Pharmaceutical Industry Fellowship Program 2015
Pharmaceutical Industry Fellowship Program 2015 Table of Contents - Greetings from......................................3 - Our Vision......................................................4 - Our History.....................................................5 - Fellowship Description & Preceptors...............................6 - Current Fellow Testimonial........................................7 - St. John's University College of Pharmacy and Health Sciences.......8 - University Component...........................................9 - Application Process and Eligibility................................10 2
Greetings from! Thank you for your interest in our company. is pleased to continue its collaboration with St. John s University through participation in the 2015 Pharmaceutical Industry PharmD Fellowship Program. is focused on the development of drugs for rare diseases where there remains a significant unmet medical need. Pursuing less common indications requires venturing into uncharted regulatory territory. This creates a unique learning opportunity in our Regulatory Affairs Department. As an integral member of a development team, the PharmD Fellow in Regulatory Affairs will participate in the evaluation of development options, issues and challenges based on the needs of health authorities in various regions around the world. They will acquire a broad understanding of the regulatory environment including guidelines, precedents, influence of politics, government resource challenges, priorities and emerging policy issues. Communication with various disciplines within the development team will also deepen and broaden the scientific foundation established during the academic portion of your education. The intellectually stimulating environment and our commitment to your continued learning is a winning combination for the start of a successful career in the pharmaceutical industry. We appreciate your interest in and welcome the opportunity to discuss our program further at the American Society of Health System Pharmacists (ASHP) Mid-Year Clinical meeting. Our Mission is to pioneer and deliver innovative therapies that transform the lives of patients with rare diseases worldwide. Robert Ashworth, PhD Vice President, Global Regulatory Affairs 3
About Our Vision At, the most important thing we make is a difference in the lives of patients with rare diseases. People living with rare diseases have incredible courage. They have to, because they have few, if any, treatment options and are often overlooked because of the rarity of their disorders. Globally, there are approximately 7,000 rare diseases and treatments exist for less than 500 of them. We can do better than this. We must do better than this. Our sole focus at is rare diseases, and we are building a global pipeline of first-in- or best-in-disease therapies. Patients are at the center of everything we do. Each of us brings a personal passion to fulfilling our mission: To pioneer and deliver innovative therapies that transform the lives of patients with rare diseases worldwide. Our values and culture are the most important drivers of our success and will support us in achieving our vision of creating a world where every person living with a rare disease has a therapy. Integrity, respect, excellence, personal ownership, teamwork, entrepreneurial spirit and fun are the values that guide our work each day and what we expect from each other. They are the fabric of the culture. We develop therapies for patients with significant unmet medical needs. This includes a treatment for Short Bowel Syndrome (SBS), a rare and potentially fatal gastrointestinal disorder in which patients are unable to absorb enough nutrients and fluids from the food they eat. We have worked closely with patients, caregivers, physicians, universities and other companies to learn how we can help people suffering from this devastating disease. In 2013, we were able to bring to market the first new treatment for SBS in approximately 40 years. is also developing the first hormone replacement therapy for Hypoparathyroidism, a rare endocrine disorder characterized by insufficient levels of parathyroid hormone. Hypoparathyroidism is the only classic endocrine disorder without an approved hormone replacement therapy. Through collaboration with people who suffer from Hypoparathyroidism, caregivers, physicians, universities and other companies we are helping patients with this devastating rare disease globally. Our pipeline includes a potential treatment for Autosomal Dominant Hypocalcemia or ADH. There is no approved therapy for this ultra-rare, life-long genetic disorder that affects both adults and children. Today, is a global rare disease company with approximately 300 employees and operations in the U.S., Canada, Europe, Latin America and Japan. We are passionate about transforming the lives of patients with rare diseases through science. Every day, we connect with people living with rare diseases. Every day, we connect with physicians, researchers, universities, policy makers and companies throughout the globe working in rare diseases. Together we can make a difference. Our vision is to create a world where every person living with a rare disease has a therapy. 4
About Our History 1986 1993 1996 1999 2003 2004 2006 2007 2008 2012 2013 2014 Today, NPS Pharma is a global rare disease company pioneering and delivering therapies to patients with rare diseases that have few, if any, therapeutic options. founded by Drs. Hunter Jackson and Thomas Parks, two dedicated research scientists from the University of Utah School of Medicine studying the medicinal effects of spider venom. enters into strategic collaborations with GlaxoSmithKline for calcilytic compounds in osteoporosis; Kyowa Hakko Kirin (previously Kririn Pharma) and Amgen for investigational medicine for the treatment of hyperparathyroidism. acquires Allelix Pharmaceuticals, including assets key to the company s current success investigational medicines for the treatment of Short Bowel Syndrome and Hypoparathyroidism. Company moves headquarters to New Jersey and first NPS Pharma molecule approved in the U.S. and Europe is marketed by Amgen for the treatment of hyperparathyroidism. osteoporosis treatment approved in Europe (and marketed by Nycomed) is not approved in the U.S., leading to significant company restructuring. re-invents itself as a rare disease company with a new strategic outsourcing business model. Dr. Francois Nader appointed as President and CEO in February of 2008. First product approved in the U.S. and Europe to treat the rare disease Short Bowel Syndrome. Company files application to market investigational medication to treat the rare disease called Hypoparathyroidism in the U.S. with plans to file in Europe. 5
