MindPharm Blog

The VP/Senior Director of Clinical Development is responsible for oversight and management of all Clinical Programs. This individual will actively participate in the development and guide the strategy, launch and overall direction of relevant clinical studies. This individual will be the lead company medical representative for both internal and external presentations.

 

Company Profile:

The Company is a private pharmaceutical company focused on the development and commercialization of small molecular kinase inhibitors. The Company?s lead compound is in IND enabling studies for the treatment of cancer and other diseases.

 

Reports to: Chief Executive Officer, CEO

 

Responsibilities:

• Lead clinical studies either directly or through a CRO
• Oversee additional studies
• Conduct and supervise these studies, analyze results, write study reports
• Contribute to the clinical sections of regulatory documents such as the IND, NDA
• Interact with regulatory agencies throughout the development process
• Apprise senior management of progress and developmental issues
• Organize consultants to ensure development activities are in line with current medical knowledge
• Interact with external vendors and clinicians
• Directly involve in preparation and management of clinical budget
• Business development involvement to continue to grow pipeline and provide input on strategic partner deals terms and arrangements
• Spend time in market development of the therapeutic area.

This includes:

• Participation at National and Regional Medical Society meetings.
• Participation at National Trade Conferences.
• Participation as Thought Leader on scientific proposals.
• Guide development of investigator alliance network.

 

Requirements:

• M.D., Ph.D., with a minimum of 5 years in the pharmaceutical industry
• working on Phase I Oncology applications preferred
• Experience with IND filing preferred
• Passion to make a significant positive impact in a small company environment
• An ability to work proactively in partnership with regulatory authorities both inside and outside the U.S
• A demonstrated ability to create and implement drug development strategies
• Outstanding team player with strong leadership and interpersonal skills
• A proven track record of working effectively on cross-functional development teams
• Experience in developing, implementing, and promoting business strategies and development within the therapeutic area
• Demonstrated problem solving ability in addressing current and anticipated issues related to clinical trial management as well as medical and regulatory development
• Strong business skills
• Comfortable working in a fast-paced and highly dynamic environment

 

For consideration please contact;

Stephanie Miller

MindPharm, LLC

www.mindpharm.net

410-448-4522

stephanie.miller@mindpharm.net

Vaccines that require refrigeration or freezing for storage add at least $200 million to the cost of distributing vaccines in developed countries this new preservation technique offers a solution.

New vaccine storage technology could revolutionize immunization in the developing world | Booster Shots | Los Angeles Times

British researchers have devised a way to capture vaccines in a glass-like membrane composed of sugar, a feat that could eliminate the need for refrigeration of vaccines and revolutionize their distribution in the developing world. Tests have shown that the technique can preserve vaccines for as long as a year at tropical temperatures, according to the report Wednesday in the journal Science Translational Medicine.

This interesting study describes a new class of broad-spectrum antivirals effective against
enveloped viruses that target the viral lipid membrane and compromises its ability to mediate virus?cell fusion. 

A broad-spectrum antiviral targeting entry of enveloped viruses ? PNAS

an antiviral small molecule, LJ001, effective against numerous enveloped viruses including Influenza A, filoviruses, poxviruses, arenaviruses, bunyaviruses, paramyxoviruses, flaviviruses, and HIV-1. In sharp contrast, the compound had no effect on the infection of nonenveloped viruses. In vitro and in vivo assays showed no overt toxicity.

Here is an article at PhysOrg about a new spray-on coating of SiO2 that appears to have an incredible range of uses.  It links to related articles that speculate about the safety aspects of its use for food-handling surfaces, but even so it appears to have a lot of potential.

Spray-on liquid glass is about to revolutionize almost everything

Spray-on liquid glass is transparent, non-toxic, and can protect virtually any surface against almost any damage from hazards such as water, UV radiation, dirt, heat, and bacterial infections. The coating is also flexible and breathable, which makes it suitable for use on an enormous array of products.

 

MindPharm is partnering with an emerging Diagnostic Assay Company engaged in the development of a Personalized Medicine Thera-nostic Testing System. We wish to identify candidates for a Vice President of Product Development who will lead the development  and commercialize efforts.

