Clinical Management

Location:

Madison, CT

Posted:

October 18, 2012

Contact this candidate

Resume:

David Friedman

Email: *********@********.***

Address: ** ******* ****

City: Madison

State: CT

Zip: 06443

Country: USA

Phone: 203-***-****

Skill Level: Experienced

Salary Range: 75

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

Experienced Scientist and Writer

I am interested in applying for a position as a Medical Writer. I have considerable experience writing technical, scientific, and clinical reports in pharmaceutical and academic settings. My relevant experience is,

Doctoral degree in Biomedical Research (Univ. Texas Health Science Center).

Instructor, Department of Medicine, Baylor College of Medicine (1990-1995).

Experienced pharmaceutical scientist for 17 years (1995-2012), principally as an Associate Director managing projects and directing teams in translational research.

In depth understanding of multiple diseases and therapeutic areas, including metabolic diseases, oncology, immunology, neurology, and cardiology.

Peer-reviewed manuscripts including 18 academic and clinical manuscripts. Publications include articles in Science, Journal of Biological Chemistry, Human Molecular Genetics, American Journal of Physiology, Circulation, Clinical Chemistry, Trends in Cardiovascular Medicine, Biochimica et Biophysica Acta, and Journal of the American Medical Association (JAMA).

Manuscripts and patents in multiple areas including energy metabolism, Alzheimers disease, stroke, oncology mechanisms, hypertrophic cardiomyopathy, myocardial infarction, Duchenes dystrophy, and myotonic muscular dystrophies.

Project management experience spanning 16 different biomarker identification and development programs while at Pfizer, Vertex, and Celgene Pharmaceuticals.

Author of numerous clinical study reports and investigator brochures.

Knowledgeable in statistics, especially in reference to clinical trials outcome data, including survival curves, hazard ratios and odds ratios.

Author and principal investigator of grants including 2 recent NIH/SBIR grants for stroke, and 6 American Heart Association grants as an academic.

Coauthor of 6 patent applications and patents.

Extensive experience in scientific literature-based research. Based upon my experience and understanding scientific and clinical principles, I can relatively easily translate the literature-based information into clear and informed content.

Familiar with a wide variety of biochemical, molecular biology, and genetic methods and data used to characterize preclinical models and patients.

Platform presentations at scientific meetings, as well as presentations to senior management for quarterly project reviews.

I look forward to discussing my sincere interest in this position.

David Friedman Ph.D.

203-***-****

*********@********.***

Personal Information:

David L. Friedman PhD

44 Winding Road

Madison, CT 06443

203-***-**** (cell)

203-***-**** (home)

*********@********.***

Specifics Relevant for the Position:

