Helen Chalk is a Clinical Development leader who has worked in Clinical and Program Management roles across the pharmaceutical, biotechnology and CRO sectors for over 25 years. She has a breadth of global industry experience including oversight of Phase 1-4 clinical trials, medical affairs and global managed access programs in indications including oncology, autoimmune disorders, respiratory disorders, cardiovascular and infectious diseases. Fueled by opportunities to build effective, cohesive teams and processes, Helen enjoys the challenges and daily risk management required to develop drugs and bring them to market.
Beyond work, Helen loves to travel with her family and spend time with her two dogs. Helen relishes any opportunity to ride horses and to volunteer in a therapeutic riding program in Norfolk, MA.
Harry Barnett Harry is the co-founder and Executive Chairman of Lubris BioPharma, a clinical-stage biotech company developing a proprietary version of the novel, ubiquitous human protein, PRG4, for use in multiple indications. Novartis owns rights to Lubris’ technology for ophthalmology. Harry’s two-decade life science career includes: (i) co-founding and executive management roles at three life science companies and two CROs; (ii) incubating, partnering and licensing successfully a wide array of pharmaceutical products and technologies including Pepcid Complete®, the OTC hearburn remedy sold by J&J, and; (iii) innovating multi-center, clinical trial processes using techniques that have been adopted as industry standard. Prior to his transition to life science and biotech, Harry was a transactional business lawyer in private practice at DLA Piper in San Diego, and later at Faneuil Advisors, Inc., an investment advisory firm based in Boston where he served as General Counsel and Executive Vice President.
Harsha K Rajasimha, Ph.D., is a serial entrepreneur, scientist, patient advocate, and philanthropist. Harsha is Founder and CEO of Jeeva Clinical Trials Inc.(https://jeevatrials.com) a AI-driven unified platform for sponsors to execute modern clinical trials with efficiency and universal accessibility. Harsha serves as the founder chairperson of the Indo US Organization for Rare Diseases (https://indousrare.org), where he is forging a new era of cross-border cooperation among various stakeholders of rare diseases in the US, India, and globally by convening the annual Indo US bridging RARE Summit (https://summit.indousrare.org) and the Abbey Meyers Khushi Bridging RARE Awards Gala.
Harsha’s 20 years of experience in precision medicine data research spans academia, federally funded research, healthcare and life science consulting, and multiple startups. Harsha made bold career moves after losing a newborn child to a rare congenital disease in 2012 and his younger brother with juvenile diabetes in 2017. He decided to apply his years of postdoctoral training at NIH and FDA to combat rare diseases. At Jeeva, Harsha leads the development of a unified software platform for efficient clinical trials for rare and common conditions that are universally accessible. He knew that technology is not the limiting factor and that patient-centered design guided by stakeholder needs and regulatory requirements would be critical ingredients of the continuously learning digital platform. By digitizing and automating manual repetitive tasks and reducing the logistical burdens on patients and study teams by over 70%, Jeeva accelerates the process of bringing new medicines or vaccines to diverse patients who need them anywhere by over 3x faster.
Harsha maintains academic affiliation at George Mason University since 2012 and has authored 17+ publications, book chapters, and patents. Harsha’s work has been recognized by Lead India Foundation 2020 Award for leadership and outstanding achievement in rare diseases, a travel award to join the NGO Committee on Rare Diseases at the United Nations headquarters, New York City in Feb 2019, NTT DATA Healthcare Life Sciences Silver award for outstanding achievement 2017, Sanofi Genzyme patient advocacy leadership award 2016, Bioscience company of the year 2014, NEI director’s innovation award 2012 for building their genomics data infrastructure. Harsha earned his M.S. in Computer Science (2004) and Ph.D. in Genetics, Bioinformatics and Computational Biology (2007) from Virginia Tech.
Experienced BioPharma professional with a strong background in Genomics, Technical Support, Training, and Clinical Biomarker Operations.