Early Phase Clinical Drug Development

Transcription

1 Massachusetts College of Pharmacy and Health Sciences, Worcester, MA Post-PharmD Fellowship Program at Novartis Institutes for BioMedical Research, Cambridge, MA Early Phase Clinical Drug Development

2 Introduction Fellowship training in the Pharmaceutical Industry setting is an exciting opportunity for you as a PharmD graduate to increase your knowledge of current and future therapeutics. It is also an excellent way to expand career options and to distinguish yourself among your peers. As a member of our drug development team, you will receive training in many areas including clinical pharmacology, drug metabolism and disposition, clinical study design, data analysis and other key fields of drug development. At Novartis, our goal is to discover and develop innovative products to prevent and cure diseases and improve patients quality of life. If you share the passion for this goal, then our Novartis Fellowship Program can provide the training and experience for you to pursue this as a career. Novartis is committed to educating and inspiring the next generation of scientists building the talent pool not only for Novartis, but the future leaders of the entire healthcare field. Successful and enduring partnerships with academia are one of the pillars of our approach. This Fellowship is a unique opportunity that the Novartis Institutes for BioMedical Research (NIBR) is offering at our headquarters in Cambridge, MA, in collaboration with Massachusetts College of Pharmacy and Health Sciences (MCPHS). Our program is designed to provide you with the highest quality and standard of training and will give you the opportunity to apply your academic background to the drug development process. We are looking for highly motivated candidates who want to make a difference in people s lives as well as to build upon their knowledge obtained in pharmacy school. Evan Beckman, MD Evan Beckman, MD Global Head, Translational Medicine Novartis Institutes for BioMedical Research 2 NIBR & MCPHS PharmD Fellowship Program 2012

3 With the numerous scientific and technologic breakthroughs in drug discovery and development, I can t think of a more exciting time to be entering into the pharmaceutical industry. Here in Novartis Oncology Translational Medicine, our strategy One Patient, One Team, and One Solution seeks to speed the development of innovative individualized cancer therapies. We are redefining cancer diagnosis and treatment by utilizing the insight, passion, and diverse talents of our associates to shape the future of cancer through providing solutions that make a difference for cancer patients. The clinical knowledge, problem solving and communication skills, and desire to succeed possessed by new PharmD graduates is very highly valued in the industry. Fellowship training is a strong foundation that will enable you to build a career through guidance, mentorship, and invaluable networking opportunities. This new fellowship offered between the Massachusetts College of Pharmacy and Health Sciences and Novartis Institutes for BioMedical Research (NIBR) in collaboration with Novartis Oncology is designed to provide you with an overall understanding of early phase oncology drug development processes from molecular target identification to clinic and to give you indepth training in oncology clinical trial operations. We are committed to professional development and are looking for a Fellow who is driven, selfmotivated, eager to learn, and has demonstrated leadership skills to add to our clinical operations group. I encourage you to consider this unique opportunity at Novartis and wish you the best of luck during the interview and selection process. Barbara Weber, MD Barbara Weber, MD Senior Vice President and Global Head, Oncology Translational Medicine Novartis Institutes for BioMedical Research NIBR & MCPHS PharmD Fellowship Program

4 MCPHS & NIBR PharmD Fellowship Program Purpose The Massachusetts College of Pharmacy and Health Sciences (MCPHS) & Novartis Institutes for BioMedical Research (NIBR) Fellowship is a two-year post-pharmd Fellowship program designed to provide highly-motivated candidates the unique opportunity to gain practical experience in early clinical drug development at NIBR. The Fellowship also presents the opportunity to increase academic skills in collaboration with Massachusetts College of Pharmacy and Health Sciences. Collectively, the Fellowship is designed to provide a comprehensive, high-quality postdoctoral experience. Goal The goal of the Fellowship is to provide qualified candidates with the training and experience to become highly skilled clinical research scientists and to foster professional growth, enhancing the potential for a successful career in the pharmaceutical industry. Objectives During this program, the Fellows will: Gain extensive, practical experience in the drug development process and learn how to function as an integral part of a drug development team Utilize their clinical and scientific knowledge in the design and conduct of numerous early phase clinical research studies Enhance their skill sets through attendance and participation in didactic, clinical and small group forums related to clinical research as well as optional advanced coursework and seminars Expand their technical writing skills by study protocol and report writing and by publishing an academic manuscript Enhance their presentation skills by presenting data at internal meetings and at a national research conference 2 NIBR & MCPHS PharmD Fellowship Program 2012

