The International Conference on Harmonisation’s Planned Drug Manufacturing Guideline: What Do Pharma Manufacturers Need To Know?

By Jennifer

International Conference on HarmonisationThe International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is an organization that brings together pharmaceutical regulatory authorities in Europe, Japan, and the United States towards the goal of standardizing processes for safe and effective drug discovery and development. On October 10th, 2014, ICH published an initial concept paper for guidance in its Quality category titled ”Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.” The resulting ICH Q12 guideline, due to be available in 2017, will complement existing quality assurance plan guidance in the pharmaceutical development and launch phases with regulatory recommendations in the later chemistry manufacturing and controls (CMC) phase. Adoption of ICH Q12 will benefit patients, pharmaceutical/ biotech companies, and regulators through continual improvement of post approval processes. So what should you do?

In this article, we will review the concept paper as well as to begin to highlight how the 3DEXPERIENCE Platform and the Licensed to Cure for BioPharma industry solution experience can help you prepare for, and implement the ICH Q12 guidance. We will follow the ICH Q12 updates closely on the blog, see all posts tagged with ICH here.

Licensedd To Cure For BioPharma

Representation of the solution (example).

While ICH Q12 is a very fitting addition to the organization’s Quality guidelines, the concept paper makes it clear that creation of the guideline is due to unforeseen gaps in the implementation of  ICH Q8-Q11, which are as follows:

 

The ICH Q12 guideline is expected to impact the following areas

  • Regulatory Dossier
    • Updates aimed at improving post approval changes
  • Pharmaceutical Quality System (ICH Q10)
    • Develop improved knowledge and change management systems
  • Post-approval Change Management Plans and Protocols
    • Establish criteria for managing and submitting post-approval changes

 

The benefits of ICH Q12 implementation include

  • Improving reliability of the supply of pharmaceuticals through more CMC change management processes
  • More standardized and useful regulatory dossiers
  • Enhance use of regulatory tools for Post-approval Change Management (PACM)
  • Continual improvement of the manufacturing process
  • Reduction of product variability
  • Increased manufacturing efficiency

 

The benefits of product lifecycle management

At Dassault Systèmes (3DS), we have long recognized the benefits of product lifecycle management in improving the drug manufacturing process and ultimately the patient experience. The Licensed to Cure for BioPharma industry solution experience powered by the 3DEXPERIENCE platform combines advances in collaboration, global product development, and information intelligence to provide operational excellence. This single version of the truth, systematic  approach to drug manufacturing fits well with the ICH Q12 vision, and we look forward to working with biotech and pharma manufacturers to guide them in adapting to these changes. You can learn more about 3DS pharma and biotech solutions by attending the 3DEXPERIENCE Forum—North America, taking place November 12-14, 2014 in Las Vegas.

The ICH Q12 guideline will represent a major change as it will be applicable over the lifecycle of the product and focused on the CMC phase. An Expert Working Group (EWG) will be comprised of assessors and inspectors with expertise in quality systems and pharma manufacturing of chemical, biological, or biotechnological products. The EWG will meet in November 2014, June 2014, and November 2015, with the Adoption of Step 2 Document occurring in Q2 of 2016 and Adoption of Step 4 Document occurring Q2 2017 (see this description for details of the ICH process). Although not all regulatory authorities (such as the Food and Drug Administration, (FDA)) adopt the ICH Guidelines directly, ICH Q12 will surely impact regulatory requirements globally.

Medical engineering’s future frontiers

By Catherine

By Catherine Bolgar*

Future technology to detect and treat diseases is coming from some surprising sources. We talk about “fighting diseases” or “fighting cancer,” for example. Well, how about using military technology for medical devices?

medical device

MelaFind, which is already on the market, uses innovative spectral imaging and software-driven technology born from missile-navigation systems to help dermatologists detect melanoma at its most treatable stage.

Melanoma accounts for only 5% of all skin cancers but is responsible for 75% of deaths. Caught early it’s almost 100% curable; however, by the time melanoma goes more than 1mm below the skin, patients have a 50% chance of dying, usually within a year.

