이번에 KAPAL 과 KASBP Washington DC Chapter 가 함께 준비한 Joint Networking Dinner 에 여러분을 초대합니다. 코로나 바이러스 팬데믹 동안 못보신 분들과 서로의 안부도 묻고 맛있는 저녁도 함께 드시면서 좋은 말씀 나누시는 기회가 되시기를 진심으로 바랍니다. 석식준비를 위해 등록을 부탁드립니다. 이미 등록을 하셨으면 감사드리고 당일에 꼭 참석해주시기를 부탁드립니다. 혹시 부득이한 사정으로 등록하셨는데 데 참석을 못하실 경우 꼭 등록 취소는 contact@kapal.org 로 간단히 이멜 부탁드립니다.
Hello, you are cordially invited to the 2022 KAPAL-KASBP Washington DC Chapter Joint Networking Dinner, which will be held on July 21, 2022 at 6 pm. There will be Korean catering dinner and drinks ready for you and your colleagues. If you have any questions related to the registration or event, please email to contact@kapal.org (KAPAL) or calciumhwang@gmail.com (KASBP DC Chapter). Please share this invitation with your colleagues and come to join the 2022 KAPAL-KASBP Washington DC Chapter Joint Networking Dinner.
— Private professional adult-only event. — Event will be held in Korean/English
Sung provides counsel to FDA-regulated companies in developing, distributing, and marketing FDA-regulated digital health products and, when necessary, in responding to regulatory and administrative enforcement actions by federal and state agencies. Sung frequently counsels clients on FDA’s legal and regulatory requirements and policies for digital health products, and provides counsel that allows companies to comply with FDA’s policies and requirements. Sung has experience in responding to FDA’s various enforcement actions such as warning letters, untitled letters, and form 483 notice of inspectional observations. Sung understands the unique business landscape of FDA-regulated products, and provides practical advice that suits the needs of the client’s business.
발표 II : 윤학희 CEO (Harry Yun) / InBody USA
Harry Yun is the CEO of InBody USA, a prominent medical device company from Korea and a worldwide leader in body composition technology with a mission to provide biomedical technology that simplifies the understanding of health and wellness. InBody USA was established in the year 2000 in Beverly Hills, California and has moved its corporate office to Cerritos, California in 2012. Under Yun’s leadership, InBody continues to successfully penetrate the US market with state-of-the-art technology. Yun is a graduate from Hankuk University of Foreign Studies (HUFS) with Masters in Economics and has extensive experience of International Marketing.
발표 III : 조성환 CTO (Sunghwan Cho) / NanoCellect Biomedical Inc
Sunghwan Cho is the CTO of NanoCellect Biomedical Inc, whose mission is to facilitate breakthrough biomedical discoveries by making cell analysis and sorting technology more affordable and easier to use. He has 15+ years of expertise in integrating microfluidics, optics, micro/nano-fabrication, and electronics for advanced biomedical devices and instruments. He is also an inventor of the company’s core technologies, including its microfluidics-based cell sorting platform, and manages the company’s research project and product development. He was selected as a Marylou Ingram Scholar of the International Society for Advancement of Cytometry (ISAC) from 2012 to 2017, recognized for his contribution to the field of cytometry.
Pinecone41 is a Fintech startup that specializes in R&D Tax Credit services and provide technology startups accurate and beneficial tax insights that can be used to fuel growth.
Alex is a Tax Partner in KPMG’s Los Angeles Federal Tax Services, Korean practice. Before joining KPMG, Alex started his career in the tax department of Deloitte Korea and performed various tax projects until he was seconded to the US office. He has more than 20 years of experience in U.S. and Korea tax consulting, income tax compliance and income tax provision.
Alex is responsible for a broad range of U.S. multi-national and foreign-owned clients doing business as single entities or joint ventures, and has extensive experience with a wide range of tax matters relating to multi-national businesses. Alex’s current and past clients include leaders in the industrial production industries and high-technology, media, and telecommunication industries.
Alex has provided tax compliance services for various engagements in size from private to multi-national public companies in the U.S. and Korea and has extensive experience in defending corporations against tax examinations by Federal and state tax authorities.
Alex also has provided tax consulting services related to merger & acquisition transactions, business transfer transactions, cross border transactions and various tax due diligence services.
Alex has strong tax technical skills and tax provision skills with extensive experience in ASC 740 and ASC 718-10 for multinational and private companies.
Shawn Kim
Managing Director, KPMG LLP
Sanghoon has over 18 years of experience in dealing with audit, tax and transfer pricing matters for multinationals operating in different industries, from manufacturing and distribution sectors to the financial industry.
Sanghoon manages tax planning, audit defense and documentation projects for significant and complex intercompany transactions, covering tangible goods, complex services, intellectual property and financing structures. He deals with tax authorities on behalf of taxpayers with respect to transfer pricing audit defense and Advance Pricing Arrangements.
Work Experience
• Dealt with tax authorities related to tax audit, tax appeal, advance pricing agreement (APA), and mutual agreement procedure (MAP)
• Assisted companies in preparing worldwide transfer pricing policies
• Assisted companies in preparing FIN 48 analyses
• Prepared transfer pricing planning study and contemporaneous transfer pricing documentations
• Prepared management service fee documentation
• Performed intellectual property valuation analyses
• Performed royalty analysis products, especially in automobile parts industry
***** Notice *****
* Please note that the webinar talk will be presented in ENGLISH language. But Q&A session will be conducted in both English and Korean.
* 이번 세미나는 Maryland 주정부 관계자 분들을 포함하여 영어권 참석자 분들이 있어, 강의는 영어로 진행될 예정입니다. 참고로 질의 응답은 영어와 한국어 모두 가능함을 안내 드립니다.
2021 KAPAL–KHIDI Bio & Health Webinar Series는 한미생명과학인 협회 (KAPAL)와 KHIDI 미국지사 웨비나 시리즈입니다.
Topic Title: Clinical Development ‘R’ us
Clinical development has been the significant challenge for drug developers due to a low likelihood of success (e.g., 9.6% from Phase I for all developmental candidates*). Regulatory sciences and strategies become increasingly critical pillars in building clinical development plan for any successful new drug development.
In this presentation, roles of regulatory sciences and strategies in the clinical development will be elaborated.
* Clinical development success rate 2006-2015, BIO Industry Analysis
About the presenter:
Sang Mok Chung, Ph.D.
Vice President of Regulatory Affairs
LG Chem Life Sciences Innovation Center, Cambridge, MA
Dr. Chung has dedicated his professional development at building expertise in regulatory science* of drug development. Dr. Chung has extensively reviewed regulatory submissions such as Investigational New Drug, New Drug Application or Biologic License Application from clinical pharmacology perspectives as part of multidisciplinary team. Dr. Chung’s review experiences cover conventional small molecules, peptides, oligonucleotides, biologics and biosimilars. Dr. Chung has therapeutic backgrounds in the areas of diabetes, lipid disorders, obesity and endocrinology (e.g., growth hormone deficiency, Cushing’s disease, or thyroid hormone) with further expansion in many other diseases (e.g., pulmonary and rheumatology), which can indicate for conventional or rare diseases. Dr. Chung has actively participated in regulatory researches as PI or co-PI, and presenting those results at scientific meetings. Dr. Chung has given lectures related the clinical development to colleges and universities.
Dr. Chung earned Ph.D. in Pharmacokinetics, College of Pharmacy, University of Illinois at Chicago.
