Writing Projects by Calendar Year

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2014 – 2016

  • Withheld. Phase IIB protocol.
  • Withheld. Wrote Phase III CSR on bioequivalence study for an ophthalmic solution.
  • Withheld. Wrote Phase IV CSR on study for an indication of ophthalmic allergy.
  • Withheld. Wrote Phase I CSR on study evaluating the pharmacokinetics of an ophthalmic solution.
  • Withheld. Wrote Phase III CSR on bioequivalence study of an agent indicated for ophthalmic surgery.
  • Withheld. Wrote Phase I Abbreviated CSR on an ophthalmic indication.
  • Withheld. Wrote Phase IV CSR on the ophthalmic indication of dry eye.
  • Withheld. Wrote Phase IIA CSR on an ophthalmic agent for the prevention of glaucoma.
  • Withheld. Wrote Phase III CSR on study evaluating the safety of an ophthalmic solution in pediatric subjects.
  • Withheld. Aided in composition of manuscript reviewing treatment options for an ocular indication.
  • Withheld. Wrote Phase II CSR on study assessing the safety and efficacy of ophthalmic solutions for dry eye.
  • Withheld. Wrote CSR for Phase III study of the efficacy and safety of an agent indicated for ophthalmic surgery.
  • RegeneRx, Bethesda, MD. Wrote Phase IIA CSR on study evaluating peptide topical gel for the treatment of epidermolysis bullosa.

2013 – 2014

  • Instrumentation Laboratory, Bedford, MA. Revised monograph on co-oximetry; worked with R&D and marketing departments.
  • Withheld. Wrote Phase III CSR for an indication of ophthalmic allergy.
  • Withheld. Wrote CSR for a pilot study evaluating nasal allergy.

2012 – 2013

  • Illumina, Inc., San Diego, CA. Wrote two clinical study reports for first-of-kind cytogenetic abnormality diagnostic device for 510(k) submission.
  • Withheld. Wrote clinical study report for Phase I study of investigational agent in combination with approved drug for the treatment of organ-specific cancer.
  • Withheld. Wrote clinical study report for Phase I study of investigational agent for Type 2 diabetes.
  • Instrumentation Laboratory, Bedford, MA. Wrote combination scientific and marketing booklet on D-dimer assays: revised introductory article by thought leader; overview of D-dimer assays; and collateral portion detailing specifications of each Instrumentation Laboratory device.
  • Health Alert Communications, Cambridge, MA. HIV/AIDS – The Facts and The Fiction and HIV/AIDS in South Africa – The Facts and the Fiction, respectively the primary and adjuvant textbooks challenging the current conceptual paradigm for the size, scale, and scope of the global HIV/AIDS epidemic. HIV/AIDS in South Africa – The Facts and the Fiction won the Will Solimene Award for Excellence in Medical Communication in 2014; the honor is awarded by the American Medical Writers Association (AMWA).

2011 – 2012

  • RegeneRx, Bethesda, MD. Continued work on Phase IIA clinical study report on investigational use of Tß4 formulation for healing of chronic dermal wounds.
  • Health Alert Communications, Cambridge, MA. An Analysis of HIV/AIDS Mortality comparing Death Counts, Surveillance Data, and Modeled Estimates, an analytical report targeted at decision-makers in the pharmaceutical and diagnostic industries, and global health care interventions, based on a review of over 3,000 scientific and medical journal articles.
  • Agate Publishing, Evanston, IL. Wrote one chapter on biotechnology and acted as content reviewer for two other chapters on cell biology and plant biology for a textbook for remedial college students.
  • Point of Care, Copenhagen, Denmark. Flew to Copenhagen on short notice to write copy for web site launching two new indications for a recently approved blood thinner.

2010 – 2011

  • INC Research, Raleigh, NC. Wrote Clinical Evaluation Report on implantable orthopedic device for a worldwide leader of joint replacement solutions.
  • Health Alert Communications, Cambridge, MA. Redefining the Size, Scope, and Scale of the AIDS Epidemic by Forensic Review of the Medical Literature, an analytical report targeted at decision-makers in the pharmaceutical and diagnostic industries, and global health care interventions; based on a review of over 3,000 scientific and medical journal articles.

