Dr Malathy Munisamy

I am an experienced and dedicated pharmaceutical physician with a strong foundation in clinical medicine. I have extensive experience in drug development and pharmacovigilance. Over the past 18 years, I have contributed to clinical trials in different areas including neurodegenerative disease, COVID-19 vaccines, and hyperlipidemia as sub-investigator and principal investigator (PI). This has led to the successful completion of clinical trials and helped the delivery of such trials to new medicines used to treat major human ailments (see publications for designated research studies). I have a proven ability to collaborate across multidisciplinary teams and excel at bridging the gap between clinical research and patient care. My expertise includes more than 100 studies in early-phase clinical research including First-in-Man studies and late-phase clinical research. I have had the opportunity to participate in and lead studies in various therapeutic areas such as urology, neurology, dermatology, vaccine therapy, orphan drug therapy, RNAi drug delivery methods, and psychedelics, complemented by a passion for advancing treatment options for patients with Alzheimer's disease and major depression. I am eager to bring my skills to a forward-thinking organization where I can drive impactful advancements in pharmaceutical medicine and contribute to global health outcomes. I am currently undertaking a part-time Masters at the University of Warwick to further develop my skills in clinical trial implementation, design, and execution.

• General Medical Council
• Medical Defence Union
• Faculty of Pharmaceutical Medicine

