Q BioMed Inc. (QBIO)

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In a Major Breakthrough Q BioMed Discovers First Biomarkers for Pediatric Nonverbal Autism Subgroup
  • Marks the first time a company has identified biomarkers that hold the potential to stratify this subset of patients

 

  • Study examined 1,953 significant autistic biomarkers, resulting in 2 significant markers tied to expressed genes and pathways responsible for speech development

 

  • Biomarkers in the nonverbal subset were distinct from children with typical speech development with or without autism

 

  • Biomarkers will help homogenize clinical trial participants and will be studied as possible diagnostic and prognostic indicators during trials

 

New York, NY – April 10, 2019 – Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotech company, announced today the discovery of two novel biomarkers for pediatric nonverbal autism, identified in a subset of children with Autism Spectrum Disorder (ASD). This marks the first time a company has been able to identify biomarkers that hold the potential to stratify this subset of children. The study took into consideration 1,953 potential biomarkers and used Vineland II scores to stratify 240 children into three groups: verbal, semi-verbal, and nonverbal autism.

 

Q BioMed CEO, Denis Corin highlighted, “This is a major breakthrough for these children and their families. To date, very little attention and research has been focused on these nonverbal autistic children. In partnership with the clinical and advocacy community, QBioMed is leading the effort to better stratify this group, while also pursuing a treatment.”

 

Children of this subset typically never develop the ability to speak, or commence with language progression between 9-14 months and then regress. Most psychologists and physicians feel comfortable providing a diagnosis of nonverbal around the age of 7 years. Each year, an estimated 18,000-20,000 newborns will go on to become autistic and nonverbal in the U.S.

 

Speaking to the benefit of the biomarker work completed to date by Q BioMed, Corin explained, “Children with ASD need safe, effective and targeted treatments that are tested under conditions that take their best interests into consideration. Today’s announcement ensures we continue to take a tailored and patient-centric approach to find those children who will benefit the most from our efforts.”

 

One of the highlights of the biomarker study was the identification of known genes and pathways that are directly implicated in speech impairment. The studies also revealed comorbidities that manifest serologically as early as 18 months (the lower limit of detection to date) even though the children do not yet manifest clinical symptoms of these diseases.

 

To date, the results would allow for the development of diagnostic capabilities for children as young as 18 months and as old as 6 years. Further studies are needed for children older than 6 years.

 

Q BioMed will continue to enrich its data set for these biomarkers over time and work with its advisory committee, regulators and partners to incorporate these biomarkers into the QBM-001 trial design. In parallel, Q BioMed is finishing the formulation of QBM-001. The completion of formulation over the next couple months will then lead to subsequent regulatory filings and ongoing IND enabling studies.

 

QBM-001 targets toddlers with pediatric nonverbal autism, where underlying commonalities – as further reinforced by this current biomarker study – lead to developmental delay, an autism diagnosis, and eventual nonverbal or very minimally verbal capability for the rest of their lives.

 

About Pediatric Nonverbal Autism

There are approximately 18,000-20,000 new cases of pediatric nonverbal autism in the U.S. each year and a similar amount in Europe. The majority of the children are diagnosed by the age of seven and fall within the autism spectrum. Individually, the economic costs for toddlers that become non- or minimally verbal is $10 million dollars on average per child over a lifetime. Collectively, an estimated $200 billion is spent yearly on individuals who are nonverbal in the U.S. Not all individuals who are nonverbal will benefit from QBM-001. However, with validated biomarkers, testing from trained specialists and genetic testing, children who fall in this targeted population can be identified, and will have a higher likelihood of responding to an approved treatment.

 

About Q BioMed Inc.

Q BioMed Inc. is a biotech acceleration and commercial stage company. We are focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets; strategic resources, developmental support, and expansion capital to ensure they meet their developmental potential, enabling them to provide products to patients in need‏.

 

Please visit http://www.QBioMed.com and sign up for regular updates

 

Forward-Looking Statements:

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

 

Contact
Denis Corin
CEO
Q BioMed Inc.
+1(646)884-7017

 

Investor Relations
+1(404) 995-6671

ir@qbiomed.com

 

Source: Q BioMed Inc.