Position Title:              Vice President of Product Development

Reports to:                            CEO and CSO

Direct reports:               4-5 FTE's; PhD, MS and BS levels

Location:                            Baltimore, MD

 

Summary:

The VP of Product Development is a critical decision maker, who will create and execute the successful development plan for commercialization of a live tumor cell testing system.

Working closely with the CEO and CSO, the successful candidate will also contribute to the  Company?s;

·       global portfolio strategy

·       regulatory strategy and compliance

·       clinical trial planning and strategy

 

Essential Functions:

·       Develop strategy and evaluate technology alternatives for the development of new products (in particular the pathology-based medical device, tumor processing cartridge and multi-analyte biomarker tests (IVDMIA)

 

·       Establish strategic product development plans, procedures and documentation for

- defining the product profile,

- product development stages, milestones,

- product testing and validation

 

·       Manage and optimize all technology transfer programs

 

·       Oversee the design and conduct of biomarker-related clinical trials including documentation, data analysis and reporting

 

·       Ensure compliance with regulatory, scientific and medical standard obligations

 

·       Together with senior management and corporate legal counsel, manage the Company?s intellectual property portfolio including updates and submission of new documentation.

 

·       Routinely present updates to Company employees and board of directors on product development programs

 

·       Develop and maintain positive relationships with valued academic, government, and industry collaborators to achieve company business goals and development strategies.

 

·       Provide leadership to research and product development teams through hiring, coaching, counseling, monitoring employee performance

 

Minimum Requirements:

·       Ph.D. in Molecular Diagnostics, BioMedical Engineering, Biochemistry or related degree

 

·       10 years of increasing responsibility successfully developing IVD products

 

·       Experience in protein-based and/or gene expression profile-based MDx development

 

·       Experience in clinical trial design and management, including regulatory requirements and result reporting of IVD products

 

·       Experience preparing 510(k)s and/or PMAs for successful and timely submission

 

·       Results oriented, entrepreneurial and self-motivating with a desire to work in a challenging and fast paced environment

 

·       Strong leadership, motivational and interpersonal skills

 

·       Strong analytical skills with the ability to develop strategies, tactics, and metrics driven implementation plans

 

·       Experience working with the FDA and a track record of gaining and expanding approvals through successful document submissions and agency meetings

 

·       Knowledge of CLIA laboratory based MDx testing

 

Work Environment:

·       Shared open office and laboratory environment

·       Early stage start?up tissue-based molecular diagnostics and personalized medicine company

 

For consideration please contact;

Stephanie Miller

MindPharm, LLC

www.mindpharm.net

410-448-4522

stephanie.miller@mindpharm.net

 

 

MindPharm is partnering with an established BioPharmaceutical company to identify candidates for an exciting Functional Imaging program designed to augment Drug Development and Biomarker Discovery.

 

Noninvasive imaging technologies are seeing increasing utilization in drug discovery and development. Across various therapeutic areas, imaging endpoints appear to offer great promises as quantifiable measures of therapeutic responses or undesirable side effects. Nonetheless, it is challenging to analyze the significant amount of data generated from the imaging study and therefore often necessitates extensive resources and expertise. Our client established an Imaging initiative in 2006 in an attempt to expedite as well as de-risk Discovery/ Development programs, particularly in the areas of Neuroscience and Oncology.

 

The level and title of this position will be based upon the candidate's experience.

 

Reports to:

Associate Director Translational Neuroimaging Imaging and Biochemical Biomarkers

Advanced Technology

 

Requirements:

·       Ph.D. in Biomedical Engineering, Neuroscience or related

·       Knowledge and experience in multi-dimensional image processing and visualization, algorithm design, software programming (e.g. C/C++, IDL or Matlab), and statistical image analysis

·       Experience in development and maintenance of analysis software under Linux or Unix

·       Experience in the analysis of large databases of multi-modal PET/SPECT/CT/MRI data

For consideration please contact;

Stephanie Miller

MindPharm, LLC

www.mindpharm.net

410-448-4522

stephanie.miller@mindpharm.net

Generically engineered to over-express the NR2B gene, Hobbie-J consistently out-performed the normal Long Evans rat at complex tasks.  A similarly engineered mouse, Doogie, showed memory improvement a decade earlier.