5 Novartis Institutes for BioMedical Research (NIBR) NIBR Overview The Novartis Institutes for BioMedical Research (NIBR) is the global pharmaceutical research organization for Novartis committed to discovering innovative medicines to treat diseases with high unmet medical need. With more than 6,000 scientists and physicians around the world, our open and entrepreneurial culture encourages collaboration as we work to push the boundaries of science to change the practice of medicine. Research at NIBR begins and ends with the patient. Recent scientific advances, such as the completion of the human genome sequence and the scale-up of massive parallel experimentation, provide vast amounts of new information. Our challenge now is to interpret mechanistic and molecular-level information in the context of human physiology and network biology in order to discover new medicines. To meet this challenge, NIBR takes a multi-faceted approach: Scientifically, we strive to push the frontiers at the intersection of chemistry, biology, and medicine, and combine traditional approaches to pharmaceutical discovery with emerging concepts from the chemical and biological sciences. At the clinical/research interface our translational medicine experts inform our discovery research, provide a smooth transition from research to the clinic, and enable potential medicines to be tested more effectively in man. NIBR & MCPHS PharmD Fellowship Program

6 Organizationally, we have created an open, collaborative, and exciting work environment. We encourage activities across geographical, cultural, and institutional barriers, as well as close collaboration with academia and biotech companies. A worldwide biotechnology hub, the Cambridge location of the NIBR headquarters puts us close to multiple renowned academic institutions and in the midst of one of the world s most impressive pools of scientific talent. The NIBR Cambridge site is home to research and translational sciences in oncology, ophthalmology, diabetes, infectious diseases, musculoskeletal disorders, and cardiovascular and metabolic conditions. There is no greater privilege than to work towards bettering human health, and no more exciting arena in which to do so than through discovery of new medicines. Mark Fishman President, NIBR 4 NIBR & MCPHS PharmD Fellowship Program 2012

7 Fellowship Overview This two-year Fellowship offered by MCPHS in conjunction with NIBR in Cambridge, MA, provides Fellows with practical experience in early clinical drug development in an immersive pharmaceutical research environment. Fellows will be exposed to a number of fundamental early clinical research studies such as first-in-human, proof-of-concept, dose escalation, pharmacokinetic drug-interaction and mechanistic profiling studies during the course of the Fellowship. In addition to early phase clinical research, Fellows will also gain insight into the multi-disciplinary aspects of the drug development process. Specific responsibilities of the Fellows will include: Acting as a member and/or leading the clinical trial team comprising of internal and external experts contributing to the study design, conduct and analysis Developing clinical trial protocols as well as contributing to the design of data capture tools and statistical analysis plans Creating and obtaining essential regulatory trial documents Orchestrating all aspects of the operational implementation of clinical trials including selection and oversight of clinical trial centers and external vendors Participating in the analysis of study data and the preparation of final study reports Contributing to program-level activities, e.g. writing of Investigator s Brochure, briefing books and safety updates Understanding and complying with Good Clinical Practice (GCP) guidelines and regulatory requirements nationally and abroad Learning to work cross-culturally with colleagues and study sites around the world Co-precepting students on advanced experiential rotations Fellows will routinely lead and/or participate in meetings with experts who will be reviewing the scientific and operational aspects of a clinical trial. They may also have the opportunity to participate in meetings with external expert panels as well as contribute to an Investigational New Drug (IND) application the process which allows clinical testing to begin in humans. Fellows also may be called upon to contribute to a New Drug Application (NDA) the regulatory process which is the final step leading to the approval of a new drug. The scope of work will allow Fellows to work within international teams and to interact with different departments within Novartis, for example Biomarker Development, Drug Metabolism and Pharmacokinetics, Preclinical Safety, Translational Medicine, Biomedical Statistics, Technical Research and Development, and Drug Regulatory Affairs. NIBR & MCPHS PharmD Fellowship Program

