Mr Aki Maeda United States

Teijin Pharma Ltd. has unique profiles managing pharmaceutical and home healthcare products and also strong value chaines from basic research to sales, maintenance and follow up to patients in both business divisions.

We are actively dedicating to look for opportunities to collaborate with the US companies including startups, instituites and investors to introduce products/technologies into JP market with some amounts of investments for the best collaborations.

We are focusing on areas of respiratory, cardiovascular, orthopedics, rehab and neurological diseases.

Mr Aki Maeda
Teijin Pharma Ltd.
Manager of Business Development 

Dr Pradip Maiti Canada

Immunimed Inc is a clinical-stage Biopharmaceutical company developing innovative egg-derived, oral potclonal antibody therapy to treat gastro-enteric infections/diseases. Our lead product IMM-001 targets super bug, Clostridium difficile, leading cause of hospital-acquired infections.

Currently is Phase II ready with remarkable clinical response in Proof on Concept multi-center clinical studies.  Phase II clinical study is planned for Q2 2015.

Year Founded
2013
Biotech Subsector
Biotech Phase of Development
Current Financing Needs

$5-6M to complete clinical development.

Current Timeline

Q1-Q2-2015

IP Status

Four patents issued and one pending

Immunimed Inc.
President 

Mr Brian Malkin 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
McGuireWoods LLP
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.

John Manzello United States

Promosome is a synthetic biology company founded to commercialize the discoveries of the late Nobel Laureate, Dr. Gerald M. Edelman, and colleague Dr. Vincent P. Mauro of The Scripps Research Institute (TSRI) in La Jolla, CA. Leveraging Dr. Edelman’s and Mauro's unparalleled expertise in the area of mRNA translation and the resulting technologies they pioneered, Promosome offers technology licensing opportunities to biotherapeutic and bioindustrial companies seeking to dramatically improve efficiencies in expression, secretion, and potentially biotherapeutic safety and dose tolerance.

In March 2014, GEHC and Promosome executed an agreement to license a subset of Promosome’s initial technology suite in support of their mammalian cell line development ambitions.

Promosome operates a developmental center in the Torrey Pines section of San Diego which focuses on expanding its mRNA translation-based toolset as well as identifying and developing a pipeline of proprietary proteins which can be differentiated by their unique manufacturing attributes (higher yields, greater homogeneity, etc.) and quite possibly by their safety profile in clinical use.

Year Founded
2004
Biotech Phase of Development
Technology Overview
Ribosomal Engagement mRNA Translation
Alliance & Collaborations
GE Healthcare Life Sciences
Current Financing Needs
5-10M USD
Current Investors
HWI
IP Status
Varying from Provisional to Granted
Recent Milestones
Exclusive Mammalian to GEHC
Management Team Highlights
Proven & Expanding
Promosome LLC
President & CEO 

Dr Kurt Marek

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
National Heart Lung and Blood Institute
LinkedIn logo Deputy Director OTAC 

Gifford Marzoni United States

DavosPharma’s corporate offering covers all the activities required to get a drug from conception to commercialization. DavosPharma has been filling this need since 1972, serving the pharmaceutical and life science market by providing discovery chemistry & biology, pre-clinical development, and all required CMC activities including custom synthesis of organic molecules, custom dosage formulation, and custom manufacturing of cGMP intermediates, APIs, and drug product. 

DavosPharma
Vice-President Global Pharmaceutical Development 

Yves Massicotte

Ropack, Inc.
President & CEO 

Nola Masterson

Science Futures Management is an investment firm based in California USA. In the Life Sciences the firm focuses on biotech therapeutics and diagnostics. The firm typically provides series A financing (equity) in the range of $25K to $5K. The firm is geographically agnostic but generally invests in companies based in the USA and Europe. The firm has no current mandate for the number of allocations it plans to make and will evaluate relevant opportunities as they surface.
Science Futures
Managing Director 

Gary Mathias United States

Year Founded
2011
Biotech Subsector
Biotech Phase of Development
Technology Overview

Thetis has discovered and is in the early stages of developing several compounds in the omega-3 arena that are quite differentiated from existing agents based on its proprietary HEALER Technology. 

