312 Experts
Jennifer Hayes
Jennifer M. Hayes is a highly accomplished and experienced Medical Affairs professional with over 21 years of experience in the hospital & healthcare, and life science industries. As a recognized leader in the field of infectious diseases, Jennifer has demonstrated exceptional leadership skills, effectively managing teams and achieving company goals. Her extensive expertise in medical affairs has allowed her to successfully manage and oversee a variety of projects and initiatives. With a career spanning multiple companies and roles, Jennifer has…
Deepthi Pabbisetty
Statistical Programming
ASAP Process, Inc.
Ophirex Statistical Programmer- DP
ASAP Process, Inc.
Ophirex Statistical Programmer- UP
ASAP Process, Inc.
Ophirex Biostatistician
Fenton Fong
.CMC, MANUFACTURING & PROCESS DEVELOPMENT:
Experienced with small molecule synthesis and biologics API manufacturing (recombinant proteins, MaB’s, secondary metabolites); Comprehensive experience and GMP knowledge in technologies for sterile, parenteral, liquid, and solid dosage forms manufacturing, fermentation, downstream processing, aseptic processing, sterility assurance; Experienced with conceptual design process, construction, commissioning & qualification of production facilities and qualification of pharmaceutical equipment and cleanroom facilities; Production process scale-up development, cost and yield analysis/improvement of production processes; Identification and testing of product quality attributes,…
Alexander Schacht
My personal vision is to ensure that payers, physicians, and patients have the right evidence
at the right time in the right format to make the right decisions for the benefit of patients. My
professional activities all support this long-term vision.
As a statistician with 20+ years experience in healthcare (academia, pharmaceutical
companies and service…
Manjula Kasoji
15 years experience in strategy and management consulting and leadershipExperience in data science and AI strategy, transformation and roadmap developmentExperience in providing strategic direction and leading technology delivery programsExperience leading funding proposal efforts with a portfolio estimate of up to $150 millionExperience in strategy and planning, governance, developing and maintaining relationships with team, stakeholders and clientsExperience managing teams (data science, program managers, software engineers)Experience hiring and leading teams, including remote, distributed teams and vendors
Iterum
hands on regulatory strategist
ASAP Process, Inc.
Business Development
ASAP Process, Inc.
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GBall
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· Thirty-six years of strong leadership, managing people and projects; 22 years as a Biostatistician, familiar with all phases of development, submissions, and interactions with regulatory authorities (therapeutic areas: vaccines, CV, diabetes, oncology, and others)
Past 5 Years:
· Created a Safety Statistics group embedded in the Global Vaccine Safety organization
· Co-leading the PhUSE Safety Analytics working group (with…
KJ Wilson
A lifetime of regulatory experience at every level, KJ Wilson has deep understanding of the pharmaceutical industry, regulatory affairs and FDA.
Min Young, PhD, RAC
A strategic thinker with extensive hands-on experience (15+ years) developing new medicines for rare diseases or areas with high unmet medical needs. Highly regarded as a dedicated, passionate and innovative Regulatory Affairs Leader throughout career. Contributed to successes of a number of development organizations.
Led and/or contributed to global licensing of 9+ products and development of 21+ products o Solid US, EU and global RA (GRA) working experience managing full-spectrum product development, marketing applications (NDAs/BLAs/MAAs: NMEs, 505(b)(2), hybrid), approvals…
Meredith Brown-Tuttle
Strategy, Intelligence and Product Development: • Member of core/executive drug development teams and/or Program Team Lead • Created and managed multiple global strategies for drugs, biologics, biosimulars and combination products • Conducted regulatory research and intelligence on a global basis for various therapeutic indications/areas • Performed gap analyses to identify potential challenges to successful IND, NDA, MAA, BLA and NDI/DS filings
Scientific Advice Meetings:
• Wrote, managed and compiled associated packages for FDA/EU/EMA/Health Canada scientific advice meetings • Conducted in-person…
lisa barbadora
1200 word content write up of 2023 Decentralized Clinical Trials predictions. Primary input- interview of thought leader, plus individual DCT trends research. To be published in pharmaceutical trade journal.
Mark Mariani, M.S.
Bernt van den Blink, MD PhD
Clinical research professional with 20+yrs academic and biotech/pharmaceutical industry experience. M.D. Ph.D. pulmonologist with expertise in (rare) respiratory, auto-immune, inflammatory and fibrotic diseases. Physician-scientist bridging basic and clinical science, thrilled to guide new discoveries through clinical development.
Gergely Balint
Highly accomplished leader of pharmaceutical industry with wide range of experience in project and organizational leadership. 20+ years of international drug development expertise coupled with strategic, operational and management experience.
◄ Core competencies include ► ★ In-depth Biopharmaceutical Industry Experience ★ Extensive Drug Development/Life Cycle Management ★ Product Development Plan Creation & Prioritization ★ Hands on Project & Program Leadership ★ US, EU, & International Experience ★ Strategic Alliance Experience
◄ Key Accomplishments ► ★ Developed asset for Phase…
Ndukwe
I love everything about Clinical Research. Most of all, I am passionate about getting Clinical Research Sites that are struggling or research naive back on track and audit ready. I went from doing lab work at the bench to researching the effects of the drugs made at the bench in people. If you are looking for a passionate, enthusiastic and high-performing Clinical Operations Consultant and Clinical Research Associate, look no further. I specialize in Site Management and Monitoring, Study Start-up,…
