Benchmarking
- Understand large and small organizations
- Measure trends
- Stay current
Networking
- Meet peers
- Find opportunities
- Stay connected
Best Practices
- Share ideas
- Learn together
- Program improvement
Modernize
- Discover latest technologies
- Streamline processes
- Remain compliant

Board of Directors

Chairperson

Karen Bartels

Karen Bartels is a Clinical Project Manager at AstraZeneca Pharmaceuticals. Currently holds the position of Investigator Sponsored Studies lead supporting global ISS studies across all therapeutic areas. She holds significant knowledge in working within the collaborative group setting, Program development: Karen has developed guidelines/working instructions/process guidelines/database systems which support IISR's across all TA's within AstraZeneca. Karen is considered to be a knowledge expert on process, and has presented at numerous external conferences on topics of general process and global delivery of ISS programsand IISRA, most notably at DIA in June 2010.

She is a founding member and Executive Director of IISRA (Investigator-Initiated Sponsored Research Association) a nonprofit professional organization supporting professionals within the pharmaceutical/biotech/and device industries supporting non company sponsored studies. In her role as IISRA Standards and Best Practice committee Chair, Best Practice guidance and position statements were developed and implemented throughout the IISRA community.; Received an MBA in Marketing from St. Joseph's University, a post Master's Certificate in Project Management from Villanova University and received Project Management Professional certification in December 2008.She is an Oncology Certified Nurse with 20+ yrs of experience in the acute care setting, prior to joining AstraZeneca, she held a roles as hospital administrator supporting the Women's Health and Oncology Service Lines for Main Line Health System.

Officers

Anton Ehrhardt • President

My experiences in the IISR world started more than 20 years ago as the author/recipient of a number of IISR grants from a variety of pharmaceutical companies while I was on the faculty of a Medical School. Over the last dozen or so years, I've designed and/or managed Medical Affairs organizations and/or IISR programs at two companies, and served on IISR grant committees at companies including Bristol-Myers Squibb, Cubist Pharmaceuticals, and Millennium: the Takeda Oncology Company. In the last couple of years, I also worked closely with a vendor to design a "soup to nuts" IISR grants application and management software program resulting in the launching of a commercial product (Navigate). Lastly, I’m passionate about IISRs and the IISR approach to industry support of some of the most innovative and important research ongoing today. As such, I’m also passionate about the ways independent investigators and industry supporters engage each other, understanding that careful management must be exercised so that IISR programs will remain vital and productive into the future. To this end, I have regularly engaged in public speaking on innovation and best practices related to compliant intent, IISR management programs, transparency & documentation, and Fair Market Valuation considerations specific to IISRs.

Ran Frenkel • Vice President

Ran Frenkel, VP International Business Development of Clinipace World Wide, based in the European headquarters in Zurich, Switzerland. With over 18 years of experience in the life science industry, Ran has excellent knowledge and understanding of its challenges and pressure, and extensive knowledge and contacts of key players in the pharmaceutical development arena. He is known for his ability to work closely with life cycle leaders, leading groups of investigators to best performance. Ran’s career spans experience of working across a large number of companies from the smallest start-up ventures, through Biotech and Medical Device companies to large CROs and drug companies. Ran specializes in performing high-level consultancy to clients in clinical research, operations and regulatory aspects. Ran obtained a pharmacy degree from the Hebrew University of Jerusalem, Israel in 1993.

Nader Molavi MD • Treasurer

Nader practiced Medicine in Iran before moving to Australia to study Biomedical Engineering. He then moved to the US and worked in the high tech industry before working on research projects at Stanford University. He has been working in different capacities in medical and clinical affairs at Abbott Laboratories, ArthroCare, and Clinovo since 2005 and has a broad experience in all aspects of clinical trials, investigator initiated-sponsored studies, EU clinical evaluations, and clinical risk management.

Patricia Westergren • Secretary

Patricia Westergren is Product Manager for Investigator Initiated and Sponsored Research (IISR) Programs at MedNet Solutions with over 30 years of diverse experience in the medical, business and legal disciplines. She is an experienced program manager in clinical research, with regulatory submissions in the U.S and Europe. For seven years Patricia managed IISR programs under Medical Affairs providing grant awards, scientific expertise, and symposium development. In her current position, she is responsible for merging clinical knowledge with technology expertise to design and produce global, comprehensive and auditable systems that address each component of the overall IISR lifecycle.

Executive Committee

Alexander M. Kostek • Executive Director

Alex leads the activities of Pfizer’s Global IIR Group, responsible for ensuring the consistent, global application of IIR processes and compliance with corporate and industry standards including GCP and ICH guidelines. He led a transition team responsible for merging U.S. and Worldwide IIR groups into a Global IIR organization, including developing a global process, addressing resourcing needs and creating a cross-functional team with IIR stakeholders to address finance, contracting, safety and clinical supply needs. His pharmaceutical career spans over fifteen years of project management, finance, clinical operations and scientific leadership positions at Merck and Company, Inc., DuPont Pharmaceuticals Company and Hoffmann-La Roche, Inc.

