Manasi (Mon-See) Sinha Jaiman, Md, Mph Email & Phone Number

San Diego, California, Us

Boston, Ma, Us

Stayed following Vertex’s acquisition of ViaCyte (Oct. 2022) to lead through the companies’ integration and oversee Vertex’s Clinical Development and Platform program. Led transformations across both culture and the clinical development process, while supporting clinical trials, and building and overseeing a ~40-member team cross-functionally for Vertex’s cell therapy device program (VX-264). Also amended the filing for VX-264 CTA (Canada/multiple EU sites) development and submissions, across both drug and device, for allogeneic stem cells within an implantable device.Established Vertex’s first Surgical Summit, resulting in transformative changes to Vertex’s surgical processes. Additionally, created SERG, the Surgery & Engineering Research Group – the first of its kind at Vertex, engaging surgeons and the research engineering team, driving innovation, significantly improving surgeon satisfaction, and yielding superior outcomes. With a focus on culture and diversity, brought the Women’s Leadership Program, “WE Belong,” from ViaCyte post-acquisition, improving employee growth opportunities and satisfaction improvement.

San Diego, Ca, Us

ViaCyte was acquired by Vertex in 2022. During Viacyte tenure, quickly advanced to CMO & Site Head – building, scaling, and leading a clinical team of 24 internationally, with additional 120 people cross-functionally. As a key leader in the Executive Team, helped develop and execute the corporate strategy, developed budgets and portfolio plans while leading during the company’s major shifts, steering a culture transformation while transforming clinical trial execution protocols. Notably, directed and provided oversight of clinical development of drug candidates across multiple platforms – from IND/CTA submissions, clinical trials and through product approvals. As a field expert in cell therapy and trial execution, led 4 global clinical trials – setting strategy, increasing recruitment for trials, supporting filing (CTA/INDs) globally; and leading multi-agency meetings with FDA & Health Canada. Also led the development of the world’s first FIH protocol using gene-edited cells in a medical device for Type 1 Diabetes and successfully executed 2 clinical trials in Canada with successful CTA filing. Additionally, provided oversight as Chair of Protocol Review Committee and Safety Committee, while also managing clinical aspects of regulatory strategies with the Regulatory Team.As integral member of Leadership, participated in Viacyte’s capital raise (Series D) with CEO and CFO, established ViaCyte’s Surgical Board, and presented at critical business meetings, conferences, including but not limited to board meetings, investigator meetings, and scientific conferences. Invited to speak at the World Medical Innovation Forum held at MassGeneral Hospital with other top experts in cell/gene therapy. With an eye for diversity, created the Women’s Leadership Program, “WE Belong.” Subsequently, led a key role in Vertex’s $320M Viacyte acquisition – working closely with the CEO and CFO, then steering end-to-end integration into Vertex.

San Diego, Ca, Us

Boston, Ma, Us

Princeton, New Jersey, Us

Brought into Covance for expertise in T1 Diabetes and a strong clinical background with a charge to scale the business and head programs. In this role, steered through the acquisition integration into LabCorp, guided the development of the Device group, and established strong relationships across the business, business partners, and key medical communities/KOLs while leading cross-functional team.Notably, brought a major T1 Diabetes oral drug to market (Sotagliflozin by Lexicon Pharmac) – leading from trial design, drug development, clinical trials/regulatory/submissions through approval. Designed and led clinical trial protocols end-to-end, working closely with country-specific agencies and provided medical and scientific consultation for sites/investigators during the trial. My teams worked closely with Quality Assurance and Regulatory teams for internal/client audits and NDA filing. Also developed strong relationships with KOLs within Diabetes, NASH, Rare Disease, and Pediatric Trials. Additionally, initiated pediatric working group to optimize strategic planning in pediatric/rare disease clinical trials, improving overall processes at Covance and supported a Virtual trial build at Covance/Labcorp in partnership with Walgreens to optimize trial efficiency. Notably, developed a mobile health platform that integrates with multiple diabetes devices leveraging Covance’s $1.2B acquisition of Chiltern and brought medical devices to the diabetes medical trials, expanding Covance/LabCorp’s device experience and leading efforts in the CGM space. Recognized and awarded four times with the “Covance Excellence Award” for exemplary work.

Princeton, New Jersey, Us

Boston, Ma, Us

Led various diabetes and obesity-related clinical research activities. Served as Co-Investigator in the development of a closed-loop system for several adult and pediatric trials, evaluating improvements in glycemic control using a bihormonal, dual-chambered “bionic pancreas” programmed to deliver insulin and glucagon in response to real-time glucose sensor monitoring data. Additionally, built the practice and pivotal clinical trial pipeline – developing the first outpatient clinical trial to study a bi-hormonal artificial pancreas in adults and pediatrics, leading to further development in pediatrics and adults.Simultaneously provide comprehensive care to children/adolescents with type 1/type 2 diabetes Mellitus and specialize in the diagnosis and treatment of all other endocrine-related conditions of infants, children and adolescents including growth, thyroid, adrenal, pubertal, pituitary, and bone disorders.

Irvine, Ca, Us

Served as Pediatric Clinical Lead overseeing all clinical trials including protocol writing and review, working with FDA, safety and data monitoring, data and statistical analysis, and manuscript writing. Led Research RN’s, Research Associates, trained fellows. Led clinical trials utilizing the bionic pancreas device including continuous glucose monitoring technology, infusion pumps and infusion sets, and diabetes-related drugs including insulin and glucagon. Conducted research on stable glucagon formulation utilizing hyperinsulinemic-normoglycemic clamp technique and served as team lead on clamp technique.Delivered key research contributions including the development of intradermal delivery of insulin and glucagon using a novel microneedle device; metabolic effects of gastric bypass surgery in young patients, and pharmacokinetic studies on multiple insulin types (lispro, aspart, glulisine, glargine).Please see below for publications, including "Outpatient Glycemic Control with a Bionic Pancreas in Type 1 Diabetes" from the NEJM, which caught national attention when published and was featured on ABC, NBC, CBS, USA Today, The WSJ and TIME Magazine.

Boston, Ma, Us

Lebanon, New Hampshire, Us

Doctor Of Medicine (Md)

Master Of Public Health (Mph), Health Systems Management

Research Fellowship, Diabetes Research Center

Clinical Fellowship, Endocrinology, Massachusetts

Internship And Residency, Pediatrics