Dr. Diego Herrera, Head of Clinical Data and Information Management, Almirall S.A., Spain. Graduated Life Science at the University of Barcelona, ​​specialized in Hematology and Biochemistry and Teaching during 3 years.

With almost 30 years working in Pharma Industry, Dr. Herrera has been evolving into different positions in the area of clinical research, clinical technologies, and innovation leadership projects. In addition to the current position, Dr. Herrera gives advisory for generating new opportunities for clinical data and technologies companies.

Nowadays, working on strategic partnerships to improve the digitalization of clinical trials by means of data integration platforms.

Dr. Ravi Sekhar Kasibhatta is currently Sr. Vice President – Clinical Research at Lupin Bioresearch Center, Pune. Previously, held various positions at Dr.Reddy’s Laboratories, Hyderabad; Apl Research Center (Aurobindo Pharma), Hyderabad; Lambda Therapeutic Research, Ahmedabad; The Nizam’s Institute Of Medical Sciences, Hyderabad.
Dr Kasibhatta completed his Ph.D. in Pharmacology from Dept. of Clinical Pharmacology and Therapeutics of the Nizam’s Institute of Medical Sciences, Hyderabad, India and M.Sc. (Bio-Sciences) from Ravishankar University Raipur, M.P. (Now Chattisgarh), India 
Dr Kasibhatta is currently heading Lupin Bioresearch Center to conduct in-vitro & in-vivo BA / BE & Clinical Equivalence Studies for Generic products, PK / PD studies of specialty products like Biosimilar, Inhalations products. He is a Clinical research professional having in-depth knowledge of Clinical, bioanalytical, pharmacokinetic & pharmacodynamics of pharmaceutical domain. Dr Kasibhatta has analytical and problem-solving skills, focussed approach, adaptive to the changing environment and progressive attitude with strong result orientation & timely deliverables. 
He is a Team leader & Key member for CRO selection & qualification, cost-effective negotiations for Clinical program of Generic product program. He has proven expertise in establishing CROs, Bioanalytical & Clinical laboratories meeting the ISO standards, ICH-GCP compliance & other applicable international quality / regulatory standards. He is also acquainted with knowledge of latest analytical platforms like LC-MS/MS, IC, ELISA etc., and improved add-on services for Biosimilar, inhalations, derma programs and Biometrics for CT studies. Dr Kasibhatta has published around 33 papers in various national & international journals. He is currently overseeing 03 candidates for Ph.D. in biomedical / analytical sciences.

Dr Rasmus Hogreffe, MSc.Med., MBA is the Head of Virtual Clinical Trials at LEO Innovation Lab. His main goal is to improve treatment for patients, by making trials better and faster than ever before, using digital and remote innovations.
He holds an Executive MBA and a Master in Medical Science (MSc. Medicine) and has, since 2010, been working in the healthcare industry in various positions within clinical research & development.
Dr Rasmus has extensive experience in the pharmaceutical industry and has been involved in more than 60 clinical trials, giving him a broad knowledge regarding every aspect of clinical research.
Furthermore, Dr Rasmus is a serial entrepreneur and has a successful record of starting and selling companies within his broad scope of interests: Digitalization of clinical trials, Patient recruitment, Real World Data, and Health innovation.

Dr. Covington has joined the executive leadership team as Senior Vice President, Research and Patient Outcomes, at Curio Digital Therapeutics, Inc. Prior to this, she served as Vice President of Real-World Data at Ciox Health, a technology company specializing in data exchange and RWD products. She is keenly focused on developing patient-centered approaches using real-world evidence (RWE) and clinical data to inform health outcomes and disease prevention. Melva has extensive expertise in public health and outcomes research (HEOR), clinical research designs, market intelligence and strategic thinking. She has deep analytic expertise in RWE across therapeutic areas and product lifecycle development.

Melva has been a leader across multiple business functions, which include medical affairs, business development, clinical operations, health advocacy and field-based engagement. She has served as strategic lead in RWE/HEOR Strategy, Evidence Generation, Market Access and Scientific Communications. Her contributions include developing and executing real-world evidence dossiers, patient registries, customer engagement models and patient recruitment strategies. She is also focused on the development, support, mentoring of professionals at various levels.

Melva has led Global and US-based teams in HEOR across several organizations, namely Roche Labs, Eli Lilly, Sanofi, Pacira and Eversana. She is passionate about integrating data and consumer perceptions contextually and then applying that knowledge to execute solutions that improve health outcomes across diverse patient populations.
She has an A.B. in Politics/Economics from The Catholic University of America, Master of Public Health and Ph.D. from the University of North Carolina at Chapel Hill. She also holds a MBA from the Johnson School at Cornell University. Melva has authored numerous publications and is an impassioned public speaker and patient advocate.

Dr Charlie is the Global Head of Clinical and Bioanalytical Quality at Viatris and is responsible for the Quality Management System that provides oversight for these R&D disciplines.  He has extensive experience in GCP Compliance and Quality Management along with work experience in Clinical Research,  Formulation development, and GCP Quality Systems.   He was instrumental in establishing the initial Clinical QA functions at GlaxoSmithKline and has extensive management experience in implementing Global GXP functions.  He was a long-standing member of the editorial board at Thompson Publishing supporting their GCP publications.   In addition to his professional carrier within the pharmaceutical industry, Dr. Charlie is a registered Pharmacist practicing for over 20 years in the US.  He is an avid sports fan with a keen interest in Lacrosse and has come to gain a fondness for Kabaddi when traveling in India.   He looks forward to his next visit to India after the pandemic to attend another Kabaddi match.

