Carlos Sattler Email & Phone Number

San Diego, Ca, Us

Provide strategic and technical clinical development and medical affairs insight

New York, New York, Us

Supported the transition of the fosmanogepix clinical activities from Amplyx Pharmaceuticals, Inc. to Pfizer, Inc.: Led the design of the Phase 3 study in invasive mold infections, including study outline authorship and the initial draft of the study protocol; continued the support of the clinical program, including oversight of ongoing Phase 1 and 2 studies, oversight of the Expanded Access/Compassionate Use Program, and participation in external meetings: participated in the development of medical/clinical content for regulatory submissions, and support of interactions with regulatory agencies, including the End of Phase 2 Meeting with the FDA, and the request for advice with the EMA. Successfully transitioned tasks and responsibilities to Pfizer, Inc.

San Diego, Ca, Us

Oversaw the Clinical Development Program for fosmanogepix, a novel systemic antifungal, including development and execution of the clinical strategy, medical oversight of Phase 1 and 2 studies, and Phase 3 planning; led the Expanded Access/Compassionate Use Program; developed the medical/clinical content for regulatory submissions, and support of interactions with regulatory agencies; prepared and presented progress reports to the Board of Directors of Amplyx; participated in external engagement activities, including independent DRC/DSMB presentations/interactions, KOL/investigator outreach, and business development support; overall support contributed to the acquisition of Amplyx Pharmaceuticals, Inc. by Pfizer, Inc.

San Diego, California, Us

Provided leadership and direction to the Global Medical and Scientific Affairs function; oversaw the development of a comprehensive Medical Affairs pre-launch plan for PEGPH20 (pegvorhyaluronidase alfa) in metastatic pancreatic cancer; served as Medical Affairs representative within cross-functional company committees and teams. Pivotal Phase III study results were negative, resulting in discontinuation of the program.

Basel, Basel-Stadt, Ch

Determined the vision and provided direction and clinical, medical and scientific leadership to Clinical Development and Medical Affairs (CDMA) for Sandoz Inc. - Member of the Sandoz US Leadership Team, leading the development of clinical and medical strategies and initiatives in support of the development and commercialization of Sandoz’s portfolio, including biosimilars and differentiated products in the US. - Built the Sandoz US CMDA organization, growing from 3 to ~50 associates in multiple functions, including clinical and medical operations, medical strategy, field medical, medical account management, strategic alliance management, medical information and communications, grants and IIT programs, and HEOR and RWE data generation. - Shaped the environment and supported Sandoz scientific and policy leadership in biosimilars through multiple external activities and engagements. - Led the launch of 4 products across different therapeutic areas (TAs) and business models: o The first biosimilar in the US o The first complex generic in neurology in the US o The first digital therapeutic in the US (for substance use disorders) o New chemical entity in dermatology

Basel, Basel-Stadt, Ch

Rahway, New Jersey, Us

Led the development and implementation of the global medical affairs strategy in support of Merck’s HPV vaccine (Gardasil®) and next-generation HPV vaccine - Served as the point of contact and Merck Vaccines representative for the HPV vaccines Working Group of the Advisory Committee for Immunization Practices (ACIP)-Centers for Disease Control and Prevention- Maintained leadership in the HPV vaccines field by overseeing medical and scientific input into scientific/thought leader strategy, implementing effective counter-competitive measures, engaging and developing global key scientific and medical leaders, and maintaining productive professional working relationships with key scientific and medical societies- Oversaw the internal and external strategy for clinical data dissemination, through presentations at scientific congresses and company-sponsored symposia, and publications

Rahway, New Jersey, Us

Led the Merck Oncology Collaborative Trials Network (OCTN) and Merck Oncology Collaborative Studies Program (OCSP), and co-chaired a team responsible for the development and implementation of a standardized oncology pipeline and portfolio management process.- Oversaw the Merck OCTN, which included leading international cancer research institutions and key opinion leaders- Oversaw the assignment of Merck-sponsored core studies to OCTN sites- Oversaw the development of OCSP Areas of Interest (AoI)/Request for Proposals- Co-Chaired a multifunctional oncology team tasked with the development of a process aimed to prioritize and select the optimum oncology portfolio, and optimize franchise decision-making

Rahway, New Jersey, Us

Provided medical and scientific leadership and input to an extended multifunctional team in support of Merck’s HPV vaccine (Gardasil), including scientific message platform development, subject matter expertise, management of company-sponsored scientific symposia and speakers trainings, implementation of expert input forums and advisory boards, Medical Affairs representation in the publications committee and investigator-initiated studies review committee

Rahway, New Jersey, Us

Provided medical and scientific support to address strategic portfolio objectives and maintain leadership in the Latin America and Caribbean region. Responsible for childhood, adolescent, and adult vaccines.- Supported product launch activities across the region- Developed and supported initiatives and engagement activities to address access and equity of access to vaccines with governments, academic leaders, and public health officials in countries within the region- Communicated to headquarters the local needs and issues of vaccine implementation within the region and recommended solutions to address these- Led regional and country speaker training sessions, company-sponsored symposia and advisory boards

Rahway, New Jersey, Us

Functioned as study lead and medical monitor for HPV vaccine trials; provided clinical support to post-filing regulatory activities; served as Product Development Team Leader for next-generation HPV vaccines.- Responsible for protocol development, oversight of clinical trials, and authorship of clinical study reports within the HPV vaccine clinical program (including four large phase III randomized, placebo-controlled, multicenter, international studies and one international HPV epidemiology study)- Served as pharmaceutical sponsor representative for a phase I/II HPV vaccine study in HIV-infected children, in collaboration with the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) and the Division of AIDS, NIAID, NIH- Provided clinical support to the regulatory affairs group for post-filing regulatory activities involving the US FDA, the EMEA/CHMP, SwissMedic, and others, including face-to-face meetings with regulators and authorship of responses to regulatory agency queries- Oversaw a multifunctional team responsible for the life cycle management of next-generation HPV vaccines, from technical development, pre-clinical and clinical development phases, to the post-approval space

Rahway, New Jersey, Us

Functioned as study lead and medical monitor for HPV vaccine trials- Responsible for protocol development, oversight of clinical trials, and authorship of clinical study reports within the HPV vaccine clinical program

In-house pediatrician in a sub-acute/chronic care pediatric hospital

Pediatric Infectious Diseases

Chief Resident-Pediatrics

Pediatric Residency

Doctor Of Medicine (M.D.), Medicine

Education record