Experienced Doctors

Shakun Malik, MD

Oncologist and Hematologist

Dr. Malik is a well renowed Thoracic Oncologist presently working as Head, Thoracic and Head & neck Cancer Therapeutics, Clinical Investigations Branch CTEP/DCTD at National Cancer Institute/NIH. She has received several FDA Recognition Awards and is a pominent speaker on various panels related to medications and cancer related treatments. Dr. Malik completed her fellowship from prestigious George Washington University in Oncology and Hematology.

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Dr. Malik is associated with several teaching and research activities both at the University and at pharmaceutical related initiatives. Her patients love her and she is very detailed, caring and compassionate doctor. Her background both at the academic and professional level has made stand out amongst the others.

  • George Washington University, Washington, District of Columbia (Hematology/Oncology Fellow)
  • Washington Hospital Center -VA Medical Center, Washington, District of Columbia (Oncology Fellow)
  • Shadyside Hospital, University of Pittsburgh, Pittsburgh, Pennsylvania (Residency)
  • University of Kashmir, Jammu and Kashmir (MBBS)

Work History

  • Head, Thoracic and Head & neck Cancer Therapeutics, Clinical Investigations Branch ¬†CTEP/DCTD National Cancer Institute/NIH
  • MO & Scientific Lead Thoracic/H&N Oncology Center for Drug Evaluation and ResearchOffice of Hematology and Oncology Products
  • Director of Multidisciplinary Thoracic Oncology Clinic Chief, the Center for Thoracic Medical Oncology
  • Associate of Drug & Therapeutic Development Team Lombardi Cancer Center Georgetown University Hospital, Washington DC
  • Clinical Assistant Professor of Medicine, Division of Hematology/Oncology at The George Washington University, Washington DC

FDA Representation member of CTEP/NCI IDSC PAM

Licensure: District of Columbia

Certifications and Memberships

  • American Society of Clinical Oncology
  • FDA Representation as member of CTEP/NCI IDSC PAM
  • Member International Association for the study of Lung Cancer (IASLC)
  • Member CALGB/ Associate Member Respiratory Core Committee

Honors & Awards

FDA Recognition Awards
  • Recipient of "CDER Special Recognition" award 2013:  for the lead FDA representative and co-chair at thoracic Workshop that led to "Master Protocol initiatives in Lung Cancer"
  • Recipient of CDER Team Excellence Award: 2012 for Xalkori and Companion Assay Team for Personalized Medicine
  • Certificate of Appreciation 2012:  in recognition for educating industry at the FDA Small Business Regulatory Education for Industry (REdI).
  • Recipient of FDA Excellence in Communication Award: 2011 for continued and extensive communication to stakeholders regarding the drug development and drug approval process for lung cancer.
  • Recipient of FDA Group Recognition award: 2011 for extraordinary efforts in advancing public Health interests despite time constraints and heavy workload.
  • On State Merit List Pre-Med, University of Kashmir
  • Best Outgoing Medical graduate, University of Kashmir

