Shampa Das is a Senior Lecturer in the antimicrobial pharmacodynamics and therapeutics group. She is an experienced Clinical Pharmacology Scientist with 17 years' experience in the pharmaceutical industry and has extensive expertise in using PK/PD for developing clinical pharmacology and dose strategies. Shampa Das graduated with a BSc in Biochemistry and Physiology at the University of Sheffield in 1995 and then a PhD at the University of Sheffield in 1999. Following a 1 year post-doc at St Mary's Hospital, University of Manchester, Shampa Das joined AstraZeneca where she worked in various roles in biopharmaceutics, DMPK, clinical pharmacokinetics and clinical pharmacology science. During her time as Clinical Pharmacology Leader and then as Director of Clinical Pharmacology at AstraZeneca's Antibiotic Business Unit she designed and lead the clinical pharmacology strategy for several early and late stage antibiotics. She has authored numerous regulatory submission documents and played a pivotal role in successfully defending new drug applications which have resulted in regulatory approval in Europe and the US. Amongst the key achievements are the successful marketing authorization approval of Zavicefta (a lactamase-lactamase inhibitor combination) where she used PK/PD to set the dose and breakpoint, and in Europe to bridge data from clinical trials in certain complicated infection indications to achieve approval in other infectious indications in the absence of clinical data. For Zinforo, a recently approved cephalosporin for the treatment of ABSSI and CAP, she achieved European and US approval for paediatric dosage labelling by the use PK/PD modelling to bridge data from both adults and clinical trials in children.
Dr. Paul Eckberg, MD.
Eckburg Medical Consulting (2000 – present)
Owner, sole proprietorship; consultant in drug development with focus on anti-infective agents (antibacterials, antifungals)
Division of Infectious Diseases & Geographic Medicine, Stanford University School of Medicine (2007 – present)
Adjunct Clinical Assistant Professor in Infectious Diseases
Intermittent, active role in patient care (Infectious Diseases inpatient service at Stanford University Hospital) and instructor of the antibiotic lecture series and various medical student workshops (Stanford Medical School).
Two decades of industry experience in anti-infective drug development
Part-time Consultant 2000 – 2007
Full-time Employee (Cerexa, Kalidex) 2007 – 2012
Full-time Consultant 2012 – present
Acting Chief Medical Officer (CMO) as consultant for multiple start-ups
Experience in virtual, start-up environments, including clinical development plans, early Phase 1 protocol development and medical monitoring, primary writing of INDs, and medical lead in direct interactions with FDA and VC boards
Extensive involvement in Phase 1–4 anti-infective trials, including protocol development, medical monitoring, safety and data review, and CSR writing
Direct involvement in FDA Advisory Committee meetings, NDAs, and drug approvals (e.g., Teflaro® 2010, AvycazTM 2015, NuzyraTM 2018, ContepoTM 2019)
First author and presenter of multiple oral abstracts and posters at international meetings, and author of numerous peer-reviewed academic manuscripts
Business development and strategic planning experience
Consultant, Regulatory Science, Drug Development and Business Strategy Highbury Regulatory Science Limited Alderley Edge, Cheshire
A leader in drug development and regulatory science with a track record of achievement in delivery regulatory approvals across a diverse range of therapy areas, Bob Clay established Highbury Regulatory Science consulting in 2014. He provides consulting support to small and mid-size growing biotech companies on regulatory and development strategies across a range of therapy areas and regions. A strategic thinker with an understanding of the broad range of public policy and business issues affecting healthcare and drug development, he has held senior positions in regulatory affairs and has a versatile experience of building external partnerships and internal change management.
Kripa is a Registered Indian Patent Agent with a strong academic record combined and extensive IP experience of ~13 years. Kripa received her PhD in Microbiology & Immunology from Albert Einstein College of Medicine (AECOM), New York, USA following which she had a brief stint as a post-doctoral researcher at Nanyang Technological University, Singapore. She then went on to pursue IP law from National University of Singapore (NUS), Singapore while working as a Patent Attorney Trainee at the UK based firm Marks and Clerk, Singapore. Given her background in applied research, an in-depth knowledge in biological sciences coupled with patent expertise, she currently consults for academia and several biotech start-ups to formulate strategies on translating basic science discoveries into products. Her consultation begins at the stage of idea inception, building product differentiation, carving out niche IP space to life cycle management.
Twenty years of experience in Drug Discovery and Development in preclinical ADME,PK, PK/PD, Modelling and Simulation, Preclinical Development (IND enabling), and clinical PK. A year's experience in Discovery and Development of molecular imaging agents for PET/SPECT imaging. Skilled in using modeling and simulation tools like WinNonLin, Simcyp, and Stardrop. Experienced in Managing Outsourced Projects with Contract Research Organizations.
