PASSION TO INNOVATE CHANGE · Institute for Pharmaceutical Industry Fellowships The Rutgers...

PASSIONTO

INNOVATE

POWERTOCHANGE

Institute for PharmaceuticalIndustry Fellowships

In 1984, at Rutgers, The State University of New Jersey, the Ernest Mario School of Phar-macy 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 Fel-lowship (RPIF) Program grew significantly and expanded to include 19 companies within the pharmaceutical and biopharmaceutical industries and over 160 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:

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 Fellowship 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 biopharmaceutical industries throughout the U.S. 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.

• provide leadership and administrative support;

• promote quality, communication, and scholarly activity; and

• arrange specialized fellowship training opportunities within the pharmaceutical and biopharmaceutical industries.

2016 RPIF Program Certificate Dinner

Program History

Joseph A. Barone, PharmD, F.C.C.P.Dean and Professor II

Ernest Mario School of Pharmacy

Michael Toscani, PharmDResearch Professor, Fellowship Director,

Institute for Pharmaceutical Industry Fellowships

Rutgers

About Bayer

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Fellowship Alumni

Bayer Consumer Health

Bayer Pharmaceuticals

Program HistoryProfessional Development Series

Application & Eligibility RequirementsKey Program Features

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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 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.

Professional Development SeriesRutgers

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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:

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Family of Leading

Companies

Outstanding Alumni Track

Record

Strong Network

The Pathway to

Industry

Enhanced Career Path

Rigorous Academic

Component

Partners include several of the top 19 global pharmaceutical and biopharmaceutical companies.

Over 850 alumni hold prominent positions at many leading companies.

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

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

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

Rutgers affiliation provides academic and professional development opportunities.

Key Program FeaturesRutgers

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Ernest Mario School of PharmacyRutgers, The State University of New Jersey

Key Program Features

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 pharmacy in 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.

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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

Application Process and Eligibility Requirements

Application materials may be submitted as early as

November 19, and applicants are encouraged to submit as

many of the required materials as possible by December 15.

Fellows for the Rutgers Pharmaceutical Industry Fellowship Program are selected on a nationally-com-petitive 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 visit-ing our website at pharmafellows.rutgers.edu

Rutgers

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About Bayer

Bayer’s mission is to research, develop, manufacture and market innovative products that improve the health of people and animals throughout the world. Throughout its 150-year history, Bayer has -- and continues to -- re-imagine science to transform lives, focusing on inventing new solutions that improve the health of patients, consumers, communities and families. As one of the most recognized brands in the world today, Bayer considers innovation to be part of the company’s DNA.

Bayer’s healthcare business has operations in over 100 countries and employs 55,700 people worldwide. As one of the world’s foremost innovators in the field of pharmaceutical and medical products, Bayer provides products that healthcare providers and patients can trust. Its success is based on translating scientific findings into new medications and products that customers and society need. Doing this requires innovative thinking, dedication and a relentless focus on doing the right thing. These core values set Bayer apart with an industry-leading portfolio of products and support that healthcare providers and their patients require.

Bayer has four operating divisions: Pharmaceuticals, Consumer Health, Crop Science, and Animal Health.

New Headquarters in WhippanyIn the U.S., Bayer opened its new headquarters in Whippany, NJ in mid-2013, bringing together employees from several sites in the New York/New Jersey area. The 700,000 sq. ft., state of the art facility is situated on 94 acres of property in a thriving suburb, with easy access to several major highways. The secure-access site features desirable amenities, such as a fitness center, large café, outdoor dining area, medical suite, coffee bar, company store and a modern, open office floor plan. The official grand opening of the new Whippany headquarters was on October 16th, 2013.

Bayer US Headquarters

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AboutBayer’s LIFE Values

Fellowship ProgramYour Time at Bayer

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Leadership means much more than retaining and extending our market positions. It applies to all our employees, not just

managers.

Following the rules of law and

regulations is a given to Bayer. Our integrity

enhances the legitimacy of our operations and

strengthens our reputation.

In today’s ever-changing business

landscape, the ability to adapt to different situations

is crucial for future success.

Efficiency implies our overall approach to make

the best possible use of our resources, thus improving our overall performance.

Bayer’s LIFE Values

Leadership Integrity Flexibility Efficiency

By working sustainably and accepting our role as a socially and ethically responsible corporate citizen – and by committing to our Bayer values – we create benefits for the communities in which we live. Science For A Better Life: this is the promise we all give to our stakeholders.