“Dermatologists are probably the last group of physicians who don’t use imaging as a standard,” says Rose Crane, chief executive and president of MELA Sciences, the Irvington, New York, company that makes MelaFind. While dermatologists are very good at spotting melanoma vs. benign moles, many cases are difficult and ambiguous for them, she says.

MelaFind uses spectral light to illuminate the skin, and then provides the doctor with 3D images, as with magnetic resonance imaging. Then, the images are analyzed with proprietary algorithms that provide the doctor with data on the probability of the lesion being a melanoma based on the largest positive, prospective study ever conducted on the disease.

It’s able to non-invasively image and analyze irregular moles 2.5mm below the skin surface where a doctor can’t see unless he/she cuts,” she says.

Near-Infrared Fluorescence Lymphatic Imaging (NIRF-LI) is another device that uses military technology for medical imaging. NIRF-LI stands for “near-infrared fluorescence lymphatic imaging,” and uses infrared military-grade night-vision technology to see the body’s lymphatic structures and flow for the first time.

Watching television coverage of nighttime operations during the first Gulf War, Eva Sevick-Muraca, now professor of molecular medicine at the University of Texas Health Science Center at Houston, or UTHealth, recalls that she “had the crazy idea that we could use near-infrared fluorescence for medical imaging. We don’t have any natural molecules in the body that fluoresce at these wavelengths, but if we could find a molecule that does and use it as a contrast agent, we could use harmless light for medical imaging.”

Indocyanine green, or ICG, fluoresces when illuminated with near-infrared light. Once a tiny amount of ICG is injected into the skin, the lymphatics draw the dye into the lymphatic vessels, through regional lymph nodes and beyond. When dim laser light illuminates tissue surfaces, the dye “lights” up, and NIRF-LI enables visualization of the ICG moving through the lymphatics, explains John Rasmussen, assistant professor at UTHealth. NIRF-LI can take pictures of this so quickly that it can image actual lymphatic flow.

The device is important because the lymphatics play a role in many diseases and conditions that are becoming more prevalent, including cancer, lymphedema, autoimmune diseases, asthma, chronic wounds, vascular disease and others.

Doctors typically check lymph nodes for cancer when removing tumors, but lymph nodes aren’t in exactly the same places in each person, so surgeons have to hunt for them. Once found, the lymph nodes are removed for biopsy to see whether they are cancerous. Eventually, using cancer-targeted imaging agents, NIRF-LI could be used for “image-guided lymph node dissection,” says Dr. Sevick, to determine whether they are cancerous before removing them.

Drs. Sevick and Rasmussen hope that they and their industrial partners, NIRF Imaging Inc., based in Montgomery, Texas, and Exelis Inc. of McLean, Virginia—the leading supplier of military night-vision goggles—will have NIRF-LI on the market as soon as next year.

Other futuristic devices aren’t linked to military technology. The MINIR robot, being developed by Jaydev P. Desai, professor of mechanical engineering and specializing in robotics at the University of Maryland, can remove brain tumors while causing minimal damage to healthy tissue. The robot is made of plastic so that it can be deployed in the brain while the patient is in a working MRI machine. A physician would view the brain and the robot on the MRI interface, and remotely control the robot toward the tumor. The robot would then electrocauterize the tumor and be guided back out.

The robot, whose prototype resembles a small finger, is called MINIR for “Minimally Invasive Neurosurgical Intracranial Robot.” Some tumors can’t be reached by common surgical approaches. “When surgeons try to get to a tumor, in the process you may cause trauma to normal brain tissue,” Dr. Desai says. “Our challenge is can we get to that location while minimizing the trauma and then can we get the tumor out.”

Another device Dr. Desai is working on is a special catheter. Physicians now use a catheter, which is thin and flexible, to get into the body, for example, into a vein.

What if you had the ability to control how to bend a thin robotic catheter with an integrated diagnostic or therapeutic device or both,” he says.

This steerable, robotic catheter could send in an optical coherence tomography probe for diagnostic imaging. That would let a surgeon better see what is happening inside the body. A catheter that can bend at a surgeon’s will “can get around structures in the body that you want to avoid,” Dr. Desai explains.

