What we do

The Investigational Drug Service (IDS) at Roswell Park Comprehensive Cancer Center is responsible for pharmacy support of clinical research studies.

The IDS team provides clinical and operational pharmacy support for patients enrolled in clinical research studies to ensure patient safety and data integrity.

We maintain appropriate regulatory documents for clinical research. IDS staff members are responsible for all aspects of investigational drug management, including accountability, ordering, receiving, destruction, returns, proper storage and dispensing.

IDS pharmacists provide medication counseling for patients enrolled in clinical research studies. They also provide medication reconciliation for patients in screening for a research study, all of which is documented in the electronic medical record (EMR). The number and complexity of research studies, especially Phase I studies, were the driving forces behind the creation of IDS by the Department of Pharmacy and the Clinical Protocol and Data Management (CPDM) office.

Responsibilities of IDS staff include study review for Scientific Review Committee and Institutional Review Board submission, amendment review, review of amended investigator brochures, study implementation, dispensing and sterile products preparation, and clinical services such as medication review and patient counseling.

An IDS staff member is also involved with implementation of investigator-initiated studies in the Roswell Park Clinical Research Network. IDS staff members provide expert consultation for each clinical research study utilizing pharmaceutical products.

Equipment

  • -20°C freezer
  • -80°C freezers
  • Refrigerators
  • Biological safety cabinets
  • Electronic Drug Accountability

Services & fees

  • Medication reconciliation for study eligibility
  • Medication review for possible interactions with study drug
  • Patient counseling
  • Inventory control and maintenance
  • Review of proposed investigator-initiated study prior to submission to ensure medication section is appropriate for implementation

Meet our team

For more infomation:

Sandra Rand, CPhT
IDS Associate II
Phone: 716-845-8196
Email: Sandra.Rand@RoswellPark.org

Kathy Galus, PharmD, RPh, BCOP
IDS Clinical Pharmacist

Denise Wells Johnson, RPh
IDS Clinical Pharmacist

Linda Wickes, BS, RPh
IDS Clinical Pharmacist

Michael Milazzo, PharmD, RPh, BCPS
IDS Clinical Pharmacist

Michael Spino, PharmD, RPh
IDS Clinical Pharmacist

John Pietkiewicz, PharmD, RPh, BCOP, BCPS
IDS Clinical Pharmacy

Nedra Thomas, CPhT
IDS Associate I

Lynne Guise, BS, RPh
IDS Clinical Pharmacist

Sarah Santos, CPhT
IDS Associate I

Roswell Park Comprehensive Cancer Center

Location and hours

Roswell Park Comprehensive Cancer Center
Investigational Drug Service
Grace Cancer Drug Center - 5th Floor
Elm and Carlton Streets
Buffalo, New York 14263

Monday – Friday, 7:30 a.m. – 4:30 p.m.

This facility is funded by NCI P30CA16056. Publications should cite the core grant in the acknowledgment section, if publications use data generated by the Core facility. Two copies of the publication acknowledging the core grant should also be submitted to the facility at Elm and Carlton Streets, Buffalo, NY 14263.

Investigational Drug Service (IDS) provides clinical and operational pharmacy related services for investigators at Roswell Park Comprehensive Cancer Center. IDS staff provide expertise in study preparation, pharmacokinetics, drug interactions, dosing and drug compounding.