About BayerRutgers

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About BayerAs a fellow at Bayer, you will be exposed to a variety of exciting opportunities that will enable you to become a leader in the pharmaceutical industry. Bayer’s new employer brand promise describes what we expect from our employees and potential candidates, and explains how each employee can succeed in the company. This employer brand promise, “Passion to Innovate | Power to Change” exemplifies our presence as a global giant and is supported by four underlying key promises that the fellow can expect upon entering the company. These four promises serve as pillars for what makes our working culture so special.

Your Time at Bayer

At Bayer you have the freedom and the license to

question the status quo and think ahead.

At Bayer you can engage in open and inspiring work with

people who share your passion to turn pioneering ideas into

life-changing solutions.

At Bayer our ideas are inspired by society’s most fascinating challenges to

enhance the lives of many, and our thinking is driven by our

customers’ needs.

At Bayer you are empowered to make an impact by being part of a

leading company that has the power and endurance it takes

to improve life – not only in today’s but in tomorrow’s

world.

PASSIONTO

INNOVATE

POWERTOCHANGE

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Bayer Consumer Health, with its U.S. headquarters in Whippany, New Jersey, is

among the top consumer healthcare companies in the world, with products in the

categories of Analgesics; Cold, Allergy, Sinus, & Flu; OTC and Rx Dermatology

including Sun Care; Foot Health; Gastrointestinals and Nutritionals. Some of the most

trusted and recognizable brands in the world today come from the Bayer portfolio of

products. These include Afrin®, Aleve®, Alka-Seltzer®, Alka-Seltzer Plus®, Apronax®,

Aspirin™, Bayer® Aspirin, Bepanthen™, Bepanthol™, Berocca®, Cal-D-Vita/Elevit™,

Canesten™, Claritin®, Coppertone®, Dr. Scholl’s®, Flanax™, Flintstones™ Vitamins,

Midol®, MiraLAX®, One A Day® Vitamins, Oxytrol® for Women, Phillips’® Milk of

Magnesia, Redoxon™, Rennie™.

The U.S. Bayer Pharmaceuticals business, headquartered in Whippany, New Jersey,

provides specialty pharmaceutical products in the areas of Hematology, Neurology,

Oncology, Cardiopulmonary, and Women’s Healthcare. Multiple products have been

approved recently in the U.S. across all of Bayer's therapeutic areas. The company also

recently expanded its Women’s Healthcare portfolio, making Bayer the only company

to offer a full range of contraception options to women- short-acting, long-acting and

permanent.

PHARMACEUTICALS

CONSUMER HEALTH

Bayer Pharmaceuticals Fellows

Bayer Consumer Health Fellows

About BayerRutgers

About Bayer

Leadership Team

Fellowship Alumni





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Leadership TeamExecutive Sponsors

Juan C. Nadal, M.D.VP, Medical Communications (Pharmaceuticals)

“The Fellowship Program provides graduates with a well-rounded and robust exposure to the pharmaceutical industry. Our preceptors are dedicated and committed healthcare professionals with extensive academic and pharmaceutical expertise. Our fellows graduate with an unforgettable experience that can ultimately lead to a gratifying career in the pharmaceutical industry.”

Yasmin Islami, MBASenior Director and Head, Early Product Commercialization, Region U.S. (Pharmaceuticals)

“PharmDs are customer focused and bring the science and medicine to our commercial evaluations. We cannot have one without the other; the expertise PharmDs can bring is invaluable to the work we do here at Bayer.”

Todd Paporello, PharmD, MBAVP, Head of North American Regulatory Affairs. Pharmaceuticals and Consumer Health

“As an alumnus of the Rutgers Fellowship, I am proud to be a part of the Bayer Fellowship Program which, as one of the most diverse programs available, will provide you with a strong foundation necessary for a successful career in the pharmaceutical industry.”

Rutgers

About Bayer

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Executive SponsorsProgram Directors

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Leadership TeamProgram Directors

Mark Rametta, DO, FACOI, FACPMedical Director in U.S. Medical Affairs-Neurology

“The Bayer/Rutgers Fellowship Program provides the new graduate with a diversified educational and practical exposure to the pharmaceutical industry. Fellows who complete this program and then enter the pharmaceutical industry will bring with them cross-functional team experiences that will smooth their transition as new hires in the industry.”

Anthony Genovese, PharmDDeputy Director, Advertising & Promotion, Global Regulatory Affairs

“Bayer is a great company for pharmacists entering the pharmaceutical industry, and those involved in the PharmD fellowship program are committed to providing pharmacists with the guidance and training necessary to become successful within the organization.”

Stephen Kaesshaefer, MS, MBA, PMPHead of Clinical Operations Project Leaders, Early Development Oncology

“The fellowship program in Global Clinical Sciences Operations provides longitudinal exposure within early clinical development (PhI & II). Providing “hands on” valuable clinical trial management experience while building on science & leadership to prepare for strong career in the pharmaceutical industry.”