*For more from Catherine, contributors from the Economist Intelligence Unit along with industry experts, join The Future Realities discussion.

Designing for the Medical Device Industry: The Future – Connected Health

By Helene
Initially posted by CORE77

With the explosion of wearable technology and legislation like the Affordable Care Act, the medical product industry is rapidly evolving. Healthcare is seeing unprecedented changes, creating new opportunities for devices that connect consumers and doctors to information faster, easier, and more efficiently.

“It’s coming to a point where there are just amazing breakthroughs every day,” says Tor Alden, Principal and CEO at HS Design (HSD), where he has been directly involved in medical design for over 14 years. “[Technologists] are innovating and changing the landscape of how healthcare is going to be done to the point where we’re not going to recognize it in the next three or four years from where it is now.” It’s a changing landscape that has caught the eye of many innovative startups, who now make up half of HSD’s client list.

These new products have amazing technology, but it needs to be humanized and centered on user needs to be successful.”

HSD is positioning itself to be a bridge connecting the medical and healthcare startups with the investment banker communities. Alden predicts that if the growth continues at this rate, that number could be closer to 80% in the next few years.

The AliveCor heart monitor. Designed by Karten Design.

One of the factors opening the door for innovation in the medical device industry is the Affordable Care Act. As requirements roll out for health care providers, there is an increasing need for new tools and products that ensure patient compliance. Take a typical hip replacement, for example: Under the Affordable Care Act, if a doctor or hospital is not tracking the compliance and rehabilitation of that patient and they return within a year with no improvement, the hospital owes money to the government. There’s a financial incentive to make sure patients get better and, therefore, to track and evaluate their progress. This could spur invention around hip replacements—possibly leading to one with a chip (i.e., embedded UDI) to track rehabilitation or remind patients to get complete their physical therapy exercises.

“The Affordable Care Act is a great opportunity for the design community right now. Everybody is trying to figure out how to innovate increase patient compliance and allow caregivers tools to manage the healthcare services,” says Alden. “Between that and the iHealth generation of iPhones, smartphones, iPads, and everybody wanting to have more control over their healthcare knowledge, there’s a huge opportunity for new products.”

In the century of the wearable device, nearly everyone has some type of personal fitness tracker. For the medical device industry, this means a rise in connected health as consumers clamor to track everything from their steps to calories to sleep cycles. With that surge in technology comes an accelerated need for the design and development of interfaces between the technology and the consumer. “This is the most interesting space that a designer could work today. It’s fascinating,” shares Aidan Petrie, Co-Founder and Chief Innovation Officer of Ximedica, a medical product development company headquartered in Rhode Island. “We work between humans and the products they use and make sure that they are more usable, satisfactory and safer.”

Ideation & Concept Design

Despite the incentive for new and better products, the medical device industry remains a difficult niche to break into, due to FDA regulations, enormous amounts of capital required, the need for a high level of specialization, and timelines that span 2–6 years. All these factors contribute to a high failure rate, causing many of these projects to be cancelled before they even reach the prototype stage.

Dassault Systèmes is trying to lower that rate of failure by creating software applications that help these companies better understand and anticipate these challenges from the beginning of a project. The software company released an all-in-one program called Ideation & Concept Design for Medical Device industry solution experience, a cloud-based platform designed specifically to take a team through the entire product development process. From initial ideation and market research to verification and validation, the system tracks deliverables and traceable requirements demanded of the strict FDA and other regulations around this sector. With Ideation & Concept Design for Medical Device, Dassault Systèmes shortens the amount of time it takes to bring a product to market, which is critical in a quickly expanding market where there is no time to waste.

The medical device industry will explode for the next twenty years. It will be the place to be focused as a designer,” says Petrie. “It’s great doing things that change people’s lives, and a product can still look beautiful at the same time.”


Check out Beyond the design of the Medical Device to dig deeper into this topic and access the “Ideation & Concept Design for Medical Device” information kit here, over on Dassault Systèmes’ site:  Ideation & concept design for medical device.



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