Archives: Speakers

Leena is a board-certified thoracic oncologist and physician-scientist in immuno-oncology with an academic and industry background in translational research and early and late clinical development. She have developed multiple investigator-initiated trials with associated correlative studies to help define biomarkers of response with a focus on immunotherapeutics in lung cancer. Leena has led phase I-III pivotal trials in lung cancer defining the role of PDL1 in the use of immunotherapy and immunotherapy combinations in NSCLC. Leena has led academic clinical and clinical research programs in immuno-oncology development and oversaw translational and clinical aspects of development of a portfolio that spanned early pre-clinical to late-phase compounds . Leena has also developed the Center for Therapeutic Innovation at DFCI– an integrated clinical/translational research center focused on early drug development.

Shawn Keogan, Ph.D., is the Director of Patient Advocacy and Professional Relations at Genmab, where she leads efforts to build strategic partnerships with advocacy organizations, professional societies, and patients. She is responsible for advancing patient engagement initiatives to gather patient perspectives and ensure they are integrated into development and commercialization strategies. Shawn holds a Ph.D. in Microbiology and Immunology from Drexel University College of Medicine.

Dr. Anna Pinsky, MD, PhD, has more than 12 years of experience in clinical research, specializing in CNS and psychiatric indications for the past 9 years. With extensive expertise in both clinical trial management and medical monitoring, she has consistently demonstrated her ability to ensure patient safety and maintain data integrity throughout the course of clinical trials.

In her role as a medical director at Rho, Dr. Pinsky serves as a medical adviser, providing strategic guidance on protocol development and risk management. She is familiar with common clinical scales and assessments, as well as various methods of their administration, including paper-based formats and digital tablets with audio and video recording. Dr. Pinsky collaborates closely with clinical teams, investigators, and sponsors to address potential challenges related to patient enrollment and retention, adherence to study protocols, and the accurate assessment of safety and efficacy endpoints. She is instrumental in developing and implementing mitigation strategies to ensure both subject safety and the generation of high-quality, reliable data that supports regulatory approvals.

Dr. Pinsky earned both her MD and PhD in Endocrinology from the Institute of Internal and Preventive Medicine in Russia.

Krishna, a technocrat from Jawaharlal Nehru University and IIM Calcutta, is the MD and CEO of AFRINEX, an international stock exchange in Mauritius established as an initiative of Government of Mauritius and supported by Government of India with BSE Technologies Pvt. Ltd. as technology and skill partner. Launched on 25th October, 2021, AFRINEX is the largest stock exchange in Mauritius by market capitalisation of listed securities.

Krishna has close to two and half decades of experience that spans across capital markets, NBFCs, telecom, insurance, etc. Prior to AFRINEX, she had setup India International Exchange (India INX) and India International Clearing Corporation (India ICC) at GIFT IFSC, India.

Throughout her career, Krishna is known for conceptualising new product development along with technology and operational implementation, thought leadership, market microstructure design, market development attracting participants with long term strategy, corporate governance, finance and regulatory policies. Throughout her career she has delivered results in new and unchartered areas handling micro and macro challenges to deliver on objectives.

Al is the Vice President of Quality Assurance and Regulatory Affairs at CVRx.  He developed and implemented the quality system and was a key participant in all clinical and commercial regulatory submission work at CVRx for more than 19 years leading to European, FDA and Australian approvals for the quality system and devices.  In addition, Al has participated in the MDIC and AdvaMed Case for Quality efforts for many years.  Through this, CVRx has volunteered to pioneer new Case for Quality programs developed in conjunction with FDA to improve the quality of medical devices in general and the CVRx product line specifically, including pilots of FDA Critical to Quality assessments, maturity model assessments for the FDA Voluntary Improvement Program (VIP) and the Medical Device Information and Analysis Sharing (MDIAS) program as a co-chair of the Governing Committee.  Prior to CVRx, Al worked for Medtronic for more than 16 years in various divisions and management roles primarily in the areas of quality and reliability.  Al has a Bachelor of Science degree in Electrical Engineering from Iowa State University and a Master of Business Administration degree from the University of Colorado.

Mac McKeen has 35 years of experience in the medical device industry in regulatory and quality roles focused on the Total Product Life Cycle related to the product development, quality compliance, clinical study, and the regulatory submission and approval of cardiovascular devices.  Recently retired Mac served as a Fellow at Boston Scientific with previous leadership roles at Guidant, Medtronic, St. Jude Medical, Cardiac Science and Phillips Medisize. In these roles Mac has prepared and submitted well over 500 submissions to FDA and global regulatory agencies.  For the last 16 years Mac has served as an Adjunct Professor at the University of Minnesota instructing undergraduate and graduate level courses in the Technology Leadership Institute on medical device development.  Throughout his career Mac has been and continues to be actively engaged in a wide range of industry and patient advocacy initiatives working directly with FDA, AdvaMed, RAPS, Medical Alley, MDIC, and the Smithsonian Institute.  Mac holds a BS in Industrial Technology from Iowa State University and an MBA from the University of Dallas and is RAC certified and has been recognized as a Fellow by the Regulatory Affairs Professional Society (F.R.A.P.S) and is currently serving on the RAPS RAC Board.

Jason Neff has over 14 years of experience in the medical device and biotechnology spaces, and has worked with AtriCure, Johnson and Johnson, Boston Scientific, and the Broad Institute of MIT. He has authored numerous clinical evaluations for EUMDR and class III cardiac devices. Jason graduated from the University of Minnesota and lives in the Twin Cities area with his family.