8 Fellows will be encouraged to identify and develop special projects of interest and will have the opportunity to attend at least one national scientific meeting annually. Furthermore, a variety of internal NIBR seminars and scientific courses designed to build scientific and professional skills will be available to Fellows, both from the perspective of individual learning, and participation as course faculty. The Fellowship will represent the third year that MCPHS and NIBR are offering this Fellowship. We are pleased to offer two, two-year fellowship positions: one in General Translational Medicine, Clinical Sciences & Innovation (CS&I), and one in Oncology Translational Medicine (OTM) at NIBR. NIBR Clinical Sciences and Innovation (CS&I) The Clinical Sciences and Innovation (CS&I) department in NIBR Translational Medicine is a dynamic group of clinical scientists responsible for the conduct and evaluation of Phase I and Phase IIa clinical studies. These studies are designed to profile safety, tolerability, pharmacokinetics and pharmacodynamics and to provide early proof of efficacy of novel compounds in humans. CS&I in Cambridge, MA, specializes in early clinical research in diabetes, cardiovascular and metabolic conditions, ophthalmology, musculoskeletal disorders, respiratory and infectious diseases. Globally, CS&I also performs clinical research in neuroscience, autoimmunity, dermatology and transplantation. Over 100 clinical sciences experts in seven CS&I locations worldwide strive to provide a smooth transition from discovery research to clinical practice and enable potential medicines to be tested more effectively in humans. Edward Wolfson, PharmD Second Year Clinical Trial Leader Fellow Clinical Sciences & Innovation The MCPHS and NIBR Fellowship Program is constructed on a solid framework of mentorship and independence. Through the interactive mentorship of experienced colleagues, Fellows are equipped with the professional skills and competencies necessary to perform in a clinical research setting. As Fellows develop this skill set, they ultimately evolve into autonomous team members capable of managing clinical studies and executing other responsibilities associated with clinical trial leadership. This unique balance of structured learning and hands-on experience ensures Fellows are successfully prepared for a promising career in clinical development. 6 NIBR & MCPHS PharmD Fellowship Program 2012

9 Zachary Lee, PharmD First Year Clinical Trial Leader Fellow Clinical Sciences & Innovation The MCPHS and NIBR fellowship program is an opportunity to strengthen and develop new skills in an environment that fosters both professional and academic development. The program allows fellows to utilize their clinical knowledge in the discovery of future therapeutics to gain new insight into the aspects of drug innovation. The ability to work in early clinical development is a rare chance to peer through the looking glass towards new, cutting-edge therapies. With new research being conducted, I anticipate extraordinary advancements in the medicines of today, to solve the problems of tomorrow. NIBR Oncology Translational Medicine (OTM) Novartis Oncology and NIBR collaborate to form Oncology Translation Medicine (OTM) to accelerate innovative oncology compounds from target discovery to commercialization, particularly by targeting patients for early trials based on molecular mechanism of drugs and diseases. The OTM function is responsible for: Developing the strategy and executing first in human and proof-of-concept clinical trials for oncology therapeutics using adaptive design Developing and executing biomarker and imaging strategies in clinical trials Providing robust research support to Oncology compounds to increase clinical trial success and maximize patient benefit through patient stratification, indication expansion, and combination therapy Management of global clinical trials using patient selection and targeted therapies Ensuring a smooth hand off to full development to speed medicines to market Kevin Huan Vo, PharmD First Year Clinical Trial Leader Fellow Oncology Translational Medicine The MCPHS and NIBR OTM fellowship program allows me to apply my clinical experience and participate in executing daily trial operations in early phase oncology studies. The program offers ample interactions within multi-disciplinary teams, both academically and professionally, to broaden my experiences and interests. The skills and knowledge I am gaining from the fellowship will bolster my professional development and provide the confidence necessary to foster a successful career in the pharmaceutical industry. NIBR & MCPHS PharmD Fellowship Program

