Jennifer Farrior

Ms. Jennifer Farrior, MS, is a skilled Clinical Research Operations Manager with a strong genetics foundation. She has two Master’s degrees; one in Biochemistry and Biophysics and one in Medical Genetics. She began her career in Genetics Clinics working with patients living with genetic diseases. She then moved to clinical trial operations. She has worked at FHI 360 for over 19 years. She has a successful record of managing complex, matrix teams while delivering trials on time and within budget. She has successfully managed non-IND trials as well as IND trials whose data supported FDA and EMA approval of the investigational study product.

· Overseeing all aspects of clinical trials for life of study (phase II to large, complex global trials)

· Selecting trial sites, assisting them with regulatory submissions and managing them remotely

· Successfully managing local and international study teams in a matrix environment

· Training trial staff (investigators and site staff)

· Effectively communicating with sponsor, government and industry partners

· Consistently meeting deadlines within project scope and budget

· Successfully preparing for and participating in FDA and EMA audits

· Contributing to Clinical Study Report (CSR) generation

• Botswana, Eswatini, Kenya, Malawi, Mozambique, South Africa, Uganda, United States, Zimbabwe

HPTN 084 is a Phase III, international Investigational New Drug (IND) study evaluating the safety and efficacy of CAB LA (long-acting injectable cabotegravir) in women. HPTN 084 was launched in November 2017. Twenty clinical sites in sub-Saharan Africa are participating in the study. Ms. Farrior managed the fast-tracked HPTN 084 protocol development process and submission to the South African Health Products Regulatory Agency (SAHPRA). She works closely with the study team which includes two African Study Chairs, staff from the National Institutes of Health (NIH)/National Institute of Allergies and Infectious Diseases (NIAID)/Division of AIDS (DAIDS), the Bill & Melinda Gates Foundation (BMGF) and two pharmaceutical partners, Gilead Sciences and ViiV Healthcare. In November 2020, the Data and Safety Monitoring Board (DSMB) halted the blinded portion of HPTN 084 for efficacy; during the same month CAB LA gained “breakthrough” status by the Food and Drug Administration (FDA). In December 2021, the FDA granted full approval to CAB LA. Subsequently, the European Medicines Agency (EMA) also approved CAB LA. HPTN 084 continues in an open-label extension phase and is currently evaluating the safety and pharmacokinetics of CAB LA in pregnant women and their infants.

CoVPN 3501 was a Phase III, IND, domestic study evaluating a monoclonal antibody (mAb) for prevention of SARS-CoV-2 infection and COVID-19 symptom reduction. CoVPN 3501 was conducted in skilled nursing facilities (SNFs) across the United States using NIAID investigators who remotely oversaw clinical staff provided by the sponsor, Eli Lilly. Clinical staff and all materials required for study implementation were deployed to SNFs using Mobile Research Units (MRUs). Ms. Farrior worked with the Eli Lilly team to develop the protocol, launch it at an unprecedented pace, and find implementation solutions.  The main phase of the study fielded in August 2020 and successfully completed enrollment in November 2020. Although Bamlanivimab was initially granted Emergency Use Authorization (EUA) by the FDA,the EUA was later revoked because the mAb is not effective against Omicron variants.

• Human immunodeficiency virus (HIV)/Acquired immunodeficiency syndrome (AIDS), Severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2)/Coronavirus disease (COVID), Sexually transmitted infections (STIs)

Horses, Horseback Riding, Hiking, Showing and Competing my Carolina Dogs

Delany-Moretlwe S, Hanscom B, Guo X, Nkabiito C, Mandima P, Nahirya PN, Mpendo J, Bhondai-Mhuri M, Mgodi N, Berhanu R, Farrior J, Piwowar-Manning E, Ford SL, Hendrix CW, Rinehart AR, Rooney JF, Adeyeye A, Landovitz RJ, Cohen MS, Hosseinipour MC, Marzinke MA; HPTN 084 Study Team. (2025) Evaluation of long-acting cabotegravir safety and pharmacokinetics in pregnant women in eastern and southern Africa: a secondary analysis of HPTN 084. Journal of International AIDS Society, 28 (1): e26401.

