Biological Materials Submission: Fill & Download for Free

Hi there,I am an IPR (Intellectual Property Rights) intern, In CSIR Innovation Protection Unit.In India, firstly, you can’t patent “an idea”, it should either a process or product( in some countries you can ). That is, you have to implement your idea (even a rough version will do), but it has to be working.“a mere scheme or rule or method of performing mental act or method of playing game; a presentation of information;” is not a patent-able subject matter.Submission of complete specification is necessary to obtain a patent. The contents of a complete specification would include the following :-1. Title of the invention.2. Field to which the invention belongs.3. Background of the invention including prior art giving drawbacks of the known inventions & practices.4. Complete description of the invention along with experimental results(in working examples).5. Drawings etc. essential for understanding the invention.6. Claims, which are statements related to the invention on which legal proprietorship is being sought. Therefore, the claims have to be drafted very carefully.7. Abstract of the invention.8. If a biological material is mentioned in a specification; then the source and geographical origin of the same is to be disclosed in the specification. For new biological material, registration number of the same given by an International Depositary Authority (IDA) is to be included in the specification along with its address. [Institute of Microbial Technology (IMTech), Chandigarh is a recognized IDA in India]Happy to help.:)

I think that the regulatory affairs agencies have been actively trying to navigate a path for this. Over the next few years, we should be expecting to see several submissions of cellular therapies notably pluripotent stem cells and the chimeric-antigen receptor T-cells (CAR-T).It is notable that CBER has written several guidance documents on cellular and genetic therapies as outlined in Cellular & Gene Therapy Products. The guidance documents are further described in Cellular & Gene Therapy Guidances. The ultimate guidance document on cellular therapeutics would be Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy.`It should be noted that the FDA wrote their major white pager on their proposal regulatory plan back in 1997.[1] That said, they generally get most of the key regulatory points right in the first go. In order of importance, the major concerns from the FDA's perspective with cellular therapies are:Direct transmission of communicable disease. The unwitting transfer of infectious diseases namely HIV and hepatitis.Processing concerns. There are process changes that may impact the safety of implanted tissues.Clinical safety and effectiveness concerns. Of course, there are the usual concerns with clinical safety and efficacy.For completeness: Promotion and labelingBaseline knowledge of the industryDisease ControlAs one can imagine, the transmission of diseases because of a cellular therapeutic is of great concern to the agency. The FDA breaks this up into three types of products. Surgical products removed from the patient and inserted back into the patient. Autologous products which are derived from the patient and stored away. Allogeneic products which are derived from a different patient.The autologous and allogeneic products are at risk of contamination from other sources, particularly viral contamination. As a result the viral control strategy is incredibly important. Surgical procedures are considered outside the scope of the FDA.Control of ProcessingThe manipulation of biological materials can introduce risk to the product which thus could alter the material's characteristics. Structural changes to the tissue would be considered minimal manipulations but changes that change the biological characteristics of the material would be considered more than minimally manipulated material.There are some distinctions between material that would be used for structural or non-structural purposes. For instance, the use of cartilage to repair a knee would be considered a homologous use of the tissue but using the cartilage for a different aspect of wound healing could be considered non-homologous use of the tissue. Tissues with a metabolic nature would fall under a different category.From a regulatory standpoint, the FDA would be interested in more than minimally manipulated materials. The use of those materials for non-homologous functions would be subject to CMC review.Clinical Safety and EfficacyA BLA would need to be submitted for biological products which undergo more than minimal manipulation, non-homologous use, or are mixed with products which are subject to these conditions. Biological products that have a metabolic component are subject to additional demonstration of clinical safety and efficacy.Japan is taking a slightly different approach to cellular product and they are treating these therapies as advanced-therapy medical products [2]There has been precedent for an approval for a cellular therapy. Provenge (sipuleucel-T) was approved for prostate cancer any while the drug isn't necessarily selling well, it did have a fairly good CMC package. It is a dose of 50 million CD54+ cells and the package has various rules on drug expiry, shipping and handling.Provenge has two manufacturing facilities, one in Seal Beach, CA and the other in Atlanta. In Europe, it uses a CMO PharmaCell and all of the facilities have been approved for manufacture. The FDA has a 80 page CMC review available. [3] In addition, their 65 page site inspection of the Morris Plains, NJ review is also available.[4]A huge chunk of the filing has been redacted but there are several elements that can be seen from the CMC review that examine the control of the manipulations, the potency of the product and the safety. The lot history is also included.Nature Biotecnology also has looked into establishing a Quality by Design guidance for cellular therapies. By examining a quality target product profile (QTPP), the critical quality attributes (CQAs) of the drug product can be established early and the risk factors of disease transmission and control of processing can be properly studied.The core CQAs that are expected for cGMP seem to be: Identity, Potency and Purity. From there, critical process parameters can be identified and this provides an opportunity to study the ranges of the critical process parameters that influence the CQAs through DoEs. From those studies, one can develop a control strategy which can be used for the CMC review.[5]With a clear understanding of what is expected from the FDA and other health authorities as well as precedent from cellular therapeutics via sipuleucel-T, one can see what is required to submit a successful BLA to the FDA. Unfortunately, gathering the CMC and clinical data will be a huge challenge and we'll have to see how companies handle the presentation of that data.Note, I am not a regulatory affairs expert and am certainly not your regulatory affairs expert. Consult your regulatory team if you want to use any of the above information.Footnotes[1] http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM062601.pdf[2] https://www.pmda.go.jp/files/000199721.pdf[3] http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM214287.pdf[4] http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM214542.pdf[5] http://www.nature.com/nbt/journal/v34/n4/full/nbt.3525.html (http://www.nature.com/nbt/journal/v34/n4/full/nbt.3525.html

