NEDP in the news

Genesis Drug Discovery and Development acquires Integrated Analytical Solutions to add "off the shelf" PK profiling capabilities to its portfolio

Genesis Biotechnology Group® (GBG) and its Contract Research Organization (CRO) arm Genesis Drug Discovery & Development™ (GD3) announced today that it has acquired the Berkeley-based CRO Integrated Analytical Solutions (IAS). Founded in 2004 and located in the San Francisco bay area, IAS is a GxP-compliant CRO providing bioanalytical, drug metabolism, and analytical chemistry services to clients worldwide.

“This is our second acquisition in the space of two months as we further expand our presence in the San Francisco bay area, which we see as a market with tremendous growth potential for drug discovery services” said Eli Mordechai, Ph.D., Chief Executive Officer (CEO) of GBG. “Adding IAS’s GxP compliant bioanalytical platform to GD3’s existing portfolio would allow us to further broaden our services around PK profiling and GLP toxicology while being in close proximity to our pharma and biotech partners on the west coast.”

“While we continue to add complementary services to expand into new markets, we are also adding scale to increase market share with our existing services” said Ben Bandaru, Ph.D., Director of Corporate Development for GBG. “Acquisition of IAS provides scale for our bioanalytical capabilities in a GLP setting.”

“The team at IAS is honored and excited to join forces with the GD3 family of CROs. We strongly believe that our membership in the GD3 portfolio will position IAS to better serve current clients while also broadening our reach to develop new customers” said Jonah Michaelian, IAS’s Managing Director. “The acquisition by GD3 will enable IAS to realize the full potential of the analytical and regulatory infrastructure it has built over the past sixteen years and to establish itself as a center for bioanalytical excellence.”

Genesis Drug Discovery and Development expands its presence in the clinical space by acquiring STATKING Clinical Services

Genesis Biotechnology Group® (GBG) and its Contract Research Organization (CRO) arm Genesis Drug Discovery & Development™ (GD3) announced today that it has acquired the Cincinnati-based CRO STATKING Clinical Services. Established in 1989, STATKING provides clinical trial services, including clinical trial management, protocol development, biostatistics, clinical data management, clinical study monitoring, medical writing, medical monitoring, safety reporting, and project management for the regulatory approval of novel drug and medical device products.

“We are very pleased to have STATKING join GBG, and this acquisition demonstrates our commitment to making GD3 a fully integrated concept to commercialization CRO,” said Eli Mordechai, Ph.D., Chief Executive Officer (CEO) of GBG. “STATKING’s acquisition strengthens our services and strategic presence throughout the life cycle of the drug development process. STATKING has achieved significant milestones in its 30 years of service, and I look forward to an exciting future together.”

“The way pharma companies work with CROs is changing. CROs are taking more of a strategic planning role, in addition to execution, in the drug discovery and development process. This model of engagement results in sponsors and CROs becoming end-to-end partners, and M&A is helping CRO’s extend their service portfolio to partner with their customers in providing greater efficiency in service and delivery across R&D continuum. The acquisition of STATKING would bring GD3 one more step closer to becoming a full service CRO” said Ben Bandaru, Ph.D., Director of Corporate Development for GBG.

STATKING and GD3 share a common vision that delivering better therapies to patients faster requires an integration of drug discovery and clinical trial services” said Rod Lashley. The addition of STATKING’s clinical services to GD3’s integrated, early-late stage drug discovery solutions will create a unique platform for clients to work with one scientific partner to enhance the speed and efficiency with which they can advance their therapies into the clinics.

Genesis Biotechnology Group announces second year of CRO relationship with Yale University

Genesis Biotechnology Group® (GBG) and its CRO arm Genesis Drug Discovery & Development™ (GD3) announced today that it has expanded its relationship with Yale University to continue to offer GD3’s integrated portfolio of preclinical services to the awardees of the Blavatnik Fund for Innovation. Initiated in 2018, this is a part of GD3’s efforts to offer early drug discovery-based services to Yale’s researchers, allowing their breakthrough research to get to the market as new drugs and treatments.

“We are delighted to partner with Yale University for a second year to accelerate the transition of fundamental biomedical discoveries into commercialization opportunities,” said Eli Mordechai, PhD, Chief Executive Officer (CEO) of GBG. “Our partnership with Yale will continue building our ongoing strong and mutually beneficial relationship with the Blavatnik Fund and Office of Cooperative Research at Yale.”

“We are deeply privileged to be chosen by Yale as a trusted partner CRO to help the entrepreneur scientists’ transition their research towards commercialization” said Prabal Banerjee, PhD, Director of Business Development for GD3. "The ability to provide integrated services to projects as they transition from discovery to development is always reassuring for partners like Yale.”

