Outsourcing in Clinical Trials Southern California 2023

Biography: Over 19 years of experience in increasing quality operations, quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Medical Device, Digital Medicine and Combination Product areas. In addition, an adjunct assistant professor at USC – School of Pharmacy – Regulatory and Quality Sciences. Regularly provides AbbVie therapeutic franchise units regulatory counsel and strategy to all aspects within the quality management system arena and regulatory affairs regarding:

• CMC Global Dossiers and Global Device Regulatory Strategy Registrations
• EU MDR/IVDR – Person Responsible for Regulatory Compliance (PRRC)
• 21 CFR Part 3 and Part 4 - Combination Products
• CE Marking
• ISO 13485:2016/MDSAP
• Product Development – Design Controls
• Risk Management
• Human Factors Engineering
• Acquisitions/Divestitures
• Import/Export – U.S. Agent
• Production Controls
• Regulatory Inspection Management
• Materiovigilance
• Health-Care Related Laws and International Regulations

Session Details: KEYNOTE DCT & HYBRID PANEL DISCUSSION 28-09-2022, 8:30 am PANEL DISCUSSION Do we need to move away from digital reliance to bring the human touch back? Is there still a big divide? AGREE OR DISAGREE 28-09-2022, 11:00 am INTERACTIVE SESSION 28-09-2022, 12:00 pm View In Agenda

Biography: 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.

Session Details: PANEL DISCUSSION Do we need to move away from digital reliance to bring the human touch back? Is there still a big divide? AGREE OR DISAGREE 28-09-2022, 11:00 am KEYNOTE New patient recruitment challenges in a post-Covid world 29-09-2022, 8:30 am View In Agenda

Biography: Bonnie Bain, PhD, is the Global Head and EVP of Healthcare Operations and Strategy. Bonnie has over 20 years’ experience in the healthcare sector and a proven track record of developing innovative solutions on both the client and agency sides of the business. Bonnie was GlobalData Healthcare’s first Western analyst, and under her leadership, the company launched a number of premium syndicated reports, analytical tools, and databases in the pharmaceuticals and medical devices space. Prior to GlobalData, Bonnie was Vice President and Global Research & Analysis Director for Informa’s Pharma Division, which includes Datamonitor Healthcare, Scrip Group, and Business Insight. Bonnie also worked for several years at Decision Resources as an Analyst and Project Manager. On the client side of the industry, Bonnie worked for several years as a Senior Manager in Marketing Strategy and Analytics at Boston Scientific, where her work contributed to the successful commercialization of the first ever Access and Visualization Platform at the company. Bonnie has a PhD in Biochemistry and Molecular Biology from Purdue University and completed a Post-Doctoral Fellowship in Molecular Pharmacology at the University Of Miami School Of Medicine. She also has a graduate certificate in Applied Management Principles from Purdue University Krannert School of Management.

Session Details: Chair’s Opening Remarks 29-09-2022, 8:25 am GLOBALDATA SPOTLIGHT Embracing Disruption in Pharma - Is COVID-19 a Catalyst for Lasting Change? 29-09-2022, 2:00 pm View In Agenda

Biography: Dr. Gal has over 30 years of medical device experience as a practicing veterinarian, academician at Tufts University School of Medicine and subsequently in industry. Dov held R&D, clinical marketing and clinical affairs positions with increasing responsibilities in private start-up, and medium to large public medical device companies. Most recently, Dov led the clinical organization for the Heart Valve Therapy business at Edwards Lifesciences, overseeing clinical trials of Class III implantable devices. Prior to Edwards Lifesciences, he led the clinical organization at Broncus Technologies, a start-up with an investigational, minimally invasive device-drug combination product for the treatment of patients with severe COPD. The system was evaluated in an international clinical trial under an IDE. Prior to Broncus, Dov was a director of clinical research at Medtronic Vascular responsible for the AAA stent graft product line

Session Details: PANEL DISCUSSION ClinOps team focus: Managing relationships and hiring in the new world 28-09-2022, 11:00 am View In Agenda

