Dr. Mishra (Ex-Genentech, Ex-NCI, Ex-NIH) is the Founder and CEO of Agility Pharmaceuticals. He is a serial entrepreneur who founded his first company after graduating high school, and second company during his PhD. Since then, he has accumulated a wealth of experienced by building, investing and advising numerous other companies. He is an investor/ co-founder/ board member of a few US based corporations focused on accelerating drug discovery & development, blockchain & digital health. Dr. Mishra is also founding president & CEO of American Association for Precision Medicine (AAPM) and is leading research efforts focused on preventing & curing chronic diseases; not only treating the sick but also providing knowledge/tools to individuals to live longer, healthier lives.
Widely recognized as a thought leader in the field of Technology and Healthcare, Dr. Mishra has keynoted, chaired, curated and organized numerous successful international conferences. Prior to Agility Pharma, Dr. Mishra served as a scientist and Principal Investigator at Genentech, Roche. Moreover, his passion for drug development and precision medicine has led to identification of new drug targets, biomarkers, companion diagnostics and several drugs/ combinations in the clinic.
His research work has been recognized globally by over 40 prestigious awards and honors. Due to his unique perspective & selfless service, he is highly respected & sought-after mentor to many. The companies that he has advised have raised multimillion dollars. Notably, he serves as a mentor and advisor to startup accelerators such as IndieBio, Health2.0’s Project Zygote and CLSI FAST program, to help grow California’s life sciences innovation ecosystem.
Near 20 years profound global leadership in Oncology Clinical Research, Regulatory Filing, Product Launch, and Business Development at the prestigious pharmaceutical companies such as Merck, Novartis, Pfizer, innovative biotech Exelixis, well-established Asian pharmaceutical company Sihuan, and cell therapy start-up CARsgen. Holding in-depth knowledge and practical leadership skills to strategically manage cross functions and efficiently deliver the results and bet the company objectives in widespread areas, including but not limited to, Pharmaceutical Quality/CMC, Nonclinical Pharmacology and Toxicology, Global Clinical Development (early to late phase, innovative & generic), Global Regulatory Submission (NDA/BLA/aNDA), Global Commercial and Product Launch, Global Business Development (Licensing In/Out, Mergers and Acquisitions), and Asset Life Cycle Management.
Leading and being major contributor for multiple oncology global regulatory submissions, including one BLA, one NDA, two MAAs, and three INDs. Proactively planned and attended numerous TC/F2F meetings (i.e. post-IND, End of Phase 2, pre-BLA, pre-MAA, post-BLA orientation, etc) with FDA, EMA, and managed numerous response and interactions to address the inquiries from ROW regulatory agencies (i.e. SWISS MEDIC, Health Canada, Australia TGA, Japan PMDA/MHLW, China FDA, etc)
Clinical Operations Leader with extensive industry and clinical trial management experience with ability to manage high-performance teams and develop cost effective solutions.
Experience covers a multitude of aspects of clinical programs in Phase I, II, III, IIIB, and IV, globally.
Ethical and sequential problem solver with multi-therapeutic acumen in clinical study management;
and a proven track record of establishing, strengthening, and improving the processes and infrastructures through interfacing with various arms of organizations including Regulatory Affairs, CMC, Project Management Teams, and other KOLs and clinical team members.
Experienced Supply Chain professional and Certified Lean Greenbelt Champion with a demonstrated history of working in the pharmaceutical/biotechnology industry. Skilled in Supply Chain Strategy, Operations Management, Cross-Functional Leadership, and Continuous Improvement.
A result-oriented technical leader with extensive drug product (solid oral, oral liquid, parenteral) development experience ranging from Discovery Support through clinical development.
- Direct experience in managing multiple CDMOs to plan, coordinate, and execute external drug product development and manufacturing activities.
- Proven record of excellence at project management, workflow development, innovative technology implementation, and timeline/budget management.
- Technical expertise: pre-formulation, formulation and process development, biopharmaceutics, and PBPK modeling.
- Broad knowledge in drug development and direct experience in managing CMC team functions within multi-disciplinary (Discovery, CMC, Drug Safety, DMPK, Clinical Operations) development team.
- Highly collaborative, change-agile, and strong problem-solving ability in a fast-paced matrix environment.
23+ years of analytical, formulation and process development from early clinical to commercial products. More than 12+ years in cross-funtional team project, tech transfer, scale-up manufacture and CRO/CMO management.
Specialties:
Tech transfer, optimal lyophilization, GLP/GMP investigation, problem-solving skills.
Formulation concepts and development strategies for oral, parenteral, ophthalmic, topical and inhalation products, including nano-emulsion and nanotechnology.
Preformulation, shelf life prediction, specifications, protein stability and CMC.
Take initiatives. Strive for quality, teamwork, and honest communication.
Vince Calderon is a Project Director at PSI CRO and is an experienced research professional working in the CRO setting for over 15 years. The majority of those years has been working in Oncology and Hematology studies in a variety of solid and non-solid malignancies. Vince Calderon has earned a Master of Business Administration from St. Edward’s University, a Master of Science in Health Research from Texas State University, and a Project Management Professional certification from the Project Management Institute.
Peter Shapiro, PhD, is the Senior Director of Drugs and Business Fundamentals for the Pharma Intelligence Center. He also serves as the Editor-in-Chief of GlobalData PharmSource. Peter previously was involved in the leading the integration of BioPharm Insight, Lead Sheet and PharmSource into GlobalData.
Prior to joining GlobalData, Peter was an Assistant Manager at Target Health, a Contract Research Organization (CRO) where he helped a diverse set of clients with the demands of bringing biologics, devices, and drugs to the market successfully. Peter also worked in small molecule drug development for Abbott Labs and on in vitro diagnostics at Ambergen, a diagnostic startup. Peter holds a PhD in Molecular and Cellular Biology from the Sackler Institute of New York University Langone Medical Center and is located in GlobalData’s office in New York City.
Ben is the CEO of LedgerDomain, founded in 2016 to bring blockchain solutions to enterprise ecosystems, unlocking a world of communal computing and real-time performance. After doing undergraduate and graduate work at MIT, Ben spent a quarter of a century incubating and investing in early-stage technology companies. In partnership with the Clinical Supply Blockchain Working Group (CSBWG), the world’s largest pharmaceutical blockchain consortium, LedgerDomain developed the world’s first iOS blockchain app for the clinical supply chain. In 2019, LedgerDomain also partnered with UCLA on a pilot for the US Food & Drug Administration (FDA) on a last-mile application that helps deliver lifesaving medications to babies.
