Regulatory Documents
Regulatory writing is Chris Jennings’ principal interest. Regulatory writing experience (Phases I through IV) includes protocols, clinical study reports (CSRs), SAE narratives as well as Investigator’s Brochures (IBs).
| Client | Task | Topic |
| Wyeth, Cambridge, MA | Abbreviated CSR | Bone Morphogenesis |
| Wyeth, Cambridge, MA | Phase III CSR | Hemophilia |
| Coley Pharmaceutical Group, Wellesley, MA | Phase I/II Protocol | Oncology |
| Coley Pharmaceutical Group, Wellesley, MA | Phase I CSR | Oncology |
| Coley Pharmaceutical Group, Wellesley, MA | Phase I/II CSR | Asthma |
| Coley Pharmaceutical Group, Wellesley, MA | IB | Asthma, Oncology, Influenza |
| Agouron Pharmaceuticals, La Jolla, CA | IB | HIV |
| NMT Medical, Inc., Boston, MA | Pivotal Phase CSR | Implantable Cardiac Device |
| Astra Pharmaceuticals, L.P., Westborough, MA | Phase IV CSR | HIV |
| Astra Pharmaceuticals, L.P., Westborough, MA | Phase II CSR | Oncology – HIV |
| MTRA, Inc., Natick, MA | CSR for 510(k) | Implantable Cardiac Device |
| Genzyme Corporation, Cambridge, MA | Phase I/II CSR | Fabry’s Disease |
| BiogenIDEC, Cambridge, MA | Narratives | Multiple Sclerosis |
| Idenix Pharmaceuticals, Cambridge, MA | Liaison w/Writing Group | HBV |
| RegeneRx, Bethesda, MD | Phase II Protocol | Diabetic Vitrectomy |
| RegeneRx, Bethesda, MD | Phase Ia Protocol | Myocardial Infarction |
| RegeneRx, Bethesda, MD | Phase Ib Protocol | Myocardial Infarction |
| RegeneRx, Bethesda, MD | Phase 1a & 1b Protocol | Myocardial Infarction |
| RegeneRx, Bethesda, MD | Phase III Protocol | Myocardial Infarction |
| RegeneRx, Bethesda, MD | IB Revision Thymosin | Beta 4 |
| RegeneRx, Bethesda, MD | Phase Ia CSR | Myocardial Infarction |
| RegeneRx, Bethesda, MD | Phase IIa CSR | Pressure Ulcers |
| RegeneRx, Bethesda, MD | Phase IIa CSR | Epidermolysis Bullosa |
| BiogenIDEC, Cambridge, MA | Narratives | Multiple Sclerosis |
| Zimmer, Warsaw, IN | CER | Knowles pins |
| Illumina, Inc. | CSR for 510(k) | Cytogenetic Repro. Study |
| Illumina, Inc. | CSR for 510(k) | Cytogenetic Clinical Study |
| Withheld | Phase I CSR | Oncology |
| Withheld | Phase I CSR | Diabetes |
| Withheld | Phase III CSR | Ophthalmology |
| Withheld | Pilot Study CSR | Ophthalmology |
| Withheld | Phase III CSR | Ophthalmology – Bioequivalence |
| Withheld | Phase IV Abbrev CSR | Ophthalmology – Allergy |
| Withheld | Phase III | Ophthalmology – Cataract Surgery |
| Withheld | Phase III CSR | Allergic Conjunctivitis |
| Withheld | Pilot Study CSR | Nasal Allergy |
| Withheld | Phase III CSR | Allergic Conjunctivitis |
| Withheld | Phase 1 CSR | PK Study –Ocular Hyperemia |
| Withheld | Phase 1 CSR | Treatment of Ocular Hyperemia |
| Withheld | Phase IV CSR | Dry Eye |
| Withheld | Phase 2a CSR | Intraocular Pressure (IOP) |
| Withheld | Phase III CSR | Ophthalmic Allergy with Atopism |
| Withheld | Publication | Ocular Itching Review |
| Withheld | Phase III CSR | Post-Cataract Surgery |
| Withheld | Phase 2b Protocol | Withheld |
