Outsourcing in Clinical Trials Southeast 2021 - A Virtual Conference
Virtual Event: 8:45 am EST
30th-31st March, 2021
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Outsourcing in Clinical Trials Southeast 2021 - A Virtual Conference
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IMPORTANT: Beware Fraudulent Emails
Outsourcing in Clinical Trials Southeast is postponed to March 30th & 31st 2021
In light of the recent global developments around the COVID-19 virus we have made the unavoidable decision to postpone Outsourcing in Clinical Trials Southeast
We have closely followed the advice of the WHO, Governments and health authorities and have at all times prioritized the well being of our attendees. The full guidance is available here: https://www.cdc.gov/coronavirus/2019-ncov/index.html
We must comply with the current restrictions and believe postponing the event is in the best interests of all concerned.
We would like to be clear that this is a postponement, and not a cancellation, and we look forward to hosting Outsourcing in Clinical Trials Southeast in March 2021.
We appreciate your support and understanding of this unavoidable course of action and look forward to a successful event later in the year.
Outsourcing in Clinical Trials Southeast 2021
OCT Southeast will be returning in a virtual format for its 9th year in 2021!
The 9th annual edition will welcome pharmaceutical companies across the Research Triangle Park to share knowledge and brainstorm solutions to issues regarding clinical trial supplies, both with regards to operational and technological challenges. Over the two days, delegates will discuss issues which affect their business and look for practical solutions.
Our dedicated and focused event which brings together over 100 clinical operations executives will be the perfect setting for showcasing what steps the industry is taking to improve processes within clinical supplies and patient centricity as well as which operational challenges are currently causing headaches for trial sponsors. Throughout the two days, delegates will enjoy a dynamic programme of case-study presentations, interactive panel discussions, prize draws and networking opportunities which will enable the audience to discover practical takeaways.
At each virtual event we create a welcoming networking environment and an educational program packed with the latest case studies, techniques and providers to set your trial apart.
What do you get access to if you register?
- Make new connections with our facilitated networking opportunities
- Deep dive into key issues by joining one of several expert-led panels and roundtables
- Hear from industry leading headline speakers
- Multiple subjects covered to encourage cross-industry learning and collaboration
- Intimate structure & higher engagement on a brand new virtual platform designed by GlobalData specifically for us
Places are limited so register your interest today!
A FANTASTIC NETWORK OF YOUR PEERS AND COLLEAGUES RIGHT AT A TAP OR CLICK OF A BUTTON
Simply register, login on the day and get ready to connect and learn. With the right network at your fingertips, learning and connecting have never been so easy.
💻 Watch live and recorded thought leadership presentations
🗣️ Take part in live Q&A with industry experts from across the globe
👩💻 One-to-one & group video chat with each solution provider
🤝 Chat & network with anyone on the platform in our Community Discussion Lounge
📊 Take part in our interactive polls
👥 Join live panel debates and discussions
🛍️ Download resources from solution providers to your event bag
TESTIMONIALS
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‘That was a superb day, it feels like we’ve been at a real, in person, conference!’ Worldwide Clinical Trials
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‘A great event, I met more people than I do at an in-person event and I’ve got loads of follow ups’ Conversis
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‘The whole setting is actually very well accomplished! Thanks again for the invitation!’ Apogenix AG

Kevin Crawford
Head of Clinical Operations,Tenax Therapeutics
Biography: Currently leading Clinical Operations at Tenax Therapeutics, Kevin M. Crawford is a 23-year clinical research veteran, having held leadership posts under such leading brands as GlaxoSmithKline (GSK), Johnson & Johnson, and United Therapeutics. A certified executive coach, contributing writer and vlogger as well, Kevin’s insights on a personal and professional mission, organizational leadership and life balance have garnered a growing cult following and demand as an executive consultant and speaker. With a Master’s degree in Biotechnology from the University of Maryland, he has published in the Journals of the American Thoracic Society and American College of Chest Physicians. Kevin lives in Raleigh, NC with his wife and three children, and when he is not “ON,” he enjoys playing soccer, kayaking, volunteering and having bad coffee with good friends
Session Details: The impact of corporate catabolism on clinical trials: Team dynamics, individual performance and bottom line 30-03-2021, 12:00 pm Crisis Scenarios: Obstacles with integrating technology in Clinical Trials 30-03-2021, 3:00 pm Debate: Decentralized Trials; the future of medicine or a disaster waiting to happen? 30-03-2021, 3:30 pm View In Agenda