Palak Venkataraman PharmD, RPh.Senior Associate Director in Medical Affairs, Bayer Consumer Health

"The Bayer/Rutgers fellowship program offers a distinctive path to gaining practical experiences and leadership opportunities that build a strong foundation for a successful career within the pharmaceutical industry. The mentors are dedicated to creating opportunities for the fellows to work on challenging and highly visible projects that facilitate advancement of their technical and professional proficiencies while making valuable contributions within the organization."

James Serpico RPh, MBA Deputy Director, New Product Commercialization U.S. Rare Diseases & Cardio

"The Bayer/Rutgers Fellowship track focusing on Commercial Pharmaceutical Business is a unique opportunity for our advanced PharmD graduates to gain valuable real-world experience participating & leading in meaningful commercial assignments and opportunities at a global leading biopharmaceutical company. Fellows that complete the two-year program will acquire relevant commercial pharmaceutical learnings, perspectives and accomplishments that will serve them as they build their own professional career path in this patient-centric Industry."

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Executive SponsorsProgram Directors

12

Bayer Consumer Health DivisionPROGRAM DIRECTOR

Palak Venkataraman PharmD, RPh.

Senior Associate Director in Medical Affairs, Bayer Consumer Health

Fellowship Departments:

Global Medical Affairs & Clinical DevelopmentU.S. Regulatory AffairsGlobal Product Development & InnovationGlobal Pharmacovigilance and Product and Quality SafetyInnovation, Research & Development Category LeadershipRx-to-OTC Switch

Bayer Consumer Health Leadership Team

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AboutGlobal Medical Affairs & Clinical Development

U.S. Regulatory Affairs

Global Pharmacovigilance & Product Quality/SafetyI&D Category Leadership

Rx-to-OTC Switch

Global Product Development & Innovation

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Bayer Consumer Health Division 2 YEAR FELLOWSHIP

Current Bayer Consumer Health Fellows

Alisha Couto, PharmD MCPHS University,

2nd Year Fellow

Jennifer Moon, PharmD Philadelphia College of Pharmacy,

1st Year Fellow

Palak Venkataraman, PharmD, RPh Senior Associate Director in Medical Affairs,


• Propel the Consumer Health business through medical and product insights and innovations in clinical research

• Develop new claims, indications, and dosage forms for OTC products

• Design, conduct, and support clinical research activities using vigorous scientific methodologies and Good Clinical Practice (GCP)

• Maintain scientific and clinical expertise to support currently marketed products, participate in the review of advertising and promotional material, and provide medical support to marketing initiatives

• Collect, review, assess, and disseminate scientific and clinical information as it relates to the company products or competitive products

• Interact regularly with all members of the global and/or U.S. clinical development teams, as well as other functions, particularly Regulatory Affairs and Project Management

• Provide support for the strategy, coordination, and implementation of advisory board meetings and FDA advisory committee meetings

• Collaborate with key opinion leaders

Current Bayer Consumer Health Preceptors

Consumer Health | Global Medical Affairs & Clinical DevelopmentRutgers

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Rx-to-OTC Switch


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Dawn Jackman Senior Associate Director,


Fenan Solomon, PharmD University of Maryland,

2nd Year Fellow

• Assist in the development, review and approval of labeling and promotional activities

• Participate in the preparation of regulatory strategies to support the development of innovative new products

• Work with various departments within the organization to ensure compliance with existing and proposed regulations

• Interface with regulatory colleagues who support our products on a local level

• Contribute to the authoring of submissions to various regulatory agencies

• Cultivate internal and external professional relationships to help further Bayer sponsored initiatives

• Assist in the management of regulatory issues which have the potential to impact our products in the global market


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Rx-to-OTC Switch


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Khyati Desai, PharmD, MSNova Southeastern University,

2nd Year Fellow

Jessica Giaquinto, PharmDButler University,1st Year Fellow

Henri MarionSenior Associate Director,

Technical Lead

Yu Shao, PhDSenior Associate Director Formulation Development

Jerry MeiselVice President, Global

Innovation & Development Center - Morristown

• Develop innovative OTC/nutritional supplement products for Bayer Consumer Health

• Design and implement pre-formulation, formulation, process, project timelines and basic analytical activities for new products using Quality by Design principles

• Perform experiments in the laboratory to formulate and test prototypes, develop a manufacturing process, and scale-up the product

• Actively engage in literature and patent searches related to products

• Participate in consumer insights based new product ideation and product design sessions

• Help design and refine prototypes with the consideration of product stability, regulatory and medical acceptability

• Interact regularly with all members of the Global Innovation and Development Teams and cross-functional members of the Core Team

