Next Generation Dx Summit 2015 - Moving Assays to the Clinic
CV.P.Blaisdell.23.may.16
1. PETER BLAISDELL, Ph.D.
pwblaisdell@gmail.com
EDUCATION
Postdoctoralresearch in microbiology, University of Minnesota,1985-86
Ph.D. in Biochemistry, University of Minnesota,1984
B. S., University of Michigan, double major in Cell Biology and Chemistry, 1978
CAREER
Currently serving on two boards:
2015 – present Member of Screening Board for Southern California Biomedical Council (SoCalBio)
SoCalBio is a non-profit organization supporting the Southern California biotech, digital health and medical device communities.
Guide start-up companies on scientific and business strategy.
In collaboration with other board members, mentor start-up companies on tactics to raise funding to support research and
market growth.
2014 – present Member of Scientific Advisory Board for Meditope Immunotherapy Company
Provide regular advice to company’s senior management on scientific strategy and development program.
In collaboration with other board members, provide input to company on future opportunities for basic research and
clinical research programs.
Participate in company presentations to potential investors (angel and venture funds).
2007 – 2014 Executive Director, Global Study Management; Bone, Neurology & Inflammation Therapeutic
Area, Amgen
Executive Director, Global Study Management; Cardiovascular-renal Therapeutic Area, Amgen
For both positions, responsibilities include:
● Head Global Study Management Department comprised of approximately 50 US and UK based directors, study managers
and staff providing operational support for clinical study design,execution and closure.
● Oversee department staff in study execution with a focus on achieving study conduct,timeline and budget targets.
● Represent Amgen on external industry work-groups including PhRMA initiative on promoting diversity in clinical trial
enrolment.
● Provide input on study design.
● Maintain business relationships across functional areas (e.g. Legal, Finance, Biostatistics) within Amgen to support
design and conduct of Therapeutic Area studies.
● Lead or contributed to SOP development and process improvements initiatives. Initiatives include:
o process development for combined drug/device studies
o optimizing data collection/cleaning
o centralized (risk based)monitoring
● Assist in hiring/training/mentoring departmental staff to ensure professional development and familiarity with SOP and
process updates.
2007 - 2007 Director, Therapeutic Area Operations, General Medicine Therapeutic Area, Amgen
● Provide guidance to Therapeutic Area Department senior management on execution of studies with a focu s on achieving
high-quality study conduct,timeline and budget targets.
● Support Therapeutic Area Vice President and physician team leaders to allocate department staff to meet project needs.
● Maintain business relationships across functional areas within Development to support design and conduct of Therapeutic
Area studies.
● Lead or contribute to SOP development and process improvement initiatives.
● Assist in hiring/training/mentoring departmental staff to ensure professional development and familiarity with SOP and
process updates
2. 2006 – 2007 Director, Clinical Research Program Management, Amgen
● Coordinated conduct of large, global clinical trial (North America, Western/Eastern EU, Russia, Latin America,
Australia) assessing mortality and cardiovascular morbidity outcomes chronic kidney disease patients
● Identify/resolve cross-functionaland regional issues in study design and implementation
● Collaborated with Global Development Leader and other functions to develop program-wide clinical strategy
● Oversaw study planning,feasibility assessment and execution including CRO and vendormanagement
● Contribute to development of study timelines, budgets and resourcing plans
● Developed protocols and contributed to clinical study reports,statistical plans, regulatory submissions and publications
● Managed/mentored regional staff and contributed to training
2004 – 2006 Associate Director, Clinical Research, Amgen
● Provided global study management for international studies assessing therapies forchronic kidney disease conducted by
Amgen
● Designed and drafted phase 2 and 3 protocols with input from external opinion leaders and clinical investigators,internal
team physicians,and representatives of functional areas (biostatistics,regulatory, data management and regulatory affairs)
● Coordinated the activities of study teams including representatives from functional areas (biostatistics,regulatory, data
management and regulatory affairs) and team physicians in conducting studies and analyzing study data
● Contributed to clinical study reports and regulatory summary documents
● Participated in teleconferences to obtain regulatory authority feedback on study and program design
● Authored publications and abstracts based on study results
● Led in-house clinical trial specialists and regional field monitors in assessing study feasibility, rapidly initiating study
centers and conducting studies
2001 - 2004 Senior Clinical Manager, Amgen
● Designed and drafting phase 2 and 3 protocols in the areas of chronic kidney disease,pulmonary disease and anaemia
management with input from external key opinion leaders and clinical investigators,internal team physicians,and
representatives of functional areas (biostatistics,regulatory, data management and regulatory affairs)
● Coordinated the activities of study teams including representatives from functional areas (biostatistics,regulatory, data
management and regulatory affairs) and team physicians in conducting studies and analyzing study data
● Coach/supervised clinical managers and clinical trial specialist direct reports in meeting project goals (direct reports
numbered between 5 –15 depending on project)
1998 - 2001 Clinical Manager, Amgen
● Designed and drafted phase 2 and 3 protocols in the areas of chronic kidney disease,cancer and infectious diseases with
input from external key opinion leaders and clinical investigators,internal team physicians,and representatives of
functional areas (biostatistics,regulatory, data management and regulatory affairs)
● Coordinated the activities of study teams including representatives from functional areas (biostatistics,regulatory, data
management and regulatory affairs) and team physicians in conducting studies and analyzing study data
● Coach/supervised clinical managers, CRA and clinical trial specialist direct reports in meeting project goals (direct
reports numbered between 5 –15 depending on project)
1995 – 1998 Senior Project Manager, Quintiles
● Coordinated clinical, biostatistical and data management activities for a sponsorconducting a phase 3 trial in patients with
glioblastoma (brain cancer).