Ed Addison
CEO,Cloud Pharmaceuticals
Biography: For 30 years, I have been a serial entrepreneur, starting multiple tech companies. Today, I am adviser to startup companies and venture capital funds, including startups originating at universities. I am a partner in Spectacular Health Ventures, a newly forming venture firm and fund in 2020 that applies advanced technology and modern trends to disruptive health ventures. I am active on the boards of startup companies. I am Chairman of Cloud Pharmaceuticals, a leader in Artificial Intelligence based drug development, located in Research Triangle Park. I am also a part-time adjunct professor/lecturer of Entrepreneurship, Product Management and Engineering. To that end, my goal is to motivate engineering students to find their passion and create breakthrough products and ventures. I advise a number ventures including Drug Logic, Parallel Profile, and PolarisQB, as well as some emerging new starts that are under wraps. My approach to venture work is unique. I work for long periods of time incubating new venture projects, but I only work on high quality, promising opportunities. With a technical background in Artificial Intelligence, Bioinformatics and Software, and a business background in Life Sciences, Healthcare and SaaS, I started 7 companies, funded 5 of them and exited 3. I have twice been named "Entrepreneur of the Year" by different organizations. I have advised 7 venture capital funds and over 20 early stage ventures. I am a frequent public speaker on entrepreneurship, innovation and new venture work, as well as on Artificial Intelligence in Healthcare. I have an interdisciplinary technical background acquired through grad school, teaching at universities and advising technical startups. It includes AI, IT, bioinformatics and genomics, HPC, parallel and distributed computing, quantum computing, IoT and drug discovery. The Covid-19 period has shifted my focus to telemedicine, more AI-based drug discovery, and new methods of capital raising. I hold a BSEE from Virginia Tech, two MS degrees from Johns Hopkins, an MBA from Duke University, and an 'online' law degree from Concord Law School at Perdue University. I completed a sabbatical year at MIT in Artificial Intelligence. This eclectic educational background along with my multi-industry experience is uniquely suited to the entrepreneurship, innovation, startup and venture capital worlds, as well as university and industry roles in managing design, innovation programs, and partnerships. I stay current by reading approximately 500 pages per day.
Session Details: A vision for the future Artificial Intelligence (AI) trial 30-03-2021, 1:30 pm View In Agenda

Greg Hottell
Director, Supply Chain Group Lead,GlaxoSmithKline
Biography: Greg Hottell is a Director in the Clinical Supply Chain team at GSK, where he is responsible for the cost-effective, patient-focused supply of investigational product for GSK’s pharmaceutical development portfolio. Since joining GSK in 2011, Greg implemented an end-to-end planning platform for clinical supplies, helped redesign GSK’s approach to clinical supply blinding and unblinding risk management, and implemented Network Capacity Planning processes, all while consistently delivering top-tier performance with on-time supply of IP to patients. Greg is a member of the ISPE North American Investigational Product community of practice steering committee. Additionally, he has been active with the Global Clinical Supplies Group since 2016 by facilitating workshops, presenting, and authoring white papers. Greg has been a Supply Chain professional since 1999, most recently holding positions of increasing responsibility at Eli Lilly & Company and Fisher Clinical Services prior to joining GSK. He holds a bachelor’s degree in Operations Management, an MBA, and is a Certified Fellow in Production and Inventory Management (CFPIM) through APICS.
Session Details: Best practices for cold chain management of clinical trial materials and investigational medicinal products to ensure sensitive materials are not compromised during transportation 31-03-2021, 1:00 pm View In Agenda

