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McDermott Will & Emery United States

McDermott Will & Emery is a premier international law firm with a unique focus in representing life sciences companies and investors in a wide variety of transactional, intellectual property and regulatory matters.  Through our Life Sciences Entrepreneurs Acceleration Program ("LEAP") we provide early stage medical device, pharmaceutical, biotechnology and diagnostic companies access to sophisticated legal services.  Learn more here: http://www.mwe.com/leap/

Website:
www.mwe.com
Service Provider Type
Sector Interest
Biotech Phase of Development
Medtech Phase of Development
Unique Capabilities
Life Sciences Entrepreneurs Acceleration Program (LEAP)

McDermott Will & Emery is dedicated to investing in innovation and serving the early stage life sciences community that creates new and revolutionary products and services. We understand that sophisticated legal services are necessary to help these groundbreaking individuals and organizations succeed. McDermott is proud to have created the Life Sciences Entrepreneurs Acceleration Program (LEAP) to help qualifying entrepreneurs and young companies avoid costly mistakes and chart their courses to success by providing support and affordable access to strategic legal advice. We provide these organizations with high quality legal services during the earliest stages of corporate life through engagement incentives in the form of deferred fees, discounts, fixed-fee arrangements and/or awards.

We understand that early stage life sciences clients need legal advice in such complex areas as corporate formation, financing, intellectual property, licensing and collaborations, and employee benefits. Our Life Sciences Industry Group has a deep bench of lawyers that are highly regarded in these specific practices. Our corporate lawyers have demonstrated success in advising life sciences companies on the full range of transactional legal needs, including licensing and partnering, mergers and acquisitions, venture capital, public offerings and royalty stream financing. Our intellectual property lawyers are renowned for protecting the IP rights of our clients both in and out of court. Finally, McDermott is a pioneer in the field of employee benefits and has been advising life sciences companies on various compensation strategies to both secure and maintain leadership.

Mr Glenn Engelmann
Vice Chair, Life Sciences McDermott Will & Emery 
Byron Kalogerou
Kristian Werling
Partner 

McGuireWoods LLP United States

Emerging, middle-market and established companies alike require sophisticated legal representation that is cost-effective and capable of responding to the rapidly changing demands of regulators and customers. As counsel to domestic and global life sciences companies at every stage of development, the Life Sciences industry group at McGuireWoods offers clients a single, coordinated team of lawyers with deep, varied experience. Our clients recognize that they are treated as firm clients and not as those of a single practitioner or office location.

We counsel clients in all major areas of law affecting life sciences businesses and at every step in the product lifecycle. We provide guidance on corporate transactions and matters involving company structure and formation, financing, facilities acquisition and leasing, and vendor contracts. We have extensive experience in healthcare and life sciences-related regulatory requirements, including compliance audits and policies, FDA notification and approvals, development of pricing programs, and reimbursement and third-party payor processes.

Regulatory policies walk hand in hand with legislative mandates. In conjunction with our full-service public affairs subsidiary, McGuireWoods Consulting, we provide strategic communications and government relations guidance that helps businesses and industry coalitions shape pending legislation and respond to state and federal initiatives.

When disputes or law enforcement investigations arise, we provide aggressive defense against allegations of theft, product liability and mass torts. We represent clients facing government inquiries and administrative actions involving a broad range of issues, from securities disclosures and financial accounting rules to data privacy, antitrust and other compliance requirements. We also investigate and vigorously pursue counterfeiters, gray marketers and abusers of supply chain systems.

As life sciences businesses grow and transform, capital sourcing and other forms of financing become an important concern. We represent clients in negotiations with private equity investors, commercial banks and other financial institutions. Similarly, our depth of experience in public offerings and middle-market mergers and acquisitions adds value to growth and technology companies when exploring liquidity events.

While life sciences businesses share many of the same concerns as companies in other industries, these issues must be addressed in the context of this highly regulated sector of the economy. Our multidisciplinary team of lawyers provides broad-spectrum, coordinated counsel on all major areas of law affecting clients’ operations and strategy. These core areas of service include labor and employment, intellectual property, state and local taxation, and international trade. Our experience in these and other areas of law enables us to provide prompt, effective counsel in the dynamic life sciences marketplace.

Website:
www.mcguirewoods.com
Year Founded
1834
Service Provider Type
Sector Interest
Biotech Subsector
Medtech Subsector
Indication
Biotech Phase of Development
Medtech Phase of Development
Unique Capabilities

Emerging growth companies in today’s life sciences industry confront a growing list of regulatory and business demands. Such companies are often financially constrained; however, there is still need for sophisticated legal representation that can be executed thoughtfully and efficiently.

McGuireWoods represents emerging private and public companies at every stage of their development, from relatively small enterprises to multibillion-dollar medical device, pharmaceutical and biotech corporations. We provide counsel and advice on entity formation and review, recommend and negotiate financing options, and provide corresponding tax advice.

