Life Science Equity Partners

Life Science Equity Partners is a private equity firm based in Palo Alto California. The firm is solely focused on life science investments. The firm will invest in companies at all stages including early-stage companies with products still in development and late-stage companies with revenue. The firm typically makes early stage investments with a 1 year exit strategy in mind. The investment size is highly variable depending on the stage of the company. The firm has the ability to invest globally with typical allocations made to companies in North America. The firm is actively seeking new investment opportunities.
Michael Bianco
General Partner 

Life Sciences Alternative Funding United States

Life Sciences Alternative Funding (LSAF) founded in 213 is a direct investment firm based in White Plains New York. The firm focuses exclusively on providing debt capital for commercial-stage medical technology companies. The firm can allocate between USD 1M-5M per investment. The firm looks to provide flexible ?tailor-made? financing solution to companies. The firm can invest globally and is currently seeking new investment opportunities.

Steve DeNelsky
President 

Lilly Asia Ventures China

Lilly Asia Ventures is the venture capital arm of Eli Lilly that focuses on investments in the life sciences in Asia, particularly China. The firm was established in 2008 and is based in Shanghai, China. The firm is stage agnostic; investing in early, growth, and up to pre-IPO opportunities. The firm’s investment size is USD 5-20 million per company. The firm primarily invests in companies in China, but is open to companies across Asia-Pacific as long as there is some sort of China angle. The firm is actively seeking new investment opportunities.

Lilly Asia Ventures primarily focuses on therapeutics but is also interested in medical devices, diagnostics, animal health, and biotech other. The firm is most interested in products that will have a significant impact on medical care in China. For therapeutics, the firm seeks best-in-class or first-in-class products. The firm is opportunistic to the indication and the phase of development and will consider products in pre-clinical up to NDA. Historically, the firm invests in therapeutics for oncology, inflammatory diseases, and metabolic disorders.

Biotech Phase of Development
Medtech Phase of Development
Capital Structure Preference
Investment Stage Preference
Judith Li
Principal 
Michael Zhang
Investment Manager 

Longitude Capital United States

Longitude Capital is a private equity group founded in 2006 with offices in Menlo Park, California and Greenwich, Connecticut. The firm has $700 million in assets and has raised two funds, with the most recent fund closing at $385m in 2012. Longitude makes both venture-stage and growth-stage equity investments, which are typically in the $10-30 million range. Longitude Capital primarily invests in North America and the European Union but may also consider opportunities in the Middle East.

Year Founded
2006
Investor Type
Biotech Phase of Development
Medtech Phase of Development
Capital Structure Preference
Investment Stage Preference
Mark Chin

Lumira Capital

Lumira Capital is a Venture Capital firm that changed its name from MDS Capital In 2007 and have been investing in companies since 1989. The firm is based in Toronto will additional offices in Boston and Montreal. The firm currently manages 2 funds for a total of approximately $180 million in assets under management. The firm’s Lumira Capital II fund currently hold approximately $115 million in assets and is looking to invest in companies across North America. The firms Merck Lumira Biosciences fund formed via a partnership with Merck Serano, currently holds around $65 million in assets and is looking for early stage opportunities in companies located in or looking to move to Quebec. The firm typically makes initial investments ranging from $2-$5 million of equity and looks to invest $8-$12 million over the lifetime of the investment. The firm plans to make 4-6 investments over the next 6-9 months.

Investor Type
Biotech Phase of Development
Medtech Phase of Development
Capital Structure Preference
Investment Stage Preference
Peter Van Der Velden
Managing General Partner 
Jacki Jenuth
Vice President 
Brian Underdown
Managing Partner 
Beni Rovinski
Managing Partner 

M.H. Carnegie & Co.

