Arati V. Rao, MD.
Palo Alto,CA
Summary
- Duke trained, NIH-funded physician-scientist with 25+ years of oncology clinical and drug development experience
- Served as faculty on NCCN (Acute Lymphoblastic Leukemia v1.0), ASCO Geriatric-Oncology and ASH scientific committee for myeloid biology
- Over 20+ INDs and global NDA/BLA filings
- Experience in early- and late-stage development, and across different platforms: small molecules, T-cell engagers, ADCs, cell therapies (CAR T and TCRs)
- M&A experience: Gilead-Kite acquisition 2017, Seagen-Pfizer merger 2023, in licensing of several molecules- including PD1-VEGF bispecific antibody from 3SBio
Overview
23
23
years of professional experience
1
1
Certification
Work History
Vice-President, Late-Stage Clinical Development
4404 Diseases Area Head, Pfizer Inc
01.2024 - Current
- Franchise Head with three therapeutic areas responsible for clinical development and overall strategy of PF-08634404, Pfizer’s PD1-VEGF bispecific antibody (in licensed from 3SBio China)
- Responsible for regulatory interactions for 6 pivotal Phase 3 studies, 3 Phase 2/3 studies, and 3 Proof-of-Concept Phase 1/2 studies across multiple therapeutic area areas- first patient dosed on several of these studies within 5 months of deal approval
- Managing and expanding therapeutic area teams for the 4404 franchise
- Collaborating cross-functionally with research, early development, Dev China teams, commercial, CI, BD to find internal and external partners for 4404 combination studies
- Jan 2024- June 2025: Served as the Thoracic TA Head and ad interim Hematology TA head. Responsible for regulatory interactions, study start up for 4 pivotal studies in lung and HNSCC cancers with sigvotatug vedotin- first-in-class IB6 vedotin ADC and PDL1-vedotin
- Managing and building a team for the thoracic oncology therapeutic area post Seagen acquisition
- Responsible for Adcetris (brenduximab vedotin)- BLA filed for ECHELON-3 study in 3rd line relapsed-refractory DLBCL with with subsequent approval Feb 12, 2025.
- Oversight of clinical development strategies for all elranatamab, maplicepert, inotuzumab ozogamicin, brentuximab vedotin, and bosutinib studies.
Vice President, Early-Stage Clinical Development
Seagen Inc
01.2023 - 01.2024
- Oversight of clinical development strategies for 9 clinical antibody drug conjugates (ADC) assets currently in clinic- 5 INDs filed in 2023
- Development and prioritization of several next generation ADC (Topo1 and other payloads) and immunotherapy programs
- Oversight and development of 2 high-priority collaborations from in-licensing agreements
- Clinical lead working with business development to evaluate and expand current portfolio.
Consultant, Cell Therapy Clinical Development
Synthekine Inc and ImmPACT Bio
02.2022 - 01.2023
- Collaborating with R&D, CMC, Regulatory and Biometrics to help Synthekine Inc get their first CAR T program (SYNCAR-001, a CD19 directed CAR with an orthogonal IL-2 receptor) into clinic, assisted with protocol amendments and PI interactions.
- Lead for pre-IND meeting and IND submissions for ImmPACT Bio's CD19/20 Bispecific CAR in B-cell malignancies. IND was cleared by the FDA Jan 2023.
- Building clinical development teams at both companies: helped hire and build out clinical operations, biometrics, and regulatory teams.
- Working with R&D at ImmPACT bio's next gen iCAR/aCAR logic gated CAR T programs in solid tumors.
Senior Vice-President and Acting CMO
PACT Pharma Inc
04.2020 - 06.2022
- Oversight of all clinical development strategies including next generation programs (PACT had no CMO or head of R&D so I functioned in that capacity during my time there)
- Responsible for all regulatory interactions, medical monitoring and execution of Phase 1 NeoTCR-P1 trial (NCT03970382)
- Prepared an S1 with executive team CFO, worked with banks and presented at all TTW meetings (PACT decided to forgo IPO given biotech market during the COVID-19 pandemic)
- In partnership with the biology teams and CMC/Tech Ops, selection of next generation therapeutic and gene editing approaches.
Executive Director, Clinical Research
Kite-Gilead
03.2016 - 03.2020
- Global Development Lead and Medical Monitor for ZUMA-2 study: Treatment of relapsed-refractory mantle cell lymphoma using anti-CD19 CAR T-cell therapy with Brexucabtagene autoleucel (TECARTUS - previously KTE-X19)
- Clinical Lead for BLA, MAA and worldwide applications. FDA approval for Brexucabtagene autoleucel (TECARTUS) was July 24, 2020.
