Pharmatek United States

Pharmatek is a contract development & manufacturing company providing dosage form development & cGMP manufacturing of oral, injectable & topical products. Founded in 1999, our services focus on the rapid advancement of small molecule & peptide drug candidates from the bench to the clinic & include:

·         Formulation & Analytical Development

·         cGMP Manufacturing

·         Clinical Packaging, Labeling & Worldwide Distribution

 

Our experience includes first-in-man strategies, solutions for poorly soluble compounds, controlled release formulations & separate facilities for the handling of cytotoxic & potent compounds.  Pharmatek’s drug delivery technologies include:

·         Solid Dispersions

·         Particle Size Reduction

·         Lipid Delivery

·         Complexation

·         Lyophilization

·         Suspensions & Emulsions

Pharmatek’s 68,000 sq. ft. facility includes 9 class 100,000 cGMP manufacturing suites, formulation & analytical laboratories, & ICH stability storage.  Pharmatek has over 150 clients globally, ranging from virtual to large pharmaceutical companies. Having manufactured product for clinical trials in the North America, Europe & Asia; Pharmatek has successfully completed several large pharma quality, EH&S & QP audits.

Mr Tim Scott
Mr Tim Scott
LinkedIn logo President 

Phoenix PharmaLabs Inc. United States

Phoenix PharmaLabs, Inc. (PPL) is a privately held, preclinical drug discovery company focused on the development and commercialization of new potent, non-addictive treatments for pain and new therapies for the treatment of opiate addiction.

PPL has developed a novel family of New Molecular Entities (NMEs) with high binding affinity at all three opiate receptors: mu, kappa and delta.  These unique ligands, derived from opioid backbones using proprietary technology, have high binding affinity at all three opioid receptors (mu, delta and kappa) and more balanced receptor activity than morphine and other opioids, with partial agonist / antagonist activity at mu, somewhat higher, but not full, kappa agonist activity, and moderate delta activity.  This profile results in first-ever opiate analgesics that appear to be non-addicting and free of all significant dangerous side effects. 

Studies of the drugs have been conducted by prominent scientists at leading institutions including Lou Harris and colleagues at Virginia Commonwealth University (VCU), Jim Woods and colleagues at the University of Michigan, and Larry Toll and colleagues at SRI International and Torrey Pines Institute for Molecular Studies.  Study results in rodents and monkeys performed by the National Institutes of Health (NIH) / National Institute on Drug Abuse (NIDA) and SRI International Laboratories demonstrated the following:

  • Robust analgesic potency (10-20x stronger than morphine)
  • Little or no euphoric reward / abuse and addiction potential in rodents and monkeys (multiple studies)
  • No dysphoria in rodents and monkeys (multiple studies)
  • Only moderate signs of respiratory depression – even at 150x dosage
  • No death from overdose - even at 350x dosage
  • LD50 = 500x dosage
  • No physical dependence in naive rodents
  • No inhibition of GI transport - even at 350x dosage
  • No Long QT syndrome risk – hERG assay
  • No significant diuresis in rodents
  • Does not precipitate withdrawal in dependent monkeys

Since the drugs do not precipitate withdrawal, they offer very promising use for addiction therapy as a preferred substitute for methadone and buprenorphine, as well as for pain. 

The drugs are orally active and inexpensive to manufacture using PPL's patented manufacturing process.  A key patent on the lead molecule for Composition, Methods and Use will be issued in the US by January, 2015, and it is currently being internationalized.

The cost and risk of achieving a New Drug Approval (NDA) from the FDA is substantially lower than other NMEs with equivalent market potential.  Few drug classes have more longitudinal testing data than opioids for use as a predictor of success in trials.  Therefore, the risk of pharmaceutical product development is significantly reduced compared to the risk of developing less understood and potentially problematic drug classes.  As described above, the assets have been effectively de-risked in animal studies covering all risks that typically manifest themselves in opioids.

