Navigating your biopharma drug candidate through early and mid-stage clinical trials

Decisions made throughout early and mid-stage clinical trials impact late-stage results and sometimes, entire programs and companies. Since some obstacles can prove overwhelming for startups, there is a lot to learn from those who successfully walked the path.

In this Endpoints News webinar, we assembled a panel of experts to weigh in on:
  • Gathering the right team to translate benchtop discoveries into clinical trials
  • Choosing the right study design to position phase 1 safety data for phase 2 efficacy trials
  • Planning clinical operations to manage diverse internal and external stakeholders
  • CMC strategies to help drug products reach patients faster
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Meredith Perry

Meredith Perry

Director, Pharmaceutics, Catalent

Meredith Perry is Director of Pharmaceutics at Catalent San Diego. Since 2012 Ms. Perry has developed a wide range of preclinical and early phase clinical formulations, joining Catalent in 2017. She focuses on helping clients to navigate the product development strategies unique to the early development of new therapies. Ms. Perry holds bachelor’s in both Chemistry and Economics from the University of California, San Diego.

Scott Braunstein

Scott Braunstein

Chief Executive Officer, Marinus Pharmaceuticals

Scott Braunstein, M.D. was appointed Chief Executive Officer of Marinus in August 2019, executive chairman in February 2019 and has served on our board since September 2018. Dr. Braunstein brings over 20 years of knowledge and experience from diverse biotechnology and pharmaceutical industry vantage points. Dr. Braunstein is currently an operating partner at Aisling Capital. He most recently served as chief strategy officer and chief operating officer at Pacira Biosciences, Inc. Prior to Pacira, Dr. Braunstein served as a healthcare portfolio manager at Everpoint Asset Management and spent 13 years with J.P. Morgan Asset Management as a healthcare analyst and managing director in the U.S. Equity team, and as portfolio manager of the JP Morgan Global Healthcare Fund responsible for managing investments in pharmaceuticals, biotechnology and medical devices.

Dr. Braunstein is currently on the board at Trevena, Inc. and Caribou Biosciences, Inc. He previously served on the boards of Constellation Pharmaceuticals (acquired by MorphoSys AG in July 2021), Ziopharm Oncology, Inc., Esperion Therapeutics, Inc. and Protara Therapeutics, Inc. Dr. Braunstein began his career as a practicing physician at the Summit Medical Group and as assistant clinical professor at Albert Einstein College of Medicine and Columbia University Medical Center. He earned his medical degree from the Albert Einstein College of Medicine and his B.S. from Cornell University.

James Christensen

James Christensen

Chief Scientific Officer, Mirati

Jamie joined Mirati in 2013 as Chief Scientific Officer. In his role, Jamie is responsible for drug discovery, translational research, drug manufacturing and companion diagnostics research. At Mirati, Jamie has led activities related to the discovery and advancement of the company’s clinical and preclinical programs, including adagrasib (KRAS G12C selective inhibitor), MRTX1133 (KRAS G12D selective inhibitor) and sitravatinib (spectrum-selective receptor tyrosine kinase (RTK) inhibitor).

Prior to Mirati, Jamie was the head of Oncology Precision Medicine and a member of the executive leadership team in the Oncology Research Unit at Pfizer. He joined Pfizer in 2003, and his responsibilities included leading oncology nonclinical research and translational sciences for programs including Sutent* and Xalkori.*

Prior to Pfizer, Jamie held positions at SUGEN/Pharmacia as a Group Leader on the Preclinical Research and Exploratory Development team. He began his industry experience at Warner Lambert/Parke-Davis.

Jamie has authored or co-authored over 140 peer-reviewed research articles in scientific journals including Science, Nature, Cancer Cell, Cancer Discovery, New England Journal of Medicine and many others. In addition, he also participates on the editorial boards for Cancer Research and Molecular Cancer Therapeutics and is a member of the Scientific Advisory panel at Bridge Bio/QED.

Jamie received his Ph.D. at North Carolina State University and his B.S. in biology from Northern Illinois University.

* Trademarks are property of their respective owners.

Arsalan Arif

Arsalan Arif

Founder & Publisher, Endpoints News

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.