McGuireWoods also has an international reputation for merger and acquisition work, representing buyers and sellers in acquisitions, divestitures and joint ventures. As part of these transactions, we regularly negotiate corporate and limited-liability buy/sell agreements, stock option or other equity plans and agreements, and employment agreements.

In the intellectual property arena, we have worked with these companies to establish appropriate protections that can limit or block misuse of IP assets by employees, investors or competitive entities. We have also assisted clients in the transfer of intellectual property rights from individual owners to entities, and in protecting and maintaining those rights during merger or acquisition.

Our FDA team provides life sciences companies with strategic regulatory guidance and preventive liability consulting. At all stages of business growth, McGuireWoods can analyze compliance strategies, prepare and file FDA submissions, provide benchmarking audit and analysis of regulatory and liability postures, establish and monitor applicable internal compliance programs, and guide clients through implementation of new business, research and development initiatives.

Mr Brian Malkin
Mr Brian Malkin
LinkedIn logo Senior Counsel 
BIO

Brian leads the firm’s FDA regulatory teams. He has more than 20 years of food and drug law practice and over nine years of intellectual property law practice. In particular, his practice includes the interrelation between patent law and food and drug law. Brian’s regulatory experience includes all types of FDA-regulated products: drugs (including animal drugs), biologics, medical devices, foods and dietary supplements, tobacco products, and cosmetics. Brian’s intellectual property experience includes FDA and patent litigation for both innovator and generic companies.

Immediately prior to law school, Brian worked as a legislative correspondent in the U.S. Senate Committee on Labor and Human Resources. He began his legal career as a regulatory counsel at the U.S. Food and Drug Administration, where he worked for more than nine years in both the Office of the Commissioner and the Center for Drug Evaluation and Research. At FDA, he focused on new product evaluations, compliance issues related to clinical investigations and intellectual property (e.g., patent term restoration). Brian’s work resulted in new product approvals as well as new industry guidance documents and policies, such as the animal efficacy rule for counter-terrorism products.

Following several years of practice in an FDA law firm, Brian recognized an unmet need to understand both food-and-drug and intellectual-property law for lifecycle management and diligence, particularly concerning products affected by the Hatch-Waxman Act, such as generic and 505(b)(2) new drug applications. As a result, Brian returned to university to obtain a Bachelor of Science degree in biochemistry. Prior to joining McGuireWoods, he practiced for more than nine years at an intellectual property law firm, where he worked on a variety of new product evaluations, FDA and patent litigations, due diligence projects, patent prosecutions, and licensing and commercial transactions.

Given his particular experiences, Brian frequently is asked to speak and write on numerous FDA- and intellectual-property-law issues, including clinical trials and new product development for complex and challenging products, such as biotechnology products, orphan drugs, generic drugs, 505(b)(2) new drug applications, patent-term restoration under the Hatch-Waxman Act, biosimilar products, tobacco products, patent-term adjustment, risk management and due diligence.

Community

Brian has been actively involved in promoting the biotechnology community locally, nationally and internationally. Locally, Brian is working with BioBuzz to help stimulate a more active bioscience workforce and a more dynamic bioscience industry throughout Maryland, Virginia, the District of Columbia and beyond. In February 2014, Brian worked with the Montgomery County Department of Economic Development to present a program on “Innovative Strategies for New Product Development.” Brian also is working with McGuireWoods to sponsor the 2014 Biomanufacturing Technology Summit (biosimilars) to be held in June 2014 by the Institute for Bioscience and Biotechnology Research at the University of Maryland. In addition, Brian served on a board of judges for a local entrepreneur contest for a chemical and life sciences class at the University of Maryland’s Mtech Biotechnology Research and Education Program. He also currently mentors two health law students through a program coordinated by the Maryland State Bar Association’s health law group. Nationally and internationally, Brian has networked with biotechnology groups in Maryland, Massachusetts and Washington state, as well as with the Biotechnology Industry Organization. He also has presented at conferences featuring topics such as orphan drugs, biosimilars, and updates from FDA’s Center for Biologics Evaluation and Research. Brian was proud to join McGuireWoods in sponsoring and participating in Life Science Nation’s Redefining Early State Investments Conference, which was held in Boston in March 2014 and featured early-stage life sciences companies, investors and service providers. In November 2013, Brian co-presented a variety of programs for a Korea-Maryland USA Bio Expo in Rockville, Maryland, on the following topics: (1) current good manufacturing practice (cGMP) and its role in regulatory drug quality, (2) current drug shortages and orphan drug disease pharmaceutical development, and (3) innovative strategies for new drug development/biobetters.

Blogging

Brian is a co-editor of McGuireWoods LLP's FDA Life blog which covers news and trends impacting the FDA and life science industry.