Biography: Few people with a cause walk the talk as boldly and graciously as Christine Von Raesfeld, founder and CEO of People with Empathy. Christine is a pillar of patient advocacy and allyship in the rare and chronic disease community. Through the lens of her lived experiences in healthcare, she has become a champion for patient voices, diversity and inclusion in clinical research, and equitable patient-sponsor partnerships. Christine has brought her unique perspective and honed expertise to countless roles as a featured speaker for numerous conferences dedicated to the rare disease community and disease awareness initiatives. Wherever possible, Christine generates momentum toward progress along her patient advocacy interests and stimulates dialog on a range of topics relevant to patients, clinicians, and industry. As a patient advisor, Christine has assisted several initiatives including the Stanford "Humanwide" Precision Medicine Program, All of Us Research, and the 23andMe Lupus initiative. For her many contributions to her field, she has been named one of the top 100 Women of Influence by Silicon Valley Business Journal, a member of the 2021 HIMSS Future 50, and one of Medika Life's medikal life 50 most influential voices in healthcare 2022  among other distinctions. With her guidance and support, we will continue to optimize the patient journey for people worldwide.

Session Details: Data: the new (s)oil in a digitally driven economy 28-09-2022, 3:00 pm View In Agenda

Biography: 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.

Session Details: PANEL DISCUSSION Do we need to move away from digital reliance to bring the human touch back? Is there still a big divide? AGREE OR DISAGREE 28-09-2022, 11:00 am AUDIENCE Q+A A playbook for how to handle an undesirable CRO-sponsor partnership & how to turn it around 28-09-2022, 4:30 pm AUDIENCE Q+A: A playbook for how to handle an undesirable CRO-sponsor partnership & how to turn it around 28-09-2022, 4:30 pm View In Agenda

Biography: Jennifer Lee is Senior Vice President of Clinical Operation, Biostats, and Data Management at Elevar Therapeutics. Jennifer brings over 25 years of industry expertise in clinical strategies, asset evaluation, and advancing novel and innovative clinical programs spanning phases I-IV across therapeutic areas, including oncology, infectious disease, inflammation, urology, CNS, cardiovascular, rare disease, and stem and cell therapies. She is an invited speaker at international conferences and has successfully submitted market applications leading to seven NDA approvals. Previously, Jennifer worked at G.D. Searle, Pharmacia, Pfizer, Astellas Gilead Sciences, and other mid- and micro-cap companies. Jennifer holds a BS in Biochemistry from the University of Illinois and an MS in Clinical Research and Regulatory Administrations from Northwestern University. She is an active mentor, Women in Bio supporter, and board member.

Session Details: PANEL DISCUSSION ClinOps team focus: Managing relationships and hiring in the new world 28-09-2022, 11:00 am FIRESIDE CHAT Establishing strong CRO/sponsor/site relationships and building trust 28-09-2022, 12:00 pm View In Agenda

Biography: 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.

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Biography: Nanomed, with the headquarter at Cupertino, CA, applies innovative microfabrication technology to make a delivery tool for skincare actives. This is a new way of overcoming skin barrier and delivering actives without needle injection. The product successfully went through two clinical trials and got into the finals of Asian Innovation Award together with IBM Healthsolution Lab's product sponsored by the Wall Street Journal and won Silver Prize in 2010. Nanomed's antiblemish product was successfully launched at AAD, the largest dermatology annual meeting in US. Together with Sephora's product, Nanomed's delivery product got into the top three for the International Package Design Award (tool category) at 2012 HBA Global in New York City.

Session Details: A Fireside Chat on…Regenerative Medicine as a future trend 28-09-2022, 3:00 pm View In Agenda

Biography: Dr. Lei Zhang has over25 years of experience spanning across the biotech/biopharma, medical device, diagnostic, and CRO industries. Her unique drug development lifecycle expertise includes global clinical development & operations, scientific innovation, and regulatory interactions with the FDA (CDER, CBER, CDRH). Dr. Zhang engaged various therapeutic indications in oncology, cardiology, endocrinology, dermatology, OB/GYN, gastroenterology, urology, and infectious diseases. Her track record includes contributions to development strategy, corporate partnership, clinical trial design and execution (Phase I-III, 510(k), PMA) as well as regulatory submissions. Lei provides leadership overseeing functional teams in clinical/regulatory affairs, program management, Biostat, data management, medical writing, CRO/vender selection. Dr. Zhang received her M.S. from Beijing Medical Univ. and Ph.D from Germany; performed postdoc research at MIT. Lei is an active speaker at biotech & biopharma forums on clinical/regulatory topics.  