Furthermore, a vast amount of opioid testing data is available concerning the transition of effects of pure opioid compounds from animals to humans.  Consequently, our scientific experts and advisors predict that the risk of problems in toxicology and safety pharmacology is very low.  The prediction correlation from animals to humans is very high, and thus there is a high level of confidence that the compounds will be safe, effective and beneficial for humans.   

Recently our drug family has also attracted attention for Animal Health applications, primarily due to the lack of respiratory depression and GI tract side effects as well as the likelihood that the drugs would likely be unscheduled (or at most scheduled as Class IV or V).

The strategic objective of our company is to enter into one or more license agreements with appropriate market leader(s) that have the resources and motivation to further develop, commercialize, and maximize the market potential of PPL’s family of drugs.  We are making steady progress towards the achievement of that objective. Following submission of a BAA grant proposal to the DoD, we were invited by the U.S. Army Medical Research and Material Command (USAMRMC) to submit a full application for a $3.6 million grant for the advancement of our PPL-103 compound for pain, and we are currently awaiting the results. In the meantime we are exploring other potential funding opportunities and strategic collaborations. 

Year Founded
2002
Biotech Subsector
Biotech Phase of Development
Technology Overview
PPL has developed a novel family of New Molecular Entities (NMEs) with high binding affinity at all three opiate receptors: mu, kappa and delta. These unique ligands, derived from opioid backbones using proprietary technology, have high binding affinity at all three opioid receptors (mu, delta and kappa) and more balanced receptor activity than morphine and other opioids, with partial agonist / antagonist activity at mu, somewhat higher, but not full, kappa agonist activity, and moderate delta activity. This profile results in first-ever opiate analgesics that appear to be non-addicting and free of all significant dangerous side effects. Studies of the drugs have been conducted by prominent scientists at leading institutions including Lou Harris and colleagues at Virginia Commonwealth University (VCU), Jim Woods and colleagues at the University of Michigan, and Larry Toll and colleagues at SRI International and Torrey Pines Institute for Molecular Studies. Study results in rodents and monkeys performed by the National Institutes of Health (NIH) / National Institute on Drug Abuse (NIDA) and SRI International Laboratories demonstrated the following: • Robust analgesic potency (10-20x stronger than morphine) • Little or no euphoric reward / abuse and addiction potential in rodents and monkeys (multiple studies) • No dysphoria in rodents and monkeys (multiple studies) • Only moderate signs of respiratory depression – even at 150x dosage • No death from overdose - even at 350x dosage • LD50 = 500x dosage • No physical dependence in naive rodents • No inhibition of GI transport - even at 350x dosage • No Long QT syndrome risk – hERG assay • No significant diuresis in rodents • Does not precipitate withdrawal in dependent monkeys. Since the drugs do not precipitate withdrawal, they offer very promising use for addiction therapy as a preferred substitute for methadone and buprenorphine, as well as for pain. The drugs are orally active and inexpensive to manufacture using PPL's patented manufacturing process. The cost and risk of achieving a New Drug Approval (NDA) from the FDA is substantially lower than other NMEs with equivalent market potential. Few drug classes have more longitudinal testing data than opioids for use as a predictor of success in trials. Therefore, the risk of pharmaceutical product development is significantly reduced compared to the risk of developing less understood and potentially problematic drug classes. As described above, the assets have been effectively de-risked in animal studies covering all risks that typically manifest themselves in opioids. Furthermore, a vast amount of opioid testing data is available concerning the transition of effects of pure opioid compounds from animals to humans. Consequently, our scientific experts and advisors predict that the risk of problems in toxicology and safety pharmacology is very low. The prediction correlation from animals to humans is very high, and thus there is a high level of confidence that the compounds will be safe, effective and beneficial for humans.
Alliance & Collaborations
Research alliances: SRI International, Torrey Pines Institute for Molecular Studies, Virginia Commonwealth University (VCU), the University of Michigan, The Rockefeller University, and BioDuro / PPD; Synthesis alliance: Mallinckrodt, Inc.; Preclinical toxicology alliance: Calvert Labs