Q BioMed Inc Announces Acquisition of Cancer Pain Drug Metastron™ from GE Healthcare

Strategic Acquisition Gives Company Ownership of Brand Name Drug and Related Market Authorizations in 22 Countries in Which Metastron™ is Already Registered and Approved for Sale

 

NEW YORK, November 28, 2018 — Q BioMed Inc. (OTCQB: QBIO), a biotechnology acceleration company, is pleased to announce that it has entered into agreement to acquire the metastatic skeletal cancer palliation drug, Metastron™, from GE Healthcare.

 

The agreement gives Q BioMed ownership of the brand, trademarks and market authorizations in 22 countries. In addition, all historical and current sales and distribution data related to those market authorisations will be assigned or transferred to Q BioMed to allow for as seamless a transition as possible in all markets.

 

Q BioMed CEO Denis Corin said of the deal, “This is a major deal for Q BioMed. Strategically, it affirms our belief in this drug as an effective and underutilized non-opioid therapy for the treatment of debilitating pain associated with skeletal cancer metastases. Importantly, as we enter this market, we will now have access to all information related to Metastron in 22 countries in which the drug is already approved for sale.” Mr. Corin continued, “This gives us a tremendous springboard to accelerate our revenue potential and establishes a formidable barrier to entry as we grow this market. With regards to the market, it is important to note that our focus is not on the short-term horizon, but rather on the long-term strategic initiative as we look 2 and 5 years down the road at expanding the therapeutic scope for the drug.”

 

The acquisition agreement with GE Healthcare covers the purchase of the radiopharmaceutical drug Metastron™ and all related intellectual property (IP) including, but not limited to the brand, sales and distribution data, patent, trademark and market authorizations for Metastron in 22 countries in exchange for an undisclosed upfront payment, one milestone payment based on sales and a single digit royalty for 15 years. The first commercial sale of Metastron is expected to occur after the successful transfer or assignment of all IP, material sales and distribution data, technical transfer and establishment of manufacturing capabilities to be made by Q BioMed under the appropriate regulatory filings required by the jurisdictions in which Metastron is sold.  The complete transfer and establishment of approved manufacturing facilities will take several months with the relevant international health authorities.

 

Q BioMed looks forward to updating shareholders and all stakeholders as we advance through the transaction and more importantly, we look forward to providing this drug to the thousands of patients around the world who may depend on it well into the future.

 

Please visit www.QBioMed.com and sign up for regular updates and additional information and see our 8K filed today.

 

Follow us on Social Media @QBioMed

 

 

About Q BioMed Inc.

 

Q BioMed, Inc. is a biomedical acceleration and development company. We are focused on licensing and acquiring biomedical assets across the healthcare spectrum. Q BioMed is dedicated to providing these target assets the strategic resources, developmental support and expansion capital they need to meet their developmental potential so that they can provide products to patients in need.

 

Please visit www.qbiomed.com and sign up to receive regular updates. Follow us on social media @QBioMed.

 

Forward-Looking Statements

 

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: inspection of the proposed third-party manufacturing facility by the FDA or other comments or requests from the FDA in connection with the above mentioned regulatory filing; failure of the proposed third-party manufacturing facility to pass an inspection by the FDA; regulatory risks; risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

 

Contact:
Denis Corin
CEO
Q BioMed Inc.
+1 (646) 884-7017

Source:  Q BioMed Inc.

Q BioMed Provides Important Update on QBM001 Developmental Drug Targeting a Non-Verbal and Minimally Verbal Patient Subset on the Autism Spectrum

Company Further Develops Its Autistic Spectrum Disorder (ASD) Drug Technology and Expects Several Development Partnerships In Anticipation of Clinical Program in 2019

 

NEW YORK, October 9, 2018 /PRNewswire/ — Q BioMed Inc. (OTCQB: QBIO), a biotechnology acceleration company, is pleased to provide an update on QBM001, its Autistic Spectrum Disorder (ASD) drug development program for non-verbal or minimally verbal autistic children.

