Dr Michel Levesque United States

Siragen Pharmaceuticals is a drug discovery and development company, focused on novel approaches to treat Aging and Neurodegenerative Disorders such as Alzheimer’s Disease. Siragen is developing a group of small lead molecules that tackles Alzheimer’s Disease and aging neurons by novel strategy different from current unsuccessful approaches.   Siragen Pharmaceuticals, based in San Diego, California, was incorporated in May 2014, and is a spin off of Neurogeneration Inc. Siragen's products will be for the brain what cholesterol agents are for the heart.

Website:
www.siragen.com
Year Founded
2014
Biotech Subsector
Medtech Subsector
Biotech Phase of Development
Technology Overview

Sira-9 targets a specific pathway of the stress response due to oligomer toxicity. Siragen has identified targets within this pathway that prevents the synapse loss induced by synaptic dysfunction and synaptotoxicity. Siragen has also identified another target, which alleviates age-associated phenotypes and extends the life span of neurons by reducing inflammation. These small molecules are specific and can be easily delivered as a pro-drug.

Alliance & Collaborations
UCSD, Duke University, UCLA, Salk Institute
Current Financing Needs

$5M

Current Timeline

Siragen’s development programs are focused on 1) target identification 2) target validation 3) hit to lead identification and optimization 4) in vivo studies and 5) begin clinical trials on identified compounds. The Company aims to develop its pipeline of novel molecules to clinical proof of concept and partner with industry leaders for late stage development and commercialization

Current Investors

Private

IP Status

•  expanding IP portfolio

Recent Milestones

• Target identified and validated for drug discovery in Alzheimer’s disease • Successful assay development for hits • Lead candidate Sira-9 currently in development for Alzheimer’s disease

Management Team Highlights

The team consists of CEO and Founder: Michel Levesque, MD, entrepreneur and neuroscientist, CSO and Co-Founder: Mohamedi Kagalwala, neurochemist and neurobiologist. Scientific advisory board consists of prominent scientist Dr. Eliezer Masliah (neuropathologist and neurodegenerative disorders expert, UCSD), Dr. Kalpana Merchant (Ex CSO, Translation Science at Eli Lilly Pharmaceuticals) and Dr. Anthony Means (pharmacologist, Baylor College of Medicine)

Siragen Pharmaceuticals, LLC
Founder 

Mr Andy Levien United States

Did you know that 10-15% of LASIK patients are turned away due to inadequate eye measurement equipment?  This laser refractive eye surgery market has a crying need for the next generation measurement tool now to capture these additional patients and improve on existing procedures and outcomes.

Did you know that ophthalmologists suffer significant measurement problems in accurately predicting the ELP (Effective Lens Position) in cataract surgery/Intra-Ocular Lens (IOL) procedures?

The ArcScan Artemis-3 system addresses both of these market needs and more.

ArcScan has already raised all funding needed ($3 million) to enter the laser refractive surgery market, with product introduction expected in 12 months.

The ArcScan Series A Preferred funding round of $3 million currently has $1 million available to investors from now through February, 2015, or until sold-out, whichever occurs first.

ArcScan is attending the RESI conference to raise the final $1,000,000 in Series A Preferred share subscriptions, which will allow us to accelerate entry into the large cataract surgery/IOL market and nearly double the size of the business.

Please request a meeting at RESI or contact ArcScan CEO Andy Levien for an executive summary and further investment details.

Website:
www.ArcScan.com
Year Founded
2007
Main Sector
Medtech Phase of Development
Technology Overview
Very high frequency ultrasound combined with precision control of scanner motion
Current Timeline
12 months to US product launch
IP Status
6 issued patents, 3 licensed (from Cornell), 12 applications
Mr Andy Levien
ArcScan
LinkedIn logo CEO & President 
BIO

Andy’s career in industrial and medical device instrumentation and automation and controls, spans companies from startup to Fortune 100. His diverse experience from shop floor to the C-Suite and as a leader in product and business development, global operations, supply chain and manufacturing operations, equips him with the skills that expertly guide leadership teams to breakthrough strategies and their implementation, delivering new pathways to customer value creation, revenue growth and operating profits.

A collaborative leadership style and keen technical, business, and emotional intelligence is underpinned by his passion to create a transparent, shared vision through a planning process encompassing lean management principles: accountability to clearly defined performance metrics, a detailed plan to execute, and effective communication of the plan to stakeholders at all levels in the organization.

Kevin Liang United States

Excel Venture Management is a venture capital firm that was founded in 2008 and is based in Boston, Massachusetts. The firm has managed one fund with committed capital of $125 million, and the firm is currently raising the second fund. Excel Venture Management seeks to make equity investments into life science companies from early to late stages. The typical investment size ranges from $3 million to $ 5million. The firm plans to invest in 4-5 companies over the next 6-9 months and prefers to invest in companies based in US.

Year Founded
2008
Investor Type
Medtech Phase of Development
Capital Structure Preference
Investment Stage Preference
Excel Venture Management

James Lovgren United States

ORIG3N is a biotech company based in Boston, MA. The scientific mission is to deliver a disease-modeling platform targeting rare genetically inherited diseases. By advancing screening projects using iPSC-derived differentiated cells and rapidly delivering the resulting data to inform therapeutic decisions, ORIG3N will replace trial & error guess work of treating disease and enable longer, healthier lives. 