  • TP-252 is an ionic derivative of eicosapentaenoic acid that delivers EPA with remarkable bioavailability in animal models. Unlike anything known in the omega-3 arena, TP-252 is a solid, stable, free-flowing drug substance that is suitable for tablet formulations and for potential use in fixed dose combination products with statins.
  • TP-113 (bis-metformin glutamate DHA) is a novel oral agent for treatment of T2DM as a 2nd generation metformin product with substantial differentiating pharmacological attributes and intellectual property protection. Its PPP targets significant HbA1c reduction as its primary clinical endpoint with enhanced pharmacological benefits that include insulin resistance resolution, multiple mechanistic effects on hepatic gluconeogenesis that could translate into lower metformin dosing requirements, and reduced serum triglyceride (TG) levels.
  • TP-352, an ionic derivative of docosahexaenoic acid that delivers DHA with remarkable bioavailability in animal models, has prospects for treatment of NASH based on the anti-fibrotic, metabolic and TG lowering effects of DHA.
  • TP-110 (bis-metformin glutamate EPA) has prospects as a first in class agent for treatment of PCOS based on the clinically established effects of its active moeties for ovulation restoration, reduced insulin resistance and enhanced anti-androgenic effects.  
Alliance & Collaborations
Marette Laboratory
Supporting Metrics or Evidence

HEALER Technology applied to already approved APIs with established safety records.

Current Financing Needs

$25 million to fund TP-113 through Phase IIa

Current Timeline

INDs can be opened on lead candidates within 12 months due to non-clinical safety efficiencies based on prototype candidate already vetted by FDA

Current Investors

Connecticut Innovations and Angel Investors

IP Status

Issued patents (US8765811, US8993124, US8901107) and non-provisional patent applications under petition to make special 

Recent Milestones
  • TP-113 preclinical studies in mice showing PDX formation
  • IND allowance establishing non-clinical safety of Thetis compounds
  • Extensive rodent pharmacokinetic studies demonstrating unique PK properties
  • Pre-formulation feasibility studies completed on lead candidates
  • Issued composition of matter patents on metformin compounds (TP-113/110)
Management Team Highlights

Frank Sciavolino, PhD, Chief Scientific Officer

  • former Pfizer R&D executive (Zithromax) and in-licensing (Celebrex)
  • PhD, Organic Chemistry, University of Michigan
  • Over 30 issued patents

Gary Mathias, MBA, Chief Financial Officer

  • Over 25 years as healthcare investment banking and entrepreneur
  • Former SVP, GE Equity, Healthcare
  • MBA, Yale University; BA Economics, Harvard College

Alexander Fleming, MD, Senior Clinical & Regulatory Officer

  • Former supervisory physician, DMEP, FDA
  • Expert in metabolic disease
  • MD, Board Certified, Endocrinology, Emory University

Andre Marette, PhD, Lead Investigator and Scientific Advisor

  • Professor of Medicine, Institute for Heart & Lung Research, Laval University
  • Pfizer Research Chair, Pathogenesis of Insulin Resistance and CVD
  • Recent publication on PDX effect on insulin resistance (Nat. Med. 5/11/2014)

Michael Van Zandt, PhD, Director, Discovery Chemistry

  • Former Director, Institute for Pharmaceutical Discovery (1996-2012)
  • PhD, Organic Chemistry, Wayne State University

Robert Lipper, PhD, Technical Consultant, Formulation

  • VP, Biopharmaceutics, BMS (1984-2008)
  • PhD, Pharmaceutical Chemistry, University of Michigan

Mehar Manku, PhD, Scientific Advisory

  • former Chief Scientific Officer, Amarin Corp.
  • Executive editor, PLEFAs
  • Inventory on 61 patents in polyunsaturated fatty acids
Thetis Pharmaceutcals
CFO