2009 – 2010

  • RegeneRx, Bethesda, MD. Wrote Phase IIA clinical study report on investigational use of Tß4 formulation for healing of chronic dermal wounds.
  • Health Alert Communications, Cambridge, MA. Finalization of a book proposal for Chris Jennings’ third literary work on AIDS.

2008 – 2009

  • RegeneRx, Bethesda, MD. Protocol Amendment, Phase IA; investigational use of Tß4 formulation for cardio-protection post-MI (myocardial infarction).
  • RegeneRx, Bethesda, MD. Protocol Amendment, Phase IB; investigational use of Tß4 formulation for cardio-protection post-MI (myocardial infarction).
  • Acceleron Pharma, Inc., Cambridge, MA. Composition of a manuscript reporting outcomes of investigations into the ligand-binding affinities of recombinant Type II activin receptors for submission to peer-review journal.
  • RegeneRx, Bethesda, MD. Protocol Amendment 2, Phase IA & IB; investigational use of Tß4 formulation for cardio-protection post-MI (myocardial infarction).
  • RegeneRx, Bethesda, MD. Protocol Amendment 3, Phase IA & IB; investigational use of Tß4 formulation for cardio-protection post-MI (myocardial infarction).
  • BiogenIDEC, Cambridge, MA. Aided in format and content redesign of pipeline report, internally circulated document reporting and summarizing monthly progress, outcomes, and alerts regarding all BiogenIDEC pipeline programs, research through post-marketing.
  • BiogenIDEC, Cambridge, MA. Wrote patient final SAE narratives for multiple sclerosis clinical trial ending in 2008.
  • BiogenIDEC, Cambridge, MA. Wrote patient SAE narratives for interim report on multiple sclerosis clinical trial scheduled to end in 2010.
  • RegeneRx, Bethesda, MD. Blinded Interim Safety Summary – Phase IA; interim report used for the “go/no go” decision on implementing Phase IB; investigational use of Tß4 formulation for cardio-protection post-MI (myocardial infarction).
  • RegeneRx, Bethesda, MD. Updated Investigator’s Brochure.
  • RegeneRx, Bethesda, MD. Wrote abstract for submission to wound-healing conference.
  • RegeneRx, Bethesda, MD. Wrote Phase IIA clinical study report on investigational use of Tß4 formulation for healing of chronic dermal wounds.

2007 – 2008

  • Volunteer NGO work (Banda Aceh, Sumatra, Indonesia).
  • RegeneRx, Bethesda, MD. Protocol Amendment for Phase II study, Tß4 ophthalmic solution, investigational healing adjuvant for corneal re-epithelialization after corneal debridement during vitrectomy.

2006 – 2007

  • JFK Communications, Yardley, PA. Wrote poster for ASCO conference about the resolutions of the Scientific Leadership Council in GI Cancers (GI SLC) regarding oncology treatment, research, and clinical trial design.
  • Anne Klein & Associates, Marlton, NJ. Wrote white paper on the content of a symposium on the measurement of QT interval prolongation via ECG during clinical trials to determine the risk of Torsade de Pointes from new therapeutic drugs under NDA investigation.
  • Anne Klein & Associates, Marlton, NJ. Wrote trade journal article about the conduct of Phase I trials in Europe under the new European Clinical Trial Directive: the success of collaboration between a biotech and a CRO, and the utility of utilizing such Phase I trials to add value to investigative compounds.
  • BiogenIDEC, Cambridge, MA. Wrote adverse event (AE) narratives leading to patient withdrawal and/or study drug discontinuation for a clinical study report: an investigation of a multiple sclerosis drug.
  • Bayer Diagnostics, Inc., Tarrytown, NY. Wrote preliminary drafts for submission to a scientific (analytical) journal on a cardiac troponin diagnostic assay used to differentiate myocardial infarction from other causes of chest pain/shortness of breath as presented in the emergency room.
  • Biosite, Inc., San Diego, CA. Wrote project poster abstract for submission to the Emergency Nurses Association (ENA) for the ENA Leadership Conference, Boston, 2007. Abstract was accepted and poster was completed in-house.

2005 – 2006

  • Idenix Pharmaceuticals, Inc., Cambridge, MA. Aided in compilation of three Phase II clinical study reports (eCTD) for NDA on antiviral agent versus Hepatitis B (HBV). In this stop-gap measure, wrote portions of Clinical Summary Report, parts of CSRs, and acted as liaison between outside vendor writing group and in-house medical experts.