Session Details: Chair’s Opening Remarks 28-09-2022, 8:20 am KEYNOTE DCT & HYBRID PANEL DISCUSSION 28-09-2022, 8:30 am FIRESIDE CHAT Establishing strong CRO/sponsor/site relationships and building trust 28-09-2022, 12:00 pm View In Agenda

Biography: Steven Chen, MD, MBA is the Chief Medical Officer of Avelas Biosciences in La Jolla, CA, a company with a drug/device combination focused on intraoperative margin detection.  He is also a surgical oncologist in San Diego, CA.  Dr. Chen received his medical degree and completed general surgery and critical care residencies at the University of Michigan, followed by a surgical oncology fellowship at the John Wayne Cancer Institute.  Subsequently, he was  the Chief of Breast Surgery at UC Davis Medical Center, and an Associate Professor of Surgery at City of Hope National Medical Center.  He serves as the Director of Surgical Oncology at OasisMD.  Dr. Chen is a past President of the American Society of Breast Surgeons and serves on committees for a number of professional societies including the American Medical Association and the American College of Surgeons

Session Details: PANEL REUNION DEBATE POST COVID: How long will we feel ripples of the pandemic? 29-09-2022, 11:00 am View In Agenda

Biography: Stefan N. Lukianov, AM MS is the first-time JHU grad student founder of Salve Therapeutics, Inc. of Los Angeles, CA.  He has undergraduate degrees from the University of Maine and masters from the University of Pittsburgh and Harvard University in the biomedical sciences.  He has worked in reputable labs at Boston Children’s Hospital, Brigham and Women’s Hospital, McLean Hospital and the UPMC Hillman Cancer Center. He also has extensive experience in science journalism and education that contribute to his company leadership and vision.

Session Details: Speaker Hosted Roundtables 29-09-2022, 3:00 pm View In Agenda

Biography: Collaborative and outcome-based biopharmaceutical servant-leader providing 20+ years of clinical operations experience. Passionately advancing the mission of improving patients’ lives through timely and efficient execution of clinical trials. Adept at building and managing cross-functional teams comprising internal and/or external partners and CROs to meet the dynamic business needs of virtual start-ups to leading life science companies.

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Biography: Certificated professional for clinical research and regulatory affairs, with over 15 years of experience in designing, conducting, and reporting clinical & medical trials for investigational therapeutic products and companion diagnostic/prognostic products. Broad clinical and scientific knowledge and industrial experience across multiple therapeutic areas including diabetes, GI, oncology, and rheumatology. Experience in working with both small molecules and biologic agents. Track record in executing and overseeing clinical studies from early phase to large-scale global registrational trials (phase I to IV), including clinical reporting and regulatory submissions that have led to successful market approvals in multiple products. Accomplished in mid-sized to large pharmaceutical corporations, with ability to balance corporate obligations with day-to-day responsibilities of developing effective and safe new therapies and clinical tools.

Session Details: EDC: Discovering data capture in the age of Decentralized and Hybrid trials 28-09-2022, 2:00 pm View In Agenda

Biography: Clinical Operations Leader with over 18 years of drug development and clinical project management experience. I am very passionate about drug development process and bringing new therapies to patients in need. My expertise benefits small and large biotech and pharmaceutical companies with all stages of drug and medical device development programs. I have worked in the following therapeutic areas: Alzheimer’s disease, oncology (hematologic malignancy T- cell therapy, and solid tumors), cardiology (stem cell therapy), infectious diseases, endocrinology and rare diseases.