Eshleman SH, Fogel JM, Piwowar-Manning E, Chau G, Cummings V, Agyei Y, Richardson P, Sullivan P, Haines CD, Bushman LR, Petropoulos C, Persaud D, Kofron R, Hendrix CW, Anderson PL, Farrior J, Mellors J, Adeyeye A, Rinehart A, St Clair M, Ford S, Rooney JF, Mathew CA, Hunidzarira P, Spooner E, Mpendo J, Nair G, Cohen MS, Hughes JP, Hosseinipour M, Hanscom B, Delany-Moretlwe S, Marzinke MA. (2022) Characterization of Human Immunodeficiency Virus (HIV) Infections in Women Who Received Injectable Cabotegravir or Tenofovir Disoproxil Fumarate/Emtricitabine for HIV Prevention: HPTN 084. Journal of Infectious Diseases, 225 (10): 1741-1749.

Delany-Moretlwe S, Hughes JP, Bock P, Ouma SG, Hunidzarira P, Kalonji D, Kayange N, Makhema J, Mandima P, Mathew C, Spooner E, Mpendo J, Mukwekwerere P, Mgodi N, Ntege PN, Nair G, Nakabiito C, Nuwagaba-Biribonwoha H, Panchia R, Singh N, Siziba B, Farrior J, Rose S, Anderson PL, Eshleman SH, Marzinke MA, Hendrix CW, Beigel-Orme S, Hosek S, Tolley E, Sista N, Adeyeye A, Rooney JF, Rinehart A, Spreen WR, Smith K, Hanscom B, Cohen MS, Hosseinipour MC, on behalf of the HPTN 084 study group. (2022) Cabotegravir for the Prevention of HIV-1 in Women: Results from HPTN 084, a Phase 3, Randomized Trial. Lancet, 399 (10337) 1779-1789.

Seneviratne HK, Tillotson J, Lade JM, Bekker LG, Li S, Pathak S, Justman J, Mgodi N, Swaminathan S, Sista N, Farrior J, Richardson P, Hendrix CW, Bumpus NN. (2021) Metabolism of Long-Acting Rilpivirine After Intramuscular Injection: HIV Prevention Trials Network Study 076 (HPTN 076). AIDS Research and Human Retroviruses, 37(3), 173–183.

Cohen MS, Nirula A, Mulligan MJ, Novak RM, Marovich M, Yen C, Stemer A, Mayer SM, Wohl D, Brengle B, Montague BT, Frank I, McCulloh RJ, Fichtenbaum CJ, Lipson B, Gabra N, Ramirez JA, Thai C, Chege W, Gomez Lorenzo MM, Sista N, Farrior J, Clement ME, Brown ER, Cluster KL, Van Naarden J, Adams AC, Schade AE, Dabora MC, Knorr J, Price KL, Sabo J, Tuttle JL, Klekotka P, Shen L, Skovonsky DM; BLAZE-2 Investigators (2021). Effect of Bamlanivimab vs Placebo on Incidence of COVID-19 Among Residents and Staff of Skilled Nursing and Assisted Living Facilities: A Randomized Clinical Trial. JAMA, 326(1), 46–55.

Bekker LG, Li S, Pathak S, Tolley EE, Marzinke MA, Justman JE, Mgodi NM, Chirenje M, Swaminathan S, Adeyeye A, Farrior J, Hendrix CW, Piwowar-Manning E, Richardson P, Eshelman SH, Redinger H, Williams P, Sista ND on behalf of the HPTN 076 Study Team. (2020) Safety and Tolerability of Injectable Rilpivirine LA in HPTN 076: A Phase 2 HIV Pre-exposure Prophylaxis Study in Women. EClinicalMedicine, 21: 100303.

