionally, external rotations are available including

opportunities with our holding company, Roche. Throughout the rotational

period, PDR Fellows are precepted by dedicated mentors as they further

their drug development knowledge.

Activities

The primary goals of the Fellowship are to provide the Fellow with a thorough

knowledge of US Medical Affairs core functions, with a focus on Medical

Communication activities, and to develop foundational scientific and professional

skill sets required for a successful career within the pharmaceutical industry

• Gain therapeutic proficiency of products within the Oncology portfolio

• Create relevant, balanced, accurate, customer-focused medical content for

external scientific engagement with worldwide and local customers

• Leverage clinical expertise to proficiently search internal and external databases,

critically evaluate scientific data, and develop evidence-based medical responses

• Provide medical review of materials for scientific exchange and promotional use

• Work with medical team to execute tactics supporting the overall medical

strategy

• Support pre- and peri-approval activities for new molecular entities and line

extensions

• Analyze and share actionable clinical and scientific insights with colleagues

cross-functionally

• Provide support for medical booth at congresses

Overview

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A network of clinical and scientific collaborators within the US Medical

Affairs Oncology medical unit is responsible for developing and executing

the medical strategy for both marketed products and pipeline molecules in

the oncology space for the US affiliate. In addition to ensuring strategic

alignment across various Medical Affairs functional areas, the network

supports Medical Communication activities, which include communicating

customer-focused, timely, accurate, and fair-balanced information on

Genentech’s products to respond to unsolicited medical information

questions, providing medical review of materials for both scientific exchange

and promotional use, supporting and collaborating with internal partners,

and sharing actionable customer insights to drive medical strategy.

The US Medical Affairs/Medical Communications Fellowship is a 2-year

program designed to expose the Fellow to a broad range of US Medical

Affairs activities within the Oncology medical unit, with a focus on Medical

Communication activities. Based on individual interests, the fellow can gain

exposure to other medical affairs activities, such as publications, scientific

exchange/engagement, scientific congress planning, and

pharmacoeconomics. The focus of the second year is determined by the

mutual interests of the fellow and the company and may include

opportunities for rotations.

US Medical Affairs/Medical Communications (Oncology)

Kirstie Marasigan, Pharm.D.

Fellow 2018-2020

University of the Sciences,

Philadelphia College of Pharmacy

Kimberly Wu, Pharm.D.

Fellow 2019-2021

Rutgers University


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Overview

US Medical Affairs/Medical Science Liaison

• A network of clinical and scientific collaborators

is responsible for developing and executing

medical strategy for both marketed and pipeline

molecules for the US affiliate. In addition to

ensuring strategic alignment across various

Medical Affairs functional areas, the network

supports Medical Science Liaison (MSL) activities

by serving as subject matter experts and

supporting various Medical Affairs initiatives at

Genentech’s headquarters in South San

Francisco.

• The US Medical Affairs/MSL Fellowship is a two-

year program based in South San Francisco,

designed to expose the Fellow to a broad range of

corporate and field- based US Medical Affairs

activities within their assigned medical unit. The

focus of the second year is determined by the

mutual interests of the Fellow and the company.

US Medical Affairs/Medical Science Liaison

ActivitiesMedical Affairs Component: The Fellowship will provide the Fellow with a thorough knowledge of US

Medical Affairs core functions and develop foundational scientific and professional skill sets required for a

successful career within the industry. The Fellow will have the opportunity to participate in or lead:

• Therapeutic proficiency in products within the Medical Unit’s portfolio

• Tactic execution with the Medical Directors/Medical Science Directors that support the overall medical strategy

• Pre- and peri-approval preparations for new molecular entities

• Development of training and tools for the field medical team

• Medical Affairs responsibilities at national/regional medical conferences

• Clinical and scientific insights with colleagues in Marketing, Managed Care, and other cross functional departments as needed

• Advisory boards and investigator meetings with other healthcare providers (HCPs) and enhance presentation and scientific

exchange skills

Medical Science Liaison Component: Alongside the Medical Affairs experience, the Fellow

will also have an opportunity to develop an appreciation of the MSL role. The Fellow will have the

opportunity to participate in or lead:

• MSL strategy and planning sessions with MSL Leadership

• Legal and compliance guidance that frames MSL activity

• In-field scientific exchange experience through provision of provider education

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

• Planning and adjusting MSL research

Anna Yang, Pharm.D.

Fellow 2018-2020

Rutgers University


Hunter Davis, Pharm.D.

Fellow 2018-2020

University of California,

San Francisco School of Pharmacy

Dakota J. Rosenfelt, Pharm.D.

Fellow 2019-2021

University of Missouri, Kansas City

School of Pharmacy

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ActivitiesIn the first year, the Fellow will work with the Global Alliance and Asset Directors on the following key

activities within Alliance Management:

• Be the “face of Roche/Genentech” to external partner companies. Typically liaising with CEO,

alliance counterpart, and senior leadership of our partner companies.

• Strategic leadership of alliances which emerge from various deals including in-licensing, out-

licensing, research collaborations, as well as leading integration following merger and acquisition

deals.