  • Motzer RJ, Russo P, Grünwald V, Tomita Y, Zurawski B, Parikh O, Buti S, Barthélémy P, Goh JC, Ye D, Lingua A, Lattouf JB, Albigès L, George S, Shuch B, Sosman J, Staehler M, Vázquez Estévez S, Simsek B, Spiridigliozzi J, Chudnovsky A, Bex A. Adjuvant nivolumab plus ipilimumab versus placebo for localised renal cell carcinoma after nephrectomy (CheckMate 914): a double-blind, randomised, phase 3 trial. Lancet. 2023 Mar 11;401(10379):821-832. doi: 10.1016/S0140-6736(22)02574-0. Epub 2023 Feb 9. PMID: 36774933.
  • Kamdar M, Solomon SR, Arnason J, Johnston PB, Glass B, Bachanova V, Ibrahimi S, Mielke S, Mutsaers P, Hernandez-Ilizaliturri F, Izutsu K, Morschhauser F, Lunning M, Maloney DG, Crotta A, Montheard S, Previtali A, Stepan L, Ogasawara K, Mack T, Abramson JS; TRANSFORM Investigators. Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma (TRANSFORM): results from an interim analysis of an open-label, randomised, phase 3 trial. Lancet. 2022 Jun 18;399(10343):2294-2308. doi: 10.1016/S0140-6736(22)00662-6. Erratum in: Lancet. 2022 Jul 16;400(10347):160. PMID: 35717989.
  • Kuderer NM, Choueiri TK, Shah DP, Shyr Y, Rubinstein SM, Rivera DR, Shete S, Hsu CY, Desai A, de Lima Lopes G Jr, Grivas P, Painter CA, Peters S, Thompson MA, Bakouny Z, Batist G, Bekaii-Saab T, Bilen MA, Bouganim N, Larroya MB, Castellano D, Del Prete SA, Doroshow DB, Egan PC, Elkrief A, Farmakiotis D, Flora D, Galsky MD, Glover MJ, Griffiths EA, Gulati AP, Gupta S, Hafez N, Halfdanarson TR, Hawley JE, Hsu E, Kasi A, Khaki AR, Lemmon CA, Lewis C, Logan B, Masters T, McKay RR, Mesa RA, Morgans AK, Mulcahy MF, Panagiotou OA, Peddi P, Pennell NA, Reynolds K, Rosen LR, Rosovsky R, Salazar M, Schmidt A, Shah SA, Shaya JA, Steinharter J, Stockerl-Goldstein KE, Subbiah S, Vinh DC, Wehbe FH, Weissmann LB, Wu JT, Wulff-Burchfield E, Xie Z, Yeh A, Yu PP, Zhou AY, Zubiri L, Mishra S, Lyman GH, Rini BI, Warner JL; COVID-19 and Cancer Consortium. Clinical impact of COVID-19 on patients with cancer (CCC19): a cohort study. Lancet. 2020 Jun 20;395(10241):1907-1918. doi: 10.1016/S0140-6736(20)31187-9. Epub 2020 May 28. Erratum in: Lancet. 2020 Sep 12;396(10253):758. PMID: 32473681; PMCID: PMC7255743.
  • Castellino SM, Pei Q, Parsons SK, Hodgson D, McCarten K, Horton T, Cho S, Wu Y, Punnett A, Dave H, Henderson TO, Hoppe BS, Charpentier AM, Keller FG, Kelly KM. Brentuximab Vedotin with Chemotherapy in Pediatric High-Risk Hodgkin's Lymphoma. N Engl J Med. 2022 Nov 3;387(18):1649-1660. doi: 10.1056/NEJMoa2206660. PMID: 36322844; PMCID: PMC9945772.
  • Jänne PA, Riely GJ, Gadgeel SM, Heist RS, Ou SI, Pacheco JM, Johnson ML, Sabari JK, Leventakos K, Yau E, Bazhenova L, Negrao MV, Pennell NA, Zhang J, Anderes K, Der-Torossian H, Kheoh T, Velastegui K, Yan X, Christensen JG, Chao RC, Spira AI. Adagrasib in Non-Small-Cell Lung Cancer Harboring a KRASG12C Mutation. N Engl J Med. 2022 Jul 14;387(2):120-131. doi: 10.1056/NEJMoa2204619. Epub 2022 Jun 3. PMID: 35658005.