Dr Andy Lawton is a consultant for Risk Based Approach Ltd, specialising in business changes related to ICH (E6 R2/3 and E8 R1), in particular QTL’s, QbD and RBM.

Dr Andy has been working in the clinical development arena for over 42 years and has covered most roles/tasks and was a Founding Committee Member of ACDM, Member of TransCelerate RBM, QTL, Data Transparency, eSource work streams and also a Member of EFPIA WG on Data Transparency.

A Clinician and Researcher, Dr Anupama Ramkumar is the principal consultant and CEO of Arkus Research Pvt. Ltd, a clinical consulting company engaged with pharmaceutical companies and CROs worldwide.

With over 26 years of medical experience and 22 years of experience in Clinical Research Industry she bridges the field of medicine and pharmacology effectively and is a sought after clinical development and GCP expert as well as technical strategy advisor for pharma companies and research units.

She has set up and guided clinical teams through several successful clinical development programs across multiple therapeutic areas, been led regulatory interactions and audits which include USFDA, AFFSAPS, WHO, ANVISA in companies such as Lambda Therapeutic Research, Dr. Reddy’s Biologicals, Alembic Pharmaceuticals to name a few.

 Her forte lies in demystifying GCP to build practical and effective Quality management systems for regulated drug development with a focus on compliance and operational excellence.

Her experience in clinical trials across all phases for NCEs, Biosimilars,Vaccines etc and insights from multiple interactions with regulators brings values to the projects she engages in.

Dr. Ashish Mungantiwar is currently working as Executive President in  R and D in Macleods Pharmaceuticals Limited, Mumbai. He is heading Bioequivalence, Pathology, Clinical Trials and Pharmacovigilance. He has rich experience of more than 20years in Pharmaceuticals industry. Dr. Ashish completed his PhD in Pharmacology from Mumbai.

He served as Study Director for more than 3000 Bioequivalence studies. Conducted studies on orals, inhaler, in vitro phosphate/Bile acid binding studies, Vasoconstriction studies on topical steroids, IVRT/ IVPT studies on topicals.

He has successfully handled more than 40 regulatory  inspections   from USFDA, WHO, UKMHRA, DCGI,  ANVISA , Malaysia and Thailand. As Head of Pharmacovigilance, he ensures Benefit risk management of all Macleods pharmaceuticals drugs throughout their life cycle and ensures all required Pharmacovigilance obligations as per PvPI, US FDA and MHRA. He has successfully faced USFDA Inspection on Pharmacovigilance.

As Head of Clinical trials, he has completed more than 100 clinical trials in phase III and phase IV in  various therapeutic segments for different regulatory authorities like DCGI, WHO and US FDA

He has been invited as speaker in various international and national conferences. As Laboratory Director of Pathology, he has successfully faced inspections from NABL several times.

He  plays pivotal role in identifying new products for domestic market and leads the team of formulation development for domestic market. He has obtained more than 20 new drug approval from DCGI as first time launch in Indian market and is actively presenting the cases to Subject Expert Committee of DCGI.  He has more than 30 publications in international and national journal. Dr.Ashish holds two patents on his name and five patent are under pending for grant. He has also written chapter in book of Scientific basis of Ayurvedic Therapy CRC Press Washington.  Dr. Ashish is guide for PhD students. Four students successfully completed PhD under his guidance and currently 3 students are pursuing.

Ms Erika Stevens leads research transformation advisory and assurance services. In this capacity, she advised cancer centers, life sciences, AMCs, hospitals and health systems process improvement initiatives for productivity, quality and efficiency in operations, cross-functional relationships, administration, manufacturing and compliance. Her regulatory knowledge and quality oversight of the Code of Federal Regulations (CFR) includes, but is not limited to, GMP, GLP and GCP. Ms. Stevens has over 20 years of research/ R&D experience, including over 12 years in research management serving in roles such as Vice President Research, Senior Managing Director, Director Clinical Trials Office, Director of Clinical Research, Interim Executive Director, Clinical Trials Office and Director of Research Operations. Ms. Stevens is a past president of the Association of Clinical Research Professionals (ACRP) New York Metropolitan Chapter. Ms. Stevens served as chair, for two terms, of the editorial advisory board for “The Clinical Researcher,” the peer reviewed journal publication for Association of Clinical Research Professionals (ACRP). Ms. Stevens is the Chair of the Associate Board of Trustees. Erika is a director for Brightpoint Care and served on the MAGI advisory board. She is also a frequent speaker on research operations and compliance practices at international conferences. Additionally, she is a published author whose work appears in a variety of peer journals including the American Journal of Obstetrics & Gynecology, The Monitor, Clinical Researcher, Regulatory Focus, Applied Clinical Trials, Clinical and Translation Science and the Journal of Mental Health and Aging.
Ms. Stevens holds her B.A. from the University of Vermont, her M.A. from Case Western Reserve University and her M.A. from Temple University. She also holds a Graduate Certificate in Gerontology from Case Western University.