Presentations

  • Shakun Malik, John Johnson, Karen Bijwaard, Robert Becker, Patricia Keegan and Richard Pazdur "Targeted therapies for the treatment of non-small cell lung cancer (NSCLC): Bull’s Eye or Missed Target?" Poster presentation ASCO 
  • Shakun Malik, Ann Farrell, Xu, Qiang (Casey), Rajeshwari Sridhara, Robert Justice, Poor Representation of Women, Older Age groups and Minorities in US Approval Trials for Non-Small Cell Lung Cancer: FDA Review O44: Location: Elicium II. Oral Session: NSCLC - Advanced Stage and Statistics 12:30 - 14:00 14th World Conference on Lung Cancer, July 3-7, 2011, Amsterdam
  • Shakun Malik; Ann T Farrell; Rajeshwari Sridhara; Qiang (Casey) Xu; Robert Justice; Richard Pazdur Gender, Age and Ethnic representation in Non-Small Cell Lung Cancer (NSCLC) US registration trials: FDA Review Center for Drug Evaluations and Research, Division of Drug Oncology Products; FDA: Poster Presentation  ASCO Annual Meeting 2011. Chicago Illinois.
  • S. M. Malik, E. Mansfield, I. M. Waxman, R. Charlab Orbach, P. Cortazar, R. Becker, R. L. Justice & R. Pazdur "Defining Success in Personalized Therapy Development:  FDA Perspective"  Poster Presentation  ASCO-NCI-EORTC Annual Meeting on Molecular Markers in Cancer 
  • Shakun Malik, Rajeshwari Sridhara, Ian Waxman, Robert Justice & Richard Pazdur "Prime time for prospective randomized trials of targeted therapies with validated targets in lung cancer FDA perspective" AACR/ISLAC Joint Conference on "Molecular Origins of Lung Cancer" Jan. 11-14, 2010, in Coronado, California. 1st AACR/IASCL meeting January 12th in San Diego California, USA.
  • Shakun Malik, Robert Justice, Ann T Farrell, Rajeshwari Sridhara, and Richard Pazdur. "Approved Therapies for Advanced  Non-Small Cell Lung Cancer, Food and Drug Administration Overview" 13th World Conference on Lung Cancer San Francisco July 31st - August 4th 2009
  • Rajeshwari Sridhara, Ph.D. and Shakuntala Malik, M.D. "Challenges in Regulatory Marketing Approval of Drugs for the Treatment of Advanced Non-Small Cell Lung Cancer Based on Non-inferiority Trials" 13th World Conference on Lung Cancer San Francisco July 31st - August 4th 2009.
  • M. J. Pishvaian, J. L. Marshall, J. J. Hwang, S. Malik, A. R. He, J. F. Deeken, C. B. Kelso, I. Cotarla, M. S. Berger; Georgetown University, Washington, DC; Gemin X Pharmaceuticals, Malvern, PA.A phase I trial of GMX1777, an inhibitor of nicotinamide phosphoribosyl transferase (NAMPRT), given as a 24-hour infusion. Poster Presentation ASCO 2009.
  • Chiappori, M. T. Schreeder, M. M. Moezi, J. Stephenson, J. L. Blakely, R. Salgia, Q. S. Chu, S. M. Malik, M. M. Modiano, M. S. Berger; H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL; Oncology Specialists PC, Huntsville, AL; Florida Oncology Associates, Jacksonville, FL; US Oncology, Greenville, SC; The West Clinic, Memphis, TN; University of Chicago, Chicago, IL; Cross Cancer Institute, Edmonton, AB, Canada; Georgetown University, Washington, DC; Arizona Clinical Research Center (ACRC), Tucson, AZ; Gemin X Pharmaceuticals , Malvern, PAA phase Ib trial of Bcl-2 inhibitor obatoclax in combination with carboplatin and etoposide for previously untreated patients with extensive-stage small cell lung cancer (ES-SCLC). Poster Presentation ASCO 2009.
  • Brian T. Collins, MD, Kelly Erickson, BA, Sean P. Collins, MD, PhD, Gregory Gagnon, MD, Sonja Dieterich, PhD, Cristina Reichner, MD, MohamedA. Elsawaf, MD, David Earl-Graef, MD, Carlos Jamis-Dow, MD, Filip Banovac, MD, Shakun Malik, MD and Eric D. Anderson, MD CYBERKNIFE® FRAMELESS, IMAGE-GUIDED, HIGH-DOSE, FRACTIONATED, STEREOTACTIC, RADIOSURGERY SYSTEM WITH THE SYNCHRONYTM MOTION TRACKING MODULE IN THE TREATMENT OF SMALL PERIPHERAL INOPERABLE LUNG TUMORS presented at American College of Chest Physicians. 
  • Eric D. Anderson, MD, FCCP, Brian T. Collins, MD, Gregory Gagnon, MD, Sean Collins, MD, PhD, Carlos Jamis-Dow, MD, Filip Banovac, MD, Shakun Malik, MD, Nadim Haddad, MD, Marc Margolis, MB ChB and Cristina Reichner, AND A MODIFIED TRANSBRONCHIAL ASPIRATION NEEDLE TECHNIQUE MD FIDUCIAL PLACEMENT FOR CYBERKNIFE® STEREOTACTIC RADIOSURGERY USING FLEXIBLE BRONCHOSCOPY