Supporting Metrics or Evidence
Opioid Receptor Binding Affinities of PPL-103 Ki (nM): Mu: 0.36 +/- 0.11; Delta: 2.47 +/- 0.105; Kappa: 0.29 +/- 0.03. Functional Activities of PPL-103 – EC50 (nM) and % Stimulation: Mu: 4.30 +/- 2.13 and 22.60% +/- 0.05%; Delta: 9.01 +/- 2.64 and 39.80% +/- 3.9%; Kappa: 2.99 +/- 0.92 and 41.7% +/- 5.0%. Antinociception of PPL-103: Compared to morphine's ED50 of 2.0 to 4.0 mg/kg, PPL-103's ED50 of 0.2 mg/kg was ten-fold to twenty-fold more potent than morphine. Several Self Administration studies as well as Conditioned Place Preference (CPP) and Conditioned Place Aversion (CPA), Physical Dependence and Drug Discrimination studies in rodents and monkeys have been conducted to assess the degree to which PPL’s novel opioid compounds elicit either euphoric reward (which can lead to abuse and addiction) or dysphoria. The results of all studies show no significant signs of either euphoric reward / abuse potential or dysphoria. Several Self Administration studies as well as Conditioned Place Preference (CPP) and Conditioned Place Aversion (CPA), Physical Dependence and Drug Discrimination studies in rodents and monkeys have been conducted to assess the degree to which PPL’s novel opioid compounds elicit either euphoric reward (which can lead to abuse and addiction) or dysphoria. The results of all studies show no significant signs of either euphoric reward / abuse potential or dysphoria. Studies showed no death from overdose at 350x dose and no constipation at 350x dose. LD50 = 500x dose.
Current Financing Needs
Approximately $3.6 million will be needed to complete preclinical studies, obtain IND and produce GMP material to support human clinical trials. (This may be funded by a USAMRMC grant.) Subsequently, approximately $3 million will be required to advance the compound through simultaneous Phase I / II trials in Australia to reach POC in humans prior to licensing.
Current Timeline
Completion of preclinical trials and IND approval in 2016. Completion of simultaneous Phase I / II trials in Australia to reach POC in humans in 2017.
Current Investors
Founders and angel investors
IP Status
For the lead molecule a Composition, Methods and Use patent application was filed in 2010 and will be issued in the US by January, 2015. It is currently being internationalized. Other Methods and Use patents on related molecules have been issued as well.
Recent Milestones
Completed de-risking studies of lead molecule; patent approval of Composition, Methods and Use patent of lead molecule
Management Team Highlights
Management Team & Board of Directors: John Lawson, Ph.D., Founder, Board Chairman and Chief Scientist - the primary developer of PPL’s intellectual property; formerly headed the Neurochemistry R&D Group at SRI International; William Crossman, President, CEO and Board Member - launched and developed numerous emerging technology companies; served as CEO, CFO and CDO of enterprises ranging from start-ups to Fortune 100 level companies; Timmy Chou, Vice President, CFO and Board Member - founding partner of Spectra Consulting Group; experience as CEO and CFO of numerous emerging companies, serves on the Boards of several public and private companies; Lawrence Toll, Ph.D., Chief Neuropharmacologist and Board Member; Director of the Neuropharmacology Department of Torrey Pines Institute for Molecular Studies and SRI International; co-discoverer of the nociceptin opioid peptide; Chris Tew, Vice President, Board Member - senior sales and marketing executive of bioscience companies including VP Sales for Protocol Systems (Welch Allyn); Theodore Stanley, M.D., Board Member - Chairman and Founder of ZARS Pharma; formerly Director of Research of the University of Utah. Board of Advisors: Louis Harris, Ph.D. - Harvey Professor at VCU; member of the Drug Evaluation Committee for the NIH; founding member of the Committee on Problems of Drug Dependence (CPDD) for the National Institute on Drug Abuse (NIDA); a preeminent researcher in behavioral testing of opioids in animal models; Anthony Fox, M.D., Ph.D. – a recognized expert in strategic clinical planning and the evaluation and selection of contract research organizations (CROs); President of EBD Group, a pharmaceutical consulting firm; Mary Jeanne Kreek, M.D., Senior Attending Physician and Patrick E. and Beatrice M. Haggerty Professor, Head of Laboratory of Biology of Addictive Diseases, The Rockefeller University; recipient of numerous professional awards; John Mendelson, M.D., Senior Scientist, California Pacific Medical Center Research Institute; specific expertise in the design and supervision of human clinical trials of controlled substances; Shayne Gad, Ph.D., Principle, Gad Consulting; recipient of the American College of Toxicology Lifetime Contribution Award; 35 years experience in toxicology, statistics and risk assessment; authored or edited 44 published books in the fields.
William Crossman
President & CEO 