Daniel Bromberg

Daniel is a Senior Consultant at Polaris Management Partners and has over five years of experience in the life science industry and has served in roles that span from basic neurophysiology research to the development of innovative software solutions. Daniel was a Manager in the Medical Affairs department at Jazz Pharmaceuticals where his responsibilities included managing IISs, CME grants, publications, MSL strategy, and KOL management. Most recently, he was a Product Manager at the UBC-Envision Group where he focused on the Visiontracker product for IIS and Medical Education grant management. He has spent the last three years on the vendor side successfully serving life science companies and has implemented numerous global Medical Affairs solutions. He holds a BA in Biology from Reed College.

Jocelyn Ulrich

Jocelyn Ulrich, MPH is currently a Senior Project Manager in the Medical Affairs department at Human Genome Sciences (HGS). Jocelyn has over 8 years of experience in the pharmaceutical and biotech industries and has held positions in Medical Affairs, SOP Training and Processes, and Global Investigator-Initiated Research (IISR) in the Infectious Disease, Oncology, and Rheumatology therapeutic areas. In her role at HGS, Jocelyn oversees the IISR program and provides project management across Medical Affairs functions. Prior to joining HGS, Jocelyn was the External Partner Liaison at Pfizer, where she provided project and relationship management for both US and international research collaborations and alliances with government agencies, cooperative groups, research networks, and academic medical centers to increase collaboration and improve the probability of success. Jocelyn has been a member of the Investigator-Initiated Sponsored Research Association (IISRA) since 2010 and is currently the Standards and Best Practice Committee Chair. She received her MPH in Health Policy and Management from NYU in 2009 and a Master of Music in Vocal Performance from Boston University School for the Arts in 1995.

Jonathan Chambers

Jonathan Chambers is the Medical Affairs Manager for Pierre Fabre, UK. Pierre Fabre is the second largest independent French pharmaceutical company, celebrating their 50th year in health and beauty. Oncology is a key priority and currently 50% of the medical R&D budget in the group goes to oncology. Jonathan provides the medical and scientific strategy to support a specialist portfolio of oncology products with a focus on demonstrating the value of oral chemotherapy by setting up lasting collaborations with UK physicians.

Jonathan started his career as a research scientist at the Royal Brompton Hospital, London (1994-1999) where he developed an interest in exercise physiology and rehabilitation in heart and lung disease. Jonathan joined the pharmaceutical industry in 1999 and has gained extensive experience in clinical development and medical affairs with SmithKline Beecham (GSK), AstraZeneca, Boehringer Ingelheim and Novartis before joining Pierre Fabre Ltd as their UK medical affairs manager in May 2011.

Jonathan is a member of the UK Chemotherapy Partnership, The Investigator Initiated Sponsored Research Association, International Association for the Study of Lung Cancer, The ABPI Cancer Working Group, Professional Member of the Institute of Clinical Research and Member of the European College of Sport Science.

Recently, Jonathan has been involved in the development and delivery of investigator initiated trials and real world data research projects, involving key opinion leaders, patient groups, industry and other collaborators in lung, breast and bladder cancer. These hospital audits aim to accelerate adoption of chemotherapy into guidelines and medical practice, improve patient quality of life, improve efficiency and generate data and publications to support innovation, patient outcomes and health-economic evaluations.

Ornah Levine-Dolberg

Born in Jerusalem, a mother of three, Dr. Levine-Dolberg received her degree in medicine from the Ben Gurion University of the Negev in 1990. She performed her residency in psychiatry at the Sheeba Medical Center in Ramat-Gan from 1991 to 1996, qualifying cum laude. Head of department for the psychiatric day hospital 1996-2002 she implemented many innovative treatment approaches including art therapy, drama therapy, bibliotherapy and more. During this period she had an academic appointment in the department of psychiatry at the Tel Aviv University, Sackler School of Medicine and was involved in training of medical students, residents in psychiatry and in scientific research and publication.

Dr. Levine-Dolberg joined the pharmaceutical industry in 2003, first as the medical director of Lundbeck in Israel and from 2006 as the Director of Medical Affairs for Mood and Anxiety Disorders.

In her current position Dr. Levine-Dolberg is responsible for investigator initiated research on the company’s portfolio of therapeutics for mood and anxiety disorders, among other medical affairs functions including advisory boards, thought leader development, continuing medical education activities, etc.

Ouadah Hadjebi

After finishing my PhD in Biomedicine, I went on working in pre-clinical studies for kidney transplants at the University of Barcelona (Barcelona, Spain); Bellvitge Hospital and pancreatic cancer at the Institute for Medical Investigations (IMIM) in Barcelona. Then in September 2009, I started as a clinical expert manager for all IISR (medical devices and drugs)at Biocompatibles (Great Britain) until the end of 2011. This position was global and thus I dealt with trials in the US, South America, Asia and Europe. I have spoken at the exl-Pharma conference on European IITs for the last 2 years, and I have created a new Journal called the Investigator Sponsored Trials Journal (the IST Journal url: www.istjournal.eu). This Journal started in January 2012.