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Clinical Fellowship Alumni
Genentech offers Clinical Research Fellowships in its South San Francisco Product Development Clinical Inflammation (PDCI) program.
As members of the Clinical Development group at Genentech, Fellows work closely with top institutions and physicians to deliver on Genentech's commitment to develop novel therapeutics. The Fellowship can last for up to one year and is geared towards third- and fourth-year Fellows with a strong interest in clinical research.
Learn more about the program from our alumni below.
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Ariella Kelman, MD
- Genentech
- Group Medical Director - Actemra
Q:When did you join our Fellowship program?
A: 2005
Q: What were your Fellowship activities?
A: I was interested in clinical aspects of drug development. As a Genentech fellow, I was an integral member of the clinical development team. Using my clinical expertise, I provided input in designing three Phase 2 and 3 clinical trials and was the lead author of the protocols for them. I also was the lead scientist for designing post hoc, exploratory analyses, the results of which led to publication and presentation at international scientific meetings. I reviewed clinical trial designs in a number of disease areas, as well. I gained first hand experience in several aspects of drug development, including statistics, pharmacokinetics, clinical operations, drug safety/pharmacovigilence, regulatory affairs, and commercial perspectives. During the fellowship year, I had fantastic support from two mentors, one physician at Genentech and one at my university. I feel fortunate at how much responsibility I was trusted with as a fellow, and the experience ultimately led to my decision to pursue a career in biotechnology development.
Q: What were your publications during your Fellowship?
A: None during the fellowship year, but several published the following year(s) as a result of work done during the fellowship.
Full Manuscripts:
Mease PJ, Cohen S, Gaylis NB, Chubick A, Kaell AT, Greenwald M, Agarwal S, Yin M, Kelman A. Efficacy and Safety of Retreatment in Patients with rheumatoid Arthritis with Previous Inadequate Response to Tumor necrosis factor Inhibitors: Results from the SUNRISE Trial. J Rheumatol. 2010 May;37(5):917-27.
Bingham CO 3rd, Looney RJ, Deodhar A, Halsey N, Greenwald M, Codding C, Trzaskoma B, Martin F, Agarwal S, Kelman A. Immunization responses in rheumatoid arthritis patients treated with rituximab: results from a controlled clinical trial. Arthritis Rheum. 2010 Jan;62(1):64-74.
Abstract:
Emery P, Breedveld F, Martin-Mola E, Pavelka K, Szczepanski L, Kim D, Magrini F, Behrendt C, Kelman A. Relationship between peripheral B cell return and loss of EULAR response in RA patients treated with rituximab, abstract American College of Rheumatology meeting 2006.
Q: Where are you now?
A: I am a Group Medical Director at Genentech. I have also had the opportunity to maintain a faculty position within a teaching hospital by maintaining an active clinical and teaching practice. -
Hubert Chen, MD
- UCSF
- Assistant Clinical Professor, Division of Pulmonary and Critical Care Medicine
Q: When did you join our Fellowship program?
A: 2005 to 2007
Q: What were your Fellowship activities?
A: As a clinical research fellow I had the opportunity to participate in a breadth of activities. Foremost, I was allowed to take the lead in several analyses utilizing registry data to characterize the epidemiology and natural history of severe asthma in the U.S. During my fellowship, I also had the opportunity to work closely with clinical scientists on trials at various stages in the drug development process, including Phase 2, Phase 3b, and Phase 4 studies. In particular, I gained first-hand experience writing study protocols, monitoring study visits, reviewing safety data, reporting adverse events to regulatory agencies, submitting for drug label changes, and interacting with key opinion leaders at investigator meetings. Most importantly, I learned how to operate effectively within the context of a cross-functional team consisting of bench scientists, clinician investigators, biostatisticians, clinical operation managers, health outcome researchers, and safety/regulatory experts.
Q: What were your publications during your Fellowship?