Website:
www.orig3n.com
Biotech Subsector
Medtech Subsector
Technology Overview
ORIG3N specializes in the generation of patient specific iPSC-derived cardiomyocytes, neurons, and hepatocytes. We have also built a unique iPSCs bank, called Life Capsule, with fully consented samples from patients with various neurodegenerative and cardiac diseases. Utilizing the diverse patient population from Life Capsule, we are able to provide patient and disease specific cell models.
Management Team Highlights
Successful repeat entrepreneurs, the founding team has 60+ years of experience in life science. Robin Smith, the CEO has 3 prior successful exits - the most recent two were VC backed and both sold to publicly traded companies; provided 24:1 return and 74%IRR to prior investors.
James Lovgren
ORIG3N
LinkedIn logo CBO 

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 

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 

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 

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 

Robert Maurer United States

IR2Dx Company Overview:

IR2Dx has developed a proprietary, breakthrough analysis and reporting system for multi-marker diagnostic test panels, to provide highly personalized treatment strategies for patients with Type 2 diabetes.  While control of glucose levels remains an important factor in the treatment of the disease, the IR2Dx platform evaluates the individual disease pathways for each patient, providing critical information regarding multiple markers and their overall pattern, all of which contribute to management of underlying disease.  This information can then be used by physicians to guide treatment decisions to deliver precision medicine in diabetes. 

Today, there are approximately 382 million people with diabetes in the world, and this number is expected to grow to 592 million by 2035.  The worldwide available market for early detection and drug response diabetes diagnostics is greater than $20 billion.  IR2Dx can enter the market within the current reimbursement and regulatory environments, and is ready to launch its first products in H1 2015 through commercial laboratories.

The IR2Dx platform provides personalized treatment information and recommendations to physicians based on a proprietary decision tree algorithm, greatly enhancing the clinical utility of a laboratory report.  Existing reimbursement levels for the panel markers in the U.S. and key international markets adequately cover the addition of the IR2Dx analysis and reporting. 

The platform is a software-based decision analysis tool. The analysis is performed on results from commercially available diagnostic tests run using standard laboratory bench top systems, requiring no tailored equipment, no custom design of the test system itself, and no capital investment.  Lab technicians upload the multi-marker panel testing results to the IR2Dx proprietary web portal to access the company’s decision support tool analysis product. In the initial commercialization phase, each laboratory will have a specific customized software product, and will pay for each report on a per-use basis. 

In the current U.S. regulatory environment for such products, with “health management IT functionalities”, such as the IR2Dx analysis and reporting system, near-term requirements for premarket review are unlikely, though the FDA may give additional guidance at any time. The IR2Dx platform is protected by a strong and broad intellectual property portfolio combining substantial data and know-how with issued patents in the U.S. and Europe. The company’s issued patents carry claims for use of its analysis platform and combination of markers for treatment guidance “with all glucose lowering drugs.”

 The company anticipates launch of the proprietary IR2Dx platform in H1 2015, introducing its first clinical decision support products through commercial laboratories. 

Year Founded
2008
Biotech Subsector
Medtech Subsector
Biotech Phase of Development
Medtech Phase of Development
Technology Overview

In 2002, IR2Dx company founders observed that anti-diabetic therapies reduced adverse cardiology events across multiple drug classes, while at the same time, cardiovascular drugs were reducing diabetes conversions. Further, it has long been recognized that cardiovascular disease is a comorbidity of diabetes. IR2Dx founders concluded that cardiovascular disease and Type 2 diabetes are manifestations of the same underlying conditions, and by analyzing information on relevant markers, treating physicians could be provided with information to help guide drug selection and assess drug response, making improved treatment possible. The research identified pathway biomarkers that significantly elucidate the evolution, and optimal treatment, of the disease while continuing to provide glucose control, throughout the treatment process with a patient. These biomarkers are: high-sensitivity C-reactive protein (hsCRP), intact proinsulin, insulin, adiponectin and C-peptide. Through the IR2Dx patented methods and systems of evaluating the baseline and subsequent levels of these markers, the physician is given a previously unavailable, cost effective window into the pathways and causes of his/her patient’s specific disease, with the opportunity to intervene therapeutically before the disease state progresses further. Specifically, the IR2Dx platform, for the first time in diabetes, provides physicians with easily accessible clinical information to aid in: • Assessment of the current state of a patient’s metabolic pathways; • Determination of the likely further progression of disease; and, • Determination of optimal treatment strategies for the patient.

Alliance & Collaborations
Discussions are underway with commercial laboratory and kit development partners.
Supporting Metrics or Evidence

To date, the IR2Dx diagnostic panel markers have been used prospectively on over 14,000 patients across 35 clinical trials, with over 40 publications. These studies validated the use of the panel markers, and covered patients at all stages of disease including prediabetes, across the range of anti-diabetic drug- classes. These studies demonstrated improvements in group mean HbA1c levels, the present standard for clinical success in the diabetes field.

Current Financing Needs

$12 million, can be staged to support commercial laboratory rollout and kit development ($5 million), and further clinical studies ($7 million).

Current Timeline

At commercialization

Current Investors

Friends & Family, Founders, Physicians

IP Status

Patents issued in US and Europe

Management Team Highlights

Highly Experienced Team. CEO has over 40 years in the diagnostics field (including 17 years at Abbott Diagnostics), and all management team members have over 30 years in biotech. Many of our key advisors are well recognized world leaders in diagnostics, diabetes and cancer.

IR2Dx
CEO