• Assist with managing the product development process from concept phase to the post-launch analysis phase

• Write development plans, reports, and CMC technical regulatory documents for projects and share scientific work with other functions

• Author and review chemistry, manufacturing, and controls (CMC) sections (Module 3) of Global Dossiers, variations of currently registered products, and quality overall summaries of dossiers

• Interact with manufacturing sites, Global and Local Regulatory colleagues to gain alignment on CMC documentation


Consumer Health | Global Product Development & InnovationRutgers

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Rx-to-OTC Switch


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2 YEAR FELLOWSHIPCurrent Bayer Consumer Health Fellows

Justin Mathew, PharmDPhiladelphia College of Pharmacy,

1st Year Fellow

Jadine Stephan, RPhGlobal Safety Leader, Global Drug Safety

• Prepare safety assessments for new and existing products including medical products, and medical devices

• Work in a global safety environment applying skills and knowledge in a multi-national regulatory environment

• Collaborate with colleagues in medical affairs, clinical development and regulatory affairs to conduct benefit risk assessments

• Develop risk mitigation strategies in support of bringing new products to market

• Contribute to the preparation of a variety of scientific and regulatory documents including Common Technical Documents, Periodic Benefit-Risk Evaluation Reports, and labeling justification documents


Bayer Consumer Health DivisionConsumer Health | Global Pharmacovigilance and Product and Quality Safety

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Rutgers

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Rx-to-OTC Switch


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Bayer Consumer Health DivisionConsumer Health | Innovation & Development Category Leadership

2 YEAR FELLOWSHIP


Margaret Gryszkiewicz, PharmDDirector, R&D Category Technical Lead

Daina Nanchanatt, PharmDTemple University,

1st Year Fellow

• Investigate scientific leads into new / emerging technology that may deliver meaningful benefit to our consumers, and translates it into highly relevant consumer experiences and high value new products

• Support the identification of consumer-compelling innovative products and claims that form the basis of a differentiated, sustainable pipeline

• Participate on the I* R&D Category Leadership Team, which is a cross functional team responsible to drive innovation in I*R&D that is consistent with our business strategies

• Gain cross-functional knowledge of drug development

• Leverage the science of the therapeutic category and insights into consumer needs to support a scientifically robust pipeline of highly-valued consumer products/claims

• Support a stronger link between the commercial organization and R&D organization

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Rutgers

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Rx-to-OTC Switch


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Bayer Consumer Health DivisionConsumer Health | Rx-to-OTC Switch

2 YEAR FELLOWSHIP

• Support all phases of a Switch project in the role of a Switch Team member through assisting with:

• Assessment of new prescription molecules for Switch potential

• Scientific/medical support for preliminary commercial assessments

• Creation of development plans

• Drafting regulatory dossiers

• Scientific/medical support for development of commercialization strategy, plans, execution and launch

• Technology-enablement and innovation applied to switch of molecules in need of special requirements beyond the traditional path to market, i.e. Drug Facts Labeling

• Key interfaces:

• Bayer Pharmaceutical functions

• Licensing partners

• Global Functions and Resources Supporting Pharmaceutical and Consumer Health, e.g. Medical Affairs, Safety/Toxicology, Pharmacovigilance, Pharmaco-epidemiology, Clinical Operations, R&D Information Center, Consumer Science, Development Centers of Excellence, Regulatory Affairs

Maggie Gandhi, PharmDPhiladelphia College of Pharmacy,

1st Year Fellow

Amy Replogle, M.S. Director, Rx to OTC Switch Science


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Rutgers

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Rx-to-OTC Switch


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Bayer Pharmaceuticals DivisionPROGRAM DIRECTOR

Mark Rametta, DO, FACOI, FACPMedical Director in US Medical Affairs

Neurology

PROGRAM DIRECTOR

James Serpico, RPh, MBADeputy Director, New Product

Commercialization, U.S. Rare Diseases and Cardiology

PROGRAM DIRECTOR

Stephen Kaesshaefer, MBAHead of Operations Project Support,

Oncology

PROGRAM DIRECTOR

Anthony Genovese, PharmD Deputy Director, Advertising &

Promotion, Global Regulatory Affairs


Clinical Operations


Global Regulatory Affairs


Medical CommunicationsMedical Science Liaison (Oncology)


Business Development & LicensingEarly Pipeline Strategic MarketingCorporate & Government Customers/U.S. Managed Markets Business UnitGlobal Market Access/Health Economics & Outcomes ResearchRare Disease Business UnitNew Product Commercialization

