STEM Career Exploration Guide: Biomaterials and Regenerative Medicine

Definition

The biomaterials/regenerative medicine industry, usually lumped under the title of “biofabrication,” involves two separate, but overlapping areas of research:

Regenerative medicine is defined by therapies that are meant to regenerate or replace human cells to restore/establish typical function. This includes cell and gene therapies as well as scaffold placement and 3D-fabricated organs.

Biomaterials is a broader term, and encompasses any material, synthetic or biologic, that is used to reconstruct or replace tissues. This also includes tissue-like material that is derived from biology — currently that’s mainly fabrics and some plastics (more trendy, bio-art stuff). The definition is evolving, and some use it when describing biofuel/biochemical companies also.

Behaviors

• Non-therapeutic biomaterial companies are consumer-focused and act like tech startups
  • Often have strong marketing programs to appeal to consumer opinion, flashy websites to appeal to fashion brands
  • Most have not released mass-production methods but are working on batch-size clothing release
    • Participate in fashion industry, including showcases and art exhibitions

• Regenerative medicine companies exist in complex, highly-regulatory environments and number in the 10’s with respect to FDA approvals
  • Space is mixed with both large pharmaceutical companies and startups as well as medium-sized companies working in the space
  • Successful startups are bought in phase 1-2 of clinical trials if results are good; are then incorporated into themed product suites under label of “biologics”; tough to get preclinical approval to move into phase 1
  • Heavily connected to academia, vast majority of startups are associated with universities; rely on academic laboratories to perform preclinical testing, etc.
  • Cell therapy is the transplantation of viable cells into the body to replace diseased tissue; currently only a couple of dermatological cell therapies approved and 1-2 immune cell therapies for cancer
    • A natural progression of cell therapy is to assemble organs/tissues using these cells and place them in the body ⇒ biomaterials
  • Gene therapy is the use of viral vectors or gene delivery mechanisms to edit cell DNA directly in the body, correcting genetic disorders, cancer, etc.

• Biomaterials companies include organ and tissue fabrication companies, 3D bioprinting companies, and companies that make synthetic biomaterials to aid in tissue regeneration
  • Vast majority of pharmaceutical and medtech companies are looking to make investments in this field
    • Organ fabrication: involves tissue engineering, typically done with bioreactors OR 3D bioprinters; no full, functioning organ has ever been fabricated yet, and none have been approved
    • Tissue fabrication: can involve edited or non-edited cells (non-edited cells do not have to go through FDA approval process and are instead given a certification as a tissue bank); only two tissue fabrication therapies are approved, and these are for the skin (overlap with cell therapies). Edited cells go through tough regulatory process; some strides have been made in kidney, heart and lung tissue
    • Synthetic biomaterials/scaffolds: do not involve cells; rather, have webs of material that are implanted into the body and encourage cells to grow into it. Highly materials-science based vs. biology; companies have more regulatory flexibility. Had not been successful until the advent of 3D printers + new materials. (ex. Spider silk, types of plastic, collagen, hydrogel matrix)
    • Combination Products: involve both scaffolding and cells (engineered or non-engineered)
  • Most of the market currently taken by orthopedics (bone) because this is what products exist and are easiest to get approval for

Types of Roles Available

• Tissue Engineer/Materials Scientist/Research Associate: Research positions more specific than pharma/biotech — tissue or human-focused genetic engineering for non-synthetic therapeutics; materials science for synthetic therapeutics
• Clinical or Regulatory Affairs: Finds research laboratories to perform preclinical testing with; writes NIH, DARPA grants for preclinical testing; analyzes preclinical results and determines whether enough for FDA; keeps track of clinical trials within the company and of competitors
• Manufacturing and Quality Affairs: Mixture of mechanical, chemical and biological: how to scale up production processes to get a lot of product efficiently with low error
• Management: Working with investors, setting up collaborations/meetings with large pharmaceutical companies, establishing business plan

Valued Skills

• Strong laboratory or technical background: for regenerative medicine and tissue/organ fabrication, human cells and lentiviral modification as well as cellular biomechanics; for synthetic biomaterials, materials science
• For non-therapeutic biofabrication: creativity, design aptitude, chemical synthesis knowledge
• Organizational skills, efficiency, precision: good documentation is important

Relevant Companies

Therapies

Non-Therapies (i.e. consumer products)

Industry News to Follow/Professional Organizations to Join

• A16z Bio: Andreesen Horowitz has a large regenerative medicine portfolio and often writes about it in their biological fund newsletter.
• Alliance for Regenerative Medicine (ARM): Industry group for regenerative medicine companies, has member companies working in the field (good place for searching for companies)
• Advanced Regenerative Manufacturing Institute (armi): Similar to ARM but hosts more consumer-focused events; conferences on biofabrication
• Biofabricate: Collaborative to promote sustainable bio-based materials in fashion and consumer industry, releases reports and publications

Relevant Yale Majors/ Courses