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.

Year Founded
1834
Service Provider Type
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.

Med Qiao Group LLC United States

Jean Yao, PhD, with 20+ years of extended experience in the areas of biology, medical research, and medical industry, has held various positions at Mayo Clinic and University of Minnesota. She funded Med Qiao Group LLC as for the Bridge between US and China in life science. Med Qiao provides business consulting services that include investment funding, market analysis, intellectual property protection, clinical trial arrangement, product approval application, China branch or division establishment as well as marketing, promotion, distribution and onsite manufacturing of medical products.

Jean Yao
Managing Partner 

MedPro Investors

MedPro Investors is a group of accredited investors based in New York USA. The group is made up of over 1 healthcare professionals seeking to invest in technologies that significantly advance the standard of care. The group considers companies at a range of stages and is geographically agnostic. Since the members are investing their own capital the investment size and capital structure are highly flexible. The group is actively seeking new investment opportunities and is open to leading financing rounds.
Stephen Nagler
Executive Director 

MidCap Financial LLC

MidCap Financial is a commercial finance firm that was founded in 28 with offices in Bethesda MD Chicago IL and Los Angeles CA. The firm focuses on providing debt financing solutions to healthcare companies. The firm generally provides loans of around $15 million and is involved in approximately 15 new deals each year. The firm considers companies located around globe.
Josh Groman
Managing Director 
James Taylor
Director 

National Heart Lung and Blood Institute

The Office of Translational Alliances and Coordination (OTAC) at the National Heart, Lung, and Blood Institute supports the development of innovative biomedical products to address unmet medical needs in the heart, lung, blood and sleep fields.  OTAC is home to the NHLBI's small business programs (SBIR and STTR) and the NIH Centers for Accelerated Innovations.

The NHLBI's SBIR and STTR programs comprise one of the largest sources of early-stage capital for U.S. small business, acting as engines of innovation for developing and commercializing novel technologies and products that aid in the prevention, diagnosis, and treatment of heart, lung, blood, and sleep diseases and disorders. The NHLBI provides grant and contract funding opportunities and resources to support small businesses performing research and development on technologies related to the mission of NHLBI. With an annual budget of $85M, the NHLBI funds about 200 companies each year through the Institute's small business programs.

The NIH Centers for Accelerated Innovations accelerate translation of scientific discovery into commercial products that improve health for patients. This unique public-private partnership is changing the way discoveries with scientific and commercial potential are identified and developed.

Dr Kurt Marek
Dr Kurt Marek
LinkedIn logo Deputy Director OTAC 
Dr Gary Robinson
Dr Gary Robinson
LinkedIn logo Business Development Specialist 

New Leaf Venture Partners

New Leaf Venture Partners is a venture capital company formed in 25 with offices in New York and San Mateo California. The firm currently manages two funds with its most recent fund having closed at $45 million in 27. The firm is looking to make equity investments ranging from $1-$25 million over the lifetime of the investment. The firm looks for companies primarily in the United States and some select opportunities in Europe. The firm plans to make between 1-5 investments over the next year.
Mike Dybbs
Principal 

Novo Nordisk

Novo Nordisk was founded in 1923 and is based in Bagsvaerd Denmark with additional R&D sites in Seattle WA Beijing China and Bangalore India. The firm is actively seeking to in-license assets and also forms research collaborations and co-marketing and distribution partnerships with other biotech companies. Novo Nordisk is focused on developing protein and peptide therapeutics and protein delivery devices. The firm has also in-licensed antibodies. Indications of interest include metabolic disorders blood and immune disorders growth disorders and inflammatory disorders. Within the inflammation fieldthe firm is particularly targeting therapies based on cytokines and on molecules on the surface of cells involved in immune regulation. The firm is interested in certain orphan conditions. In addition to partnering and in-licensing Novo Nordisk has a corporate venture fund Novo AS. The firm also offers research grants and resources for studies into Novo Nordisk's products.
Charles Gray
Sourcing Director 
Tomas Landh
Director 

Omnes Capital France

Comprising 10 investment professionals, Omnes Capital’s venture capital team acquires minority stakes in young companies with high growth potential. Its main areas of interest are financing innovative business ventures in the information technology and life sciences sectors (drug development, diagnostics, medical devices, bioproduction).

For 12 years, Omnes Capital has managed FCPI mutual funds (French regulated mutual funds investing in innovative companies).

Bruno Montanari
Director 

PATH

PATH is an international nonprofit global health organization that was founded in 1977 and is headquartered in Seattle with 12+ employees in more than 3 offices around the world. PATH is one of the largest nonprofit organizations in global health today. PATH works on a wide array of emerging and persistent global health issues in the areas of health technologies maternal health child health reproductive health vaccines and immunization and emerging and epidemic diseases such as HIV malaria and tuberculosis. PATH is best known for developing and adapting technologies such as improved vaccination devices and new tools to prevent cervical cancer to address the health needs of developing countries. It targets health problems evaluates possible solutions and assesses whether they would be useful in finding health solutions.
Bill Cadwallader
Senior Commercialization Officer Diagnostics 
Greg Zwisler
Commercialization Officer 

PBM Capital Group

PBM Capital is a hybrid family office and operating company based in Charlottesville Virginia with an additional office in New York City. The firm is funded and led by the successful life science entrepreneur Paul Manning who started and sold several companies in his career. The firm can make investments ranging from approximately $5 to $1 million into companies and due to its funding structure has no requirements for holding period or capital structure. The firm makes investments in the forms of equity controlling interest in-licensing MBO/LBO growth capital and is also willing to co-invest. The firm is looking for companies located around the globe and makes around 5-15 investments in a given year.
Jayson Rieger
SVP of Business Development & Portfolio Management