Clinical Scientist Experience: My career as a clinical scientist extents over 20 years, beginning with a faculty position in the Department of Medicine at Baylor College of Medicine. In this capacity, I was responsible for conducting my own research program and collaborating with other Baylor investigators when appropriate. My own research was in the area of energy shuttles that sustain specific cellular activities, including DNA replication and ion transport in specific tissues. My expertise with antibody discovery and characterization also facilitated several collaborative projects in neuromuscular diseases, such as Duchenes dystrophy and myotonic muscular dystrophy. After 5 years in this role, I moved into the pharmaceutical industry taking a position with Pfizer Central Research. In my role at Pfizer, I was a group leader responsible for identifying meaningful clinical endpoints for patients enrolled in their drug trials. These endpoints included biochemical, genetic, and cellular biomarkers that would be used to assess patient response at early time-points, and throughout the course of clinical trials. The majority of clinical trials were in the area of neurology, including traumatic brain injury, Alzheimers disease, and affective disorders. To facilitate the identification of new and clinically meaningful markers, I sought input from key opinion leaders and occasionally established fruitful collaborative relationships. The most notable in this regard, was an Alzheimers marker collaboration with the National Institute of Health (NIMH branch) that I set up, managed, and maintained for over 5 years (see patents and publications, below). Following a merger and restructuring at Pfizer, I then moved to Vertex Pharmaceuticals where I worked on head injury and oncology biomarkers. At Vertex, I was a group leader of a proteomics group tasked with identification of novel biomarkers. This effort culminated in the development of a novel mass spectrometry approach, for use in the quantification of phosphorylation cascades. This technique enabled the identification of pathways driving growth of specific types of cancer cells, and allowed for quantitative comparisons of the activation state of pathways in a given cell type, and also between different cancer cell types (see patents, below). Following a management restructuring at Vertex, I left for a position at Bayer Pharmaceuticals. Unfortunately, after less than a year the entire site was closed. I then moved to Celgene where I set up a cell-based pharmacodynamics lab, and a small group that supported oncology and inflammation programs. In this role, we set up novel approaches that captured and interrogated blood-borne, circulating tumor cells in patients enrolled in their clinical trials. These cells were then evaluated to understand mechanisms underlying patient-specific responses to molecularly targeted therapeutics. After only 3 short but successful years, I had to resign and return to Connecticut due to a divorce and custody issues for my son. Since that time I have been involved in several startup companies interested in extending my previous work on head injury markers and circulating tumor cells. Recently, I was briefly employed by OSI Pharmaceuticals (January, 2012 through June, 2012), to lead their clinical biomarker group. I had to resign, however, when the transition of their biomarker group from Boulder to Farmingdale did not take place as planned.

Clinical Study Reports: In my role as group leader while at Pfizer, Vertex, and Celgene, I was responsible for writing reports that summarized the work that my group accomplished. These reports included data and interpretations concerning patient responses to test articles under consideration in clinical trials, and included the following examples,

Cardiac and Head Trauma Biomarkers. (Baylor College of Medicine)

Application of novel markers and assays to detect head injury and stroke in support of CP-101,606. (Pfizer)

Identification of biomarkers for bipolar disorder. (Geodon, Pfizer)

Phase 2a and 2b trial to demonstrate proof-of-mechanism and proof-of-concept for 906, a first generation JNK inhibitor. (Celgene)

Phase 2 biomarkers for Sorafenib in melanoma.(Bayer)

Circulating cell-based markers for mantle cell lymphoma. (Celgene)

Contributing author for efficacy sections for 7 INDs and 3 NDAs. (Pfizer)

Data Analysis and Interpretation: As part of my role as group leader, I was responsible for data analysis based upon the work of 17 direct reports that contributed experimental data while under my supervision. As such, I am familiar with a wide range of scientific assays including immunoassays, mass spectrometry assays, enzyme activity assays, bioassays, UV/VIS chromatographic assays, and genetic assays (HRMA and FISH). In addition, I am familiar with a wide range of types of clinical data including, survival curves, pharmacodynamics, pharmacokinetics, toxicology, and safety data.

Scientific and Clinical Literature Research: Beginning with my graduate work, and continuing through to the present, I spend considerable time reading the primary literature emanating from basic science and clinical journals. In addition, I have extensive experience in extracting and assimilating information from scientific and clinical articles from a wide range of journals. Based upon my experience and understanding of basic science and clinical principles, I find that I can relatively easily translate the literature-based information into clear and informed content.

Scientific and Clinical Manuscripts: I published 18 articles in well-respected, peer-reviewed journals. In most of these articles I contributed the majority of the data, analysis, literature research, and text, including revisions when necessary. In many cases, I presented this data in poster format at national scientific and clinical meetings as well.

Principal author for 8 manuscripts published into peer-reviewed journals.

Coauthor for 3 manuscripts published into peer-reviewed journals.

Contributor to 6 manuscripts published into peer-reviewed journals.

The journals included the following; Science, Journal of Biological Chemistry, Human Molecular Genetics, American Journal of Physiology, Circulation, Clinical Chemistry, Trends in Cardiovascular Medicine, Biochimica et Biophysica Acta, and Journal of the American Medical Association (JAMA).