Bayer Pharmaceuticals Leadership Team

Rutgers

About Bayer

Leadership Team

Fellowship Alumni


Bayer PharmaceuticalsAbout


Medical Affairs (Oncology)Global Pharmacovigilance

Business Development & LicensingEarly Pipeline Strategic Marketing

Brand Marketing, U.S. Managed MarketsMarketing, Rare Diseases Business Unit

New Product CommercializationGlobal Market Access

Global Regulatory AffairsClinical Operations

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Bayer Pharmaceuticals Division 2 YEAR FELLOWSHIP

Current Bayer Pharmaceuticals Fellows

Current Bayer Pharmaceuticals Preceptors

Saleem Noormohamed, PharmD, MBA

Deputy Director, Medical Information Services- Oncology

Solveig Halldorsdottir, PhDDirector, Medical Information

Services

Frank Pignataro, PharmDDirector, Medical Information

Services

Tara Pummer, PharmD Deputy Director, Medical

Information Services- Women's Healthcare

Amy Zhou, PharmD Rutgers University,

1st Year Fellow

Valentina Pampulevski, PharmDPhiladelphia College of Pharmacy,

1st Year Fellow

• Provide balanced, written, and verbal scientific responses to inquiries from health care professionals in a compliant manner

• Identify, document, and process adverse events and product complaints

• Research medical literature and evaluate scientific data to develop evidence-based medical content for responses

• Review advertising and promotional materials to ensure medical accuracy

• Collaborate with cross-functional team members to ensure advertising and promotional materials meet legal, medical, regulatory and commercial objectives

• Provide medical information booth support at medical conferences

• Develop medical educational materials and present lectures to sales training groups and other company employees

Medical Affairs | Medical CommunicationsRutgers

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Cynthia Quince, PharmDNational Director Oncology MSLs

Matt Fisher, PharmDDeputy Director, Medical Science

Liason-Oncology

• The Fellow will work with the U.S. Medical Affairs Oncology Department during their tenure in the Fellowship Program

• Engage in the exchange of data and knowledge in a scientific and balanced manner as they relate to clinical research, disease state awareness, pipeline assets, and therapeutic trends

• Gain an understanding of thought leader (TL) engagement, mapping, and territory management by developing and fostering relationships with critical stakeholders, TLs, Health Care Professionals (HCPs) and institutions

• Attend and actively participate in relevant scientific and professional meetings, including major medical meetings and Bayer Advisory Boards

• Participate in the review process and discussion strategy for Investigator Initiated Research (IIR) as well as Company Sponsored Studies (CSS)

• Evaluate funding requests for Continuing Medical Education and Grants (as needed)



Medical Affairs | Medical Science Liaison (Oncology)NEW

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Tony Luu, PharmDUniversity of Southern California,

2nd Year Fellow

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Teresa Rafferty, RN, MBAHead of Operational Excellence and Project

Management

Sarah Ullman, PharmDLong Island University College of Pharmacy,

1st year Fellow

• Gain hands-on experience within the global team of Medical Affairs Oncology over the course of the fellowship program

• Rotate through various Medical Affairs Functional groups including, publications, scientific communications, operations and pipeline:

• Assist in the development of a life-cycle management strategy that improves the clinical care of patients by addressing unmet medical needs through various channels (ex. phase IV trials, investigator-initiated research (IIRs), real world data, etc.)

• Draft and provide input in the design, conduct and support of clinical research studies

• Review investigator-initiated research proposals , participate in review committee and process

• Participate in publication subcommittee meetings to plan and implement appropriate publication strategies and tactics for Bayer oncology drugs

• Develop content and ensure the accuracy and scientific quality of manuscripts as well as abstracts, posters, and oral presentations of the latest clinical data at Bayer symposia, international congresses, and other educational programs

• Develop internal global communications and education for Bayer oncology products

• Develop high-quality (relevant, rigorous, balanced) global medical information documents for healthcare customers in response to unsolicited inquiries about Bayer oncology products

• Provide medical review of Bayer product materials in collaboration with a cross-functional team and communicate product information to health care professionals and customers

• Assist in coordination and planning of advisory board meetings


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Rutgers

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Joel Krasnow, M.D.Global Safety Leader, Global Drug Safety

• Critically evaluate and communicate scientific information regarding Bayer and competitor products

• Prepare safety assessments for new and existing products including pharmaceuticals, medical devices and combination products

• Work in a global safety environment applying skills and knowledge across different geographies and cultures

• Collaborate with colleagues in a multi-disciplinary setting to conduct benefit:risk assessments and risk minimization plans for existing and new products. These disciplines include medical affairs, clinical development, regulatory affairs and etc. Rotations in other functional areas can be arranged

• Draft scientific and regulatory documents including Common Technical Documents, Periodic Benefit-Risk Evaluation Reports, and labeling justification documents