This partner arrangement was made possible by a grant from the Blavatnik Family Foundation. This multi-year grant supports the Blavatnik Fund for Innovation at Yale, which was designed to bridge the gap between life science research and business and support faculty in the commercialization of applied research and technology. The fund’s recent commitment of $25 million has created new opportunities for emerging ventures and biotech companies.

Genesis Biotechnology Group acquires Comparative Biosciences, Inc. (CBI) to add GLP Toxicology and Safety Pharmacology to its portfolio of Preclinical Services

Genesis Drug Discovery & Development (GD3), a member of Genesis Biotechnology Group (GBG) announced today that it has acquired Comparative Biosciences, Inc. (CBI), a Contract Research Organization (CRO) located in Sunnyvale, California. CBI is specialized in GLP (Good Laboratory Practice) Toxicology and Safety Pharmacology projects for IND-enabling research studies. This portfolio addition will enable GD3 to expand its pre-clinical services to GLP based studies by (1) offering integrated, single-point-of-contact services throughout the project lifetime, (2) streamlining all phases of the discovery cycle and (3) enabling new discoveries to progress rapidly from project inception through pre-clinical development. CBI’s skilled team of scientists, will work synergistically with GD3’s existing services around preclinical drug discovery.

“This acquisition is another strategic milestone for GBG in support of our vision to build a world class fully integrated CRO,” says Dr. Eli Mordechai, CEO of GBG. “Adding CBI is another way to differentiate our capabilities in the preclinical space. The acquisition of CBI significantly enhances our capabilities for providing IND enabling studies in Toxicology and Safety Pharmacology to better serve our industry partners.”

“M&A transactions in several sectors are paused or abandoned due to pandemic, but the CRO sector is less affected” says Dr. Ben Bandaru, Director of Corporate Development at GBG. We are seeing a temporary uptake in our service business as Pandemic related restrictions have forced Pharma and Biotech companies to increase outsourcing. However, timing of when things return to normalcy is still uncertain, so providing forward guidance continues to be a challenge in the short term.”

“Selling a business that we have built in a span of 20 years is not an easy decision but we are excited to be a part of GD3’s integrated portfolio of contract research services, as it would benefit our clients tremendously” says Dr. Carol Meschter, CEO of CBI. This acquisition allows us the opportunity to provide a more complete package of services to our clients and creates opportunity for our team to grow and evolve with a boarder platform.

Genesis Drug Discovery & Development (GD3) Announces Appointment of Anthony Rohr, as Chief Executive Officer of PharmOptima.

PharmOptima, a member of Genesis Drug Discovery & Development (GD3), the contract research organization (CRO) arm of Genesis Biotechnology Group® (GBG), has announced the appointment of Anthony Rohr as its new Chief Executive Officer. In this capacity, as an expansion of his current role in Business Development, he will provide leadership, oversight, and coordination for the development and management of new preclinical drug discovery platforms.

Anthony brings a wealth of experience in a senior leadership capacity from his previous role at MPI Research, Inc. He is an experienced strategist with deep industry knowledge and an understanding of how to build CRO business while leveraging operational scale across a dispersed footprint. He is a strong leader with a proven track record of developing diverse and high performing teams.

“I am excited to undertake this role as part of such a dynamic and knowledgeable PharmOptima team,” said Rohr. “With the addition of laboratory space and scientific staff on the horizon and our reputation as a quality and responsive CRO, PharmOptima is positioned to leverage our strengths and investment into a prosperous future. I am also thrilled to be a part of the Genesis Drug Discovery and Development leadership team. We continue to round out our preclinical services through organic growth and acquisitions in the pursuit of creating the best fullservice preclinical organization in the market.”

Anthony has distinguished himself with over 15 years of experience in the preclinical research and CRO industries. “We look forward to continuing to work closely with Anthony in his newly expanded role as an advisor and collaborative partner to pharmaceutical, sponsor, and academic organizations” said Dr. Eli Mordechai, CEO of Genesis Biotechnology Group.

http://www.genesisbiotechgroup.com/press/PharmOptima_CEO.pdf

Genesis Biotechnology Group Acquires New England Discovery Partners

Genesis Drug Discovery & Development (GD3), a member of Genesis Biotechnology Group, has acquired New England Discovery Partners (NEDP), a Contract Research Organization (CRO) specializing in synthetic and medicinal chemistry. This chemistry service portfolio addition will enable the GD3 family of companies to expand its pre-clinical drug research and discovery services to partners in pharma and academia by (1) offering integrated, single point-of-contact services throughout the project lifetime, (2) streamlining all phases of the discovery cycle and (3) enabling new discoveries to move rapidly from project inception through preclinical development.