I also served as ad hoc reviewer for 10 articles by journal editors.

White Papers: In my role as group leader, one of my responsibilities was to propose new technologies and new approaches to monitoring patients enrolled in clinical trials. The mechanism for this process begins with the submission of White Papers. To this end, I authored over a dozen white papers submitted to pharmaceutical executive management teams for proposed drug targets and diagnostic strategies.

Grants: I have written many grants as an academic, and more recently as a consultant in the biotech field. These included 2 NIH/SBIR grants on traumatic brain injury and stroke, and 6 American Heart Association grants as an academic.

Regulatory Documents: I have contributed as an author for over a dozen protocol documents required by regulators, including those required for compliance with of Good Laboratory Practices (GLP), and data submission for drug approvals.

Patents: The patents and patent applications, listed below, are a partial measure of success in my career, and for which I was also a contributing author.

Presentation Skills: I have considerable experience presenting scientific and clinical data and associated arguments to learned audiences. My experience extends from national scientific meetings to quarterly review meetings to senior management in the pharmaceutical industry. These include the following examples,

Quarterly presentations to senior Pfizer management on behalf of the Clinical Diagnostics Group (16 scientific contributors).

Invited presentations to national meetings including,

Understanding Kinase Signaling and Drug Specificity Through Quantification of Kinase Drive. David L. Friedman, Vertex Pharmaceuticals. Platform presentation at 3rd International Protein Phosphorylation Drug Discovery World Summit; San Diego 2005.

Optimization of a Quantitative Method for Phosphorylation Site Occupancy Analysis. Mass Spectrometry in the Life and Health Sciences. Molecular Cellular Proteomics, 4, S415-S428, 2005.

Multiple poster presentations at national scientific meetings including American Society Biochemistry and Molecular Biology, American Heart Association, Society for Neuroscience.

Familiar with most computer software relevant to presentations and publications.

11. Project Management: In my role as group leader in the pharmaceutical industry, I was responsible for directing and managing projects necessary to support clinical development of pipeline candidates. This required close cooperation and coordination between groups to maintain the timelines necessary to deliver validated assays for clinical development programs. There are several stages to this process, each requiring different groups to participate, in order to deliver validated assays identified and required as part of final clinical trial protocols. At different phases of the projects, individuals from the following groups were included in the work-flows as participants; Biomarker Identification Group (usually my group), Assay Development Group, Clinical Development Group (for the specific program), Clinical Operations Group (for sample acquisition), outside CROs (for sample transport and tacking), and Legal. In cases where there were outside collaborators, as in the case of Alzheimers Biomarker Identification Program, additional outside groups were also part of the project management process. In this later example, both the National Institutes of Mental Health and Oxford Glycosciences (Oxford, England) were active participants. A major part of my success in managing projects was my in-depth understanding of the contributions of the various groups, as well as my experience and ability to work with a wide range of personalities from various levels within and outside of the organization.

12. Interactions with Project Teams and Outside Collaborators: Communication with outside experts was also part of my role while in the pharmaceutical industry. These discussions were intended to enlist consultants, collaborators, key opinion leaders, and clinical trial investigators. Within various pharmaceutical companies, these discussions were intended to solicit cooperation within and between various project teams.

Employment History

1. Consulting for a Rare-Cell Capture Technology company, Creative Micro Tech, Potomac, MD 20854. August 2012 to Present.

2. OSI Pharmaceuticals (Farmingdale, NY); Jan, 2012 to Present. I joined OSI in January as they were moving from Boulder, CO as the head of Pharmacodynamics- similar to the role I maintained at Celgene. Unfortunately, the group members decided not to move to Long Island and I resigned the position as of June 13, 2012 after the position was downsized.

3. Consulted for a start-up diagnostic company: 2010 and resigned Feb 2011.

4. Celgene Corporation (Summit, NJ); Oct 1, 2007 to April 29, 2010

Associate Director in Clinical Pharmacology, and Head of Pharmacodynamics.