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Biography: AJ Bergmann is currently the Chief Financial Officer of Capricor Therapeutics, Inc. (NASDAQ: CAPR). Mr. Bergmann joined Capricor in 2011 and he also serves as the Company’s corporate treasurer. During his time at Capricor, Mr. Bergmann directly coordinated the Company’s reverse merger and subsequent uplisting to the NASDAQ and financings yielding over $100.0 million, to date. He has experience in developing corporate and financial strategy alternatives and executing strategic plans. Mr. Bergmann manages the Company’s finance, accounting, business development, and human resource functions. Prior to joining Capricor, Mr. Bergmann had experience in accounting, finance, and operations management of companies ranging in size from start-ups to mid-size companies. Most recently he was with the business management firm, Gettleson, Witzer, and O’Connor, in Beverly Hills, California, where he focused on accounting and finance for several production studios generating motion picture releases and worldwide revenue that exceeded $1 billion. The firm’s clients included foundations, trusts, and independent actors, writers, producers and directors across the entertainment industry. While at the firm, he focused on budgeting, tax forecasting, and asset management. Earlier in his career, Mr. Bergmann served in financial positions in various industries. Mr. Bergmann graduated from Providence College with a Bachelor of Science degree in Management and a minor in Finance. He has an M.B.A. from the University of Southern California’s Marshall School of Business.

Session Details: Facing up to increased trial costs: Top tips for staying in budget 29-09-2022, 12:00 pm View In Agenda

Biography: Dr Ghoddusi has over 15 years of experience in some of the most challenging areas of oncology with focus on drug discovery and clinical development. Dr Ghoddusi has broad and overarching insights into unmet therapeutic areas with expertise in translational sciences and clinical biomarker development which allows him to provide unique perspective on how to propel therapeutic projects from discovery to approval. Trained as a translational pathologist he has held numerous positions at large pharmaceutical and small biotech companies including Novartis, Celgene, and Juno Therapeutics. His current focus is Immuno-oncology, Gene and Cellular Therapy.

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Biography: 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.

Session Details: PANEL REUNION DEBATE POST COVID: How long will we feel ripples of the pandemic? 29-09-2022, 11:00 am View In Agenda

Biography: I am the CEO at OrPro Therapeutics, a biotechnology company in San Diego, CA developing biologic drug solutions to unmet needs in serious epithelial diseases including cystic fibrosis. My training is in genetics (Ph.D.) and mechanical/biochemical engineering (M.S.), both from Duke University where I was also an undergraduate. I went into industry for post-doctoral studies at the biotechnology research center at Ciba-Geigy Corp. (Novartis) and have over three decades of academic and industrial research and senior management experience in protein and metabolic engineering, bio-based manufacturing, and drug discovery / development. I am passionate about the life sciences and the clinical and commercial potential of novel therapeutics and applications of synthetic biology.

Session Details: Speaker Hosted Roundtables 29-09-2022, 3:00 pm View In Agenda

Biography: Sverre Bengtsson started in the clinical trials industry over 30 years ago. He started as a statistician/statistical programmer, later into data management and since over 20 years into business development. He has been working in both CRO’s as well as in clinical trials technology companies, including the global first ePRO company. Sverre is very interested in making clinical trials efficient, in both study design but also in the processes and technologies used.   Sverre co-founded Viedoc Technologies 19 years ago and is responsible for some of the major accounts but also the vision around the company. He’s on the board of both some industry organisations and in clinical technology companies.

Session Details: Decentralized clinical trials and hybrid trials: how to help patients and sites through technology and processes 28-09-2022, 11:30 am View In Agenda

Biography: Jena is an experienced research manager with 10 years of experience in enabling digital solutions within academic and industry sponsored clinical trials. As a 2021 PharmaVoice100 recipient and Best Decentralized Clinical Trial Businesswoman of 2022, Jena is most known for establishing Medable's Patient Success department and Patient Caregiver Network. These teams engage and empower expert patient and caregiver advocates to assist product development, refine study workflows, and tailor the overall trial experience. This results in meaningful, actionable, and patient-focused solutions. She is incredibly passionate about enabling effective therapies to get to patients faster by disrupting legacy standards with scalable and personalized digital solutions. Prior to Medable, she worked as a Clinical Research Manager at Harvard Medical School and Stanford University School of Medicine. She has co-authored over 30 peer-reviewed publications focusing on how to leverage machine-learning, artificial intelligence, and remote patient monitoring to triage, diagnose, and provide early intervention for children with autism spectrum disorder