2004 – 2005

  • Serono Laboratories, Inc., Rockland, MA. Conducted online literature review and wrote medical communications letters for clinicians on three topics regarding the use of recombinant human growth hormone.
  • Bayer Diagnostics, Bayer HealthCare LLC, Tarrytown, NY. Ghostwrote a journal article describing how difference in assay architecture may give rise to analytical outcome discrepancies between the assay representing industrial standard diagnostic assay and a new biotechnological device for a particular allergen.
  • Matritech, Inc., Newton, MA. Wrote a review article for British quasi-journal on the application of Matritech’s nuclear matrix protein assay that detects urothelial cancer.
  • Stokes Biocommunication, Inc., Katonah, NY. Wrote and collaborated on three training modules for a cosmetic dermatological device for AIDS patients versus AIDS-associated lipoatrophy.
  • Stokes Biocommunication, Inc., Katonah, NY. Condensed 40 pages of visual aids into two 2-minute audio scripts for media animation: one for an anti-diabetic agent, one for a beta-blocker.
  • Sepracor, Inc., Westborough, MA. Wrote peer-review article reviewing published literature on the epidemiological and clinical markers of insomnia and its treatment with specific pharmaceutical agents.

2003 – 2004

  • Wyeth, Cambridge, MA. Wrote an abbreviated report for bone morphogenetic protein clinical trial.
  • Wyeth, Cambridge, MA. Wrote a clinical trial report for hemophilia coagulation product.
  • Biosphere Medical, Rockland, MA. Synopsized and translated clinical journal publications into 1-page synopses palatable to the salesforce.
  • ActivX Biosciences, Inc., San Diego, CA. Investor Presentation slide show. Created slide show for the President and Chief Scientific Officer. Presented ActivX and its proprietary tools for directly determining protein activity (new and revolutionary capability) via existing analytical platforms.
  • Nucleic Acid Diagnostics, Bayer HealthCare LLC, Berkeley, CA. Wrote an editorial for European pharmacotherapy journal describing differential diagnostic algorithms for viral hepatitis and the clinical management of viral hepatitis vis-à-vis Bayer’s serological and nucleic acid diagnostic assays and corresponding instrumentation platforms.
  • Bayer Diagnostics, Bayer HealthCare LLC, Tarrytown, NY. Wrote an editorial for European pharmacotherapy journal describing diagnosis and management of HIV infection vis-à-vis Bayer’s serological and nucleic acid diagnostic assays and corresponding instrumentation platforms.
  • Foxfire Interactive, North Attleboro, MA. Consulted creatively and scientifically on the creation of DVD that introduced the multidisciplinary surgical team prior to treatment of morbid obesity, including splash presentation, screen layout, content, interrogative questions, and morbid obesity.

2002 – 2003

  • Coley Pharmaceutical Group, Wellesley, MA. Wrote protocol for a Phase I/II study evaluating combination therapy with an oligonucleotide and a monoclonal antibody versus metastatic breast cancer.
  • Bayer Diagnostics, Inc., Tarrytown, NY. Wrote first draft only of a review manuscript for European journal submission in order to expedite deadline delivery.
  • Coley Pharmaceutical Group, Wellesley, MA. Wrote a clinical trial report for a Phase I study evaluating therapy with an oligonucleotide versus cancerous skin conditions.
  • Coley Pharmaceutical Group, Wellesley, MA. Wrote a clinical trial report for a Phase I/II evaluating therapy with an oligonucleotide versus allergic asthma.
  • Coley Pharmaceutical Group, Wellesley, MA. Updated a clinical summary section for an Investigator’s Brochure.

1999 – 2000

  • Matritech, Inc., Newton, MA. Wrote a journal article on the application of Matritech’s nuclear matrix protein assay that detects urothelial cancer; published in Journal of Urology.
  • MTRA, Inc., Natick, MA. Compiled a clinical trial report for Canadian submission for an implantable cardiac device.
  • Agouron Pharmaceuticals, La Jolla, CA. Compiled investigator’s brochure on antiretroviral agent (HIV). Project was discontinued due to acquisition.
  • Agouron Pharmaceuticals, La Jolla, CA. Collaborated with principal author, statistician, and other selected representatives to write journal article about trial of antiretroviral agent. Project was discontinued due to acquisition.