Fellowship Description & Preceptors A Two-Year Post-doctoral (PharmD) Fellowship This is a two year post-doctoral (PharmD) pharmaceutical industry fellowship designed to develop and expand the fellow s skills to work effectively in the pharmaceutical industry. is offering one two-year fellowship position in Regulatory Affairs that will be based in Bedminster, New Jersey. PRECEPTORS Regulatory Affairs Regulatory Affairs provides strategic regulatory guidance and expertise to support global development of investigational and marketed products to ensure smooth and successful drug application submissions and approvals. The fellow will develop a solid understanding of global drug development (primarily focused on US and Europe) as well as strategies related to interactions and communications with health authorities, while gaining hands-on experience through participating on cross-functional project teams. The fellow will also support coordination and review of necessary documentation required for submissions to health authorities. In addition, the fellow will develop skills in the review of advertising and promotional materials to support products. Component Year 1: The first full year will be spent in Regulatory Affairs Year 2: Opportunity to rotate (3 12 months) through various departments at depending on the fellow s level of interest These departments may include, but are not limited to: Clinical Development Medical Publications Commercial Operations/Marketing Pharmacovigilance External Rotations with FDA (3 months) Jehan Rowlands, PharmD Director, Regulatory Affairs Alyssa Wyant Senior Director, International Regulatory Affairs 6
Fellow Testimonial First-Year Regulatory Affairs Fellow Michael Cronin, PharmD The St. John s University/ Regulatory Affairs Fellowship offers a truly unique post-doctoral industry experience. As an international biotech company that focuses on rare diseases, provides its fellows the opportunity to become an integral part in the global development of new therapies for patients who truly have an unmet medical need. As a fellow, I am working with cross-functional teams and learning how to provide strategic regulatory support to speed the development of investigational new drugs. Under the strong mentorship of my preceptors at, I am acquiring knowledge and experience necessary to build a strong foundation and lead a successful career in the pharmaceutical industry. Integrity, respect, excellence, personal ownership, teamwork, entrepreneurial spirit and fun are the values that guide our work each day and what we expect from each other. 7
St. John s University College of Pharmacy and Health Sciences About St. John s St. John s University s primary campus is located on a residential 105-acre campus in Queens, New York and was founded in 1870 by the Congregation of Mission (Vincentian) Community. Recognized for its outstanding academic programs, rich student life, vibrant diversity and Big East vitality, the university boasts a population of over 20,000 students and 140,000 alumni across five metropolitan campuses. The nationally recognized St. John s College of Pharmacy and Health Sciences prepares students for rewarding careers as practitioners, researchers, and leaders in government and industry. Founded in 1929, the College offers numerous healthcare-related programs at the undergraduate and graduate levels including the entry-level Doctor of Pharmacy degree, Master of Science degrees in Pharmaceutical Sciences and Pharmacy Administration, and the Doctor of Philosophy in Pharmaceutical Sciences degree. St. John s College of Pharmacy and Health Sciences is committed to shaping compassionate health care professionals to serve humanity through excellence in health care and biomedical research. Faculty, students and alumni of the College are actively involved in basic sciences as well as clinical research, and provide pharmaceutical care to a diverse patient population. The College continually works in partnership with numerous healthcare organizations throughout the New York metropolitan area to ensure the promotion, practice and delivery of the highest-quality health care services and research. Building on a dedication to greatness, its metropolitan location and its strategic alliances with leading healthcare institutions, the College empowers effective leaders, good citizens, and moral and ethical individuals. St. John s College of Pharmacy and Health Sciences is committed to shaping compassionate health care professionals. 8
St. John s University College of Pharmacy and Health Sciences University Component Each fellow will have opportunities at the University to participate in activities to promote professional development including: Formal and informal educational opportunities Completion of a formal teaching excellence program Collaborative research projects with St. John s faculty Development of continuing education courses Active participation in the College s fellows/ residents seminar series Enrollment in Graduate degree programs available at the University to further his or her educational development (Master s or PhD degrees) On-campus teaching opportunities within the Doctor of Pharmacy Program Completion of an individual research project Benefits of the Fellowship The fellowship provides a competitive stipend and benefits package, including individual comprehensive health insurance through St. John s University. Upon successful completion of the fellowship program, a certificate will be awarded by St. John s University College of Pharmacy and Health Sciences and. 9
Application Process Eligibility for Fellowship To be eligible, candidates must be graduates of an Accreditation Council for Pharmacy Education (ACPE) accredited Doctor of Pharmacy Program before the start of the fellowship term and have a strong interest in a career in the pharmaceutical industry. Participation in the ASHP Midyear Clinical Meeting Personnel Placement Service (PPS) is strongly encouraged, but not required. Interviews begin Sunday, December 7th, 2014 at the ASHP Midyear Clinical Meeting in Anaheim, California. Candidates are encouraged to set up an interview in advance by emailing Dr. Joseph Brocavich at brocavij@stjohns.edu. Interested Candidates Should Send REQUIRED ITEM DEADLINE Curriculum Vitae December 17, 2014 Letter of intent December 17, 2014 Official college transcript December 27, 2014 Three letters of recommendation December 27, 2014 Please send all correspondence (electronic and hardcopy) to: Joseph M. Brocavich, Pharm. D. Senior Associate Dean for Pharmacy Programs Associate Clinical Professor College of Pharmacy and Health Sciences St. John s University 8000 Utopia Parkway Queens, NY, 11439 Email: brocavij@stjohns.edu 10
is headquartered in Bedminster, New Jersey USA with offices in Canada, Europe, Latin America and Japan. Global Headquarters 550 Hills Drive Bedminster, NJ 07921 USA +1 908 450 5300 www.npsp.com 2014 ceuticals, Inc.