Pharmacovigilance | Global Pharmacovigilance and Product and Quality Safety NEW

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Frederick Nelson, MBA Deputy Director, Business Development &

Licensing – U.S. Region

Mark Youssef, PharmDRutgers University,

1st Year Fellow

Ikechukwu Oji, PharmDHoward University College of Pharmacy,

1st Year Fellow

• Pro-actively identify BD&L opportunities to complement the U.S. portfolio and implement the U.S. BD strategy

• Interpret scientific and medical information to assess attractiveness of targets for in-licensing, acquisitions, and partnering deals

• Integrate market and commercial data to support evaluation of portfolio development opportunities

• Actively collaborate with cross-functional teams from Medical Affairs, Regulatory Affairs, Intellectual Property, and Marketing in due diligence assessments

• Work with senior members of the BD&L team to provide recommendations and U.S. perspectives to global projects and strategy

• Fellows in this position will have primary responsibilities supporting the RX/Pharmaceuticals business


Bayer Headquarters - Leverkusen, Germany

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G Commercial | Business Development & LicensingRutgers

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Yasmin Islami, BS, MBASenior Director and Head, Early Product

Commercialization - Region U.S.

Peter Chan, PharmD Bouve School of Pharmacy,

1st year Fellow

• Assist the U.S. Pharma business in ensuring optimal commercial and marketing input is provided and incorporated into pre-Phase 3 global development programs, across all therapeutic areas

• Prepare “indication backgrounders”, which integrate scientific, medical, marketing, and business aspects for therapeutic areas being pursued by pipeline compounds

• Support preparation of materials for, and actively participate on, cross functional Commercial Development Teams, which are responsible for developing the U.S. input and position for pipeline projects

• Coordinate internal process and support preparation for market research studies and competitive intelligence to assess projects with respect to target product profiles, differentiation, opportunities, challenges, and revenue forecasts for pipeline compounds

• Collaborate with senior members of the U.S. Business Units, Market Access, and Medical Affairs functions to provide U.S. perspectives to Global Project Teams



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G Commercial | Early Pipeline Strategic MarketingRutgers

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John Berrios, MBADirector, Channel Strategy

Samuel Jensen, PharmDRutgers University,

1st Year Fellow

Malay Naik, PharmDRutgers University,

2nd Year Fellow

Pranvi Parekh, PharmD, MBA

University of Tennessee,2nd Year Fellow

• Gain hands-on experience within Corporate & Government Customers (CGC), Bayer’s U.S. Managed Markets Department

• Serve as U.S. Managed Markets Brand Managers, rotating through Bayer’s therapeutic areas (i.e. Women’s Healthcare, Oncology, Neurology, and Rare Diseases) directly supporting Managed Markets Brand Directors

• Gain a deeper understanding of all managed markets segments and customers (i.e. health plans/PBMs, specialty pharmacy, trade, integrated delivery networks, group purchasing organization, and government)

• Facilitate patient access to Bayer’s product portfolio by collaborating with in-house and field-based managed markets colleagues, cross-functional teams, key customers, and market access agencies to drive forward business and serve customers by:

• Supporting creation of product value propositions to managed markets customers by working with market research, health economics and outcomes research, medical affairs, and the business unit

• Developing promotional materials for our products and training field-based account executives on appropriate use of pieces

• Managing strategic relationships and projects with agency partners

• Supporting review of marketing materials through the promotional review process with legal, medical, and regulatory colleagues


Commercial | Brand Marketing, U.S. Managed MarketsRutgers

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Sarit Rotman, PharmD, MBADirector, New Product

Commercialization, US Rare Diseases & Cardio

James Serpico, RPh, MBADeputy Director, New Product Commercialization, U.S. Rare

Diseases and Cardiology

Bradley Browning, PharmD, MBAUniversity of Kentucky,

2nd Year Fellow

Jennifer Restivo, MBAVP, Marketing Hematology

Therapeutic Area - Hematology

• Develop and roll out patient and healthcare provider focused marketing material, involving management of agency partners in order to meet strategic mandates, budget, and timelines

• Manage overall marketing budget and other critical portfolio operations tactics

• Lead in product launch project management • Engage in market research, competitive intelligence, and

advisory boards • Collaborate with cross-functional partners to ensure

proper planning and execution of strategic objectives Current Bayer Pharmaceuticals Preceptors

Commercial | Marketing, Rare Diseases Business UnitNOT

RECRUITIN

G

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Bayer Pharmaceuticals DivisionCommercial | New Product Commercialization

2 YEAR FELLOWSHIPCurrent Bayer Pharmaceuticals Preceptors

• Contribute to the execution of commercial activities in the US commercialization/launch readiness plans to ensure cross-functional alignment and achieve launch preparedness and excellence