Joy Carson
Vice President, Clinical Development & Operations,AskBio
Biography: Joy Carson is the VP of Clinical Development and Operations at Asklepios Biopharmaceutical (AskBio), where she leads the design and implementation of clinical protocols across indications, and oversees the AskFirst Patient Advocacy program. With more than 30 years of experience in the design and implementation of clinical trials, she began her career in the Behavioral Neuroscience laboratory at MIT, and has split her experience among academia, sponsors, and CROs. Currently focused on opportunities using viral vectors in the delivery of gene therapy and vaccines, she also has extensive experience in oncology drug development. Her experience spans first-in-human through post-registration studies, with study sample sizes from 3 – 500,000.
Session Details: Building your study around the patient to promote overall success within trials 30-03-2021, 9:00 am Speaker Hosted Virtual Roundtables 31-03-2021, 9:00 am View In Agenda

Nickie Ryan
Associate Director, Clinical Operations,Precision BioSciences
Biography: Nickie's experience includes the following: industry experience at contract research organizations (CRO) and biotech. Broad project management across matrix teams encompassing clinical development, alliance management, and business development. Study-level oversight and accountability for multiple functional departments to include project management, clinical operations, data management, pharmacovigilance, quality assurance, start-up and regulatory. Project and line management experience and strong organization skills. CRO business development activities including, client development, alliance relationship management, bid defense meetings, and project costing. Global clinical trial management experience including North America, Europe, Asia Pacific. In depth understanding of the drug development process, clinical trials conduct, GCP, ICH, FDA CFR and international regulations. Experience in Phase I - IV clinical trials, including multi-phase protocol design. Experience evaluating and performing due diligence of potential candidates. Experience in all steps of site start-up.
Session Details: Best methods of maintaining a successful relationship with a CRO to ensure each milestone is seamlessly met 31-03-2021, 12:00 pm View In Agenda

Jamie Christensen
Director,Silk Tech Pharmaceuticals
Biography:
Session Details: Lessons learned: Creating a data review plan to ensure adequate data monitoring thresholds are established and followed in your trial 30-03-2021, 11:00 am View In Agenda

Deborah Covington
Global Clinical Outsources Management & Contracts and Financial Planning,Grifols
Biography:
Session Details: Case Study: Juggling a fully outsourced model with multiple vendor contracts as a small biopharma 31-03-2021, 2:00 pm View In Agenda

Chad Whitaker
Associate Director, Business Operations& Program Management,Aerami Therapeutics, Inc.

Michael McLaughlin
Associate Director, Clinical Operations,Dermavant
Biography: Mike McLaughlin, MS, MSEd, RAC, has over 20 years of clinical research experience working in various roles at both small and large pharmaceutical companies and in a variety of CRO environments. Since 2017, he has served as Associate Director, Clinical Operations at Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in medical dermatology
Session Details: Speaker Hosted Virtual Roundtables 31-03-2021, 9:00 am Outsourcing from a Small Biopharma Perspective 31-03-2021, 10:30 am View In Agenda

Doug Cary
President,Cary Pharmaceuticals
Biography: Dr. Cary's entire professional career has been in the pharmaceutical industry. He has extensive experience in injectable products research and development as well as Drug Development. An MBA degree has given him the background to be an effective leader in New Business Development. At Abbott he successfully championed the development of pre-mixed drugs, as well as the Add-Vantage Drug Delivery System. He also played a critical role in the identification and commercialization of PCA (patient controlled analgesia). He is a co-founder of a successful specialty pharmaceutical company, Cary Pharmaceuticals Inc. and is the sole inventor of US patent 6,197,827 titled, Nicotine Addiction Treatment.
Session Details: Q&A: Looking at the best methods for securing funding for early stage clinical trials 30-03-2021, 10:00 am View In Agenda