1998 – 1999

  • Matritech, Inc., Newton, MA. Wrote a journal article on the application of Matritech’s nuclear matrix protein assay that detects urothelial cancer; published in American Clinical Laboratory.
  • Matritech, Inc., Newton, MA. Wrote a journal article on the application of Matritech’s nuclear matrix protein assay that detects urothelial cancer; submitted to a medical journal published in India.
  • Astra Pharmaceuticals, LP, Westborough, MA. Wrote a clinical trial report for controlled study designed to evaluate safety and efficacy of magnesium sulfate supplementation in moderating ionized hypomagnesemia and hypocalcemia subsequent to Foscavir® (foscarnet sodium) injection therapy for treatment of cytomegalovirus (CMV) disease in AIDS patients.
  • Astra Pharmaceuticals, LP, Westborough, MA. Wrote a clinical trial report for study designed to evaluate the safety and efficacy of intravenous administration of Foscavir® (foscarnet sodium) injection in reducing the size and preventing the development of new cutaneous or oral Kaposi’s Sarcoma (KS) lesions in patients with AIDS.
  • BBK, Newton, MA. Identified and located population of rheumatoid arthritis patients; developed and administered questionnaire to determine whether this population would be willing to participate in a clinical trial involving endoscopy to monitor effects of study drug on stomach and intestines.
  • BBK, Newton, MA. Conducted interviews of principal clinical investigator and study coordinators in order to identify obstacles to patient recruitment for a clinical trial involving an implantable port for renal dialysis.
  • Genzyme Corporation, Cambridge, MA. Compiled a “shell” clinical trial report (complete except for “Results” sections) for a Phase I/II trial involving a recombinant human enzyme.
  • BBK, Newton, MA. Acted as primary contact for principal investigators at 17 sites during development of patient recruitment campaign for the National Emphysema Treatment Trial (NETT) of the National Heart, Lung, and Blood Institute (NHLBI).

1997 – 1998

  • Enrico Design, Marblehead, MA. Wrote collateral for ultrasonic-switched automatic faucet controller for medical and food preparation handwashing environments.
  • BBK, Newton, MA. Conducted literary and online research, and clinical investigator interviews, for message platform development of cancer bone pain medication.
  • BBK, Newton, MA. Conducted interviews of principal clinical investigator and patient advocacy organization in preparation for a patient recruitment campaign for a clinical trial.
  • Feinstein Kean Partners, Cambridge, MA. Attended media conferences regarding Alzheimer’s Disease for competitive assessments.
  • C.R. Bard, Inc., Billerica, MA. Collaborated with independent designers to create eight page, 4-color marketing brochure introducing Bard Electrophysiology’s new LabSystem Duo electrophysiology device.
  • GelTex Pharmaceuticals, Inc., Waltham, MA. Ghostwrote two scientific journal articles regarding clinical applications of cholesterol and bile acid-absorbing polymers.
  • Dawson Marketing Group, Lexington, MA. Wrote copy for a marketing brochure for machine vision devices and data symbology.
  • Creative Medical Communications, New York, NY. Wrote synopses of slide presentations on cholesterol-reducing drug.
  • Elensys, Inc., Woburn, MA. Conducted research on patient drug-taking compliance for direct-mail campaign aimed at increasing patient compliance with antihypertensive drugs.
  • ZOLL Medical Corporation, Burlington, MA. Wrote a journal article about the use of a hand-held, pen-computer by the personnel of the Escambia County Emergency Medical Service, Pensacola, Florida.
  • Hologic, Inc., Waltham, MA. Wrote a data sheet for optional software package used with bone densitometers.
  • Stokes Biocommunication, Inc., Katonah, NY. Wrote a review of lipid metabolism for sales training module.
  • Mediphacs, Inc., Morris Plains, NJ. Rewrote a medical journal article regarding combination therapy for Pneumocystis Carinii Pneumonia in patients with AIDS.
  • Elensys, Inc., Woburn, MA. Wrote a series of educational letters in a direct-mail, patient-compliance campaign encouraging patients to comply with a 6-month drug therapy for endometriosis.
  • Arthur D. Little, Cambridge, MA. Wrote a series of case studies for marketing brochures describing how AD Little’s engineering and/or development expertise aided its clients.

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