- Responsible for publication of study in NEJM and oral session presentation at ASH 2019 annual meeting
- Responsible for BTD, PRIME, REMS, NTAP applications for KTE-X19
Associate Professor of Medicine
Duke University
06.2003 - 02.2016
- Responsible for patient care, clinical trials and research-related activities in acute myeloid and lymphoid malignancies
- NIH funded (K12, R03) physician scientist
- Mentored residents, fellows and junior faculty
- PI/Co-PI for over 50+ clinical trials
Education
Fellowship- Hematology Oncology And Geriatrics -
Duke University
Durham, North Carolina, NC06-2003
Residency, Internal Medicine -
Duke University
Durham, North Carolina, NC06-2000
Bachelor of Medicine Bachelor of Surgery (MBBS) -
B.J. Medical College, David Sassoon Hospitals
Pune, India12.1996
Higher Secondary Certificate - Biology
Fergusson College
Pune, India07.1990
Skills
- Results driven oncology drug developer motivated by speed to cure
- Decisive, strategic and participative leadership style
- Ability to weather large transformations and build strong teams within companies after acquisitions
- Empathetic leader who cares about team connections
Accomplishments
1. AACR Lung Cancer Task Force: April 2024- Present
2. Faculty, American Society of Hematology (ASH) Scientific Committee on Myeloid Neoplasia (Jan 2015 - Jan 2017)
3. Faculty and Chair, Task Force on Acute Myeloid Leukemia, International Society of Geriatric Oncology (SIOG) (Jan 2015- 2017)
4. Faculty-Abstract Reviewer for American Society of Hematology, Section 613: Acute Myeloid Leukemia: Clinical Studies. (Jun 2015 -Mar 2016)
5. Co-chair and organizer of Friday Scientific Workshop at annual meeting of American Society of Hematology on Hematology and Aging: Highlighting Novel Science and Developing a Research Agenda (Dec 2014)
6. Faculty and Chair, ASCO University and Cancer Education Committee, geriatric oncology track (Jun 2012- Jun 2015)
7. Faculty, National Comprehensive Cancer Network (NCCN) committee for Acute Lymphocytic Leukemia (ALL) guidelines (May 2011 – Mar 2016)
Faculty: Cancer and Aging Research Group (CARG) (Jan 2011- Mar 2016
Certification
American Board of Internal Medicine, Diplomate #201777
Internal Medicine
Medical Oncology
Selected Awards and Honors
2010: CALGB Career Development Award for Excellence in Clinical Research
2009: Highly selective award for junior faculty; IACRLRD Meeting, Ohio State University
2007: Wendell Rosse M.D. Teaching Award. Presented by the Duke University Hematology-Oncology Fellows for Excellence in Teaching
2002: American Society of Clinical Oncology Merit Award
1996: B.J. Medical College, India. Graduated with First Class Honors
1994: B.J. Medical College, India. Distinction in Oto-Rhino-Laryngology. Awarded to student with highest examination results in the field
1990: Fergusson College, Pune, India. Graduated first class with honors in Biology. Awarded to top 1% of premedical graduates statewide
Scientific Publications and Presentations
- 30+ Peer-reviewed publications in NEJM, Nature, Journal of Clinical Oncology etc
- Book chapters, editorial reviews, and over 30+ abstracts presented at congresses
- Full publication list per request or on Google Scholar
- 30+ presentations at congresses, invited lectures and symposia
Timeline
Vice-President, Late-Stage Clinical Development
4404 Diseases Area Head, Pfizer Inc
01.2024 - Current
Vice President, Early-Stage Clinical Development
Seagen Inc
01.2023 - 01.2024
Consultant, Cell Therapy Clinical Development
Synthekine Inc and ImmPACT Bio
02.2022 - 01.2023
Senior Vice-President and Acting CMO
PACT Pharma Inc
04.2020 - 06.2022
Executive Director, Clinical Research
Kite-Gilead
03.2016 - 03.2020
Associate Professor of Medicine
Duke University
06.2003 - 02.2016
Fellowship- Hematology Oncology And Geriatrics -
Duke University
Residency, Internal Medicine -
Duke University
Bachelor of Medicine Bachelor of Surgery (MBBS) -
B.J. Medical College, David Sassoon Hospitals
Higher Secondary Certificate - Biology
Fergusson College