Rodney Villanueva
Associate Psychiatry Residency Program Director,Aerami Therapeutics
Biography:
Session Details: Ensuring trials are reaching diverse populations as a means of ensuring success by meeting enrolment quotas 31-03-2021, 2:30 pm View In Agenda

Ryan Hovda
Head of Clinical Outsourcing,Novan, Inc
Biography: Ryan Hovda, Head of Outsourcing at Novan, Inc., has ~13 years of Pharmaceutical Industry outsourcing, contracts management, and client/service provider relationship management experience. Mr. Hovda has represented both service provider and sponsor organization negotiations, beginning his career at Parexel as a pricing analyst and culminating in a contracts departmental leadership position during his tenure there. Making the switch to sponsor side representation, Mr. Hovda has held leadership roles within the clinical development contracts/vendor management teams at Biogen, Array Biopharma (acquired by Pfizer), and Bioverativ (acquired by Sanofi). In his current role at Novan, he is responsible for both clinical development outsourcing (encompassing CRO/vendor outsourcing, clinical site contracting, and related financial/relationship management oversight), and also supports pre-clinical, CMC, and other business related contracts and outsourcing activities. Mr. Hovda holds an undergraduate degree in finance, and a MBA from National University.
Session Details: Fireside chat: Navigating RFP development to ensure strong contract negotiation to promote clear communication and milestones within your study 31-03-2021, 11:00 am View In Agenda

Chris Warner
VP of Clinical Operations, Lexicon Pharmaceuticals,
Biography: Chris is an innovative, results-driven, detail-oriented leader with over 30 years of pharmaceutical industry experience in the clinical operations, clinical development, and project management space. His past work history includes tenure at both large and small pharmaceutical companies, as well as the CRO industry. Chris currently works as VP, Clinical Operations at Lexicon Pharmaceuticals a small biotechnology company located in The Woodlands, Tx.
Session Details: Speaker Hosted Virtual Roundtables 31-03-2021, 9:00 am View In Agenda

Daniel Recinella
EVP Device Development,Amsel Medical Corporation
Biography: Mr. Recinella has over 35 years of experience in medical devices and has taken numerous products from feasibility to commercialization. His experience covers a wide array of devices ranging from Class I to Class III and has included the development of implants, combination products, hardware and consumables. Most of his career has been spent in engineering (R&D and Operations) and project management, but he also has experience in product management, regulatory and clinical. Dan started his career at Sarns (a division of 3M) where he was part of the team developing one of the first LVAD’s as well as consumables for open heart surgery procedures. From there he moved on to Mansfield Scientific, followed by AngioDynamics where he last served as interim Chief Technology Officer before leaving in 2012. Dan was at Veniti where he served as one of the executive level managers and led R&D, Operations, Clinical and Regulatory. He left Veniti after the company was successfully acquired by Boston Scientific in 2018. More recently, Dan served as the EVP of Device Development for ImmunSYS, Inc, a start-up company focusing on immunotherapy treatment for adenocarcinomas. Dan currently is the VP of Product Development for Amsel Medical Corporation. Amsel is developing a novel method for the treatment of non-compressible vessel trauma. Dan is named on numerous patents and patent applications. Dan holds a bachelor’s degree in Mechanical Engineering from the University of Michigan-Ann Arbor and an MBA from State University of New York-Albany.
Session Details: Q&A: Effective techniques for reviving a study that has gone off track 31-03-2021, 11:30 am View In Agenda