10 NIBR Fellowship Leadership Team Jamie Hutchinson, MA NIBR CS&I (General Medicines) Principal Clinical Scientist Clinical Sciences & Innovation The collaboration between NIBR and MCPHS is one with which I am proud to be involved. Both institutions are committed to providing an outstanding educational experience while preparing Fellows for future involvement in the pharmaceutical industry. Robert Maietta Fellowship Group Lead CS&I (General Medicines) Clinical Trial Leader III Clinical Sciences & Innovation As relatively new fellowships, the MCPHS and NIBR programs offer Fellows the unique opportunity to actively participate in the development of their own experience. The wealth of expertise and resources provided by both institutions ensure that Fellows are equipped with the proper guidance and tools to effectively achieve program objectives and successfully prepare for promising futures in clinical research. Heather DiBenedetto, MS RAC NIBR OTM OTM Fellowship Director Cambridge Site Head Clinical Operations Oncology Translational Medicine As a MCPHS alumnus, I am very excited to be collaborating with MCPHS to give a PharmD Fellow the unique opportunity to explore early phase oncology clinical development and to see the passion here at Novartis that exists in finding new drugs to treat cancer. Lyh Ping Lam, PharmD Fellowship Group Lead OTM Clinical Trial Leader Oncology Translational Medicine Completing a Fellowship is an invaluable extension to your pharmacy training. This Fellowship bridges the gap between academia and industry by providing in-depth hands-on experience in early phase clinical research. The opportunity to learn new skills and build lasting professional relationships is critical to a successful career in the pharmaceutical industry. 8 NIBR & MCPHS PharmD Fellowship Program 2012

11 Fellowship Advisory Board The Fellowship Advisory Board is an assembly of PharmD graduates that have completed industry fellowships in clinical development with other programs. As well-experienced fellowship alumni, these board members serve as valuable sources of fellow mentorship and program guidance. Kiran Dole, PharmD Clinical Trial Leader III Clinical Sciences & Innovation The NIBR and MCPHS Fellowship program is an exciting opportunity to learn the fundamentals of early drug development in an accelerated manner with hands on experience. Fellows in this program can count on a supportive teamwork environment to enhance the transition from the the classroom to the practical realities of bringing drugs to market, with a heavy focus on clinical trial conduct. Therese Swan, PharmD Clinical Trial Leader II Clinical Sciences & Innovation Fellows in CS&I are able to use their clinical knowledge and develop their research abilities in the effort to bring new drugs from the lab bench to patients. NIBR presents a unique opportunity to work with people from different cultures around the globe in a fast-paced, challenging, and extremely rewarding environment. Craig Trusley, PharmD, MS Clinical Trial Leader II Clinical Sciences & Innovation The CS&I fellowship prepares recent PharmD graduates for a career in pharmaceutical drug development. The challenges and successes experienced are excellent preparation for future advancement. Ample opportunities for networking enable fellows to build key connections with others in pharmaceutical industry. NIBR & MCPHS PharmD Fellowship Program