My work at Celgene was aimed at understanding the immunomodulatory mechanisms conferred by Revlimid and related IMiD compounds. These studies were applied to both liquid and solid tumor Oncology programs. To this end, we set up several interrelated platforms for rare cell enrichment to extract, quantify, and characterize circulating tumor cells. We utilized both flow-based and slide-based cytometry approaches to quantify and characterize cells. These enriched cells, in the case of Mantle Cell Lymphoma, were phenotyped (Cyclin D1) and genotyped using 5 different FISH assays, and applied to circulating mantle cells. These cells were enriched using a four-step process that included both positive and negative selection. Enriched cells were then smeared onto slides and interrogated with commercially available probes. The slides were scanned using the laser scanning cytometer to enable objective and automated genetic analysis. In addition, high resolution DNA melt analysis (HRMA) was applied for identified ras point mutations in CRC samples, as well as a cross-validation approach for the FISH assays.

In addition, my group established several novel, tissue-based, immunohistochemical assays to establish proof-of-mechanism, phosphorylation-sensitive, immunoassays for MAPK inhibitors. These assays were developed from scratch, fully validated in animal models, and then applied to human subjects enrolled in first-in-man studies. Following a validation in human subjects, these assays were used in a dose escalation crossover study with 15 patients. All assay validation and sample analysis were carried out and documented under GLP conditions. We were able to demonstrate a dose-dependent, and statistically significant, reduction in the phosphorylation of downstream substrates from this small, well-controlled study. This enabled the appropriate dose to be used in subsequent phase 2b clinical studies.

5. Bayer Pharmaceuticals (West Haven, CT); September 2006 to June 2007

Biomarker Scientist in the Clinical Pharmacology Department.

In this capacity I worked on novel immunoassays in support of several phase 2 and phase 3 Oncology candidates. This included the development of novel and quantitative immunohistochemical assays used to assess the extent of target inhibition. Most of this work was done via outsourcing including CROs as there was no laboratory facility available to me at this time. Unfortunately the site was closed 6 months after my arrival and I took a position at Celgene in NJ.

6. Vertex Pharmaceuticals; October 15, 2001 to May 16, 2006

Associate Director in Biomarker Technologies, and Head of the Proteomics Group.

In this capacity I was responsible for setting up a proteomics and immunoassay group including the hiring of 8 individuals. We established and validated complex assays that employed a combination of antibodies and mass spectrometry to enable quantitative phosphorylation analysis. These assays were applied to 5 different kinase programs and across several therapeutic areas including Oncology, Inflammation, Cardioprotection, and Stroke.

7. Pfizer Central Research; June 3, 1995 to October 1, 2001

Senior Research Investigator, and Group Leader in the Clinical Diagnostics, Genetics, and Measurements Group.

The laboratory at Pfizer required me to set up a facility for biomarker identification, antibody development, and assay development. My group included 3 direct reports and included the responsibility to define and purchase all equipment. Nearly all of the worked was devoted to generation and characterization of antibodies derived from rabbits, mice, and purified from phage display recombinant libraries. In addition, our work in the inflammation arena required characterization of autoantibody and related interferences to immuno-ELISA assays. The success of this group is marked, in part, by the numerous patents and publications listed below. More importantly, we contributed many novel markers and validated assays used in phase 2 and phase 3 clinical programs and data subsequently used in FDA filings and internal decision-making. I left this position over 6 years later due to a restructuring following the Warner Lambert acquisition, and took a position at Vertex in Cambridge, MA.

8. Baylor College of Medicine; July 1, 1990 to June 3, 1995

Independent Investigator and Instructor in the Department of Medicine.

In this capacity, I was a Research Instructor required to carry out an independent research program and maintain my laboratory with 1 direct report. Much of this worked required the development and characterization of novel antibodies and immunoassays. The work spanned several therapeutic areas including cardiology, neurosciences, and neuromuscular disorders. My productivity was marked in part by 12 publications and several patents during this time period.