A: Chen H, Gould MK, Blanc PD, Miller DP, Kamath TV, Lee JH, Sullivan SD. Asthma control, severity, and quality of life: Quantifying the effect of uncontrolled disease. J Allergy Clin Immunol. 2007; 120(2):396-402. Chen H, Blanc PD, Hayden M-L, Bleecker ER, Chawla A, Lee JH. Assessing productivity loss and activity impairment in severe or difficult-to-treat asthma. Value in Health. 2008; 11(2):231-239.
Peters AT, Klemens JC, Haselkorn T, Weiss ST, Grammer LC, Lee JH, Chen H. Insurance status and asthma-related healthcare utilization in patients with severe asthma. Ann Allergy Asthma Immunol. 2008; 100:301-307.
Chen H, Johnson CA, Haselkorn T, Lee JH, Israel E. Subspecialty differences in asthma characteristics and management. Mayo Clin Proc. 2008; 83(7):786-793.
Haselkorn T, Fish JE, Chipps BE, Miller DP, Chen H, Weiss ST. Effect of weight change on asthma-related health outcomes in patients with severe or difficult-to-treat asthma.
Haselkorn T, Chen H, Miller DP, Fish JE, Peters SP, Weiss ST, Jones CA. Asthma control and activity limitations: Insights from the Real-World Evaluation of Asthma Control and Treatment (REACT) study. Ann Allergy Asthma Immunol. 2010;104:471-477.Respir Med. 2009; 103:274-283.
Q: Where are you now?
A: I am currently working for Genentech as a Associate Medical Director for Product Development Immunology - Respiratory team. -
Hal Barron
- Genentech
- Executive Vice President, Head of Global Product Development
Q: When did you join our Fellowship program?
A: In 1996
Q: What were your Fellowship activities?
A: I worked on NRMI, exploring real world epidemiology of acute MI.
Q: What were your publications during your Fellowship?
A: Magid DJ. Calonge BN. Rumsfeld JS. Canto JG. Frederick PD. Every NR. Barron HV. National Registry of Myocardial Infarction 2 and 3 Investigators. Relation between hospital primary angioplasty volume and mortality for patients with acute MI treated with primary angioplasty vs thrombolytic therapy. JAMA. 284(24):3131-8, 2000 Dec 27.
Shlipak MG. Go AS. Frederick PD. Malmgren J. Barron HV. Canto JG. Treatment and outcomes of left bundle-branch block patients with myocardial infarction who present without chest pain. National Registry of Myocardial Infarction 2 Investigators. Journal of the American College of Cardiology. 36(3):706-12, 2000 Sep.
Canto JG. Shlipak MG. Rogers WJ. Malmgren JA. Frederick PD. Lambrew CT. Ornato JP. Barron HV. Kiefe CI. Prevalence, clinical characteristics, and mortality among patients with myocardial infarction presenting without chest pain. J AMA. 283(24):3223-9, 2000 Jun 28.
Vaccarino V. Parsons L. Every NR. Barron HV. Krumholz HM. Impact of history of diabetes mellitus on hospital mortality in men and women with first acute myocardial infarction. The National Registry of Myocardial Infarction 2 Participants. American Journal of Cardiology. 85(12):1486-9; A7, 2000 Jun 15.
Canto JG. Every NR. Magid DJ. Rogers WJ. Malmgren JA. Frederick PD. French WJ. Tiefenbrunn AJ. Misra VK. Kiefe CI. Barron HV. The volume of primary angioplasty procedures and survival after acute myocardial infarction. National Registry of Myocardial Infarction 2 Investigators. New England Journal of Medicine. 342(21):1573-80, 2000 May 25.
Canto JG. Rogers WJ. French WJ. Gore JM. Chandra NC. Barron HV. Payer status and the utilization of hospital resources in acute myocardial infarction: a report from the National Registry of Myocardial Infarction 2. Archives of Internal Medicine. 160(6):817-23, 2000 Mar 27.
Barron HV. Rundle AC. Gore JM. Gurwitz JH. Penney J. Intracranial hemorrhage rates and effect of immediate beta-blocker use in patients with acute myocardial infarction treated with tissue plasminogen activator. Participants in the National Registry of Myocardial Infarction-2. American Journal of Cardiology. 85(3):294-8, 2000 Feb 1.