Publications

  • Shakun Malik, Brian Collins, Hwang at al Phase I trial of Bexarotene combined with Docetaxel in patients with advanced solid tumors. Journal Clinical Lung Cancer
  • Shakun Malik, Ke Liu, Xu Qiang, Robert Justice, Ann Farrell, Rajeshwari Sridhara, Shenghui Tang, Milinda Vialpando, and Richard Pazdur. Pralatrexate (Folotyn®) for patients with relapsed or refractory peripheral T-cell lymphoma: FDA Drug Approval Summary Journal of  Clin Cancer Res; 16(20); 4921-7. ©2010 AACR.
  • Shadi Yousefi, Brian T. Collins, Cristina A. Reichner, Eric D. Anderson, Carlos Jamis-Dow, Gregory Gagnon, Shakun Malik, Blair Marshall, Thomas Chang, Filip Banovac. Clinical Lung Cancer Volume 8 Issue 4 2007.
  • Daniel Moore, MD, Philip Cohen, MD, and Shakun Malik, MD HIV-Related Large B-cell Lymphoma Confined to the Bone Marrow With a Fulminant Clinical Course: A Case Report and Literature Review Clinical Advances in Hematology & Oncology Volume 5, Issue 8 
  • Cristina A. Reichner ,Brian T. Collins,Gregory J. Gagnon,Shakun Malik,Carlos Jamis-Dow andEric D. Anderson. Georgetown University Hospital, Washington, DC, USA Placement of fiducials via flexible bronchoscopy for the treatment of lung cancer with CyberKnife. Journal of Bronchology Volume 12 
  • Brian T. Collins, Kelly Erickson, Sean P. Collins, Gregory J. Gagnon, Sonja Dieterich, Donald A. McRae, Cristina Reichner, Thomas Chang, Carlos Jamis-Dow, Filip Banovac, Shakun Malik, Eric D. AndersonCyberKnife frameless image-guided high-dose fractionated stereotactic radiosurgery with the synchrony motion tracking module in the treatment of single small peripheral lung tumors. Robotic Radiosurgery by Springer page 145-153
  • Eric D. Anderson, Brian T. Collins, Gregory J. Gagnon, Sean P. Collins, Timothy Mahoney, Filip Banovac, Carlos Jamis-Dow, Shakun Malik, Cristina A. Reichner Robotic Radiosurgery by Springer page 105-110.
  • Malik, S., Krasnow, S., & Wadleigh, R., "Closure of T - E Fistulas with Primary Chemotherapy in Patients with Esophageal Cancer". The Cancer Journal, 73:1321 - 1323, March, 1994.
  • Malik, S. & Krasnow, S., "Chemotherapy in Lung Cancer" in Handbook of Pulmonary Drug Therapy. ED. S.Spangold, R. Nicklas & P. Witorsh.
  • Marshall John, Eisenberg Steven, Johnson Michael, Hanfelt John, Dorr Andrew, El-Ashry Dorraya, Oberst Michael, Fuxman Yair, Holmlund Jon & Malik Shakun. A Phase II Trial of ISIS 3521 In patients with metastatic colorectal cancer. Journal of Clinical Colorectal Cancer,Vol 4
  • Shakun Malik, Jimmy Hwang and John Marshall. Chemotherapy use in organ dysfunction,  Book Chapter, 2004.
  • Malik, S.  "Treatment of Factor Inhibitors in Post-Surgical Patients" in Handbook of Hematology ED. B. Alving

Invited Speaker

  • ASCO CRC meeting presentation "how to develop priorities related to the development of biomarkers, surrogate endpoints and innovative trial designs". March 2nd 2012 at ASCO headquarters
  • Drug development and approval in the era of molecularly targeted therapy FDA Perceptive. CAP IASLC AMP Lung Cancer Biomarkers Conference December, 12th 2010.
  • FDA Basis for NDA Approval CALGB Respiratory Core Committee meeting September 23-25, 2010. Chicago, Illinois.
  • FDA Perspective on Drug and Companion Diagnostic Development. 2nd Niagara Lung Cancer Symposia, Ontario Canada; September 9th-10th 2010
  • Defining Success in Oncology Drug Development" May 13th 2010. Emory University, Grand rounds. Atlanta Georgia.
  • Session Chair NSCLC - ADVANCED DISEASE II. Session: PD9 Location: Moscone West, Room 2020-2022, Level 2. 13th World Conference on Lung Cancer San Francisco July 31st - August 4th 2009.FDA Representation at Lung Cancer Workshop May 2009.
  • Lung Cancer Prevention Group, Pooks Hill Marriott, MD 
  • Editorial Board member " European Journal of Clinical Hematology/Oncology"
  • Speaker for Spring and Fall: The Pharmaceutical Education & Research Institute, Inc. (PERI) Courses "Updates in Lung Cancer"  2004- current