Smart rat 'Hobbie-J' produced by over-expressing a gene that helps brain cells communicate

Dubbed Hobbie-J after a smart rat that stars in a Chinese cartoon
book, the transgenic rat was able to remember novel objects, such as a toy she played with, three times longer than the average Long Evans female rat, which is considered the smartest rat strain. Hobbie-J was much better at more complex tasks as well, such as remembering which path she last traveled to find a chocolate treat.

Using mouse embryonic stem cells, Duke researchers were able to grow a patch of cardiomyocytes that could contract and conduct electrical impulses.

New Strategy For Mending Broken Hearts?

By mimicking the way embryonic stem cells develop into heart muscle in a lab, Duke University bioengineers believe they have taken an important first step toward growing a living "heart patch" to repair heart tissue damaged by disease.

The two newly discovered bNAbs, called PG9 and PG16, are the first to have been identified in more than a decade and resulted from a massive collaboration of researchers from the global North and South, from academia and industry, from within and outside the HIV field that analyzed upwards of 1,800 HIV-infected volunteers in developing countries around the world.

Two new antibodies found to cripple HIV: Potential key to AIDS vaccine

Researchers at and associated with the International AIDS Vaccine Initiative (IAVI), at The Scripps Research Institute, and at the biotechnology companies Theraclone Sciences and Monogram Biosciences have discovered two powerful new antibodies to HIV that reveal what may be an Achilles heel on the virus. They published their work in Science this week.

This breakthrough has implications for repairing damaged retinas and for providing a laboratory model to investigate new drugs and treatment for genetically linked eye conditions.

Retina Cells Created From Skin-derived Stem Cells

A team of scientists from the University of Wisconsin-Madison School of Medicine and Public Health has successfully grown multiple types of retina cells from two types of stem cells ? suggesting a future in which damaged retinas could be repaired by cells grown from the patient's own skin.

An animal study revealed that metformin was able to boost T-cell response, a reslut that could potentially revolutionize vaccine strategies.

Diabetes drug revs up effectiveness of vaccines - FierceVaccines

Metformin triggers AMP-activated protein kinase, a key component in energy metabolism that is used in the development of memory T-cells. "When we give metformin, it's like giving the T-cell response a boost," Russell Jones of McGill University in Canada told Reuters.

The result is surprising since the process does not work when used on "higher" plants.  It could yield a low cost alternative to culturing mammalian cells to produce the proteins.


Biotechnology: Engineered Moss Can Produce Human Proteins

In collaboration with researchers at the University of Freiburg im Breisgau, the PhD student Marc Gitzinger carried out tests to see what happens when unmodified human or mammalian genes are inserted into the moss genome. They transferred the foreign, unmodified genes into the moss and discovered that the moss was easily able to manufacture the proteins encoded therein.

In addition to being painless, the results of the glucose test are sent wirelessly to a wrist display or computer. 

Blood testing, mosquito style

Electrical engineers at the Schulich School of Engineering at the University of Calgary have patented a device called the Electronic Mosquito. The patch is approximately the size of a deck of cards and contains four micro-needles that "bite" sequentially at programmed intervals. The needles are electronically controlled to penetrate the skin deep enough to draw blood from a capillary, but not deep enough to hit a nerve.

Currently being tested in mice, human trials are expected to take another two years before the ink used in the diagnostic "tattoo" can be marketed.


Nano Ink 'Tattoo' Could Monitor Diabetes: Discovery News

A special tattoo ink that changes color based on glucose levels inside the skin is under development by Massachusetts-based Draper Laboratories. The injectable nanotech ink could eventually free diabetics from painful blood glucose tests.

In a new tactic in the fight against cancer, Cornell researcher Michael
King has developed what he calls a lethal "lint brush" for the blood --
a tiny, implantable device that captures and kills cancer cells in the
bloodstream before they spread through the body.

Device could filter cancer cells from blood

King used selectin molecules -- proteins that move to the surface of blood vessels in response to infection or injury. Selectin molecules normally recruit white blood cells (leukocytes) which "roll" along their surfaces and create an inflammatory response -- but they also attract cancer cells, which can mimic the adhesion and rolling process. Once the cancer cells adhered to the selectin on the microtube's surface, King exposed them to a protein called TRAIL (for Tumor Necrosis Factor Related Apoptosis-Inducing Ligand), which binds to two so-called "death receptors" on the cancer cells' surface, setting in motion a process that causes the cell to self-destruct.