• Blarcamesine for the treatment of Early Alzheimer's Disease: Results from the ANAVEX2-73-AD-004 Phase IIB/III trial., Macfarlane S, Grimmer T, Teo K, O'Brien TJ, Woodward M, Grunfeld J, Mander A, Brodtmann A, Brew BJ, Morris P, Short C, Kurrle S, Lai R, Bharadwaj S, Drysdale, Sturm J, Lewis SJG, Barton D, Kalafatis C, Sharif S, Perry R, Mannering N, MacSweeney JE, Pearson S, Evans C, Krishna V, Thompson A, Munisamy M, Bhatt N, Asher A, Connell S, Lynch J, Rutgers SM, Dautzenberg PL, Prins N, Oschmann P, Frölich L, Tacik P, Peters O, Wiltfang J, Henri-Bhargava A, Smith E, Pasternak S, Frank A, Chertkow H, Ingram J, Hsiung GR, Brittain R, Tartaglia C, Cohen S, Villa LM, Gordon E, Jubault T, Guizard N, Tucker A, Kaufmann WE, Jin K, Chezem WR, Missling CU, Sabbagh MN., J Prev Alzheimers Dis., 01/01/25, 12, 1, 100016, 10.1016/j.tjpad.2024.100016, 39800452
• Phase 2 Trial of Anti-TL1A Monoclonal Antibody Tulisokibart for Ulcerative Colitis., Sands BE, Feagan BG, Peyrin-Biroulet L, Danese S, Rubin DT, Laurent O, Luo A, Nguyen DD, Lu J, Yen M, Leszczyszyn J, Kempiński R, McGovern DPB, Ma C, Ritter TE, Targan S; ARTEMIS-UC Study Group., N Engl J Med., 09/26/24, 391, 12, 1119-1129, 10.1056/NEJMoa2314076, 39321363
• A second update on mapping the human genetic architecture of COVID-19., COVID-19 Host Genetics Initiative., Nature., 09/01/23, 621, 7977, E7-E26, 10.1038/s41586-023-06355-3, 37674002, PMC10482689
• Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: an exploratory substudy of a randomised, observer-blinded, placebo-controlled, phase 3 trial., Toback S, Galiza E, Cosgrove C, Galloway J, Goodman AL, Swift PA, Rajaram S, Graves-Jones A, Edelman J, Burns F, Minassian AM, Cho I, Kumar L, Plested JS, Rivers EJ, Robertson A, Dubovsky F, Glenn G, Heath PT; 2019nCoV-302 Study Group., Lancet Respir Med., 02/01/22, 10, 2, 167-179, 10.1016/S2213-2600(21)00409-4, 34800364, PMC8598212
• Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine., Heath PT, Galiza EP, Baxter DN, Boffito M, Browne D, Burns F, Chadwick DR, Clark R, Cosgrove C, Galloway J, Goodman AL, Heer A, Higham A, Iyengar S, Jamal A, Jeanes C, Kalra PA, Kyriakidou C, McAuley DF, Meyrick A, Minassian AM, Minton J, Moore P, Munsoor I, Nicholls H, Osanlou O, Packham J, Pretswell CH, San Francisco Ramos A, Saralaya D, Sheridan RP, Smith R, Soiza RL, Swift PA, Thomson EC, Turner J, Viljoen ME, Albert G, Cho I, Dubovsky F, Glenn G, Rivers J, Robertson A, Smith K, Toback S; 2019nCoV-302 Study Group., N Engl J Med., 09/23/21, 385, 13, 1172-1183, 10.1056/NEJMoa2107659, 34192426, PMC8262625
• Effect of an RNA interference drug on the synthesis of proprotein convertase subtilisin/kexin type 9 (PCSK9) and the concentration of serum LDL cholesterol in healthy volunteers: a randomised, single-blind, placebo-controlled, phase 1 trial., Fitzgerald K, Frank-Kamenetsky M, Shulga-Morskaya S, Liebow A, Bettencourt BR, Sutherland JE, Hutabarat RM, Clausen VA, Karsten V, Cehelsky J, Nochur SV, Kotelianski V, Horton J, Mant T, Chiesa J, Ritter J, Munisamy M, Vaishnaw AK, Gollob JA, Simon A., Lancet., 01/04/14, 383, 9911, 60-68, 10.1016/S0140-6736(13)61914-5, 24094767, PMC4387547
• Safety and efficacy of RNAi therapy for transthyretin amyloidosis., Coelho T, Adams D, Silva A, Lozeron P, Hawkins PN, Mant T, Perez J, Chiesa J, Warrington S, Tranter E, Munisamy M, Falzone R, Harrop J, Cehelsky J, Bettencourt BR, Geissler M, Butler JS, Sehgal A, Meyers RE, Chen Q, Borland T, Hutabarat RM, Clausen VA, Alvarez R, Fitzgerald K, Gamba-Vitalo C, Nochur SV, Vaishnaw AK, Sah DW, Gollob JA, Suhr OB., N Engl J Med., 08/29/13, 369, 9, 819-29, 10.1056/NEJMoa1208760, 23984729
• The use of sildenafil in patients with erectile dysfunction in relation to diabetes mellitusa study of 1,511 patients., Ng KK, Lim HC, Ng FC, Li MK, Consigliere D, Chia SJ, Moorthy P, Munisamy M., Singapore Med J., 08/01/02, 43, 8, 387-90, 12507022
• Clinical efficacy and safety of sildenafil citrate (Viagra) in a multi-racial population in Singapore: A retrospective study of 1520 patients., Lim PH, Li MK, Ng FC, Chia SJ, Consigliere D, Gooren L, Ng KK, Munisamy M, Perianan M., Int J Urol., 06/01/02, 9, 6, 308-15, 10.1046/j.1442-2042.2002.00425.x, 12110094

• Standard Operating Procedures Written
• Seizure Management
• Lumbar Puncture
• Management of Severe Dystonia
• Serious Adverse Event Reporting
• Trainer for clinical & technical staff
• Immediate clinical assessment & management of severe dystonia
• Resuscitation during a seizure and call for help
• Subcutaneous injection training
• Documentation of rashes through photographic evidence
• Basic and Intermediate Life Support Training
• Recognizing, calling for help, assisting and recording Severe Adverse Events
• Lumbar Puncture Clinic – Training was delivered using atraumatic needles for the lumbar puncture procedure.
• Undergraduate Teaching – UCL, London.
• Undergraduate Teaching at the University of Leeds.
• Undergraduate Teaching at Bradford Royal Infirmary.
• Assessor role for Nurse Prescribing.
• Trainee mentor for Sub-Investigators in clinical studies.
• Protocol training for junior staff
• Study-related procedure training for junior staff