Aakanksha Khandelwal
Global Commercial Leader in Oncology at Daiichi Sankyo, Inc.
Executive in oncology bringing new therapies to patients
A visionary and cross-functional leader with a strong grounding in both the R&D and commercial sides of the biopharma business with a passion for bringing innovative products to patients. Strong expertise in oncology having worked as a regulator, scientist, commercial leader and strategist.
Daiichi Sankyo, Inc.
https://www.linkedin.com/company/daiichi-sankyo
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Global Commercial Leader in Oncology
EMD Serono, Inc.
https://www.linkedin.com/company/emd-serono-inc
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Global Head of Portfolio Strategy & Innovation
EMD Serono, Inc.
https://www.linkedin.com/company/emd-serono-inc
Greater Boston Area
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Head of Innovation & Scientific Leadership
EMD Serono, Inc.
https://www.linkedin.com/company/emd-serono-inc
Led the US launch of BAVENCIO and the XALKORI co-promote while helping to build out a new Oncology Franchise from the ground up. I also led the cross-functional launch team and franchise strategy as well as brand planning across multiple products and tumor types. Much of my time was  spent working closely with the field team and meeting with customers.
Greater Boston Area
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US Brand Lead- BAVENCIO
Merck Group
https://www.linkedin.com/company/merck-group
Worked with top management across all healthcare businesses to define strategic priorities to enable global market success and deliver on operational plan. Translated business performance in positioning Merck externally to the investment community. Also, led the deep dive and refresh of internal processes and governance to enhance operations.
Germany
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Director-Merck Healthcare President's Office
EMD Serono, Inc.
https://www.linkedin.com/company/emd-serono-inc
Developed models and tools to enable stronger cross-functional commercial planning across various stages of a product lifecycle including launch. I further applied this in conducting due diligence and building out the commercial model for company’s first fertility technology BD deal.
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Associate Director-Global Operations Business Management & Planning
University of Maryland School of Medicine
https://www.linkedin.com/company/university-of-maryland-school-of-medicine
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Adjunct Assistant Professor
FDA
https://www.linkedin.com/company/fda
- Led the clinical pharmacology team in the US approval of two new biologics (an antibody-drug conjugate and an immunotherapy)
- Evaluated Investigational New Drug (IND), Biosimilar IND, New Drug (NDA), and Biologic License Applications (BLA) in oncology and hematology for over 200 different products
- Successfully initiated regulatory research whose results led to the office-wide implementation of new guidance for industry
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Clinical Pharmacologist - Oncology/Hematology
MBA
Additional consulting projects: 
Roche: Global Product Strategy - Oncology - GAZYVA Launch Team (Basel, Switzerland; Aug. 2012- May 2013)
Heron Health -Market Access & Pricing Consultant (London, UK; Oct. 2012- Feb. 2013)
Johnson & Johnson: Health Economics & Market Access- Reimbursement (Dubai, UAE; June 2012- Aug. 2012)
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London Business School
https://www.linkedin.com/school/london-business-school/
Ph.D.
Pharmacology (Concentration: Oncology)
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University of Maryland Baltimore
https://www.linkedin.com/school/university-of-maryland-baltimore/
B.S.
Biochemistry/Molecular Biology
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University of Maryland Baltimore County
https://www.linkedin.com/school/university-of-maryland-baltimore-county/
Immune checkpoint inhibitors (ICIs) have revolutionized the treatment of cancer, improving outcomes in patients with advanced malignancies. The use of ICIs in clinical practice, and the number of ICI clinical trials, are rapidly increasing. The use of ICIs in combination with other forms of cancer therapy, such as chemotherapy, radiotherapy, or targeted therapy, is also expanding. However, immune-related adverse events (irAEs) can be serious in up to a third of patients. Critical questions remain surrounding the characteristics and outcomes of irAEs, and how they may affect the overall risk–benefit relationship for combination therapies. This article proposes a framework for irAE classification and reporting, and identifies limitations in the capture and sharing of data on irAEs from current clinical trial and real-world data. We outline key gaps and suggestions for clinicians, clinical investigators, drug sponsors, patients, and other stakeholders to make these critical data more available to researchers for pooled analysis, to advance contemporary understanding of irAEs, and ultimately improve the efficacy of ICIs.
Immune-related adverse events associated with immune checkpoint inhibitors: a call to action for collecting and sharing clinical trial and real-world data
Journal for the Immunotherapy of Cancer
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8256840/
Antibody–drug conjugate (ADC) development started about three decades ago with the hypothesis that toxins conjugated to antibodies would enhance antitumor activity and reduce toxicity by delivering toxins to specific tumor sites. Since then, the field has evolved to include potent small molecule drugs (SMD) and radiolabeled drugs conjugated to antibodies targeting both solid tumors and hematologic malignancies. Improved ADC technology has paved the way for increased drug delivery to the target tumors and decreased normal tissue exposure to cytotoxic agents. Radio-immunoconjugates (RICs) present a different set of challenges leading to unique development pathways. Several factors need to be taken into consideration when developing RICs, such as decay of radioactivity, potentially higher exposure to normal tissue caused by lower specificity, and dehalogenation leading to a loss of signal. This chapter focuses on antibodies conjugated to SMDs.
Book chapter: Antibody-Drug Conjugate Development
Springer
https://link.springer.com/chapter/10.1007/978-1-4614-5456-4_2
Multiple publications in peer-reviewed journals in the field of oncology as a scientist as well as a regulator at the FDA.
https://in.linkedin.com/in/aakanksha-khandelwal-ba28b5137
Gurgaon
Aakanksha Khandelwal
Audit Manager at Deloitte Tohmatsu Consulting LLC.
https://in.linkedin.com/in/aakanksha-khandelwal
Bengaluru
Aakanksha Khandelwal
Investment Banking • Unitus Capital • PGDM-Finance
https://in.linkedin.com/in/aakanksha-khandelwal-276594135
Mumbai
Aakanksha Khandelwal
Software Engineer at FynTune Solution Serving Notice Period
https://in.linkedin.com/in/aakanksha-khandelwal-76548978
Mumbai
Aakanksha Khandelwal
Banking professional with more than 10 years of experience