Melody began her clinical career over 35 years ago at Abbott HPD in Illinois; she moved to California to work for Syntex (now Roche). She has worked for several small biotech companies with experience in medical devices, pharmaceuticals, biologicals, drug/device combinations, and drug delivery systems. In 2001 she relocated to AUSTRALIA to establish a subsidiary of Clinimetrics; she subsequently worked for St. Jude Medical–Australia. Upon returning to San Diego in mid-2009 she was a clinical consultant for a few years before returning to industry in 2015. She is currently employed by Avelas Biosciences, a COI Pharmaceuticals company.
Archives: Speakers
Kenneth Kleinhenz
Kenneth Kleinhenzhas held numerous executive-level quality assurance and regulatory affairs position at public and private biotechnology companies to include 15 years of service as the Vice President and Chief Operating Officer at Cytori Therapeutics, a device-based, adipose-focused stem cell company. Previously, Mr. Kleinhenz was the Vice President of Quality and Regulatory at Avelas Biosciences, Director of Regulatory Affairs at MacroPoreBiosurgery, Chief Microbiologist for Becton Dickinson, and theManager of Quality Assurance and Regulatory Affairs at Pacific Pharmaceuticals. Mr. Kleinhenz is a veteran of the United States Navy where he served as a Clinical Microbiologist for 6 years at the NavalHospital, San Diego. Mr. Kleinhenzreceived his BS in Microbiology at the University of California, San Diego (UCSD) and his MBA in Technology Management at the University of Phoenix.
Reginald Hooks
Reggie Hooks has been active in clinical research since 2004. Being a native Oklahoman, he graduated with an MPH in Epidemiology from the University of Oklahoma Health Sciences Center and an MS in Forensic Science from the University of Central Oklahoma. In addition to his education, his perspectives on clinical research are further derived from his prior work experiences in the laboratory, at research sites, with a CRO, and with non-profit and for-profit sponsors. Reggie has managed the conduct of clinical trials across multiple therapeutic areas in over 15 countries and specializes in expedited site activation, and the development and implementation of creative study rescue activities. Reggie enjoys teaching at professional conferences and volunteering his time as a career development mentor for junior research professionals
Ken Wilson
Ken has been in the industry for over 30 years, with just over 20 in the CRO world, at Quintiles, Statprobe, and Clinimetrics/Omnicare. Ken joined Pfizer in 2010 in an outsourcing role, and has been leading outsourcing efforts for multiple development programs. Experience prior to Pfizer includes hands-on and line management roles in Statistical Programming, Biostatistics, Data Management, and Project Management, as well as overall responsibility for a local CRO office in San Diego that employed more than 70 local employees.
Christopher Lemasters
Chris LeMasters is the EVP & Chief Operating Officer of Amplyx Pharmaceuticals, now a wholly owned subsidiary of Pfizer, Inc. Amplyx has focused on the development of novel first-in-class therapies for infectious disease affecting immune compromised patients. He led the strategic efforts that resulted in Amplyx’s acquisition by Pfizer in April 2021.
Mr. LeMasters was previously Executive Vice President and Chief Business Officer of Mirati Therapeutics, a clinical-stage oncology company, where he was responsible for corporate development, strategy and investor relations. During his three years in this role, he oversaw the successful expansion of the company and its market capitalization from $100 million in 2016 to nearly $5 billion in December 2019.
Andy Spinks
Andy Spinks is a Pfizer Digital IT Director based in La Jolla on the US West Coast. He has extensive IT experience spanning his 20 years with the company. His current role is Global Business Technology Lead for the Pfizer Next Generation Clinical Trials (NGCT) program. This 3 year program (which is now coming to a close) has dramatically enhanced the way Pfizer conducts Clinical Trials, simplifying what had become a complicated and unsustainable business model spanning many processes, partners and systems by bringing control back in house. The new model works with single processes and systems across the global clinical trial landscape Pfizer operates in and has been designed to smooth a quicker path to future growth and change.
Previously Andy led La Jolla Informatics teams spanning Research, Development and Enterprise parts of the organization. He began his Pfizer career in Sandwich (UK) in May 1999 as an IT Project Manager.
Mary Jarosz
Mary Jarosz joined Daré Bioscience in 2018 and serves as the company’s Global Head of Regulatory Affairs. Prior to Daré, Ms. Jarosz was an independent Regulatory Affairs Consultant working with life sciences companies on regulatory strategies supporting prescription drugs, medical devices and combination products for US and Global markets. From 2014-2016, She was the Senior Vice President of Regulatory Affairs and Quality Assurance for Evofem, Inc. During her tenure, she led the regulatory team to a successful NDA filing under a 505 (b)(2) pathway and facilitated numerous interactions with the FDA, EMA and other regulatory bodies. From 2011 to 2014, Ms. Jarosz served as Vice President of Regulatory Affairs and Quality Assurance for WomanCare Global and was the Director of Regulatory Affairs for WomanCare Global from 2010 to 2011. During her tenure at WomanCare Global, Ms. Jarosz had the opportunity to work with several NGOs including PSI, FHI 360, DKT and other global non-profit organizations including the World Health Organization (WHO), United States Agency for International Development (USAID) and The Population Council.
From 1996 to 2010, Ms. Jarosz served as the President and Principle Consultant for Jarosz Regulatory Services specializing in regulatory planning, strategy and implementation for large and specialty pharmaceutical companies worldwide. Ms. Jarosz spent the early part of her career working in international regulatory affairs for Abbott Laboratories.
Ms. Jarosz has published in several journals, including Regulatory Affairs Focus and ESRA Rapporteur, has presented at regulatory conferences and served as a guest lecturer for several universities. She was Head of Publications and Publicity for The Organization for Professionals in Regulatory Affairs (TOPRA), North America Leadership Team. Prior to her experience in the pharmaceutical industry, Ms. Jarosz was a Clinical Pharmacist at Michael Reese Hospital in Chicago, Illinois and a Pediatric Intensive Care Clinical Pharmacist at the University of Wisconsin Hospital. Ms. Jarosz holds a Baccalaureate of Science in Pharmacy, is an appointed Fellow of TOPRA (FTOPRA), is RAC certified, and is a Registered Pharmacist in the states of Illinois and Wisconsin.
Robbie Alton
Kara Bortone
Kara is responsible for setting the strategic direction and overseeing all pipeline activities for sourcing, selection, screening, onboarding, optimizing and tracking the portfolio across JLABS globally. Kara joined the JLABS team in 2012, shortly after the flagship JLABS site opened at Janssen R&D in San Diego. In her previous role, Kara executed on external engagement, sourcing innovation, portfolio management, operational excellence, educational programming, and P&L for the JLABS in San Diego site. Kara also serves as an Instructor for the I-Corps at NIH program, a program aimed at commercializing biomedical technologies, where she serves as Domain Expert in Therapeutics for NIH SBIR recipient companies. Kara came to JLABS from Galapagos NV in Belgium, where she had various roles of increasing responsibility, including business development, marketing, investor relations and medical communications at a time when the company grew from 60 to more than 800 employees and completed its initial public offering on Euronext. Kara holds a BS in Chemistry from the University of North Carolina at Chapel Hill and a PhD in Biochemistry from the University of Texas at Austin.