Posts Tagged Pharmacology
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on October 4, 2012
Pradeep Fernades, co-founder and President of Cellworks Group (www.cellworksgroup.com), discussed new derisked and innovative approach to developing therapies with enhanced probability of success at www.bio2devicegroup.org .
This new approach based on integrating biology and computing, enables a new paradigm that dramatically can reduce spending for developing new therapies. Currently $100B is spent globally, each year for pharmaceutical R&D. The cost for development of each new drug is estimated to be between $1 to $4B, depending on how the math is done. While published research and data is exploding, the overload of information makes it increasingly challenging to meaningfully use the information. The pharmaceutical industry is pouring more and more money into the R&D and increasingly has lesser probability of success. Problem is that despite the technology advancement, the drug development process remains fundamentally unchanged and drug development is validated very late in clinical trials. Real understanding of drugs is only possible during clinicals and even then the underlying mechanism of action if frequently unclear.
Informatics can bridge the gap and improve the outcomes, both better consumer oriented information that include monitoring of patient, drug, and trends as well as development oriented information that includes information about genomics, proteomics, biology etc. Cellworks Group is focused on development oriented informatics, which have traditionally been aimed at leveraging information technology and software algorithms to help manage large data sets, extract information from large data sets, and allow visualization of data. Their engineering model further goes from analyzing and extracting information to predicting information through abstraction modeling, simulation, and synthesis. This is contrary to traditional model where biologist begins at the lab, puts the drug in and if there is expected effect, then the initial hypothesis is confirmed which does not frequently happen. In this model, based on mathematical modeling, equation at each interaction within the cell, is analyzed and understood. This is a predictive computational disease model based on integrating insights of thousands of scientists, research data, experimental protocols, and clinical trends, that is mathematically observed at cellular level. Fernandes shared several ongoing collaborations and validations in oncology, rheumatoid arthritis, and anti-infection that are under way.
Essentially this is a process for finding innovative new therapies that begins with very explicit assumptions. It is based on leveraging functional representation of biology using mathematics. Relationship of each interaction is represented using differential equations. It emulates human disease physiology computationally and integrates it with understanding biological efficacy and toxicity. The process enables prediction of clinical outcomes as well as novel non-obvious insights and is many times speedier than wet approaches. It is about time that these new approaches be explored so that drug development process goes through an overhaul rather than small, incremental enhancements to make it more cost-effective.
For the opportunities below, please send resume to wd_darshana at hotmail dot com.
IT Project Manager (Contract Opportunity) – Bay Area, CA
There is contract opportunity for IT Project Manager with a Biotech company. The start date for the contract is July, 1 and the project is expected to last 9-12 months. The candidate is expected to have 10-15 years of experience in Project Management. Job responsibilities include, plan, execute, and finalize projects according to strict deadlines and within budget, acquiring resources and coordinate the efforts of team members and third-party contractors or consultants in order to deliver projects according to plan. Responsibilities also include, define project scope, goals and deliverables to develop full-scale project plans, liaise with project stakeholders on an ongoing basis, supervise project team members, identify and resolve issues and conflicts within the project team, proactively manage changes in project scope, and identify potential crises. The immediate projects include implementing company laptop encryption system, learning management system validation, and completion of proof of concept deliverables pertaining to data mapping and data migration between HR Master and AWR and Exterro.
Junior Software Embedded Engineer – Sunnyvale, CA
There is an immediate opportunity for Junior Embedded Engineer in $60-$80K salary range with a reputed contract engineering company, located inSunnyvale,CA. This position requires an understanding of both hardware and software and how each can influence the other at all levels of the design process. This opportunity offers a chance to work on a wide range of fun and interesting projects and an opportunity to work with and be mentored by a world class team of staff and consultants. Requirements include MSEE + 1-2 years experience or BSEE + 2-3 years experience, keen interested in embedded systems and some experience with a number of current processor architectures, e.g. PIC, MSP430, ARM. Also required, an ability to program embedded systems in C, C++ or other languages, knowledge of assembly language, knowledge of test equipment such as oscilloscopes, logic analyzers etc and how to use them, experience with schematic capture, along with the ability to build simple prototype electronic circuits, and ability and skill to interpret customer requirements into design ideas and the knowledge and confidence to take those forward into a working solution with the assistance of other members of staff.
Quality Engineer – San Jose, CA
Drug delivery company has an immediate opening for Senior Quality Engineer with 10+ years pharmaceutical industry experience in sterile manufacturing and process qualifications for injectible drugs. Experience in documentation and batch process and automation quality systems setup and management experience is required. Qualifications should include BS in Chemical Engineer, Mechanical Engineering or related. This is a grounds level opportunity to work on game changing technology with solid IP and secure funding, under the leadership veteran leader with several successful companies. Compensation will be commensurate with experience and will include stock options, with great potential.