Revati Tatake
PhD, Global Director of Databases and Analytics,GlobalData
Biography: Revati Tatake currently serves as a Global Director of Databases and Analytics at GlobalData, where her primary responsibilities are to lead the development and continuous enhancement of integrated databases and analytical tools for providing competitive and business intelligence for pharmaceutical and biotechnology sectors Revati has more than 20 years’ experience, both in academic research and the healthcare industry, during which time she focused on basic and clinical research, drug discovery and competitive intelligence projects across many therapeutic areas. After academic career at Tata Cancer Research Institute and the University of Connecticut Health Center, she began her healthcare industry career at Boehringer Ingelheim Pharmaceuticals, where she led drug discovery projects involving small molecules, gene therapy and cell therapy for cardiovascular diseases, Rheumatoid arthritis and Diabetes. In addition to leading drug discovery projects, Revati co-chaired novel target identification group, scouted novel technologies for enhancing drug discovery efforts, established collaborations with experts in academic institutions to complement internal projects and evaluated in-licensing opportunities for their scientific and technical merit. She is a co-inventor on several issued US patents and applications related to the projects on cell and gene therapies. Before joining GlobalData, Revati worked at Citeline, where she was involved in competitive intelligence and analytics of clinical trials and pharmaceutical products. Revati holds a PhD in Tumor Immunology from Tata Cancer Research Institute. She was a post-doctoral fellow at the University of Connecticut Health Center.
Session Details: Debate: Decentralized Trials; the future of medicine or a disaster waiting to happen? 30-03-2021, 3:30 pm Challenges and considerations for cell therapy trials 31-03-2021, 1:30 pm View In Agenda

Frank Leu
CEO, Novapeutics,
Biography:
Frank Leu is a Co-Founder and CEO of Novapeutics at Philadelphia, PA - a biopharma spun-out from the University of Pennsylvania, developing a first-in-class small molecule beta-cell restoration curative for type 2 diabetes. Prior, Frank was at a specialty pharma Verto Institute, developing biologic therapeutics for treating the neuroendocrine cancer. Frank graduated with a Pharmacology Ph.D. from Weill Cornell Graduate School of Medical Sciences in 2001, and then post-doc in a Howard Hughes Medical Institute laboratory at the Rockefeller University in molecular enzymology. He has served as an adjunct instructor at the Rutgers Cancer Institute of NJ, and is an adjunct professor at the pharmacology department of the Thomas Jefferson Medical University. Frank also founded BioPharMatrix developing blockchain solutions to lifescience innovations at all phases, and serves as advisor to the Pennovations center working with 1776 / Benjamins Desk. Frank is a thought leader in the blockchain architecture innovations in the life-sciences and drug development, Frank serves on multiple advisory boards and frequently served as chairman, speaker, moderator, and facilitator for many life-sciences and drug development events.
Session Details: View In Agenda

Katrina Norial, Business Development Associate, Novotech
Business Development Associate,Novotech
Biography:
Session Details: Running Global Trials with Regional CRO Specialists 30-03-2021, 9:30 am View In Agenda

Deb Kientop
Vice President, Strategic Development, Oncology,Synteract
Biography:
Deb Kientop brings over 25 years of experience in oncology drug development. She started in the cancer research labs at the University of Wisconsin and then moved into business development, medical affairs and clinical development roles within pharma and CRO. Her career has included thought leader engagement, product lifecycle planning, strategy development and execution for proposals and bid defenses, as well as corporate strategy and alliance management. Through her work with oncology investigators and patient advocacy organizations, she has been able to incorporate insights into patient-centric development strategies. Kientop is also a published author and cancer patient advocate.
Prior to joining Synteract, Kientop was the Vice President of Life Sciences at Inteliquet, a healthcare technology company. Previously, she held senior director strategy positions at two large CROs, as well as numerous biopharmaceutical organizations including MedImmune, MGI Pharma and Eisai. Kientop holds a Bachelor of Science in Pharmacology and Toxicology and a Master of Business Administration from the University of Wisconsin
Session Details: View In Agenda