Tolley EE, Li S, Zangeneh SZ, Atujuna M, Musara P, Justman J, Pathak S, Bekker LG, Swaminathan S, Stanton J, Sista N. (2019) Acceptability of a Long-acting Injectable HIV Prevention Product Among US and African Women: Findings from a Phase 2 Clinical Trial (HPTN 076). Journal of the International AIDS Society, 22 (10): e25408.

McKinstry LA, Zerbe A, Hanscom B, Farrior J, Kurth A, Stanton J, Li M, Elion R, Leider J, Branson B, El-Sadr WM. (2017) A Randomized-Controlled Trial of Computer-based Prevention Counseling for HIV-Positive Persons (HPTN 065). Journal of AIDS and Clinical Research, 8 (7): 714.

Buchacz K, Farrior J, Beauchamp G, McKinstry L, Kurth AE, Zingman BS, Gordin FM, Donnell D, Mayer KH, El-Sadr WM, Branson B for the HPTN 065 Study Team. (2017) Changing Clinician Practices and Attitudes Regarding the Use of Antiretroviral Therapy for HIV Treatment and Prevention: Results from the HPTN 065 Study. Journal of the International Association of Providers of AIDS Care, 16 (1): 81-90.

Kurth AE, Mayer K, Beauchamp G, McKinstry L, Farrior J, Buchacz K, Donnell D, Branson B, El-Sadr W for the HPTN (065) TLC-Plus Study Team. (2012) Clinician Practices and Attitudes Regarding Early Antiretroviral Therapy in the United States. Journal of Acquired Immune Deficiency Syndrome, 61(5): e65-e69.

Farrior JH, Weaver DD, Kling TF, Klatte E. (2002) Progressive Vertebral Fusion of Unknown

Etiology: A Case Report. American Journal of Medical Genetics, 112(2): 221-227.

Peet J, Weaver DD, Vance GH. (1998) 49,XXXXY: A Distinct Phenotype. Three New Cases and Review. Journal of Medical Genetics, 35 (5): 420-424.

Peet JH, Sadler TW. (1996) Mouse Embryonic Cardiac Metabolism Under Euglycemic and Hypoglycemic Conditions. Teratology, 54(1): 20-26.

Presentations

Marzinke MA, Voldal E, Hanscom BS, Guo X, Piwowar-Manning E, Agyei Y, Farrior J, Stranix-Chibanda L, Nakabiito C, Saidi F, Ford SL, Rinehart AR, Rooney J, Soto-Torres L, Cohen MS, Hosseinipour M, Delany-Moretlwe S, HPTN 084 Study Team.  Evaluation of Long-Acting Cabotegravir (CAB-LA) Pharmacokinetics During Pregnancy: A Sub-Study Analysis of the HPTN 084 Open Label Extension Study. Symposium – Use of Long-Acting Injectable Cabotegravir in Pregnant & Lactating People. IAS 2024. 25 July 2024.

Delany-Moretlwe S, Voldal E, Saidi F, Stranix-Chibanda L, Bhondai-Mhuri M, Mandima P, Mgodi N, Mukwekwerere P, Mpendo J, Nahirya Ntege P, Nakabiito C, Innes S, Kalonji D, Bock P, Mathew C, Panchia R, Singh N, Spooner E, Nuwagaba-Biribonwoha H, Dadabhai S, Makhema J, Mudhune V, Farrior J, Rose S, Piwowar-Manning E, Holt M, Soto-Torres L, Zwerski S, Rooney J, Rinehart A, Cohen M, Hosseinipour M on behalf of the HPTN 084 study team.  Initial evaluation of injectable cabotegravir (CAB-LA) safety during pregnancy in the HPTN 084 open-label extension. Symposium – Use of Long-Acting Injectable Cabotegravir in Pregnant & Lactating People. IAS 2024. 25 July 2024.