Precision NanoSystems Canada

Precision NanoSystems Inc. (“PNI”) has developed proprietary technology (NanoAssemblr) and companion Reagent Kits (SUB9KITS) that enable the simple manufacture of novel nanoparticles that are used to delivery genetic and small molecule medicines (nanomedicines). Nanomedicines are the "FedEx" of the health-care industry and are used for cell-specific delivery of research tools, diagnostic imaging agents and drugs to study, diagnose and treat disease. PNI's products are commercialized and in high demand from many of leading RNA and small molecule therapeutic biotechnology and pharmaceutical companies.  http://www.precisionnanosystems.com/products/

Year Founded
2010
Biotech Phase of Development
Current Financing Needs
PNI is currently raising Series A financing.
Recent Milestones
PNI launched its flagship NanoAssemblr Benchtop and SUB9KIT products in H2 2013. Since that time, PNI has seen significant latent demand for its products and is rapid expanding product manufacturing to satisfy market need. Additionally, PNI has achieved important technical milestones in it's large-scale nanomedicine platform and SUB9KIT products.
Management Team Highlights
PNI’s management, directors & advisors have collectively contributed to over 100 patents and 500 papers, started over 20 biotech companies, raised over $1B in financing/deals and have brought 4 drugs to market. PNI’s CEO, Dr. James Taylor has over 10 years of experience in commercializing biotech and has lead PNI since invention. PNI’s COO, Dr. Euan Ramsay, has 13 years commercializing biotech, has secured over $40M in leveraged financing, and has developed nanomedicines to clinical trials.
James Taylor
CEO 
Euan Ramsay
COO 

Prize4Life

Prize4Life is a non-profit organization founded in 2006 in Cambridge, MA focused on accelerating therapy development for amyotrophic lateral sclerosis (ALS, aka Lou Gehrig's disease). Prize4Life uses incentive prizes to attract new minds and drive innovation in ALS drug development. The organization is running the $1M Avi Kremer ALS Treatment Prize4Life challenge for preclinical validation of a novel ALS therapeutic in an ALS mouse model, and submissions to this prize will be accepted until June 6th 2015. In addition to prizes, Prize4Life also runs infrastructure programs to support the ALS research community, such as the ALS FORUM, an online portal of cutting edge research and drug development news in ALS (www.researchals.org).

Sara Shnider
Executive Director 

Prolog Ventures United States

Prolog Ventures is a venture capital firm based out of St. Louis Missouri that was founded in 2001. The firm is currently making investments out of its vintage 2013 4th fund of approximately $100 million. The firm is looking to make equity investments in companies ranging from $500,000 to $3 million. The firm will invest in companies across the United States and plans to make approximately 3-4 investments over the next 6-9 months.