• Participate in new product teams to help establish commercialization plans for later stage assets

• Support brand planning/launch planning process and collaborate with cross-functional teams (including Medical Affairs, Regulatory, Corporate & Government Customers, Global)

• Compile competitive intelligence and provide data analyses/reports

• Engage in market research activities

• Assist in preparing US commercial assumptions and recommendations into US business cases

Sarit Rotman, PharmD, MBADirector, New Product

Commercialization, US Rare Diseases & Cardio

NEWLY

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Bayer Pharmaceuticals DivisionCommercial | Global Market Access

2 YEAR FELLOWSHIP


Jennifer Pocoski, PharmD, MPHGlobal Market Access Strategy, HematologyDeputy Director, GHEOR Specialty Medicine,

Bayer Alum, 2007-2009

Brian Cuffel, PhDVP and Head Market Access,

Oncology

Parth Vashi, PharmDHoward University College of Pharmacy,

1st Year Fellow

• Drive the pharmaceutical business through market access and payer insights across the development lifecycle

• Deliver value optimizing market access strategies and tactics to achieve and maintain access/reimbursement for key brands

• Contribute to target product value profiles, market assessments, and clinical trial program design discussions

• Achieve a diverse experience with the methods and practices of health economics and outcomes research

• Design, conduct, and support outcomes research studies such as patient preference, and burden of illness evaluations to better characterize patient and population unmet needs through database analysis and literature review

• Conduct economic analyses (i.e. budget impact and cost effectiveness)

• Develop patient report outcomes (PROs) strategies

• Prepare Global Value Dossiers and related communication tools for use by regional and country colleagues

NOT

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Anthony Genovese, PharmD Deputy Director, Advertising & Promotion, Global Regulatory

Affairs

Deepika Jalota, PharmD Senior Director, Global

Regulatory Affairs Specialty Medicine, Oncology

Jana Bodorova, MSc Senior Director and Head

Regulatory Affairs, Therapeutic Area General Medicine II

Irene Darras, PharmD MCPHS University,

2nd Year Fellow

Lee Severson, PharmD Wisconsin-Madison School of

Pharmacy, 1st Year Fellow

• Provide regulatory expertise and guidance in all aspects of the drug development process to ensure the production of quality submissions during pre and post-marketing phases

• Ensure compliance with Corporate and Regulatory standards allowing for expeditious review and approvals

• Maintain marketed products including all promotional activities in compliance with regulatory requirements

• Understand and apply the principles of regulatory affairs

• Gain working knowledge of regulations, guidelines and standard practices

• Develop the operational proficiency of effective regulatory professional

• Areas of Opportunity: Global Regulatory Strategy (U.S. & International), U.S. Advertising and Promotion, Global Labeling, Regulatory Intelligence & Analytics, Global CMC management (drugs & biologics), Submission Planning and Management, Consumer Health Regulatory Affairs


Regulatory Affairs | Global Regulatory AffairsRutgers

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31


Andy Hwang, PharmD Senior Study Manager

Jian P. Mei, PharmD University of Michigan,

2nd Year Fellow

Corinne Iacobucci, PharmD Rutgers University,

1st Year Fellow

• Understand the management of phase I clinical trials from study concept to clinical study report.

• Support and lead the study team by managing all activities as defined per SOPs/OI and ensure regular study team meetings

• Understand budgeting, payments, accruals, and forecasting

• Ensure all relevant IT-systems are updated with current and accurate information

• Train and oversee CROs/vendors: kickoff meetings, study start-up, conduct, and closeout

• Interact with all members of the clinical development team (regulatory affairs, statistics, data management, medical writing, drug supply, etc)

• Develop protocol/amendment in collaboration with other study team members

• Gather and assess patient data review and safety reports


Global Clinical Sciences | Clinical Operations


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Leadership Team

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32

Bayer Fellowship AlumniEmployed at Bayer

Omar McMillan, PharmDBayer Fellow, 2012-2014Medical Science Liaison, Hematology

Scott Beeman, PharmD, MBABayer Fellow, 2012-2014Global Franchise Manager, Women's HealthCare

Arthur Graber, PharmDBayer Fellow, 2014-2015Medical Science Liaison, Oncology

Alyson Sous Andrikanich, PharmDBayer Fellow, 2009-2011Associate Director, Advertising & Promotion, Global Regulatory Affairs

Sabrina Meyers, PharmDBayer Fellow, 2008-2010Medical Science Liaison, Oncology

Ashley Doyle, PharmDBayer Fellow, 2013-2015Medical Science Liaison, Oncology

Brittny Rule, PharmD, MBABayer Fellow, 2014-2016Associate Director of Marketing, Rare Diseases - Cardiology