Voldal E , Hanscom B, Eshleman S, Piwowar-Manning E, Agyei Y , Nyarota K , Angira F, Dadabhai S,  Gadama D, Mirembe BG, Hunidzarira P, Innes S , Kalonji D , Makhema J, Mandima P , Marais A , Mpendo J, Mukwekwerere P, Mgodi N , Naidoo V, Nahirya Ntege P, Nuwagaba-Biribonwoha H, Roos E, Singh N,  Siziba B , Spooner E , FarriorJ, Rose S, Soto-Torres L, Rooney J, Rinehart AR, Landovitz R, Cohen MS, Delany-Moretlwe S for the HPTN 084 team. Positive Predictive Value of HIV Serological Tests in HPTN 084 Trial. Oral Presentation at IAS 2023. 23-26 July 2023.

Delany-Moretlwe s, Hanscom B, Angira F, Dadabhai S, Gadama D, Mirembe B, Bhondai M, Innes S, Kalonji D, Makhema J, Mandima P, Marais A, Mpendo J, Mukwekwerere P, Mgodi N, Naidoo V, Nahirya- Ntege P, Nuwagaba-Biribonwoha H, Roos E, Singh N, Siziba B, Spooner E, Farrior J, Rose S, Piwowar-Manning E, Burton M, Soto-Torres L, Rooney J, Rinehart A, Cohen M, Hosseinipour M on behalf of the HPTN 084 study team. Initial PrEP product choice: results from the HPTN 084 open-label extension. Oral Presentation at IAS 2023. 23-26 July 2023.

Delany-Moretlwe S, Hughes JP, Bock P, Dadabhai S, Gadama D, Hunidzarira P, Innes S, Kalonji D, Makhema J, Mandima P, Mathew C, Mpendo J, Mukwekwerere P, Mgodi, Nahirya Ntege P, Nakabiito C, Nuwagaba-Biribonwoha H, Panchia R, Angira F, Singh N, Spooner E, Farrior J, Rose S, Berhanu R, Agyei Y, Eshleman SH, Marzinke M, Piwowar-Manning E, Beigel-Orme S, Hosek S, Adeyeye A, Rooney J, Rinehart A, Hanscom B, Cohen M, Hosseinipour M, on behalf of the HPTN 084 study team. Long acting cabotegravir: updated efficacy and safety results from HPTN 084. Oral Presentation at AIDS 2022. 29 July-02 August 2022.

Delany-Moretlwe S, Hughes JP, Guo X, Hanscom B, Hendrix C, Farrior J, Berhanu RH, Rinehart A, Ford S, Rooney JF, Adeyeye A, Landovitz RJ, Cohen MS, Hosseinipour MC, Marzinke M. Evaluation of CAB-LA Safety and PK In Pregnant Women in the Blinded Phase of HPTN 084. Poster Presentation at CROI 2022; 12-16 February 2022.

Marzinke M, Delany-Moretlwe S, Agyei Y, Piwowar-Manning E, Anderson P, Hendrix C, Rose S, Farrior J, Adeyeye A, Hanscom B, Rinehart A, Rooney JF, Cohen MS, Hosseinipour MC, Eshleman S on behalf of the HPTN 084 study team. Long-acting Injectable PrEP in Women: Laboratory Analysis of HIV Infections in HPTN 084. Poster Presentation at IAS 2021 (Virtual); 18-21 July 2021.

Farrior J, Dye BJ, Moore AT, Lucas JP, Long LA, Andrew P, Hinson K and Sista ND. Expanding the Scope of Existing Clinical Research Networks to Response to the COVID-19 Pandemic. Poster at

Triangle Global Health Consortium, Virtual Annual Conference; 3December 2020.

Bekker LG, Shuying SL, Tolley B, Marzinke MA, Mgodi N, Justman JE, Swaminathan S, Adeyeye A, Farrior J and Sista N. HPTN 076: TMC278 LA Safe, Tolerable and Acceptable for HIV Pre-Exposure Prophylaxis. Poster at Conference on Retroviruses and Opportunistic Infections, Seattle, Washington; 14 February 2017.