Education History:

1. Baylor College of Medicine

* Post-Doctoral Fellow; 1988-1990

* Department of Medicine

* Understanding disease mechanisms

* Energy shuttle systems in brain and muscle

2. University of Texas Health Science Center

* Graduated 1990 (Completed Research in 1988, Defended in 1990)

* Ph.D. in Biochemistry

* Multiple forms of GABA Receptors in the Rabbit Retina (Dissertation)

3. Cleveland State University

Graduated 1980

B.S. in Biology

Manuscripts:

1. Sunderland T, Mirza N, Putnam KT, Linker G, Bhupali D, Durham R, Soares H, Kimmel L, Friedman DL, Bergeson J, Csako G, Levy JA, Bartko JJ, Cohen RM. APOE e4 affects CSF b-Amyloid1-42 but not CSF tau in healthy normal controls. Biol Psychiat. 2004;56: 670-676.

2. Sunderland T, Linker G, Mirza N, Friedman DL, Kimmel K, Friz J, Manett G, Zimmermann M, Tang B, Putnam KT, Bartko JJ, Cohen RM. Decreased CSF b-Amyloid1-42 and Increased CSF Tau in Alzheimer's. J Amr Med Assoc. 2003;289:2094-2103.

3. Chen L, Roberts R, Friedman DL. Expression of brain-type creatine kinase and ubiquitous mitochondrial creatine kinase in the fetal rat brain: evidence for a nuclear energy shuttle. J Comp Neurol. 1995;363(3):389-401.

4. Greve G, Bachinski L, Friedman DL, Czernuzewicz G, Anan R, Towbin J, Seidman CE, Roberts R. Isolation of a de novo mutant myocardial beta MHC protein in a pedigree with hypertrophic cardiomyopathy. Hum Mol Genet. 1994;3(11):2073-2075.

5. Friedman DL, Roberts R. Compartmentation of brain-type creatine kinase and ubiquitous mitochondrial creatine kinase in neurons: evidence for a creatine phosphate energy shuttle in adult rat brain. J Comp Neurol. 1994;343(3):500-511.

6. Lin L, Perryman MB, Friedman D, Roberts R, Ma TS. Determination of the catalytic site of creatine kinase by site-directed mutagenesis. Biochim Biophys Acta. 1994;1206 (1):97-104.

7. Perryman MB, Friedman DL, Fu YH, Caskey CT. Molecular genetics of Myotonic dystrophy. Trends in Cardiovascular Medicine. 1994;3:82-84.

8. Pizzuti A, Friedman DL, Caskey CT. The Myotonic dystrophy gene. Arch Neurol. 1993; 50(11):1173-1179.

9. Payne RM, Friedman DL, Grant JW, Perryman MB, Strauss AW. Creatine kinase isoenzymes are highly regulated during pregnancy in rat uterus and placenta. Am J Physiol. 1993;265(4Pt1):E624-635.

10. Friedman DL, Kesterson R, Puleo P, Wu AH, Perryman MB. Recombinant creatine kinase proteins and proposed standards for creatine kinase isoenzyme and subform assays. Clin Chem. 1993;39(8):1598-1601.

11. Fu YH, Friedman DL, Richards S, Pearlman JA, Gibbs RA, Pizzuti A, Ashizawa T, Perryman MB, Scarlato G, Fenwick RG. Decreased expression of myotonin-protein kinase messenger RNA and protein in adult form of myotonic dystrophy. Science. 1993;260(5105):235-238.

12. Bies RD, Friedman D, Roberts R, Perryman MB, Caskey CT. Expression and localization of dystrophin in human cardiac Purkinje fibers. Circulation. 1992;86(1): 147-153.