Session Details: How to combine tech and patient perspectives to decrease costs and increase enrollment 28-09-2022, 12:30 pm View In Agenda

Biography: Based in Los Angeles, Gary has 26 years of drug development experience, holding global leadership positions in Information Technology, Clinical Operations, and Quality Assurance. Passionate about innovation and business transformation, Gary has spent the last 4 years working to advance industry adoption and regulatory acceptance of the virtual, decentralized and hybrid clinical trial models, and is currently exploring how elements of these may serve to streamline early phase clinical trials.

Session Details: Fast-Track Your Phase 1 Clinical Trial 28-09-2022, 2:30 pm View In Agenda

Biography: Abie Ekangaki is responsible for bringing expertise in biostatistics to shape clinical trial design strategies and methodologies for regulatory submissions and otherwise and provides broad biostatistical consulting for both internal and external clients. He advises on efficient trial designs for clinical trial programs and applies his statistical expertise, drug development, and operational experience across different therapeutic areas. With more than 25 years of experience as a biostatistician, Dr. Ekangaki has worked as a research scientist with the World Health Organization in Switzerland, as a statistics lecturer at Macquarie University in Australia, and has over 19 years in the pharmaceutical industry in both large pharma and CROs, where he has held several lead technical and senior leadership positions.

Session Details: Phase 2 Dose-Finding Trials: Are Adaptive Designs Preferred? 29-09-2022, 10:00 am View In Agenda

Biography: Ms. Adams joined us as our Vice President of Clinical Operations in August 2006, was promoted to Senior Vice President of Clinical Operations in July 2014, and was promoted to Executive Vice President of Clinical Operations in January 2019. Prior to joining us, Ms. Adams was a Manager of Clinical Operations at Pfizer, Inc., a pharmaceutical corporation, from 2004 to 2006 and at Biogen Idec, Inc., a biotechnology company, from 2002 to 2004. Ms. Adams managed clinical trials at Pfizer that contributed to the 2006 approval of Sutent® in renal cell carcinoma and gastrointestinal stromal tumors, and she managed clinical trials at Biogen Idec that fulfilled post-approval commitments for Zevalin® and Rituxan®. Ms. Adams has managed both early and late-stage oncology studies of small molecules as well as biologics in the areas of lymphoma, lung, colorectal, ovarian, kidney, sarcoma and breast cancers. From 2000 to 2002, she managed non-oncology programs at Quintiles Inc., a service provider for biopharmaceutical and health sciences companies, including studies in the areas of allergy and pulmonary disease. Ms. Adams received a B.A. in Kinesiology and Biology from the University of Colorado and an M.B.A. in Technology Management from The University of Phoenix.

Session Details: PANEL DISCUSSION ClinOps team focus: Managing relationships and hiring in the new world 28-09-2022, 11:00 am IN-HOUSE VS OUTSOURCE Developing and nurturing in-house teams in companies with limited resources to streamline ClinOps; when do you ACTUALLY need to outsource? 29-09-2022, 9:30 am View In Agenda

Biography: Kim Hedges has 25 years of experience in managing patients by utilizing digital health solutions to expand access virtually to healthcare and clinical research.  She has expertise in executing solutions to implement, oversee and ensure best practices are integrated into the end-user experience for providers, sites, and patients.  She helped pioneer the application of mobile-first strategies for use across a variety of healthcare settings for providers, payers, academic institutions, and patients to expand access to care virtually.  Ms. Hedges has focused on the use of real-world experiences and insights gained to drive the successful implementation of mobile and virtual clinical trials.  Her current focus involves collaboration in digital health strategy & solutions from protocol assessment through solution deployment.