12 Massachusetts College of Pharmacy and Health Sciences, Worcester/Manchester (MCPHS-W/M) Educational Mission Fellowship programs at the Massachusetts College of Pharmacy and Health Sciences, Worcester/Manchester (MCPHS-W/M) are established to provide high-quality, post-graduate educational opportunities for motivated individuals seeking advanced exposure to academics in addition to daily immersion in the biopharmaceutical industry. Rapid growth and interest in perpetuating our Fellowship programs requires special care to ensure quality, strength and continued development. Fellows will gain experience in the areas of teaching and research by participating in various courses and research with Faculty preceptors or other Faculty with mutual interest in selected research topics. MCPHS Worcester-Manchester Campuses Massachusetts College of Pharmacy and Health Sciences provides an academic environment to guide and support fellows toward a successful career in the biopharmaceutical industry. As a private institution with a history of specializing in health sciences, MCPHS offers programs that embody scholarship, professional service and community outreach. Through MCPHS, the Fellow will have the opportunity to gain teaching and research experience in an academic setting. MCPHS faculty and company program leaders mentor fellows according to their scholarly and professional interests throughout the two year program. As an adjunct assistant professor at MCPHS, Fellows will have the opportunity to: Develop, coordinate, and teach courses at the Worcester or Manchester campus Co-precept students on advanced experiential rotations Create and publish scholarly research and/or review articles 10 NIBR & MCPHS PharmD Fellowship Program 2012

13 Present data at scientific and clinical meetings Participate in professional development seminars with other Fellows and Residents from MCPHS-affiliated programs. MCPHS W/M Faculty Michael Malloy, PharmD Professor and Dean Massachusetts College of Pharmacy and Health Sciences School of Pharmacy Worcester/Manchester I am excited that the School of Pharmacy-Worcester/Manchester at Massachusetts College of Pharmacy and Health sciences has partnered with NIBR to develop a first class Industrial Fellowship program. This is done by combining the history of success and resources offered through NIBR along with a focused plan for mentorship of the Fellows. Our work with NIBR will continue to build a long-term partnership and create a unique Fellowship embodying the best both institutions have to offer. My vision is that the success of this Fellowship will be repeated through future Fellowship opportunities between NIBR and the School of Pharmacy. Valerie Coppenrath, PharmD, BCPS Assistant Professor of Pharmacy Practice Massachusetts College of Pharmacy and Health Sciences School of Pharmacy Worcester/Manchester My primary role as a pharmacist is education. In this Fellowship, it is my goal to teach Fellows how to teach. Determining the best way to convey information and facilitate learning is an important skill that will be a valuable asset in any area of pharmacy practice. NIBR & MCPHS PharmD Fellowship Program

14 Application Process and Eligibility Requirements Program Design Duration: Two years Location: Massachusetts School of Pharmacy and Health Services, Worcester, MA and Novartis Institutes for BioMedical Research, Cambridge, MA Number of positions: Two Start date: July 1 Eligibility Fellows will be selected on a nationally competitive basis, with interviews at the American Society of Health Systems Pharmacists (ASHP) Midyear meeting. Applicants must have a Doctor of Pharmacy degree from an ACPE accredited college of pharmacy and be legally authorized to work in the United States. Candidates must have strong written and verbal communication skills and a strong interest in pursuing a career in the biopharmaceutical industry. Certificate of Completion MCPHS-W/M and NIBR will award a certificate upon successful completion of the Fellowship program. Compensation Fellows will receive a competitive stipend and benefit package, including comprehensive health insurance from MCPHS. Attendance to one or more professional meetings, conferences or workshops will be sponsored by NIBR. Application Participation in the Personnel Placement Service (PPS) at the ASHP Midyear Clinical Meeting is strongly encouraged, but not required. Interested individuals should submit a letter of interest and curriculum vitae electronically to [email protected] by December 20 th. Please reference either CS&I, OTM, or both programs in all correspondence. Early submission is highly encouraged due to the competitive nature of the Fellow selection process. For further information, please visit: nibrfellowships Top candidates will be invited for onsite interviews at NIBR in January. Three letters of recommendation and an official college transcript are due prior to the onsite interview. The letters of recommendation should be sent electronically to the addresses above. Official college transcripts should be mailed to: Valerie Coppenrath, PharmD, BCPS Massachusetts College of Pharmacy and Health Sciences 19 Foster Street Worcester, MA NIBR & MCPHS PharmD Fellowship Program 2012

15 Massachusetts College of Pharmacy & Health Sciences - Worcester/ Manchester Biopharmaceutical Industry Fellows NIBR & MCPHS PharmD Fellowship Program

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