M.H. Carnegie & Co. founded in 21 is a venture capital and private equity firm based in Sydney Australia. The currently has about $2 million in committed capital across several funds. The firm invests in several sectors including the Life Sciences. The firm can make early to late stage investments typically allocating USD 2-5 million per company. The firm is currently interested in companies abroad that plan to set up operations in Australia as the firm is mandated to invest in Australian-based companies. The firm plans to make 2-3 new investments in the next 12 months and is actively seeking new opportunities.
Mark Carnegie
Principle 
Trevor Moody
Principle 

Marvao Medical Devices Ireland

Marvao Medical is an early stage medical device company founded in 2006 to develop and commercialize products that reduce the incidence of catheter related bloodstream infections. Our first 2 product lines target a $1B global market opportunity. The first product line is now FDA cleared and is being evaluated at 3 centers in the US with very positive results. We are seeking to raise funds in mid/late 2015 to support full commercialization of this product which will enable the company to become highly profitable in early 2017.

 

Year Founded
2006
Medtech Subsector
Indication
Medtech Phase of Development
Technology Overview
We have developed a technology platform that aims to reduce the risk of catheter related bloodstream infections (CRBSI) in patients who require long term vascular access. We have received FDA clearance for our first commercial application of this platform, a hemodialysis (HD) catheter, which is now being clinically evaluated at 3 centres in the US. Our next commercial application is a line of central venous catheters used to deliver chemotherapy, antibiotics, nutrition, and hydration. The overall global opportunity for these two applications is >$1B.
Alliance & Collaborations
In 2008 we entered into a strategic OEM partnership with Harmac Medical Products. Harmac has major manufacturing facilities in the US, Ireland, and Mexico. They have supported our product development programs (including our FDA applications), built our clinical evaluation product, and are now well positioned to rapidly scale up production in 2015.
Supporting Metrics or Evidence
Clinically reported CRBSI rates for HD catheters range between 1.6 and 5.5 events/1000 catheter days. Our HD catheter clinical evaluation has accumulated 3000 catheter days to date with only 1 reported CRBSI event, yielding a rate of 0.3/1000 catheter days. These results have attracted significant interest from healthcare providers who recognise our product's potential to help deliver significantly better care at lower cost within their centers.
Current Financing Needs
Marvao is fully funded to meet our product development and clinical evaluation milestones in 2015. We are looking for new investors to come in alongside our existing investors in Q3 2015 to support our 2016 commercialization program. Our financial model indicates that a quantum of $2.0 - $2.5M is needed to enable the company to become profitable in early 2017.
Current Timeline
In January 2015 we will start the 2nd phase of our clinical evaluation by working directly with one of the world’s two largest HD service providers. The objective is to measure CRBSI rates over 10,000 catheter days across multiple centres in their network. This company is also the market’s single largest purchaser of HD catheters. We expect that low CRBSI rates observed over the course of this evaluation will translate into a significant catheter supply agreement in 2016.
IP Status
Our core technology is currently protected by 4 issued US patents, with 4 additional applications underway. We are in the process of further expanding this portfolio to cover commercially critical product features beyond our core technology.
Recent Milestones
Passed our 2nd FDA QSIT audit in Q3 2014. Passed our annual ISO 13485 certification audit in Q3 2014. Third HD catheter 510k clearance obtained from the FDA in Q4 2014
Management Team Highlights
Eamonn Hobbs: Chairman of the Board. Mark Saab: Co Founder, Principal Investor, Non Executive Director. Chris Davey: Co Founder, CEO
Chris Davey
CEO 

Mayo Clinic Ventures

Mayo Clinic Ventures serves to commercialize Mayo Clinic technologies for the benefit of patients worldwide while generating revenue to support clinical practice, research and education at Mayo Clinic. The office has licensed hundreds of technologies in the fields of medical devices, diagnostics, therapeutics, and healthcare IT, and has focused efforts in technology-based ventures and start-ups.  Mayo Clinic Ventures also has a $20M venture capital fund which is used to spin out companies that are developing products based on Mayo Clinic research.

Kelly Krajnik
Business Development Manager 

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.