Session Details: Decentralized clinical research is more than just technology: how concierge services facilitate successful implementations 28-09-2022, 11:30 am View In Agenda

Biography: Kelly Franchetti is a Sr. Vice President and Global Head of Patient Insights and Strategy at YPrime. A highly experienced registered nurse who continues to spend time with patients directly, her diverse background comprises patient advocacy and clinical research. Kelly has over 25 years of experience in obtaining and discerning the patient and caregiver experience as well as developing strong relationships with advocacy groups on a global scale. She has extensive experience in multiple therapeutic areas such as oncology, cardiovascular, endocrinology, orthopedics, infectious disease, neurology, pediatrics, and critical care. This depth and breadth of experience translate into a keen understanding of how patients think regarding their treatment giving her a singular perspective on the best way to approach patients with their treatment options, and an understanding that proves invaluable to her pharmaceutical and clinical research stakeholders.

Session Details: Remember the patient? Humanizing Decentralized Clinical Trials during their study journey 29-09-2022, 9:00 am View In Agenda

Biography: Since 2002 Jorge has been involved in pharmaceutical, biotech, and biologics research in a variety of roles including clinical, operations, finance, market Intelligence and business development at the site level, SMO, CRO, and now for clinical supply solutions and access at TrialCard.  Past employment includes Sarkis Clinical Trials, Radiant Research, Covance, Interventional Concepts,  MedPrimo Research as an independent consultant, FutureLife LLC advisory board member, and the University of Florida/VAMC Department of Neurology.  Cumulatively he has been involved in over 350 clinical trials including Phase I-IV, PK/PD, vaccine, 510k submission, vaccine research, and has conducted both pediatric and adult trials. Mr. Franceschi completed his undergraduate work at the University of Florida in Food Science & Human Nutrition and completed his Masters of Science in Health with emphasis in nutrition at the University of North Florida in Jacksonville.  A majority of his clinical trial work has been within the CNS realm supporting major depressive disorder, anxiety, bipolar, ADHD, and PTSD research but most recently he is learning about and supporting clinical teams needing oncolytic co-therapy medications.

Session Details: Innovative solutions for today’s clinical trial needs 28-09-2022, 4:00 pm View In Agenda

Biography: For the last few years, Nisha has been a patient advocate for the rare disease community, raising public awareness of the genetic skin disorder Epidermolysis Bullosa. Through the EveryLife Foundation’s Rare Disease Week on Capitol Hill and Rare Across America events, along with other organizations' advocacy events, she has shared her story with members of Congress to encourage them to support policies that benefit rare disease patients. She currently represents EB Research Partnership on EveryLife Foundation's Community Congress. Previously, she spent six years on the board of directors of The Shanti Project, a San Francisco–based nonprofit that enhances the health, quality of life, and well-being of people with serious illnesses. Nisha lives in South San Francisco, CA and works at mbaMission, a leading MBA admissions consulting firm, guiding applicants to top business schools in the U.S. and abroad in building their personal brands by identifying and showcasing the strongest aspects of their candidacy in their applications. She is also a certified business etiquette trainer, and coaches organizations on positive professional behaviors. Her BA in Communication from the University of Pennsylvania and deep interest in understanding the consumer inspired her to initially pursue a career in marketing research, which led her to positions at Time Inc., Rosetta, and KPMG LLP in New York City. After getting her MBA from the University of Michigan Ross School of Business, Nisha worked in brand management in San Francisco at Big Heart Pet Brands (now part of The J.M. Smucker Company).

Session Details: How to combine tech and patient perspectives to decrease costs and increase enrollment 28-09-2022, 12:30 pm View In Agenda

Biography:

Session Details: KEYNOTE DCT & HYBRID PANEL DISCUSSION 28-09-2022, 8:30 am View In Agenda

Biography: Senior Vice President of Integrated Customer Solutions and Trial Oversight As Senior Vice President of Integrated Platforms and Trial Oversight at Clario, Tim is responsible for delivering solutions that bring together the Clario portfolio of products to provide exceptional experiences for patients, sites, and sponsors.  His team focuses on minimizing the burden for patients and sites through the delivery of intuitive streamlined applications by uniquely combining traditional eCOA, Respiratory, Cardiac Safety and Imaging interactions in a harmonized ecosystem. Tim has 25 years’ experience of working in healthcare, with a focus on the medical imaging industry. He has held many executive positions, including Product Line Executive, CTO, CSO, and also as President and CEO at ImageIQ, where he led the company’s deployment of software engineering, high-resolution imaging and custom-tailored image analysis, to support the delivery of high-quality imaging data for clinical research