Rogers WJ. Canto JG. Barron HV. Boscarino JA. Shoultz DA. Every NR. Treatment and outcome of myocardial infarction in hospitals with and without invasive capability. Investigators in the National Registry of Myocardial Infarction. Journal of the American College of Cardiology. 35(2):371-9, 2000 Feb.
Michaels AD. Maynard C. Every NR. Barron HV. Early use of ACE inhibitors in the treatment of acute myocardial infarction in the United States: experience from the National Registry of Myocardial Infarction 2. National Registry of Myocardial Infarction 2 participants. American Journal of Cardiology. 84(10):1176-81, 1999 Nov 15.
Canto JG. Kiefe CI. Williams OD. Barron HV. Rogers WJ. Comparison of outcomes research with clinical trials using preexisting data. American Journal of Cardiology. 84(8):923-7, A6, 1999 Oct 15.
Vaccarino V. Parsons L. Every NR. Barron HV. Krumholz HM. Sex-based differences in early mortality after myocardial infarction. National Registry of Myocardial Infarction 2 Participants. New England Journal of Medicine. 341(4):217-25, 1999 Jul 22.
Barron HV. Rundle A. Gurwitz J. Tiefenbrunn A. Reperfusion therapy for acute myocardial infarction: observations from the National Registry of Myocardial Infarction 2. Cardiology in Review. 7(3):156-60, 1999 May-Jun.
Every NR. Frederick PD. Robinson M. Sugarman J. Bowlby L. Barron HV. A comparison of the national registry of myocardial infarction 2 with the cooperative cardiovascular project. Journal of the American College of Cardiology. 33(7):1886-94, 1999 Jun.
Canto JG. Taylor HA Jr. Rogers WJ. Sanderson B. Hilbe J. Barron HV. Presenting characteristics, treatment patterns, and clinical outcomes of non-black minorities in the National Registry of Myocardial Infarction 2. American Journal of Cardiology. 82(9):1013-8, 1998 Nov 1.
Go AS. Barron HV. Rundle AC. Ornato JP. Avins AL. Bundle-branch block and in-hospital mortality in acute myocardial infarction. National Registry of Myocardial Infarction 2 Investigators. Annals of Internal Medicine. 129(9):690-7, 1998 Nov 1.
Gurwitz JH. Gore JM. Goldberg RJ. Barron HV. Breen T. Rundle AC. Sloan MA. French W. Rogers WJ. Risk for intracranial hemorrhage after tissue plasminogen activator treatment for acute myocardial infarction. Participants in the National Registry of Myocardial Infarction 2. Annals of Internal Medicine. 129(8):597-604, 1998 Oct 15
Goldberg RJ. Mooradd M. Gurwitz JH. Rogers WJ. French WJ. Barron HV. Gore JM. Impact of time to treatment with tissue plasminogen activator on morbidity and mortality following acute myocardial infarction (The second National Registry of Myocardial Infarction). American Journal of Cardiology. 82(3):259-64, 1998 Aug 1.
Barron HV. Michaels AD. Maynard C. Every NR. Use of angiotensin-converting enzyme inhibitors at discharge in patients with acute myocardial infarction in the United States: data from the National Registry of Myocardial Infarction 2. Journal of the American College of Cardiology. 32(2):360-7, 1998 Aug.
Barron HV. Bowlby LJ. Breen T. Rogers WJ. Canto JG. Zhang Y. Tiefenbrunn AJ. Weaver WD. Use of reperfusion therapy for acute myocardial infarction in the United States: data from the National Registry of Myocardial Infarction 2. Circulation. 97(12):1150-6, 1998 Mar 31
Barron HV. Viskin S. Lundstrom RJ. Swain BE. Truman AF. Wong CC. Selby JV. Beta-blocker dosages and mortality after myocardial infarction: data from a large health maintenance organization. Archives of Internal Medicine. 158(5):449-53, 1998 Mar 9.
Barron HV. Viskin S. Lundstrom RJ. Wong CC. Swain BE. Truman AF. Selby JV. Effect of beta-adrenergic blocking agents on mortality rate in patients not revascularized after myocardial infarction: data from a large HMO. American Heart Journal. 134(4):608-13, 1997 Oct.