Paulina Estrada, PharmDBayer Fellow, 2007-2009Regulatory Strategist, Women's HealthCare

Dana Huang, PharmDBayer Fellow, 2010-2012Medical Science Liaison, Oncology

Jennifer Pocoski, PharmD, M.P.H.Bayer Fellow, 2007-2009Global Market Access Strategy, HematologyDeputy Director, GHEOR Specialty Medicine

Alice Kim, PharmDBayer Fellow, 2014-2016Associate Manager, Oncology Sales Strategy and Operations

Chinelo Okany, PharmDBayer Fellow, 2014-2016Senior Manager, Global CMC Documen-tation

Dan Kim, PharmDBayer Fellow, 2014-2016Manager, Regulatory Affairs - Established Products

Greg Balani, PharmDBayer Fellow, 2014-2016Manager, Global Business Develop-ment & Licensing - Consumer Health

Andrianna Guo, PharmDBayer Fellow, 2014-2016Associate Manager, Channel Marketing - Health Plans & PBMs

Fellowship AlumniEmployed at Bayer

Employed ElsewhereEmployed Elsewhere (cont'd)

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Bayer Fellowship AlumniEmployed Elsewhere

Mona Patel, PharmDBayer Fellow, 2011-2013Therapeutic Manager, Medical Information, Celgene Corporation

Kunal Kunani, PharmDBayer Fellow, 2012-2014Manager, Regulatory AffairsNoven Pharmaceuticals, Inc.

Kinjal Jariwala, PharmDBayer Fellow, 2012-2014 Global Risk Management Plan Associate ManagerNovartis

Joosung Kim, PharmDBayer Fellow, 2012-2014 Senior ConsultantNavigant Consulting

Rebecca Lalani, PharmDBayer Fellow, 2012-2014 Associate Manager, Regulatory AffairsAdvertising and PromotionGilead

Ruth Kim, M.P.H.Bayer Fellow, 2011-2013Global Oncology Epidemiologist, ForecastingBristol-Myers Squibb

Kyechin Chen, PharmDBayer Fellow, 2012-2014Channel Marketing Dexcom, Inc.

Kevin Chan, PharmDBayer Fellow, 2013-2015Project Manager, US Marketing Insmed, Inc.

Kim Le, PharmDBayer Fellow, 2013-2015Senior Scientific Specialist Merck

Meena Ramachandra, PharmDBayer Fellow, 2013-2015Regulatory Reviewer Food and Drug Administration Office of Prescription Drug Promotion

Theia Monera, PharmD, M.S.Bayer Fellow, 2011-2013Medical Science LiaisonCSL Behring

Elbert Chang, PharmDBayer Fellow, 2009-2011Manager, I&I Medical InformationCelgene Corporation

Samantha Forder, PharmDBayer Fellow, 2014-2016

Erica H. Dankiewicz, PharmDBayer Fellow, 2010-2012Senior Medical Information SpecialistAcorda Therapeutics



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Bayer Fellowship AlumniEmployed Elsewhere

Anish Patel, PharmDBayer Fellow, 2005-2007Senior Director, Clinical Educators Pharmacyclics

John McBrideBayer Fellow, 2006-2008Project DirectorParexel

Shivani Gandhi Bayer Fellow, 2014-2016U.S. Regulatory LeadAmgen

Adrienne Aiello, PharmDBayer Fellow, 2008-2010Manager, Global Medical Communications Genzyme

Tamy Recchia, PharmDBayer Fellow, 2006-2008Associate Director, Medical Research; Medical Research & Strategy, Thrombosis Daiichi Sankyo

John VaileBayer Fellow, 2005-2007Associate DirectorDermatology Unit Novartis

Elaine Nadeau, PharmDBayer Fellow, 2010-2012Medical Science Liaison, NeurologyAcorda Therapeutics

Sergio Gatoulis, PharmDBayer Alum, 2010-2012Director, Clinical ResearchPfizer, Inc.

Chris Wang, PharmDBayer Fellow, 2014-2016Manager, Regulatory Affairs Advertising and PromotionAmgen

Payal Patel, PharmDBayer Fellow, 2009-2011Medical Science LiaisonAcorda Therapeutics

Vrunda Patel, PharmDBayer Fellow, 2009-2011Manager, Regulatory IntelligenceCelgene

Elias Gatoulis, PharmD, RPhBayer Fellow, 2012-2014 Associate Director in Regulatory Affairs Novartis



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PASSION TO INNOVATE CHANGE · Institute for Pharmaceutical Industry Fellowships The Rutgers...

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