Session Details: Train the trainer: How to train patients in an era of decentralized clinical trials 28-09-2022, 12:30 pm View In Agenda

Biography: Aditya is the Regional Director of Business Development at Novotech, the Asia Pacific specialist CRO. He has extensive experience helping sponsor companies make their trials a reality across a range of projects from first in human to phase iv.  

Session Details: The Biotech landscape: Market trends, patterns and predictions 28-09-2022, 9:15 am View In Agenda

Biography: Matthew has over 20 years’ experience designing global real-world evidence solutions to support the development and commercialization of pharmaceutical / biotechnology products and devices.  His experience covers a wide-range of therapeutic areas, as well as strategic objectives from natural history programs, external control arm studies for regulatory approval, and global safety-surveillance mandate. His technical expertise includes program strategy and operational structure in disease and product registries, prospective pharmacoeconomic studies, and systematic reviews of scientific literature.

Session Details: RWE and the outsourcing paradigm – considerations for consensus and innovation 28-09-2022, 9:45 am View In Agenda

Biography: As a Solutions Consultant with eClinical Solutions, Dan serves as a subject matter expert for the elluminate Clinical Data Cloud, the foundation of digital trials. Dan is responsible for presenting the robust data management solutions made possible with elluminate, and can customize product demonstrations to address specific customer needs.

Session Details: 15minute Tech Showcase: Data-Driven Operations and Oversight with elluminate 28-09-2022, 2:30 pm View In Agenda

Biography: Highly experienced project manager with specialization in clinical operations and logistics. Over 10 years of experience managing industry-sponsored clinical trials in Biotech, CRO, and academic settings.

Session Details: Technological Advances in Clinical Trials – Exploring the Value of Decentralization 29-09-2022, 1:30 pm View In Agenda

Biography: Dr. Ahmar U. Zaidi is a pediatric hematologist who spent the last several years at the Children’s Hospital of Michigan, where he helped care for over 800 patients with sickle cell disease. He currently serves as Medical Director, Clinical Development for Agios Pharmaceuticals. Along with numerous publications and clinical trial experience, he has worked tirelessly as an advocate for sickle cell disease patients, fueled by a belief that medical misinformation and disinformation steadily contribute to poor outcomes in sickle cell disease patients.  He co-founded and hosts the sickle cell educational podcast, Cheat Codes; and has been an advocate for social media as a tool for patient and physician education.  He currently serves as the Chair of the Hematology Anti-Racism Task Force for the American Society of Hematology and the Chair of the Board for The Sickle Cell Reproductive Health Directive.

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Biography: Alexis Garelli has over 15 years of diverse healthcare information and pharmaceutical software technology experience. She has worked with Calyx for over 7 years as a key strategic leader and director in IRT solutions and services.

Session Details: How to leverage IRT to match the increasing need for flexibility in the clinical supply chain 29-09-2022, 11:30 am View In Agenda

Biography: Brittany Maley has more than 16 years of experience in customer service, instructional design, and research, working in the pharmaceutical industry for the last seven years. Along with her experience in gathering insights to enhance recruitment and retention, she uses her degrees in education and educational technology, and instructional design to bring the patient voice to clinical trials using creative and innovative methods.

Session Details: Train the trainer: How to train patients in an era of decentralized clinical trials 28-09-2022, 12:30 pm View In Agenda

Biography: Proficient clinical research/medical affairs professional with demonstrated success in a multitude of roles across numerous therapeutic areas and study phase in the US, Canada, APAC and EMEA. Provider of high quality independent consulting services to Medical Device, Biotechnology, and Pharmaceutical clients in support of study start-up, ongoing, rescue, and close out activities of clinical trials in all phases.

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