Selby JV. Fireman BH. Lundstrom RJ. Swain BE. Truman AF. Wong CC. Froelicher ES. Barron HV. Hlatky MA. Variation among hospitals in coronary-angiography practices and outcomes after myocardial infarction in a large health maintenance organization. New England Journal of Medicine. 335(25):1888-96, 1996 Dec 19.
Q: Where are you now?
A: Executive Vice President, Head of Global Product Development. Chief
Medical Officer responsible for the products of the combined portfolio of Roche and Genentech. -
Kasia Owczarczyk, MD
- University College in London
- Specialty Registrar
Q: When did you join our Fellowship program?
A: In August 2008
Q: What were your Fellowship activities?
A: The experimental part of the fellowship included analysis of next generation sequencing data from synovial tissue of RA patients as well as work into developing and prospective validation of predictive biomarkers for response to B cell depleting therapies. The first was a basic research project that allowed me to familiarize myself with cutting edge sequencing technology, as well as with platforms to analyze terabytes of data. The latter was a large scale clinical research project aimed to find predictive biomarkers for treatment, very much in keeping with the notion of personalized medicine that is currently being pursued by physicians, scientists and regulatory bodies alike.
Q: What were your publications during your Fellowship?
A: None during the fellowship year, but below is my most recent publication. ELEVATED BLOOD PLASMABLAST MRNA MARKERS ARE NEGATIVE PREDICTORS OF RESPONSE TO RITUXIMAB IN RHEUMATOID ARTHRITIS; K. Owczarczyk, Z. Su, A.R. Abbas, K. Wolslegel, C. Holweg, P. Lal, W. Dummer, A. Kelman, P. Brunetta, M. Sorani, D. Leong, P. Fielder, D. Yocum, W. Ortmann, M. Townsend, T.W. Behrens; Ann Rheum Dis 2011;70(Suppl3):69.
Most recent publications:
Owczarczyk K, Lal P, Abbas AR, Wolslegel K, Holweg CT, Dummer W, Kelman A, Brunetta P, Lewin-Koh N, Sorani M, Leong D, Fielder P, Yocum D, Ho C, Ortmann W, Townsend MJ, Behrens TW. A Plasmablast Biomarker for Nonresponse to Antibody Therapy to CD20 in Rheumatoid Arthritis. Sci Transl Med. 2011 Sep 21;3(101):101ra92.
Oral presentations: EULAR 2011 (presentation 0010 ELEVATED BLOOD PLASMABLAST MRNA MARKERS ARE NEGATIVE PREDICTORS OF RESPONSE TO RITUXIMAB IN RHEUMATOID ARTHRITIS).
Q: Where are you now?
A: Currently, I am a Specialist Registrar in Clinical Oncology at Mount Vernon Cancer Center in London, UK. -
Annie Chan, MD
- Stanford University
- Vitreoretinal Fellow
Q: When did you join our Fellowship program?
A: August 2009
Q: What were your Fellowship activities?
A: As a clinical research fellow, I was a member of the Ophthalmology group, under late development. My focus was on publications and presentations from the BRAVO/CRUISE trials and from ANCHOR/MARINA/SAILOR trials. I reviewed Investigator Sponsored Trials protocols and proposals in monthly Clinical Trial Review Committee meetings. I gained some experience in clinical trial monitoring in the DME RISE/RIDE trials. I helped develop a protocol for patient reported outcomes in the Geographic Atrophy program. I was also involved in a business development assessment with Roman Rubio. I was able to attend a course in Principles and Concepts in Clinical Trials for Eye Researchers sponsored by ARVO (The Association for Research in Vision and Ophthalmology.
Q: What were your publications during your Fellowship?