Brian Clevinger
Managing Director 

Promosome LLC 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
John Manzello
President & CEO 

PxRadia Inc. United States

PxRadia is applying its HD-mAb technology platform to provide increased therapeutic potency to biosimiliar monoclonal antibodies. These antibodies are directed to validated targets such as Her-2, CD-20 and PD-1/PD-L.  We and our partners will share new IP and rights and differentiation from current products in the marketplace.

Website:
www. pxradia.com
Year Founded
2012
Biotech Subsector
Biotech Phase of Development
Technology Overview
HD-mAb Technology Platform Potentiates Therapeutic Efficacy of Monoclonal Antibodies
Alliance & Collaborations
Pending
Current Financing Needs
$2M
Current Investors
LH Financial, NYC
IP Status
Files
Recent Milestones
Seed Round Financing
Management Team Highlights
Alton C. Morgan, Serial Entrepreneur & world renown Expert in Monoclonal Antibodies
Ms Gail Thurston
VP Corporate Development 
Dr Alton C Morgan
President and CEO 

RCT Ventures

RCT Ventures invests in early-stage life science companies including medical devices, drug discovery platforms, and research tools.

Paul Grand
Paul Grand
LinkedIn logo Managing Director 
BIO

Grand is responsible for sourcing RCT’s investments in medical devices and representing RCT on the boards of its portfolio companies.

Prior to joining RCT, Grand was co-founder and VP Operations of Imagine Pharmaceuticals, which developed a platform to selectively deliver therapeutics and other compounds across the blood brain barrier. He was also co-founder and CEO of MicroSurgeon, which developed a microwave thermal ablation device for the treatment of solid tumors.

Grand has extensive experience in new company formation and fund raising. Since 1990, he has built, operated, recruited management and raised financing for eight high technology, medical device and biotechnology companies. Grand also was a Managing Director for Fruition Ventures, a group of private equity investors focused primarily on tech companies.

Grand is actively involved in programs to encourage bio-entrepreneurship, innovation and commercialization of University technologies. He has lectured, judged business plans, and mentored students and scientists at numerous universities, including UCLA, Stanford, USC, and UCSF. Grand serves as an investment advisor to the LARTA NIH Commercialization Assistance Program for SBIR program awardees. He is on the Oversight Committees for the Coulter Translational Research Partnership Programs at USC and University of Washington. Grand is a reviewer for proof of concept and commercialization-focused funding programs for the University of California system-wide, USC, University of Utah and University of Colorado. 

Grand is a frequent panelist at biomedical conferences. He has spoken at more than 100 conferences, been featured in hundreds of articles in publications including Forbes, New York Times and Wall Street Journal and appeared as an expert on Bloomberg Television, CNN, and CNN/FN. Grand serves as Producer and Host for the MedTech Innovator competition that seeks to discover outstanding early-stage MedTech opportunities - http://medtechinnovator.com

Chad Souvignier
Managing Director 

Recursion Pharmaceuticals United States

The Problem: Pharmaceutical development has traditionally focused on intense study of an explicit molecular target related to a specific disease of interest. This strategy is costly and inefficient.

 

The Solution: We have developed technology that can be scaled to quickly, precisely, reliably, and simultaneously model thousands of genetic diseases in human cells and evaluate the effect of thousands of individual drugs on those disease models. We've built a computational platform that recognizes structural changes in millions of diseased cells and then identifies drugs that return those diseased cells to a healthy state.

 

Proof of Concept: We have already used an early version of this platform to discover a potential treatment for one genetic disease. We have IP for this drug, and have already been approached about licensing.  We are scaling our platform now to enable us to achieve our goal of discovering and partnering to bring to market treatments for at least 100 genetic diseases in 10 years.

Dr Chris Gibson
LinkedIn logo CEO, Recursion Pharmaceuticals 

Rhamnopharma, Inc. United States

Year Founded
2010
Biotech Subsector
Biotech Phase of Development
Current Financing Needs
Initial
IP Status
Issued US patents
Recent Milestones
Identification of novel MOA
Management Team Highlights
Founder experienced in drug development
Anton Leighton
CEO