 

Q BioMed continues to develop its intellectual property including its patent pending QBM-001 drug technology, which is being tested for pediatric developmental nonverbal disorder in toddlers within the autism spectrum disorders. Working with its medical and scientific advisors, Q BioMed is focusing on QBM001 candidate formulations that seek to provide an improved safety profile in preclinical studies. Q BioMed has visited with many potential trial sites in the U.S. and Europe over the last 9 months in preparation for the planned clinical trial of its drug candidate.

 

Denis Corin, CEO of Q BioMed Inc. stated, “We are grateful for the feedback from clinicians, patients and their families and medical and scientific advisors. All are excited about the roadmap for QBM-001 over the next 6 months and look forward to reporting on our progress.”

 

QBM-001 targets toddlers with pediatric developmental nonverbal disorder, where an underlying commonality of this subgroup is elevated blood markers that lead to developmental delay, an autism diagnosis and eventual nonverbal or very minimally verbal capability for the rest of their lives.

 

Although the nonverbal or very minimally verbal subgroup is definable by the lack of language development, there is no diagnostic tool to identify the children at risk at an early age. As such, Q BioMed has vetted diagnostic options over the last 9 months that could offer a way to diagnose these children as early as two years of age. These tools will be a part of the upcoming clinical trial in order to help validate them as potential biomarkers. Q BioMed is looking forward to announcing these partnerships in the coming months as we complete and submit the regulatory filings required for orphan drug designation and an IND to initiate the planned clinical trial.

 

In preparation for the clinical trial, Q BioMed is preparing partnerships with a Contract and Development Manufacturing Organization (CDMO) to start manufacturing, and Contract Research Organizations (CROs) to finish preclinical studies, submit a pre-IND, orphan drug designation filing and continue to secure its intellectual property through patent filings.

 

About Pediatric Development Nonverbal Disorder 

There are approximately 18,000 new cases of pediatric developmental nonverbal disorder in the US each year and a similar amount in Europe. The majority of the children are diagnosed as young children and fall within the autism and epilepsy spectrum disorders. Individually, the economic costs for toddlers that become non- or minimally verbal is ten million dollars on average per person over their life. Collectively, an estimated 200 billion dollars is spent yearly on individuals who have become nonverbal in the US. Not all individuals who become nonverbal will benefit from QBM-001. However, with validated biomarkers, testing from trained specialists and genetic testing, children who fall in this targeted population can be identified, and will have a higher likelihood of responding to treatment.

 

About Q BioMed Inc. 

Q BioMed Inc. “Q” is a biomedical acceleration and development company. We are focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q is dedicated to providing these target assets, strategic resources, developmental support, and expansion capital to ensure they meet their developmental potential, enabling them to provide products to patients in need.

 

Please visit http://www.qbiomed.com for more information and signup for regular updates. Also, follow us on Social Media @QbioMed #QbioMed $QBIO

 

Forward-Looking Statements:

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

 

Contact:
Denis Corin
CEO
Q BioMed Inc.
+1-888-357-2435

SOURCE Q BioMed Inc.

Q BioMed Takes the Stage in the Expanded Access Debate at European Early and Managed Access Program Conference

Q BioMed Orphan Drug VP, who started the first Expanded Access Program Database asked to Speak on Panels and run Roundtable at the Early and Managed Access Program Conference in the UK from October 22nd to 24th 2018

 

NEW YORK, October 26, 2018 /PRNewswire/ — Q BioMed Inc. (OTCQB: QBIO), a biotechnology acceleration company, is pleased to announce that Robert Derham, a member of the Q BioMed team and founder of CheckOrphan and architect of the world’s first access program database, hosted a roundtable discussion on how companies can compliantly communicate their expanded access program and participated on a panel discussion about how to more effectively work with patients and patient organizations when executing an expanded access program.

 

Expanded access programs are highly regulated programs that provide people with medicine that has not yet been approved on the market. Expanded access programs are receiving more attention as legislation known as “The Right to Try” bill passed in March of this year in the USA. FDA is responsible for regulating requests for expanded access use and most cases are handled over the phone within 24 hours when it is a matter of life of death.

 

Denis Corin, CEO of Q BioMed Inc. stated, “We live in an exciting time, where talk about gene therapy, stem cells and other cutting edge therapies is becoming reality. Thus we can now treat very difficult diseases that have no current treatment, which makes expanded access programs an avenue of hope for patients and their families. However, it is imperative for companies to plan early and engage regulators, health care professionals and advocates to ensure all stakeholders are prepared and can act in the best interest of the patient.”

