Drew N. Kelner, PhD, is a classically trained Biochemist with 30 years of experience in the Biopharmaceutical Industry as both a hands-on scientist and scientific leader in process, analytical, and formulation development, product commercialization, and product quality assessment.
During his long tenures at Bayer and Amgen, Dr. Kelner had the privilege of participating in the development, registration and/or lifecycle management of 15 biological drugs (9 BLAs), including Epogen, Neupogen, Aranesp, Neulasta, Prolia, Kogenate (Factor VIII), and Vectibix. He has deep experience in the development of biologicals for oncology and immune disorders, including Imlygic, the first licensed oncolytic virus for melanoma, and Blincyto, the first licensed immunotherapy (for leukemia) using a bifunctional ("BITE") antibody. His experience covers all aspects of biopharmaceutical product development, with proven expertise in the commercialization of manufacturing and quality operations for biopharmaceuticals, as well as extensive experience with global regulatory filings at all stages of the product lifecycle. Dr. Kelner’s development and commercialization experience cover both innovator (including first-in-class) therapeutics as well as multiple biosimilars.
Litigation Support - As President of Colorado Biotechnology Consultants, Dr. Kelner has experience as an expert consultant for Biopharmaceutical Patent Infringement and Trade Secrets litigation. He has written multiple declarations (U.S.) and Affidavits (Canada), largely around issues related to biosimilar patent infringement, leveraging his vast knowledge of the scientific literature and experience as a process development leader in both establishing intellectual property while designing ways around existing patents to enable unencumbered process and product development (where feasible).
Areas of Expertise: Dr. Kelner's scientific expertise covers all aspects of bioprocess development and commercialization, including extensive expertise in regulatory filings on a global basis. His areas of expert knowledge include Protein Biochemistry, Cell Biology, Immunology, and Protein Pharmacokinetics.
Ideal Client Engagement:
Eric F. Forister, PhD is an Economist with expertise in industrial organization, applied microeconomics, and applied econometrics. He has extensive experience in applying economic insights to understand firm and market behavior, analyzing large datasets using advanced econometric and statistical techniques, and designing and evaluating surveys. He has co-authored medical research papers and legal publications on class certification and market definition. As a consultant, Dr. Forister has addressed issues such as:
Dr. Forister has analyzed dozens of industries including consumer packaged goods, luxury goods, food products, medical services, biotechnology, legal services, fitness, clothing, entertainment, real estate, air and ground transportation, telecommunications, television, electronics, heavy industry, advertising, restaurants, automobiles, gasoline, payment processing, and illicit markets.
Episode #11- A look at how to work with an expert using regression analysis.
Nevium specializes in managing and increasing the value of intellectual property portfolios. You have your business plan; you have your marketing plan…Where is your IP plan? Quite surprising, most businesses don’t have an IP plan; nonetheless even know the total contents of their IP portfolio. At Nevium, we manage and monetize intellectual property and intangible assets. We believe these assets need to be identified, organized and managed in order to maximize value.
Nevium specializes in valuing, managing, monetizing and providing expert testimony related to intellectual property. Nevium values IP for business transactions, tax/estate, joint venture negotiations, transfer pricing and bankruptcy.
Nevium builds and manages intellectual asset management strategies for clients who want to monetize their IP. Mr. Bania and Mr. Buss are frequent lecturers on IP valuation and licensing issues and publish articles for numerous industry publications. Areas of expertise include music, apparel, publishing, film, food, automotive, sporting goods, furnishings, advertising, media, photography, retail and not for profit.
Consulting Services Include:
Doug Bania, CLP, Founding Principal, has over a decade of expertise in managing, valuing and monetizing intellectual property. Prior to founding Nevium, Mr. Bania managed 100s of projects related to brands, intellectual property and the related intangible assets. He has assisted clients in intellectual property matters related to acquisitions, litigation, bankruptcy, tax, estate, family and marital disputes, and licensing. Mr. Bania delivers presentations and seminars on IP valuation, management and damages issues for various business and legal entities across the United States.
Brian Buss, CFA, Founding Principal, is a Chartered Financial Analyst with over 20 years of experience in valuations, financial analysis, and corporate finance both in the United States and overseas. Mr. Buss provides strategic advice for intellectual property portfolios and transactions, guidance in determining economic damages, and profit apportionment in civil litigation, and performs valuations of trademarks, patents, copyrights, brand assets, trade secrets, technology assets, celebrity endorsements and marketing activities, and other intangible assets. Prior to founding Nevium, Brian Buss managed over 100 cases as an economic and valuation expert. He has developed financial models and forecasts for acquisitions, business valuations, licensing transactions, and new business ventures. His entrepreneurial experience includes serving as co-founder and financial officer for a technology start-up. Prior to launching Nevium, he worked at San Diego-based consulting firms, Westpac Institutional Bank, and Deloitte & Touche’s Financial Advisory Services group in New Zealand and San Francisco. Mr. Buss has been engaged to speak by various institutions, both nationally and internationally, on topics concerning finance, valuation, and damages.
|San Diego Office|
415 Laurel Street, Suite 341
San Diego, CA 92101
|Los Angeles Office|
9107 Wilshire Blvd., Suite 450
Beverly Hills, CA 90210
Sidney P. Blum, CPA, CFE, CPEA, CFF has over 30 years of professional experience in the areas of Forensic Accounting, Intellectual Property Economic Damages, Royalty Audits, and General Economic Damages. 2017 California CPA of the Year & 2012 Certified Fraud Examiner of the Year Mr. Blum is a Certified Fraud Examiner, Certified Professional Environmental Auditor, and Certified in Financial Forensics by the AICPA.
As a world leading Royalty Auditor and Risk Advisor, Mr. Blum has deep knowledge of Georgia-Pacific factors and other major influencers on reasonable royalty rates for patent litigation. He led the national royalty audit practices for Big 4 firms Ernst & Young and KPMG where he also wrote the global methodologies for both firms. He is one of five members of the Board of Regents with the 80,000 member Association of Certified Fraud Examiners.
Clients: Mr. Blum's clients have included Adobe, Amgen, Beats Electronics, DGA, Disney, Dolby, DreamWorks, DTS, DKNY, Ed Hardy, General Electric, General Motors, IGT, IMG, Marvel, Mattel, McDonalds, Microsoft, MLB, and the NFL to name a few. Commonly audited industries include consumer products, electronics, software, apparel, media and entertainment, aerospace, automotive for trademarks, patents and copyrights.
Mr. Blum’s two books published by Oxford University Press and LexisNexis on financial terms in contracts are leading sources of valuable information for attorneys and contract negotiators. He has also made numerous presentations to law firms, professional groups, universities, and others regarding contract compliance and auditing. View Sidney Blum's Expert Witness Profile.