Depends. There are different branches of feminism.Mainstream feminism (called liberal feminism by those outside of it) may be based on gender equality, or it may be based on equality of rights and protection under the law for all genders.Radical feminism is about abolishing gender, and liberating women from a system of power based opression. (“The Patriarchy” not to be confused with “men” or “all men” or even “powerful men.”)Gender=\=biological sex.Gender= Feminine, Masculine, Genderfluid, Transgender, GenderQueer, etc.Biological sex= Male, Female, intersex (how we, as a species, reproduce and the reproductive organs we are born with for that purpose)Gender is a power structure within which we are all socialized. Feminine traits are assigned to females and they emphasize and exaggerate traits that society had deemed are suitable to women- helplessness, weakness, passivity/reception, softness, submissiveness, etc. Masculine traits are assigned to males and they emphasize and exaggerate traits that society has deemed are suitable to men- strength, action, hardness, dominance, aggression, etc.Radical feminists do not focus on gender equality, but gender abolition (in other words- no enforced gender roles to maintain the power structure of male supremacy over females). What Radfems do acknowledge is that women throughout history and around the globe are subjigated based on their female biology, not their gender identity.Under this model, biological females seek to end the opression of everyone (male and female) under gender roles, and to end the subjugation of women under men, as individuals but also as a class.Radical feminism recognizes that gender roles are enforced (force, coercion) upon all of us, in order to maintain the power imballance (inequality of power). This is how equality is addressed- not by personal equality, but by equality of power. Meaning that the goal is for no sex class to have power (economic, legal, social, etc) over the other. If this were the case, women as a class as well as individual girls and women, would not be seen as and treated as inferior to men. Women would have equal power to make choices for their lives. But as it stands, women make choices from an unequal (subjigated) societal position, so their choices are actually a result of coercion- and are either “submission” or “resistance” rather than a neutral or “empowering” choice.So in that essence you can see that feminism has nothing to do with gender (“how one identifies”) equality. It is about women and girls biological material bodies and and the exploitation and jubilation thereof.