 

The conference also discussed the augmenting role that expanded access programs play in Europe and the rest of the world. In Europe, expanded access programs are regulated by EMA and then approved and governed at the national level by the respective country’s health administrators. Some have governing bodies that regulate an expanded access program, while other countries handle each request on a case by case basis.

 

About Expanded Access Programs

Expanded access programs are regulated programs put in place to through coordination between regulators and pharmaceutical manufacturers to allow physicians to request access to specific medicines where their patient is unable to access that medicine through clinical trials or via the usual commercial route. The decision to treat a patient as part of an access program is based on the clinical judgment of their physician, and is applicable where there is a genuine unmet medical need and no alternative treatments available.

 

CheckOrphan Access Program Database

CheckOrphan launched the database in 2015, in collaboration with Idis (now Clinigen), to create a resource for the rare disease community who wish to access a specific medicine, but find that it is currently unavailable to them. The listings include information about the therapeutic areas and specific indications where such access programs have been put in place by pharmaceutical manufacturers. Due to regulations governing unlicensed medicines, entries submitted to CheckOrphan for review and publication will not be mentioning product names. Where product names are mentioned on any detail pages, this information is taken from other publicly available sources.

 

About Q BioMed Inc.

Q BioMed Inc. “Q” is a biomedical acceleration and development company. We are focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q is dedicated to providing these target assets, strategic resources, developmental support, and expansion capital to ensure they meet their developmental potential, enabling them to provide products to patients in need.

 

Please visit http://www.qbiomed.com for more information and signup for regular updates. Also, follow us on Social Media @QbioMed #QbioMed $QBIO

 

Forward-Looking Statements:

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

 

Contact:
Denis Corin
CEO
Q BioMed Inc.
+1-888-357-2435

SOURCE Q BioMed Inc.

About Q BioMed

Our vision is to create a pipeline of innovative biomedical assets in various stages of development in multiple therapeutic areas. Our strategy will minimize risk, share success and accelerate our technologies from incubation to monetization.

 

We are dedicated to acquiring and providing strategic resources and expansion capital to innovative healthcare companies that strive to provide much needed healthcare and related products to patients in need. By partnering with exceptional entrepreneurs we aim to help to create market-leading products in the biomedical and healthcare sector. As entrepreneurs and investors with operational and technical expertise we embrace a collaborative approach to capital formation and business development.

 

  • identify
    Criteria match and fit

 

Preliminary scientific and commercial criteria review. Determining management’s expectations and flexibility moves the asset to the next step.

 

  • analyze
    Asset and development plan

 

Due diligence is combined with a validation of management’s
development and capital requirements.

 

  • invest
    Capital attached to goals

 

Performance-based capital is deployed to meet specific and mutually agreed goals in each stage

 

  • accelerate
    Increase investment and ownership

 

Additional resources are infused to move the asset through development stages and to a value-creating inflection point.

 

  • monetize
    Operate, partner, license, IPO or sell

 

Assets can be sold, licensed, joint-ventured or operated as cash flow positive product lines. QBIO’s goal is to maximize value for its shareholders.

 

THE RIGHT FIRM

 

Focuses exclusively in the biotechnology and healthcare sectors, targeting a broad spectrum of biomedical products and healthcare solutions. Q’s expertise is in business & product development and the capital formation required for phased advancement of products.

 

 

THE RIGHT SOLUTION

 

Our team assists companies by utilizing our strategic partners and network of experts to provide public market access for private company assets. 80% of biomedical start ups lack capital and resources to transition from incubation to development and beyond.

 

 

THE RIGHT STRATEGY

 

Q expects to maximize risk-adjusted returns by focusing on value-driven assets from early stage to near-revenue businesses where the technical, regulatory, and commercial risks have been mitigated or where major valuation inflections are imminent.