NEDP’s skilled team of chemists, with almost 250 years of combined pharma and CRO experience, will work synergistically with GD3’s existing services around uHTS, computational chemistry, and structural biology. http://www.genesisbiotechgroup.com/press/PR_GD3_NEDP.pdf

New England Discovery Partners Secures STTR Grant

New England Discovery Partners team up with Yale School of Medicine to develop novel small molecule drugs that combat severe viral disease caused by mosquito-transmitted viruses. The drugs are designed to specifically target those human proteins that the viruses need to successfully establish infection. The drugs will have broad-spectrum activity against multiple medically important flaviviruses including West Nile virus, Dengue virus and Zika virus. This work stems from a multidisciplinary collaboration with expertise in viral genetics, drug discovery, and medicinal chemistry and a team composed of Dr. Joseph Contessa of Yale School of Medicine, Dr. Jan Carette of Stanford, and Dr. Michael Van Zandt from Branford’s New England Discovery Partners (https://nedp.com).

The group has been awarded a small business technology transfer (STTR) grant of $600,000 from the National Institutes of Health in order to advance this approach for generating new medicines to treat infectious diseases.

Patent Application Awarded for Resolvin-Based Therapeutic Agents

The U.S. Patent and Trademark Office has granted US Patent No. 10,130,719 which provids composition of matter patent protection for TP-317, a novel derivative of Resolvin E1 (RvE1) for treatment of inflammatory bowel disease (IBD).

Resolvins, are endogenous lipid autacoids that play a critical role in regulating inflammation resolution and tissue repair throughout the body. By delivering therapeutic doses of Resolvins to activate these intrinsic pathways, the drug candidate offers a new approach for treating inflammatory disease by activating intrinsic inflammation resolution pathways without compromising immune function.

This work has been completed as part of a sponsored research collaboration with Thetis Pharmaceuticals.

RNA-Based Therapeutics: Discovery of Novel Small Molecule Inhibitors of the Group II Intron

Medicinal chemists at New England Discovery Partners have co-authored a ground-breaking paper on novel RNA-based small molecule antimicrobials. While working in collaboration with Professor Anna Marie Pyle at Yale University, a team of medicinal chemists at NEDP have discovered a novel series of group II intron inhibitors for treatment of fungal infections.

This work demonstrates that biologically important RNA molecules can be targeted with high specificity, potency and efficacy using the tools of medicinal chemistry and microbiology. This promising new class of antimicrobials, which targets a fungal-specific RNA processing mechanism, is likely to be far less toxic to humans than existing types of therapy. Although work still needs to be done, this first-generation series of inhibitors already have potencies comparable to amphotericin B, the current standard of care.

This important work, which was published in Nature Chemical Biology (Fedorova et al, (2018) 14, 1073-1078), has been the subject of commentary in Chemical & Engineering News, Nature Reviews Drug Discovery, Genetic Engineering and Biotechnology News and other media outlets (see links below).

This work was generously funded through a Small Business Innovative Research (SBIR) grant from the NIH, National Institute of Allergy and Infectious Diseases (Grant 1R43AI115951-01A1).

Published Paper: Small molecules that target group II introns are potent antifungal agents
Olga Fedorova, G. Erik Jagdmann, Rebecca L. Adams, Lin Yuan, Michael C. Van Zandt and Anna Marie Pyle
Nature Chemical Biology 2018 Vol 14, pages 1073–1078.
https://www.ncbi.nlm.nih.gov/pubmed/30323219

Palacino, “The splice is right” J. News and Views in Nature Chem. Biol. (2018).
https://www.ncbi.nlm.nih.gov/pubmed/30323218

Nature Reviews Drug Discovery, “Small molecules targeting a tertiary RNA structure fight fungi”
https://www.ncbi.nlm.nih.gov/pubmed/30482965

Genetic Engineering and Biotechnology News: “Fungal RNAs targeted”
https://www.genengnews.com/news/fungal-rnas-targeted-by-small-molecule-drugs/

Chemical & Engineering News: “Targeting RNA’s tertiary structure”
https://cen.acs.org/pharmaceuticals/drug-discovery/Targeting-RNAs-tertiary-structure/96/i43

Thetis Pharmaceuticals Extends Research Collaboration with NEDP for 6th Straight Year

Thetis Pharmaceuticals, a privately-held biopharmaceutical company developing novel small molecule therapies based on a class of potent pro-resolving lipid mediators known as Resolvins, extended it collaboration with New England Discovery Partners for the sixth straight year.

Frank Sciavolino, Ph.D., co-founder, president and chief scientific officer of Thetis commented, “New England Discovery Partners has played a critical role in the success of our company. Michael Van Zandt and the team have done a magnificent job developing new innovative syntheses that will enable cost-effective, large-scale production of these highly complex molecules.”

Resolvins, part of the superfamily of Specialized Pro-Resolving Lipid Mediators (SPMs), are endogenous lipid autacoids that play a critical role in regulating inflammation resolution and tissue repair throughout the body. By delivering therapeutic doses of Resolvins to activate these intrinsic pathways, the drug candidate offers a new approach to treating inflammatory disease by activating intrinsic inflammation resolution pathways without compromising immune function.

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