Injection Molding Machine Building & Manufacturing Engineer – San Jose, CA
The ideal candidate for this job will be an expert in injection molding with 10+ years of deep experience. Experience working with suppliers is not enough. Experience with tool design and mold machine building is required. Also required, mold design, AND operating, and fabricating of injection molding machines. Working knowledge of design/development of manufacturing systems with emphasis on new molds and molding processes, creating and understanding mold flow analysis and ability to implement installations or modifications of new equipment and/or machinery to support the injection molding processes is required. Hands on experience in the tooling part of plastic injection molding, taking apart and adjusting molds on a daily basis will be called upon. Experience in Autocad and SolidWorks and BS in Mechanical Engineering is required. Experience in vacuum forming, a huge plus. This is a grounds level opportunity to work on game changing technology with solid IP and secure funding, under the leadership veteran leader with several successful companies. Compensation will be commensurate with experience and will include stock options, with great potential.
PS – this is a very specialized opportunity and requires mold machine building experience to work on the first prototype that the CEO has built for very customized medical application.
Clinical Project Manager
The position will support US and OUS clinical trials in a cross-functional role to support the clinical study team.
Essential functions include manage clinical trial operations with a specific focus on European feasibility investigations, establish and maintain study master files, work with sites to prepare submissions, secure study documentation, and negotiate contracts, manage case report form data and monitoring activities, develop and refine clinical trial procedures, create and prepare materials for Investigator, Coordinator, and DSMB meetings, prepare Case Report Forms, support field clinical staff with significant involvement in site assessments, monitoring activities, site audits, and site closures as needed, write and file Adverse Event reports, annual reports, and other communications with Ethics Committees, Competent Authorities, and Institutional Review Boards, perform clinical data entry, report generation, work with sites to resolve data queries, support investigators with publication activities, as needed, provide regulatory support for US and OUS clinical submissions, interface with Regulatory Affairs department to provide support for ongoing regulatory activities, provide support for new and ongoing regulatory submissions, provide support for Product Development and Operations, development, writing of Manuals and training materials, and participate in clinical validation and product development verification activities
BS in life sciences or equivalent with a minimum of 5 years related experience in supporting medical device clinical trials is required. Experience working directly with US and EU sites and working with clinical data and database experience, strongly desired. Familiarity with literature searches, experience monitoring sites, and scientific writing skills, preferred. About 10% travel will be required.
Machinist – San Antonio, TX
Innovative medical device/ biotech in Texas has an immediate opening for Machinist. The company is found by a veteran leader with number of prior successes and this is an opportunity to contribute at grounds level, in a promising startup. (Stock options could make this a once in a lifetime kind of an opportunity). The mechanical engineer/ technician will work with other engineers to develop innovative drug delivery systems. The candidate must be familiar with fabricating small parts or tooling on a lathe and mill. Successful candidate will have combination of mechanical and electrical skills. At least 5 years experience in medical device industry is required.
Pharmacologist with In-Vivo Experience: San Antonio, TX
A dynamic company, found by a veteran leader of several successful startups, involved in the development of drug-device combination products for treating chronic diseases, has an opening for a Biologist. This is once in a lifetime kind of an opportunity to work on exciting technology with game changing potential. The applicant must have a BS with a minimum of 8 years (or MS with at least 6 years) of hands-on laboratory experience. The individual is expected to have a breadth of experience in in-vitro and in-vivo biological research supporting various drug/ device development programs across multiple therapeutic areas including CNS, oncology, cardiovascular and metabolic diseases.
The applicant will support and work with external institutions including CROs and academic institutions especially for conducting in vivo studies in small as well as large animals. Additionally the applicant will set up and run a variety of routine in vitro research paradigms as needed such as isolated tissue and cell-based assays as well as quantitative assays for small molecules, peptides and proteins using techniques such as FTIR, HPLC, and immunoassay. The applicant will work with a multidisciplinary team of experts and provide biology support with minimal supervision on various ongoing projects. The position requires a strong background in cell biology, chemistry, biochemistry, immunology, physiology or a related area. Position, salary and benefits are commensurate with experience.
Ultra Low Power Analog Design Engineer – San Jose, CA
There is an opening in CA & TX for ultra low power analog design engineer for a company found by a veteran leader of several successful companies. This is an exciting opportunity to work on cutting edge technology, with a great promise. Compensation will be commensurate with experience, in addition to the stock options. The stock options could make this highly attractive opportunity. The position requires 6+ years of experience with medical device low power analog circuit design and embedded design experience.
My colleague is working on the opportunities below. If you have an interest, please mention the opportunity in the subject line, with your name and send your resume and I will forward it to him.
Director of Clinical – San Jose, CA
VP of RA/QA – Redwood City, CA
Senior Manager of RA/QA – San Francisco, Ca