 

PIPELINE

 

 

Strontium Chloride Sr89 Injection, USP

 

Following intravenous injection, soluble strontium compounds behave like their calcium analogs, clearing rapidly from the blood and selectively localizing in bone mineral. Uptake of strontium by bone occurs preferentially in sites of active osteogenesis, thus primary bone tumors and areas of metastatic involvement (blastic lesions) can accumulate significantly greater concentrations of strontium than surrounding normal bone. Strontium-89 Chloride is retained in metastatic bone lesions much longer than in normal bone, where turnover is about 14 days. In patients with extensive skeletal metastases, well over half of the injected dose is retained in the bones. Excretion pathways are two-thirds urinary and one-third fecal in patients with bone metastases. Urinary excretion is higher in people without bone lesions. Urinary excretion is greatest in the first two days following injection. Strontium-89 is a pure beta emitter and Strontium-89 Chloride selectively irradiates sites of primary and metastatic bone involvement with minimal irradiation of soft tissues distant from the bone lesions. (The maximum range in tissue is 8 mm; maximum energy is 1.463 MeV.) Clinical trials have examined relief of pain in cancer patients who have received therapy for bone metastases (external radiation to indexed sites) but in whom persistent pain recurred.

 

 

About QBM – 001

 

QBM-001 is given to high-risk genetically identified children during the second year of life to regulate faulty membrane channels that are known to cause migraines and/or seizures. This drug acts as an allosteric regulator of these faulty channels in the brain to potentially alleviate the condition and allow toddlers to actively develop language and speech and avoid life-long speech and intellectual disability of being non-verbal. QBM-001 also reduces inflammation in the brain and by so doing can reduce the amount of long-term nerve loss.

 

 

About UTTROSIDE-B Chemotherapeutic

 

P Uttroside-B appears to affect phosphorylated JNK (pro survival signaling) and capcase activity (apoptosis inliver cancer)

 

> A natural compound
> Fractionated Saponin derived from S. nigrum
> Small molecule
> Steroid Glycoside

 

Uttroside B increases the cytotoxicity of a variety of liver cancer cell types

> Up to 10x more potent than Sorafenib in pre clinical studies

 

 

About MAN-01
Topical Eyedrops for Glaucoma

 

First in class drug for Intraocular Eye Pressure. No new drugs in”IOP” for 20 years Only drug targeting the critical ‘Schlemms’ Canal. The Schlemms Canal is responsible for 70%-90% of fluid drainage in the eye.

 

We are developing a unique set of molecules to treat vascular related diseases, such as Primary Open Angle Glaucoma, Pediatric Glaucoma, Cystic Kidney Disease, and Inflammation via our proprietary research platform.

 

MAN-01 faciltiates the drainage of liquid through the Schlemm’s Canal testing on mice as consistently delivered positive results in relieving IOP.

 

TEAM

 

Denis D Corin
CEO and Chairman

 

Mr. Denis D. Corin is Chief Executive Officer and Chairman of the Board. Mr. Corin is an experienced public company executive and management consultant. He has worked almost exclusively in the biomedical field for over 13 years from large pharma and diagnostic companies to small innovative biotech. He has served in various senior executive roles and has been instrumental in building and restructuring businesses. Mr. Corin has raised millions of dollars in development capital to advance businesses. Mr. Corin also served as a Management Consultant to the executives and board of TapImmune Inc. (NASD:TPIV), a clinical stage immune-oncology company through 2014, He holds a Bachelors Degree majoring in both Economics and Marketing & Advertising Management from the University of Natal, South Africa.

 

 

William Rosenstadt
General Counsel and Director

 

Mr. William Rosenstadt is a partner and a co-founder of Ortoli Rosenstadt LLP and head of the firm’s capital markets and securities practice and co-chair of the firm’s Asian practice. He has been practicing corporate and securities law since 1995. He represents entrepreneurs, public companies, hedge funds, private equity funds and other corporate entities on complex international and corporate transactions. He has represented public companies in the U.S., Europe and Asia. William is proud to be given the opportunity to help Q BioMed create value for its shareholders and bring life changing solutions to as many patients as possible.

 

David Laskow-Pooley
VP Product Development

 

Mr. Laskow-Pooley has 30 years of experience in all aspects of the discovery, development and commercialization of pharmaceutical products, diagnostics and devices. He is an industry veteran and has a distinguished career working for numerous pharmaceutical and life sciences companies. He has held director, executive officer and general management posts in both small and major multinational companies including GSK, Abbott, Amersham plc, Life technologies, OSI, Bilcare and Surface Therapeutics.