A: Conference abstract:
Bhisitkul RB, Gray S, Murahashi WY, Saroj N, Rundle A, Rubio R, Chan A. "Anatomical Outcomes of the BRAVO Study of Intravitreal Ranibizumab in Patients With Macular Edema Following Branch Retinal Vein Occlusion," ARVO (2010).Conference abstract:
Chan A, Hariprasad SM, Chung, Wong P, Tuomi L. "Delayed Responders in the Treatment of Neovascular Age-Related Macular Degeneration (AMD) With Ranibizumab in the MARINA, ANCHOR, PIER and SAILOR Studies," ARVO (2010), ASRS (2010).
Q: Where are you now?
A: I am currently a vitreoretinal fellow at Stanford University. -
Nisha Archarya, MD
- UCSF
- Assistant Professor, Director of the Uveitis Service
Q: When did you join our Fellowship program?
A: July 2005-June 2006
Q: What were your Fellowship activities?
A: I worked with the Tissue, Growth and Repair clinical sciences group and specifically with the Lucentis team. This was prior to FDA approval of Lucentis for macular degeneration, so I was able to help analyze data from some of the pivotal Phase 3 clinical trials and to take charge of subgroup analyses using the data. I worked with a biostatistician and developed the research questions, helped guide analyses, and was responsible for manuscript preparation and publication.
I learned the nuts and bolts of designing and implementing large-scale clinical trials in ophthalmology, and had the opportunity to participate in data and safety monitoring meetings.
I also participated in the clinical trials review committee to review and provide critiques on proposals for investigator-sponsored trials.
Given that my career goal is to design and implement clinical trials in an academic setting, my experience during this fellowship was invaluable. In the span of one year, I was able to have an immersive hands-on experience that provided me with a strong foundation to develop into a trialist.
Q: What were your publications during your Fellowship?
A: Boyer, D, Antoszyk, A, Awh, C, Bhisitkul, R, Shapiro, H, Acharya, N, for the MARINA Study Group. Subgroups Analysis of the MARINA Study of Ranibizumab in Neovascular Age-related Macular Degeneration. Ophthalmology, 2007 Feb;114(2):246-52.
Kaiser, P, Blodi, B, Shapiro, H, Acharya, N, for the MARINA Study Group. Angiographic and Optical Coherence Tomographic Results of the MARINA Study of Ranibizumab in Neovascular Age-related Macular Degeneration. Ophthalmology, 2007 Oct;114(10) 1868-75.
Kaiser, P, Brown, D, Zhang, K, Hudson, H, Holz, F, Shapiro, H, Schneider, S, Acharya, NR. Ranibizumab for Predominantly Classic Neovascular Age-related Macular Degeneration: Subgroup Analysis of First-year ANCHOR Results. American Journal of Ophthalmology, 2007 Dec;144(6):850-7.
Q: Where are you now?
A: Following my Genentech fellowship, I joined the full-time faculty at UCSF/F.I. Proctor Foundation as a clinician-scientist. I received a K23 career development award from the NIH to conduct ancillary studies to NIH-funded clinical trials. My clinical focus has been ocular inflammatory disease, and I am Director of the Uveitis Service. I am also the uveitis fellowship director and teach residents and fellows in clinic. I have developed a research program in ocular inflammatory disease with a focus on epidemiological studies and clinical trials, including collaborative international studies. -
Jason Ehrlich, MD
- Genentech
- Associate Medical Director
Q: When did you join our Fellowship program?
A: July 2008
Q: What were your Fellowship activities?
A: I entered the fellowship program following completion of my Ophthalmology residency at Stanford. I had two key goals for my fellowship year: 1) Participate in novel and important ophthalmic research using the unique clinical trial data available at Genentech, and 2) learn as much as I could about ophthalmic drug development "from the inside", particularly regarding clinical trial design and implementation. My key scientific accomplishment was helping to advance a pharmacogenomics project that the Lucentis clinical team was undertaking in collaboration with our colleagues in the Research & Development group; this resulted in several presentations at the ARVO and AAO ophthalmology congresses. I participated in all aspects of the Lucentis clinical team's work, including coauthoring a clinical study report, reviewing investigator-sponsored study protocols, and participating in the creation of a new Lucentis Phase III study. I also continued to see patients, and teach residents at Stanford and the Palo Alto Veterans' Hospital. Overall, it was a highly successful and educational year - so much so that I have stayed at Genentech as a full-time member of the Clinical Ophthalmology group!