● Coordinated clinical activities for a sponsorconducting a trial supporting development of a cell separation device for the
isolation of peripheral blood stemcells in patients with advanced malignancies.
● Coordinated clinical, regulatory, statisticaland data management activities for a sponsorconducting a phase 3 trial of
gamma interferon in atopic dermatitis patients.
● Coordinated activities of clinical, statistics,data, pharmacokinetics and medical writing in the production of study reports
and integrated summaries (ISS and ISE) in support ofNDA and CANDA for a sponsordeveloping Alzheimer’s disease
therapy.
● Coordinated activities of statistics,data management and medical writing in for sponsorconducting a 20,000 patient/200
site, Phase 4 international study of cystic fibrosis therapy. Aggressive schedules on ad hoc sponsor/FDA requests
required rapid turn-around of client requests.
3. 1997 Adjunct Instructor, San Francisco State University, San Francisco, CA
● Designed and taught graduate business course in technology management; course content included designing a
technology strategy,forecasting change in the technology landscape,and the role of R&D in an integrated business
strategy.
PUBLICATIONS:
Books
Twenty-First Century Pharmaceutical Development. PW Blaisdell, Editor, Interpharm Press, 2001.
Journal Articles
Fragile Bridge Between Strategy and Execution - The Clinical Manager in Drug Development. P Blaisdell. Drug Information
Association Forum. 2009.
The Calcimimetic AMG 073 Reduces Parathyroid Hormone and Calcium x Phosphorus in Secondary Hyperparathyroidism. JS
Lindberg, SM Moe, WG Goodman, JW Coburn, SM Sprague, W Liu, PW Blaisdell, RM Brenner, SA Turner, KJ Martin. Kidney
International, 2002.
The Calcimimetic Agent AMG 073 Lowers Plasma Parathyroid Hormone Levels in Hemodiaysis Patients with Secondary
Hyperparathyroidism. WG Goodman, GA Hladik, SA Turner, PW Blaisdell, DA Goodkin, W Liu, YM Barri, RM Cohen, JW
Coburn. J Am Soc Nephrol 13: 1017-1024. 2002.
Psyllium Fiber Reduces Rise in Postprandial Glucose and Insulin Concentrations in Patients with Non-Insulin Dependent Diabetes.
JG Pastors,PW Blaisdell, Balm TK, Asplin CM, Pohl SL. Am J Clin Nutr 53(6): 1431-1435. 1991.
Cell-free Transcription and Translation of Isolated Restriction Fragments Localize Bacteriophage T-5 Pre-early Genes. PW
Blaisdell, HR Warner. J Virology 57(3): 759-764, 1986.
Partial Purification and Characterization ofa Uracil-DNA Glycosylase from Wheat Germ. P Blaisdell, H Warner. J Biol Chem
258: 1603-1609, 1983.
Abstracts
Increased Hospitalization Associated With Higher Cytokine Levels Among Haemodialysis (HD) Patients. C Critchlow, P
Blaisdell, M Krishnan, B Bradbury, C Stehman-Breen. American Society of Nephrology, 2006.
Elevation of Cytokine Levels Among Haemodialysis Patients. C Critchlow, P Blaisdell, M Krishnan, C Stehman-Breen. Nation
Kidney Foundation,2006.
The Calcimimetic AMG 073: A Potential Novel Therapy for Secondary Hyperparathyroidism (SHPT). GA Block, DW Coyne,
WG Goodman, MR Silver, PW Blaisdell, KA Olson, SA Turner, JS Lindberg. American Society of Nephrology. 2002
Two-year Treatment with the Calcimimetic AMG 073 in Hemodialysis Patients with Secondary Hyperparathyroidism (SHPT).
SM Moe, SM Sprague, S Adler, SJ Rosansky, MB Albizem, PW Blaisdell, MD Guo, WG Goodman. American Society of
Nephrology, 2002.
The Calcimimetic AMG 073 Reduces Parathyroid Hormone, Phosphorus,and Calcium x Phosphorus Product in Patient s with End
Stage Renal Disease and Secondary Hyperparathyroidism. JS Lindberg, SM Moe, WG Goodman, JW Coburn, SA Turner, PW
Blaisdell, LC McCary, RM Brenner, W Liu, KJ Martin. A 3052, American Society of Nephrology, 2000.
Single Doses of the Calcimimetic AMG 073 Reduce Parathyroid Hormone Levels in a Dose Dependent Manner in Haemodialysis
Patients with Secondary Hyperparathyroidism. JW Coburn, YM Barri, SA Turner, PW Blaisdell, DA Goodkin, W Liu,WG
Goodman. A 3027, J Am Soc Nephrol 11: 2000.
4. Multiple Doses of the Calcimimetic AMG 073 Reduce Parathyroid Hormone Levels in a Dose Dependent Mannerin Hemodialysis
Patients with Secondary Hyperparathyroidism. WG Goodman, GA Hladik, SA Turner, PW Blaisdell, DA Goodkin, W Liu, RM
Cohen, JW Coburn. A 3029, J Am Soc Nephrol 11: 2000.
Recent Presentations
Registries and Post-ApprovalStudies Congress (sponsored by CBI). ‘Is There any Difference Between Pre and Post-Approval
Studies?’, 2012.
Bio-Science Forum. ‘So Your Want to Design a Clinical Trial: Designing Clinical Research in Challenging Times’, 2014.
Southern California Biomedical Council. ‘Clinical Research in Challenging Times’, 2014.
University of California, Santa Barbara, Center for Science & Engineering Partnerships,California NanoSystems Institue,
‘Clinical Research in Challenging Times’, 2015.
Memberships
Drug Information Association (DIA).