  • Richardson PG, Jacobus SJ, Weller EA, Hassoun H, Lonial S, Raje NS, Medvedova E, McCarthy PL, Libby EN, Voorhees PM, Orlowski RZ, Anderson LD Jr, Zonder JA, Milner CP, Gasparetto C, Agha ME, Khan AM, Hurd DD, Gowin K, Kamble RT, Jagannath S, Nathwani N, Alsina M, Cornell RF, Hashmi H, Campagnaro EL, Andreescu AC, Gentile T, Liedtke M, Godby KN, Cohen AD, Openshaw TH, Pasquini MC, Giralt SA, Kaufman JL, Yee AJ, Scott E, Torka P, Foley A, Fulciniti M, Hebert K, Samur MK, Masone K, Maglio ME, Zeytoonjian AA, Nadeem O, Schlossman RL, Laubach JP, Paba-Prada C, Ghobrial IM, Perrot A, Moreau P, Avet-Loiseau H, Attal M, Anderson KC, Munshi NC; DETERMINATION Investigators. Triplet Therapy, Transplantation, and Maintenance until Progression in Myeloma. N Engl J Med. 2022 Jul 14;387(2):132-147. doi: 10.1056/NEJMoa2204925. Epub 2022 Jun 5. PMID: 35660812; PMCID: PMC10040899.
  • Hong DS, Van Tine BA, Biswas S, McAlpine C, Johnson ML, Olszanski AJ, Clarke JM, Araujo D, Blumenschein GR Jr, Kebriaei P, Lin Q, Tipping AJ, Sanderson JP, Wang R, Trivedi T, Annareddy T, Bai J, Rafail S, Sun A, Fernandes L, Navenot JM, Bushman FD, Everett JK, Karadeniz D, Broad R, Isabelle M, Naidoo R, Bath N, Betts G, Wolchinsky Z, Batrakou DG, Van Winkle E, Elefant E, Ghobadi A, Cashen A, Grand'Maison A, McCarthy P, Fracasso PM, Norry E, Williams D, Druta M, Liebner DA, Odunsi K, Butler MO. Autologous T cell therapy for MAGE-A4+ solid cancers in HLA-A*02+ patients: a phase 1 trial. Nat Med. 2023 Jan;29(1):104-114. doi: 10.1038/s41591-022-02128-z. Epub 2023 Jan 9. PMID: 36624315; PMCID: PMC9873554.
  • Yan M, Ouyang Q, Sun T, Niu L, Yang J, Li L, Song Y, Hao C, Chen Z, Orlandi A, Ishii N, Takabe K, Franceschini G, Ricci F, Verschraegen C, Liu Z, Zhang M, Lv H, Liu L, Yang X, Xiao H, Gao Z, Li X, Dong F, Chen X, Qiao J, Zhang G. Pyrotinib plus capecitabine for patients with human epidermal growth factor receptor 2-positive breast cancer and brain metastases (PERMEATE): a multicentre, single-arm, two-cohort, phase 2 trial. Lancet Oncol. 2022 Mar;23(3):353-361. doi: 10.1016/S1470-2045(21)00716-6. Epub 2022 Jan 31. PMID: 35085506.
  • Tawbi HA, Forsyth PA, Hodi FS, Algazi AP, Hamid O, Lao CD, Moschos SJ, Atkins MB, Lewis K, Postow MA, Thomas RP, Glaspy J, Jang S, Khushalani NI, Pavlick AC, Ernstoff MS, Reardon DA, Kudchadkar R, Tarhini A, Chung C, Ritchings C, Durani P, Askelson M, Puzanov I, Margolin KA. Long-term outcomes of patients with active melanoma brain metastases treated with combination nivolumab plus ipilimumab (CheckMate 204): final results of an open-label, multicentre, phase 2 study. Lancet Oncol. 2021 Dec;22(12):1692-1704. doi: 10.1016/S1470-2045(21)00545-3. Epub 2021 Nov 10. PMID: 34774225; PMCID: PMC9328029.
  • Haanen J, Ernstoff MS, Wang Y, Menzies AM, Puzanov I, Grivas P, Larkin J, Peters S, Thompson JA, Obeid M. Autoimmune diseases and immune-checkpoint inhibitors for cancer therapy: review of the literature and personalized risk-based prevention strategy. Ann Oncol. 2020 Jun;31(6):724-744. doi: 10.1016/j.annonc.2020.03.285. Epub 2020 Mar 17. PMID: 32194150.