Outsourcing in Clinical Trials Southern California 2022

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: 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: 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: A Fireside Chat on…Regenerative Medicine as a future trend 28-09-2022, 4:30 pm Chair’s Opening Remarks 29-09-2022, 8:25 am FIRESIDE CHAT Establishing strong CRO/sponsor/site relationships and building trust 29-09-2022, 12:00 pm 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: KEYNOTE DCT & HYBRID PANEL DISCUSSION 28-09-2022, 8:30 am PANEL DISCUSSION ClinOps team focus: Managing relationships and hiring in the new world 28-09-2022, 11:00 am View In Agenda

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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 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 29-09-2022, 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, 4:30 pm View In Agenda

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Session Details: CASE STUDY: Creating synergy between internal teams to strengthen the patient perspective through advisory boards 28-09-2022, 2:00 pm View In Agenda

Biography: Dr. Lei Zhang has over 25 years of experience spanning across the biotech/biopharma, medical device, and diagnostic industries. Her unique drug development lifecycle expertise includes clinical development/operations, scientific innovation and regulatory interactions with the FDA (CDER, CBER, CDRH). Lei serves as VP of Global Scientific & Regulatory Affairs at Frontage Labs. She obtained her PhD in Germany and performed Postdoc Research at MIT.

Session Details: Chair’s Opening Remarks 28-09-2022, 8:20 am KEYNOTE DCT & HYBRID PANEL DISCUSSION 28-09-2022, 8:30 am 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: 20+ years in biotech/biopharma industry, with expertise in oncology and biologics: starting as a scientist (first employee of the company) developing oncolytic virus and bacteria as live biologic drug products for cancer diagnosis and immunotherapy in human and veterinarian medicine, growing along with the company from department director to Associate VP and to VP. Currently leading Phase I, II & III clinical development in the US and Europe (UK and Germany) as VP of Clinical Trial Operations. Closely interact with regulatory agencies (FDA, USDA & NIH OBA of the US, MHRA of UK, PEI of Germany, etc.), large academic (e.g. Stanford School of Medicine, UCSD & Moores Cancer Center, NIH, Dana Farber Cancer Institute/Harvard Medical School, University of Tuebingen, University of Wuerzburg, University of Leeds, University of Surrey, Institute of Cancer Research UK, etc.) and institutions (e.g., Memorial Sloan-Kettering Cancer Center, California Veterinary Specialists, University Clinic Tuebingen, Royal Marsden Hospital, Royal Surrey County Hospital, Florida Hospital, etc.), CROs, biotech and pharmaceutical companies, and key opinion leaders. Represent the company and present clinical and preclinical data in conferences and business partnership/licensing meetings.

Session Details: PANEL DISCUSSION ClinOps team focus: Managing relationships and hiring in the new world 28-09-2022, 11:00 am Clinical development strategies of cancer immunotherapy with the ‘end’ in mind 28-09-2022, 3:00 pm 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.

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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.

Session Details: IN-HOUSE VS OUTSOURCE 28-09-2022, 12:00 pm View In Agenda

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: 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, 9:30 am 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.

Session Details: Exploring the laboratory aspects of clinical trials in the new age 28-09-2022, 4:00 pm View In Agenda

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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

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Session Details: Managing clinical studies at medical device startups 29-09-2022, 1:30 pm View In Agenda