Category: Meeting

본 행사는 주 미국 대한민국 대사관에서 주최하며 한국보건산업진흥원 및 한미생명과학인협회 (캘리포니아)에서 주관하는 온라인 웨비나 및 오프라인으로 동시 진행되는 행사 입니다.

이벤트 신청 페이지: https://www.eventbrite.com/e/349092704677

연사 소개

발표 I : 박성원 변호사 (Sung Park) / Reed Smith LLP

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.

2022 KAPAL–KHIDI Bio & Health Webinar Series는 한미생명과학인 협회 (KAPAL)와 KHIDI 미국지사 웨비나 시리즈입니다.

Topic Title: US R&D Tax Credit & Corporate Tax

o “US R&D Tax Credit Introduction”

Christina Ahn, CPA, R&D Credit Specialist, Ardius (acquired by Gusto)

o “US Corporate Tax Filing Requirements and Transfer Pricing Issues”

Alex Koo, Tax Partner, KPMG LLP / Shawn Kim, Managing Director, KPMG LLP

About the presenter:

Christina Ahn, CPA

R&D Credit Specialist, Ardius (acquired by Gusto)

Co-founder and CEO, Pinecone41

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.

Top Skills

Financial Analysis, Data Analysis, Corporate Tax

Experience

Ardius (acquired by Gusto, R&D Credit Specialist), Pinecone41 (CEO), KPMG (Tax Manager), Deloitte Tax LLP (Senior Tax Consultant), Mah & Associates (Staff Accountant)

Alex Koo

Tax Partner, KPMG LLP

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.

* Please note that the webinar talk will be presented in KOREAN language.