• Effective leadership of collaborations within Genentech Research (gRED), Roche Research (pRED),

Development or Commercialization and those that are across all therapeutic areas (i.e., Oncology,

Neurology, Immunology, Infectious Disease, Personalized Health Care, etc.)

• Lead and negotiate deals which arise from existing alliances. Allows for the opportunity to create

and lead a cross-functional deal team, as well as lead diligence activities, term sheet, and

contractual negotiations.

• Establish and lead joint governance committee meetings to ensure appropriate decision making on

partnered programs. These meetings include Roche/Genentech senior leadership as well as senior

leadership from partner companies (i.e., Joint Steering Committee, Joint Development and Joint

Commercialization Committee Meetings).

• Work closely with cross-functional research, development and commercial teams to align on

strategy with the partner as well as negotiate financial terms, implement contractual amendments,

influence key decision makers, and ultimately ensure efficient progress of the partnership.

• Participate in out-partnering or divestment of commercial products in coordination with Roche

global functions.

In the second year, the Fellow will have the option to rotate into another function within Pharma

Partnering or explore other opportunities within Roche/Genentech.

OverviewPartnering 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.

Pharma Partnering

Priya Patel, Pharm.D.

Business Development Fellow 2018-2020

Purdue University College of Pharmacy

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Within Pharma Partnering, Business Development and Alliance

Management work in harmony to pursue key collaborations that

build on the Roche portfolio and strategically grow partnerships

to further the Roche mission of “Doing Now What Patients

Need Next.”

45%of our R&D pipeline

externally sourced

122partnerships managed in

2017 by Roche Partnering

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!

Patrick Phuong, Pharm.D.

Clinical Science - Late Stage

Development

Genentech, Inc.

South San Francisco, CA

2016-2017

Matthew Schmidt, Pharm.D.

Competitive Intelligence

Genentech, Inc.


2017

Alex Morris, Pharm.D. Clinical

Science - Pediatric Oncology

Genentech, Inc.


2017

Daniel Da Costa, Pharm.D.

Translational Medicine

Oncology – pRED

Roche Innovation Center

New York, New York

2015-2016

Daphne Torre, Pharm.D. US

Oncology Marketing-Commercial

Genentech, Inc.


2015-2016

Maksim Nestor, Pharm.D

Business Development

Roche Innovation Center

New York, NY

2014-2015

Jerald Grace, Pharm.D.

Regulatory Affairs

Roche Diagnostics

Indianapolis, IN

2011-2012

Andrew Chia, Pharm.D., M.S.

Global Product Strategy

Genentech Inc.


2014-2015


Commercial Regulatory Affairs

Oncology - pRED

Genentech Inc.


2012-2013

Mary Liu, Pharm.D.

Regulatory Policy, Strategy, and

Intelligence

Hoffman-La Roche, Inc.

Washington, DC

2011-2012

Rotation Opportunities17

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Recent Roche Group Fellows

Linh Tran, Pharm.D.

Global Medical Information Leader

Product Development Medical Affairs

Genentech, A Member of the Roche Group

2017-2019 US Medical Affairs Fellow

Sarah Troutman, Pharm.D.

Associate Clinical Scientist

Product Development Oncology


2017 - 2019 Clinical Science –

Product Development Oncology Fellow

Jennifer Chang, Pharm.D., MBA.

Global Studies Manager

Product Development Global Operations


2015 - 2017 Clinical Operations Fellow

Angeline Lo, Pharm.D., MA

Global Studies Manager

Product Development Global Operations


2015 - 2017 Clinical Operations Fellow

Himika Patel, Pharm.D., MS

Associate Clinical Scientist

Product Development Oncology


2017 - 2019 Regulatory Affairs Fellow

Anthony Guan, Pharm.D.

Program Manager



2017 - 2019 Regulatory Affairs Fellow

Sierra Hill, Pharm.D.

Medical Science Director

U.S Medical Affairs


2016-2017 Medical Affairs/MSL Fellow

Hannah (Xinhui) Huang, Pharm.D.

Safety Science Associate Director

Safety Science Oncology


2015-2017 Drug Safety and Risk Management Fellow

WHERE ARE THEY NOW?

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Alumni Testimonials9

Salah El-Saheb Pharm.D.

Fellow 2006-2008, Clinical Operations Leader - USMA, Evidence Generation, Genentech, A Member of the Roche Group.

“The fellowship at Roche/Rutgers provided me with relevant experiences and leadership opportunities that allowed me to grow my career within the pharmaceutical

industry with the help of so many mentors through the company/program. Without this long-standing program, I wouldn't have been able to touch as many medicines that

make great impact to patients and I look forward to continuing developing more in the future.”

Natasha Singh Pharm.D., RPh

Fellow 2007-2009, Global Development Team Leader & Senior Principal Safety Scientist, Genentech, A Member of the Roche Group.

“The Rutgers Pharmaceutical Industry Fellowship program at Roche is the perfect stepping stone in the transition from the classroom into a real world setting. The

preceptors and alumni here at Roche provide an exceptional foundation for a support system that is over 20 years in the making.”