Roger Nolan
President, BioKier,
Biography: Roger has 30 years of management and drug development expertise from his leading roles in preclinical and clinical drug development programs, regulatory strategy and interactions, funding, and outsourcing to specialist service providers. With his experience in basic research, large and small pharma, and CRO settings he provides valuable insight into business and R&D operations for pharma/biotech companies. His specific therapeutic areas of expertise are in diabetes, oncology, gene therapy, and cardiovascular indications. He is currently President and Co-Founder at BioKier and was previously CEO at Plakous Therapeutics and Senior Scientist in Clinical Development at Cato Research. Roger received a PhD in Pharmacology and Biochemistry from Melbourne University and completed Postdoctoral fellowships at the National Institute of Environmental Health Sciences and at Burroughs Wellcome.
Session Details: Q&A: Looking at the best methods for securing funding for early stage clinical trials 30-03-2021, 10:00 am View In Agenda

John McAdory
Head of Clinical Operations,SillaJan, Inc

Dr. Scott Trieber
Vice President, Strategic Development, Synteract,
Biography: Dr. Treiber is a CRO industry veteran with 28 years of clinical development experience. Most recently, Dr. Treiber was Chief Operating Officer at Elligo Health Research. Before that, he was Executive Vice President, Biopharmaceutical Development and GM at Chiltern. Dr. Treiber began his career as a Clinical Research Assistant at a large CRO. Since that time, 23 of his 28 years in the industry have been at CROs. He has also worked at Hospira and Elligo Health Research gaining valuable pharma and site network experience, respectively. Dr. Treiber has expertise in clinical operations, clinical development, medical affairs, data management/statistics, pharmacovigilance/safety and quality. He has broad therapeutic expertise in neuroscience, oncology, hematology, pain, cardiovascular, gastroenterology, respiratory and women’s health. Scott has a BA in biology from the University of Iowa, a PhD in neuroscience from the University of California Santa Cruz and an MBA from New York Institute of Technology.
Session Details: The Progression of Targeted Therapies: Addressing & Surmounting the Complexities in Clinical Development 30-03-2021, 2:00 pm View In Agenda

Julia Forjanic Klapproth
Owner & Senior Partner, Trilogy ,
Biography: After receiving her PhD in developmental neurobiology, Julia started her career as a medical writer in the regulatory group at Hoechst Marion Roussel (later Sanofi) in 1997. Since then she has been president of the European Medical Writers Association (EMWA) twice (2001-2002, 2007-2009). In 2002, Julia co-founded Trilogy Writing & Consulting, a company specialized in providing regulatory medical writing. In addition to managing the company as President/Senior Partner, she writes a wide array of clinical documents including study protocols, study reports, and is specialized in the clinical parts of CTD submission dossiers.
Session Details: The value proposition of good medical writing for clinical study protocols 30-03-2021, 10:30 am View In Agenda
Sponsors























Advanced Clinical is a global clinical research services organization, providing CRO, FSP, Strategic Resourcing and Consulting Services for biopharmaceutical and medical device organizations. Our company is committed to improving all lives touched by clinical research and we address the hopes of patients and healthcare professionals with industry-leading services and technology in life sciences. Visit our website to learn more about how we deliver a Better Clinical Experience.

With over 40 years’ experience, 600 beds and locations in NA, EU and Asia, Celerion conducts First-in-Human, clinical Proof-of-Concept and patient dose response studies, cardiovascular safety and NDA-enabling clinical pharmacology research. Celerion provides full study services including statistics, data management and biostatistics (including PK/PD analysis), and bioanalytical services.



Pharm-Olam International delivers cost effective, quality clinical services to pharma and biotech sponsors across all therapeutic areas in more than 40 countries. Since 1994, we have been committed to our objective: to create value for our clients by satisfying their clinical development needs with consistent and dependable solutions and services.

Pharm-Olam International
SPONSORSHIP OPPORTUNITIES
The program for the event is currently available for download. Please get in touch with us if you would like to be part of the program
Nicholas McCudden
Sponsorship Manager
T: +61 280 978 126
E: nicholasmccudden@arena-international.com
SPEAKING OPPORTUNITIES
The program for the event is currently available for download. Please get in touch with us if you would like to be part of the program
Chloe Roberts
Director of Events- OCT Series
T: +44 (0) 207936 6822
E: chloe.roberts@arena-international.com