 

 

Ari Jatwes
Business Development Analyst

 

Mr. Ari Jatwes is an analyst and a banker, with over twenty years of experience. He began his career in a large accounting firm, progressing to a reputable investment bank, where he gained his experience in mergers and acquisitions. Over the last decade Mr. Jatwes interest and focus has been in the biotech and pharma sector, which included trading biotech stocks from start up to late stage biotech companies, advising management and raising capital for their needs. He has played a role in several successful contracts and transactions in the healthcare space – with emphasis on the life sciences and immunotherapy. Mr. Jatwes holds two Master degrees and a Bachelor Degree from the University of South Africa and the University of Natal.

 

 

Robert Derham
VP Orphan Products

 

Robert Derham has focused the majority of his career working with rare diseases and orphan products. For the past seven years he has focused on driving corporate change within medium and large pharmaceutical companies to transition their corporate strategy to an orphan drug development approach. In addition to driving corporate change, he conducted business development for companies looking for partnering, licensing or acquisition opportunities in the orphan drug space. Prior to that, he worked for Mondobiotech, Novartis, Syngenta Biopharma and Alexis Biopharma, always focused on orphan indications and corporate development. Robert is also the founder of CheckOrphan, a comprehensive media and information source for all news, videos, clinical trials, research, treatments and more about rare diseases and orphan products. He also has degrees in medical immunology and biochemistry and thoroughly enjoys diving into the science and research of the rare diseases, with which he is working.

 

 

Dr. Rick Paniccucci
Director and Advisor Pharmaceutical Development

 

Dr. Rick Panicucci is the Vice President of Pharmaceutical Development at WuXi AppTec. He is responsible for providing scientific leadership in the areas of Developability, Formulation Development and GMP Manufacturing.Dr. Panicucci plays an important role in the early stages of drug discovery for various companies. His responsibilities include solid state chemistry and formulation development of all small molecule therapeutics in early development, and developing novel drug delivery technologies for small molecules and large molecules including siRNA.Prior to WuXi he held the position of Global Head of Chemical and Pharmaceutical Profiling (CPP) at Novartis from 2004 to 2015, where he led the development and implementation of innovative dosage form designs and continuous manufacturing paradigms. He has also held positions as the Director of Formulation Development at Vertex Pharmaceuticals and Senior Scientist at Biogen.Dr. Panicucci received his Ph.D. in Physical Organic Chemistry at the University of Toronto, and has two post doctoral fellowships at University of California at Santa Barbara and the Ontario Cancer Institute. Dr. Panicucci will advise our technology partner, Mannin Research Inc.’s development both scientifically and commercially.

 

 

Amy Ripka
Advisor Medicinal Chemistry

 

Dr. Amy Ripka is Executive Director of Medicinal Chemistry at WuXi AppTec. She started her career at Bristol Myers Squibb and over 17 years has worked in various capacities in medicinal chemistry with many small companies, including EnVivo (FORUM) Pharmaceuticals as Head of Chemistry, Infinity, Daiamed, HydraBiosciences and FoldRx. Her current responsibilities include strategic planning in medicinal chemistry, early library drug design utilizing multiple in silico methods, hit optimization and overall screening architectures to advance early stage compounds through Phase I-II clinical development. Dr. Ripka’s therapeutic specialties include Neuroscience, Oncology, Thrombosis and Anti-Infective Disease areas. She has led multiple early stage programs resulting in four clinical candidates, two of which are marketed drugs. Her career has spanned big pharma, biotech and CROs where she has made significant contributions to each of these.Dr. Ripka, was elected by her peers to Chair the prestigious Medicinal Chemistry Gordon Research Conference and is currently serving a second elected term as the Industrial Councilor for the MEDI Division of the American Chemical Society.Dr. Ripka, received her Ph.D. in Chemistry from the University of Wisconsin-Madison with a double concentration in organic and medicinal chemistry, and did her post-doctoral studies with Nobel Laureate K. Barry Sharpless from The Scripps Research Institute. Dr. Ripka will advise Mannin’s scientific development and growth.

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