Chi-Sing Nip Pharm.D., MBA

Fellow 2001-2003, Director – Global Labeling and Established Products, Genentech, A Member of the Roche Group.

“The Rutgers Pharmaceutical Industry Fellowship program at Roche was my window of opportunity into a completely different facet of pharmacy – industry! The fellowship

allowed me to fully leverage my training as a pharmacist both from a science and patient perspective. More importantly, I met and learned from so many incredible people

that helped shape who I am today and the key driver for me to establishing the Industry Pharmacy Residency Program in PDR Mississauga (Roche Canada).”

Jessica Priest, Pharm.D.

Fellow 2005-2007, Senior Medical Science Liaison – Neuroscience, Genentech, A Member of the Roche Group.

“The fellowship provided me with hands-on experience across various functional roles within Roche/Genentech. This experience helped me to gain an appreciation of the

multifaceted aspects of research, development and commercialization of medications. In addition, this cross-functional experience allowed me to build my internal network

of colleagues and friends that have allowed me establish successful connections with my internal colleagues and my customers in the field." .


Fellow 2011-2013, Program Director, Product Development Regulatory - Oncology, Genentech, A Member of the Roche Group.

“The Genentech/Rutgers fellowship jump-started my career in Regulatory Affairs especially given I had no prior industry experience. The preceptors and alumni exemplify a

strong commitment to the fellow's technical and soft skill development to ensure the fellow's success. The program provides an opportunity to make an innovative impact at

the global level of healthcare.”

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Rutgers Pharmaceutical Industry Fellowship Program


Rutgers, The State University of New Jersey

Program History

In 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.

Following the successful pilot, the Rutgers Pharmaceutical Industry Fellowship (RPIF) Program

grew significantly and expanded to include 21 companies within the pharmaceutical and

biopharmaceutical industries and over 200 fellows annually.

In 2002, Dr. Ernest Mario generously provided an endowment to establish the Institute for

Pharmaceutical Industry Fellowships to enhance and promote the role of pharmacists in industry

through the RPIF Program. The Institute staff members:

• Provide leadership and administrative support;

• Promote quality, communication, and scholarly activity; and

• Arrange specialized fellowship training opportunities within the pharmaceutical and

biopharmaceutical industries.

Rutgers, The State University of New Jersey, with approximately 70,875 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 part of Rutgers Biomedical and Health Sciences, the only state

school of pharmacy in New Jersey, with approximately 1,300 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 advanced training in the

pharmaceutical and biopharmaceutical industries.

Joseph A. Barone, Pharm.D., F.C.C.P.

Dean and Professor II


Michael Toscani, Pharm.D.

Research Professor,

Fellowship Director

Institute for Pharmaceutical Industry

Fellowships

Professional Development Series

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; professional writing, presentations, meeting facilitation, negotiating, 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

professional network of fellows, faculty, alumni, and other industry executives.

20

Key Program Features

Recently in 2018, our program has expanded to offer interdisciplinary fellows’ training by adding

select physician fellowship opportunities to our well-established program.

The RPIF Program has thrived under the leadership of the founder, Dr. Joseph A. Barone, Dean and

Professor II of the Ernest Mario School of Pharmacy and Dr. Michael Toscani, Research Professor and

the Director for the Institute for Pharmaceutical Industry Fellowships.

More than 1,000 post-doctoral fellows have completed the RPIF Program, most of whom are pursuing

influential and rewarding careers in the pharmaceutical and biopharmaceutical 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 pharmaceutical and biopharmaceutical industries and the fellow’s functional area.

amily of Leading Companies–Partners include several of the top 21 global pharmaceutical and

biopharmaceutical companies.

utstanding Alumni Track Record–Over 1,000 alumni hold prominent positions at many leading

companies.

trong Network—Over 200 fellows each year develop valuable, lasting connections with each

other, alumni, preceptors and faculty.

he Pathway to Industry–Since 1984, the Rutgers program has been nationally recognized, trusted,

and proven as the pathwayto industry for pharmacists.

nhanced Career Path–Increasingly challenging assignments build depth of experience and

enhance the potential for an accelerated career path.

igorous Academic Component–Rutgers affiliation provides academic and professional

development opportunities.

FOSTER

21

The Rutgers Pharmaceutical Industry Fellowship Program FOSTERs the growth and development of future

pharmaceutical and biopharmaceutical industry professionals through the following key program features:

Application Process and Eligibility Requirements:

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 may

submit their application materials (curriculum vitae, three letters of recommendation and a letter of intent)

beginning November 23, 2019 and complete a program interest form online by visiting our website at:

pharmafellows.rutgers.edu

All application materials must be submitted electronically, and applicants are strongly encouraged to submit

the above documents by December 1st.

Please address your Letter of Intent & Letters of Recommendation to:

Joseph A. Barone, Pharm.D., F.C.C.P.

Dean and Professor II


Rutgers, The State University of New Jersey

160 Frelinghuysen Road

Piscataway, NJ 08854-8020

2019 RPIF Program Certificate Dinner

pharmaceutical industry fellowship program · roche/genentech’s product development global (pdg)...

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