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

Kathy Galus, PharmD, RPh, BCOP
IDS Clinical Pharmacist
Phone: 716-845-8370
Email: Kathy.Galus@RoswellPark.org

Denise Wells Johnson, RPh
IDS Clinical Pharmacist
Phone: 716-845-3298
Email: Denise.WellsJohnson@RoswellPark.org

Linda Wickes, BS, RPh
IDS Clinical Pharmacist
Phone: 716-845-8583
Email: Linda.Wickes@RoswellPark.org

Michael Milazzo, PharmD, RPh, BCPS
IDS Clinical Pharmacist
Phone: 716-845-4680
Email: Michael.Milazzo@RoswellPark.org

Michael Spino, PharmD, RPh
IDS Clinical Pharmacist
Phone: 716-845-4680
Email: Michael.Spino@RoswellPark.org

John Pietkiewicz, PharmD, RPh, BCOP, BCPS
IDS Clinical Pharmacy
Phone: 716-845-4680
Email: John.Pietkiewicz@RoswellPark.org

Nedra Thomas, CPhT
IDS Associate I
Phone: 716-845-4680
Email: Nedra.Thomas@RoswellPark.org

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

Lynne Guise, BS, RPh
IDS Clinical Pharmacist
Phone: 716-845-4250
Email: Lynne.Guise@RoswellPark.org

Sarah Santos, CPhT
IDS Associate I
Email: Sarah.Santos@RoswellPark.org

Image
Roswell Park Comprehensive Cancer Center

Location and hours

Roswell Park Comprehensive Cancer Center
Investigational Drug Service
Clinical Research Center - 7 North
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.

Publications

  • Adjei AA, Dy GK, et al. A phase 1 study of the PI3K/mTOR inhibitor PQR309 evaluating safety, pharmacokinetics (PK) and pharmacodynamics (PD) in patients (pts) with advanced solid tumors. J Clin Oncol 2016; 34(15)_suppl (May 2016) 2560-2560.
  • Chen H, Dy G, et al. A Phase II Study of Etirinotecan Pegol (NKTR-102), a Topoisomerase-I lnhibitor Polymer Conjugate, in Small Cell Lung Cancer; Journal of Thoracic Oncology; 12(1), Supplement, S695–S696
  • Dy G, Kim ES, et al. A phase II randomized, placebo-controlled trial evaluating nintedanib versus placebo as prophylaxis against radiation pneumonitis in patients with unresectable non-small cell lung cancer (NSCLC ) undergoing chemoradiation therapy (CRT): A National Comprehensive Cancer Network-sponsored study. J Clin Oncol 2016 34(15)_suppl
  • Adjei A, Dy, G, et al. A phase I dose-escalation study of TAK-733, an investigational oral MEK inhibitor, in patients with advanced solid tumors, Invest New Drugs 2017 35(1); 47-58
  • Rosen L, Ma W, Adjei A, et al. A first-in-human phase I study to evaluate the MEK1/2 inhibitor, cobimetinib, administered daily in patients with advanced solid tumors. Invest New Drugs; 2016 34(5); 604-613
  • Boland P, Iyer R, Ma W, et al. A phase I/II study of nintedanib and capecitabine in refractory metastatic colorectal cancer J Clin Oncol 2017; 35(4) suppl.759
  • Puzanov I, Dy G, Adjei A, et al. Phase 1 trial of tivantinib in combination with sorafenib in adult patients with advanced solid tumors Invest New Drugs 2015 33; 159-168
  • Ngamphaiboon N, Dy G, et al. A phase I study of the histone deacetylase (HDAC) inhibitor entinostat, in combination with sorafenib in patients with advanced solid tumors Invest New Drugs 2015 33; 225-232
  • Bakhribah H, Dy G, Adjei AA, et al. A phase I study of the toll-like receptor 5 (TLR5) agonist, entolimod in patients (pts) with advanced cancers. J Clin Oncol 33, no. 15_suppl (May 2015) 3063-3063 abstract
  • Fetterly G, Dy G, Ma W, et al. A phase I study to assess the safety, tolerability, and PK of dovitinib (D) in combination with gemcitabine (G) and capecitabine (C) in patients with advanced solid tumors. J Clin Oncol 32, no. 15_suppl (May 2014) 2603-2603 abstract
  • Naing A, Dy G, et al. A phase I trial of KX2-391, a novel non-ATP competitive substrate-pocket- directed SRC inhibitor, in patients with advanced malignancies. Invest New Drugs 2013; 31: 967-973
  • Ma, W, Dy G, Adjei AA, et al. A phase I and pharmacokinetic study of a weekly dosing schedule of paclitaxel injection concentrate for nano-dispersion (PICN) in patients with advanced solid tumors. J Clin Oncol 32, no. 15_suppl (May 2014) 2566-2566 abstract
  • Ma, W, Dy G, Adjei AA, et al. A pharmacokinetic and dose-escalating study of paclitaxel injection concentrate for nano-dispersion (PICN) alone and with carboplatin in patients with advanced solid tumors. J Clin Oncol 31, no. 15_suppl (May 2013) 2557-2557 abstract