13. Friedman DL, Roberts R. Purification and localization of brain-type creatine kinase in sodium chloride transporting epithelia of the spiny dogfish, Squalus acanthias. J Biol Chem. 1992;267(6):4270-4276.

14. Friedman DL, Perryman MB. Compartmentation of multiple forms of creatine kinase in the distal nephron of the rat kidney. J Biol Chem. 1991;266:224**-*****.

15. Hamburg RJ, Friedman DL, MB Perryman. Metabolic and diagnostic significance of creatine kinase isoenzymes. Trends in Cardiovascular Medicine. 1991;1(5): 195-200.

16. Hamburg RJ, Friedman DL, Olson EN, Ma TS, Cortez MD, Goodman C, Puleo PR, Perryman MB. Muscle creatine kinase isoenzyme expression in adult human brain. J Biol Chem. 1990;265(11):6403-6409.

17. Friedman DL, Redburn DA. Evidence for functionally distinct subclasses of gamma-aminobutyric acid receptors in rabbit retina. J Neurochem. 1990;55(4):1189-1199.

18. Friedman DL, Hejtmancik JF, Hope JN, Perryman MB. Developmental expression of creatine kinase isozymes in mammalian lens. Exp Eye Res. 1989;49(3):445-57.

Patents and Applications

1. Perryman MB, Kesterson R, Friedman DL, Roberts R. Stable Isoforms of Creatine Kinase for Standard Markers and Diagnosis. EP 0571085.

2. Caskey CT, Fu YH, Friedman DL, Pizzuti A, Fenwick RG. Diagnosis of Myotonic Muscular Dystrophy. US 5552282.

3. Parekh RB, Bruce JA, Philp R, Kimmel L, Friedman DL. Method for the Computer Isolation of Proteins. US 6459994.

4. Durham KL, Friedman DL, Herath HMAC, Kimmel L, Parekh RB, Potter DM, Rohlff C, Silber BM, Snyder PJ, Soares HD, Stiger TR, Sunderland PT, Townsend, RR, White WF, Williams SA. Nucleic acid molecules, polypeptides, and uses therefore, including diagnosis and treatment of Alzheimers disease. WO 20246767.

5. Chenard BL, Friedman DL, Kimmel L, Nelms L, Silber BM, Soares H, White WF. Method of Monitoring Neuroprotective Treatment. WO 200332894.

6. Friedman DL, Botfield MC. Quantification and Site Specific Profiling of Protein Phosphorylation. WO 2005/019832 A2.

Relevant Unpublished Abstracts

1. Friedman DL. Understanding Kinase Signaling and Drug Specificity Through Quantification of Kinase Drive. Platform presentation at 3rd International Protein Phosphorylation Drug Discovery World Summit; San Diego. 2005.

2. Wei R, Burgess M, Fitzgibbon M, Friedman D, Botfield M. Optimization of a Quantitative Method for Phosphorylation Site Occupancy Analysis. Molecular Cellular Proteomics. 2005; 4:S415-S428.

3. Friedman DL, Nanayakkara V, Burgess M, Raitt D, Wei R, Fitzgibbon M, Licklider L, Botfield M. Quantification of Site-specific Phosphorylation Using Stable Isotope Tagged Internal Standards: Demonstration of the In Vivo Mechanism of Action for Inhibitors in the MAPK Kinase Pathway. Molecular Cellular Proteomics. 2003;2:S1-S15.

References

1. Ken Takeshita MDVice President, Clinical RDCelgeneSummit, NJ, USA ********-***-**************@*******.***

2. Brydon Bennett PhDSr. Director - Inflammation Research Experimental Therapeutics Group Celgene 4550 Towne Centre Court San Diego, CA 92121

858-795 4814email: ********@*******.***

3. Patricia Rohane MD

Vice President, Clinical Research and Development,

Immunology and Inflammation at Celgene Corporation

908-***-****

(Currently at Sanofi-Aventis)

4. Henry Lau

(Former) Executive Director,

Clinical Pharmacology,