Joined Zeneca in 1994 after a PhD from Imperial College and post-doctoral research at the University of Waterloo-Kitchener, Canada.
His 20 years of experience in medicinal chemistry has been spread across CNS/pain (GPCRs), anti-infectives (enzyme inhibitors) and oncology (kinases, proteases, phenotypic screening, radiometal antibody conjugates).
A secondment into the computational chemistry group led to the development of globally used AZ internal data-mining and exploitation tools. His work at AZ has focused on early stage projects and method development. He is also the author of a medicinal chemistry primer, visiting lecturer at the University of Manchester, and AZ Bangalore.
Dr. Sadler has worked in industry for over 10 years and has been at the forefront of discovery toxicology in both the pharmaceutical and agrichemical industry. Using her broad technical background, scientific knowledge and experience she creates project-specific preclinical packages that address safety issues, with the aim to provide prospective understanding of the major safety risks, thereby influencing chemical design, creating mitigation strategies and expediting progression through GLP-safety studies and initiation of clinical trials. Her expertise includes design and implementation of bespoke preclinical safety packages to identify the safety hazards, assess the safety risks and develop risk mitigation strategies, incorporating in silico, in vitro and in vivo experiments, from target identification through to development.
Dr. Sadler has a proven track record of problem solving in investigative toxicology, elucidating mechanisms of toxicity thereby understanding relevance to humans. Through innovative preclinical experimental design, coupled with extensive understanding of the opportunities and limitations of preclinical models, she has influenced and refined the design of clinical trials to increase efficient execution of the clinical plan.
Suri Venkatachalam was the founder and CEO of Connexios Life Sciences Pvt. Ltd. Connexios a Bangalore based pharmaceutical company till his transition out of the company in 2016. Connexios built a unique a unique translational network biology approach and leveraged it to discover a portfolio novel therapeutics for unmet clinical needs in the area of diabetes and diseases of metabolism. Some of these candidates are in the initial stages of clinical development. At Connexios, Suri developed and drove the overall business, scientific and IP strategy converging in two partnerships with global pharmaceutical majors. He is also a co-founder and chairman of Achira Labs, a Bangalore based start-up developing a diagnostics technology platform based on a unique microfluidics based approach. He is an Adjunct Faculty at NCF (Nature Conservation Foundation), Mysore.
Before founding Connexios in 2003, Suri was part of the founding team of Metahelix Life Sciences Pvt. Ltd. an Agri-biotech company based in Bangalore. Before, his move to industry, Suri was a Research Associate in Indian Institute of Science, Bangalore; a visiting scientist at the computer science department of Linkoping University, Sweden, an adjunct associate fellow at the National Institute of Advanced Studies, Bangalore and a LJIS Burroughs-Wellcome post doctoral fellow in computational neuroscience at the University of California, San Diego. Suri holds a Bachelors degree in Chemical Engineering and a PhD in condensed matter physics from the Indian Institute of Science.
Pradeep Fernandes is currently advising on Strategy and Business Development for Bugworks Research. Prior to this he was CEO and Co-Founder of Netto Logic, a company focused on customer engagement for Small business. Before starting Netto Logic, Pradeep was President and co-founder of Cellworks Group, Inc, a company focused on delivery novel, effective and de-risked therapies. He was responsible for raising more than $20M in financing, identifying the goto market strategy, partnering with US companies and architecting their virtual disease platform. Pradeep has spent most of his career in the semiconductor and software algorithms domain and is now applying those ideas and practices in the life sciences arena. Prior to joining Cellworks, Pradeep was Vice President and General Manager of Synthesis Solutions at Cadence Design Systems, Inc. (NASDAQ: CDNS) following its very successful acquisition of Get2Chip in 2003. Under Pradeep's leadership, Get2Chip's synthesis solution was one of the most externally recognized and the fastest growing product in Cadence's product line up. Before founding Get2Chip, Pradeep was part of the executive team of TriQuest Design Automation, which was acquired by Summit Designs (MENT). Before joining Triquest, Pradeep co-founded CyberX, a company focused on development of highly integrated smart ethernet switches. Earlier, Pradeep spent several years at Synopsys and LSI Logic, where he started his career. Pradeep has a MSEE and BSCS/EE. He has multiple patents in Cancer, Immunology, Systems Biology, EDA and many technical publications to his credit in the EDA, DSP, Communication and Parallel Processing areas. He received the Sigma Xi outstanding research award for his thesis. He is also an advisor and investor in several early stage companies.