Q: What were your publications during your Fellowship?
A: Ehrlich, J.S., Ianchulev, T., Shapiro, H., Freisenhahn, M., Gateva, V., Graham, R., "Genome-Wide Association Study Reveals New Loci Associated with Patient Response to Ranibizumab Treatment for Neovascular AMD," Platform Talk, American Academy of Ophthalmology Meeting, October 2009. Best Paper of Session Award.
Ianchulev, T., Ehrlich, J.S., Shapiro, H., Graham, R., "Additive effects of complement pathway genetic polymorphisms on choroidal neovascular phenotypes and response to ranibizumab treatment," Poster Presentation, American Academy of Ophthalmology Meeting, October 2009
Zhang, K., Seddon, J., Ianchulev, T., Yee, W., Shapiro, H., Graham, R., Ehrlich, J.S., "Complement Allele Association with Baseline Lesion Characteristics and Anatomic Outcomes following Ranibizumab Treatment," Poster Presentation, Retina Congress Meeting, October 2009.
Feiner, L., Ehrlich, J.S., Ward, J., and Tuomi, L., "Classification and Regression Tree Analysis to Identify Predictive Factors for Visual Acuity Outcomes in Ranibizumab Trials," Poster Presentation, Association for Research in Vision & Ophthalmology Meeting, May 2009
Ehrlich, J.S.,Zhang, K., Ianchulev, T., Shapiro, H., and R. Graham, "Further Analyses of AMD Genetic Risk Variants Associated with CNV Phenotypes and Treatment Response in Ranibizumab Pivotal Trials," Poster Presentation, Association for Research in Vision & Ophthalmology Meeting, May 2009.
Tran, I., Colman, S., Bressler, N., Suner, I., Lee, P., Rubio, R., Ehrlich, J.S., Fitzgerald, K., "Patient Perspective of the Burden of RVO: A Qualitative Understanding of Vision Related Functioning and the NEI VFQ-25," Poster Presentation, Association for Research in Vision & Ophthalmology Meeting, May 2009.
Q: Where are you now?
A: I have remained at Genentech as a full-time member of the Clinical Ophthalmology group. I am the clinical lead for Lucentis development programs in Diabetic Macular Edema, and am the Medical Monitor for two international Phase III studies. I am also the Clinical representative for the Lucentis Safety Team and have continued my work in ophthalmic diagnostics and pharmacogenomics. I work extensively with colleagues in Biostatistics and provide clinical guidance on publications, presentations, and exploratory analyses related to Lucentis clinical trials. I've also had the opportunity to assist in the development of clinical strategies for new Lucentis programs, and provide clinical expertise to a wide range of business partners at Genentech, including colleagues in our Commercial/Marketing and Business Development groups. -
Vijay Rao, MD
- Genentech
- Clinical Fellow
Q: When did you join our Fellowship program?
A: July, 2010
Q: What were your Fellowship activities?
A: I have been working with the Inflammation group on the IL-6 inhibitor, Actemra. Specifically, I have been assisting the team with the design and implementation of a large CV outcome trial with the drug. In addition, I have initiated a retrospective analysis of the five, pivotal phase III trials with Actemra to better understand the relationship between lipid parameters, inflammation, and CV risk. One aspect of this project is looking at the safety profile of statin use in rheumatoid arthritis patients. I have also been working on a project in conjunction with UCSF and the B-HOPS Herceptin group to develop an echocardiographic "risk-score" for Herceptin cardiotoxicity.
Q: What were your publications during your Fellowship?
A: The title of my abstract is: "Risk Factors for Major Adverse Cardiovascular Events in Rheumatoid Arthritis Patients Treated with Tocilizumab". I will be presenting this at ACR in Chicago this coming November 2011 (oral presentation).
Q: Where are you now?
A: I am practicing general, non-invasive cardiology with a private practice called Indiana Heart Physicians in Indianapolis, IN. I am the associate director of clinical research for the group.