Farrior J, Zerbe A, Kurth A, Hansom B, McKinstry L, Zingman BS, Gordin F, Donnell D, Branson B, El-Sadr WM for the HPTN 065 Study. Clinician and Patient Attitudes toward Financial Incentives for HIV Care (HPTN 065). Poster at Conference on Retroviruses and Opportunistic Infections, Boston, Massachusetts; 25 February 2016.

Kurth A, Farrior J, Hansom B, McKinstry L, Stanton J, Zerbe A, Elion R, Leider J, Branson B, El-Sadr for the HPTN 065 Study Team. Computer-based Prevention Counseling for HIV-infected Persons (HPTN 065). Poster at Conference on Retroviruses and Opportunistic Infections, Boston, Massachusetts; 24 February 2016.

El-Sadr WM, Kurth A, Farrior J, Buchacz K, Hansom B, McKinstry L, Elion R, Patel V, Donnell D, Branson B for the HPTN 065 Study. Prevention for the HIV-infected Persons in HPTN 065: Room for Improvement. Poster at Conference on Retroviruses and Opportunistic Infections, Boston, Massachusetts; 24 February 2016.

Buchacz K, Farrior, J, Beauchamp G, McKinstry L, Kurth A, Zingman BS, Gordin F, Donnell D, El-Sadr W, Branson B. Providers’ Attitudes and Practices Related to ART use for HIV Care and Prevention. Poster at Conference on Retroviruses and Opportunistic Infections, Seattle, Washington; 25 February 2015.

Gamble T, Corcoran P, Stanton J, Watkins P, Greene E, Farrior J, Elion R, Amenichi-Enahoro S, and El-Sadr W. Geographic Utilization of Gift Cards Used for Financial Incentives to Encourage Viral Suppression: Findings from HPTN 065. Poster at HIV Research for Prevention Conference, Cape Town, South Africa; 30 October 2014.

El-Sadr WM, Donnell DJ, Gamble TR, Greene E, Farrior JH, Watkins PS, Stanton J, Beauchamp G, McKinstry L, Zerbe A and Kurth A. TLC-Plus (HPTN 065): Update on Implementation of a Community-focused HIV Prevention Study in the US with a Focus on Expanded HIV Testing. Oral presentation at the Third International HIV Treatment as Prevention Workshop, Vancouver, BC; 24 April 2013.

El-Sadr WM, Branson BM, Donnell DJ, Hall HI, Gamble TR, Farrior JH, Watkins PS, Greene E, Zerbe A, Buchacz K and Kurth A. TLC-Plus (HPTN 065): Design and Implementation of a Community-focused HIV Prevention Study in the US. Oral presentation at the Second International HIV Treatment as Prevention Workshop, Vancouver, BC; 24 April 2012.

Kurth AE, Mayer, K, Beauchamp, G, McKinstry, L, Farrior, J, Buchacz, K, Simon, G, Zellan, J, Donnell, D, Branson, B, El-Sadr W. Clinician Practices and Attitudes Regarding Early Antiretroviral Therapy in the US. Poster at XIX International AIDS Conference, Washington, DC; 26 July 2012.

Farrior, JH, Kurth, A, Zerbe, A, Branson, B, and El-Sadr, W. Lessons Learned from Modifying Software for a Computer-Delivered Prevention Intervention. Poster at 7th International Conference

on HIV Treatment and Prevention Adherence, Miami, Florida; 4 June 2012.

Kurth, AE, Mayer, K, Beauchamp G, McKinstry L, Farrior, J, Buchacz, K, Donnell D, Branson B, El-Sadr W. Clinician Practices and Attitudes Regarding Early Antiretroviral Therapy in the US. Poster at International HIV Treatment as Prevention Workshop, Vancouver BC; 23 April 2012.