Siddhartha Shrivastava, PhD

Vice President, Head of CMC and Global Technical Operations

Sidd is proven leader and well published scientific technical operations executive with track record of bringing and maintaing lifecyle of lifesaving drugs globally. Some of the biologic drugs that Sidd managed include-Remicade®, Stelara®, ATryn®, Cerezyme®, Fabrazyme®, Thyrogen®, rhASM® , Praluent®, Dupilumab® ; like wise few of the small molecule drugs managed by him include- Allegra®, Proctosedyl®, Flomax®, Elegard®, Primaquine®, Duexis®, Cholestagel®, Nicoderm®, Zinquesta®, Glyburide® etc.

He is member of executive leadership responsible and partnering in creating and implementing business plans and strategies, achieving company’s financial goals and network wide objectives along with increasing network operating performance. Have maintained multi billion $$ franchise portfolio for top global pharmaceutical producers like Sanofi and on the other hand have also helped establish new biotech and CMO-CDMOs.

Experienced in leading research, early to late-stage process development, commercial launch, cGMP commercial manufacturing (DS/DP) and reprocessing of bio-therapeutic drugs. Seasoned in developing, leading, transforming and sustaining multisite high-performance matrix organizations and teams. Accomplished leader in process development and manufacturability assessment; CMC program management; CMO management for Phase I/II/III clinical trial material and commercial manufacturing; Assets and partnering due diligence, Establishing new PD, analytical and commercial manufacturing facilities; IND/IMPD, BLA/MAA regulatory filings and product life-cycle management; Consent Decree Remediation and GxP Quality Operations.

Recently, Sidd was acting as Head of North America Technical Operations for Sanofi. Prior to that he worked with Patheon Biologics and helped established their US biologics CDMO bussiness. Currently Sidd is working with talented team of Cue Biopharma as their Head of Global Operations and CMC, where they are developing first in class injectable novel fusion proteins to selectively engage and modulate tumor-specific T cells directly within the patient’s body to transform the treatment of cancer. The company’s proprietary Immuno-STAT™ (Selective Targeting and Alteration of T cells) platform, is designed to harness the body’s intrinsic immune system without the need for ex vivo manipulation. Cue biologics are designed to deliver the natural immune system signals in the context of cancers – the result is targeted therapies for tailored immune activation that engage only the relevant cancer-specific immune cells, while avoiding the indiscriminate immune activation that often leads to severe side effects.
Currently Cue has two molecules in clinic with many others in late stages of getting ready to enter (IND) followed by multiple more in various stages of development.
Cue's lead IL-2-based therapeutic, CUE-101 Immuno-STAT for the treatment of head and neck cancer has shown strong positive response and getting ready for entering into pivitol trials with Fast Track Designation from FDA. Cue's second candidate CUE-102 Immuno-STAT is in clinical study for the potential treatment of people with recurrent/metastatic solid tumors (Basket trials) who have failed conventional therapies.